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Could the biosimilar market stall before it ever really started?
NATIONAL HARBOR, MD. – If the United States does not step up and create a thriving biosimilars market soon, it risks destroying the market not only domestically but internationally as well.
This was the warning Gillian Woollett, senior vice president at Avalere, provided to attendees at the annual meeting of the Academy of Managed Care Pharmacy.
She prefaced her warning by quoting Alex Azar, secretary of Health & Human Services, who said that those “trying to hold back biosimilars are simply on the wrong side of history,” though Ms. Woollett said they “may be on the right side of the current economic model in the United States.”
And despite the probusiness, procompetition philosophy of current HHS leadership, there has been very little movement on creating a competitive market for biosimilars in the United States, evidenced by the very expensive regulatory requirements that biosimilar manufacturers need to meet in order to get products to market.
“It’s not that we won’t have competition in the U.S.,” she said. “I think we will. We do have that innovation. ... It’s just that biosimilars may not ultimately be part of that competition. And for that, we will pay a price, and I actually think the whole world will pay a price because if we are not providing the [return on investment], I am not sure the other markets can sustain it.”
One issue biosimilars have is the lack of recognition of the value that they bring.
“That biosimilars offer the same clinical outcomes at a lower price is yet to be a recognized value,” she said. “To me that’s a really surprising situation in the United States.”
Ms. Woollett disclosed no relevant conflicts of interest.
To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health care providers and patients about biosimilars and how they can be used for IBD patient care. Learn more at www.gastro.org/biosimilars.
NATIONAL HARBOR, MD. – If the United States does not step up and create a thriving biosimilars market soon, it risks destroying the market not only domestically but internationally as well.
This was the warning Gillian Woollett, senior vice president at Avalere, provided to attendees at the annual meeting of the Academy of Managed Care Pharmacy.
She prefaced her warning by quoting Alex Azar, secretary of Health & Human Services, who said that those “trying to hold back biosimilars are simply on the wrong side of history,” though Ms. Woollett said they “may be on the right side of the current economic model in the United States.”
And despite the probusiness, procompetition philosophy of current HHS leadership, there has been very little movement on creating a competitive market for biosimilars in the United States, evidenced by the very expensive regulatory requirements that biosimilar manufacturers need to meet in order to get products to market.
“It’s not that we won’t have competition in the U.S.,” she said. “I think we will. We do have that innovation. ... It’s just that biosimilars may not ultimately be part of that competition. And for that, we will pay a price, and I actually think the whole world will pay a price because if we are not providing the [return on investment], I am not sure the other markets can sustain it.”
One issue biosimilars have is the lack of recognition of the value that they bring.
“That biosimilars offer the same clinical outcomes at a lower price is yet to be a recognized value,” she said. “To me that’s a really surprising situation in the United States.”
Ms. Woollett disclosed no relevant conflicts of interest.
To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health care providers and patients about biosimilars and how they can be used for IBD patient care. Learn more at www.gastro.org/biosimilars.
NATIONAL HARBOR, MD. – If the United States does not step up and create a thriving biosimilars market soon, it risks destroying the market not only domestically but internationally as well.
This was the warning Gillian Woollett, senior vice president at Avalere, provided to attendees at the annual meeting of the Academy of Managed Care Pharmacy.
She prefaced her warning by quoting Alex Azar, secretary of Health & Human Services, who said that those “trying to hold back biosimilars are simply on the wrong side of history,” though Ms. Woollett said they “may be on the right side of the current economic model in the United States.”
And despite the probusiness, procompetition philosophy of current HHS leadership, there has been very little movement on creating a competitive market for biosimilars in the United States, evidenced by the very expensive regulatory requirements that biosimilar manufacturers need to meet in order to get products to market.
“It’s not that we won’t have competition in the U.S.,” she said. “I think we will. We do have that innovation. ... It’s just that biosimilars may not ultimately be part of that competition. And for that, we will pay a price, and I actually think the whole world will pay a price because if we are not providing the [return on investment], I am not sure the other markets can sustain it.”
One issue biosimilars have is the lack of recognition of the value that they bring.
“That biosimilars offer the same clinical outcomes at a lower price is yet to be a recognized value,” she said. “To me that’s a really surprising situation in the United States.”
Ms. Woollett disclosed no relevant conflicts of interest.
To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health care providers and patients about biosimilars and how they can be used for IBD patient care. Learn more at www.gastro.org/biosimilars.
Orthopedic ambulatory surgery centers beat inpatient services on cost
NATIONAL HARBOR, MD. – Hospital outpatient departments (HOPDs) and (IPs) with similar levels of postoperative opioid use, according to a new study.
Fanta Waterman, PhD, director of medical and health sciences at Pacira Pharmaceuticals, and colleagues retrospectively published the results of their investigation in the Journal of Managed Care & Specialty Pharmacy supplement for the annual meeting of the Academy of Managed Care Pharmacy.
Investigators evaluated data from 126,172 commercially insured patients who underwent one of six orthopedic surgical procedures between April 2012 and December 2017. Using the Optum Research Database, they pooled data from patients who had received total knee arthroplasty (TKA), partial knee arthroplasty, total hip arthroplasty (THA), rotator cuff repair (RCR), total shoulder arthroplasty, and lumbar spine fusion.
More than half (51%) of the patients were male, and the patients averaged 58 years of age. Most patients who underwent any of the six surgical interventions had the procedures performed at IPs (68%), while 18% had their operations at HOPDs and 14% were perfomed at ASCs.
TKA, RCR, and THA were the most common procedures performed (32%, 27%, and 20%, respectively). While no fluctuation was observed in the total number of IP procedures performed during 2012-2017, researchers noted a marked increase in ASCs (58%) and HOPDs (15%).
At the 30-day mark, the total all-cause postsurgical costs associated with IPs ($44,566) were more than double that of HOPDs ($20,468) and ASCs ($19,110; P less than .001). Moreover, multivariate adjustment showed that postsurgical costs accrued 30 days after surgery for HOPDs and ASCs were 14% and 27% lower than IPs (P less than .001), respectively.
Additionally, each group exhibited similar evidence of opioid use in the 12-month period prior to undergoing surgery, ranging from 63% to 65%. Postsurgical opioid use among opioid-naive patients was the highest in the HOPD group at 96% prevalence, with IPs and ASCs trailing with 91% and 90% (P less than .001), respectively. However, the postsurgical prevalence of opioid use in patients who had used opioids before surgery was 95% for IPs and HOPDs and 82% for ASCs (P less than .001).
SOURCE: Waterman F et al. AMCP NEXUS 2019, Abstract U12.
NATIONAL HARBOR, MD. – Hospital outpatient departments (HOPDs) and (IPs) with similar levels of postoperative opioid use, according to a new study.
Fanta Waterman, PhD, director of medical and health sciences at Pacira Pharmaceuticals, and colleagues retrospectively published the results of their investigation in the Journal of Managed Care & Specialty Pharmacy supplement for the annual meeting of the Academy of Managed Care Pharmacy.
Investigators evaluated data from 126,172 commercially insured patients who underwent one of six orthopedic surgical procedures between April 2012 and December 2017. Using the Optum Research Database, they pooled data from patients who had received total knee arthroplasty (TKA), partial knee arthroplasty, total hip arthroplasty (THA), rotator cuff repair (RCR), total shoulder arthroplasty, and lumbar spine fusion.
More than half (51%) of the patients were male, and the patients averaged 58 years of age. Most patients who underwent any of the six surgical interventions had the procedures performed at IPs (68%), while 18% had their operations at HOPDs and 14% were perfomed at ASCs.
TKA, RCR, and THA were the most common procedures performed (32%, 27%, and 20%, respectively). While no fluctuation was observed in the total number of IP procedures performed during 2012-2017, researchers noted a marked increase in ASCs (58%) and HOPDs (15%).
At the 30-day mark, the total all-cause postsurgical costs associated with IPs ($44,566) were more than double that of HOPDs ($20,468) and ASCs ($19,110; P less than .001). Moreover, multivariate adjustment showed that postsurgical costs accrued 30 days after surgery for HOPDs and ASCs were 14% and 27% lower than IPs (P less than .001), respectively.
Additionally, each group exhibited similar evidence of opioid use in the 12-month period prior to undergoing surgery, ranging from 63% to 65%. Postsurgical opioid use among opioid-naive patients was the highest in the HOPD group at 96% prevalence, with IPs and ASCs trailing with 91% and 90% (P less than .001), respectively. However, the postsurgical prevalence of opioid use in patients who had used opioids before surgery was 95% for IPs and HOPDs and 82% for ASCs (P less than .001).
SOURCE: Waterman F et al. AMCP NEXUS 2019, Abstract U12.
NATIONAL HARBOR, MD. – Hospital outpatient departments (HOPDs) and (IPs) with similar levels of postoperative opioid use, according to a new study.
Fanta Waterman, PhD, director of medical and health sciences at Pacira Pharmaceuticals, and colleagues retrospectively published the results of their investigation in the Journal of Managed Care & Specialty Pharmacy supplement for the annual meeting of the Academy of Managed Care Pharmacy.
Investigators evaluated data from 126,172 commercially insured patients who underwent one of six orthopedic surgical procedures between April 2012 and December 2017. Using the Optum Research Database, they pooled data from patients who had received total knee arthroplasty (TKA), partial knee arthroplasty, total hip arthroplasty (THA), rotator cuff repair (RCR), total shoulder arthroplasty, and lumbar spine fusion.
More than half (51%) of the patients were male, and the patients averaged 58 years of age. Most patients who underwent any of the six surgical interventions had the procedures performed at IPs (68%), while 18% had their operations at HOPDs and 14% were perfomed at ASCs.
TKA, RCR, and THA were the most common procedures performed (32%, 27%, and 20%, respectively). While no fluctuation was observed in the total number of IP procedures performed during 2012-2017, researchers noted a marked increase in ASCs (58%) and HOPDs (15%).
At the 30-day mark, the total all-cause postsurgical costs associated with IPs ($44,566) were more than double that of HOPDs ($20,468) and ASCs ($19,110; P less than .001). Moreover, multivariate adjustment showed that postsurgical costs accrued 30 days after surgery for HOPDs and ASCs were 14% and 27% lower than IPs (P less than .001), respectively.
Additionally, each group exhibited similar evidence of opioid use in the 12-month period prior to undergoing surgery, ranging from 63% to 65%. Postsurgical opioid use among opioid-naive patients was the highest in the HOPD group at 96% prevalence, with IPs and ASCs trailing with 91% and 90% (P less than .001), respectively. However, the postsurgical prevalence of opioid use in patients who had used opioids before surgery was 95% for IPs and HOPDs and 82% for ASCs (P less than .001).
SOURCE: Waterman F et al. AMCP NEXUS 2019, Abstract U12.
REPORTING FROM AMCP NEXUS 2019
Strategy critical to surviving drug shortages
NATIONAL HARBOR, MD. –
“Statistically speaking, there is no proof that patients are worse off from drug shortages,” Matt Grissinger, RPh, director of error-reporting programs at the Institute for Safe Medication Practices, told the audience at the annual conference of the Academy of Managed Care Pharmacy. The data and anecdotes he presented suggest the contrary.
As Mr. Grissinger pointed out, drug shortages can create a sequela of events that stress health care workers seeking to find the next-best available and most appropriate therapy for their patients. In the process, numerous medication-related errors can occur, resulting in patient harm, including adverse drug events and even death.
One potential problems is erroneous or inappropriate drug substitution stemming from mis- or uncalculated doses because of factors such as incorrect labeling and lack of knowledge regarding acceptable therapeutic interchanges. Other potential errors include non–therapeutically equivalent drug substitutions, resulting in supraoptimal therapy or overdoses, and unfamiliarity with drug labeling from outsourced facilities.
As a result, patients may experience worse outcomes as a consequence of the drug shortage: Worsening of the disease, disease prolongation, side effects stemming from alternative drug selections, untreated pain, psychological effects, severe electrolyte imbalances, severe acid/base imbalances, and death.
While a paper trail can help piece together clues regarding how a medication error occurred, documentation or lack thereof can also introduce errors when drug shortages occur.
Any changes to a drug order or prescription that deviate from the prescriber’s original request require prescriber approval but can still create opportunities for error. While documenting these changes and updating labeling is essential, appropriate documentation does not always occur and raises the question of who is responsible for making such changes.
Drug shortages also challenge a clinician’s professional judgment. Mr. Grissinger cited an example in which a nurse used half of a 0.5-mg single-use vial of promethazine for a patient requiring a 0.25 mg dose. The nurse wrote on the label that the remainder should be saved. While the vial was manufactured for one-time use, whether to discard the unused contents in a situation of drug shortages required the nurse to make a judgment call. In this case, the nurse chose to save the balance of the drug – a choice Mr. Grissinger stated he might have made had he been in a similar situation.
Additionally, drug shortages can create a climate in which more ethical questions arise – especially with regard to disease states such as cancer.
“If you only have 10 vials of vincristine, who gets it?” Mr. Grissinger asked the audience.
To help answer these difficult life-or-death questions, hospital settings need to engage the ethics committees and social workers.
While education plays a vital role in bringing attention to and addressing errors stemming from drug shortages, Mr. Grissinger cautioned the audience not to rely on education as the solution.
“Education is a poor strategy for addressing drug shortages,” he said. While education can draw awareness to drug shortages and subsequent medication-related errors, Mr. Grissinger recommends that organizations implement strategies to help ameliorate the havoc created by drug shortages.
Drug shortage assessment checklists can help organizations evaluate the impact of shortages by verifying inventory, and proactively searching for alternatives. From there, they can enact strategies such as assigning priority to patients who have the greatest need, altering packaging and concentrations, and finding suitable therapeutic substitutions.
NATIONAL HARBOR, MD. –
“Statistically speaking, there is no proof that patients are worse off from drug shortages,” Matt Grissinger, RPh, director of error-reporting programs at the Institute for Safe Medication Practices, told the audience at the annual conference of the Academy of Managed Care Pharmacy. The data and anecdotes he presented suggest the contrary.
As Mr. Grissinger pointed out, drug shortages can create a sequela of events that stress health care workers seeking to find the next-best available and most appropriate therapy for their patients. In the process, numerous medication-related errors can occur, resulting in patient harm, including adverse drug events and even death.
One potential problems is erroneous or inappropriate drug substitution stemming from mis- or uncalculated doses because of factors such as incorrect labeling and lack of knowledge regarding acceptable therapeutic interchanges. Other potential errors include non–therapeutically equivalent drug substitutions, resulting in supraoptimal therapy or overdoses, and unfamiliarity with drug labeling from outsourced facilities.
As a result, patients may experience worse outcomes as a consequence of the drug shortage: Worsening of the disease, disease prolongation, side effects stemming from alternative drug selections, untreated pain, psychological effects, severe electrolyte imbalances, severe acid/base imbalances, and death.
While a paper trail can help piece together clues regarding how a medication error occurred, documentation or lack thereof can also introduce errors when drug shortages occur.
Any changes to a drug order or prescription that deviate from the prescriber’s original request require prescriber approval but can still create opportunities for error. While documenting these changes and updating labeling is essential, appropriate documentation does not always occur and raises the question of who is responsible for making such changes.
Drug shortages also challenge a clinician’s professional judgment. Mr. Grissinger cited an example in which a nurse used half of a 0.5-mg single-use vial of promethazine for a patient requiring a 0.25 mg dose. The nurse wrote on the label that the remainder should be saved. While the vial was manufactured for one-time use, whether to discard the unused contents in a situation of drug shortages required the nurse to make a judgment call. In this case, the nurse chose to save the balance of the drug – a choice Mr. Grissinger stated he might have made had he been in a similar situation.
Additionally, drug shortages can create a climate in which more ethical questions arise – especially with regard to disease states such as cancer.
“If you only have 10 vials of vincristine, who gets it?” Mr. Grissinger asked the audience.
To help answer these difficult life-or-death questions, hospital settings need to engage the ethics committees and social workers.
While education plays a vital role in bringing attention to and addressing errors stemming from drug shortages, Mr. Grissinger cautioned the audience not to rely on education as the solution.
“Education is a poor strategy for addressing drug shortages,” he said. While education can draw awareness to drug shortages and subsequent medication-related errors, Mr. Grissinger recommends that organizations implement strategies to help ameliorate the havoc created by drug shortages.
Drug shortage assessment checklists can help organizations evaluate the impact of shortages by verifying inventory, and proactively searching for alternatives. From there, they can enact strategies such as assigning priority to patients who have the greatest need, altering packaging and concentrations, and finding suitable therapeutic substitutions.
NATIONAL HARBOR, MD. –
“Statistically speaking, there is no proof that patients are worse off from drug shortages,” Matt Grissinger, RPh, director of error-reporting programs at the Institute for Safe Medication Practices, told the audience at the annual conference of the Academy of Managed Care Pharmacy. The data and anecdotes he presented suggest the contrary.
As Mr. Grissinger pointed out, drug shortages can create a sequela of events that stress health care workers seeking to find the next-best available and most appropriate therapy for their patients. In the process, numerous medication-related errors can occur, resulting in patient harm, including adverse drug events and even death.
One potential problems is erroneous or inappropriate drug substitution stemming from mis- or uncalculated doses because of factors such as incorrect labeling and lack of knowledge regarding acceptable therapeutic interchanges. Other potential errors include non–therapeutically equivalent drug substitutions, resulting in supraoptimal therapy or overdoses, and unfamiliarity with drug labeling from outsourced facilities.
As a result, patients may experience worse outcomes as a consequence of the drug shortage: Worsening of the disease, disease prolongation, side effects stemming from alternative drug selections, untreated pain, psychological effects, severe electrolyte imbalances, severe acid/base imbalances, and death.
While a paper trail can help piece together clues regarding how a medication error occurred, documentation or lack thereof can also introduce errors when drug shortages occur.
Any changes to a drug order or prescription that deviate from the prescriber’s original request require prescriber approval but can still create opportunities for error. While documenting these changes and updating labeling is essential, appropriate documentation does not always occur and raises the question of who is responsible for making such changes.
Drug shortages also challenge a clinician’s professional judgment. Mr. Grissinger cited an example in which a nurse used half of a 0.5-mg single-use vial of promethazine for a patient requiring a 0.25 mg dose. The nurse wrote on the label that the remainder should be saved. While the vial was manufactured for one-time use, whether to discard the unused contents in a situation of drug shortages required the nurse to make a judgment call. In this case, the nurse chose to save the balance of the drug – a choice Mr. Grissinger stated he might have made had he been in a similar situation.
Additionally, drug shortages can create a climate in which more ethical questions arise – especially with regard to disease states such as cancer.
“If you only have 10 vials of vincristine, who gets it?” Mr. Grissinger asked the audience.
To help answer these difficult life-or-death questions, hospital settings need to engage the ethics committees and social workers.
While education plays a vital role in bringing attention to and addressing errors stemming from drug shortages, Mr. Grissinger cautioned the audience not to rely on education as the solution.
“Education is a poor strategy for addressing drug shortages,” he said. While education can draw awareness to drug shortages and subsequent medication-related errors, Mr. Grissinger recommends that organizations implement strategies to help ameliorate the havoc created by drug shortages.
Drug shortage assessment checklists can help organizations evaluate the impact of shortages by verifying inventory, and proactively searching for alternatives. From there, they can enact strategies such as assigning priority to patients who have the greatest need, altering packaging and concentrations, and finding suitable therapeutic substitutions.
REPORTING FROM AMCP NEXUS 2019
Could the biosimilar market stall before it ever really started?
NATIONAL HARBOR, MD. – If the United States does not step up and create a thriving biosimilars market soon, it risks destroying the market not only domestically but internationally as well.
This was the warning Gillian Woollett, senior vice president at Avalere, provided to attendees at the annual meeting of the Academy of Managed Care Pharmacy.
She prefaced her warning by quoting Alex Azar, secretary of Health & Human Services, who said that those “trying to hold back biosimilars are simply on the wrong side of history,” though Ms. Woollett said they “may be on the right side of the current economic model in the United States.”
And despite the probusiness, procompetition philosophy of current HHS leadership, there has been very little movement on creating a competitive market for biosimilars in the United States, evidenced by the very expensive regulatory requirements that biosimilar manufacturers need to meet in order to get products to market.
“It’s not that we won’t have competition in the U.S.,” she said. “I think we will. We do have that innovation. ... It’s just that biosimilars may not ultimately be part of that competition. And for that, we will pay a price, and I actually think the whole world will pay a price because if we are not providing the [return on investment], I am not sure the other markets can sustain it.”
One issue biosimilars have is the lack of recognition of the value that they bring.
“That biosimilars offer the same clinical outcomes at a lower price is yet to be a recognized value,” she said. “To me that’s a really surprising situation in the United States.”
Ms. Woollett continued: “It’s not even acknowledged as a basic truth in the United States, which again suggests the business model may not be there for biosimilars.”
Ms. Woollett disclosed no conflicts of interest relevant to her presentation.
NATIONAL HARBOR, MD. – If the United States does not step up and create a thriving biosimilars market soon, it risks destroying the market not only domestically but internationally as well.
This was the warning Gillian Woollett, senior vice president at Avalere, provided to attendees at the annual meeting of the Academy of Managed Care Pharmacy.
She prefaced her warning by quoting Alex Azar, secretary of Health & Human Services, who said that those “trying to hold back biosimilars are simply on the wrong side of history,” though Ms. Woollett said they “may be on the right side of the current economic model in the United States.”
And despite the probusiness, procompetition philosophy of current HHS leadership, there has been very little movement on creating a competitive market for biosimilars in the United States, evidenced by the very expensive regulatory requirements that biosimilar manufacturers need to meet in order to get products to market.
“It’s not that we won’t have competition in the U.S.,” she said. “I think we will. We do have that innovation. ... It’s just that biosimilars may not ultimately be part of that competition. And for that, we will pay a price, and I actually think the whole world will pay a price because if we are not providing the [return on investment], I am not sure the other markets can sustain it.”
One issue biosimilars have is the lack of recognition of the value that they bring.
“That biosimilars offer the same clinical outcomes at a lower price is yet to be a recognized value,” she said. “To me that’s a really surprising situation in the United States.”
Ms. Woollett continued: “It’s not even acknowledged as a basic truth in the United States, which again suggests the business model may not be there for biosimilars.”
Ms. Woollett disclosed no conflicts of interest relevant to her presentation.
NATIONAL HARBOR, MD. – If the United States does not step up and create a thriving biosimilars market soon, it risks destroying the market not only domestically but internationally as well.
This was the warning Gillian Woollett, senior vice president at Avalere, provided to attendees at the annual meeting of the Academy of Managed Care Pharmacy.
She prefaced her warning by quoting Alex Azar, secretary of Health & Human Services, who said that those “trying to hold back biosimilars are simply on the wrong side of history,” though Ms. Woollett said they “may be on the right side of the current economic model in the United States.”
And despite the probusiness, procompetition philosophy of current HHS leadership, there has been very little movement on creating a competitive market for biosimilars in the United States, evidenced by the very expensive regulatory requirements that biosimilar manufacturers need to meet in order to get products to market.
“It’s not that we won’t have competition in the U.S.,” she said. “I think we will. We do have that innovation. ... It’s just that biosimilars may not ultimately be part of that competition. And for that, we will pay a price, and I actually think the whole world will pay a price because if we are not providing the [return on investment], I am not sure the other markets can sustain it.”
One issue biosimilars have is the lack of recognition of the value that they bring.
“That biosimilars offer the same clinical outcomes at a lower price is yet to be a recognized value,” she said. “To me that’s a really surprising situation in the United States.”
Ms. Woollett continued: “It’s not even acknowledged as a basic truth in the United States, which again suggests the business model may not be there for biosimilars.”
Ms. Woollett disclosed no conflicts of interest relevant to her presentation.
REPORTING FROM AMCP NEXUS 2019
The challenges of contracting for value, not volume in prescription drugs
NATIONAL HARBOR, MD. – Paying for value over volume is being seen as a key part of driving down the cost of prescription drugs. But setting up value-based contracts can be a challenge.
“In Utah, we thought we would be an appropriate laboratory to try and figure out, ‘Is there a way that we can do this different?’ ” Diana Brixner, PhD, of the University of Utah, Salt Lake City, said at the annual meeting of the Academy of Managed Care Pharmacy. “How can we be creative and have alternatives to high-deductible plans in Utah through value-based–type programs?”
The state considered three different options, she noted. The first option was value-based drug coverage, which pays for only those drugs that are deemed valuable by an independent source. Uptake on these types of contracts has been slow, Dr. Brixner noted, particularly as patient advocates have argued that some drugs may not be cost effective but are still the best choice for certain patients. In those cases, value-based drug coverage has the potential to hinder access.
“There are certainly still different areas and issues that need to be worked out, but in concept, this could potentially help the solution of getting more affordable care to patients,” Dr. Brixner said.
The second option is outcomes-based contracting, which involves working with manufacturers to determine appropriate disease states with vetted outcomes measures and building pharmacy contracts around them.
“We are very optimistic about the potential for outcomes-based contracting as well,” Dr. Brixner said.
CVS has looked into zero copays for preventive medicines, Dr. Brixner said. She added that studies have shown the potential for millions in savings from these kinds of arrangements.
But there are concerns with all of these designs. Drug manufacturers, for instance, have concerns about getting accurate data to determine the payment parameters. Another concern from the manufacturer side is the inability to discuss information about off-label drug use that could be important to negotiating a value-based contract.
For payers, a key concern is making sure there are measurable outcomes, as well as appropriate risk sharing.
In the end, different conditions lend themselves to different types of value-based contracting, Dr. Brixner said. For example, multiple sclerosis is better suited to a value-based drug coverage contract, while rheumatoid arthritis fits better in an outcomes-based contracting design.
Kenneth Schaecher, MD, associate chief medical officer of the University of Utah Health Plan, highlighted some of the challenges of value-based care from a payer perspective, including determining outcomes to use in contracts.
“One of the challenges that we get is trying to decide what is a measure that is important to both the health plans and the patients and the providers,” he said. “If the measure is not reflective of an outcome relative to those, it is going to be very hard to impact it” through a value-based contract. He noted that patient-reported outcomes do not work well in value-based contracts.
The timeliness of the data can also present a challenge, especially when factoring in member turnover from health plans.
But there are examples of success, he noted. Dr. Schaecher highlighted a few examples, including an outcomes-based contract between Cigna and Merck for Januvia and Janumet, which included higher discounts for improvements in hemoglobin A1c across the insured population. Additional discounts were offered if adherence improved. And if both outcomes and adherence improved, Cigna would move the drugs to formulary tiers with lower copays.
NATIONAL HARBOR, MD. – Paying for value over volume is being seen as a key part of driving down the cost of prescription drugs. But setting up value-based contracts can be a challenge.
“In Utah, we thought we would be an appropriate laboratory to try and figure out, ‘Is there a way that we can do this different?’ ” Diana Brixner, PhD, of the University of Utah, Salt Lake City, said at the annual meeting of the Academy of Managed Care Pharmacy. “How can we be creative and have alternatives to high-deductible plans in Utah through value-based–type programs?”
The state considered three different options, she noted. The first option was value-based drug coverage, which pays for only those drugs that are deemed valuable by an independent source. Uptake on these types of contracts has been slow, Dr. Brixner noted, particularly as patient advocates have argued that some drugs may not be cost effective but are still the best choice for certain patients. In those cases, value-based drug coverage has the potential to hinder access.
“There are certainly still different areas and issues that need to be worked out, but in concept, this could potentially help the solution of getting more affordable care to patients,” Dr. Brixner said.
The second option is outcomes-based contracting, which involves working with manufacturers to determine appropriate disease states with vetted outcomes measures and building pharmacy contracts around them.
“We are very optimistic about the potential for outcomes-based contracting as well,” Dr. Brixner said.
CVS has looked into zero copays for preventive medicines, Dr. Brixner said. She added that studies have shown the potential for millions in savings from these kinds of arrangements.
But there are concerns with all of these designs. Drug manufacturers, for instance, have concerns about getting accurate data to determine the payment parameters. Another concern from the manufacturer side is the inability to discuss information about off-label drug use that could be important to negotiating a value-based contract.
For payers, a key concern is making sure there are measurable outcomes, as well as appropriate risk sharing.
In the end, different conditions lend themselves to different types of value-based contracting, Dr. Brixner said. For example, multiple sclerosis is better suited to a value-based drug coverage contract, while rheumatoid arthritis fits better in an outcomes-based contracting design.
Kenneth Schaecher, MD, associate chief medical officer of the University of Utah Health Plan, highlighted some of the challenges of value-based care from a payer perspective, including determining outcomes to use in contracts.
“One of the challenges that we get is trying to decide what is a measure that is important to both the health plans and the patients and the providers,” he said. “If the measure is not reflective of an outcome relative to those, it is going to be very hard to impact it” through a value-based contract. He noted that patient-reported outcomes do not work well in value-based contracts.
The timeliness of the data can also present a challenge, especially when factoring in member turnover from health plans.
But there are examples of success, he noted. Dr. Schaecher highlighted a few examples, including an outcomes-based contract between Cigna and Merck for Januvia and Janumet, which included higher discounts for improvements in hemoglobin A1c across the insured population. Additional discounts were offered if adherence improved. And if both outcomes and adherence improved, Cigna would move the drugs to formulary tiers with lower copays.
NATIONAL HARBOR, MD. – Paying for value over volume is being seen as a key part of driving down the cost of prescription drugs. But setting up value-based contracts can be a challenge.
“In Utah, we thought we would be an appropriate laboratory to try and figure out, ‘Is there a way that we can do this different?’ ” Diana Brixner, PhD, of the University of Utah, Salt Lake City, said at the annual meeting of the Academy of Managed Care Pharmacy. “How can we be creative and have alternatives to high-deductible plans in Utah through value-based–type programs?”
The state considered three different options, she noted. The first option was value-based drug coverage, which pays for only those drugs that are deemed valuable by an independent source. Uptake on these types of contracts has been slow, Dr. Brixner noted, particularly as patient advocates have argued that some drugs may not be cost effective but are still the best choice for certain patients. In those cases, value-based drug coverage has the potential to hinder access.
“There are certainly still different areas and issues that need to be worked out, but in concept, this could potentially help the solution of getting more affordable care to patients,” Dr. Brixner said.
The second option is outcomes-based contracting, which involves working with manufacturers to determine appropriate disease states with vetted outcomes measures and building pharmacy contracts around them.
“We are very optimistic about the potential for outcomes-based contracting as well,” Dr. Brixner said.
CVS has looked into zero copays for preventive medicines, Dr. Brixner said. She added that studies have shown the potential for millions in savings from these kinds of arrangements.
But there are concerns with all of these designs. Drug manufacturers, for instance, have concerns about getting accurate data to determine the payment parameters. Another concern from the manufacturer side is the inability to discuss information about off-label drug use that could be important to negotiating a value-based contract.
For payers, a key concern is making sure there are measurable outcomes, as well as appropriate risk sharing.
In the end, different conditions lend themselves to different types of value-based contracting, Dr. Brixner said. For example, multiple sclerosis is better suited to a value-based drug coverage contract, while rheumatoid arthritis fits better in an outcomes-based contracting design.
Kenneth Schaecher, MD, associate chief medical officer of the University of Utah Health Plan, highlighted some of the challenges of value-based care from a payer perspective, including determining outcomes to use in contracts.
“One of the challenges that we get is trying to decide what is a measure that is important to both the health plans and the patients and the providers,” he said. “If the measure is not reflective of an outcome relative to those, it is going to be very hard to impact it” through a value-based contract. He noted that patient-reported outcomes do not work well in value-based contracts.
The timeliness of the data can also present a challenge, especially when factoring in member turnover from health plans.
But there are examples of success, he noted. Dr. Schaecher highlighted a few examples, including an outcomes-based contract between Cigna and Merck for Januvia and Janumet, which included higher discounts for improvements in hemoglobin A1c across the insured population. Additional discounts were offered if adherence improved. And if both outcomes and adherence improved, Cigna would move the drugs to formulary tiers with lower copays.
REPORTING FROM AMCP NEXUS 2019
Technology softens prior authorization pain points
NATIONAL HARBOR, MD. – Nebulous pricing associated with prior authorization continues to be a major pain point for health care professionals, but this may become a thing of the past – thanks to a technology called real-time pharmacy benefit.
Real-time pharmacy benefits (RTPB) is software or a software component that allows practicing clinicians to look up a patient’s out-of-pocket costs for a specific drug, regardless of the patient’s health insurance coverage. Users can see the costs, copayment, and deductible for branded and generic, as well as compare insurance costs versus cash pricing.
Lindsey Colbert, RN, program manager for care team efficiency at HealthPartners, and Leann McDowell, PharmD, supervisor, pharmacy utilization management at HealthPartners, investigated how integrating RTPB software into their existing platforms and operations could help address pricing nuances and their associated burden on patients and health care professionals. They presented the results of their pilot test and post–pilot test expansion at the annual meeting of the Academy of Managed Care Pharmacy.
“Historically, clinicians were told not to quote prices, because having numerous insurance plans made it difficult to know what was going to be covered,” Ms. Colbert said. “Now, with real-time benefits, clinicians have pricing information readily available to them.”
HealthPartners pilot-tested RTPB at two locations before expanding to additional sites. They found that integrating real-time pharmacy benefits information improved the user experience and added cost savings for patients while improving workflow efficiency.
Health care professionals were more like to use RTPB for inquiries when the perceived patient cost was $50 or more – a price many clinicians perceive to be too expensive for many patients.
Before RTPB implementation, participating health care professionals reported waiting at least 45 minutes to get pricing on drugs requiring prior authorization. Integrating the RTPB software shaved the wait time down to 4 minutes – allowing them to quote drug prices to patients at the point of service.
Despite the benefits, everyone is not on board with RTPB.
Health care professionals already feel burdened by the information requirements of their electronic health records systems. They “count the number of computer clicks they have to make, so getting them to make an additional click to use RTPB requires another buy-in,” Ms. Colbert said.
While participating health care professionals were asked to run every prescription through RTPB, they reported using the software only when they knew a patient would either perceive cost as a potential barrier, or if they knew a drug would be expensive.
Investigators said they plan to continue working with clinicians to make RTPB integration more user-friendly by eventually eliminating the additional computer click required to run the program. They also plan to monitor the progress of the National Council for Prescription Drug Programs – developer of RTPB – regarding its adaptation of its new standard.
NATIONAL HARBOR, MD. – Nebulous pricing associated with prior authorization continues to be a major pain point for health care professionals, but this may become a thing of the past – thanks to a technology called real-time pharmacy benefit.
Real-time pharmacy benefits (RTPB) is software or a software component that allows practicing clinicians to look up a patient’s out-of-pocket costs for a specific drug, regardless of the patient’s health insurance coverage. Users can see the costs, copayment, and deductible for branded and generic, as well as compare insurance costs versus cash pricing.
Lindsey Colbert, RN, program manager for care team efficiency at HealthPartners, and Leann McDowell, PharmD, supervisor, pharmacy utilization management at HealthPartners, investigated how integrating RTPB software into their existing platforms and operations could help address pricing nuances and their associated burden on patients and health care professionals. They presented the results of their pilot test and post–pilot test expansion at the annual meeting of the Academy of Managed Care Pharmacy.
“Historically, clinicians were told not to quote prices, because having numerous insurance plans made it difficult to know what was going to be covered,” Ms. Colbert said. “Now, with real-time benefits, clinicians have pricing information readily available to them.”
HealthPartners pilot-tested RTPB at two locations before expanding to additional sites. They found that integrating real-time pharmacy benefits information improved the user experience and added cost savings for patients while improving workflow efficiency.
Health care professionals were more like to use RTPB for inquiries when the perceived patient cost was $50 or more – a price many clinicians perceive to be too expensive for many patients.
Before RTPB implementation, participating health care professionals reported waiting at least 45 minutes to get pricing on drugs requiring prior authorization. Integrating the RTPB software shaved the wait time down to 4 minutes – allowing them to quote drug prices to patients at the point of service.
Despite the benefits, everyone is not on board with RTPB.
Health care professionals already feel burdened by the information requirements of their electronic health records systems. They “count the number of computer clicks they have to make, so getting them to make an additional click to use RTPB requires another buy-in,” Ms. Colbert said.
While participating health care professionals were asked to run every prescription through RTPB, they reported using the software only when they knew a patient would either perceive cost as a potential barrier, or if they knew a drug would be expensive.
Investigators said they plan to continue working with clinicians to make RTPB integration more user-friendly by eventually eliminating the additional computer click required to run the program. They also plan to monitor the progress of the National Council for Prescription Drug Programs – developer of RTPB – regarding its adaptation of its new standard.
NATIONAL HARBOR, MD. – Nebulous pricing associated with prior authorization continues to be a major pain point for health care professionals, but this may become a thing of the past – thanks to a technology called real-time pharmacy benefit.
Real-time pharmacy benefits (RTPB) is software or a software component that allows practicing clinicians to look up a patient’s out-of-pocket costs for a specific drug, regardless of the patient’s health insurance coverage. Users can see the costs, copayment, and deductible for branded and generic, as well as compare insurance costs versus cash pricing.
Lindsey Colbert, RN, program manager for care team efficiency at HealthPartners, and Leann McDowell, PharmD, supervisor, pharmacy utilization management at HealthPartners, investigated how integrating RTPB software into their existing platforms and operations could help address pricing nuances and their associated burden on patients and health care professionals. They presented the results of their pilot test and post–pilot test expansion at the annual meeting of the Academy of Managed Care Pharmacy.
“Historically, clinicians were told not to quote prices, because having numerous insurance plans made it difficult to know what was going to be covered,” Ms. Colbert said. “Now, with real-time benefits, clinicians have pricing information readily available to them.”
HealthPartners pilot-tested RTPB at two locations before expanding to additional sites. They found that integrating real-time pharmacy benefits information improved the user experience and added cost savings for patients while improving workflow efficiency.
Health care professionals were more like to use RTPB for inquiries when the perceived patient cost was $50 or more – a price many clinicians perceive to be too expensive for many patients.
Before RTPB implementation, participating health care professionals reported waiting at least 45 minutes to get pricing on drugs requiring prior authorization. Integrating the RTPB software shaved the wait time down to 4 minutes – allowing them to quote drug prices to patients at the point of service.
Despite the benefits, everyone is not on board with RTPB.
Health care professionals already feel burdened by the information requirements of their electronic health records systems. They “count the number of computer clicks they have to make, so getting them to make an additional click to use RTPB requires another buy-in,” Ms. Colbert said.
While participating health care professionals were asked to run every prescription through RTPB, they reported using the software only when they knew a patient would either perceive cost as a potential barrier, or if they knew a drug would be expensive.
Investigators said they plan to continue working with clinicians to make RTPB integration more user-friendly by eventually eliminating the additional computer click required to run the program. They also plan to monitor the progress of the National Council for Prescription Drug Programs – developer of RTPB – regarding its adaptation of its new standard.
REPORTING FROM AMCP NEXUS 2019
Get ready for changes in polypharmacy quality ratings
NATIONAL HARBOR, MD. – and managed care organizations should start preparing now for the shift.
Panelists at an Oct. 30 session at the annual meeting of the Academy of Managed Care Pharmacy presented strategies for addressing the three areas of polypharmacy that will be tracked in the new rating system, which will replace the current high-risk medication measurement that is being retired this year.
Anticholinergic medications
The first area presented by the panelists was polypharmacy use of multiple anticholinergic medications in older adults (Poly-ACH). The new quality measure will examine the percentage of members aged 65 years or older who are using two or more anticholinergic medications concurrently.
“We know that anticholinergic burden increases the risk of cognitive decline in particular, but it’s also associated with a higher risk of falls, an increased number of hospitalizations, and [diminished] physical function,” said Marti Groeneweg, PharmD, supervisor of clinical pharmacy services at Kaiser Permanente.
Dr. Groeneweg noted that, in addition to using multiple drugs in this class, patients can also benefit from a decrease in the dosage of their drugs, so that should also be considered in managing the medication of beneficiaries.
She highlighted a program Kaiser Permanente started in the Northwest United States to reduce the concurrent use of these drugs. The program targeted tricyclic antidepressants – nortriptyline, in particular.
The company instituted a multipronged approach that included provider detailing of the risks of using multiple drugs and how they could taper schedules, as well as providing them with other supporting resources and a list of safer, alternative drugs. It also reached out to patients to educate them about the risks of their medications and why it was important for them to taper their medications. The third part of the approach was to use the EHR to provide doctors with the best-available information at the point of prescribing. And finally, there was a pharmacist review process put in place for more complex cases.
Dr. Groeneweg emphasized that this information was incorporated into existing programs.
The intervention, which is fairly new, has not been in place long enough to know exactly how well it is working, but early indicators suggest “we are on the right track,” she said, noting that to date there has been a decrease of 28% in the number of tricyclic antidepressant prescriptions per 1,000 Medicare members per month.
CNS medications
The second area the panelists addressed was the polypharmacy use of multiple CNS-active medications in older adults (Poly-CNS).
Rainelle Gaddy, PharmD, Rx clinical programs pharmacy lead at Humana Pharmacy Solutions, , noted that the clinical rationale for this measure was the “increased risk of falls and fractures when these medications are taken concurrently.”
She pointed out that taking one or more of the CNS medications can result in a 1.5-fold increase in the risk for falls, and that risk increases to 2.5-fold if two or more drugs are taken. In addition, a high-dose of these medications can lead to a threefold increase in risk of recurrent falls.
Dr. Gaddy highlighted a number of interventions that could be implemented when the managed care organization is not integrated in the way Kaiser Permanente is.
“Pharmacists can pay a pivotal role [in helping] patients who are receiving these Poly-CNS medications because they are able to interact and talk through the actual patient picture for all their medications ... because pharmacists have always been seen as being a trusted source,” she said.
Dr. Gaddy added that health plans can take a more direct role in reaching out to patients, for example, through telephone outreach, as well as direct mail, email, and newsletters.
“We want to make sure that members have as much information as possible,” she said.
She added that it is very important to include physicians and other prescribers in this process through faxes and information included in EHRs.
Opioids and benzodiazepines
The final measure highlighted during the session was the one measuring the concurrent use of opioids and benzodiazepines.
Dr. Gaddy noted that taking the two concurrently is associated with a fourfold increase in risk of opioid overdose and death, compared with opioid use without a benzodiazepine.
She noted that a black box warning on the risks of concurrent use was added to both opioids and benzodiazepines in August 2016 and that resulted in a 10% decrease in the concurrent use.
“This new measure is intended to ensure that the downward trend continues. CMS has indicated as such,” Dr. Gaddy said.
Most of the intervention strategies she highlighted were similar to those for the Poly-CNS category, including the use of medication therapy management programs and targeted interventions, telephone outreach to members, and provider detailing and outreach.
“Provider detailing is really key,” Dr. Gaddy said. “On any given day, it’s so easy for physicians to see 30 patients. The great thing about the provider detailing is that you are able to give the provider a ‘packet’ of their members, you can identify and/or aid in showing them the risk assessment associated with members taking these medications, and then equip them with pocket guides and [materials so they can] streamline the medications.”
NATIONAL HARBOR, MD. – and managed care organizations should start preparing now for the shift.
Panelists at an Oct. 30 session at the annual meeting of the Academy of Managed Care Pharmacy presented strategies for addressing the three areas of polypharmacy that will be tracked in the new rating system, which will replace the current high-risk medication measurement that is being retired this year.
Anticholinergic medications
The first area presented by the panelists was polypharmacy use of multiple anticholinergic medications in older adults (Poly-ACH). The new quality measure will examine the percentage of members aged 65 years or older who are using two or more anticholinergic medications concurrently.
“We know that anticholinergic burden increases the risk of cognitive decline in particular, but it’s also associated with a higher risk of falls, an increased number of hospitalizations, and [diminished] physical function,” said Marti Groeneweg, PharmD, supervisor of clinical pharmacy services at Kaiser Permanente.
Dr. Groeneweg noted that, in addition to using multiple drugs in this class, patients can also benefit from a decrease in the dosage of their drugs, so that should also be considered in managing the medication of beneficiaries.
She highlighted a program Kaiser Permanente started in the Northwest United States to reduce the concurrent use of these drugs. The program targeted tricyclic antidepressants – nortriptyline, in particular.
The company instituted a multipronged approach that included provider detailing of the risks of using multiple drugs and how they could taper schedules, as well as providing them with other supporting resources and a list of safer, alternative drugs. It also reached out to patients to educate them about the risks of their medications and why it was important for them to taper their medications. The third part of the approach was to use the EHR to provide doctors with the best-available information at the point of prescribing. And finally, there was a pharmacist review process put in place for more complex cases.
Dr. Groeneweg emphasized that this information was incorporated into existing programs.
The intervention, which is fairly new, has not been in place long enough to know exactly how well it is working, but early indicators suggest “we are on the right track,” she said, noting that to date there has been a decrease of 28% in the number of tricyclic antidepressant prescriptions per 1,000 Medicare members per month.
CNS medications
The second area the panelists addressed was the polypharmacy use of multiple CNS-active medications in older adults (Poly-CNS).
Rainelle Gaddy, PharmD, Rx clinical programs pharmacy lead at Humana Pharmacy Solutions, , noted that the clinical rationale for this measure was the “increased risk of falls and fractures when these medications are taken concurrently.”
She pointed out that taking one or more of the CNS medications can result in a 1.5-fold increase in the risk for falls, and that risk increases to 2.5-fold if two or more drugs are taken. In addition, a high-dose of these medications can lead to a threefold increase in risk of recurrent falls.
Dr. Gaddy highlighted a number of interventions that could be implemented when the managed care organization is not integrated in the way Kaiser Permanente is.
“Pharmacists can pay a pivotal role [in helping] patients who are receiving these Poly-CNS medications because they are able to interact and talk through the actual patient picture for all their medications ... because pharmacists have always been seen as being a trusted source,” she said.
Dr. Gaddy added that health plans can take a more direct role in reaching out to patients, for example, through telephone outreach, as well as direct mail, email, and newsletters.
“We want to make sure that members have as much information as possible,” she said.
She added that it is very important to include physicians and other prescribers in this process through faxes and information included in EHRs.
Opioids and benzodiazepines
The final measure highlighted during the session was the one measuring the concurrent use of opioids and benzodiazepines.
Dr. Gaddy noted that taking the two concurrently is associated with a fourfold increase in risk of opioid overdose and death, compared with opioid use without a benzodiazepine.
She noted that a black box warning on the risks of concurrent use was added to both opioids and benzodiazepines in August 2016 and that resulted in a 10% decrease in the concurrent use.
“This new measure is intended to ensure that the downward trend continues. CMS has indicated as such,” Dr. Gaddy said.
Most of the intervention strategies she highlighted were similar to those for the Poly-CNS category, including the use of medication therapy management programs and targeted interventions, telephone outreach to members, and provider detailing and outreach.
“Provider detailing is really key,” Dr. Gaddy said. “On any given day, it’s so easy for physicians to see 30 patients. The great thing about the provider detailing is that you are able to give the provider a ‘packet’ of their members, you can identify and/or aid in showing them the risk assessment associated with members taking these medications, and then equip them with pocket guides and [materials so they can] streamline the medications.”
NATIONAL HARBOR, MD. – and managed care organizations should start preparing now for the shift.
Panelists at an Oct. 30 session at the annual meeting of the Academy of Managed Care Pharmacy presented strategies for addressing the three areas of polypharmacy that will be tracked in the new rating system, which will replace the current high-risk medication measurement that is being retired this year.
Anticholinergic medications
The first area presented by the panelists was polypharmacy use of multiple anticholinergic medications in older adults (Poly-ACH). The new quality measure will examine the percentage of members aged 65 years or older who are using two or more anticholinergic medications concurrently.
“We know that anticholinergic burden increases the risk of cognitive decline in particular, but it’s also associated with a higher risk of falls, an increased number of hospitalizations, and [diminished] physical function,” said Marti Groeneweg, PharmD, supervisor of clinical pharmacy services at Kaiser Permanente.
Dr. Groeneweg noted that, in addition to using multiple drugs in this class, patients can also benefit from a decrease in the dosage of their drugs, so that should also be considered in managing the medication of beneficiaries.
She highlighted a program Kaiser Permanente started in the Northwest United States to reduce the concurrent use of these drugs. The program targeted tricyclic antidepressants – nortriptyline, in particular.
The company instituted a multipronged approach that included provider detailing of the risks of using multiple drugs and how they could taper schedules, as well as providing them with other supporting resources and a list of safer, alternative drugs. It also reached out to patients to educate them about the risks of their medications and why it was important for them to taper their medications. The third part of the approach was to use the EHR to provide doctors with the best-available information at the point of prescribing. And finally, there was a pharmacist review process put in place for more complex cases.
Dr. Groeneweg emphasized that this information was incorporated into existing programs.
The intervention, which is fairly new, has not been in place long enough to know exactly how well it is working, but early indicators suggest “we are on the right track,” she said, noting that to date there has been a decrease of 28% in the number of tricyclic antidepressant prescriptions per 1,000 Medicare members per month.
CNS medications
The second area the panelists addressed was the polypharmacy use of multiple CNS-active medications in older adults (Poly-CNS).
Rainelle Gaddy, PharmD, Rx clinical programs pharmacy lead at Humana Pharmacy Solutions, , noted that the clinical rationale for this measure was the “increased risk of falls and fractures when these medications are taken concurrently.”
She pointed out that taking one or more of the CNS medications can result in a 1.5-fold increase in the risk for falls, and that risk increases to 2.5-fold if two or more drugs are taken. In addition, a high-dose of these medications can lead to a threefold increase in risk of recurrent falls.
Dr. Gaddy highlighted a number of interventions that could be implemented when the managed care organization is not integrated in the way Kaiser Permanente is.
“Pharmacists can pay a pivotal role [in helping] patients who are receiving these Poly-CNS medications because they are able to interact and talk through the actual patient picture for all their medications ... because pharmacists have always been seen as being a trusted source,” she said.
Dr. Gaddy added that health plans can take a more direct role in reaching out to patients, for example, through telephone outreach, as well as direct mail, email, and newsletters.
“We want to make sure that members have as much information as possible,” she said.
She added that it is very important to include physicians and other prescribers in this process through faxes and information included in EHRs.
Opioids and benzodiazepines
The final measure highlighted during the session was the one measuring the concurrent use of opioids and benzodiazepines.
Dr. Gaddy noted that taking the two concurrently is associated with a fourfold increase in risk of opioid overdose and death, compared with opioid use without a benzodiazepine.
She noted that a black box warning on the risks of concurrent use was added to both opioids and benzodiazepines in August 2016 and that resulted in a 10% decrease in the concurrent use.
“This new measure is intended to ensure that the downward trend continues. CMS has indicated as such,” Dr. Gaddy said.
Most of the intervention strategies she highlighted were similar to those for the Poly-CNS category, including the use of medication therapy management programs and targeted interventions, telephone outreach to members, and provider detailing and outreach.
“Provider detailing is really key,” Dr. Gaddy said. “On any given day, it’s so easy for physicians to see 30 patients. The great thing about the provider detailing is that you are able to give the provider a ‘packet’ of their members, you can identify and/or aid in showing them the risk assessment associated with members taking these medications, and then equip them with pocket guides and [materials so they can] streamline the medications.”
REPORTING FROM AMCP NEXUS 2019
Synchronizing refills saves money, improves outcomes
NATIONAL HARBOR, MD. – according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.
Investigators with Pharmacy Quality Alliance (PQA) used data from Truven MarketScan Research Databases to conduct a retrospective cohort study of more than 20,000 patients eligible for inclusion in PQA’s diabetes medication adherence measure. To be included, patients needed to have two or more prescriptions for diabetes medications (excluding insulin), statins, or renin-angiotensin system antagonists. About 80% of patients were commercially insured and 20% came from Medicare supplement insurance (Medigap) plans.
Commercially insured patients whose medication refills were synchronized had better medication adherence than did matched controls (67.7% vs. 57.4%) and lower median health care expenditures ($3,687 vs. $7,480).
The same was true for patients with Medicare supplemental insurance. Synchronized patients in this group also had better medication adherence than controls, at 86.5% vs. 70.4% and lower median health care expenditures ($7,353 vs. $10,592).
Based on their findings in diabetes patients, “I think we should synchronize refills,” Matthew K. Pickering, PharmD, senior director of research and quality strategies at PQA, said. “However, there are populations that were not represented in this, like COPD [chronic obstructive pulmonary disease]. That’s another high-comorbidity, high-cost population that should be studied.”
Session moderator Laura Happe, PharmD, editor in chief of the Journal of Managed Care and Specialty Pharmacy, questioned Dr. Pickering about the barriers to medication synchronization.
In previous research, “we discovered that some patients were resistant to synchronizing their medication refills because of the copays – having all of their copays at one time, rather than spreading them out over the month,” Dr. Happe said.
“Certainly, patients may not be able to afford all their copays at one time, so that can be a barrier,” Dr. Pickering said. “With medication synchronization programs, there’s a lot of variation across the board. Patients can choose which medication to synchronize in some programs. Others only synchronize the three-star medication, etc. But there are real barriers and they should be explored.”
Pharmacy Quality Alliance is a nonprofit public-private partnership that develops pharmacy quality measures in collaboration with the Centers for Medicare & Medicaid Services.
Dr. Pickering disclosed no relevant conflicts of interest.
NATIONAL HARBOR, MD. – according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.
Investigators with Pharmacy Quality Alliance (PQA) used data from Truven MarketScan Research Databases to conduct a retrospective cohort study of more than 20,000 patients eligible for inclusion in PQA’s diabetes medication adherence measure. To be included, patients needed to have two or more prescriptions for diabetes medications (excluding insulin), statins, or renin-angiotensin system antagonists. About 80% of patients were commercially insured and 20% came from Medicare supplement insurance (Medigap) plans.
Commercially insured patients whose medication refills were synchronized had better medication adherence than did matched controls (67.7% vs. 57.4%) and lower median health care expenditures ($3,687 vs. $7,480).
The same was true for patients with Medicare supplemental insurance. Synchronized patients in this group also had better medication adherence than controls, at 86.5% vs. 70.4% and lower median health care expenditures ($7,353 vs. $10,592).
Based on their findings in diabetes patients, “I think we should synchronize refills,” Matthew K. Pickering, PharmD, senior director of research and quality strategies at PQA, said. “However, there are populations that were not represented in this, like COPD [chronic obstructive pulmonary disease]. That’s another high-comorbidity, high-cost population that should be studied.”
Session moderator Laura Happe, PharmD, editor in chief of the Journal of Managed Care and Specialty Pharmacy, questioned Dr. Pickering about the barriers to medication synchronization.
In previous research, “we discovered that some patients were resistant to synchronizing their medication refills because of the copays – having all of their copays at one time, rather than spreading them out over the month,” Dr. Happe said.
“Certainly, patients may not be able to afford all their copays at one time, so that can be a barrier,” Dr. Pickering said. “With medication synchronization programs, there’s a lot of variation across the board. Patients can choose which medication to synchronize in some programs. Others only synchronize the three-star medication, etc. But there are real barriers and they should be explored.”
Pharmacy Quality Alliance is a nonprofit public-private partnership that develops pharmacy quality measures in collaboration with the Centers for Medicare & Medicaid Services.
Dr. Pickering disclosed no relevant conflicts of interest.
NATIONAL HARBOR, MD. – according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.
Investigators with Pharmacy Quality Alliance (PQA) used data from Truven MarketScan Research Databases to conduct a retrospective cohort study of more than 20,000 patients eligible for inclusion in PQA’s diabetes medication adherence measure. To be included, patients needed to have two or more prescriptions for diabetes medications (excluding insulin), statins, or renin-angiotensin system antagonists. About 80% of patients were commercially insured and 20% came from Medicare supplement insurance (Medigap) plans.
Commercially insured patients whose medication refills were synchronized had better medication adherence than did matched controls (67.7% vs. 57.4%) and lower median health care expenditures ($3,687 vs. $7,480).
The same was true for patients with Medicare supplemental insurance. Synchronized patients in this group also had better medication adherence than controls, at 86.5% vs. 70.4% and lower median health care expenditures ($7,353 vs. $10,592).
Based on their findings in diabetes patients, “I think we should synchronize refills,” Matthew K. Pickering, PharmD, senior director of research and quality strategies at PQA, said. “However, there are populations that were not represented in this, like COPD [chronic obstructive pulmonary disease]. That’s another high-comorbidity, high-cost population that should be studied.”
Session moderator Laura Happe, PharmD, editor in chief of the Journal of Managed Care and Specialty Pharmacy, questioned Dr. Pickering about the barriers to medication synchronization.
In previous research, “we discovered that some patients were resistant to synchronizing their medication refills because of the copays – having all of their copays at one time, rather than spreading them out over the month,” Dr. Happe said.
“Certainly, patients may not be able to afford all their copays at one time, so that can be a barrier,” Dr. Pickering said. “With medication synchronization programs, there’s a lot of variation across the board. Patients can choose which medication to synchronize in some programs. Others only synchronize the three-star medication, etc. But there are real barriers and they should be explored.”
Pharmacy Quality Alliance is a nonprofit public-private partnership that develops pharmacy quality measures in collaboration with the Centers for Medicare & Medicaid Services.
Dr. Pickering disclosed no relevant conflicts of interest.
REPORTING FROM AMCP NEXUS 2019
Migraine therapy efficacy leaves ambiguities
NATIONAL HARBOR, MD. –
“There’s very little consistency in study design, making it difficult to make real-world comparisons,” said Carly Rodriguez, PharmD, FAMP, pharmacy director at Moda Health. Dr. Rodriguez presented data on the efficacy and pharmacoeconomic factors of migraine therapy at the annual meeting of the Academy of Managed Care Pharmacy.
The paucity of translatable evidence makes comparing and evaluating newer migraine therapies – such as botulinum toxins and calcitonin gene-related peptide (CGRP) inhibitors – particularly difficult.
These two injectable drug classes are not first-line treatments for migraine; they are currently reserved for patients who are refractory to at least one prophylactic treatment, but they offer important alternatives and additions to therapy.
“OnabotulinumtoxinA makes a good case because it costs less than a single ER visit, but there’s not enough supporting data,” Dr. Rodriguez said. According to a report from the Institute for Clinical and Economic Review (ICER) that evaluated the clinical efficacy and economic impact associated with onabotulinumtoxinA, administering the drug saved $157/headache day averted for 20 baseline headaches per month and $223/headache day avoided for 15 baseline headaches per month.
OnabotulinumtoxinA administration showed a moderate yet significant health benefit in preventing chronic migraines by reducing the number of headache days patients experienced by more than 50%. No benefit for episodic migraines was observed.
Several single- and multicenter studies found that onabotulinumtoxinA produced positive outcomes such as a decreased number of visits to urgent care centers, a lower average number of migraines patients experienced, and improved quality of life.
An ICER report investigating CGRP inhibitors found that the cost of anti-CGRP therapy may not produce viable clinical benefits.
Both botulinum toxins and CGRP inhibitors require prior authorization, and their injectable dosage forms restrict the settings in which they are administered and dispensed. Because botulinum toxins must be administered by a health care professional, the vast majority of these drugs are restricted to medical settings, with brand-to-generic substitution often varying among health plans. For this reason, botulinum toxins rarely appear on formularies. Several health plans consider botulinum toxins interchangeable and may give prescribers options to select the botulinum toxin product of their choice.
According to Dr. Rodriguez, there is some variability as to whether CGRP therapies are available in community pharmacy settings or are restricted to specialty pharmacies. Additionally, some plans consider all CGRP inhibitors to be interchangeable, while others take a more conservative approach.
Overall, generic drugs continue to dominate migraine drug therapy, with triptans leading the way. Generics that are heavily prescribed include beta-blockers, antidepressants, and antiepileptics.
More than 37 million people living in the United States suffer from migraines – approximately 8% of the overall population. Women are four times as likely to have migraines than men.
NATIONAL HARBOR, MD. –
“There’s very little consistency in study design, making it difficult to make real-world comparisons,” said Carly Rodriguez, PharmD, FAMP, pharmacy director at Moda Health. Dr. Rodriguez presented data on the efficacy and pharmacoeconomic factors of migraine therapy at the annual meeting of the Academy of Managed Care Pharmacy.
The paucity of translatable evidence makes comparing and evaluating newer migraine therapies – such as botulinum toxins and calcitonin gene-related peptide (CGRP) inhibitors – particularly difficult.
These two injectable drug classes are not first-line treatments for migraine; they are currently reserved for patients who are refractory to at least one prophylactic treatment, but they offer important alternatives and additions to therapy.
“OnabotulinumtoxinA makes a good case because it costs less than a single ER visit, but there’s not enough supporting data,” Dr. Rodriguez said. According to a report from the Institute for Clinical and Economic Review (ICER) that evaluated the clinical efficacy and economic impact associated with onabotulinumtoxinA, administering the drug saved $157/headache day averted for 20 baseline headaches per month and $223/headache day avoided for 15 baseline headaches per month.
OnabotulinumtoxinA administration showed a moderate yet significant health benefit in preventing chronic migraines by reducing the number of headache days patients experienced by more than 50%. No benefit for episodic migraines was observed.
Several single- and multicenter studies found that onabotulinumtoxinA produced positive outcomes such as a decreased number of visits to urgent care centers, a lower average number of migraines patients experienced, and improved quality of life.
An ICER report investigating CGRP inhibitors found that the cost of anti-CGRP therapy may not produce viable clinical benefits.
Both botulinum toxins and CGRP inhibitors require prior authorization, and their injectable dosage forms restrict the settings in which they are administered and dispensed. Because botulinum toxins must be administered by a health care professional, the vast majority of these drugs are restricted to medical settings, with brand-to-generic substitution often varying among health plans. For this reason, botulinum toxins rarely appear on formularies. Several health plans consider botulinum toxins interchangeable and may give prescribers options to select the botulinum toxin product of their choice.
According to Dr. Rodriguez, there is some variability as to whether CGRP therapies are available in community pharmacy settings or are restricted to specialty pharmacies. Additionally, some plans consider all CGRP inhibitors to be interchangeable, while others take a more conservative approach.
Overall, generic drugs continue to dominate migraine drug therapy, with triptans leading the way. Generics that are heavily prescribed include beta-blockers, antidepressants, and antiepileptics.
More than 37 million people living in the United States suffer from migraines – approximately 8% of the overall population. Women are four times as likely to have migraines than men.
NATIONAL HARBOR, MD. –
“There’s very little consistency in study design, making it difficult to make real-world comparisons,” said Carly Rodriguez, PharmD, FAMP, pharmacy director at Moda Health. Dr. Rodriguez presented data on the efficacy and pharmacoeconomic factors of migraine therapy at the annual meeting of the Academy of Managed Care Pharmacy.
The paucity of translatable evidence makes comparing and evaluating newer migraine therapies – such as botulinum toxins and calcitonin gene-related peptide (CGRP) inhibitors – particularly difficult.
These two injectable drug classes are not first-line treatments for migraine; they are currently reserved for patients who are refractory to at least one prophylactic treatment, but they offer important alternatives and additions to therapy.
“OnabotulinumtoxinA makes a good case because it costs less than a single ER visit, but there’s not enough supporting data,” Dr. Rodriguez said. According to a report from the Institute for Clinical and Economic Review (ICER) that evaluated the clinical efficacy and economic impact associated with onabotulinumtoxinA, administering the drug saved $157/headache day averted for 20 baseline headaches per month and $223/headache day avoided for 15 baseline headaches per month.
OnabotulinumtoxinA administration showed a moderate yet significant health benefit in preventing chronic migraines by reducing the number of headache days patients experienced by more than 50%. No benefit for episodic migraines was observed.
Several single- and multicenter studies found that onabotulinumtoxinA produced positive outcomes such as a decreased number of visits to urgent care centers, a lower average number of migraines patients experienced, and improved quality of life.
An ICER report investigating CGRP inhibitors found that the cost of anti-CGRP therapy may not produce viable clinical benefits.
Both botulinum toxins and CGRP inhibitors require prior authorization, and their injectable dosage forms restrict the settings in which they are administered and dispensed. Because botulinum toxins must be administered by a health care professional, the vast majority of these drugs are restricted to medical settings, with brand-to-generic substitution often varying among health plans. For this reason, botulinum toxins rarely appear on formularies. Several health plans consider botulinum toxins interchangeable and may give prescribers options to select the botulinum toxin product of their choice.
According to Dr. Rodriguez, there is some variability as to whether CGRP therapies are available in community pharmacy settings or are restricted to specialty pharmacies. Additionally, some plans consider all CGRP inhibitors to be interchangeable, while others take a more conservative approach.
Overall, generic drugs continue to dominate migraine drug therapy, with triptans leading the way. Generics that are heavily prescribed include beta-blockers, antidepressants, and antiepileptics.
More than 37 million people living in the United States suffer from migraines – approximately 8% of the overall population. Women are four times as likely to have migraines than men.
REPORTING FROM AMCP NEXUS 2019
Expect some congressional action on drug prices, but not major reform
NATIONAL HARBOR, MD – Congress is considering two separate, comprehensive proposals to address the escalating cost of drug prices, but neither is expected to make it to the President’s desk.
The more likely scenario is that parts of these bills aimed at reforming the Medicare Part D prescription drug program could be added on to a must-pass budget bill before the end of 2019, according to Ross Margulies, senior associate in the Washington office of the law firm Foley Hoag.
A bill championed by House Speaker Nancy Pelosi (D-Calif.), H.R. 3, is considered dead on arrival in the Senate since Senate Majority Leader Mitch McConnell (R-Ky.) has stated that the upper chamber will not take it up, Mr. Margulies said at the annual meeting of the Academy of Managed Care Pharmacy.
Despite this, the House is expected to move on H.R. 3 in mid-November. The bill has gone through three committee markups, and each have amended its language. The final bill language has not been released yet.
Meanwhile in the Senate, the Prescription Drug Pricing Reduction Act (S. 2543) enjoys some bipartisan support, but Mr. Margulies questioned whether there was enough to pass it.
But there are some provisions in both pieces of legislation that have bipartisan support and could ultimately be passed though other legislative vehicles, he said.
One proposal that is common to both bills is a cap on out-of-pocket spending by Part D beneficiaries, though the bills differ on how high to set the cap. The House bill caps annual beneficiary spending at $2,000, while the Senate proposal caps it at $3,600.
The lack of a cap “has increasingly raised some issues over the years as we have seen more and more specialty drugs come on the market that push individuals into the catastrophic phase in that first or second phase of that first or second refill,” Mr. Margulies said.
Another area that is garnering bipartisan support is reforming the structure of Medicare Part D.
Mr. Margulies noted that generally the Part D program has enjoyed bipartisan and consumer support and there “hasn’t been a major restructuring of the Part D benefit since its creation more than a decade ago.”
“I really think this is an area where Congress is in a bipartisan way very focused,” he added.
The redesign proposals in the two bills would fundamentally change how the catastrophic phase is covered. The out-of-pocket limits would eliminate beneficiary cost sharing in this phase, currently set at 5% of list price with no cap on spending, and dramatically reduce the government’s financial exposure during this phase.
Currently, the federal government covers 80% of the cost of drugs for beneficiaries in catastrophic coverage, and the plan sponsors cover the remaining 15%. The House and Senate plans both reduce government coverage to 20%. Under the House proposal, drug plans would be responsible for 50% while manufacturers would cover the remaining 30%. The Senate bill proposes a split of 60% for plans and 20% for manufacturers.
“Under either of these proposals, manufacturers with the highest-priced specialty drugs are probably going to fare the worst because you have that new open-ended liability in the catastrophic phase,” Mr. Margulies said.
On the plan side, “plans will face increased pressure to control costs/utilization,” he added.
These proposals could encourage manufacturers to reduce list prices and drug plans to more aggressively negotiate rebates and discounts.
One element of H.R. 3 that is not a part of the Senate bill is the requirement that the secretary of the Department of Health & Human Services negotiate drug prices for a certain number of high-cost drugs each year. Those negotiations would be backstopped by an international pricing index, with the aim of bringing the prices paid in the United States much closer to the lower prices paid internationally.
H.R. 3 also includes a hefty excise tax for manufacturers who either don’t participate in the negotiations or fail to offer price reductions that are within a specified percentage of the international pricing index.
Mr. Margulies noted that Speaker Pelosi was hoping to get White House endorsement on the drug negotiation provision, since it is similar to regulations proposed by HHS earlier this year, but impeachment proceedings have derailed any chance of getting that endorsement.
Mr. Margulies made no financial disclosures related to his presentation.
NATIONAL HARBOR, MD – Congress is considering two separate, comprehensive proposals to address the escalating cost of drug prices, but neither is expected to make it to the President’s desk.
The more likely scenario is that parts of these bills aimed at reforming the Medicare Part D prescription drug program could be added on to a must-pass budget bill before the end of 2019, according to Ross Margulies, senior associate in the Washington office of the law firm Foley Hoag.
A bill championed by House Speaker Nancy Pelosi (D-Calif.), H.R. 3, is considered dead on arrival in the Senate since Senate Majority Leader Mitch McConnell (R-Ky.) has stated that the upper chamber will not take it up, Mr. Margulies said at the annual meeting of the Academy of Managed Care Pharmacy.
Despite this, the House is expected to move on H.R. 3 in mid-November. The bill has gone through three committee markups, and each have amended its language. The final bill language has not been released yet.
Meanwhile in the Senate, the Prescription Drug Pricing Reduction Act (S. 2543) enjoys some bipartisan support, but Mr. Margulies questioned whether there was enough to pass it.
But there are some provisions in both pieces of legislation that have bipartisan support and could ultimately be passed though other legislative vehicles, he said.
One proposal that is common to both bills is a cap on out-of-pocket spending by Part D beneficiaries, though the bills differ on how high to set the cap. The House bill caps annual beneficiary spending at $2,000, while the Senate proposal caps it at $3,600.
The lack of a cap “has increasingly raised some issues over the years as we have seen more and more specialty drugs come on the market that push individuals into the catastrophic phase in that first or second phase of that first or second refill,” Mr. Margulies said.
Another area that is garnering bipartisan support is reforming the structure of Medicare Part D.
Mr. Margulies noted that generally the Part D program has enjoyed bipartisan and consumer support and there “hasn’t been a major restructuring of the Part D benefit since its creation more than a decade ago.”
“I really think this is an area where Congress is in a bipartisan way very focused,” he added.
The redesign proposals in the two bills would fundamentally change how the catastrophic phase is covered. The out-of-pocket limits would eliminate beneficiary cost sharing in this phase, currently set at 5% of list price with no cap on spending, and dramatically reduce the government’s financial exposure during this phase.
Currently, the federal government covers 80% of the cost of drugs for beneficiaries in catastrophic coverage, and the plan sponsors cover the remaining 15%. The House and Senate plans both reduce government coverage to 20%. Under the House proposal, drug plans would be responsible for 50% while manufacturers would cover the remaining 30%. The Senate bill proposes a split of 60% for plans and 20% for manufacturers.
“Under either of these proposals, manufacturers with the highest-priced specialty drugs are probably going to fare the worst because you have that new open-ended liability in the catastrophic phase,” Mr. Margulies said.
On the plan side, “plans will face increased pressure to control costs/utilization,” he added.
These proposals could encourage manufacturers to reduce list prices and drug plans to more aggressively negotiate rebates and discounts.
One element of H.R. 3 that is not a part of the Senate bill is the requirement that the secretary of the Department of Health & Human Services negotiate drug prices for a certain number of high-cost drugs each year. Those negotiations would be backstopped by an international pricing index, with the aim of bringing the prices paid in the United States much closer to the lower prices paid internationally.
H.R. 3 also includes a hefty excise tax for manufacturers who either don’t participate in the negotiations or fail to offer price reductions that are within a specified percentage of the international pricing index.
Mr. Margulies noted that Speaker Pelosi was hoping to get White House endorsement on the drug negotiation provision, since it is similar to regulations proposed by HHS earlier this year, but impeachment proceedings have derailed any chance of getting that endorsement.
Mr. Margulies made no financial disclosures related to his presentation.
NATIONAL HARBOR, MD – Congress is considering two separate, comprehensive proposals to address the escalating cost of drug prices, but neither is expected to make it to the President’s desk.
The more likely scenario is that parts of these bills aimed at reforming the Medicare Part D prescription drug program could be added on to a must-pass budget bill before the end of 2019, according to Ross Margulies, senior associate in the Washington office of the law firm Foley Hoag.
A bill championed by House Speaker Nancy Pelosi (D-Calif.), H.R. 3, is considered dead on arrival in the Senate since Senate Majority Leader Mitch McConnell (R-Ky.) has stated that the upper chamber will not take it up, Mr. Margulies said at the annual meeting of the Academy of Managed Care Pharmacy.
Despite this, the House is expected to move on H.R. 3 in mid-November. The bill has gone through three committee markups, and each have amended its language. The final bill language has not been released yet.
Meanwhile in the Senate, the Prescription Drug Pricing Reduction Act (S. 2543) enjoys some bipartisan support, but Mr. Margulies questioned whether there was enough to pass it.
But there are some provisions in both pieces of legislation that have bipartisan support and could ultimately be passed though other legislative vehicles, he said.
One proposal that is common to both bills is a cap on out-of-pocket spending by Part D beneficiaries, though the bills differ on how high to set the cap. The House bill caps annual beneficiary spending at $2,000, while the Senate proposal caps it at $3,600.
The lack of a cap “has increasingly raised some issues over the years as we have seen more and more specialty drugs come on the market that push individuals into the catastrophic phase in that first or second phase of that first or second refill,” Mr. Margulies said.
Another area that is garnering bipartisan support is reforming the structure of Medicare Part D.
Mr. Margulies noted that generally the Part D program has enjoyed bipartisan and consumer support and there “hasn’t been a major restructuring of the Part D benefit since its creation more than a decade ago.”
“I really think this is an area where Congress is in a bipartisan way very focused,” he added.
The redesign proposals in the two bills would fundamentally change how the catastrophic phase is covered. The out-of-pocket limits would eliminate beneficiary cost sharing in this phase, currently set at 5% of list price with no cap on spending, and dramatically reduce the government’s financial exposure during this phase.
Currently, the federal government covers 80% of the cost of drugs for beneficiaries in catastrophic coverage, and the plan sponsors cover the remaining 15%. The House and Senate plans both reduce government coverage to 20%. Under the House proposal, drug plans would be responsible for 50% while manufacturers would cover the remaining 30%. The Senate bill proposes a split of 60% for plans and 20% for manufacturers.
“Under either of these proposals, manufacturers with the highest-priced specialty drugs are probably going to fare the worst because you have that new open-ended liability in the catastrophic phase,” Mr. Margulies said.
On the plan side, “plans will face increased pressure to control costs/utilization,” he added.
These proposals could encourage manufacturers to reduce list prices and drug plans to more aggressively negotiate rebates and discounts.
One element of H.R. 3 that is not a part of the Senate bill is the requirement that the secretary of the Department of Health & Human Services negotiate drug prices for a certain number of high-cost drugs each year. Those negotiations would be backstopped by an international pricing index, with the aim of bringing the prices paid in the United States much closer to the lower prices paid internationally.
H.R. 3 also includes a hefty excise tax for manufacturers who either don’t participate in the negotiations or fail to offer price reductions that are within a specified percentage of the international pricing index.
Mr. Margulies noted that Speaker Pelosi was hoping to get White House endorsement on the drug negotiation provision, since it is similar to regulations proposed by HHS earlier this year, but impeachment proceedings have derailed any chance of getting that endorsement.
Mr. Margulies made no financial disclosures related to his presentation.
REPORTING FROM AMCP NEXUS 2019
