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Thu, 01/18/2024 - 13:36

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

 

 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

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A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

 

 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

 

 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

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