Telaprevir Not Cost-Effective for All Hepatitis C Patients

SAN FRANCISCO – Telaprevir is unlikely to be cost-effective as a first-line agent in treatment-naive genotype 1 hepatitis C patients with the CC interleukin 28B polymorphism, according to economic modeling of previously published data.

That’s because most of them don’t need telaprevir; about two-thirds will have a sustained virologic response (SVR) – essentially a cure – with standard pegylated interferon alfa/ribavirin therapy. It makes more economic sense to try that approach first, keeping telaprevir (Incivek) in reserve for patients who relapse or fail to respond, said lead investigator Dr. Ziad Gellad of Duke University, Durham, N.C.

SVR rates with that approach are about 90%, the same as if telaprevir was used right from the start. "The same proportion of the population will be cured whether you use telaprevir upfront or whether you use it as rescue. Maybe it’s worth reconsidering whether everyone needs these expensive drugs," Dr. Gellad said.

Of course, patients might not want to endure a 48-week or longer interferon/ribavirin regimen when adding telaprevir from the start may shorten treatment to 24 weeks, and it’s unclear at this point if insurers would ask them to do so. "Everybody is still working through those [payment] issues" following telaprevir’s May 2011 Food and Drug Administration approval, Dr. Gellad said.

Current labeling indicates that the drug can be used combination with interferon and ribavirin for both HCV treatment-naive patients and those who’ve failed initial dual therapy, suggesting a role as either a first- or second-line agent. Labeling also notes that the CC IL28B genotype – as opposed to the CT or TT genotypes – strongly predicts response to dual therapy.

There are commercially available screening blood tests for the polymorphism. The patent on the technology is shared by Duke, Merck, and Duke scientists who discovered it. It’s mostly academic hepatologists who screen for the polymorphism at present, said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

Although the study results support the test’s utility, Dr. Gellad, who has no ownership rights to the patent, cautioned that the "use of IL28 screening is still unclear. It may be that there are other pretreatment predictors that will also be helpful, or it may be, as many have argued, that on-treatment response is the best predictor [of outcome], rendering IL28 testing obsolete. This is still a matter of debate."

Dr. Gellad and his colleagues compared previously published SVR rates, and their associated costs, for three regimens. The first, standard 48 weeks of interferon and ribavirin, cost $54,931 and gave patients an estimated 19.38 quality-adjusted life years (QALYS). Interferon/ribavirin for 24 weeks – in individuals with rapid virologic responses – cost $46,785 and gave patients 19.26 QALYS. Modeling included re-treating nonresponders and relapsers with a 48-week telaprevir-inclusive regimen.

In the third strategy, individuals got 12 weeks of telaprevir in combination with either 24 or 48 weeks of interferon and ribavirin, again based on their virologic responses. The approach cost $68,788 and gave people 19.34 QALYS.

With all three approaches leading to SVRs in about 90% of patients and just over 19 QALYS, paying more for the same ultimate result makes little economic sense, the researchers concluded.

The study "is very important," said Dr. Liang, also chief of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others. We are all very excited about the approval of [direct-acting antivirals like telaprevir] that clearly enhance treatment response, but perhaps not one size fits all. Maybe this could be a way for us to save some money," he said.

Dr. Gellad and his colleagues will continue to study the issue, and plan to include boceprevir (Victrelis) – another direct-acting HCV antiviral approved in May – to their modeling. "The story will get more interesting," he said.

Dr. Gellad is a consultant to and gets grant support from Merck, maker of boceprevir. He said that the company was not involved in the study.

SAN FRANCISCO – Telaprevir is unlikely to be cost-effective as a first-line agent in treatment-naive genotype 1 hepatitis C patients with the CC interleukin 28B polymorphism, according to economic modeling of previously published data.

That’s because most of them don’t need telaprevir; about two-thirds will have a sustained virologic response (SVR) – essentially a cure – with standard pegylated interferon alfa/ribavirin therapy. It makes more economic sense to try that approach first, keeping telaprevir (Incivek) in reserve for patients who relapse or fail to respond, said lead investigator Dr. Ziad Gellad of Duke University, Durham, N.C.

SVR rates with that approach are about 90%, the same as if telaprevir was used right from the start. "The same proportion of the population will be cured whether you use telaprevir upfront or whether you use it as rescue. Maybe it’s worth reconsidering whether everyone needs these expensive drugs," Dr. Gellad said.

Of course, patients might not want to endure a 48-week or longer interferon/ribavirin regimen when adding telaprevir from the start may shorten treatment to 24 weeks, and it’s unclear at this point if insurers would ask them to do so. "Everybody is still working through those [payment] issues" following telaprevir’s May 2011 Food and Drug Administration approval, Dr. Gellad said.

Current labeling indicates that the drug can be used combination with interferon and ribavirin for both HCV treatment-naive patients and those who’ve failed initial dual therapy, suggesting a role as either a first- or second-line agent. Labeling also notes that the CC IL28B genotype – as opposed to the CT or TT genotypes – strongly predicts response to dual therapy.

There are commercially available screening blood tests for the polymorphism. The patent on the technology is shared by Duke, Merck, and Duke scientists who discovered it. It’s mostly academic hepatologists who screen for the polymorphism at present, said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

Although the study results support the test’s utility, Dr. Gellad, who has no ownership rights to the patent, cautioned that the "use of IL28 screening is still unclear. It may be that there are other pretreatment predictors that will also be helpful, or it may be, as many have argued, that on-treatment response is the best predictor [of outcome], rendering IL28 testing obsolete. This is still a matter of debate."

Dr. Gellad and his colleagues compared previously published SVR rates, and their associated costs, for three regimens. The first, standard 48 weeks of interferon and ribavirin, cost $54,931 and gave patients an estimated 19.38 quality-adjusted life years (QALYS). Interferon/ribavirin for 24 weeks – in individuals with rapid virologic responses – cost $46,785 and gave patients 19.26 QALYS. Modeling included re-treating nonresponders and relapsers with a 48-week telaprevir-inclusive regimen.

In the third strategy, individuals got 12 weeks of telaprevir in combination with either 24 or 48 weeks of interferon and ribavirin, again based on their virologic responses. The approach cost $68,788 and gave people 19.34 QALYS.

With all three approaches leading to SVRs in about 90% of patients and just over 19 QALYS, paying more for the same ultimate result makes little economic sense, the researchers concluded.

The study "is very important," said Dr. Liang, also chief of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others. We are all very excited about the approval of [direct-acting antivirals like telaprevir] that clearly enhance treatment response, but perhaps not one size fits all. Maybe this could be a way for us to save some money," he said.

Dr. Gellad and his colleagues will continue to study the issue, and plan to include boceprevir (Victrelis) – another direct-acting HCV antiviral approved in May – to their modeling. "The story will get more interesting," he said.

Dr. Gellad is a consultant to and gets grant support from Merck, maker of boceprevir. He said that the company was not involved in the study.

SAN FRANCISCO – Telaprevir is unlikely to be cost-effective as a first-line agent in treatment-naive genotype 1 hepatitis C patients with the CC interleukin 28B polymorphism, according to economic modeling of previously published data.

That’s because most of them don’t need telaprevir; about two-thirds will have a sustained virologic response (SVR) – essentially a cure – with standard pegylated interferon alfa/ribavirin therapy. It makes more economic sense to try that approach first, keeping telaprevir (Incivek) in reserve for patients who relapse or fail to respond, said lead investigator Dr. Ziad Gellad of Duke University, Durham, N.C.

SVR rates with that approach are about 90%, the same as if telaprevir was used right from the start. "The same proportion of the population will be cured whether you use telaprevir upfront or whether you use it as rescue. Maybe it’s worth reconsidering whether everyone needs these expensive drugs," Dr. Gellad said.

Of course, patients might not want to endure a 48-week or longer interferon/ribavirin regimen when adding telaprevir from the start may shorten treatment to 24 weeks, and it’s unclear at this point if insurers would ask them to do so. "Everybody is still working through those [payment] issues" following telaprevir’s May 2011 Food and Drug Administration approval, Dr. Gellad said.

Current labeling indicates that the drug can be used combination with interferon and ribavirin for both HCV treatment-naive patients and those who’ve failed initial dual therapy, suggesting a role as either a first- or second-line agent. Labeling also notes that the CC IL28B genotype – as opposed to the CT or TT genotypes – strongly predicts response to dual therapy.

There are commercially available screening blood tests for the polymorphism. The patent on the technology is shared by Duke, Merck, and Duke scientists who discovered it. It’s mostly academic hepatologists who screen for the polymorphism at present, said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

Although the study results support the test’s utility, Dr. Gellad, who has no ownership rights to the patent, cautioned that the "use of IL28 screening is still unclear. It may be that there are other pretreatment predictors that will also be helpful, or it may be, as many have argued, that on-treatment response is the best predictor [of outcome], rendering IL28 testing obsolete. This is still a matter of debate."

Dr. Gellad and his colleagues compared previously published SVR rates, and their associated costs, for three regimens. The first, standard 48 weeks of interferon and ribavirin, cost $54,931 and gave patients an estimated 19.38 quality-adjusted life years (QALYS). Interferon/ribavirin for 24 weeks – in individuals with rapid virologic responses – cost $46,785 and gave patients 19.26 QALYS. Modeling included re-treating nonresponders and relapsers with a 48-week telaprevir-inclusive regimen.

In the third strategy, individuals got 12 weeks of telaprevir in combination with either 24 or 48 weeks of interferon and ribavirin, again based on their virologic responses. The approach cost $68,788 and gave people 19.34 QALYS.

With all three approaches leading to SVRs in about 90% of patients and just over 19 QALYS, paying more for the same ultimate result makes little economic sense, the researchers concluded.

The study "is very important," said Dr. Liang, also chief of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others. We are all very excited about the approval of [direct-acting antivirals like telaprevir] that clearly enhance treatment response, but perhaps not one size fits all. Maybe this could be a way for us to save some money," he said.

Dr. Gellad and his colleagues will continue to study the issue, and plan to include boceprevir (Victrelis) – another direct-acting HCV antiviral approved in May – to their modeling. "The story will get more interesting," he said.

Dr. Gellad is a consultant to and gets grant support from Merck, maker of boceprevir. He said that the company was not involved in the study.