The New Paradigm of Hepatitis C Therapy
The New Paradigm of Hepatitis C Therapy
The sequelae of hepatitis C impose a high economic burden. It has been estimated that in 2012, the healthcare cost of HCV was $6.5 billion, and it has been predicted the cost will peak at $9.1 billion in 2024. A retrospective analysis of data from a large, managed care organization claims database suggested that the annual all-cause medical costs of patients diagnosed with HCV were almost twice as high as enrollees without diagnosed HCV. The health burden of HCV largely relates to the development of advanced liver disease, which can lead to liver transplant. In the United States, HCV is the leading cause of hepatocellular carcinoma, and it is likely that more cases of hepatocellular carcinoma, decompensated cirrhosis and liver transplants due to HCV will be observed in the coming years. The medical cost of hepatocellular carcinoma has been estimated as $23 755–44 200 per year per person, and the cost of liver transplant has been estimated as $201 110 per year per person. Additional disease burden and costs are generated by extrahepatic manifestations of HCV infection including cryoglobulinemic vasculitis, lymphoproliferative disorders, renal disease and rheumatoid-like polyarthritis.
The addition of telaprevir or boceprevir to PEG-IFN plus RBV has changed the pharmacoeconomics of treating HCV. Adding the directly acting antivirals to PEG-IFN and RBV can increase the cost of treatment up to $50 000, depending upon individual regimens needed, yet the antivirals also increase the success rates of therapy. At present, economic evaluations of telaprevir or boceprevir with PEG-IFN and RBV are limited. A decision analysis of telaprevir and boceprevir indicated that triple therapy including telaprevir or boceprevir was cost-effective when compared with dual PEG-IFN and RBV therapy in patients with genotype 1 infection, although the results were dependent on the cost of protease inhibitors, treatment adherence rates and extent of fibrosis. More recently, a study from Mount Sinai in New York has estimated that the real cost of reaching end of therapy with triple therapy may be as high as $147 000 when the cost of side effect management is included.
As new all-oral regimens enter the market, several factors will affect their cost-effectiveness: success rates in patients with advanced liver disease or difficult-to-treat HCV genotypes, costs related to monitoring and managing treatment-related toxicities, extent of clinically relevant viral resistance and duration of therapy. The costs of new agents will also be considered against the costs of current IFN-based therapy, which is challenging to administer and has side effects requiring ongoing management. The dominant factor in cost assessments of treatment should be the efficacy of the treatment because all those who fail experience most or all of the cost and none of the benefit. But high projected costs of new directly acting antiviral treatments may result in lack of access for some patients. Industry-created assistance and co-pay programmes can be instrumental in making treatment more affordable and accessible. Public health programmes to support engaging HCV-infected persons in care should also be explored to provide infrastructure for wrap-around services that may not be reimbursable (e.g. coordination of care or peer support). Given the projected high costs of treatment, relatively minor investments in patient support mechanisms are easily justified but not often implemented because of the nature of the fee-for-service healthcare delivery system in the United States. Enhanced communication between physicians and third-party payers may increase the availability of new therapies to patients.
Pharmacoeconomics of Hepatitis C
The sequelae of hepatitis C impose a high economic burden. It has been estimated that in 2012, the healthcare cost of HCV was $6.5 billion, and it has been predicted the cost will peak at $9.1 billion in 2024. A retrospective analysis of data from a large, managed care organization claims database suggested that the annual all-cause medical costs of patients diagnosed with HCV were almost twice as high as enrollees without diagnosed HCV. The health burden of HCV largely relates to the development of advanced liver disease, which can lead to liver transplant. In the United States, HCV is the leading cause of hepatocellular carcinoma, and it is likely that more cases of hepatocellular carcinoma, decompensated cirrhosis and liver transplants due to HCV will be observed in the coming years. The medical cost of hepatocellular carcinoma has been estimated as $23 755–44 200 per year per person, and the cost of liver transplant has been estimated as $201 110 per year per person. Additional disease burden and costs are generated by extrahepatic manifestations of HCV infection including cryoglobulinemic vasculitis, lymphoproliferative disorders, renal disease and rheumatoid-like polyarthritis.
The addition of telaprevir or boceprevir to PEG-IFN plus RBV has changed the pharmacoeconomics of treating HCV. Adding the directly acting antivirals to PEG-IFN and RBV can increase the cost of treatment up to $50 000, depending upon individual regimens needed, yet the antivirals also increase the success rates of therapy. At present, economic evaluations of telaprevir or boceprevir with PEG-IFN and RBV are limited. A decision analysis of telaprevir and boceprevir indicated that triple therapy including telaprevir or boceprevir was cost-effective when compared with dual PEG-IFN and RBV therapy in patients with genotype 1 infection, although the results were dependent on the cost of protease inhibitors, treatment adherence rates and extent of fibrosis. More recently, a study from Mount Sinai in New York has estimated that the real cost of reaching end of therapy with triple therapy may be as high as $147 000 when the cost of side effect management is included.
As new all-oral regimens enter the market, several factors will affect their cost-effectiveness: success rates in patients with advanced liver disease or difficult-to-treat HCV genotypes, costs related to monitoring and managing treatment-related toxicities, extent of clinically relevant viral resistance and duration of therapy. The costs of new agents will also be considered against the costs of current IFN-based therapy, which is challenging to administer and has side effects requiring ongoing management. The dominant factor in cost assessments of treatment should be the efficacy of the treatment because all those who fail experience most or all of the cost and none of the benefit. But high projected costs of new directly acting antiviral treatments may result in lack of access for some patients. Industry-created assistance and co-pay programmes can be instrumental in making treatment more affordable and accessible. Public health programmes to support engaging HCV-infected persons in care should also be explored to provide infrastructure for wrap-around services that may not be reimbursable (e.g. coordination of care or peer support). Given the projected high costs of treatment, relatively minor investments in patient support mechanisms are easily justified but not often implemented because of the nature of the fee-for-service healthcare delivery system in the United States. Enhanced communication between physicians and third-party payers may increase the availability of new therapies to patients.
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