Is the High Cost of New Hep C Drugs Worth the Money?
Those who had previously resigned to a lifetime of battling the chronic Hepatitis C virus finally have hope. The newer, direct-acting antiviral medications have broken through the 50th percentile barrier of Hepatitis C treatment success. While the new drugs currently boast over a 95 percent chance of viral eradication, their extremely high price tags make them grossly restrictive. Despite their astronomical cost, an analytic model has determined that the Hepatitis C all-oral drug regimens are an economically sound investment.
Hepatitis C Medication Evolution
Previous to 1989, Hepatitis C had yet to be identified and was merely known as Non-A Non-B Hepatitis. Below is a general timeline for the more prominent medications used to fight the Hepatitis C virus and their effectiveness:
- 1991 – Although this type of interferon had a low success rate, the Food & Drug Administration (FDA) approved Intron A (interferon alfa-2b), the first treatment for Hepatitis C.
- 1998 – Used alongside interferon alfa-2b, ribavirin is approved by the FDA for treating Hepatitis C.
- 2001 and 2002 – Slight improvements were made to interferon and ribavirin medications, but the treatment success rate remained at or below 50 percent. Side effects were often severe.
- 2011 – To be added to pegylated interferon and ribavirin therapy, first generation triple therapies were approved by the FDA; namely boceprevir and telaprevir. Treatment success rates began to pass the 50 percent mark, but not without some challenging side effects.
- 2013 – Also added to pegylated interferon and ribavirin therapy, second generation triple therapies were approved by the FDA: sofosbuvir and simeprevir. Treatment success rates climbed even higher (some groups achieved success rates in the 90th percentile), but the pegylated interferon and ribavirin side effects remained problematic.
- 2014 – Finally getting rid of the pegylated interferon injection, all-oral treatment for Hepatitis C becomes FDA approved. The ledipasvir/sofosbuvir (Harvoni) was approved first and was soon followed by ombitasvir/paritaprevir/ritonavir and dasabuvir (Viekira Pak). Treatment success rates soar to 95 to 100 percent in certain populations.
- 2015 – Maintaining a very high treatment success rate, the momentum of all-oral regimens builds with the approval of daclatasvir to be used with sofosbuvir and ombitasvir, paritaprevir and ritonavir (Technivie) with ribavirin for genotype 4 without scarring or cirrhosis.
- 2016 – All oral Hepatitis C drugs released this year target harder to treat populations. Elbasvir/grazoprevir, with or without ribavirin earned FDA approval and boasts treatment success rates up to 97 percent for genotype 1 and up to 100 percent for genotype 4. Sofosbuvir/velpatasvir is approved for genotypes 1 through 6.
Since 2014, the all-oral Hepatitis C treatment regimens are boasting very high success rates. However, the cost of these medications is staggering – costing nearly $90,000.
The Study Claiming Hep C Drugs Are Economically Sound
Using a decision-analytic Markov model, investigators analyzed the therapeutic benefit and total treatment cost with the quality-adjusted cost of care associated with treatment regimens for Hepatitis C genotype 1. Four approved regimens in treatment-naïve genotype 1 chronic Hepatitis C patients were compared:
- Pegylated interferon and ribavirin – the old standard of care that yielded a 50 percent treatment success rate
- First generation triple therapy – boceprevir + pegylated interferon + ribavirin
- Second generation triple therapy – sofosbuvir + pegylated interferon + ribavirin and simeprevir + pegylated interferon + ribavirin
- All oral direct-acting antiviral regimens – ledipasvir/sofosbuvir (Harvoni) and ombitasvir + paritaprevir/ritonavir + dasabuvir ± ribavirin
The researchers measured the cost of treatment against the patient’s adjustment in years of living a quality life. They valued one quality year of life at a worth of $50,000. As published in the journal Medicine, the all-oral therapies provide the most economic benefit. Although the all-oral therapies increase Hepatitis C drug costs by nearly $50,000, the number of quality years it adds to a patient’s life is financially worthwhile. Despite being funded by one of the pharmaceutical companies behind an all-oral regimen, the impact of this analysis is poignant.
Allocating a monetary amount to each year living a high-quality existence may seem arbitrary and materialistic, but it is an economist’s approach to determining long-term value. Based on this financial analysis, forking over the big bucks to eliminate Hepatitis C with an all-oral treatment regimen is worthwhile for both the patient and their economic value to society.
http://www.harvoni.com/discover-harvoni/clinical-study-results, Harvoni, Retrieved October 23, 2016, Gilead Sciences, Inc., 2016.
http://www.hepatitiscentral.com/medications-to-treat-hepatitis-c-a-timeline/, Medications to Treat Hepatitis C – A Timeline, Retrieved October 23, 2016, Hepatitis Central, 2016.
https://www.ncbi.nlm.nih.gov/pubmed/27741116, Assessment of cost of innovation versus the value of health gains associated with treatment of chronic hepatitis C in the United States: The quality-adjusted cost of care, Younossi, ZM, et al, Retrieved October 21, 2016, Medicine, October 2016.
https://www.viekira.com/about-viekira, About Viekira XR, Retrieved October 23, 2016, AbbVie, Inc., 2016.