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Is the High Cost of New Hep C Drugs Worth the Money?

December 13, 2018

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A recently released study takes on the question, “Does the value of the new Hepatitis C drugs legitimize their price?”
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Updated November 8, 2019

Those who had previously resigned to a lifetime of battling the chronic Hepatitis C virus have hope. While the new drugs currently boast over a 95 percent chance of viral eradication, their extremely high price tags can 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 in 2016 targeted harder to treat populations. Elbasvir/grazoprevir (Zepatier), with or without ribavirin earned FDA approval boasting treatment success rates up to 97 percent for genotype 1 and up to 100 percent for genotype 4. Sofosbuvir/velpatasvir (Epclusa) was approved for genotypes 1 through 6.
  • 2017 – The two medications released include a combination of glecaprevir and pibrentasvir (Mavyret) as an 8 week oral treatment for all HCV genotypes without cirrhosis and treatment-naive with estimated success rates from 92-100%, while combination therapy sofosbuvir, velpatasvir and voxilaprevier (Vosevi) was the first once-daily, single tablet approved for genotypes 1-6 who were previously treated with sofosbuvir indicating success rates between 96-97%.

Since 2014, the all-oral Hepatitis C treatment regimens are boasting very high success rates. However, the cost of some treatments is staggering – costing up to $147,000.

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. At that time, four approved regimens in treatment-naïve genotype 1 chronic Hepatitis C patients were compared:

  1. Pegylated interferon and ribavirin – the old standard of care that yielded a 50 percent treatment success rate
  2. First generation triple therapy – boceprevir  +  pegylated interferon + ribavirin
  3. Second generation triple therapy – sofosbuvir  +  pegylated interferon + ribavirin and simeprevir + pegylated interferon + ribavirin
  4. All oral direct-acting antiviral regimens – ledipasvir/sofosbuvir (Harvoni) and ombitasvir /paritaprevir/ritonavir /dasabuvir (Viekira)  ±  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.

Medications to treat Hepatitis C – A timeline. (n.d.). Retrieved November 08, 2019, from https://www.hepatitiscentral.com/medications-to-treat-hepatitis-c-a-timeline/

A simple treatment regimen for hep c. (n.d.). Retrieved October 23, 2016, from http://www.harvoni.com/discover-harvoni/clinical-study-results

Younossi, Z. M., Park, H., Dieterich, D., Saab, S., Ahmed, A., & Gordon, S. C. (2016). Assessment of cost of innovation versus the value of health gains associated with treatment of chronic hepatitis C in the United States. Medicine, 95(41). doi:10.1097/md.0000000000005048

 

 

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