Sara White, Doctor of Pharmacy, Masters in Public Health and is the resident expert on drug pricing, generics and healthcare accessibility.
The following articles covers the release of new hep C generics from two large pharmaceutical companies fighting for the HCV market share in the US. First article is authored by Sara White, the second article is authored by Tara Reid.
September 15th in 2018, the manufacturer of Harvoni and Epclusa made a questioning and controversial move in the pharmaceutical industry; they started making generics. A full 12 years for Harvoni and 14 years for Epclusa, before their patents would expire.
Primary reason for this move by Gilead, was the stiff competition they would start facing from Abbvie’s Mavyret, the savings range from $48,200 to $68,100 for Epclusa and Harvoni, respectively.
Generic Harvoni and generic Epclusa are offered through Gilead’s subsidiary, Asegua Therapeutics.
According to J.P. Morgan, the Asegua Therapeutics grabbed almost 20% of the generic Epclusa market in early 2018. The generic version of Epclusa (velpatasvir 100mg and sofosbuvir 400mg) is priced at $24,000.
Original price of Epclusa is $74,600 a huge discount for its generic version.
While Abbvie’s Mavyret is priced at $26,400, so Gilead undercut the competition by $2400.
Abbvie is a late comer (August 2017) in the hepatitis C treatment market, but currently has 41% of the market with their 8 week treatment course of Mavyret. Mavyret treats 6 major genotypes of hepatitis C.
Today, the blockbuster sales and profits that were part of Gilead’s image are history. Competition has reduced the prices significantly to over 75% in the past two years.
Now Gilead is ramping up for increased sales with its copycat generics trying to get a bigger share of HCV market, with lower prices and lower co-payments at the local pharmacy.
Medicaid plans in various states are working with Gilead to promote its generic HCV campaign.
However, it may have come too late to the party. Mavyret has a strong presence in Medicaid programs around the country and is the leader with hepatitis C treatments.
In 2019 Gilead will promote their authorized generic Harvoni and generic Epclusa aggressively in Medicaid markets, according to Laura Hamill, Gilead’s EVP of worldwide commercial operations.
Generics accounted for almost 25% of Gilead’s hepatitis C revenues of $355 million in the second quarter 2019. Which is down 35% from last year.
Robin Washington, the CFO of Gilead Science, told that the company is very encouraged by the generics or copycats gain in market share. She also stated that it will give the company a competitive edge in HCV treatment market.
Epclusa generic prescriptions have increased 77% in the third quarter. Generic Harvoni has not done as well and has reduced about 10% in prescriptions, according to a J.P. Morgan analysis and recent report.
This third quarter has been tough for Abbvie’s Mavyret, took a 16.3% loss in prescriptions.
Branded Harvoni lost 25% year over year and branded Epclusa was down 7.5% in prescriptions compared to last year.
Overall the market has been competitive in 2019, this year in 2020 we will see more consolidation in prices for many generics.
Pharmacies are Now Carrying Generic Harvoni and Generic Epclusa
Tara Reid, Master’s in Public Health, has been a regular contributor on infectious disease, such as hepatitis C and hepatitis B. She also has written about a variety of medical & pharmaceutical related topics like drug pricing policy, orphaned drugs, innovative cancer treatments and medical tourism.
This article below discusses the availability of generics of popular branded hepatitis C drugs that are more affordable than in previous years.
Scarring of the liver and liver cancer are caused by a viral infection from the hepatitis C virus.
Unfortunately, there is no vaccination for hep C compared to hepatitis A and B.
The good news is there is a treatment for hepatitis C with Harvoni (ledipasvir 90mg and sofosbuvir 400mg) and Epclusa, both have a good cure rate.
The prescription cost for these new hep C drugs are high, the price tag can go up to $200,000 for 24 weeks of treatment.
Gilead Sciences invented and patented the only reliable treatment of hepatitis C. There was no competition for Gilead until Abbvie’s Mavyret came in to the market which was priced at $26,400, took a bite out of the HCV market.
Names of the new generic?
As previously mentioned Harvoni is ledipasvir 90mg and sofosbuvir 400mg, but they’re calling it ledipasvir/sofosbuvir.
Epclusa’s generic name is velpatasvir/sofosbuvir, velpatasvir 100mg and sofosbuvir 400mg strength.
Both Harvoni and Epclusa come in only one strength as mentioned above.
Generics according to the FDA are exact copies of the name brand medicine.
What are the prices of these generics?
The list price of both generics are $24,000. A pretty good deal compared to what they were priced a few years ago.
Harvoni was priced at $94,500, while Epclusa retailed at $74,760. Both prices are for 84 tablets and the most common 12 week course of treatment.
Most pharmacies you can get a pretty good discount and your copays will be around $10,000.
Are the side effects of the generics the same as branded Epclusa and Harvoni?
Yes, because the brand name and the generic are identical copies, the side effects are the same.
Most patients taking generics or brand name treatments reported some of these side effects:
- Lethargy (tiredness)
- Insomnia (not able to sleep)
Some patients experienced allergic reactions like:
- Slight depression
- Brain fog (not able to think clearly)
- Difficulty breathing or shortness of breath
- Weakness or tired feeling
According to the most recent clinical trials of Harvoni and Epclusa, they are safe and effective. The side effects are minimal for majority of patients.
The only drawbacks and push backs from consumer advocacy groups that the prices of both the brand and generics are rather high for most Americans.
For the past few years there have been protests regarding the pricing of these new hep C treatments.
Drug pricing is a complex issue as is accessibility to medical/healthcare is in our country.
Healthcare organizations and pharmaceutical companies invest billions of dollars in research and development to innovate.
We thank them to bring these life saving meds to market and provide a solution for millions of people here in America and around the world.
Sunny Pharma hopes to encourage this types of dialogue to facilitate engagement that we all hold so dear to our heart, our health and our family and friends’ health.