Epclusa – The Latest Hepatitis C Treatment for All Genotypes
In the last few years, there has been a boom of new Hepatitis C drugs. The latest of them, Epclusa (sofosbuvir-velpatasvir), was approved by the FDA on 28th of June 2016. First generic Epclusa was launched by Beacon Pharma under a name Sofosvel.
Here are quick facts about Epclusa:
- 1st Hepatitis C drug that has a high cure rate for all (1-6) genotypes
- Epclusa costs $74,760 per 12-week treatment – considerably less than Sovaldi ($84,000) and Harvoni ($94,500)
- Generic version of Epclusa is already available in 101 developing countries, according to Gilead's announcement
- First generic Sofosvel by Beacon Pharma is already on the market for less than $2,000
- Epclusa has comparable side effects to other Hepatitis C treatments; primarily fatigue and headaches
- Manufactured by Gilead Sciences (producer of Harvoni and Sovaldi)
- Primary use for genotype 2 and 3 treatment (genotype 1 is a choice Harvoni vs Epclusa, or others)
Epclusa and Cure Rate
There are 6 genotypes of Hepatitis C, which reflects 6 different strains of Hepatitis C virus. The developed drugs such as Harvoni, Sovaldi, Viekira Pak, Daklinza and so on were approved to treat certain genotypes, but not all. Epclusa, however, is the first Hepatitis C treatment that is registered for all 6 genotypes.
“This approval (of Epclusa) offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. (source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm508915.htm)
In the US, a majority of Hepatitis C patients (75%) suffer from genotype 1. Fortunately, treatment for genotype 1, even with severe liver cirrhosis, is very successful treated with existing medicines (Harvoni vs Epclusa).
Genotypes 2 or 3, affecting roughly 20 to 25% of Americans, are known as harder-to-treat genotypes – especially genotype 3. The treatment of genotype 3, for example, thus far included a combination of Sovaldi and Daklinza, boosting the costs of treatment to $147,000, according to Bloomberg. Epclusa can now become a drug of choice for genotype 2 and 3, because of high cure rate and easy to manage regimen. On the whole, Epclusa price is also lower than the price of Harvoni and Sovaldi in the US.
According to Epclusa's clinical studies, the sofosbuvir-velpasvir combo successfully cured Hepatitis C in 95-99% of patients with mild liver cirrhosis. Patients with moderate to severe cirrhosis experienced 94% of cure rate being on 12-week Epclusa regimen. The cure rate of Epclusa vs Harvoni are thus comparable.
You can find full prescribing information for Epclusa here.
Epclusa Cost or Price
Hepatitis C treatment cost has been rigorously discussed in the past because of the high cost of existing treatments. Epclusa cost in the US is surprisingly below the cost of Sovaldi and Harvoni. Here are Hepatitis C medication costs in the US for standard 12-week treatment:
- Harvoni (90mg ledipasvir/400mg sofosbuvir) – Price: $94,500
- Sovaldi (400mg sofosbuvir) – Price: $80,000
- Viekira Pak – Price: $83,319
- Zepatier – Price: $54,600
Epclusa is priced at $74,760 in the US. Click To Tweet This is below other Gilead's blockbusters Harvoni and Sovaldi for several thousand dollars. However, it has to be mentioned that Gilead offers majority of patients 25% discount via co-pay program, bringing the price of medications below $74,760. If you compare Epclusa vs Sovaldi price or Epclusa vs Harvoni price with co-pay included, Epclusa is actually more expensive than either of them. On the other hand, Epclusa co-pay program was also introduced, lowering the price of co-pay Epclusa to $56,070.
Other drugs such as Viekira Pak or Zepatier can have other disadvantages such as complicated regimen. You can check more about comparison of Hepatitis C medications here.
Epclusa cost in the US – $74,760
12-week of treatment with Epclusa costs $74,760 or $890 per pill. This price range is a considerable reduction from the price of other Hepatitis C treatments such as Sovaldi ($84,000) and Harvoni ($94,500). However, the price of Epclusa is still extremely high which prevents many patients from getting the drug.
Insurance might cover part of the costs – and every patient should talk to their insurance companies about how much they will cover – but most will have to pay part of the Epclusa cost or all of the Epclusa cost.
US costs of Epclusa and other drugs are usually the highest in the world. This is what was the major reason to start medical tourism. At first, US citizens went to Canada to buy medicines at 20-50% discount. Now with fully fledged medical tourism, patients go to Europe or even India. In the case of Hepatitis C medications, the cost of Epclusa in India for example can be 99% lower than in the US. One has to understand that these patients are not primarily price-hunters; they are patients desperately seeking the medications they are unable to afford in the US.
Cheaper Epclusa – Gilead Co-pay program
Gilead is offering a co-pay program that will cover 25% of the total cost of Epclusa. Despite that fact, the sum that is leftover for the patients to cover, is still more than $50,000. This is a price point only few patients can manage to pay right away.
You can read more about Gilead co-pay program on their website.
Epclusa Cost in India
Gilead has announced that 11 Indian manufacturers are licenced to make a generic version of Epclusa. Generic sofosbuvir-velpatasvir pills are available to India and 101 countries in development for a much reduced price. In the case of Harvoni, the price of treatment in India, for example, is $900, while the US price of treatment is $94,500.
In the case of Epclusa, it would not be unheard of to expect the same massive reduction in the cost of generic version of Epclusa.
Epclusa Cost in Europe
EMA (European Medical Agency) gave the marketing authoritization for Epclusa on 8th of July, 2016, about two weeks after FDA approved the same regimen. Here you can read about EMA's approval of Epclusa in European Union.
There are no information about how much does Epclusa costs in Europe.
Epclusa Cost in Canada
New Health Canada has approved Epclusa at the cost of $60,000 for a standard 12-week treatment. Click To TweetThis is almost $15,000 less than in the US. However, the cost of Epclusa in Canada is still considered very high in comparison with the generic version of Epclusa we're expected to get from India.