How come generic Epclusa can cost less than $1,000?

Original Epclusa, a newly developed Hepatitis C drug, was launched on 28th of June 2016 with a cost of $74,760 per standard treatment. A majority of Hepatitis C patients, both in developed and undeveloped countries, cannot afford the new Hepatitis C treatment because of such high prices. The solution is to wait for generic Epclusa (sofosbuvir/velpatasvir) the price of which can be up to 98% lower than the original medicine – as low as less than $1,000 per treatment.

First generic Epclusa hit the market already – Sofosvel by Beacon Pharma

Generic Epclusa is by a definition of generic medicine an exact copy of original Epclusa and has the same effectiveness and side effects.

sofosvel generic epclusa
First generic Epclusa – Sofosvel by Beacon Pharmaceuticals

Usually India is the first country that develops generic drugs. However, in the case of Epclusa, it was a Bangladesh-based company Beacon Pharma that developed the first Epclusa generic – they are marketing it under a trademark name Sofosvel.

Sofosvel

The originator of Epclusa – Gilead Sciences – gave licenses to produce generic versions of Epclusa to several Indian and third world countries based pharmaceutical companies.

Beacon Pharma is the first of such companies that developed and got an FDA approval for a first generic Epclusa called Sofosvel. Sofosvel will shortly be available in more than 60 undeveloped countries, including India, Pakistan and Egypt. There is no doubt that the low price of Sofosvel will attract patients from the US and EU who would rather save more than $70,000 by traveling to India or Bangladesh to get the medications they desperately need. In a short time, it will probably be possible to buy generic Epclusa online and ship it to your home address within a few days.

Sofosvel regimen and cure rate

Sofosvel consists of 400 mg sofosbuvir and 100 mg velpatasvir pills, the same as Epclusa. The treatment lasts for 12 weeks and has a very simple regimen – one pill of Sofosvel per day. Beacon Pharma offers the sofosbuvir/velpastavir in 6 tablets packages. For a 12 week treatment, a Hepatitis C patient needs 84 tablets – this means a patient has to acquire 14 packages of Sofosvel for a single treatment. Luckily, the cure rate of Epclusa/Sofosvel is above 95% for all genotypes.

Epclusa is the first developed Hepatitis C medication that was approved by FDA for all genotypes of Hepatitis C. Genotype 1, 2, 3, 4, 5 and 6 patients are now all covered by the same drug. In the developed countries, however, Epclusa is primarily intended to be used by genotype 2 and 3 patients. For other patients, the preferred treatment is still Sovaldi or Harvoni.

Epclusa generic in India

India is the leading country as far as generic medicines go. Previous Hepatitis C medications such as generic Harvoni or generic Sovaldi were first developed in India. Gilead has given licenses to Indian manufacturers who are still in the process of developing their versions of generic Epclusa.

According to some sources, generic Epclusa in India will be available in November or December of 2016.

Sofosvel can still be obtained in India. However, Beacon is a Bangladesh-based producer and at this time India is still waiting for the first producer to develop the sofosbuvir/velpastasvir pills. This may happen in 2016 but in 2017 there will be a dozen (12 manufacturers) Epclusa generic on Indian market. Needless to say, this will drive the prices of generic Epclusa down in a dramatic way.

Example of Harvoni generics and how drug price can be reduced

Harvoni, the world most known Hepatitis C medicines, has a price tag of $94,500 in the US.

After several Indian companies created Harvoni generics in 2015, the price of generic Harvoni treatment (such as Hepcinat-LP Hepcvir) was reduced to below $1,000. This is almost 99% reduction in price because of generic competition.

Because there are so many potential Epclusa generics manufacturers in India, the likelihood of fierce competition between these companies will likely drive the price down in the same manner. Hepatitis C patients from all over the world and with all genotypes can reasonably expect to get their hands on generic Epclusa for less than $1,000 per treatment.

Who will produce generic versions of Epclusa in India?

The originator has stated that it has given licenses to 12 Indian manufacturers to produce generic Epclusa. These are likely the same companies that were given licenses to produce generic versions of previous Hepatitis C treatment, such as Sovaldi and Harvoni.

Companies that may manufacture Epclusa in India probably include:

  • Natco Pharma
  • Mylan Laboratories
  • Heterolabs
  • Cipla
  • Ranbaxy Laboratories
  • Cadila Healthcare
  • Sequent Scientific 
  • Strides Arcolab

You can read more about the agreement between Gilead and Hepatitis C generic producing companies on Reuters.

The originator is still earning a profit by giving licenses – they collect royalties from every generic Epclusa pill sold. Given that India, Pakistan, Egypt and other countries together represent a massive market with more than 100 million Hepatitis C patients, these royalties add up. However, what is more important, is that patients get the medicines they desperately need for low prices and with the quality of production that the originator guarantees via licensed companies.

Why is generic Epclusa so important?

Since 2013's launch of Sovaldi, we have a very good cure for Hepatitis C. In the last years, Hepatitis C has been transformed from a deadly disease to a perfectly curable one. However, more than 500,000 people a year still die because of Hepatitis C or Hepatitis C related problems. Why?

The developed drugs, such as Sovaldi, Harvoni, Viekira Pak and now Epclusa, are simply too expensive for patients with an average income. Much has been done to reduce prices of Hepatitis C drugs but results are not what patients would want. For example, the US patients can help to get at most 25% reduction on their $80,000+ bill for Hepatitis C drugs.

Generic Hepatitis C drugs were a salvation in this respect. They can be obtained for less than $1,000 in countries such as India and Bangladesh. However, for a third world country patient $1,000 is still a lot of money, considering that he or she has to go through a medical diagnosis that consists of genotyping.

Hepatitis C Genotyping and how Epclusa is a salvation

Before Epclusa, a patient had to undergo Hepatitis C genotyping to figure out which HCV genotype is present in the liver and to choose different drugs accordingly. This genotype test can cost up to $300. In undeveloped world, fetching out $300 just to get a genotype seemed unreasonable.

With Epclusa, doctors can skip the genotyping because Epclusa is the first pan-genotype Hepatitis C medicine. This means that is about equally effective (above 95%) for all genotypes. This in effect saves $300 per patient.

When a doctor confirms a patient to be Hepatitis C positive, he or she can prescribe Epclusa regardless of genotype a patient is suffering from. This means that a lot more patients can now be safely and effectively treated, especially in the undeveloped countries where genotyping was the barrier to treatment due to its high price.

Having generic Epclusa is vital for undeveloped world

Of course, saving $300 for a genotype test would be nothing compared to $74,760 price of original Epclusa. This is where generic versions of Epclusa, such as Sofosvel, have to come into play.

Patients in less developed countries need generic Epclusa because of its low cost. India or Egypt, for example, are very reluctant to pay huge sums of money to pay for original Epclusa. However, producing a generic version of Epclusa which may cost less than $1,000 is something they can consider paying for, at least partly, for their citizens.

Generic Epclusa in the developed world

“There is bound to be crossborder movement of any goods that costs $1 in one country and $1,000 in other,” said Andrew Hill, Department of Pharmacology and Therapeutics of University of Liverpool.

Dr. Andrew Hill raises a very important question – why would lets say US or EU citizens pay $74,760 for original Epclusa if they can get generic version of same quality and effectiveness for less than $1,000 in India?

import of drugs for personal use
Article of WTO that allows import of drugs for personal use.

This is the problem the pharmaceutical originators are facing; and there is not much they can do to combat it. With the existence of free market and the regulation of World Trade Agreement which specifically states that import of small amount of goods for personal use (such as Hepatitis C medications) is permitted, medical tourism is flourishing.

The originators are actively trying to prevent this but the loop-hole in world's medicine market is currently open for everybody to use. Pharmaceutical producers are regularly criticised about the high prices of new drugs, especially in the Hepatitis C treatment area, even by the US Senate. The case of Epclusa and generic versions of Epclusa are bound to be no different than Harvoni or Viekira Pak.

A short introduction to Epclusa

Here is Doctor Joe Galati explaining Epclusa in a 6-minute video.

Ask us about generic Epclusa and share your experiences in the comment

Hepatitis C Society of NDA is an online-based society where everybody – a patient, a doctor, a concerned citizen – can join and share his or her opinion on the treatments and the economic aspect of Hepatitis C therapeutic area.

We welcome your experiences with Hepatitis C treatments and would like to hear from you. Share your opinion about generic Epclusa or other topics in the comments or visit our forum. Let us help each other with real-world experiences about dealing with Hepatitis C.

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