Gilead’s Generics Steal Market Share from Abbvie’s Mavyret

Sara White, PharmD

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.

generic vs. name brand drugs from the fda
Generic Vs. Name Brand

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 MPH, Sunny Pharma
Tara Reid, MPH

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.

Source: Walmart pharmacy

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:

  • Headache
  • Diarrhea
  • Nausea
  • Lethargy (tiredness)
  • Insomnia (not able to sleep)

Some patients experienced allergic reactions like:

  • Slight depression
  • Brain fog (not able to think clearly)
  • Dizziness
  • 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.

Cost of Harvoni: Hepatitis C Treatment

Cost of Harvoni: Hepatitis C Treatment

Cost of Harvoni

sara white
Sara White, PharmD

 

Sara White, Doctor of Pharmacy, Masters in Public Health and is the resident expert on drug pricing, generics and healthcare accessibility.

There is no vaccine to prevent hepatitis C.  However, there are new drugs that have a high cure rate for most hepatitis C infections.

This article covers the cost of Harvoni, a drug that has a very high cure rate for hepatitis C.

Cost of Harvoni?

Sunny Pharma Steve Flamm Hepatologist
Source: University of Pennsylvania “Liver transplant cost is $577,000.00” says Dr. Steven Flamm, Hepatologist

Hepatitis C is an infectious disease that damages the liver over time.  In 2014, new hepatitis C drugs were invented that can cure most people with hepatitis C. 

The cost of Harvoni is $94,500 for 84 tablets for 12 weeks of treatment.  The 8 week treatment course with Harvoni is $63,000 for 56 tablets.  Some hepatitis C patients have to take Harvoni for 24 weeks course, which is $189,000 for 168 tablets.

Now, these prices are high according to Dr. Steven Flamm, of Penn Center for Viral hepatitis, but when you compare the prices to a liver transplant its a fraction of the price.

Many pharmaceutical companies and scientists are working on new ways that to reduce the cost of hepatitis C medicine.

 

Why is the cost of Harvoni high?

We all understand that pharmaceutical companies invest billions of dollars on research and innovation.

Large pharmaceutical companies like Merck, Gilead Sciences, Abbott and many others have a very difficult time on deciding on how to price the cost of hepatitis C treatments.

Usually, most hepatitis C treatments are always more expensive than their predecessors, like Peg-Interferon and Ribavirin.

Today, the direct acting antivirals (DAAs), that cure hepatitis C, were developed and patented by Gilead Sciences. The drug patent reduces competition from other large and small drug manufacturers.

harvoni cure rate
Source: Harvoni TV commercial

Right now there is no competition for manufacturing and distribution; the price of Harvoni is going to be high.

Price of Harvoni is also high because only a small number of Americans will take this hepatitis C treatment.

Smaller the number of patients the higher the cost of each tablet of Harvoni ($1,125).

Approximately, 3.5 million Americans suffer from hepatitis C, but only half know they have it.

United States Centers for Disease Control Presents Key Facts:

  • Hepatitis C is spread from an infected person to a non infected person by blood.
  • Most with hepatitis C do not show any symptoms, but it they do show symptoms, then the liver disease can be at an advanced stage.
  • Liver cancer is caused by hepatitis C and liver transplants are the leading result.
  • Those born between 1945 to 1965 (Baby Boomers) have the highest rates of hepatitis C.

Hepatitis C Prevention Tips from Centers of Disease Control and Prevention (CDC).

  • Get tested if you were born between 1945 to 1964
  • Get tested if you have had a blood transfusion or an organ transplant before 1992
  • Do not share needles
  • Injecting drug users have a high risk of hepatitis C transmission

Drug pricing is very complex.  Many millions of Americans are infected with hepatitis C and researchers are working towards making it more affordable.

 

Hepatitis C Drug Costs

harvoni $94,500 sovaldi $84,000 sunny pharma, generic harvoni generic sovaldi generic epclusa
Source: CBS News; Gilead owns the patent to Harvoni

United States Food and Drug Administration (FDA) has approved direct acting antiviral medications in tablet form to treat hepatitis C in 2014.

Today, there are several hepatitis C treatments that have been approved by the FDA, but still the costs remain high.

The cost of Harvoni varies between insurance plans, pharmacy and the patient’s medical history.

With that said, there are an average or approximation of the cost of Harvoni, according to the University of Washington.

Harvoni (ledipasvir 90mg and sofosbuvir 400mg) is $1,125 per pill. 84 tablets for 12 weeks course is $94,500, 56 tablets for 8 weeks course is $63,000. The 24 weeks course is $189,000.

The costs of Harvoni are high for the treatment of hepatitis C.

There are new treatments developed by researchers that are $54,600 for a 12 week course of treatment.

We should see the price of hepatitis C treatments come down.

 

Cost of Harvoni Covered by Insurance?

cost of harvoni with insurance sunny pharma
Source: CBS News; Insurance plans vary for the coverage of Harvoni

Insurance coverage of hepatitis C often depends on the insurance policy and general health of the patient.

If a patient has not responded well to previous hepatitis C treatment or if the patient is showing signs of advanced liver disease, then insurance companies sometimes offer to pay or cover the cost of Harvoni.

A patient must be free of alcohol and drug use to be eligible for treatment for most insurance companies.

This process helps insurance companies to save money when treating hepatitis C patients.

Once a patient find out they have hepatitis C or is diagnosed, their doctor will recommend various hep C treatments.

Then, the insurance company will find out which treatments (medicine) the patient is eligible under their insurance plan coverage.

 

What if you don’t have insurance?

American liver foundation drug discount card
Source: American Liver foundation; Drug Discount card can lower the cost of Harvoni

There are options if an insurance plan does not cover for treatments.

Patient assistance programs help with lowering the cost of some specific treatments.

For more help with costs, see the following resources:

My Support Path was setup by the manufacturers of Harvoni, Gilead Sciences and is a good place to start to get prescription assistance for your treatment.

Another great source for discounts on hepatitis C treatment is Needy Meds, they have helped millions of people with reducing the price of everyday prescriptions. They also can provide a solution for Harvoni.

The American Liver Foundation has made available a Drug Discount Card that may help alleviate the costs of Harvoni and other new hepatitis C treatments.

 

Take Away

Understanding the process of getting financial assistance and lower price discounts can be hard and challenging.

A patient may talk to their doctor to recommend a specialist that focuses on financial assistance or a social worker that has experience getting lowered price treatment for Harvoni.

It is worth the time and effort to research all options to get treatment and cured of hepatitis C.