There has been some late-breaking news: on June 28, 2016, the Food and Drug Administration (FDA) approved Epclusa for the treatment of hepatitis C genotypes 1, 2, 3, 4, 5, and 6. Epclusa is a combination of two drugs combined into one pill taken once a day. The treatment duration for all of the genotypes is 12 weeks. The recommendation from the FDA included in the Highlights of Prescribing Information:
Treat patients without cirrhosis or with compensated cirrhosis with Epclusa (no ribavirin). The cure rates: 97% to 100%
Treat patients with decompensated cirrhosis with Epclusa plus ribavirin. The cure rates: 85% to 100%
The price tag for a 12-week course of therapy is $74,760. I will provide more detailed information in next month’s HCV Advocate newsletter.
In this month’s edition of the HCV Advocate newsletter we have the following articles:
SnapShots by Alan Franciscus –I discuss three studies—(1) the next Gilead triple therapy, (2) the effect of race on hepatitis C disease progression and death, and (3) the relationship of alcohol to cirrhosis and liver cancer.
HCV Advocate Monthly Pipeline Update – I have updated the drug pipeline to include information about Gilead’s salvage therapy and new data from Regulus Therapeutic Inc.–note: RG-101 was recently put on hold by the FDA.
Effective May 13, 2016, CDPHP expanded its coverage of chronic Hepatitis C treatment. Coverage will no longer be denied based on fibrosis level or based on drug or alcohol use. To see if you may be eligible for coverage, please contact your physician.
After threatening to sue Gilead Sciences over the cost of its hepatitis C treatments, the commonwealth of Massachusetts has reached a deal with the drug maker to receive rebates for most of its residents who are infected with the chronic disease.
The deal, which begins Aug. 1., is expected to save the state a significant amount of money, but projected savings were not disclosed. However, the cost of hepatitis C drugs for about 2,800 people covered by MassHealth, which is the commonwealth’s Medicaid program, has so far totaled about $318 million from late 2014 through early 2016, according to a statement from the agency. A MassHealth spokeswoman, however, said the state expects lower unit costs to be offset by more people being treated, so the state is not forecasting any change in net spending.
Gilead’s Harvoni treatment will be the exclusive therapy for about 80 percent of MassHealth Members, although the agency also negotiated rebates for the older Sovaldi medication and Daklinza, a hepatitis C medicine sold by Bristol-Myers Squibb, which would be used to treat about 20 percent of those who are infected with specific strains of the disease.
The state’s Medicaid program announced Thursday it is lifting restrictions that prevented many patients from getting powerful drugs that can cure hepatitis C, after negotiating new discounts from two manufacturers.
The changes at MassHealth, as the program is known, take effect Aug. 1.
The agreement lowers the cost of three brands of a new class of drugs that are highly effective against the liver-destroying virus — but are expensive.
After a long dry spell, the pharmaceutical research industry has brought to market a spate of innovative treatments that can extend life and often have fewer side effects than older treatments. But these medicines are not affordable to most of the people who need them. Recent treatments for hepatitis C and cancer – both widespread conditions globally – can cost from $50,000 annually to well over $150,000.
At the other end of the spectrum, the generic pharmaceutical industry is losing interest in manufacturing older, off-patent medicines because the market price has been slashed to a level that it no longer provides an incentive to produce them. The result is either low-quality medicines, or no medicines at all. Two clear examples of this phenomenon are Benzathine penicillin, the antibiotic of choice for certain bacterial infections, and methotrexate, used to treat arthritis, psoriasis, and certain cancers. These products, still needed and often prescribed, are frequently unavailable in health systems.
These recent trends represent a two-fold setback: on the one hand, new medicines are out of reach of even the wealthiest countries, on the other, older medicines are in great shortage.
Epclusa is first treatment for all forms of the disease
Drug will mainly be used in patients with genotypes 2 and 3
Gilead Sciences Inc.’s hepatitis C drug was approved by U.S. regulators for all forms of the viral disease, making it the first treatment with such a comprehensive label.
The drug, called Epclusa, can be used by patients with any of the six genotypes of hepatitis C, the U.S. Food and Drug Administration said Tuesday in a statement. The liver disease affects 130 million to 150 million people globally, according to the World Health Organization.
Gilead has set a list price of $74,760 for a 12-week course of treatment, Chief Executive Officer John Milligan said by telephone. That’s lower than the list prices of its best-selling treatments Sovaldi, at $84,000, and Harvoni, $94,500. The Foster City, California-based company has been criticized in the past for the costs of its drugs.
FDA Approves Epclusa for Treatment of Chronic Hepatitis C Virus Infection
Silver Spring, Maryland–(ENEWSPF)–June 28, 2016. The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.
“This approval 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.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the genotype helps inform treatment recommendations and the duration of treatment. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small numbers of patients are infected with genotypes 4, 5 or 6. According to the Centers for Disease Control and Prevention, HCV infection becomes chronic in approximately 75 to 85 percent of cases. Patients who suffer from chronic HCV infection over many years may have complications, such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and death.