Gilead Pharmaceuticals announced September 25, 2018, it is moving into the generics business, with a newly created subsidiary called Asequa Therapeutics. Gilead announced in January of 2019, they will start selling in the U.S. “authorized” generic versions of two of its three hepatitis C (HCV) drugs, Harvoni, and Epclusa even though the patents on these drugs are not expired.
The list price of the generics will be $24,000, which is considerably lower than its original price tag of $84,000 for Sovaldi, $95,000 for Harvoni and $75,000 for Epclusa.
With pan-genotypic treatments, there is a big shift in the market to use treatments that work for all genotypes, such as Epclusa, and Vosevi, which are both made by Gilead, and Mavyret which is made by AbbVie.
Janssen pulled out of the Hep C market with discontinuing Olysio in May 2018. AbbVie is discontinuing Technivie and Viekira XR (Viekira Pak not included) which will only be available until January 1, 2019.
AbbVie took the first major move to turn the tide of high hepatitis C treatment prices with it’s leading drug, Mavyret with a lower price tag of $26,400.
Ulmer Raffat of Evercose ISI in a research note stated, “I doubt Gilead can make a move like this and competitors won’t respond. It’s possible this will start another round of pricing flux in this market.”
What does this mean for the hepatitis C patient? It’s likely those who have been denied treatment by their insurance companies due to the high cost of treatment will now be getting another chance of approval and receive treatment.
Physicians, as well as patients, may take a sigh of relief with changes coming in 2019 with the possibility of reducing the amount of hepatitis C cases in the U.S.
Connie Welch with Life Beyond Hep C states, “With generic treatments available in the U.S. with lower cost, we hope this will allow more hepatitis C patients to be treated with an early diagnosis and lessen the chance of patients having complications with further liver damage such as cirrhosis, ascites, liver cancer, and liver transplant. Treatment for hepatitis C does not cure cirrhosis.
Patients should not have to wait until they develop fibrosis or later stages of liver damage to receive treatment. Patients should never be told, “you’re not sick enough to be treated.”
The cure rate for the majority of hepatitis C treatment is 95% to 99%, which cures the hepatitis C virus, and stops further liver damage occurring. Though the liver can regenerate from a certain amount of liver damage, the liver cannot repair from severe damage (scarring) of cirrhosis. Cirrhosis is associated with other complications such as ascites, liver cancer and liver transplant. Early treatment of hepatitis C can save lives.
This entry was originally published on Life Beyond Hepatitis C, and is reprinted with permission.