Hep-C patients push P.E.I. government to approve drugs

makers of Sovaldi say the cost of a 12-week course of treatment with that drug would be approximately $55,000

Published on May 31, 2014

Screen capture of Sovaldi, a drug to treat hepatitis C

More than 200 people have written letters or signed petitions calling on the province to immediately add two new drugs to treat hepatitis C to the P.E.I. Pharmacare Formulary.

Kathleen Critch, one of those involved  in efforts to bring these drugs to P.E.I., says those efforts are ongoing and others are expected to add their voice to the call for provincial authorities to act.

Critch, whose mother has hepatitis C, says Islanders deserve access to these drugs.

"I hope that you will do everything in your power to make them available to the Islanders who need them," she stated in a letter to the provincial government.

The drugs in question, Sovaldi and Galexos, are currently being reviewed by the province of Nova Scotia.

Sovaldi was approved by Health Canada in December, while Galexos was approved by the same agency last November.

Both have been approved in the U.S. by the FDA.

A petition addressed to Premier Robert Ghiz and Health and Wellness Minister Doug Currie asks for those treatments to be added to the provincial catastrophic drug plan because of the costs involved.

In a letter to  deputy minister for Health and Wellness, Dr. Michael Mayne, Critch  says providing access to these drugs would benefit  not just those Islanders suffering from hepatitis C but also  the government that is paying for their health care.

Referencing figures from the Public Health Agency of Canada, supporters say more than 1,000 Islanders currently have hepatitis C and could benefit from the use of these drugs.

The makers of Sovaldi say the cost of a 12-week course of treatment with that drug would be approximately $55,000.

While that may seem expensive, petitioners say it's far less than the cost of a liver transplant many people with the disease may require.

Critch noted that in the United States, for example, the average billing for a liver transplant was $577,100.

That number includes the costs for the 30 days pre-transplant care, procurement of the liver, hospital transplant admission, the cost of the physicians during the transplant, the 180 days post-transplant admission and the cost of the OP immunosuppressants and other prescriptions.

Critch said the cost of treatment with Sovaldi is just 16 per cent of the cost of a transplant.

"You could buy at least six drug treatments in the United States for the cost of one transplant."

A spokeswoman for the Department of Health and Wellness says the department is aware of these two drugs.

"The coverage of new drugs by P.E.I. Pharmacare programs is based upon the clinical recommendations of a national advisory committee after a drug has been approved by Health Canada," the spokeswoman said.

"The department will be watching with interest the outcome of these reviews, as well as the work of the Pan-Canadian Pricing Alliance. That committee determines the safety and value to citizens of these drugs - these two particular drugs are very expensive."

The spokeswoman said the department looks forward to opportunities that may improve the lives of Islanders living with hepatitis C while recognizing the importance of clinical expert advice and contributing factors such as resources.

She noted the department recently added the drugs Boceprevir (Victrelis) and Telaprevir (Incivek) to the provincial formulary.

 

FACT BOX

Following are brief descriptions of the two drugs the province is being asked to add to the formulary.

Sovaldi is a once-a-day prescription medicine that is used with other antiviral medicines to treat chronic hepatitis C infection in adults.  

In a study of 327 patients who had no prior hepatitis C treatments and who all received Sovaldi once daily for 12 weeks along with another oral medicine, ribavirin and a weekly injection, peginterferon alfa, 89 per cent of those with the most common type of hepatitis C (genotype 1) were cured.

"Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed," a statement from the drug's manufacturer says.

Galexos is a protease inhibitor that works by blocking the protease enzyme that enables the hepatitis C virus (HCV) to replicate in host cells, Galexos is administered, like Sovaldi, by oral capsule, once daily for 12 weeks in combination with pegylated interferon and ribavirin, followed by pegylated interferon and ribavirin alone for an additional 12 or 36 weeks.

Dr. Morris Sherman, associate professor of medicine at the University of Toronto, was quoted recently as saying that data from clinical trials have shown that in combination with pegylated interferon and ribavirin, Galexos can give patients, even those who have failed previous treatment with pegylated interferon and ribavirin, a chance to cure the disease with a manageable side-effect profile.