Yesterday the Canadian Agency for Drugs and Technologies in Health (CADTH) sent out notice that they are currently seeking patient group input for the hep C treatment grazoprevir/elbasvir, developed by Merck.
Grazoprevir/elbasvir is a once-daily, single-pill hep C treatment made up of grazoprevir, a NS3/4A protease inhibitor, and elbasvir, a NS5A inhibitor. It is being tested on patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, or advanced liver cirrhosis or inherited blood disorder.
In April, the Food and Drug Administration (FDA) in America gave the treatment Breakthrough Therapy designation to treat patients with hep C genotype 1 with end stage renal disease on hemodialysis, and patients with hep C genotype 4 or 6. The Breakthrough Therapy designation helps fast-track treatments through the American drug approval process when they treat serious diseases and their clinical trial results show that the drug may be a large improvement over existing therapies.
In Canada, Health Canada is currently reviewing the treatment. It has not been approved for use yet.
About Patient Group Input Reports Requested by CADTH
Within the Canadian drug approval process, Health Canada evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.
During Common Drug Reviews, CADTH requests patient input reports. These patient input reports help ensure that health outcomes and issues important to patients are incorporated into the Common Drug Review process in a formal and meaningful way.
They help ensure that patients and their loved ones can be a part of the drug review process!