Holkira Pak (generic name: ombitasvir / paritaprevir / ritonavir and dasabuvir) has been listed on the pan-Canadian Pharmaceutical Alliance‘s most recent table of active drug product negotiations. Negotiations between the pan-Canadian Pharmaceutical Alliance (pCPA), a negotiations team from different provinces and territories that works to get the best value for brand name and generic drugs for publicly funded drug programs, and Holkira Pak’s manufacturer, AbbVie, are currently underway.
Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. After which, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) assesses the drug’s clinical and cost-effectiveness as it compares to other treatments.
For Holkira Pak, CADTH started this step on November 3rd, 2014, when it called for patient input. Although, Holkira Pak’s submission for a Common Drug Review is listed as only being accepted on December 3rd, 2014, one month later.
According to the pan-Canadian Pharmaceutical Alliance (pCPA)’s website, once a CDR is complete, the pCPA may then step in after deciding that joint pan-Canadian negotiations for the drug will occur. A province/territory then assumes the lead in negotiations, contacts the manufacturer, and negotiations get underway. If an agreement is reached about treatment prices, the lead province, the manufacturer, and the other jurisdictions all sign a Letter of Intent. The Letter of Intent ends the pCPA’s involvement in the drug’s approval process.
Provinces/territories then make their own final decisions about funding the drug or not through their healthcare plans. If they choose to do so, they then sign a product listing agreement with the manufacturer.
This is where it gets a bit more interesting. Currently, Holkira Pak is listed by CADTH as still undergoing a CADTH Common Drug Review (CDR). The last step listed as completed on the CDR’s Submission Status sheet for Holkira Pak is dated May 28th, 2015. On May 28th, the CDR reports and the recommendation by the Canadian Drug Expert Committee (CDEC), the committee of experts who review all of the data and analyses involved, were sent to the provincial/territorial drug plans and the drug’s manufacturer. A target date for the final CDEC recommendations being sent to drug plans and manufacturer is tentatively listed as 15 business days after that, June 18th.
The pan-Canadian Pharmaceutical Alliance’s most recent table of active drug product negotiations, the one that lists Holkira Pak as a new drug product undergoing negotiations, was dated April 30th, 2015.
And so, we wait. We wait for news from all three parties currently involved, AbbVie (Holkira Pak’s manufacturer), CADTH, and the pan-Canadian Pharmaceutical Alliance.
Holkira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-oral, short-course, interferon-free treatment that can be taken with or without ribavirin.
In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).
For more information about Holkira Pak, CADTH, the pan-Canadian Pharmaceutical Alliance, or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.