Significant changes have been made to British Columbia’s drug review process in recent months to make the process quicker and to improve transparency.
The B.C. government announced the awarding of five contracts of about $50,000 annually to independent experts and their teams to conduct clinical evidence reviews about the comparative safety, efficacy, and/or effectiveness for drug submissions. Initially, there were concerns that the highly lauded University of British Columbia’s Faculty of Medicine group, Therapeutics Initiative (TI), would be left out of the revamped process. TI has done evidence-based drug reviews for the B.C. government since 1996 and has been credited for keeping costs down on prescription drugs and for advising of possible medication and drug treatment dangers. However, three of the five contracts have been awarded to TI members, with the remaining given to experts at the B.C. Drug and Poison Information Centre and the Providence Health Care and Coastal Health Research Institutes.
All members of the drug review process are now required to declare any conflicts of interest in order to facilitate transparency. The government anticipates that the new review process will be faster, as the review teams have nine to 12 months to reach a decision, about 25 percent less time than given previously.
The newly structured clinical evidence review teams will coordinate with the Common Drug Review (CDR) operated by the Canadian Agency for Drugs and Technologies in Health, an independent, nonprofit agency funded by Canadian federal, provincial, and territorial governments. CDR also conducts objective, rigorous reviews of the clinical and cost effectiveness of drugs, and provides formulary listing recommendations to the publicly funded drug plans in Canada (except Québec). Any drug submissions that are not reviewed by the CDR will be reviewed by one of the five contracted teams on a rotational basis.
Once reviews by the contracted team or the CDR are complete, they submit their decision to the province’s Drug Benefit Council (DBC). The DBC is an independent advisory panel that makes recommendations to the Health Ministry on whether and how drugs should be covered by Pharmacare. The final decision is made by the Health Ministry.
The B.C. government also announced a new plan to allow pharmaceutical companies to have four distinct opportunities—instead of one—during the drug review process to vouch for their product’s value and cost-effectiveness under B.C.’s Pharmacare Plan. B.C. Health Minister Kevin Falcon’s office stated that such changes will allow for increased industry feedback to avoid unanswered questions remaining at the end.
Sources:
http://www.theglobeandmail.com/news/national/british-columbia/critics-decry-change-in-drug-approval-process/article1810990/ (subscription required)
http://www2.news.gov.bc.ca/news_releases_2009-2013/2011HSERV0004-000054.htm