How drugs make their way onto the provincial list for government reimbursement:
Step 1: Authorization from Health Canada
A pharmaceutical manufacturer seeking to sell a new drug in Canada must submit an application to Health Canada for review.
Health Canada assesses the drug’s safety, clinical effectiveness (how well it prevents or controls disease) and quality of its manufacturing process.
Approval from Health Canada does not necessarily mean a drug will be funded by a province or territory.
This is primarily to assess if the drug is safe and has a minimum clinical efficacy; it isn’t required to have a meaningful effect.
Step 2: Recommendation
Once authorized for sale by Health Canada, non-cancer drugs go to the Canadian Drug Review (CDR) while cancer drugs go to the pan-Canadian Oncology Drug Review (pCODR). In Quebec, both cancer and non-cancer drugs go to the Institut national d’excellence en santé et en services sociaux (INESSS).
Expert committees from the organizations review the scientific evidence and costs to determine whether the drug works better than the usual treatment and whether the cost is reasonable.
They then make recommendations on whether the drug should be publicly funded. They sometimes recommend the drug with certain conditions.
INESSS first assesses the therapeutic value of a medication. If this is not satisfactory, the institute sends a notice to that effect to the provincial Health Department.
If the drug’s therapeutic value has been established, INESSS then evaluates the drug based on four criteria: reasonableness of price charged; cost-effectiveness ratio; impact on the health of the population; effect on the basic prescription drug insurance plan.
Drugs at INESSS are evaluated by its Standing Scientific Committee on Entry to the List of Medications.
In terms of looking at the therapeutic value, INESSS goes further than Health Canada. If a drug shows survival difference of 28 days or longer between those treated and those not, it tries to determine if that’s a meaningful outcome for those patients.
The committee is always looking for meaningful outcomes. For example, reducing hospital stays is a meaningful outcome that also reduces costs to the system.
Once the standing committee has completed its evaluation, it is sent to the board of INESSS, which follows its recommendations 99 per cent of the time.
Once a drug goes to INESSS, it can be approved within a few months.
Step 3: Provinces decide whether to make the drug available for public programs
Provincial health departments use the recommendations of the various expert committees to make their own decisions. They may consult their own expert committees and will take into consideration the effect on health services and the overall budget.
Over the last several years, Quebec health ministers have occasionally rejected the advice of INESSS and allowed very costly drugs despite the Institute’s recommendation that the price should be lowered to achieve cost effectiveness.
Sources: Pan-Canadian Oncology Drug Review, Canadian Partnership Against Cancer
kseidman@montrealgazette.com
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