Overview of How New Non-Oncology Drugs Become Available in Canada
Before prescription drugs become accessible through public drug plans in Canada, there is a multi-step process for regulating and reviewing new medications. Each part of the process involves the review of specific aspects of a new drug – safety, efficacy, price, value and affordability. The following is a brief overview of these steps.
Health Canada (takes approx. 1-2 years)
- The drug sponsor (person or company who takes responsibility for the application) submits an application to Health Canada, including clinical trial data for review of the new drug (for more information on clinical trials, see our Clinical Trials page).
- Health Canada conducts an evaluation to determine if the drug is safe and effective and has undergone good manufacturing practices.
- At this time, there is no opportunity for patient / patient groups to provide input into the review process.
- If it is deemed to be safe, and effective, the drug is approved to be sold in Canada and receives a Notice of Compliance (NOC) and drug identification number.
- Health Canada’s approval of a drug for sale in Canada does not necessarily mean that provincial and territorial governments will fund it or that private plans will cover it.
There are some additional programs related to this process for certain medications and circumstances. Though these may not be relevant to psoriatic treatments to date, they are processes that are important to treatment access in general.
Notice of Compliance with Conditions – the sponsor has agreed to undertake additional studies to confirm the clinical benefit of the product.
Priority Review Process – some life-saving drugs are expedited.
Special Access Program – physicians can apply to Health Canada for use of drugs not yet approved on a case-by-case basis. If the manufacturer agrees to make it available, and Health Canada approves it, then the cost of the medication is the responsibility of the patient unless the manufacturer agrees to provide it free of cost or at a reduced price.
Patented Medicines Review Board (PMPRB)
- Within seven days of a NOC assignment by Health Canada, or after the drug is first offered for sale in Canada, the manufacturer has to report to PMPRB.
- PMPRB reviews the price set by the manufacturer to ensure that it is not excessive relative to the cost of the drug in countries other than Canada (as listed in federal regulations) and other considerations.
- Recent changes to PMPRB regulations are set to come into place in July 2020. These changes include a new requirement for PMPRB to assess the value of each new drug using cost-effectiveness analyses.
- To ensure compliance with regulated prices, PMBRB continues to review prices intermittently.
- As PMPRB regulations are under review, some processes are subject to change.
Common Drug Review - Canadian Agency for Drugs and Technologies in Health (CADTH) (takes approx. up to one year)
- Drug manufacturer submits application to CADTH’s Common Drug Review (CDR).
- An evaluation committee reviews the drug for clinical and cost-effectiveness and patient impact relative to other available drugs.
- There is a formal process for patient groups to make submissions to CDR to be taken into account as part of the review.
- CADTH makes a final recommendation to provinces, territories and the federal government about whether a drug should be paid for by public drug plans.
Institut national d'excellence en santé et services sociaux (INESSS)
- INESSS conducts the same evaluation but for the province of Quebec.
- There is a formal process for patient groups to make submissions to INESSS to be taken into account as part of the review.
Pan-Canadian Pharmaceutical Alliance (pCPA) (takes several months on average)
- Based on CDR, pCPA decides whether to negotiate a price on behalf of all provinces, territories and federal government drug plans.
- Provinces, territories and federal governments negotiate price with drug manufacturer.
- Currently there is no opportunity for patient groups to provide input into this process.
- If an agreement is made on price and terms/conditions, a letter of intent is signed.
Provincial funding review
- It is then up to each participating jurisdiction to make their final decision on funding the drug product through their own public drug plan and enter into a jurisdiction-specific product listing agreement with the manufacturer.
- Each province has its own process for reviewing drugs for public funding. In British Columbia, there is a formal process for patients, patient groups and caregivers to provide a submission to be taken into account as part of the review.
- Provinces that publicly fund a drug follow pCPA pricing, although they are not mandated to list a drug even if a Letter of Intent was signed.
- If the pricing is turned down by pCPA and no agreement is reached, jurisdictions will generally not list the drug.
- If no pCPA negotiation took place, province/territory/federal government can negotiate directly with the drug manufacturer.
Last updated July 24, 2020.