the drug approval process in Canada

Just because a new therapy has been shown to be effective in a clinical trial doesn’t mean that it is automatically available in Canadian hospitals, clinics or pharmacies.  Before a drug can be used in Canada, it must go through a rigorous approval process at Health Canada.  Health Canada does not look solely at whether a new agent is safe, but at the balance between risks and benefits.

If the drug company’s submission is approved, Health Canada will issue a Notice of Compliance (NOC) and give the drug a Drug Identification Number (DIN).  This means the company is now allowed to market the new drug in Canada.  In some cases, Health Canada may award a Notice of Compliance with Conditions (NOC/C).  A drug awarded with a NOC/C is given a DIN but the sponsoring company must agree to special conditions or requirements, such as for more research or professional and patient education.

Once a new agent is approved for use in Canada, the manufacturer must make a submission to the national Common Drug Review (CDR) committee.  The Common Drug Review was set up by the federal government to make recommendations as to whether new drugs should be covered under provincial formularies – the list of medications they will pay for.  The hope was that it would streamline the drug review process and help to encourage greater consistency across the country.

In reality, most provincial drug plans continue to make their own decisions as to which medications they will or will not list.  As a result, the coverage of new agents often varies across the country.  In some cases, even when a new agent is added to a formulary, the decision as to whether to pay for it is made on a case-by-case basis.  This special authorization process requires your physician to write a letter to the drug plan, explaining why you require this particular medication.

• reimbursement of new therapies

There are basically four ways of paying for cancer drugs:

• the drug is on the list of approved medications of the provincial or federal health insurance drug plan of which you are a member (either as a general benefit or through a special authorization process)
• you have a private drug plan which will pay for the drug in question (many private plans also have formularies or lists of drugs they will cover)
• you pay for the drug yourself
• if you meet certain financial eligibility criteria, assistance may be provided by the drug manufacturer

• minimize out-of-pocket costs

It may take some research to ensure you have optimal access to new prescription medications – and to minimize your own out-of-pocket costs.  Here are some tips to help you.

• Know your health insurance coverage.  Some provinces only provide drug coverage for people who are 65 and older or on social assistance.  But others may have a variety of plans, such as special coverage for those facing substantive prescription drug costs.  Drugs provided through cancer care centres can also vary between province to province. Talk with your cancer team social worker or pharmacist or call your provincial ministry of health to learn about all your options.
• If you have private health insurance or a drug plan at work, sit down and carefully review your benefits.  If you are employed, meet with your Human Resources department or union representative to help you better understand your benefits.  Ask your doctor what drugs you may need in the future, and check to see if your plan covers them.  Try to coordinate the benefits so any portion of a drug cost that is not paid for by one plan is applied to the next.
• Some private insurance plans require that you pay up-front and then apply for reimbursement.  If this is a problem for you (e.g. you need a very expensive drug), ask your insurance company to allow your pharmacy to send the bill directly to it. 
• Don’t be afraid to advocate for yourself.  For instance, if your employee health plan does not cover a certain drug, ask your employer or human resources manager if the company can make an exception in your case.  Or ask your employer if they would waive the cap on your drug coverage. 
• Find someone to work with you to advocate for the drug coverage you need.  This someone can be a family member, for instance, or a friend.  This person can help continue to advocate for you even when you cannot.
• If you are refused coverage of a medication you need, appeal.  Sometimes the refusal may be the result of nothing more than faulty paperwork.  And sometimes insurance companies will change their mind if you appeal. 
• Some pharmaceutical companies have free services that will help you search for coverage of specific drugs or even supply you with the drug you require.  Talk with your cancer care team or search online to see if you may be eligible for such a program.

For more information, check out www.DrugCoverage.ca, a free resource providing information about prescription drug reimbursement in Canada.  There is also additional information on this site on how to be your own advocate when you need new or emerging therapies.