We need better access to new cancer treatments

Strides in cancer research have increased survival rates and provided a better quality of life for patients. But getting the best treatment as soon as possible remains a matter of life and death for many Canadians. Patients and families in B.C. live with the hope that a new, effective treatment will be available when they need it.

Health Canada has recognized the need to keep up with the pace of innovations, which have allowed new cancer drugs to be brought to market sooner. It has worked to speed up approval of promising new therapies.

But that doesn’t mean approved drugs are funded more quickly or at all. Few patients consider that the cancer treatment recommended by their doctor and often available in other countries may not be approved for funding, essentially meaning it will be inaccessible.

Since health care is under the jurisdiction of the provinces and territories, it’s up to them to decide if a drug will be eligible for public reimbursement. For cancer drugs, they broadly follow the recommendation of the pan-Canadian Oncology Drug Review (pCODR) when making final reimbursement and coverage decisions.

Comprised of oncologists, physicians, pharmacists, economists, an ethicist and patients, the pCODR typically relies on randomized control trials to make its decisions. However, trials aren’t always feasible, appropriate or ethical for the evaluation of new treatments. Non-comparative data increasingly is being used. The criteria pCODR uses for trials data hasn’t kept pace with cancer-research breakthroughs.

For many new targeted therapies, the patient population is too small to conduct the usual trial or the time required is precious years cancer patients don’t have. Once a drug is deemed safe and effective, it may be fast-tracked, enabling patients to have access quickly. These fasttrack drugs are often submitted to the regulatory body with non-comparative data.

Increasingly, pCODR has been rejecting these funding submissions.

In a policy paper that Lymphoma Canada published earlier this year, we found that beginning in 2015 the number of pCODR submissions supported by evidence from non-comparative data increased significantly. Yet the rate of negative recommendations also increased. Between January 2015 and the end of December 2017, 63 per cent of submissions received negative recommendations from pCODR. In the three prior years, the negative recommendation rate was just 25 per cent.

This month, health researchers and policy-makers who have the power to speed up access to new treatments and save lives are meeting in Halifax for a conference hosted by the Canadian Agency for Drugs and Technology in Health, the agency that’s home to pCODR. Lymphoma Canada and 12 other cancer organizations are calling on the attendees to advocate for reforming pCODR’s approach. We are also urging B.C. Health Minister Adrian Dix to ask the federal health minister to update and modernize the way they approve access to cancer drugs.

There are two key ways pC O DR can improve the process and health of Canadians. First, it can issue positive recommendations by providing for temporary funding while drug manufacturers address perceived uncertainty of the clinical value. Under such circumstances, policies and procedures regarding evidence collection would need to be established.

Second, in addition to acquiring more robust or mature trial data, real-world evidence can be collected to reduce uncertainty. Collaboration among relevant stakeholders could be leveraged to ensure that pCODR’s recommendations, and the data on which they are based, remain sound and relevant over time. Costs could be managed through innovative risk-sharing and other price-control and reduction agreements.

While we acknowledge there are limitations to estimating the value of a new treatment using non-comparative clinical studies, this setting is increasingly becoming the final stage of clinical evaluation for new cancer drugs, especially for rare cancers, tumours with distinct molecular profiles or where no standard of care exists.

Increased requirements for evidence of a drug’s clinical and cost effectiveness before use may seem reasonable to reduce uncertainty, but patients can’t wait. Policy-makers shouldn’t deny or delay the funding of drugs when there is sufficient data showing their efficacy and safety for a vulnerable patient population.