Health-related quality of life is often not collected for investigational cancer drugs or used to calculate the balance of costs and benefits when they are submitted for reimbursement, according to a new Canadian study published in Cancer, a peer-reviewed journal of the American Cancer Society.

Both the efficacy and the expense of a medication determine whether or not the cost of a drug will be reimbursed, and this effectiveness is often considered in terms of cost per quality-adjusted life-year (QALY) where one QALY equates 1 year in perfect health.

In Canada, recommendations for reimbursement come from the Canadian Agency for Drugs and Technologies in Health and, specifically, from its pan-Canadian Oncology Drug Review (pCO-DR) group. A common standard of $50,000 Canadian dollars per QALY is often used, meaning that a new technology associated with a cost per QALY of less than $50,000 will be reimbursed.

While clinical trials were not originally designed to address reimbursement decisions and have not reported on data that is meaningful to patients, trial results are currently used for such. To determine whether recent cancer drug trials collect such information, researchers reviewed drug manufacturers' submissions to pCODR between 2015 and 2018. They looked to see whether information on health-related quality of life was collected alongside cancer drug trials and used to calculate QALYs in analyses submitted to pCODR for reimbursement recommendations.

Among the 43 submissions evaluated by pCODR, the gain in QALYs in most submissions was small, and in 65% of cases, the submitter’s best estimate of cost-effectiveness of the drug was in excess of $100,000 per QALY. Approximately 56% of submissions did not include original data on health-related quality of life, with most relying instead on evidence from previous studies.

These findings demonstrate that drug companies or manufacturers may not be including meaningful improvements in drug therapies that matter the most to patients, according to the study authors.

“If drug prices continue to rise and are to be reimbursed by insurance companies or publicly funded systems, these drugs must offer benefit relative to their costs. Benefit should not be an abstract measure but rather one that is valued by patients,” said lead study author Adam Raymakers, PhD.

Reference
Adam J. N. Raymakers, Dean A. Regier, Stuart J. Peacock. Health‐related quality of life in oncology drug reimbursement submissions in Canada: A review of submissions to the pan‐Canadian Oncology Drug Review. Cancer, 2019; DOI: 10.1002/cncr.32455.