Canadian Study Shows Greater Alignment Between Clinical Benefit, Cancer Drug Prices

A study published in JAMA Network Open Tuesday looked at the links that exist between approval characteristics, clinical benefit, and prices for cancer drugs recommended for reimbursement in Canada by the Canadian Agency for Drugs and Technologies in Health (CADTH).

The authors noted that prices for drugs approved by the FDA or the European Medicines Agency have soared over the past decade, despite what they called “an increasing disconnect between clinical benefit and prices.”

The retrospective cohort study examined anticancer drugs for treatment of solid tumors in adult patients receiving positive reimbursement recommendations from inception in 2011 to 2020. Researchers excluded medicines for supportive care, hematologic neoplasms, and pediatric indications, as well as biosimilars.

Clinical benefit was defined by using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS), where a score of 4 or 5 in the metastatic setting or A or B in adjuvant settings were considered substantial clinical benefit. The MCBS is based on clinical trials and captures a broad range of evidence, including hazard ratios, quality of life, and toxicity.

Using reports from CADTH, which provides funding recommendations to provinces and territories (except Quebec), the authors extracted supporting trials’ characteristics and monthly drug prices; the drug prices did not reflect confidential discounts.

Kruskal-Wallis and Mann-Whitney tests were used analyze approval characteristics and prices, and linear regression was used to determine the link between percentage improvement in progression-free survival (PFS) and overall survival (OS) with monthly prices.

There were 78 positive reimbursement recommendations for solid tumors during the time period of the study. Most (53%) of the recommendations were for new indications of existing drugs; 30 (38%) were for novel drugs and 7 (9%) were for resubmissions that received previous negative decisions.

The study found that in Canada, monthly prices were significantly different for cancer drugs with substantial benefit vs low benefit per MCBS scores. This is different than in the United States and Europe, the authors noted.

Cancer therapies that provided a substantial clinical benefit were linked with a higher median monthly price ($6207; range, $1723-$34,305) compared with therapies deemed to have a low benefit ($4437; range, $782-$11,733) per ESMO-MCBS score (P < .001).

The highest-priced class of therapy, immune checkpoint inhibitors, had a monthly median cost of $8533 (range, $5668-$34,305). There was a significant difference between the median monthly treatment costs of drugs that received recommendations for melanoma compared with other tumor types (eg, monthly price: melanoma, $8342; range, $782-$34,305 vs gastrointestinal, $4293; range, $2105-$17,500; P < .001).

In addition, conditional recommendations were linked with higher median monthly prices compared with regular recommendations ($6184; range, $1723-$34,305 vs $3289; range, $782-$7298; P < .001).

Similarly to other research, there was only a weak correlation between monthly drug prices and percentage gains in median PFS (R² = 0.040) and OS (R² = 0.361).

The authors noted that the correlation of population-level benefit with drug prices is not measured and that while the United States does not have a health technology assessment (HTA) body like Canada and European nations, their study’s findings should be not be inferred to mean that having an HTA is a reason for rational drug pricing in line with clinical benefits.

Reference

Jenei K, Meyers D, Gyawali B. Assessment of price and clinical benefit of cancer drugs in Canada, 2011-2020. JAMA Netw Open. 2023;6(1):e2253438. doi:10.1001/jamanetworkopen.2022.53438