Oncology Drug Coverage Determination Takes Months

Coverage determination for oncology drugs can be delayed for months after regulatory approval, according to research published in JAMA Oncology.

Researchers found that coverage determination by pharmacy and therapeutics committees (PTCs) is “frequently delayed for months” after a cancer drug is approved by the US Food and Drug Administration (FDA).

However, lag times vary, and the determination delay has improved over time, “suggesting that PTC determinations are becoming more efficient,” the researchers wrote.

For this study, the researchers evaluated the time from FDA approval to PTC determination between 2010 and 2019 for 127 payers. There were a total of 89 oncology drugs with 974 PTC determination dates.

The median coverage lag was 4.2 months, and the median lag range was 32.2 months. The median lag between oncology drug approval and PTC determination was 10.9 months in 2010, and this decreased to 3.4 months in 2018. The median lag range decreased from 39.8 months in 2010 to 14.4 months in 2018.

A more recent year of FDA approval was significantly associated with lower odds of a long lag between approval and determination (odds ratio [OR], 0.20; 95% CI, 0.07-0.59) and of a large lag range (OR, 0.54; 95% CI, 0.34-0.85).

There was no association between determination lag and drug class, orphan drug status, or FDA expedited review pathways, including fast track designation, priority review, and accelerated approval.

“These results indicate that PTC determinations are frequently delayed for months after initial FDA approval and that lag periods are highly variable among payers,” the researchers concluded. “Coupled with drug coverage being frequently subject to formulary exclusions and restrictions across many coverage plans, our results indicate that the existing payer system for oncology care may severely hamper patient access to effective drugs.”

Reference

Haque W, Rana I, Zahid S, Hsiehchen D. Lengthy and variable delays in oncology drug coverage determination. JAMA Oncol. Published on October 19, 2023. doi:10.1001/jamaoncol.2023.4488

This article originally appeared on Cancer Therapy Advisor