- Several newly approved drugs for lung cancer, including Bristol-Myers Squibb's Opdivo and Merck's Keytruda are overpriced relative to a value-based price benchmark, according to a new report released this week by the Institute for Clinical and Economic Review.
- Opdivo (nivolumab) would need to be discounted by between 57% and 68% in order to clear a benchmark of $100,000 to $150,000 per quality-adjusted life (QALY) gained, ICER found. The price of Keytruda (pembrolizumab) would need to come down as well, between 39% and 61%.
- ICER's efforts to assess the cost-effectiveness of new drugs has sparked backlash from the pharma industry, which has criticized the research organization's methodology and motivations.
ICER did caution that there was "substantial uncertainty" in its cost-effectiveness estimates for the new checkpoint inhibitors, pointing to the differences in indications and in the assays used to test for PD1/PDL1 levels.
Still, the report likely won't be received well by drugmakers, who have spoken out publicly against ICER's approach before. Bristol-Myers, for instance, has previously criticized ICER's assessment of its multiple myeloma drug Empliciti, which called for the price to be lowered by between 75% and 89% per vial.
Pricing new drugs is a difficult balance, particularly in light of the sustained outrage over rising prescription drug costs in the U.S.
ICER has attempted to examine the value of several drug classes, taking into account efficacy, safety, existing treatment options and other variables. Previous reports have covered hepatitis C,high cholesterol and multiple myeloma. These assessments, many of which have determined lower prices are in order, have been seized by some as a way to criticize pharmaceutical companies.
ICER also assessed the value for Roche's Tecentriq (atezolizumab), although it is not yet approved in the U.S. for non-small cell lung cancer (NSCLC) Similar to the findings for Opdivo and Keytruda, ICER indicated the price of Tecentriq would need to be reduced by between 31% and 53% to meet ICER's QALY benchmark.
The three drugs were reviewed only in the context of second-line use in EGFR- advanced NSCLC, compared to treatment with docetaxel in patients who progressed from a chemotherapy doublet. ICER did not model first-line use for the drugs due to "a lack of publicly comparative evidence."
The PD-1 inhibitors Opdivo and Keytruda are also used to treat melanoma, though that is a smaller market than NSCLC.
ICER also looked at long-term costs, outcomes, and cost-effectiveness of first-line therapy with several tyosine-kinase inhibitors (TKIs) in advanced NSCLC in EGFR+ patients, compared to platinum-based chemotherapy. The report found all cost-effectiveness figures to fall below the upper limit of its price benchmark ($150,000/QALY).
Correction: Following publication of this article, the Institute for Clinical and Economic Review released a corrected version of its evidence report which lowered the percentage discount required of Keytruda to meet ICER's value-based price benchmark from an original range of 61%-73% to between 39%-61%. For Tecentriq, the changes lowered the required discount from 47%-62% to between 31% and 53%. The required discount for Opdivo, on the other hand, was increased from 52%-65% to between 57%-68%.