Ahead of an ICER meeting to review evidence and vote on cost-effectiveness ratings for non-small cell lung cancer treatments, a group of oncologists is airing “serious concerns” about the organization’s assessment techniques. The docs have laid out principles that they believe should serve as the “start of a discussion” around building a value framework.
Published on the oncology news platform OBR, the editorial takes issue with a recent report by the Institute for Clinical and Economic Review that concluded several NSCLC meds would need deep discounts in order to be cost-effective. After reading the report, the docs say they're concerned about “ICER’s ability to interpret clinical evidence and reach conclusions on drug value that are scientific, comprehensive, and unbiased.”
Last month, Boston-based cost watchdog ICER said that new checkpoint inhibitor drugs from Roche ($RHHBY), Bristol-Myers Squibb ($BMY) and Merck ($MRK) would need discounts ranging from 31% to 68% to meet a quality-adjusted life year benchmark of $100,000 to $150,000 in second-line use. In past reviews, the institute has scrutinized the price tags on some of pharma’s biggest launches. An ICER committee meets today to review the NSCLC report.
BMS, maker of the big-selling Opdivo, said ICER takes a “static approach to what is an incredibly dynamic environment” in its statement on the NSCLC report. Concerned it could be used to justify limiting patient access, BMS says the final report “inaccurately devalues” drugs such as Opdivo.
And limited access is certainly not what any of the three PD-1/PD-L1 drugmakers want. With Tecentriq just approved for second-line lung cancer use earlier this week, all three of them are now battling it out in that arena, where serious sales are at stake.
The oncologists, though, wrote in OBR that they’re worried ICER’s focus on “population-level health” would likely hurt patients “on an individual, clinical needs basis.” Following their review of ICER’s NSCLC report, the oncologists said “ICER appears to represent a perspective that is less oriented towards patient benefit than towards motivations that would limit patient access to new therapeutic options.”
They’re recommending a framework that relies on input from “clinicians who have extensive and active expertise.” The docs also advocate patient-focused assessments and a method that includes peer review, continuous updates and “evidence-based” medicine.
ICER chief scientific officer Daniel Ollendorf told FiercePharma that his institute believes in all of those principles, and further, “we feel like our work embodies those principles.” He said ICER consults disease experts for any review it's working on.
On the point that ICER focuses on population-level data, Ollendorf said that a lack of “clear and distinct knowledge around the subset of patients who are likely to benefit” makes it impossible for the institute to predict which patients will benefit from the new immuno-oncology meds.
“At this point, a minority of patients actually benefit,” Ollendorf said. “Patients who get the benefit, receive a substantial benefit. The problem is that we don’t have good enough targeting technology yet to be able to predict who those patients are."
Ollendorf argued that ICER does indeed stress patient-centered endpoints in its reviews, citing an effort by the institute to gather contextual information from patients such as the stigma associated with lung cancer. He said the group has made “multiple changes” in its process to encourage patient input.
The oncologists who wrote the op-ed certainly aren’t alone with their worries about ICER’s value assessment methodology. In the year-plus span that the institute has been doing cost-effectiveness ratings, numerous pharma companies and organizations have come out against its review system. ICER recently released more than 300 pages of comments from those involved as it works to tweak its drug assessment methodology.
Among the complaints were claims that ICER uses “largely inaccurate” uptake assumptions and that it should be more transparent. Amgen in a letter said ICER should change its calculations to avoid making a drug's cost the "main determinant of health system value."
In speaking with FiercePharma, Ollendorf said the institute takes public comment “very seriously,” and will adjust its framework after considering input.
Over the summer, a feud between biopharma and the group escalated when an industry group claimed that insurance companies were funneling money to the organization to put pressure on drug prices.
ICER calls for deep discounts to Opdivo, Keytruda, Tarceva, and others in NSCLC
Controversial drug-cost watchdog ICER mulls changes, and pharma's full of suggestions
New myeloma meds offer improvement, but are far too expensive: Report
Facing a new assessment of Kyprolis, Amgen castigates cost-effectiveness team's methods
BMS joins Amgen in blasting ICER myeloma report
Nonprofit snags $5.2M grant to investigate U.S. drug pricing
Pharma accuses payers of using cash to sway U.S. cost watchdog
Cost watchdog says PCSK9 meds should cost 85% less. Realistic or not?