PhRMA warns that use of ICER's cost-effectiveness thresholds would limit drug access for Medicare patients

An analysis by drug wholesaler AmerisourceBergen's Xcenda division suggests that if Medicare Part B applied cost-effectiveness thresholds such as those utilised by the Institute for Clinical and Economic Review (ICER) as the basis for coverage policy, the number of patients in the US facing access barriers to clinically important physician-administered treatments would rise substantially.

The study, authored on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), indicated that if a single-value threshold was introduced, 59 percent to 93 percent of patients could be forced to switch to a medicine deemed cost-effective by ICER's framework. The analysis compared ICER's assessments, regarding what treatments are deemed "highest value," to utilisation by Medicare Part B of medicines for rheumatoid arthritis, multiple sclerosis, non-small-cell lung cancer (NSCLC) and multiple myeloma.

The study found that in 2016, more than 200 000 Medicare Part B beneficiaries with the four conditions used a physician-administered drug evaluated by ICER. Findings showed that if Medicare adopted an ICER-based formulary, nearly 140 000 of these patients could lose access to their doctor's choice of treatment and may be forced to switch to a medicine deemed cost-effective. Specifically, the analysis suggested that 93 percent of patients with multiple sclerosis would be affected, 67 percent with multiple myeloma, 62 percent with NSCLC and 59 percent with rheumatoid arthritis.

"The science of value assessment is not keeping pace with innovation, and we need better tools to measure the value of medicines," remarked Stephen Ubl, CEO of PhRMA, adding "we support advancing these tools from being focused on rigid, budget driven methodologies toward more flexible approaches that include perspectives of what patients value."

In 2016, the Center for Medicare & Medicaid Innovation proposed a pilot programme to encourage doctors to prescribe less expensive therapies under Medicare's Part B programme. The second part of the initiative would have seen the use of value frameworks, such as those developed by ICER, to implement reference-based pricing, although the proposal was withdrawn in late 2017 after facing criticism.

Earlier this year, Sanofi and Regeneron Pharmaceuticals cut the price of Praluent (alirocumab) based on input from ICER, with plans to offer discounts of up to 69 percent on the PCSK9 inhibitor. For related analysis, see ViewPoints: ICER heats up the US drug pricing debate.

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