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US drug pricing watchdog to update real-world data, voting policy for 2020

U.S. drug pricing watchdog the Institute for Clinical and Economic Review proposed a new 2020 framework for determining the value of medicines, including renewed efforts to use real-world evidence and putting new benefits in front of the independent committee to vote on when considering drug appraisals.

The watchdog, or ICER, produces reports that assess the evidence of a drug's effectiveness both in years of life that patients gain and the quality of life offered by the treatment. The two values allow ICER to establish a comparable benchmark for pricing, called a quality-adjusted life year, or QALY.

In the new 2020 framework proposal, ICER reaffirmed its commitment to using real world evidence in its evaluations, but also pledged to explore new partnerships with organizations to generate new data to assist published data sources. The need for inclusion of more real world data in these evaluations is one of the most commonly heard criticisms of ICER's drug assessments, the organization said in an Aug. 21 news release.

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ICER also plans to revamp its voting structure to better value other benefits and considerations that should be included when deciding where to place a medicine on the value-based drug pricing scale.

Final evidence reports will be reviewed after one year to establish if any new evidence has emerged that might effect ICER's recommendations, and an update will be developed as necessary.

A "controversies and uncertainties" section will also be added to evidence reports, addressing any alternative model structures suggested by manufacturers and other stakeholders providing comment on the drug being evaluated.

ICER will host a webinar Sept. 4 to provide information on the 2020 framework proposal. A public comment period will be held through 5 p.m. ET on Oct. 18, with the finalized framework expected to be issued Dec. 18.

In a separate initiative, ICER is also developing new guidelines for gene and cell therapies, which can cost millions of dollars but potentially provide one-time cures.