Abstract

In 2014, the Institute for Clinical and Economic Review (ICER) became the focus of attention for publishing a report concluding that new drug treatments for Hepatitis C offered low value for US healthcare payers based on a clinical and economic assessment. This research systematically analyzes ICER reports of drugs and discusses their potential future role in drug pricing. All publically available final ICER reports of pharmaceuticals (01/01/2014-12/31/2017) were screened and key data extracted. 19 ICER reports of pharmaceuticals were identified, encompassing 65 drugs in 37 conditions/subgroups. 56 panel votes of their clinical benefits deemed 64% clinically effective by majority vote. 39% were clearly (≥80% votes) clinically effective, with 25% clearly not clinically effective. Clinical ratings were provided for 58 drugs : 52% achieved ≥B rating, 17% C–D and 31% I or P/I. A cost-utility assessment was undertaken for 49 drug:indication pairings. Even at the highest WTP threshold of 150,000/QALY, only 29% therapies were deemed cost-effective, with a mean 46% discount required for an ICER<$150,000. Of 30 votes on the “care value” of a product, based on their clinical and cost-effectiveness, 33% were rated as low value, 3% low/intermediate, 43% intermediate, 7% intermediate/high, and 13% high. Of 11 votes on the “health system value” of products, based upon their anticipated budget impact and affordability, 100% were deemed low value. ICER reports have generally concluded that assessed therapies offer important clinical benefits but generally do not justify their economic impact. These reports currently do not influence coverage/pricing decisions but there is anecdotal evidence of insurers using these in negotiations. For example they were formally cited as part of Medicare Part B payment model reform discussions, indicating ICER reports may play a greater role in future reforms to US drug reimbursement as payers struggle to manage increasing costs.

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