The Institute for Clinical and Economic Review (ICER) has released a white paper detailing strategies to enhance the affordability of GLP-1 obesity drugs, including the improvement of patent-quality review processes.
According to the announcement, if the Patent Trial and Appeal Board (PTAB) initiates a review of U.S. Patent 9,474,780—central to tirzepatide's composition-of-matter protection—Empower Clinic Services LLC’s inter partes review could signify a pivotal moment in GLP-1 drug affordability. Director John A. Squires now personally decides on instituting PTAB reviews. Should this institution occur and the ’780 claims be declared unpatentable, enabling earlier generic or biosimilar competition, it would lead to significant price reductions independent of manufacturer coupons. Analysts highlight that competitive entry typically results in durable price declines, as observed in previous small-molecule and biologic markets.
Retail prices for GLP-1 drugs remain high. Self-pay or cash programs list Wegovy at $499 per month and Zepbound between $349–$499 per month depending on strength, compared with historical retail prices exceeding $1,000 monthly. Insured patients’ out-of-pocket expenses range from $0–$25 under active coupon programs to full cash rates when coupons lapse or coverage excludes weight-loss indications. This pricing uncertainty places a burden on employers and public payers seeking predictable spending and equitable access.
Employer plans are increasingly strained by these costs. The International Foundation of Employee Benefit Plans (IFEBP) 2025 survey indicates that GLP-1s now account for 10.5% of annual claims, up from 8.9% the previous year; 27% of employers report these drugs consume 15% or more of total claims. Medicare covers semaglutide only for cardiovascular-risk patients, while Medicaid policies vary by state, leading to inconsistent access. If tirzepatide’s ’780 patent were invalidated, broader market entry could alleviate payer budgets by introducing sustained downward price competition beyond manufacturer rebate strategies.
Obesity affects approximately 40% of U.S. adults, with type 2 diabetes contributing an additional $412.9 billion annually in costs. These interconnected epidemics drive substantial clinical demand for GLP-1 therapies. Should related formulation patent U.S. 11,357,820 also face narrowing challenges, payer leverage would further increase. Empower Clinic Services LLC and similar challengers view PTAB reviews as supportive of innovation and patient interests: quality patent review leading to competition and affordability.
ICER is an independent nonprofit health technology assessment organization founded in 2006 and based in Boston. It evaluates the clinical and economic value of medical innovations and provides reports used by payers and policymakers to align drug prices with demonstrated value while maintaining incentives for innovation.
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