Two-thirds of new drugs launched above cost-effectiveness thresholds, ICER reports

A report by the Institute for Clinical and Economic Review and West Health reveals that median inflation-adjusted net launch prices for new U.S. prescription drugs rose 35% from $190,000 in 2022 to $257,000 in 2025. Two-thirds of newly approved drugs evaluated by ICER exceed cost-effectiveness thresholds, with 25% priced over $500,000 annually. Insurers reject 40% of prescriptions for new drugs, while drugmaker trade group PhRMA disputes ICER's findings as flawed.

ICER evaluations of drug cost-effectiveness

• ▪Vertex Pharmaceuticals' non-opioid pain drug Journavx was launched within ICER's cost-effectiveness thresholds, while Vertex and CRISPR Therapeutics' Casgevy required a 7% reduction from its $2.2 million price to meet value standards.
• ▪The Institute for Clinical and Economic Review estimated that Insmed's lung-disease drug Brinsupri and Merck & Co.'s Winrevair require 90% price discounts to meet cost-effectiveness guidelines.
• ▪Two-thirds of newly approved prescription drugs reviewed by the Institute for Clinical and Economic Review between 2022 and 2025 were launched at prices exceeding ICER's cost-effectiveness thresholds.
• ▪The Institute for Clinical and Economic Review evaluates drug value using a cost-effectiveness benchmark of $100,000 to $150,000 per quality-adjusted life year gained.

Surging launch prices for new drugs

• ▪The median net launch price of newly approved U.S. prescription drugs rose 35% after adjusting for inflation, increasing from $190,000 in 2022 to $257,000 in 2025, according to a report by ICER and West Health.
• ▪Approximately 25% of new prescription drugs launched in the U.S. in 2025 had annual net prices exceeding $500,000, while another 34% were priced between $200,000 and $500,000.
• ▪After adjusting for drug characteristics such as orphan status and gene therapies, median annual net launch prices for U.S. prescription drugs increased by 18% per year between 2022 and 2025.
• ▪The median list price for newly approved U.S. prescription drugs, adjusted for inflation, rose 24% from 2022 to $293,000 in 2025.

ICER Hypertension drug evaluation

• ▪An August 2026 draft report by ICER found that new aldosterone synthase inhibitor hypertension drugs cost between $833,000 and $2.08 million per quality-adjusted life year gained compared with generic alternatives.
• ▪ICER calculated that treating more than 2% of eligible patients with baxdrostat at its base price would exceed its $821 million potential budget-impact threshold.
• ▪An ICER equity analysis calculated that Black Americans, who have a 57.8% hypertension prevalence rate, could see 20% greater benefit from effective blood pressure treatments than the general U.S. population.

Approval status of new hypertension drugs

• ▪AstraZeneca's baxdrostat was approved by the FDA in May 2026 for treatment-resistant hypertension following positive Phase 3 BaxHTN trial results.
• ▪Mineralys Therapeutics' aldosterone synthase inhibitor lorundrostat has an FDA action date scheduled for December 22, 2026.

High rates of insurance claim rejections

• ▪Four in 10 prescription claims for the 26 new medicines reviewed by ICER between 2022 and 2025 were rejected by health insurers.
• ▪Nearly two-thirds of Medicare claims for 26 outpatient drugs analyzed by ICER were rejected within 30 days of initial submission due to coverage restrictions or pretreatment reviews.
• ▪PhRMA spokesperson Chanse Jones acknowledged that coverage rejections and administrative hurdles by insurers delay and deny patient access to new treatments.

Federal drug pricing policies

• ▪Donald Trump has formed more than a dozen deals asking drugmakers to adopt most-favored nation drug pricing in exchange for tariff relief.
• ▪The Institute for Clinical and Economic Review suggested drug manufacturers may be raising launch prices to maximize profits before government Medicare price negotiations and most-favored nation pricing deals take effect.