New Drug Launch Prices Stay High While Patients Wait for Access

New drug launch prices are still high, even though the pace of increase has slowed. In its 2026 Launch Price and Access Report, published October 20, 2026, the Institute for Clinical and Economic Review (ICER) found that the median annual net launch price rose 35% between 2022 and 2025 after adjusting for inflation. The list price rose 24% over the same period.

Most of the increase came early. The median net price rose 32% from 2022 to 2023, then edged up 4% in 2024 before dipping 2% in 2025 to about $257,000. Even so, about one in four drugs approved in 2025 launched above $500,000 a year, and another 34% launched between $200,000 and $500,000. The report also tracks whether patients can get these drugs, and the answer is often no.

Where new drug launch prices stand in 2025

ICER analyzed 47 novel drugs approved by the US Food and Drug Administration (FDA) in 2025. The median annual list price was $293,304, and the median annual net price was $257,369, with a range of $101 to $3,147,000. Orphan drugs made up 55% of the group, oncology drugs 30%, and biologics 40%. Gene and cell therapies were 9% of approvals and ultra-rare drugs 11%, both smaller shares than in earlier years. For the highest-priced drugs of the year, see the most expensive drugs of 2025.

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Table 1. Median annual launch price by approval year, adjusted to 2025 dollars

Source: ICER, 2026 Launch Price and Access Report, Table 3.3. Values for 2022 to 2024 were adjusted to 2025 dollars.

Price trend after adjusting for drug mix

The raw median rises partly because the mix of drugs changes from year to year. ICER therefore fitted a regression model that controls for product type, therapeutic area, orphan status, ultra-rare status and other characteristics. After those adjustments, list prices rose an estimated 16% per year and net prices 18% per year between 2022 and 2025. Neither estimate is statistically significant: the 95% confidence interval for net price runs from -5% to 46% per year. ICER therefore reads the result as a possible upward drift, not a confirmed trend.

The 2025 dip also has a composition explanation. Fewer drugs in the typically higher-priced groups were approved that year. But the median price for those groups also fell from 2024 to 2025, so ICER says both factors contributed.

Launch prices against ICER’s value benchmark

ICER compared 26 drugs approved between 2022 and 2025 that it had already reviewed with its Health Benefit Price Benchmark (HBPB). The HBPB is the price range that fairly reflects the health benefit a treatment provides over a patient’s lifetime. Only 8 of the 26 (31%) were priced at or below that range at launch.

For the rest, the gap is wide. ICER estimates a median additional discount of 63% (interquartile range 33% to 75%) would be needed to reach the $150,000 per equal value life year threshold. Reaching the $100,000 per quality-adjusted life year threshold would require a median additional discount of 71% (interquartile range 53% to 81%). Attruby, for transthyretin amyloid cardiomyopathy, would need discounts of 79.5% to 92.8%, and Winrevair for pulmonary arterial hypertension would need 82.7% to 91.2%, depending on the threshold.

ICER’s previous report estimated more than $1 billion in excess first-year spending on drugs approved between 2022 and 2024. This year’s report does not repeat that estimate, because the number of reviewed drugs since the last report was too small.

Patients wait: fill rates and rejections in year one

ICER used IQVIA’s Longitudinal Access and Adjudication Data (LAAD) to follow new-to-brand prescriptions for 26 outpatient pharmacy drugs approved between July 2024 and June 2025, the cohort that had enough claims to analyze. For each prescription, it recorded what happened in the 30 days after the first claim was filed.

Only about one in three prescriptions (36%) was filled in that window. Another 39% were rejected, most often for non-coverage, and 12% were approved and dispensed but never picked up. Rejections for prior authorization or step therapy accounted for 7%.

Table 2. Adjudication of new-to-brand outpatient pharmacy prescriptions within 30 days, by payer (%)

Source: ICER, 2026 Launch Price and Access Report, Figure 4.2. “Reversed” means the claim was approved and dispensed, but the patient did not pick up the prescription.

Medicare was the hardest payer. Nearly 60% of its claims were rejected for non-coverage. ICER links much of that to new-to-market blocks, in which a plan withholds coverage while it reviews a new drug. ICER’s Fair Access criteria call for coverage policies within three months of approval.

The written policies looked mostly reasonable. For eight drugs, ICER compared the coverage policies of the five largest US health plans by covered lives with its Fair Access criteria. Of those policies, 87.5% met the criteria on clinical eligibility, step therapy and prescriber restrictions. ICER’s point is that compliant wording does not guarantee access. Most drugs in the cohort needed several submission attempts before they were filled.

Two drug examples

Journavx, a non-opioid for acute pain, shows the payer gap clearly. Commercial claims were filled 63% of the time, against 16% for Medicare and 37% for Medicaid. The majority of Medicare claims (71%) were rejected for non-coverage. ICER also cites an outside study that found Journavx covered for 10.7% of Medicare enrollees, compared with 62.3% of commercial enrollees.

Attruby (acoramidis) was filled 42% of the time within 30 days, and more than half of its prescriptions were rejected, mostly for non-coverage. A manufacturer-cited analysis reported that more than 90% of Medicare Part D plans covered Attruby by August 2025, nine months after approval. ICER calls a nine-month delay excessive, because its Fair Access criteria expect coverage within three months.

Out-of-pocket costs depend heavily on who pays

Medicaid patients paid the least. For most outpatient drugs, Medicaid out-of-pocket costs averaged under $1 a month. Medicare patients paid the most for most drugs, often two to five times what commercial patients paid. ICER points to manufacturer copay cards, which Medicare enrollees cannot use, as one reason.

The gap is visible in the claims. 71% of commercial claims had a $0 out-of-pocket cost, against 48% of Medicare claims. 28% of Medicare claims cost more than $1,500 out of pocket, compared with 5% of commercial claims. Part D had no out-of-pocket cap in the second half of 2024. The cap took effect on January 1, 2025, and the data cover both periods, so the Medicare figures blend the two.

What ICER recommends

ICER’s conclusion calls for prices tied to benefit at launch, cost-sharing based on net rather than list price, and coverage policies that follow its Fair Access criteria. The report also notes that 83% of 2025 approvals were first approved in the US, up from 65% in earlier years. That matters for the most-favored-nation (MFN) pricing debate, because a voluntary MFN framework could delay launches in other countries. ICER concludes: “A voluntary de-escalation of the status quo is likely to ensure affordable access for all patients while preserving incentives for future innovation.”

Source: Agboola F, Wright A, Lee W, Phillips M, Lin GA, Lee M, Emond SK. 2026 Launch Price and Access Report. Institute for Clinical and Economic Review, October 20, 2026. Read the full report at icer.org.