ICER's launch price and access report: 5 key takeaways and 5 questions we should all be asking

Abstract

Improving prescription drug affordability and patient access remains a key policy objective in the US health care system, yet not every proposed solution will help us achieve this goal. To contribute to this ongoing policy discussion, the Institute for Clinical and Economic Review (ICER) published a report in October 2025 to evaluate the launch prices of new Food and Drug Administration (FDA)-approved drugs and patient access to those therapies. This article highlights five key takeaways from the report and proposes five critical questions for consideration. Based on findings from ICER's Launch Price and Access report, this article offers key recommendations to move the US health care system toward one that pays for value and delivers affordable access for patients, while driving the next wave of innovation.

Introduction

Improving prescription drug affordability and patient access remains a key policy objective in the US health care system, yet not every proposed solution will help us achieve this goal. To contribute to this ongoing policy objective, the Institute for Clinical and Economic Review (ICER) published a report on launch price and access trends, evaluating year-to-year patterns in prescription drug launch prices and examining patient access barriers to newly launched drugs.¹ In the US, drugmakers are not required to price their products based on the overall health benefits they provide; this report also evaluates the impact of this pricing approach on the broader health system.¹

Published in October 2025, the report examined 154 novel agents approved by the US FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) over a three-year period (2022 to 2024). Novel agents are new drugs that have never been approved or marketed in the US and therefore do not include generics, biosimilars, or drugs previously approved for other indications. In this article, we present five key takeaways from the analyses and propose five critical questions for consideration. Based on findings from this inaugural Launch Price and Access report, we offer key recommendations from ICER to move the US healthcare system toward one that pays for value and delivers affordable access for patients, while driving the next wave of innovation.

New drug, high price tag. Can we afford it?

Looking back at 2024, the average list price for newly launched drugs exceeded $300 000 annually.¹ After accounting for rebates and other discounts, the average launch net price was over $270 000. Let's take a step back to 2014, when the launch price of $84 000 for a course of Sovaldi, a drug that transformed hepatitis C treatment, was considered both unprecedented and extreme.^2,3 This historical context underscores the substantial escalation in drug pricing that has occurred since that time. Today, 10 years later, we are no longer surprised when a new drug, transformative or not, launches at half a million dollars or more. More than 35% of drugs introduced in 2024 had an annual net price greater than $500,000, with four exceeding one million dollars. An additional 18% were launched at prices between $250 000 and $500 000. Although drug companies argue that high drug prices are necessary to sustain innovation,⁴ questions remain regarding the affordability of these innovations for the healthcare system and patients, as well as whether every high-priced product represents true innovation that provides transformational or even incremental benefit for patients.

While high drug prices are a concern across the entire spectrum of therapies, the rapid growth of orphan drugs compounds this trend. Approximately 6 in 10 novel drugs approved by the FDA in 2022, 2023, and 2024 had orphan designations (Table 1).¹ Among drugs approved between 2022 and 2024, the average annual launch price for orphan drugs was about 11 times that of non-orphan drugs ($409 000 vs $38 000).¹ However, many orphan products also secure FDA approval for non-orphan indications.⁵ Largely due to the increased use of orphan drugs for secondary non-orphan indications, orphan drug treatments account for about a third or more of US drug expenditure, with a significant share of that spending directed to non-orphan indications.^6,7

Table 1.

Novel drugs* approved, 2022-2024.

	2022	2023	2024
Novel drugs, n	39	58	52
Orphan products, n (%)	24 (62%)	34 (59%)	33 (63%)

Excludes vaccines, blood or plasma-based products, and imaging or diagnostic agents.

The price tag is getting higher. Is it sustainable?

Although drug affordability has been one of the few areas of bipartisan consensus in the United States for several years,^8,9 historical trend analyses indicate that, without concrete policy changes addressing launch prices, these prices will likely continue to rise at rates exceeding inflation, gross domestic product growth, and health care expenditure growth. Previous analysis examining newly marketed drugs in the US from 2008 to 2021 found that launch prices for new drugs increased exponentially by 20% per year.¹⁰ The median launch price of drugs increased from over $2000 in 2008 to over $180 000 in 2021.¹⁰

ICER's analysis of drugs launched between 2022 and 2024 showed a 51% increase in median annual net launch price (ie, the actual amount the manufacturer receives after rebates, discounts, and other reductions) after adjusting for inflation, rising from just over $180 000 to over $270 000 (Table 2).¹ To determine whether these changes were driven by shifts in the types of new drugs being approved, further analysis was conducted. Even after adjusting for drug characteristics such as gene or cell therapies, orphan products, and specific therapeutic areas, including oncology and endocrine/metabolic drugs, launch prices increased by 33% annually.¹

Table 2.

Launch price: median annual list and net price.

	2022	2023	2024
Median List Price (range)
All drugs	$249 257 ($853−$3 677 128)	$306 937 ($487-$3 285 018)	$308 749 ($660-$4 250 000)
Orphan products	$357 520 ($3309-$3 677 128)	$397 138 ($6005-$3 285 018)	$515 000 ($50,261-$4 250 000)
Non-orphan products	$45 242 ($853-$267 905)	$45 237 ($487-$1 294 502)	$32 000 ($660-$537 000)
Median Net Price (range)
All drugs	$182 271 ($452-$3 151 824)	$264 938 ($390-$3 285 018)	$274 795 ($660-$4 250 000)
Orphan products	$333 458 ($3309-$3 151 824)	$392 525 ($5882-$3 285 018)	$515 000 ($38,390-$4 250 000)
Non-orphan products	$35 426 ($452-$267 905)	$37 230 ($390-$1 268 612)	$31 091 ($660-$537 000)

High drug prices have a real impact on patients. A new poll from KFF found that about one in five adults reports not filling a prescription due to cost.¹¹ However, the impact is not just on patients, but on everyone in the health care system. Health insurance premiums are rising at unsustainable rates, and significant increases in the number of uninsured are expected. The poll showed that almost four in ten insured adults under the age of 65 worry about affording their monthly health insurance premiums.¹¹

A high price tag is not the end of the story. Are we paying for value?

As an organization that cares deeply about pricing to value, a high launch price in itself would not be a concern for ICER if a therapy has a high long-term value. This means society is paying a reasonable amount for the benefits it provides to patients over an extended period, often a lifetime.

However, ICER's analysis of approximately 15% of drugs approved between 2022 and 2024 found that only about 30% of these therapies were priced to value.¹ The remaining 70% had annual net prices above ICER's Health Benefit Price Benchmark (HBPB), resulting in excess spending of $1.3 to $1.5 billion in the first year post-approval alone.¹

The underpinning of ICER's analysis is to ask two simple questions: what is the net health benefit of the new treatment compared with the existing standards of care, and how much are we, as society, paying for this benefit? ICER answers these questions using a transparent, rigorous approach over an eight-month review process that offers multiple opportunities for public comment from all stakeholders (such as patients, drugmakers, health insurers, and others). Our research conclusions are subject to public deliberation and vote by independent appraisal committees consisting of policy experts, health economists, patients, and medical evidence experts outside of ICER. ICER's HBPB suggests a price range, net of any discounts and rebates, that aligns fairly with the overall health benefits the treatment provides for patients over their lifetime, based on the data available at the time of drug approval. Prices at or below these thresholds help ensure that the health benefits gained by patients using new treatments are not outweighed by health losses resulting from long-term cost pressures that lead individuals to become under-insured or uninsured.

One response to ICER's Launch Price and Access report was that ICER's HBPBs are not considered objective standards of value by everyone. Whether ICER's approach is universally accepted or not, one question remains for us to answer as a society: Are we paying for value? High prices for drugs without any anchoring to how well those drugs actually work are just driving up overall health care costs, and these spiraling prices lead directly to reduced access and higher out-of-pocket expenses for all patients. Our evaluation showed that a significant proportion of manufacturers do not provide a justification for their product's launch price.¹ For those that provide a justification, the majority cite alignment with clinical and economic value, although the specifics of how this value is evaluated are rarely disclosed. One notable exception was Eisai's pricing justification for Leqembi,¹² which included transparent use of evidence and cost-effectiveness analysis to justify the price, shifting the discussion from the price justification to alignment on underlying model assumptions and methods. Other pricing justification often cited by manufacturers is the drug's novelty.¹ However, in thinking about value, we should not just be talking about novelty or the “innovation” we’re getting, but about how good it is for patients. This is the approach ICER brings and continues to bring to the conversation. ICER provides an evidence-based value assessment, which encourages higher prices for drugs that work really well, and lower prices when there is uncertainty in how well the drug works, or current data shows that it doesn’t work that well.

While there are often other practical considerations, such as the size of the eligible patient population or unmet need, that may be relevant to a drug's pricing, these decisions are too often made without rigorous evidence and with little transparency. More transparency from drugmakers on how prices are determined will help policymakers address affordability in a more systematic and evidence-based manner.

A new drug does not translate into payer readiness for coverage decisions. Can we do better?

An FDA approval kicks off a complex series of interactions between the manufacturer and various payers to negotiate access policies, which must be completed before patients receive the new treatment. As part of this process, payers often review the clinical trial data, especially for high-cost or fast-tracked drugs. They may require time to understand the likely positioning of the new drug in the treatment sequence and estimates of its relative clinical effect compared with the current standard of care, before making a final coverage decision. Our analysis based on the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database, which contains information on specialty drug coverage decisions issued by up to 18 large US commercial health plans, showed that insurance coverage policies were lacking, even up to one year after approval for the majority of the drugs launched in 2024.¹ For many drugs, there appeared to be at least a six-month delay in posting coverage policies, even for first-in-class drugs where no other treatments were previously available. This is consistent with a prior study that found a median time to coverage issuance of 209 days.¹³ This delay may also reflect the impact of new-to-market blocks. For example, while the Centers for Medicare & Medicaid Services mandates review of a newly approved drug within 180 days,¹⁴ commercial payers may have a different timeline, with reviews of certain drug categories occurring only once a year. Although, in principle, these delays can be justified to allow an insurer adequate time to review the clinical evidence, the lack of timely coverage policies could limit or delay access, as without a policy, patients would need to engage in lengthy exception or prior authorization processes. How can we do better for patients? More active horizon scanning to proactively identify emerging therapies that address significant unmet needs, coupled with early evidence evaluation, will help limit these delays and enhance patient access.

A new drug does not mean patient access. How do we center innovation on patient access?

Our analysis of IQVIA's Longitudinal Access and Adjudication Data of a sample of drugs approved in 2024 showed that about 6 in 10 commercial new-to-brand prescriptions were rejected in the first quarter of 2025.¹ Non-coverage of the drug was the most common reason for rejection, perhaps reflecting that the establishment of coverage policies often significantly lags approval dates. We also facilitated group discussions with patient advocacy groups to learn about access challenges, and the majority highlighted insurance-related issues, including prior authorization burden, step-therapy concerns, the complexity of government insurance programs, and differences in care received by insurance type.¹ However, patient advocates across multiple conditions—rare and common—also highlighted other factors, beyond insurance coverage, that impact access, including health system complexity, health inequities, drug administration burden, and cost-related issues. Patient advocates noted that, due to the complexity of our health care system, delays in diagnosis were common, often serving as the first barrier to accessing medications. Stigma and bias around certain conditions, such as mental illness, including discrimination based on race, socioeconomic status, and other factors, also created barriers for patients seeking care.

In terms of barriers related to the therapy itself, patient advocates highlighted treatment burden and cost as major concerns for patients. We heard that a complex method of administration may impair access to treatment, particularly if the treatment requires administration in a health care setting.

Finally, out-of-pocket costs were highlighted as a significant barrier for patients. Our analysis showed that 35% of covered commercial new-to-brand prescriptions for newly approved drugs in 2024 were abandoned.¹ Abandonment rates may be due to high out-of-pocket costs, high deductibles that have not yet been met, or a lack of cost transparency. Although patient assistance programs sponsored by manufacturers or non-profit entities can help individuals who cannot afford the drug, patients noted that the process of obtaining this financial assistance can be cumbersome and has limitations, such as being time-limited. Also, patients noted that copay accumulators implemented by insurance companies can exacerbate financial challenges. These accumulators do not count any contributions from patient assistance programs or co-pay cards toward the annual deductible, leaving the patient responsible for the full amount and increasing financial stress. Centering innovation around patient access will require all stakeholders to work together to identify barriers to patient access and create solutions that actually benefit patients.

Conclusion and recommendations

ICER's inaugural Launch Price and Access report identified several opportunities to improve patient access and affordability. First, the significant escalation of launch prices, even on a net basis, often out of line with value for patients, highlights the need for an independent assessment of price and value. Research conducted by organizations such as ICER can help the health care system navigate the tension of innovation, affordability, and access. Independent assessment helps drugmakers identify which treatments will command high prices, allowing pipeline development decisions to focus on the most promising therapies that provide benefit to patients. This also helps purchasers to know how much to pay for new medicines. By anchoring prices to value and reducing or eliminating utilization management and cost sharing for fairly priced drugs, drug manufacturers, payers, and purchasers can collectively de-escalate the cycle of increasing prices, access restrictions, and patient cost burdens. Such a voluntary de-escalation is likely to be a more welcome approach to reform than the many policy options being discussed now around government price negotiation, international reference pricing, and reforms to pharmacy benefit manager practices.

Second, although payers’ use of new-to-market blocks is intended to delay coverage pending clinical and economic review, this approach creates a substantial access barrier, affecting over half of covered lives in 2024,¹⁵ underscoring the need for enhanced payer preparedness for patients. Payers can address this by committing to faster adjudication of new therapies by preparing coverage policies before FDA approval, to avoid the frustration and potential harm to patients who cannot access a newly approved medicine due to new-to-market blocks. ICER's independent assessment takes this approach by evaluating emerging drug therapies, issuing reports, and holding public meetings at or near the time of approval by the US Food and Drug Administration (FDA), to provide stakeholders with a timely independent evaluation of the benefits, risks, and economic considerations surrounding a new treatment. A major challenge to this approach is data availability. As such, for this commitment from payers to succeed, it is also incumbent on drugmakers to publish clinical trial data early, before FDA approval, to facilitate early decision-making by payers.

Third, when innovation does not account for the fragmented and complex nature of the health care system or other societal barriers, it often becomes inaccessible to patients. This issue is the primary motivation for ICER's policy roundtable. ICER's policy roundtable is the culmination of ICER's public meeting on each assessment, where we examine how to apply the evidence on the innovation to real-world practice and policy. This roundtable discussion typically includes all key stakeholders: patients and/or representatives from patient advocacy organizations; clinical experts in the topic under review; representatives from the manufacturer(s) of the therapies under review; and payer/purchaser representatives (ie, public and/or private insurers, pharmacy benefit managers, or employers). Insights from these policy round table conversations can be useful for drugmakers, payers, and other stakeholders working to ensure patients have access to new innovations.

In conclusion, stakeholders need to act urgently to address the real harm the status quo is creating for patients and society. Independent assessments of pricing and access, conducted by ICER through our many individual drug reviews and public meetings each year, can serve as a guidepost for a more just and affordable system.

Supplementary material

Supplementary material is available at Health Affairs Scholar online.