When a new specialty drug receives FDA approval, the regulatory milestone is only the beginning of the access journey. Most commercial health plans and pharmacy benefit managers automatically block new drugs from their claims adjudication systems until a pharmacy and therapeutics (P&T) committee completes its clinical review and issues a formal coverage policy. This "new-to-market block" means the drug cannot be dispensed at the pharmacy or administered under the medical benefit until the plan explicitly allows it. For patients and prescribers, the drug exists but cannot be accessed through insurance.
The scale of the problem is documented in ICER's 2025 Launch Price and Access Report. Analysis of IQVIA's Longitudinal Access and Adjudication Data showed that about six in ten commercial new-to-brand prescriptions were rejected in the first quarter of 2025. Non-coverage was the most common reason for rejection, reflecting that coverage policy establishment often significantly lags approval dates. On average, only 29% of dispensed commercial new-to-brand prescriptions were ultimately successfully filled overall.
This article is for market access leads, commercial operations teams, and hub and patient assistance program (PAP) managers who need to understand how the new-to-market block works, what drives the coverage gap, and what to do about it before approval day.
What the new-to-market block is and how it works
The claims system lock
Most commercial health plans and PBMs maintain formularies that list the drugs eligible for coverage. When a drug receives FDA approval and enters the market, it does not automatically appear on these formularies. Instead, the plan's claims adjudication system treats the drug as non-covered until a P&T committee or medical policy committee reviews the clinical evidence and makes a formal coverage determination.
OPM's 2025 Consolidated Pharmacy Benefits Guidance for FEHB carriers describes this process directly: "Some Carriers routinely block new-to-market drugs from the claims adjudication system until the P&T or medical committee reviews the drug." While OPM's language addresses federal employee health plans specifically, the practice is widespread across commercial insurance. ICER's report found that new-to-market blocks affected more than half of covered lives in 2024.
The block operates as a default denial. When a pharmacy attempts to process a claim for a blocked drug, the claim is rejected at the point of sale. The prescriber may need to initiate a prior authorization request, a formulary exception, or a medical necessity review, none of which can be resolved quickly because the plan has no established policy against which to evaluate the request. In the absence of a posted coverage policy, patients face a formulary labyrinth with no clear path to approval.
UnitedHealthcare's Review at Launch program
UnitedHealthcare maintains one of the most explicit new-to-market blocking policies. Its "Review at Launch for New to Market Medications" policy, updated quarterly, lists specific newly approved drugs that require prior authorization upon market entry. In February 2026, UHC added Boncresa (denosumab-mobz), Exdensur (depemokimab-ulaa), Nufymco (ranibizumab-leyk), and Yartemlea (narsoplimab-wuug) to its Review at Launch Medication List. In January 2026, it added Itvisma (onasemnogene abeparvovec-brve) and Osvyrti (denosumab-desu).
Under UHC's policy, drugs on the Review at Launch list are evaluated based on health plan benefits, whether the medication is a reimbursable service, and medical necessity. Medical necessity reviews use FDA-approved labeling including indication, patient age requirements, dosing recommendations, contraindications, and clinical trial inclusion criteria, along with compendia listings and current standard of care. Authorization is limited to the maximum FDA-approved dose and frequency for no more than six months. The medications remain on the Review at Launch list until UHC's P&T committee completes its evaluation and determines a final utilization management strategy.
This is the operational reality of the new-to-market block: a structured, deliberate process that takes months, during which patients cannot access the drug through their insurance without navigating an exceptions process that many prescribers do not have the bandwidth to pursue.
The 180-day coverage gap: Medicare vs. commercial timelines
CMS requirement for Part D plans
CMS requires Medicare Part D plans to make formulary decisions for new drugs within 180 days of FDA approval. The Medicare Prescription Drug Benefit Manual Chapter 6 establishes this timeline as the outer bound for plan sponsors to complete their P&T review and issue a coverage determination. For drugs selected for the Medicare Drug Price Negotiation Program, the Inflation Reduction Act further requires that these drugs be covered on all Part D formularies starting in the applicable year.
In practice, Part D plans are increasingly tightening formulary management. Avalere Health's analysis of 2026 Part D formulary files found that coverage for the top 100 brand drugs by Part D spending is declining slightly, decreasing by 2 percentage points for MA-PDs. Prior authorization use for covered brand drugs continues to increase, up 3 percentage points for PDPs and 2 percentage points for MA-PDs. Most covered drugs are now placed on coinsurance tiers rather than fixed copay tiers, with the average share of all drugs on coinsurance tiers rising from 48% in 2025 to 63% in 2026 for MA-PDs.
OPM's 120-day requirement for FEHB plans
OPM's 2025 Carrier Letter goes further than the CMS standard. It requires FEHB carriers to "review and effectuate a decision on formulary placement for all new-to-market drugs within 120 days of the drug being available for dispensing." For drugs with "significant clinical impact," defined as those that "may prevent or reduce loss of bodily function or prevent death if used as a treatment or preventive measure as soon as possible," OPM expects the timeframe to be "appreciably accelerated."
OPM also specifies that while the new-to-market block is in effect, the formulary exception process applies. This means that patients and prescribers can request coverage for blocked drugs through the plan's exception mechanism, but the burden of demonstrating medical necessity falls entirely on the prescriber, and the plan has no obligation to expedite its review.
Commercial plans have no federal deadline
For the roughly 180 million Americans with commercial insurance, there is no federal requirement that plans make timely coverage decisions for new drugs. ICER's analysis of the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database found that insurance coverage policies were lacking even up to one year after approval for the majority of drugs launched in 2024. 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.
The SPEC database tracks coverage decisions issued by up to 18 large U.S. commercial health plans. At the December 2024 cutoff, only 18 of the 56 drugs approved in 2024 had policies available for analysis. By April 2025, that number had risen to just 24 of 56. Drugs approved in the first half of 2024 were more likely to have policies available, but for drugs approved in the second half of 2024, coverage policies were not found for the majority of payers at either cutoff.
What ICER's 2025 data reveals about first-quarter rejection rates
The six-in-ten rejection finding
ICER's analysis of IQVIA's LAAD data examined 17 drugs with at least 100 total commercial written prescriptions in the first quarter of 2025. The data showed that the majority of commercial new-to-brand prescriptions for newly approved drugs were rejected. On average, only 29% of total dispensed commercial new-to-brand prescriptions were ultimately successfully filled.
Rejection rates were greater than 50% regardless of whether the drug was first-in-class, considered an orphan drug, or deemed cost-effective by ICER. 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. Non-oncology drugs were more likely to be rejected (63% vs. 42% for oncology drugs), a finding that may reflect the more standardized treatment guidelines and more frequent formulary updates in oncology.
The Miplyffa case study
Miplyffa (arimoclomol), the first treatment approved for Niemann-Pick disease, type C, illustrates the coverage gap in practice. Approved by the FDA in September 2024, only 11% of available policies explicitly covered the drug by December 2024. Policy coverage rose to 50% by April 2025, seven months after approval. Fill rates for Miplyffa in Q1 2025 were below 10%.
Even for drugs with strong clinical profiles, the timeline is slow. Winrevair (sotatercept), approved for pulmonary arterial hypertension in March 2024, had coverage policies available from 78% of plans by April 2025, but that still left more than one-fifth of plans without a policy more than a year after approval. These data are consistent with a prior study that found a median time to coverage issuance of 209 days. A 2026 PhRMA-commissioned study quantified the downstream impact: 17–31% of patients experienced coverage delays of five or more weeks depending on therapeutic area, two to four rejections were typical before approval, and up to 67% of patients studied could not fill their new prescription within a year. Of those who failed to overcome the initial denial, 64–82% did not fill any prescription at all after one year.
Evidence payers demand before lifting the block
When a P&T committee reviews a new-to-market drug, the evidence evaluation typically covers the following domains:
| Evidence domain | What payers evaluate | Common gaps |
|---|---|---|
| FDA-approved indication and label | Approved population, dosing, contraindications, boxed warnings | Narrow label limits coverage to subpopulation only |
| Clinical trial data | Pivotal trial design, endpoints, inclusion/exclusion criteria, dosing | Placebo-controlled trials without active comparator data |
| Compendia listings | Drug compendia such as AHFS, Clinical Pharmacology, Micromedex, UpToDate | New drugs often lack compendia listings at launch |
| Current standard of care | How the new drug fits into existing treatment algorithms | No head-to-head data against current standard |
| Cost-effectiveness data | ICER assessments, budget impact models, health economic analyses | Manufacturer AMCP dossiers that are too long or lack transparency |
UHC's Review at Launch policy explicitly states that medical necessity reviews use "FDA approved labeling, including but not limited to indication, patient age requirements, dosing recommendations, contraindications, and clinical trial inclusion criteria," along with "Compendia (if available)" and "Current standard of care, as per evidenced based literature (if available)."
The parenthetical qualifiers matter. New drugs frequently lack compendia listings at launch, and evidence-based literature for a drug approved weeks ago may be limited to the manufacturer's own clinical trial publications. Without independent evidence, payers have limited basis for coverage decisions, and the default position is to maintain the block.
The operational playbook: what to do 18 months before approval
Start early: the 18-to-24-month window
Kristine McGaughey, vice president of Implementation at ConnectiveRx, described the optimal pre-launch engagement timeline at Access USA 2026: "An optimal timeline is 18 to 24 months. You want to be able to pull in the right stakeholders such as market access, patient services, your hub teams, and really start to map out what that patient journey looks like." McGaughey cautioned that the window narrows significantly within six to nine months of approval: "When you aren't engaged prior to those windows, you have very little time to pivot and make those changes without creating additional friction for your time to therapy."
Pre-file AMCP dossiers with major payers
The AMCP Format for Formulary Submissions is the standard framework for presenting clinical and economic evidence to U.S. payers. While manufacturers cannot proactively send dossiers to formulary decision-makers in most cases, they can prepare pre-approval information exchange (PIE) documents and ensure that dossiers are complete and current when requested through FormularyDecisions.com or by a P&T committee. The dossier must include head-to-head comparator data, a transparent economic model, real-world evidence where available, and a concise value proposition. Payers report that most dossiers are too long, missing critical evidence, or lack methodological transparency.
Map PBM and health plan review cycles
Each PBM and health plan operates on its own P&T committee calendar, typically meeting quarterly. If a drug is approved three weeks after a committee meeting, the next review opportunity may be three months away. Market access teams should map each major plan's review cycle timing and align their evidence submissions to the earliest possible review date. For plans that accept mid-cycle reviews or expedited reviews for drugs with significant clinical impact, teams should prepare the documentation that supports an accelerated timeline.
Engage medical affairs for KOL education before launch
Key opinion leader (KOL) education should begin before approval. P&T committee members and medical directors consult with clinical experts when evaluating new drugs. If the clinical community is not yet familiar with the drug's evidence base, the payer's medical reviewers have fewer sources to draw upon. Medical affairs teams should prioritize KOL engagement in therapeutic areas where payer review is most rigorous and where treatment guidelines are most influential.
Set up hub services and patient support programs before approval
Hub services, copay assistance programs, and patient support infrastructure must be operational before approval day. The new-to-market block means that many patients will face out-of-pocket costs or access denials in the early months. Manufacturer assistance programs can bridge the gap. ICER's report found that a large proportion of new-to-brand prescriptions had a $0 out-of-pocket cost, likely reflecting the use of manufacturer copay cards that allow patients to obtain initial prescriptions at no cost. If the hub is not operational at launch, this bridge is unavailable.
Create prior authorization support materials for prescribers
Prescribers need templates, documentation checklists, and letter templates that align with the specific criteria payers will use to evaluate prior authorization requests. Because many plans will not yet have a published coverage policy for a new drug, prescribers are often guessing at what evidence the plan requires. Market access teams should prepare PA support materials based on the drug's label, pivotal trial inclusion criteria, and anticipated payer criteria, and distribute them to target prescribers before launch.
Monitor formulary decision timing by plan type
Tracking which plans have issued coverage policies, and when, should begin on approval day. The SPEC database and proprietary payer tracking tools can provide early signals. Market access teams should maintain a coverage decision tracker segmented by plan type (commercial, Medicare Part D, Medicaid, FEHB), region, and PBM. This tracker feeds directly into field-based market access team priorities and determines where to deploy dedicated payer liaison resources.
IRA and Part D redesign: how 2026 changes the calculus
The $2,100 out-of-pocket cap
In 2026, the Inflation Reduction Act's $2,100 annual out-of-pocket cap for Medicare Part D beneficiaries takes effect. This cap fundamentally changes plan economics and formulary incentives. Plans bear a larger share of drug costs above the catastrophic threshold, and the shift is already visible in formulary design. Avalere found that the share of plans with three or more coinsurance tiers will increase by 22 percentage points for MA-PDs in 2026, building on a 32-percentage-point increase from 2024 to 2025.
MFP drugs must be covered
Drugs with Maximum Fair Prices (MFPs) established through the Medicare Drug Price Negotiation Program must be covered on all Part D formularies starting in 2026. CMS has stated it does not intend to require specific tiering or utilization management requirements for MFP drugs in 2026, but plans must submit justification if they disadvantage these products relative to therapeutic alternatives. Milliman's analysis noted that manufacturers of MFP drugs may offer supplemental rebates to ensure favorable tier placement, and competitors of negotiated drugs may need to increase rebates to maintain formulary coverage.
Plans are shifting management for non-negotiated competitors
Avalere's initial analysis found that plans are not only adjusting management for MFP drugs but may also be shifting management for non-negotiated competitors in the same therapeutic classes. This means that a new drug launching in a class where a competitor has a negotiated MFP may face more stringent prior authorization or step therapy requirements than it would have in previous years, as plans reevaluate the entire class's formulary positioning.
The Wegovy access cautionary tale
Wegovy (semaglutide) under Part D illustrates the limits of even favorable policy changes. Despite receiving an expanded cardiovascular risk reduction indication in March 2024 that made it eligible for Medicare Part D coverage, Wegovy remains extremely limited. Milliman's analysis found that it is excluded from all PDPs and included on very few MAPD plan formularies, covering less than 1% of beneficiaries. Commercial coverage has also been declining, with a reported 42% increase in people without Wegovy coverage in 2026 compared to 2025. The lesson for launch teams: regulatory eligibility does not guarantee formulary access, even for drugs with strong clinical evidence and massive patient demand.
What to monitor next
Several developments will shape the new-to-market access landscape in the remainder of 2026 and into 2027:
The 2027 MFP cohort. CMS will announce Maximum Fair Prices for the next cohort of negotiated drugs. Launch teams with products in affected therapeutic classes should begin modeling formulary displacement scenarios now.
January 2027 Blizzard Season. Infinitus AI's 2026 State of Specialty Drug Access report documented the "Blizzard Season" phenomenon: every January, insurance benefits reset, prior authorization requirements reset, formularies change, and patients face new access barriers. For drugs launching in late 2026, the January 2027 benefit reset will be the first major stress test of their formulary positioning.
CMS proposed rule on anti-obesity medications. CMS's November 2024 proposed rule (CMS-4208-P) would reinterpret statute to permit Part D coverage of anti-obesity medications for the treatment of obesity. If finalized, this would reshape formulary strategy for GLP-1 receptor agonists and their competitors.
OPM enforcement of the 120-day requirement. OPM's 2025 Carrier Letter sets a 120-day deadline for FEHB carriers to make formulary decisions on new-to-market drugs. How carriers respond, and whether OPM enforces compliance, will be a signal for broader commercial market practices.
Payer adoption of AI-assisted PA processing. Infinitus AI and other platforms are automating prior authorization workflows. If AI-assisted processing reduces the operational burden on prescribers and accelerates PA turnaround, it could partially offset the coverage gap by enabling faster exception processing for blocked drugs. But it could also enable plans to maintain blocks longer, knowing that the exceptions process is more efficient.
The new-to-market block is a structural feature of the U.S. payer system, not a bug. Market access teams that treat it as a known variable, and build their launch timelines around it starting 18 to 24 months before approval, will be positioned to narrow the coverage gap. Teams that wait until approval day to engage with payer review processes will find that the first 180 days have already been lost.
Sources
ICER. 2025 Launch Price and Access Report. October 2025. https://icer.org/wp-content/uploads/2025/10/ICER_2025_Launch-Price-and-Access-Final-Report_For-Publication.pdf
PMC. "US Drug Launch Prices and Patient Access: 2025 Report." https://pmc.ncbi.nlm.nih.gov/articles/PMC13032863
U.S. Office of Personnel Management. FEHB Program Carrier Letter 2025-07: Consolidated Pharmacy Benefits Guidance for the FEHB Program. April 25, 2025. https://www.opm.gov/healthcare-insurance/carriers/fehb/2025/2025-07.pdf
UnitedHealthcare. Review at Launch for New to Market Medications. Community Plan Medical Benefit Drug Policy CS2025D0060L. Updated February 2026. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medicaid-comm-plan/review-at-launch-new-to-market-medications-cs.pdf
Avalere Health Advisory. "Part D Formulary Management Tightens in 2026." November 2025. https://advisory.avalerehealth.com/insights/part-d-formulary-management-tightens-in-2026
Milliman. "Prescribing a Part D Formulary for the New IRA World." December 2024. https://www.milliman.com/en/insight/prescribing-part-d-formulary-new-ira
Pharmaceutical Commerce. "How to Get Specialty Drug Launches Right from Pre-Launch to Patient Access." March 20, 2026. https://www.pharmaceuticalcommerce.com/view/how-to-get-specialty-drug-launches-right-from-pre-launch-to-patient-access
Infinitus AI. "The State of Specialty Drug Access 2026." April 2026. https://www.infinitus.ai/resources/report-state-of-access-2026
PhRMA. "New Study: PBMs and Commercial Insurers Are Quietly Blocking Prescription Access." April 2026. https://phrma.org/blog/new-study-pbms-and-commercial-insurers-are-quietly-blocking-prescription-access
