Inflation Reduction Act Impact in 2025 (Pharmacy formulary, PA, QL updates)
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Describes formulary, prior authorization (PA), quantity limit, and mail-order service changes for Care Continuum (CCUM) driven by IRA-related financial impacts and 2025 program changes; affects Medicare and Commercial lines as specified.
Wegovy (semaglutide) received a Medicare-eligible indication for prevention of cardiovascular events and a new PA will require established cardiovascular disease and BMI >=27 kg/m2.
Express Scripts mail order will no longer fill prescriptions written for less than a 35-day supply (effective March 1, 2024) for Commercial and ACA IFP members.
Multiple prior authorization (PAR) criteria and preferred product lists updated across Medicare and Commercial (including addition of Simlandi as preferred adalimumab product).
Multiple drug-specific PA entries and new Medicare-specific PA items are being added for effective date 1.1.2025.
Initial and continuation criteria are being updated for many products to align with CMS submission format and to add required medical information.
Several biologics and supportive care products are being removed from the Medicare formulary or having status changed due to rebate considerations.
Medicare-specific prescription restrictions and prescriber requirements are being added for certain products (e.g., Wegovy prescriber restrictions).
Coverage Criteria and Formulary Changes
Wegovy initial coverage criteria
Covered when ALL of the following are met
Wegovy is specialty tier (tier 5) and requires prior authorization (PAR-700); PA will mirror the approval study and absence of required documentation may trigger denial.
PAR alignment and preferred product updates
PAR updates and consistency requirements
Applies variably by PAR document and product.
General PA update criteria
Updates effective 1.1.2025 include the following general coverage adjustments
Specific per-product details are in the individual PAR documents effective 1.1.2025.
Step therapy / preferred product criteria
Medicare-specific stepping requirements
Applies to specified oncology and other product PARs; details vary by PAR.
The policy includes Medicare-specific quantity limit exception criteria for selected products that are explicitly labeled Do not override this quantity limit. Examples include Omvoh (mirikizumab-mrkz) 100 mg/mL pen with a limit of 2 per 28 days and Velsipity (etrasimod) 2 mg tablets with a limit of 30 per 30 days. These edits apply to the Medicare (NHP Medicare) benefit and should not be manually overridden when processing Medicare claims.
The Medicare quantity level limit updates table also shows the formal addition of these limits (Omvoh 2/28 days; Velsipity 30/30 days) to the policy's quantity limit schedule, reinforcing that these are active Medicare QLs and subject to the stated non-override instruction.
Several products have been removed from the Medicare formulary or had their status changed for administrative or rebate-related reasons rather than clinical safety or efficacy determinations. Examples called out for Medicare effective 1.1.2025 include removal of Jay Verzenio (to be managed under a separate PA for rebate reasons) and removal of Lumoxiti as obsolete.
Supportive care and biologic products were adjusted due to rebate considerations: multiple pegfilgrastim/filgrastim originator and biosimilar products (e.g., Neupogen, Neulasta, Nivestym, Releuko, Ziextenzo, Fulphila, Fylnetra, Neulasta Onpro) were removed or reclassified with preferred alternatives identified (for example, Granix, Zarxio, Nivestym and Stimufend referenced as preferred). These changes are administrative formulary decisions driven by rebate arrangements and are reflected in the 1.1.2025 PA updates.
Certain commercial quantity limit edits are explicitly designated Do not override this quantity limit. The commercial QL updates list includes multiple entries where the policy text repeats the non-override instruction; an illustrative example is the commercial update that adds Omvoh pens with a commercial quantity limit of 2 per 28 days and marks the edit as not eligible for override. Additionally, the commercial edits include changes to Ajovy (225 mg autoinjector) quantity from 3/90 days to 1 per 30 days, reflecting stricter commercial QL enforcement where override is not permitted without applicable policy justification.
The document differentiates administrative or rebate-driven formulary removals from clinical "not medically necessary" determinations. For example, the 1.1.2025 Medicare PA updates list several products being removed specifically due to rebate considerations (e.g., Jay Verzenio moved to separate PA; multiple supportive-care biologics removed) and note that these are changes made for rebate/administrative reasons rather than clinical NMN findings.
Where products are removed or status-changed for rebate reasons, the policy does not frame those removals as clinical NMN decisions; instead, they reflect formulary management and preferred-product selection tied to contractual and rebate considerations.
PAR Entries, Codes, and Key Clinical Values
| PAR-278 | Rilonacept (Arcalyst) |
| PAR-281 | Tetrabenazine |
| PAR-284 | Golimumab (Simponi) |
| PAR-286 | Ustekinumab (Stelara) |
| PAR-287 | Tocilizumab (Actemra) |
| PAR-300 | Abatacept (Orencia) |
| PAR-302 | Kalydeco, Orkambi |
| PAR-311 | Korlym (mifepristone) |
| PAR-315 | Tofacitinib (Xeljanz variants) |
| PAR-317 | Insulin (Humalog Mix 50-50 note) |
| PAR-278 | Rilonacept (Arcalyst) |
Provider Actions, Prior Authorization, and Documentation
Wegovy (PAR-700) prior authorization required
Wegovy (semaglutide) is a tier 5 specialty medication (PAR-700) that requires prior authorization for Commercial and Medicare. The PA criteria will mirror the FDA approval study and must document that the patient has established cardiovascular disease (prior MI, stroke, or established peripheral arterial disease), a BMI ≥ 27 kg/m2, and that therapy will be used with a reduced‑calorie diet and increased physical activity.
- PA identifier: PAR-700
- Document established CVD (prior MI, stroke, or established peripheral arterial disease).
- Document BMI ≥ 27 kg/m2.
- Confirm use with reduced‑calorie diet and increased physical activity per approval study.
Updated PARs for anti‑inflammatory biologics (preferred products added)
Multiple anti‑inflammatory biologic PAR documents are being updated to align with Express Scripts ICCV criteria and to add or designate preferred products (for example, Simlandi added as an additional preferred adalimumab product across PARs).
- Updates apply to PAR-250, PAR-275, PAR-276, PAR-277, PAR-284, PAR-286, PAR-287, PAR-356, PAR-402, PAR-408, PAR-413 and others.
- Preferred product lists (e.g., Simlandi) are being added to Medicare and Commercial PARs.
Updated PA requirements effective 1.1.2025
Many PARs will require updated initial and continuation criteria effective 1.1.2025; these updates include adding required medical information, prescriber restrictions for select products, and continuation/reauthorization requirements aligned to CMS submission format.
- Effective date for many changes: 1.1.2025.
- Required documentation must be submitted with initial PA and at reauthorization; criteria formatting adjusted to align with CMS.
Metformin step removed for GLP‑1 / GIP‑GLP‑1 PARs
Metformin step therapy requirement has been removed from GLP‑1 and GIP/GLP‑1 prior authorization pathways for both Medicare and Commercial lines of business.
- Applies to PAR-634 (GLP-1 agonist) and PAR-639 (GIP/GLP-1 agonist).
- Change implemented due to rebate considerations.
Medicare step therapy — required trials of preferred agents
Some Medicare criteria will require members to step through specified preferred agents before coverage of alternatives; examples include requiring trials of Calquence and Brukinsa for mantle cell lymphoma/CLL/SLL prior to coverage of certain therapies.
- Preferred‑agent stepping is driven by rebate and formulary considerations.
- Applies variably by PAR and indication; review the specific PAR for step requirements.
Required documentation for 2025 PAR updates
For many PAR updates effective 1.1.2025, prior authorization requests must include additional required medical information and documentation; prescriber restrictions and continuation documentation may also be required at initial request and reauthorization.
- Required information may include diagnosis, relevant labs, prior therapy history, and dosing/frequency details.
- Prescriber restrictions added for select medications and must be documented when applicable.
Submit required medical information with PA and reauthorization
Prior authorization submissions must include the specified medical information required by the PAR (for both initial and continuation requests), such as diagnosis, required labs, history of prior therapies, and evidence supporting continuation of therapy.
- Continuation requests must include prior documentation of initial approval criteria and dosing/frequency appropriateness.
- Specific required fields vary by PAR—follow the PAR's listed required medical information.
Wegovy PA denial risk if CVD or BMI not documented
Wegovy coverage will be denied if the PA does not document established cardiovascular disease (prior MI, stroke, or established peripheral arterial disease) and BMI ≥ 27 kg/m2 as required by the approval‑study‑based PA criteria.
- Absence of documentation of established CVD or BMI ≥ 27 kg/m2 is a trigger for denial.
ESI mail‑order minimum day supply — <35 days will be returned
Express Scripts mail‑order will not fill prescriptions written for less than a 35‑day supply for Commercial and ACA individual/family plan members; prescriptions sent to ESI mail order with a supply <35 days may be rejected or returned.
- Change effective March 1, 2024 (Commercial and ACA IFP impacted; Medicare and retail not impacted).
- Providers should send updated prescriptions requesting 90‑ or 100‑day supplies where clinically appropriate.
Denial risk for missing required documentation or prescriber info
Failure to submit required medical documentation and required prescriber information with a PA request may result in denial; many 2025 PAR updates explicitly add required documentation and prescriber restrictions.
- Ensure prescriber identity and any prescriber restrictions are documented when required by the PAR.
- Include all required medical records, labs, and prior therapy history at initial PA and reauthorization to avoid documentation‑linked denials.
Background and Rationale
Wegovy (semaglutide) has received an expanded, Medicare-eligible indication for prevention of cardiovascular events in adults with established cardiovascular disease. Coverage and prior authorization criteria for Wegovy require that the patient have established cardiovascular disease (history of prior myocardial infarction, stroke, or established peripheral arterial disease) and a body mass index of >= 27 kg/m2, consistent with the approval study population.
Prior authorization (PAR-700) for Wegovy will mirror the approval study criteria, including use in combination with a reduced-calorie diet and increased physical activity, placement on the specialty tier (tier 5), and associated member cost considerations.
Definitions and Continuation Notes
Initial Therapy Criteria (Drug-class Specific)
GLP-1 initial therapy PA changes
Medicare and Commercial GLP-1/GIP-GLP-1 PA adjustments
Applies to class PARs (e.g., PAR-634, PAR-639) as indicated.
Effective 1.1.2025 alignment with CMS submission format may apply to some PARs.
Initial therapy requirements (general)
Initial authorization requires submission of specified clinical data
Specific required elements vary by PAR and are detailed in each product's authorization document.
Continuation and Reauthorization Criteria
Continuation therapy requirements
Continuation and reauthorization requirements being added or clarified in 2025 PAR updates
Applies variably by PAR; effective 1.1.2025 updates add or clarify these requirements.
Continuation criteria (general)
Continuation criteria added or clarified for many products
Specific documentation elements and timing are defined within each product's PAR.
Step Therapy Requirements
| Step | Requirement | Applies to | Notes / Rationale |
|---|---|---|---|
| 1 | |||
| Members must trial and fail (or have documented contraindication/intolerance to) preferred formulary agents as specified in the applicable PAR before coverage of non‑preferred alternatives; PA criteria updated to align with ESI ICCV criteria. | |||
| Medicare and Commercial (per PAR updates) | |||
| Updates reflect alignment to ESI ICCV criteria and addition of preferred products (e.g., Simlandi added to adalimumab family); ensures formulary drugs are tried/failed before non‑preferred coverage. |
| Step | Requirement | Applies to | Notes / Rationale |
|---|---|---|---|
| 1 | |||
| Members must step through specified preferred therapies (for example, Calquence and Brukinsa) prior to coverage of alternative agents for certain oncology indications (mantle cell lymphoma, CLL/SLL) unless contraindicated or clinically inappropriate. | |||
| Medicare (1.1.2025 updates) — also referenced for Commercial consistency | |||
| Step requirement added due to rebate considerations and preferred product updates; ensures use of designated preferred agents before authorizing alternatives; applies to PARs governing oncology agents reviewed under Evicore where noted. |
Quantity Limits and Edit Notes
Site of Care and Dispensing Rules
ESI mail‑order minimum day supply (Commercial/ACA IFP)
Express Scripts mail-order will no longer fill prescriptions written for less than a 35-day supply for Commercial and ACA IFP members; Medicare and retail pharmacies are not affected.
- Initial change effective March 1, 2024.
- ESI will notify affected members by email or mail.
Oncology PARs (PAR‑630) reviewed by Evicore
Oncology products referenced by PAR-630 are reviewed by Evicore; site-of-care specifics are not enumerated within this document, but Evicore review is used for oncology prior authorizations.
Biosimilar and Preferred Product Updates
Adalimumab preferred product (Simlandi) added
Simlandi has been added as an additional preferred adalimumab product across multiple PARs for Medicare and Commercial; adalimumab family PARs were updated to reflect preferred products.
Originator products removed; preferred biosimilars designated
Certain originator supportive care and biologic products (examples: Neupogen, Neulasta and several pegfilgrastim/filgrastim products) are being removed or reprioritized due to rebate considerations, and preferred biosimilars/products (e.g., Granix, Zarxio, Nivestym, Stimufend) are identified.
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