Medication coverage change log — specialty drug prior authorization and duration updates
Customize your policy alerts
Sign up for all care_continuum policy alerts
Know when care_continuum releases new policies or updates existing guidance.
Monitor payer policy activity
Lists recent medication policy changes across multiple specialty drugs for Medicare and Commercial lines, including updated prior authorization, approval durations, diagnostic thresholds, and biosimilar PA additions; affects providers submitting prior authorizations for affected agents.
Updated approval duration to 1 year for initial, lifetime for continuation for multiple biologic agents (mepolizumab, benralizumab, tezepelumab).
Updated diagnostic/coverage criteria for multiple agents (mepolizumab nasal polyps, dupilumab COPD, risankizumab psoriasis PASI threshold, tezepelumab nasal polyps).
Updated continuation coverage durations to lifetime for several agents (risankizumab, upadacitinib, others).
Removed trial of diuretic requirement for heart failure indication for finerenone (Kerendia).
Added Oncology products Lunsumio Velo and Rybrevant Faspro to Medicare review list.
Added new indication/product Zoryve 0.05% cream for Medicare and removed BSA and additional AD requirements.
Added Rezdiffra to Commercial formulary.
Updated Wakix criteria to reflect indication for EDS or cataplexy in patients 6 years and older.
Stelara biosimilars prior authorization added for Commercial.
Coverage Criteria Updates
The coverage criteria for finerenone (Kerendia) have been revised: the prior requirement for a trial of a diuretic for the heart failure indication has been removed. Providers submitting prior authorization requests for finerenone should no longer document or provide evidence of a failed diuretic trial as a condition of coverage for the heart failure indication.
Clinical Thresholds & Coding Notes
What Providers Must Do
Updated prior authorization requirements — include new agents and revised durations
Submit prior authorization requests per payer process reflecting the updated agent list, indications, and approval durations; note that new Commercial prior authorization is required for ustekinumab biosimilars (Stelara biosimilars) and several agents have revised initial and continuation approval durations (initial = 1 year; continuation = lifetime) that must be requested on the PA.
- Include the specific drug and indication on the PA (e.g., risankizumab psoriasis with PASI score where applicable).
- Request the updated approval duration (initial = 1 year; continuation = lifetime) when applicable.
Step therapy updates — removed trial requirements (e.g., diuretic for finerenone)
Do not document or require trials that have been removed from step-therapy rules — for example, the prior requirement for a diuretic trial for finerenone (Kerendia) has been removed and should not be presented as a prerequisite for approval.
- Omit documentation of a diuretic trial for Kerendia heart failure indications in PA submissions.
- Review other step-therapy tables for removed AD/BSA requirements (e.g., Zoryve changes) before requesting additional trials.
Clinical documentation required to support revised criteria and thresholds
Provide clinical documentation that demonstrates the patient meets the revised diagnostic thresholds and criteria referenced in the policy (for example, record the PASI score when required and indicate prior approval duration being requested for initial versus continuation coverage).
- Include objective scores where specified (e.g., PASI score ≥ 7 for psoriasis when applicable to risankizumab requests).
- Document indication-specific clinical findings and prior treatment history that align with the updated criteria and requested approval duration (initial 1 year vs continuation lifetime).
Denial risk if updated clinical thresholds or duration rules are not met
Requests that do not meet the revised criteria, objective thresholds, or updated duration rules may be denied—examples include failure to document required PASI ≥ 7 for psoriasis or requesting durations inconsistent with the policy.
- Missing or undocumented PASI score when the policy requires PASI ≥ 7 (risankizumab psoriasis) can lead to denial.
- Requests that seek durations inconsistent with updated initial (1 year) or continuation (lifetime) coverage may be returned or denied.
Initial Approval Durations & Criteria
Initial Therapy Criteria
Initial approval is granted when the agent-specific entry criteria are met; initial approval durations have been standardized per the updates below.
Continuation Coverage Durations
Continuation Coverage Durations
Continuation (renewal) approval is granted when the member continues to meet the agent-specific clinical criteria; continuation durations have been updated as follows.
Step Therapy Changes
| Drug / Product | Removed step or trial requirement | Removed AD / BSA requirement (if applicable) | Coverage impact / note |
|---|---|---|---|
| Finerenone (Kerendia) | Removed requirement for a trial of a diuretic for the heart failure indication | Providers are no longer required to document a prior diuretic trial for Kerendia requests for the heart failure indication | |
| Zoryve (roflumilast) 0.05% cream | Removed additional atopic dermatitis (AD) requirements and removed BSA requirements from all indications | Zoryve added as a new product/indication and prior AD and BSA-specific requirements were removed per CMS feedback |
Biosimilar Prior Authorization
Commercial prior authorization added for ustekinumab biosimilars
A new prior authorization requirement was added specifically for ustekinumab (Stelara) biosimilars on the Commercial line; providers must obtain PA for these biosimilars under Commercial coverage.
- Submit a Commercial prior authorization for Stelara (ustekinumab) biosimilars per payer process.
Policy Change Background
This change log summarizes multiple policy updates made in response to ESI and CMS feedback across specialty and biologic agents. Key operational changes include standardizing initial approval durations to 1 year and continuation durations to lifetime for several agents (e.g., mepolizumab, benralizumab, tezepelumab, risankizumab, upadacitinib), adjusting diagnostic thresholds (for example, psoriasis PASI >= 7), adding new Medicare oncology reviews, and removing specific step/trial requirements such as the diuretic trial previously required for finerenone (Kerendia).
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.