Axitinib (Inlyta) — Coverage and Prior Authorization
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Defines medical necessity criteria, prior authorization requirements, and approval durations for axitinib (Inlyta) for Medicaid members, including FDA-approved and selected off-label indications and continuation criteria.
No material clinical or coverage changes in this revision.
Coverage Criteria and Authorization Rules
inv-05: Other diagnoses/indications — Covered when ONE of the following is met
Covered when ONE of the following is met
Provides routing to other policies for coverage determination.
inv-04: Continuation Therapy — All Indications in Section I — Covered when ALL of the following are met
Covered when ALL of the following are met
Prescribed regimen must be FDA-approved or recommended by NCCN. Approval duration for continued therapy (Medicaid): 12 months.
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the Health Plan's off‑label use requirements (see policy CP.PMN.53 for Medicaid) or evidence of coverage documents.
Treatment requests for indications that are not FDA‑approved and not listed in this policy will be considered not authorized unless the request includes adequate supporting clinical evidence per the applicable off‑label use policy (CP.PMN.53) or other evidence of coverage documentation demonstrating efficacy and safety for the requested use.
Where state Medicaid requirements or provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers must follow applicable state and federal requirements and the member's coverage documents when requesting coverage.
Coding and Dose Limits
Provider Responsibilities and Authorization Procedures
Prior authorization required — document diagnosis, oncology involvement, age, and dosing
Prior authorization is required for Inlyta. The provider must document the member's diagnosis, that the drug was prescribed by or in consultation with an oncologist, the member is age ≥ 18 years, and that the requested dose does not exceed 20 mg per day or is supported by practice guidelines/peer‑reviewed literature for off‑label use (prescriber must submit supporting evidence).
- Diagnosis must match the applicable criteria (e.g., relapsed/metastatic/stage IV RCC; DTC; alveolar soft part sarcoma).
- Oncologist involvement or consultation must be documented.
- Dose must be ≤ 20 mg/day or supported by literature with evidence submitted.
Formulary exception review for Marketplace members
Requests for non‑formulary agents for Health Insurance Marketplace members must be evaluated under the plan's formulary exception process; coverage is only available when the agent is on the health plan approved formulary or approved via the formulary exception policy.
- Follow the formulary exception policy for Marketplace members when the requested drug is non‑formulary.
Step therapy / alternatives — consider listed systemic therapies; Nexavar failure required for DTC
Therapeutic alternatives listed in Appendix B (e.g., pazopanib, sunitinib, cabozantinib, everolimus, sorafenib, lenvatinib) should be considered; for the DTC off‑label indication, failure of sorafenib (Nexavar) is required unless contraindicated or adverse effects occur.
- Appendix B lists alternative systemic therapies and dosing considerations.
- DTC: document failure or contraindication to Nexavar (sorafenib) when applicable.
Alert — verify prior authorization for combination and off‑label regimens
Providers should note that prior authorization may be required for combination regimens (e.g., with pembrolizumab or avelumab) and for off‑label uses; confirm authorization requirements when submitting requests.
- Combination therapy for RCC (with Keytruda®/Bavencio®) and ASPS (with Keytruda®) may require prior authorization.
Required clinical documentation — submit chart notes, labs, and supporting evidence
Submit supporting clinical documentation with the prior authorization request, such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria.
- Include evidence supporting off‑label use when applicable (practice guidelines or peer‑reviewed literature).
Follow coverage documents and legal/regulatory requirements
Providers must follow the member's coverage documents (evidence of coverage, certificate of coverage, policy) and applicable state and federal requirements when requesting coverage; this policy guides medical necessity but does not override contractual or legal obligations.
- Coverage decisions are subject to the terms, conditions, exclusions and limitations of the coverage documents and applicable law.
Denial risk — off‑label uses require sufficient supporting evidence
Requests for non‑FDA approved indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the off‑label use policy (CP.PMN.53) or the member's evidence of coverage.
- When seeking coverage for off‑label indications, submit clinical evidence demonstrating efficacy and safety as required by off‑label policy.
Coverage subject to contract terms and legal requirements
Coverage decisions and benefit administration are governed by the member's coverage documents and applicable legal/regulatory requirements; discrepancies are controlled by law and plan contractual terms.
- This clinical policy is a guide to medical necessity and does not guarantee payment.
Definitions and Reference Terms
Background and Drug Information
Axitinib (Inlyta) is an oral tyrosine kinase inhibitor indicated for advanced renal cell carcinoma. It is used as combination therapy with checkpoint inhibitors (avelumab or pembrolizumab) in the first‑line setting and as a single agent for advanced RCC after one prior systemic therapy. Product strengths available include tablets: 1 mg and 5 mg, and dosing should not exceed a maximum of 20 mg per day unless supported by practice guidelines or peer‑reviewed literature submitted by the prescriber.
Step Therapy and Therapeutic Alternatives
| Step | Requirement | Notes / therapeutic alternatives |
|---|---|---|
| 1 | Use or documented failure of alternative systemic therapies or participation in clinical trials considered prior to approval. | Appendix B lists therapeutic alternatives including pazopanib (Votrient), sunitinib (Sutent), cabozantinib (Cabometyx), everolimus (Afinitor), sorafenib (Nexavar), bevacizumab (Avastin), nivolumab (Opdivo), temsirolimus (Torisel), lenvatinib (Lenvima), and others. |
Quantity Limits and Dosing Caps
Criteria for Continued Therapy
Revision History and References
References: 1. Inlyta Prescribing Information. Pfizer Labs, Inc.; September 2022. Additional sources cited in policy development include the NCCN Drugs & Biologics Compendium, NCCN guidelines for Kidney Cancer and Thyroid Carcinoma, and the Clinical Pharmacology database. This policy was adapted from IL.PHAR.100 and approved by Meridian Health Plan with documentation of reference sources listed in the policy's reference section.
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