CurrentCentenePolicy CP.PHAR.10O

Axitinib (Inlyta) coverage

Defines medical necessity, prior authorization, and coverage criteria for axitinib (Inlyta) for members of Centene-affiliated health plans across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyAxitinib (Inlyta) coverage

Policy CodePolicy CP.PHAR.10O

Change TypeNo material change

Effective DateMay 1, 2012

Next Review Date

Key ActionProvider must submit documentation (e.g., office chart notes, lab results) demonstrating the member meets the listed initial or continued therapy criteria and prior authorization requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20 mg/daymax daily dose

5 mg BIDstarting dose (RCC)

12 moinitial duration (Commercial)

6 moinitial duration (Medicaid/HIM)

1 mg, 5 mgavailable strengths

Coverage Criteria for Axitinib (Inlyta)

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Initial Therapy (RCC)

Covered when ALL of the following are met:

Initial RCC criteria: 1) Diagnosis of relapsed, metastatic, or stage IV renal cell carcinoma (RCC); 2) Age >= 18 years; 3) Prescribed by or in consultation with an oncologist; 4) For Inlyta requests, member must use axitinib if available unless contraindicated or clinically significant adverse effects occur; 5) Prescribed as single-agent therapy OR, for clear cell histology, in combination with pembrolizumab (Keytruda) or avelumab (Bavencio) as specified; 6) Requested dose does not exceed 20 mg per day and does not exceed 4 tablets per day, OR the requested higher/off‑label dose is supported by practice guidelines or peer‑reviewed literature with prescriber-submitted evidence; 7) Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request, whichever is less.

NCCN Compendium Indications (off‑label)

Covered when ALL of the following are met for listed NCCN compendium indications:

NCCN off‑label criteria: 1) Diagnosis consistent with a listed NCCN compendium off‑label indication (examples include unresectable/locoregional recurrent/persistent or metastatic differentiated thyroid carcinoma [DTC], alveolar soft part sarcoma, thymic carcinoma); 2) Age >= 18 years; 3) Prescribed by or in consultation with an oncologist; 4) For DTC, disease is not amenable to radioactive iodine therapy; 5) Clinical trials or other systemic therapies are not appropriate or available; 6) For thymic carcinoma, Inlyta is prescribed in combination with avelumab (Bavencio) as first‑ or second‑line as specified; 7) Dose is within the FDA maximum limit for any FDA‑approved indication or, if exceeding, is supported by practice guidelines or peer‑reviewed literature with prescriber-submitted evidence; 8) Prescribed regimen must be FDA‑approved or recommended by NCCN.

Prior authorization may be required; prescriber must submit supporting evidence for off‑label use or dosing.

Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Continuation Therapy: 1) Member is currently receiving Inlyta via the Centene benefit, or documentation demonstrates the member has been receiving axitinib for at least 30 days; 2) Member is responding positively to therapy; 3) For requests to increase dose, the new dose does not exceed 20 mg per day and does not exceed 4 tablets per day, OR the increased dose is supported by practice guidelines or peer‑reviewed literature with prescriber-submitted evidence; 4) For Inlyta requests, member must use axitinib if available unless contraindicated or clinically significant adverse effects occur;

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the prescriber provides sufficient documentation of efficacy and safety consistent with the plan’s off‑label use policies. Referenced off‑label policies include CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid).

Policy history documents specific restrictions and clarifications that affect coverage determinations. Notable history items include a clear cell histology restriction limited to combination therapy with pembrolizumab (Keytruda) or avelumab (Bavencio), addition of single‑agent first‑line therapy per NCCN for RCC, and iterative updates to off‑label indications (e.g., additions and terminology changes for thyroid carcinoma, alveolar soft part sarcoma, and later thymic carcinoma). The history also records line‑of‑business approval duration changes (for Commercial, revised to 12 months or duration of request, whichever is less) and periodic alignment with NCCN compendium requirements.

Use of axitinib for non‑FDA approved indications that are not covered by this policy will be considered not authorized unless the prescriber submits supporting evidence in accordance with the referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) demonstrating efficacy and safety for the requested off‑label use.

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests must demonstrate the member meets the policy's initial or continued therapy criteria and include supporting clinical documentation as described below.

Prior authorization required for all lines of business; follow the Health Plan's clinical criteria and approval durations.
Requests for initiation or continuation must show member meets all applicable criteria in the policy (Initial Approval, Continued Therapy).

Documentation Required

Required Documentation

Providers must submit clinical documentation to support medical necessity. Examples include office chart notes, relevant laboratory results, pathology reports, diagnostic imaging, prior treatment history, and consultation notes from the prescribing oncologist.

Documentation must show diagnosis, disease stage (e.g., relapsed, metastatic, stage IV RCC), histology when applicable (e.g., clear cell), treatment intent, and prior therapies tried.
If requesting an off-label indication, prescriber must submit supporting evidence from practice guidelines or peer-reviewed literature (see policy references).
When applicable, document tablet strength needed (1 mg or 5 mg) and planned daily dose.
For dose increases, submit rationale and evidence that new dose meets the policy dose rules or is supported by guidelines/literature.

Billing Rule

Therapy Sequencing and Dose Rules

Use axitinib (Inlyta) if available unless contraindicated or clinically significant adverse effects are experienced. Dose increases and sequencing must follow the policy limits and requirements.

Maximum total daily dose = 20 mg/day; new doses must not exceed 4 tablets per day.
If requesting doses above FDA limits for an off-label use, prescriber must provide supporting practice guideline or peer-reviewed literature evidence.

Denial Risk

Denial Risk — Off‑Label and Excess Dose Requests

Requests for non‑FDA approved indications not addressed by this policy will be denied without sufficient off‑label documentation. Requests that exceed the maximum recommended total daily dose may be denied.

Non‑FDA uses must have sufficient evidence of efficacy and safety per the plan's off‑label use policies (CPCPA.09, HIM.PA.154, CP.PMN.53) or the NCCN Compendium.
Requests exceeding 20 mg/day or more than 4 tablets/day may be denied unless justified by guidelines or peer‑reviewed literature with supporting documentation.

Prior Authorization

Prior Authorization and Step Therapy Notes

Policy history and prior authorization requirements may change over time; follow the current clinical policy and Health Plan authorization rules when submitting requests.

Prior authorization requirements follow the clinical policy's clinical criteria and durations as determined by the Health Plan.
Policy history documents previous templates and step/authorization changes — providers should check the most recent policy version and Health Plan communications.

Definitions and Dosing Summary

inv-19: DTC — differentiated thyroid carcinoma (definition).

DefinitionDTC: differentiated thyroid carcinoma

Example subtypesIncludes follicular and oncocytic (formerly Hurthle cell) variants as referenced in policy appendices

Coverage noteFor DTC covered as an NCCN compendium indication, disease must be not amenable to radioactive iodine therapy when specified

inv-20: RCC — renal cell carcinoma (definition).

DefinitionRCC: renal cell carcinoma

Indication contextPolicy covers relapsed, metastatic, or stage IV RCC when criteria are met

Prescriber requirementMust be prescribed by or in consultation with an oncologist

inv-21: Dosing regimen (RCC) — Single-agent and combination dosing (5 mg PO BID and combinations with pembrolizumab or avelumab).

Single-agent dosing5 mg orally twice daily (5 mg PO BID)

Combination with avelumab5 mg PO BID with avelumab 800 mg IV every 2 weeks

Combination with pembrolizumab5 mg PO BID with pembrolizumab 200 mg IV every 3 weeks or 400 mg IV every 6 weeks

Maximum doseMaximum total daily dose 20 mg/day

Initial Therapy Criteria and Dosing

Initial Therapy

Initial therapy criteria and dosing.

Initial therapy: 1) Indication: relapsed, metastatic, or stage IV RCC; 2) Age >= 18 years; 3) Prescribed by or in consultation with an oncologist; 4) Standard single‑agent starting dose: 5 mg orally twice daily (5 mg PO BID); 5) For combination regimens with pembrolizumab or avelumab, axitinib dosing is 5 mg PO BID given with the specified immunotherapy dosing; 6) Maximum total daily dose: 20 mg/day; 7) Dose must not exceed 4 tablets per day unless an off‑label higher dose is supported by practice guidelines or peer‑reviewed literature with prescriber evidence; 8) Prescribed regimen must be FDA‑approved or recommended by NCCN.maximum 20 mg/day

Tablets available in 1 mg and 5 mg strengths; prescribers should document tablet strength.

Initial therapy (RCC)

Initial dosing for RCC per policy.

RCC initial dosing: Single‑agent therapy: 5 mg orally twice daily (5 mg PO BID). Combination therapy: 5 mg orally twice daily with avelumab 800 mg IV every 2 weeks, or with pembrolizumab 200 mg IV every 3 weeks or 400 mg IV every 6 weeks.maximum 20 mg/day

Tablets available in 1 mg and 5 mg strengths.

Step Therapy and Approval Duration History

Step	Requirement	Notes
1	Member must use axitinib (Inlyta) if available unless contraindicated or clinically significant adverse effects occur	Applies to Inlyta requests for covered indications; prescriber must provide supporting evidence if off‑label dosing or use is requested
Off‑label use requirement	Off‑label indications require that the prescribed regimen is recommended by NCCN or supported by practice guidelines/peer‑reviewed literature and prescriber submits supporting evidence	Examples of NCCN compendium indications include differentiated thyroid carcinoma, alveolar soft part sarcoma, and thymic carcinoma (see policy)

Policy change	Effect on prior authorization	Notes
Revised Commercial approval duration (01.20.22; P&T 05.22)	Commercial approval duration set to 12 months or duration of request, whichever is less	Previously referenced duration varied by length of benefit; Medicaid/HIM durations are listed separately in the policy (Medicaid/HIM: 6 months initial; continuation: 12 months)
Historical template and indication updates (multiple annual reviews)	Prior authorization requirements remain and follow clinical criteria; policy history documents template/indication clarifications but not a separate step sequence	1Q2021–1Q2023 updates clarified indication language, off‑label NCCN additions, and generic redirection wording

OpenPayer

Axitinib (Inlyta) coverage

Coverage Criteria for Axitinib (Inlyta)

Policy Identifiers, Dosing Limits, and Codes

Provider Requirements and Authorization Rules

Clinical Background

Definitions and Dosing Summary

Initial Therapy Criteria and Dosing

Criteria for Continued Therapy

Step Therapy and Approval Duration History

Quantity Limits and Maximum Doses