CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Inlyta (axitinib) coverage

Defines accepted indications, coverage criteria, and utilization management requirements for Inlyta (axitinib) for treatment of cancer for Neighborhood Health Plan of Rhode Island members processed by Evolent Specialty Services/UM.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInlyta (axitinib) coverage

Policy CodePolicy N/A

Change TypeMinor technical — no material clinical or coverage changes

Effective DateNov 29, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent/UM with evidence per FDA labeling, CMS‑recognized compendia, or NCCN/ASCO guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11/13/2024approval date

11/29/2024effective date

multiple datescommittee review history

10+committee review count

Coverage Criteria

Inclusion and RCC-specific criteria

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInlyta (axitinib) coverage

Policy CodePolicy N/A

Change TypeMinor technical — no material clinical or coverage changes

Effective DateNov 29, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent/UM with evidence per FDA labeling, CMS‑recognized compendia, or NCCN/ASCO guidelines.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Continuation requests exception: Continuation requests for a not-approvable medication are exempt from this policy when ALL of the following are met: (1) the requested medication was used within the last year; (2) the member has not experienced disease progression and/or intolerance to the requested medication; (3) additional medication(s) are not being added to the continuation request.

RCC — allowed use: Inlyta (axitinib) may be used in combination with Keytruda (pembrolizumab) as first-line treatment for recurrent or metastatic IMDC favorable risk renal cell carcinoma.

RCC — not supported uses: Policy does NOT support: (a) first-line single-agent Inlyta (axitinib) for favorable/intermediate/poor risk clear cell RCC; (b) subsequent-line clear cell RCC use of Inlyta (axitinib) combined with Bavencio (avelumab).

Position based on lack of Level 1 evidence versus recommended alternatives

Requests for Inlyta (axitinib) will be excluded or denied when any of the following apply: the member has documented disease progression while receiving Inlyta; the prescribed dose for a single administration exceeds 10 mg; or the total treatment supply exceeds the policy quantity limits of 180 (1 mg) tablets or 120 (5 mg) tablets per month. Investigational or off‑label uses that lack sufficient supporting evidence per CMS‑recognized compendia or acceptable peer‑reviewed literature are also excluded.

For renal cell carcinoma the policy does not support certain uses of Inlyta due to insufficient Level 1 evidence showing superiority to recommended alternatives. Specifically, single‑agent Inlyta as first‑line therapy for favorable, intermediate, or poor‑risk clear cell RCC is not supported. Additionally, the combination of Inlyta with avelumab (Bavencio) for subsequent‑line clear cell RCC is not supported. These positions are based on the lack of randomized trial or meta‑analytic evidence demonstrating better outcomes compared with Evolent‑recommended regimens and pathway recommendations.

Coding & Quantity Limits

Maximum monthly supply

Maximum monthly supply180 (1 mg) tablets or 120 (5 mg) tablets per month

Per-month periodLimit applies on a monthly basis as stated in the policy

Applies toInlyta (axitinib) tablets in 1 mg and 5 mg strengths

Single dose limit

Single dose limit10 mg per dose

EnforcementRequests exceeding 10 mg single dose are excluded/denied per policy

Applies toInlyta (axitinib) oral dosing

Inlyta (axitinib) — quantity limits

DrugInlyta (axitinib)

Monthly quantity limit180 (1 mg) tablets or 120 (5 mg) tablets per month

ContextQuantity limits duplicate the policy's maximum monthly supply thresholds

Inlyta (axitinib) — single dose limit

DrugInlyta (axitinib)

Single dose limit10 mg per dose (policy single dose cap)

NoteSingle dose limit duplicates the policy's stated dosing ceiling

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization and final approval are required for all Inlyta (axitinib) medication requests. Evolent is responsible for processing all medication requests submitted by network ordering providers; utilization management (UM) reviews will be performed by the Utilization Management Department and final approval decisions are made by the Utilization Management Committee. Medications not authorized by Evolent/UM may be deemed not approvable and therefore not reimbursable.

All requests must be submitted through the Evolent/UM prior authorization pathway.
Utilization Management Department conducts the review; Utilization Management Committee issues final approval.

Documentation Required

Supporting Evidence Required

Use of Inlyta must be supported by one of the following sources: FDA-approved product labeling; CMS‑recognized compendia; National Comprehensive Cancer Network (NCCN) clinical practice guidelines; American Society of Clinical Oncology (ASCO) clinical guidelines; or peer‑reviewed literature that meets CMS criteria as described in the Medicare Benefit Policy Manual Chapter 15. Requests lacking adequate supporting evidence from these sources may be denied.

Acceptable evidence: FDA labeling, CMS‑approved compendia, NCCN, ASCO, or peer‑reviewed literature meeting CMS standards.
Peer‑reviewed literature must address patient/cancer characteristics, regimen representation, clinically meaningful outcomes (e.g., ASCO guidance such as HR < 0.80 or ≥3 months benefit for OS/PFS), and study design adequacy.

Step Therapy

Therapy Positioning for RCC

For renal cell carcinoma (RCC), Inlyta (axitinib) is positioned only in specified combinations and settings. Inlyta plus pembrolizumab (Keytruda) is supported as first‑line treatment for recurrent or metastatic, IMDC favorable‑risk renal cell carcinoma. Single‑agent Inlyta as first‑line therapy (favorable/intermediate/poor risk clear cell RCC) and Inlyta plus avelumab (Bavencio) in subsequent‑line clear cell RCC are not supported by Evolent policy due to insufficient Level 1 evidence compared to recommended alternatives.

Allowed: Inlyta + pembrolizumab (Keytruda) as first‑line for recurrent/metastatic IMDC favorable‑risk RCC.
Not supported: single‑agent Inlyta first‑line for clear cell RCC (any IMDC risk category).
Not supported: Inlyta + avelumab (Bavencio) for subsequent‑line clear cell RCC.
IMDC risk assessment should be documented when asserting favorable‑risk status.

Denial Risk

Denial Triggers / Exclusion Criteria

Requests will be denied when exclusion criteria are met, including disease progression while on Inlyta, dosing above single‑dose limits, treatment exceeding monthly quantity limits, or investigational/off‑label uses lacking sufficient evidence.

Denial triggers include: member progressed while taking Inlyta (axitinib).
Dosing exceeds single dose limit of 10 mg.
Monthly supply limits exceeded: more than 180 of 1 mg tablets or 120 of 5 mg tablets per month.
Investigational or off‑label indications without sufficient CMS‑recognized compendia support or acceptable peer‑reviewed evidence as defined in policy.

Step Therapy / Preferred Alternatives

Preferred alternatives / required pathway	Unsupported single-agent or combinations (when superior alternatives exist)
Preferred alternatives include Evolent-recommended agents/regimens referenced on the New Century Health pathways (see policy pathways)	First‑line single‑agent Inlyta (axitinib) for clear cell RCC (favorable, intermediate, or poor IMDC risk)
Inlyta (axitinib) in combination with pembrolizumab (Keytruda) is permitted as first‑line therapy for recurrent or metastatic IMDC favorable risk RCC	Subsequent‑line use of Inlyta combined with avelumab (Bavencio)

Background

Axitinib (Inlyta) is an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor used in the management of renal cell carcinoma. The policy recognizes Inlyta as an option when combined with pembrolizumab (Keytruda) as first‑line treatment for recurrent or metastatic RCC in patients classified as IMDC favorable risk. Policy recommendations reference FDA labeling and established oncology evidence sources; when evidence for a use is limited, the policy relies on Level 1 evidence (randomized trials or meta‑analyses) and accepted pathway guidance (for example, recommendations from the Evolent/New Century Health pathway) to determine supported versus unsupported uses.

OpenPayer

Inlyta (axitinib) coverage

Coverage Criteria

Coding & Quantity Limits

Provider Actions & Requirements

Initial Therapy

Continuation Therapy

Step Therapy / Preferred Alternatives

Definitions

Background