ModifiedCentenePolicy CP.PHAR.69

Clinical Policy: Sorafenib (Nexavar)

Defines medical necessity criteria, prior authorization requirements, and approval durations for sorafenib (Nexavar) across FDA-approved and multiple off-label oncology indications for members of Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicySorafenib (Nexavar) coverage — clinical criteria and authorization rules

Policy CodePolicy CP.PHAR.69

Change TypeNCCN-aligned revisionsgeneric inclusionapproval duration updates

Effective DateJul 1, 2011

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating member meets indication-specific criteria (diagnosis, prescriber specialty, age ≥18, prior therapies when required).

SourceLink

POLICY UPDATE CHANGES

Policy revised to include generic sorafenib in the policy/criteria section.

For hepatocellular carcinoma (HCC) removed requirement for Child-Pugh class A or B7 and required sorafenib use as single agent.

For differentiated thyroid carcinoma (DTC) modified radioactive iodine-refractory requirement to apply only to papillary and follicular carcinomas.

For GIST added disease qualifiers and requirement that disease is imatinib-sensitive KIT or PDGFRA mutant.

Medicaid and HIM initial approval duration extended from 6 to 12 months and ICHRA line of business added.

Revised policy/criteria to include generic sorafenib and updated indication-specific requirements per NCCN (HCC, RCC, DTC, MTC, AML, GIST) and extended initial approval duration for Medicaid and HIM from 6 to 12 months.

Clarified DTC reference to oncocytic (formerly Hürthle cell) carcinoma and modified radioactive iodine-refractory requirement to apply only to papillary and follicular carcinomas.

For MTC specified disease must be metastatic and clarified progression on preferred systemic therapy, listing additional examples (Gavreto, Retevmo).

For acute myeloid leukemia added option for FLT3 mutation-positive disease and later restricted combination use to relapsed/refractory disease while removing allowance for single-agent induction/consolidation.

For GIST added requirement that disease is imatinib-sensitive KIT or PDGFRA mutant and added disease qualifiers; removed Sprycel from required prior therapies.

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Coverage Criteria and Indication-specific Requirements

Continuation Therapy

Continuation/renewal criteria applicable to all indications in Section I

Continuation therapy: 1. Member is currently receiving medication via Centene benefit or documentation supports current use for a covered indication with at least 30 days of therapy; 2. Member is responding positively to therapy; 3. For Nexavar requests, member must use sorafenib unless contraindicated or intolerant; 4. If request is for a dose increase, new dose must either a) not exceed 800 mg per day; or b) be supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Other Diagnoses/Indications

Coverage for other/unspecified diagnoses

Other diagnoses/indications: 1. If the drug has undergone a recent label change (within the last 6 months) not yet reflected in this policy, refer to the appropriate formulary/no-coverage or non-formulary policy for the relevant line of business; or 2. If the requested use is not specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (commercial, HIM/ICHRA, Medicaid).

Indication-specific coverage summaries

Coverage is determined per indication with NCCN-aligned criteria; notable revisions include:

Hepatocellular carcinoma (HCC): Removed requirement to confirm Child-Pugh class A or B7 status; added requirement for use as a single agent.

Renal cell carcinoma (RCC): Removed qualifiers 'relapsed' and 'stage IV' from criteria.

Medullary thyroid carcinoma (MTC): Specified disease must be metastatic and requires disease progression on preferred systemic therapy; examples Gavreto and Retevmo added.

Acute myeloid leukemia (AML): Added option for FLT3 mutation-positive disease; later restricted combination use to relapsed/refractory disease and removed allowance for single-agent induction/consolidation therapy.

This policy defines the medical necessity criteria and prior authorization requirements for sorafenib (Nexavar) across FDA‑approved and selected off‑label oncology indications. Coverage is determined by indication‑specific criteria (diagnosis, prescriber specialty, patient age, required prior therapies when applicable, and dosing limits) and by documentation submitted by the provider to demonstrate the member meets those criteria. The policy was revised to include generic sorafenib and updated per NCCN guidance for multiple indications.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy for the member's line of business (see policy CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid). Requests for such off‑label uses must include supporting clinical evidence per those referenced policies.

The policy restricts specific uses of sorafenib based on updated indication‑specific requirements. Notable restrictions include limiting combination use in acute myeloid leukemia to relapsed/refractory disease and removal of single‑agent sorafenib for induction or consolidation in AML. Additional diagnostic qualifiers and prior‑therapy requirements were added for several off‑label indications per NCCN updates.

Providers requesting authorization must demonstrate the member meets the detailed criteria for the requested indication. Criteria address diagnosis, involvement of an oncologist or hematologist as appropriate, age (typically Age ≥ 18), requirement to use sorafenib when Nexavar is requested unless contraindicated or intolerant, and dosing limits (see quantity limits). Documentation supporting the clinical rationale should be submitted to avoid denial.

Uses of sorafenib outside FDA‑approved indications that lack sufficient supporting evidence or do not meet the off‑label use policy requirements will be considered not medically necessary and are subject to denial. Providers should reference the applicable off‑label use policy and submit complete clinical documentation when requesting coverage for non‑standard indications.

Single‑agent use of sorafenib for induction or consolidation therapy in acute myeloid leukemia has been removed from allowable uses and is considered not medically necessary in that context. The policy now specifies restricted roles for sorafenib in AML (for example, combination therapy limited to relapsed/refractory disease and specific mutation‑positive scenarios).

Prior Authorization, Documentation, and Step Requirements

Prior Authorization

Prior Authorization Required and Approval Duration

Prior authorization is required for sorafenib (Nexavar). Approval durations vary by line of business: Medicaid/HIM/ICHRA — 12 months; Commercial — 12 months or duration of request, whichever is less. Initial approvals follow the same durations; for Medicaid and HIM initial approval duration was extended from 6 to 12 months per most recent update.

Approval durations: Medicaid/HIM/ICHRA = 12 months; Commercial = 12 months or duration of request, whichever is less
Initial approval duration for Medicaid and HIM extended from 6 to 12 months

Documentation Required

Documentation Required to Support Prior Authorization

Provider must submit supporting clinical documentation (e.g., office chart notes, lab results, imaging, pathology reports) demonstrating the member meets all indication-specific criteria. Failure to submit adequate documentation may result in denial.

Initial Therapy Criteria and Approval Durations

Initial Therapy Approval Durations

Initial approval durations and lines of business

Initial approval duration: Medicaid, HIM, and ICHRA initial approval duration = 12 months. Commercial initial approval duration = 12 months or duration of request, whichever is less.

Initial therapy notes

Initial therapy requirements revised per indication.

General: Policy now includes generic sorafenib for initial therapy; indication-specific prior therapy and disease qualifiers apply per NCCN updates (see indication-specific summaries).

Continuation and Renewal Criteria

Approval Duration / Continuation

Approval durations and renewal expectations

Approval duration: Standard approval duration is 12 months for Medicaid, HIM, and ICHRA; Commercial approvals are 12 months or the duration of the request, whichever is less.

All Indications in Section I - Continuation

Renewal/continuation conditions for ongoing therapy

Continuation: 1. Member currently receiving medication via Centene benefit or documentation supports current use and at least 30 days of therapy; 2. Member is responding positively to therapy; 3. For Nexavar requests, member must use sorafenib unless contraindicated or intolerant; 4. Dose increase requests must not exceed 800 mg per day unless supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

Continuation and initial duration

Step Therapy and Prior Therapy Tables

Indication	Step therapy requirement
Medullary thyroid carcinoma (metastatic)
Must document disease progression on preferred systemic therapy (e.g., vandetanib [Caprelsa], cabozantinib [Cometriq], selpercatinib [Gavreto], pralsetinib [Retevmo]) unless contraindicated or intolerant; clinical trial unavailable/ inappropriate is an alternative.
Gastrointestinal stromal tumor (GIST)
Must document progression on prior therapies: imatinib, sunitinib, regorafenib (Stivarga), and ripretinib (Qinlock); disease must be imatinib‑sensitive with KIT or PDGFRA mutation as specified.

Appendix B alternative	When required / Notes
Caprelsa (vandetanib); Cometriq (cabozantinib); imatinib (Gleevec); sunitinib (Sutent); Stivarga (regorafenib); Qinlock (ripretinib)
Appendix B lists these preferred alternatives and dosing; use of one or more may be required as prior therapy depending on the indication (see individual indication criteria and step therapy requirements).
Selpercatinib (Gavreto); pralsetinib (Retevmo)
Listed as examples of preferred systemic therapies for MTC; progression on preferred agents is required before sorafenib for metastatic MTC unless contraindicated or intolerant.

Indication	Preferred systemic therapy / progression requirement
Medullary thyroid carcinoma (metastatic)
Progression on preferred systemic therapy required (examples include vandetanib [Caprelsa], cabozantinib [Cometriq], selpercatinib [Gavreto], pralsetinib [Retevmo]) unless contraindicated or intolerant; prior authorization may be required for some agents.
Gastrointestinal stromal tumor (GIST)
Policy references progression on imatinib, sunitinib, regorafenib (Stivarga), and ripretinib (Qinlock) and requires disease to be imatinib‑sensitive KIT or PDGFRA mutant per NCCN updates.

Drug Definitions, Abbreviations, and Background

Sorafenib (Nexavar) — drug definition and approved indications

Generic/Brandsorafenib (Nexavar)

Drug classKinase inhibitor / multikinase inhibitor

FDA‑approved indicationsUnresectable hepatocellular carcinoma (HCC); Advanced renal cell carcinoma (RCC); Locally recurrent or metastatic, progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine

Typical dosing (initial)400 mg PO twice daily for HCC, RCC, and DTC

Maximum dose without additional justification800 mg/day

Abbreviations

Quantity Limits and Coding

sorafenib (Nexavar) — quantity limit

Quantity limit (maximum daily dose)800 mg/day

Standard single‑dose strength200 mg tablet available

Typical regimen for covered indications400 mg PO twice daily (total 800 mg/day)

Dose increases above 800 mg/dayAllowed only with supporting practice guideline or peer‑reviewed literature (prescriber must submit evidence)

Policy Summary

PayerCentene

PolicySorafenib (Nexavar) coverage — clinical criteria and authorization rules

Policy CodePolicy CP.PHAR.69

Change TypeNCCN-aligned revisionsgeneric inclusionapproval duration updates

Effective DateJul 1, 2011

Next Review Date

SourceLink

On This Page

Documentation Required

Supporting Evidence and Specialist Involvement for Off-Label Dosing

Off-label uses require additional evidence and provider attestations. If dose requested exceeds 800 mg/day or the indication is off-label, the prescriber must provide supporting evidence from practice guidelines or peer-reviewed literature. For specified off-label indications, prescriber must attest that therapy is prescribed by or in consultation with an oncologist or hematologist.

Dose limits: standard maximum = 800 mg/day unless supported by guidelines or literature (prescriber must submit supporting evidence)
Off-label dosing >800 mg/day requires citation of supporting practice guideline or peer-reviewed literature
Prescriber attestation required that therapy is prescribed by or in consultation with an oncologist/hematologist for specified off-label indications

Denial Risk

Non‑Covered Off‑Label Indications

Some off-label indications are not covered. Requests for non–FDA‑approved indications that are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided per the applicable off-label use policies.

Non‑covered: Non‑FDA approved indications not addressed in this policy will be denied unless sufficient documentation per off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (Marketplace/ICHRA), CP.PMN.53 (Medicaid)
Provider should reference the applicable off‑label use policy and submit supporting evidence when requesting coverage for indications outside this policy

Denial Risk

Denial Risk for Requests Not Meeting Indication‑Specific Criteria

Requests that do not meet the revised indication‑specific criteria (including NCCN-aligned disease qualifiers, required prior therapies, mutation or histologic requirements, metastatic or refractory disease status, or single‑agent use where required) are at high risk for denial.

Denial risk examples: missing mutation status for GIST (KIT or PDGFRA sensitive), lack of metastatic requirement documentation for MTC, absence of required prior therapies or documented progression on preferred agents, use in combination when policy restricts single‑agent use
Provider should ensure documentation explicitly demonstrates concordance with the policy criteria and NCCN recommendations to avoid denial