ModifiedmhnPolicy CP.PHAR.69

Sorafenib (Nexavar) coverage

This policy defines medical necessity criteria, prior authorization requirements, and coverage durations for sorafenib (Nexavar) for FDA-approved and specified off-label oncology indications for members of plans affiliated with Centene Corporation.

Policy Summary

Payermhn

PolicySorafenib (Nexavar) coverage

Policy CodePolicy CP.PHAR.69

Change TypeNCCN-aligned revisionsgeneric included

Effective DateJul 1, 2011

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets indication-specific approval criteria (diagnosis, specialist involvement, age ≥18, dosing ≤800 mg/day or supporting literature).

SourceLink

POLICY UPDATE CHANGES

Revised policy/criteria to include generic sorafenib and updated indication-specific requirements per NCCN (HCC, RCC, DTC, MTC, AML, GIST).

For HCC removed requirement for confirmation of Child-Pugh class A or B7 status and added requirement for use as a single agent.

For AML restricted combination use to relapsed/refractory disease and removed allowance for single agent use for induction/consolidation therapy.

Clarified disease progression on preferred systemic therapy and included Gavreto and Retevmo as additional examples; for acute myeloid leukemia added option for FLT3 mutation-positive disease.

Revised policy/criteria to include generic sorafenib and updated NCCN-aligned changes: removed Child-Pugh confirmation and added single-agent requirement for HCC; removed 'relapsed' and 'stage IV' qualifiers for RCC; added coverage for symptomatic disease in DTC; specified metastatic disease for MTC; restricted AML combination use to relapsed/refractory and removed single-agent use for induction/consolidation.

For GIST, added requirement for use as single-agent therapy and removed Sprycel from the list of required prior therapies.

800 mg/dayMaximum allowed dose under policy

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Coverage Criteria

Continuation therapy

Continued therapy — Applies to all indications in Section I

Continued therapy criteria: 1. Member is currently receiving Nexavar via the Centene benefit or documentation supports current use for a covered indication for at least 30 days. 2. Member is responding positively to therapy. 3. For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects occur. 4. If request is for a dose increase, the new dose must either: a) not exceed 800 mg per day; or b) be supported by practice guidelines or peer-reviewed literature for the relevant use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.current use >=30 days; dose <=800 mg/day unless justified

Approval durations differ by line of business.

No coverage provision is provided for patients under age 18. All listed indications in this policy require the member to be Age ≥ 18 years and documentation of age must be included with the authorization request.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid).

Changes effective with the 2Q 2025 review affect coverage: single‑agent use of sorafenib for induction or consolidation in acute myeloid leukemia is no longer allowed, and combination use is now restricted to relapsed/refractory disease. The review also incorporated other NCCN‑aligned revisions and inclusion of generic sorafenib that alter indication‑specific requirements.

If a requested use is not addressed in this policy and the provider does not submit off‑label supporting documentation per the referenced off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53), the request may be denied.

Use of sorafenib that does not meet the revised NCCN‑aligned criteria in this policy is not supported. Examples of unsupported uses under the updated criteria include: non‑metastatic medullary thyroid carcinoma where metastatic disease is now required, HCC regimens that do not follow the single‑agent requirement, and single‑agent sorafenib for AML induction/consolidation which has been removed. Providers should follow the updated indication‑specific criteria in this policy when requesting coverage.

Initial Therapy Criteria

Initial Therapy — NCCN revisions

Initial therapy criteria revised per NCCN.

Initial therapy (summary): Initial use must align with updated NCCN-based indications; specific qualifier changes were made per indication (e.g., HCC single-agent requirement, RCC qualifier removals, DTC symptomatic coverage, metastatic requirement for MTC, AML combination-use restrictions).

2Q 2025 annual review included generic sorafenib.

Continuation Therapy and Approval Durations

Approval duration / continuation

Approval durations for continued therapy vary by line of business.

Approval duration rules: Medicaid/HIM approvals: 6 months. Commercial approvals: up to 12 months or the duration of the request, whichever is less.

Continuation Therapy

Continuation therapy criteria were revised per NCCN; generic sorafenib included.

Continuation requirements (summary): Continuation of therapy requires ongoing indication per NCCN-aligned criteria and documentation of prior clinical benefit or response; generic sorafenib is an acceptable product unless contraindicated.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — provider must demonstrate member meets specific approval criteria and supply supporting documentation. Requests may be delayed or denied if required documentation is not submitted.

Prior authorization may be required for certain comparator agents (e.g., Caprelsa, Cometriq) per indication.
Failure to submit requested clinical documentation (office notes, labs, imaging, pathology, or specialty consultation notes) may result in denial or processing delays.

Documentation Required

Provider must submit supporting clinical documentation (office chart notes, labs, imaging, pathology, consultation notes, prior therapy records) that demonstrates the member meets all applicable initial and continued therapy criteria.

Documentation should include diagnosis, prescriber specialty or consultation note, member age, prior treatments and responses, and rationale for requested dose (including off‑label dosing justification).

Coding and Dose Limits

Maximum daily dose — policy threshold

Policy maximum daily doseDose does not exceed 800 mg per day for covered indications (requests exceeding require supporting evidence)

Typical dosing regimen400 mg PO twice daily for HCC, RCC, and DTC

Dose increase requirementIf request is for a dose increase, new dose must not exceed 800 mg/day or must be supported by practice guidelines or peer-reviewed literature

Maximum daily dose — concise

Numeric limit800 mg/day

Standard regimen400 mg PO twice daily (total 800 mg/day) for HCC, RCC, DTC

Evidence for exceeding

Step Therapy and Prior Therapies

Indication	Required prior therapy / step	Notes
Medullary thyroid carcinoma (metastatic)	Disease progression on preferred systemic therapy (examples: Caprelsa, Cometriq, Gavreto, or Retevmo) OR clinical trial not available/appropriate	Prior authorization may be required for Caprelsa and Cometriq; member must use sorafenib unless contraindicated; dose ≤ 800 mg/day or supported by guidelines with evidence
Soft tissue sarcoma — GIST	Progression on imatinib, Sutent, Stivarga, and Qinlock	Sorafenib must be single-agent for GIST; prior agents listed per NCCN; dose ≤ 800 mg/day or supported by literature

Indication	NCCN‑aligned prior therapy / sequencing	Policy update / note
Renal cell carcinoma (advanced)	Per NCCN sequencing for advanced RCC prior therapies as indicated by guideline; requirement qualifiers 'relapsed' and 'stage IV' removed	2Q2021–2Q2025 reviews clarified RCC to advanced RCC; criteria aligned to PI/NCCN
Differentiated thyroid carcinoma (DTC)	Per NCCN sequencing for unresectable/persistent or metastatic DTC prior options as indicated	2Q2022–2Q2025 updates added options for unresectable/persistent disease and added coverage for symptomatic disease
Gastrointestinal stromal tumor (GIST)	Prior lines per NCCN including imatinib, Sutent, Stivarga, Qinlock (previously also listed Sprycel but later removed)	Policy updated to require single‑agent use for GIST and removed Sprycel from required prior therapies per 2Q2025

Indication / context	Preferred systemic therapy or prior therapy adjustment	Step therapy expectation
Medullary thyroid carcinoma (MTC)	Preferred systemic therapies listed as examples: Caprelsa, Cometriq, Gavreto, Retevmo; progression on preferred therapy required unless contraindicated	Member must have disease progression on a preferred systemic therapy or clinical trial not available/appropriate before Nexavar (sorafenib) is approved; sorafenib required unless contraindicated; dose limits apply
Acute myeloid leukemia (FLT3‑positive, off‑label)	Policy now allows FLT3 mutation‑positive option; combination use restricted to relapsed/refractory disease; single‑agent induction/consolidation no longer allowed	Sorafenib may be used only in combination for relapsed/refractory AML per updated criteria; single‑agent maintenance post‑transplant may be allowed per specific nodes—follow criteria and submit supporting evidence for dosing
Soft tissue sarcoma (desmoid tumors, other listed subtypes)	Desmoid tumors and other sarcomas clarified for single‑agent therapy; prior therapy expectations adjusted per NCCN	Requests expected to document prior therapies where specified and use sorafenib as single agent unless contraindicated; dose ≤ 800 mg/day or supported by literature

Quantity Limits

sorafenib (Nexavar) — quantity limit

Quantity limit value800 (represents maximum daily mg limit)

Per-day interpretation800 corresponds to milligrams per day (e.g., 400 mg PO BID = 800 mg/day)

Tablet strength noteTablets available as 200 mg; 800 mg/day equals four 200 mg tablets per day

Definitions

HCC definition

Definition (HCC)Unresectable hepatocellular carcinoma (HCC)

Prescriber requirementTreatment prescribed by or in consultation with an oncologist per policy criteria

Age requirementAge ≥ 18 years for covered indications

RCC definition

Definition (RCC)Advanced renal cell carcinoma (RCC)

Prescriber requirementTreatment prescribed by or in consultation with an oncologist per policy criteria

Age requirementAge ≥ 18 years for covered indications

Background

Sorafenib (Nexavar) is an oral multikinase inhibitor indicated for unresectable hepatocellular carcinoma (HCC), advanced renal cell carcinoma (RCC), and differentiated thyroid carcinoma (DTC) refractory to radioactive iodine. The policy also lists specified off‑label oncology indications with coverage criteria when the requirements in this document are met.

Site of Care

Billing Rule

Hospital outpatient — follow state Medicaid precedence

Standard site‑of‑care rules apply for hospital outpatient settings; when state Medicaid requirements conflict with this policy, follow the applicable state Medicaid manual.

Revision History

2025-02-04annual_reviewLatest

2Q 2025 annual review: policy revised to include generic sorafenib and updated multiple indication-specific criteria per NCCN (HCC single-agent requirement and removal of Child-Pugh confirmation; RCC qualifiers 'relapsed' and 'stage IV' removed; DTC coverage added for symptomatic disease; MTC specified metastatic disease; AML combination use restricted to relapsed/refractory and single-agent induction/consolidation no longer allowed).

2025-05-25P&T_approval

P&T Approval recorded for 2Q 2025 revisions to include generic sorafenib and NCCN-aligned criteria updates.

Policy Summary

Payermhn

PolicySorafenib (Nexavar) coverage

Policy CodePolicy CP.PHAR.69

Change TypeNCCN-aligned revisionsgeneric included

Effective DateJul 1, 2011

Next Review Date

SourceLink

On This Page

Documentation Required

Dose Justification for Off‑Label or High‑Dose Requests

Dose justification required when requested daily dose exceeds 800 mg or for off‑label dosing. Prescriber must submit supporting evidence such as practice guidelines, peer‑reviewed literature, or other clinical rationale to justify doses above 800 mg/day.

If dose increase is requested during continuation, new dose must not exceed 800 mg/day unless supported by guidelines or peer‑reviewed literature with documentation.
For off‑label indications, include citations or rationale that the prescribed regimen is FDA‑approved for the indication or recommended by NCCN/other authoritative guidance.

Note

NCCN‑Aligned Criteria and Policy Revisions

Policy revised to align with NCCN-based recommendations and P&T committee approvals; providers must ensure requests meet the updated NCCN‑aligned criteria (for example: metastatic requirement for MTC, single‑agent use for HCC, and other indication‑specific changes).

Failure to meet the updated NCCN‑aligned criteria (e.g., MTC must be metastatic) may result in denial.
The policy references NCCN recommendations — prescribed regimens must be FDA‑approved or recommended by NCCN where indicated.

Step Therapy

Preferred Systemic Therapy and Prior‑Therapy Requirements

Preferred systemic therapy and prior‑therapy requirements are referenced in the policy for certain indications; providers must document progression on preferred agents when required (for example, MTC preferred systemic therapies such as Caprelsa, Cometriq, Gavreto, or Retevmo).

When prior‑therapy progression is required, include documentation of disease progression on the named preferred systemic therapy unless contraindicated or not tolerated.
Prior authorization may be required for the preferred agents listed; follow applicable prior authorization rules and provide supporting records.