ModifiedCentenePolicy CP PHAR.69

Sorafenib (Nexavar) coverage and medical necessity criteria

Defines medical necessity criteria, covered indications (FDA and selected off-label per NCCN), approval durations by line of business, dosing limits, prescriber requirements, and documentation/prior authorization expectations for sorafenib (Nexavar) and generic sorafenib.

Policy Summary

PayerCentene

PolicySorafenib (Nexavar) coverage and medical necessity criteria

Policy CodePolicy CP PHAR.69

Change TypeRevised annual review (2Q 2025) and prior quarterly updates

Effective DateJul 1, 2011

Next Review Date

Key ActionProvider must submit documentation (chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

2Q 2025 annual review revised policy/criteria to include generic sorafenib and updated indication-specific criteria per NCCN (HCC single-agent requirement, removed Child-Pugh requirement; RCC removed 'relapsed' and 'stage IV' qualifiers; DTC added symptomatic disease; MTC specified metastatic disease; AML restricted combination use to relapsed/refractory and removed single-agent induction/consolidation allowance).

Multiple prior quarterly reviews (2021-2024) updated criteria reflecting NCCN changes, approval durations, and template/generic redirection language.

3FDA-approved indications (HCC, RCC, DTC)

9Off-label NCCN-supported indications listed

800 mg/dayMaximum daily dose threshold

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200 mgTablet strength available

Coverage Summary

High-level overview: Sorafenib (Nexavar) is a multikinase inhibitor with FDA-approved indications for unresectable hepatocellular carcinoma (HCC), advanced renal cell carcinoma (RCC), and locally recurrent or metastatic, progressive differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine. The clinical policy (Reference: CP PHAR.69) incorporates FDA labeling and NCCN guidance/compendia to define covered uses and selected NCCN-supported off-label indications. Coverage stance for sorafenib is covered_with_criteria. The policy was reviewed by P&T with a P&T Approval Date of 05.25 and the policy number is CP PHAR.69.

Key thresholds & quick facts

Maximum daily dose<= 800 mg/day

Age requirementAdult (>= 18 years)

Minimum prior exposure for continuation>= 30 days of therapy

Tablet strength available200 mg

Initial and Renewal Medical Necessity Criteria

Initial Approval Criteria - Hepatocellular Carcinoma (HCC)

Sorafenib (Nexavar or generic sorafenib) is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of hepatocellular carcinoma (HCC)
Prescribed by or in consultation with an oncologist
Age > 18 years
Prescribed as a single agent
For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced
Request dosing must meet one of:

Product Availability / Dosing Codes

Product availability / dosingmixed

Tablet 200 mg

Sorafenib tablet strength available

Provider Actions and Requirements

Documentation Required

Supporting documentation required

Provider must submit documentation (such as chart notes, laboratory results, or other clinical information) supporting that the member has met all approval criteria for sorafenib requests. Documentation should demonstrate diagnosis, prior therapies, clinical status, and any items required by the specific indication.

Relevant clinic notes or consults confirming diagnosis and stage
Laboratory test results (e.g., liver function, mutation testing like FLT3 if applicable)
Imaging reports showing disease progression or response
Pathology reports or biopsy results
Documentation of prior therapies and reasons for discontinuation (toxicity, progression)

Prior Authorization

Prior authorization may be required for comparators

Prior authorization may be required for comparator or preferred/alternative systemic agents referenced in the policy per formulary and line-of-business rules. Providers should check applicable formularies and submit PA requests for those agents when required.

Background and Evidence Sources

Background/mechanism and indications: Sorafenib is a multikinase (kinase) inhibitor. FDA-approved indications listed in the policy include treatment of unresectable hepatocellular carcinoma (HCC), advanced renal cell carcinoma (RCC), and locally recurrent or metastatic, progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine. Dosing guidance in the policy references a standard regimen of 400 mg PO twice daily with a maximum daily dose of 800 mg/day, and product availability includes 200 mg tablets. The policy text states it incorporates FDA labeling and NCCN guidance/compendia to define coverage and selected off-label uses.

Evidence source	Reference
Nexavar Prescribing Information	Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; August 2023 (Nexavar Prescribing Information)
NCCN compendia/guidelines	National Comprehensive Cancer Network compendia and disease-specific guidelines (various versions 2024-2025)

Definitions

Definitions (abbreviations)

DTCDifferentiated thyroid carcinoma

HCCHepatocellular carcinoma

MTCMedullary thyroid carcinoma

RCCRenal cell carcinoma

Revision History

2025-05-25P&T ApprovalLatest

2021-2023 (quarterly reviews)Prior quarterly reviews

Multiple prior quarterly reviews (2021-2024) updated criteria reflecting NCCN changes, approval durations, and template/generic redirection language (examples: 2Q2021 added Child-Pugh A/B7 requirement for HCC then later removed; 2Q2022 modified commercial approval duration to 12 months; 2Q2023 removed 'if available' for generic redirection).

Policy Summary

PayerCentene

PolicySorafenib (Nexavar) coverage and medical necessity criteria

Policy CodePolicy CP PHAR.69

Change TypeRevised annual review (2Q 2025) and prior quarterly updates

Effective DateJul 1, 2011

Next Review Date

Key ActionProvider must submit documentation (chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

Dose does not exceed 800 mg per day<= 800 mg/day
Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Initial Approval Criteria - Renal Cell Carcinoma (RCC)

Sorafenib is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of advanced renal cell carcinoma (RCC)
Prescribed by or in consultation with an oncologist
Age > 18 years
For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced
Request dosing must meet one of:
- Dose does not exceed 800 mg per day<= 800 mg/day
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Initial Approval Criteria - Differentiated Thyroid Carcinoma (DTC)

Sorafenib is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of differentiated thyroid carcinoma (includes papillary, follicular, oncocytic [formerly Hürthle cell] carcinoma)
Prescribed by or in consultation with an oncologist
Age ≥ 18 years
Disease is refractory to radioactive iodine treatment
Disease is progressive or symptomatic
For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced
Request dosing must meet one of:
- Dose does not exceed 800 mg per day<= 800 mg/day
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Initial Approval Criteria - Medullary Thyroid Carcinoma (MTC) (off-label)