CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial PlansPolicy 2025 P 1067-14

Nexavar® (sorafenib tosylate) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Prior authorization/notification criteria for coverage of Nexavar (sorafenib tosylate) across multiple oncologic indications for UnitedHealthcare Commercial Plans. Defines initial authorization and reauthorization rules, pediatric auto-approval under 19, NCCN-based allowance, duration of authorization, and notes on state mandates and automated approvals.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial Plans

PolicyNexavar® (sorafenib tosylate) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1067-14

Change TypeRevised (9/2025)

Effective DateDec 1, 2025

Next Review Date

Key ActionMembers must meet the specified diagnosis- and treatment-based criteria for initial authorization; reauthorization requires no evidence of progressive disease.

SourceLink

POLICY UPDATE CHANGES

9/2025 annual review updated criteria for renal cell carcinoma per FDA label and updated multiple indications per NCCN guidance; moved GIST into its own section.

9/2024 annual review with no changes to clinical coverage criteria; updated references.

8/2015 increased authorization and reauthorization from 6 months to 12 months for all indications.

>=12Covered Indications

12 moAuthorization Duration

<19Pediatric auto-approval

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Coverage Summary & Scope

Scope: UnitedHealthcare Commercial Plans prior authorization/notification criteria for Nexavar (sorafenib tosylate) across multiple oncologic indications. Targeted plans: UnitedHealthcare Commercial. Coverage stance: covered_with_criteria. The policy defines initial authorization and reauthorization rules, includes an automatic processing pathway for pediatric members under 19 years (auto-approval without coverage review), and issues authorizations for 12 months. The policy includes an NCCN allowance that provides automatic allowance when the drug is recognized by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B. Effective date: 2025-12-01; Last review: 2025-09.

Key Policy Thresholds and Top-level Stats

Authorization duration12 months

Members <19 yearsPediatric auto-approval

Covered IndicationsMultiple oncology indications (>=12)

StatusCURRENT

Initial Authorization Criteria (by indication)

Pediatric patients (<19 years)

Authorization rule for members under age 19

Patient is less than 19 years of age

Advanced renal cell carcinoma - Initial Authorization

Covered when the following is met:

Diagnosis of advanced renal cell carcinoma (RCC)

Hepatocellular carcinoma - Initial Authorization

Covered when BOTH criteria are met:

ALL of the following

ONE of

Reauthorization / Continuation of Therapy Criteria

Advanced renal cell carcinoma - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

Hepatocellular carcinoma - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

Differentiated thyroid carcinoma - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

Angiosarcoma / Desmoid / Solitary fibrous tumor - Reauthorization

Applicable Codes

ICD-10 Diagnostic codes (implied; diagnosis-based coverage)ICD-10

No codes listed

Prior Authorization, Documentation & Billing

Prior Authorization

Prior authorization required

Members must meet the specified diagnosis- and treatment-based criteria for initial authorization; reauthorization requires no evidence of progressive disease. Members under 19 years auto-process without coverage review. Authorizations are issued for 12 months.

Documentation Required

Clinical documentation required for trials of other therapies / mutation status

Documentation must support the diagnosis and the disease status (recurrent, metastatic, unresectable, progressive, or symptomatic as applicable). For GIST, documentation must show history of failure, contraindication, or intolerance to all listed agents (imatinib; Qinlock/ripretinib; Stivarga/regorafenib; Sutent/sunitinib). For AML, documentation must include FLT3-ITD mutation–positive status and the applicable treatment pathway (post-allogeneic SCT in remission OR relapsed/refractory disease used with azacitidine or decitabine).

References & Guidance

References: Nexavar package insert (Aug 2023); NCCN Drugs and Biologics Compendium (accessed July 29, 2025).

Background: Nexavar (sorafenib tosylate) is a kinase inhibitor indicated for unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and locally recurrent or metastatic, progressive differentiated thyroid carcinoma refractory to radioactive iodine. The NCCN additionally recommends Nexavar for multiple other tumor types (including GIST, chordoma, osteosarcoma, AML, soft tissue sarcoma, salivary gland tumors, ovarian/fallopian tube/primary peritoneal cancer, and myeloid/lymphoid neoplasms with tyrosine kinase gene fusions). This policy aligns coverage to diagnosis-specific criteria and to NCCN-recommended regimens (with automatic allowance when NCCN recognizes the indication with Category 1, 2A, or 2B).

Definitions

Definitions: NCCN Recommended Regimens — Indications recognized by the NCCN Drugs and Biologics Compendium with Category 1, 2A, or 2B evidence and consensus.

Policy Revision History

9/2025revisedLatest

Annual review updated criteria for renal cell carcinoma per FDA label; updated hepatocellular carcinoma, thyroid cancer, soft tissue sarcoma, acute myeloid leukemia, salivary gland tumor, and myeloid/lymphoid neoplasms per NCCN recommendations; moved gastrointestinal stromal tumors into their own section per NCCN guidance.

9/2024administrative

Annual review with no changes to clinical coverage criteria; updated references.

8/2015

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial Plans

PolicyNexavar® (sorafenib tosylate) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1067-14

Change TypeRevised (9/2025)

Effective DateDec 1, 2025

Next Review Date

Key ActionMembers must meet the specified diagnosis- and treatment-based criteria for initial authorization; reauthorization requires no evidence of progressive disease.

SourceLink

On This Page

Disease is unresectable

Used as subsequent-line therapy

Differentiated thyroid carcinoma (follicular/papillary/oncocytic/medullary) - Initial Authorization

Covered when any of the below pathways are satisfied:

ANY of the following

Pathway A
- Diagnosis of follicular carcinoma OR papillary carcinoma
- Disease is unresectable locoregional recurrent or persistent OR metastatic
- ONE of
  - Patient has symptomatic disease
  - Patient has progressive disease
- Disease is refractory to radioactive iodine treatment
Pathway B
- Diagnosis of medullary thyroid carcinoma
- Disease is recurrent OR metastatic
Pathway C
- Diagnosis of oncocytic thyroid carcinoma
- Disease is unresectable locoregional recurrent or persistent OR metastatic
- Patient has symptomatic disease OR Patient has progressive disease

Angiosarcoma / Desmoid tumors / Solitary fibrous tumor - Initial Authorization

Covered when diagnosis is one of the listed sarcomas

ANY of the following

Diagnosis of angiosarcoma
Diagnosis of desmoid tumors / aggressive fibromatosis
Diagnosis of solitary fibrous tumor / hemangiopericytoma

Chordoma / Bone sarcomas (osteosarcoma, dedifferentiated chondrosarcoma, UPS) - Initial Authorization

Covered when one of the following is met:

ANY of the following

Chordoma pathway
- Diagnosis of chordoma
- Disease is recurrent
Bone sarcoma pathway
- Diagnosis of osteosarcoma OR dedifferentiated chondrosarcoma OR high-grade undifferentiated pleomorphic sarcoma (UPS)
- Not used as first-line therapy

Acute Myeloid Leukemia (AML) - Initial Authorization

Covered when all of the following are met:

ref':

title':

AML - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

Chordoma / Bone sarcomas - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

AML - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

Ovarian group - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

Salivary gland tumor - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

Myeloid/lymphoid neoplasm - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

GIST - Reauthorization

Patient does not show evidence of progressive disease while on Nexavar therapy

Billing Rule

Authorization duration and supply limits

Authorizations will be issued for 12 months for covered indications. Supply limits may be in place.

Increased authorization and reauthorization from 6 months to 12 months for all indications; annual review updated thyroid cancer and osteosarcoma criteria, moved GIST criteria under soft tissue sarcoma, and added AML criteria.