CurrentCignaPolicy N/A

Oncology - Sorafenib Prior Authorization Policy

Defines prior authorization requirements, covered indications, and coverage criteria for sorafenib (Nexavar) for Cigna-administered health benefit plans; affects prescribers and pharmacy/medical benefit clinicians requesting sorafenib.

Policy Summary

PayerCigna

PolicyOncology - Sorafenib Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation of diagnosis, prior therapies, and biomarker status as specified in the policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Multipleindications listed

1 yearstandard approval duration

NCgoverned state

Coverage Criteria for Sorafenib (Nexavar)

FDA-Approved Indications

Covered when ALL criteria specified for each FDA-approved indication are met

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Hepatocellular Cancer: Approve for 1 year if the patient is ≥ 18 years of age AND has unresectable or metastatic disease.

Renal Cell Cancer: Approve for 1 year if the patient is ≥ 18 years of age AND has relapsed or advanced disease AND has clear cell histology AND has tried at least one systemic therapy.

Thyroid Carcinoma, Differentiated: Approve for 1 year if the patient is ≥ 18 years of age AND meets ONE of the following: (i) patient has papillary or follicular thyroid carcinoma AND the disease is refractory to radioactive iodine therapy; OR (ii) patient has oncocytic (formerly Hürthle cell) carcinoma.

Other Uses with Supportive Evidence

Covered when ALL criteria specified for each supportive-evidence indication are met

Acute Myeloid Leukemia: Approve for 1 year if the patient is ≥ 18 years of age AND has FLT3-ITD mutation-positive disease as detected by an approved test AND meets ONE of the following: (i) sorafenib is used in combination with azacitidine or decitabine; OR (ii) patient has had an allogeneic stem cell transplant and is in remission.

Bone Cancer: Approve for 1 year if the patient is ≥ 18 years of age AND meets ONE of the following: (i) patient has recurrent chordoma; OR (ii) patient has osteosarcoma AND has tried one systemic chemotherapy regimen.

Gastrointestinal Stromal Tumor: Approve for 1 year if the patient is ≥ 18 years of age AND has previously tried ALL of the following: imatinib AND sunitinib AND regorafenib (Stivarga) AND ripretinib (Qinlock).

Myeloid/Lymphoid Neoplasms with Eosinophilia: Approve for 1 year if the patient is ≥ 18 years of age AND the tumor has an FLT3 rearrangement.

Ovarian/Fallopian Tube/Primary Peritoneal Cancer: Approve for 1 year if the patient is ≥ 18 years of age AND has platinum-resistant disease AND sorafenib is used in combination with topotecan.

Soft Tissue Sarcoma: Approve for 1 year if the patient is ≥ 18 years of age AND has angiosarcoma OR desmoid tumors (aggressive fibromatosis) OR solitary fibrous tumor/hemangiopericytoma.

Thyroid Carcinoma, Medullary: Approve for 1 year if the patient is ≥ 18 years of age AND has tried at least one systemic therapy.

Regimens and Combinations

Regimen	Indication	Coverage status
Sorafenib in combination with topotecan
Ovarian, Fallopian Tube, Primary Peritoneal cancer — platinum-resistant disease
Covered when ALL criteria are met: patient is ≥ 18 years of age; platinum-resistant disease; sorafenib used in combination with topotecan (Approve for 1 year)

Regimen	Indication / biomarker	Coverage status
Sorafenib plus a hypomethylating agent (azacitidine or decitabine)
Acute Myeloid Leukemia with FLT3-ITD mutation-positive disease (used for induction or postinduction therapy; also supported as post‑allogeneic stem cell transplant maintenance)
Covered when ALL criteria are met: patient is ≥ 18 years of age; FLT3-ITD mutation detected by an approved test; sorafenib used in combination with azacitidine or decitabine (Approve for 1 year)

Billing and Coding Guidance

Coding guidance / impacted codesmixed

affected codes

Policy references that providers must use the most appropriate codes as of the submission date; specific CPT/HCPCS/NDC codes not listed in document text.

inv-06: Approval duration

Standard approval duration1 year for all covered indications

Duration applied to FDA-approved indicationsApprove for 1 year if the patient meets the specified criteria for hepatocellular cancer, renal cell cancer, or differentiated thyroid carcinoma

Duration applied to supportive-evidence indicationsApprove for 1 year for other uses supported by evidence (e.g., AML with FLT3-ITD, bone cancer, GIST, myeloid/lymphoid neoplasms with eosinophilia, ovarian cancer, soft tissue sarcoma, medullary thyroid carcinoma)

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for prescription benefit coverage of sorafenib. Approvals are provided for the durations noted in the policy (typically 1 year for approved indications).

Nexavar® (sorafenib tablets) — prior authorization recommended

Step Therapy

Prior Therapy Requirements

The policy requires prior use of specified systemic therapies for certain indications before approval (for example, renal cell carcinoma requires at least one prior systemic therapy; medullary thyroid carcinoma requires prior systemic therapy). Providers should document prior therapies, including agent names and treatment dates.

Renal cell carcinoma: at least one prior systemic therapy required (e.g., axitinib, pazopanib, sunitinib, cabozantinib)
Medullary thyroid carcinoma: at least one prior systemic therapy required (e.g., vandetanib, cabozantinib, selpercatinib, pralsetinib)

Documentation Required

Documentation for Review

Requests for coverage/authorization must include clinical documentation to support the requested indication and that all policy criteria are met. This includes: patient age, diagnosis (including histology or refractory status when applicable), prior treatment history (systemic therapies, radioactive iodine when relevant), and treatment intent (unresectable/metastatic, relapsed/advanced, platinum-resistant, etc.).

Submit supporting clinical records showing diagnosis and staging
Document prior systemic therapies and dates of administration
For differentiated thyroid carcinoma, document radioactive iodine refractory status when applicable

Denial Risk

Billing / Coding Denial Risk

Claims submitted without covered diagnosis or procedure codes consistent with the policy will be denied as not covered. Providers must bill using the most appropriate and current codes as of the date of service.

Use covered diagnosis/procedure codes that match the approved indication
Ensure coding reflects prior therapies or refractory status when required

Biomarker and Diagnostic Requirements

inv-15: FLT3-ITD — biomarker requirement

Biomarker requiredFLT3-ITD mutation-positive disease as detected by an approved test

Indication tied to biomarkerRequired for approval of sorafenib in Acute Myeloid Leukemia (AML) indication

Test requirementMutation must be detected by an approved test per policy

inv-16: FLT3 rearrangement — biomarker requirement

Biomarker requiredFLT3 rearrangement detected in the tumor

Indication tied to biomarkerRequired for approval in Myeloid/Lymphoid Neoplasms with Eosinophilia

Guideline supportNCCN recommends sorafenib for myeloid/lymphoid neoplasms with FLT3 rearrangements (category 2A)

Definitions and Terminology

inv-12: Differentiated thyroid carcinoma / oncocytic carcinoma — examples and note on radioactive iodine-refractory

Examples of differentiated thyroid carcinomaPapillary and follicular thyroid carcinoma

Oncocytic carcinoma noteOncocytic (formerly Hürthle cell) carcinoma is listed separately and may be approved without the radioactive iodine–refractory requirement

Radioactive iodine–refractory requirementRadioactive iodine–refractory disease requirement applies to papillary and follicular histologies (approval requires disease refractory to radioactive iodine therapy)

inv-13: FLT3-ITD mutation-positive AML — definition and context (combination use)

DefinitionFLT3-ITD mutation-positive disease — presence of internal tandem duplication in the FLT3 gene as detected by an approved test

Treatment contextSorafenib use is supported in combination with azacitidine or decitabine for AML with FLT3-ITD

Post-transplant contextPolicy also supports use if the patient has had an allogeneic stem cell transplant and is in remission

Clinical Background

Sorafenib is a multikinase inhibitor that targets tumor cell proliferation and angiogenesis. It is FDA‑approved for treatment of unresectable or metastatic hepatocellular carcinoma, advanced renal cell carcinoma, and differentiated thyroid carcinoma (radioactive iodine‑refractory papillary or follicular histology and oncocytic/Hürthle cell carcinoma per policy placement). Clinical guidelines (NCCN) also discuss sorafenib for additional disease states such as FLT3‑ITD mutation–positive acute myeloid leukemia and various sarcomas and solid tumors; coverage in those settings is addressed under the policy’s supportive‑evidence indications.