Health Net sorafenib (Nexavar) Coverage Update

Coverage and Eligibility Criteria

Initial Therapy — Hepatocellular Carcinoma

Initial Approval — Hepatocellular Carcinoma (HCC): Covered when ALL of the following are met

HCC initial criteria: 1) Diagnosis of hepatocellular carcinoma (HCC); 2) Prescribed by or in consultation with an oncologist; 3) Age > 18 years; 4) Prescribed as a single agent; 5) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 6) Dose does not exceed 800 mg per day; 7) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN, or b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request, whichever is less.

Initial Therapy — Renal Cell Carcinoma

Initial Approval — Renal Cell Carcinoma (RCC): Covered when ALL of the following are met

RCC initial criteria: 1) Diagnosis of advanced renal cell carcinoma (RCC); 2) Prescribed by or in consultation with an oncologist; 3) Age > 18 years; 4) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 5) Dose does not exceed 800 mg per day; 6) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN, or b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request, whichever is less.

Initial Therapy — Differentiated Thyroid Carcinoma

Initial Approval — Differentiated Thyroid Carcinoma (DTC): Covered when ALL of the following are met

DTC initial criteria: 1) Diagnosis of differentiated thyroid carcinoma (DTC), including papillary, follicular, and oncocytic (Hürthle) cell carcinoma; 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Disease refractory to radioactive iodine treatment; 5) Disease is progressive or symptomatic; 6) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 7) Dose does not exceed 800 mg per day; 8) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN, or b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request, whichever is less.

Off-label Therapy — Medullary Thyroid Carcinoma

Off-label — Medullary Thyroid Carcinoma (MTC): Covered when ALL of the following are met

MTC off-label criteria: 1) Diagnosis of metastatic medullary thyroid carcinoma (MTC); 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Disease progression on preferred systemic therapy (e.g., Caprelsa, Cometriq, Gavreto, Retevmo) unless clinically significant adverse effects or contraindication; 5) Clinical trials are not available or appropriate; 6) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 7) Dose does not exceed 800 mg per day; 8) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN, or b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Prior authorization may be required for Caprelsa and Cometriq. Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request, whichever is less.

Off-label Therapy — Acute Myeloid Leukemia

Off-label — Acute Myeloid Leukemia (AML): Covered when ALL of the following are met

AML off-label criteria: 1) Diagnosis of acute myeloid leukemia; 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age > 18 years; 4) Disease is FLT3‑ITD mutation‑positive; 5) Prescribed in one of the following ways: a) In combination with azacitidine or decitabine for relapsed/refractory disease, or b) As a single agent for maintenance therapy in remission post‑allogeneic stem cell transplantation; 6) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 7) Dose does not exceed 800 mg per day; 8) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN, or b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request, whichever is less.

Off-label Therapy — Bone Cancers

Off-label — Bone Cancers (osteosarcoma, chordoma): Covered when ALL of the following are met

Bone cancer off-label criteria: 1) Diagnosis of osteosarcoma (Nexavar used as second‑line therapy as a single agent or in combination with everolimus) or chordoma (Nexavar used as single‑agent therapy for recurrent disease); 2) Prescribed by or in consultation with an oncologist; 3) Age > 18 years; 4) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 5) Dose does not exceed 800 mg per day; 6) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN, or b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Prior authorization may be required for everolimus. Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request.

Off-label Therapy — Soft Tissue Sarcoma

Off-label — Soft Tissue Sarcoma (including angiosarcoma, desmoid tumors, GIST, solitary fibrous tumor): Covered when ALL of the following are met

Soft tissue sarcoma off-label criteria: 1) Diagnosis of one of the specified soft tissue sarcomas (angiosarcoma; desmoid tumors [aggressive fibromatosis]; solitary fibrous tumor; gastrointestinal stromal tumor [GIST]); 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Prescribed as a single agent; 5) For GIST, member experienced disease progression on imatinib, Sutent, Stivarga, and Qinlock; 6) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 7) Dose does not exceed 800 mg per day; 8) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN, or b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Prior authorization may be required for listed agents. Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request.

Off-label Therapy — Ovarian Cancers

Off-label — Ovarian Cancers: Covered when ALL of the following are met

Ovarian cancers off-label criteria: 1) Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer (includes clear cell, mucinous, carcinosarcoma, low‑grade serous, grade 1 endometrioid); 2) Prescribed by or in consultation with an oncologist; 3) Age > 18 years; 4) Disease is platinum‑resistant (recurs < 6 months after platinum‑based chemotherapy); 5) Disease is persistent or recurrent; 6) Prescribed in combination with topotecan; 7) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 8) Dose does not exceed 800 mg per day; 9) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN, or b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request.

Ovarian cancers (off‑label)

Ovarian cancers (off‑label) — covered when ALL of the following are met:

Ovarian off‑label criteria: 1) Histology: epithelial ovarian, fallopian tube, or primary peritoneal cancer (includes clear cell, carcinosarcoma, mucinous, low‑grade serous, grade 1 endometrioid); 2) Age > 18 years; 3) Prescribed by or in consultation with an oncologist; 4) Disease is platinum‑resistant (recurs <6 months after platinum therapy); 5) Disease is persistent or recurrent; 6) Prescribed in combination with topotecan; 7) For Nexavar requests, member must use sorafenib unless contraindicated or intolerant; 8) Dose does not exceed 800 mg/day OR dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Dose limit and requirement for oncologist consultation explicitly stated. Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request.

Myeloid/Lymphoid Neoplasms (off‑label)

Myeloid/lymphoid neoplasms with eosinophilia (off‑label) — covered when ALL of the following are met:

Myeloid/lymphoid neoplasms criteria: 1) Diagnosis of lymphoid, myeloid, or mixed‑lineage neoplasm with FLT3 rearrangement (eosinophilia); 2) In blast or chronic phase; 3) Age > 18 years; 4) Prescribed by or in consultation with an oncologist or hematologist; 5) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 6) Dose does not exceed 800 mg/day OR dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

FLT3 rearrangement and specialist involvement required. Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request.

Continued Therapy

Continuation therapy — covered when ALL of the following are met:

Continuation therapy: 1) Member currently receiving Nexavar via the Centene benefit or documentation supports that member has received Nexavar for at least 30 days for a covered indication; 2) Member is responding positively to therapy; 3) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 4) If request is for a dose increase, the new dose meets one of the following: a) New dose does not exceed 800 mg per day, or b) New dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).<= 800 mg/day

Documented prior use and positive response required for continuation. Approval durations: Medicaid/HIM 6 months; Commercial 12 months or duration of request.

For requests for sorafenib (Nexavar) to treat metastatic medullary thyroid carcinoma (MTC), the policy expects trial or intolerance of preferred systemic agents unless contraindicated. Specifically, coverage as an off‑label indication requires documentation of progressive disease on a preferred systemic therapy such as Caprelsa, Cometriq, Gavreto, or Retevmo, unless the member experienced clinically significant adverse effects or has a contraindication. Prior authorization may be required for some of those agents; prescribers must document prior therapy and rationale for using sorafenib instead.

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 policies (CP.CPA.09 for commercial, HIM.PA.154 for the health insurance marketplace, and CP.PMN.53 for Medicaid). Requests for such off‑label uses should include relevant supporting evidence per those off‑label policies.

Uses that are non‑FDA approved and are not supported by sufficient evidence per the referenced off‑label use policies are considered not medically necessary and will be denied. The prescriber must submit peer‑reviewed literature or guideline support when seeking coverage for non‑FDA uses; absent that documentation, coverage is not authorized.

Initial Therapy Requirements

Initial therapy — general

Initial therapy criteria for FDA‑approved indications require specialist involvement, adult age, single‑agent prescribing, sorafenib use for Nexavar requests, dosing limits, and evidence‑based regimen selection.

Initial therapy general: 1) Prescribed by or in consultation with an oncologist; 2) Age > 18 years; 3) Prescribed as a single agent where specified by indication; 4) For Nexavar requests, member must use sorafenib unless contraindicated or clinically significant adverse effects are experienced; 5) Dose does not exceed 800 mg/day (typical regimen 400 mg PO BID for HCC, RCC, DTC); 6) Prescribed regimen must be FDA‑approved or recommended by NCCN, or dose/regimen must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Applies across FDA‑approved indications (HCC, RCC, DTC); typical dosing 400 mg PO BID.

Initial Therapy — specified off‑label requirements

Initial therapy requirements where specified in off‑label criteria sets:

Initial dosing and specialty prescriber:

Continuation / Renewal Requirements

Continuation therapy durations

Approval durations for continuation/renewal

Continuation approval durations: Commercial approvals: 12 months or duration of request, whichever is less; Medicaid/HIM approvals: 6 months.

Prescribed regimen must be FDA‑approved or recommended by NCCN.

Continuation Therapy — requirements for ongoing Nexavar use

Continuation therapy requirements for ongoing Nexavar use:

Continuation nodes: 1) Member has been on Nexavar ≥ 30 days via the benefit or documentation supports current use for a covered indication; 2) Member is responding positively to therapy; 3) For Nexavar requests, member must use sorafenib (or generic sorafenib) unless contraindicated or intolerant; 4) If request is for a dose increase, the new dose must not exceed 800 mg/day or must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).<= 800 mg/day

Step Therapy / Prior Treatment Expectations

Requirement	Details / Policy language
Prior use or progression on preferred agents expected
For certain off-label indications (e.g., MTC, bone cancers, GIST) the policy expects disease progression on or prior use of listed preferred systemic therapies unless contraindicated or clinically significant adverse effects are experienced.
Examples of preferred systemic therapies referenced include: Caprelsa, Cometriq, Gavreto, Retevmo, imatinib, Sutent, Stivarga, Qinlock; prior authorization may be required for some agents (e.g., Caprelsa, Cometriq).
Policy notes that prior use/progression expectations apply unless the agent is contraindicated or adverse effects preclude its use.
Policy revisions and supporting rationale referenced in annual reviews (NCCN-based updates) clarify and expand preferred-therapy expectations across indications.

Prescriber documentation requirement	Policy language / examples
Documentation of prior guideline‑preferred therapies
Prescriber must document disease progression on preferred systemic therapy where specified (e.g., for metastatic MTC: progression on Caprelsa, Cometriq, Gavreto, or Retevmo) unless contraindicated or clinically significant adverse effects are experienced.
For GIST, prescriber must document progression on imatinib, Sutent, Stivarga and Qinlock prior to Nexavar where specified.
Prescriber/consulting oncologist must submit supporting evidence if dose or regimen exceeds standard limits or when off‑label dosing is used (practice guidelines or peer‑reviewed literature).
Prior authorization may be required for some preferred agents; failure to provide required documentation may result in denial.

Coding and Dosing Information

No explicit CPT/HCPCS/ICD/NDC codes in provided segmentsmixed

No codes listed

Maximum daily dose

Maximum daily dose800 mg/day

Typical dosing regimen400 mg PO twice daily (400 mg PO BID)

Dose increase allowanceMay exceed 800 mg/day only if supported by practice guidelines or peer‑reviewed literature with prescriber submission of evidence

Quantity, Dose, and Packaging

sorafenib (Nexavar) dosing, tablet strength, max daily dose

Typical adult dosing400 mg PO twice daily (400 mg PO BID)

Available tablet strength200 mg tablet

Maximum daily dose800 mg/day

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required and Approval Duration

Prior authorization required. Requests for Nexavar (sorafenib) must have prior authorization. Approval durations: Commercial — up to 12 months or the duration of the request, whichever is less; Medicaid / HIM — generally 6 months for off‑label indications specified as such; Continued therapy approvals — Commercial 12 months or duration of request (whichever is less); Medicaid/HIM — 12 months for continued therapy unless otherwise noted.

Commercial approval duration: 12 months or duration of request, whichever is less
Medicaid/HIM approval duration for many off‑label indications: 6 months
Continued therapy: Commercial 12 months or duration of request; Medicaid/HIM 12 months

Documentation Required

Documentation Required to Support Requests

Provider must submit documentation (e.g., chart notes, pathology reports, laboratory results, imaging, treatment history, and peer‑reviewed literature when requesting an off‑label indication) demonstrating that the member meets all applicable approval criteria. For off‑label uses, the prescriber must submit supporting evidence if the requested dose or indication is supported by practice guidelines or peer‑reviewed literature.

Administration Setting

Note

Oral agent — outpatient/home administration

Sorafenib is an oral agent intended for outpatient/home administration; documentation that the medication is being used in the outpatient/non‑infusion setting may be required for continuation approvals.

Policy: “Oral agent — administered in outpatient/home setting per provider discretion; continuation criteria require documentation of outpatient/non‑infusion use.”

Background and Drug Description

Sorafenib (Nexavar) is an oral multikinase inhibitor used in oncology. Within this policy, its off‑label use for medullary thyroid carcinoma is described as a systemic therapy option when patients have progressed on preferred agents or cannot tolerate them. For MTC requests the policy explicitly requires specialist involvement (prescribed by or in consultation with an oncologist), adult age (≥18 years), use of sorafenib unless contraindicated, and adherence to the dosing limit (dose not to exceed 800 mg per day unless supported by guidelines or literature).

Definitions and Terms

Sorafenib (Nexavar) — definition

Drug class/identitySorafenib (Nexavar) — an oral multikinase/kinase inhibitor used in oncology

FDA‑approved indications (selected)Unresectable hepatocellular carcinoma (HCC); advanced renal cell carcinoma (RCC); locally recurrent or metastatic progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine

Route of administrationOral

Differentiated thyroid carcinoma (DTC) definition

DefinitionDifferentiated thyroid carcinoma (DTC) — includes papillary, follicular, and oncocytic (Hürthle cell) carcinoma

Relevant policy contextDTC is an FDA‑approved indication for sorafenib when locally recurrent or metastatic, progressive, and refractory to radioactive iodine

Policy Revision History

2025-02-04revisedLatest

2Q 2025 annual review: policy/criteria updated to include generic sorafenib; HCC criteria revised to remove Child‑Pugh A/B7 confirmation and require single‑agent use; RCC qualifiers 'relapsed' and 'stage IV' removed; DTC coverage expanded to include symptomatic disease; MTC clarified to require metastatic disease; AML combination use restricted to relapsed/refractory disease and single‑agent induction/consolidation allowance removed.

2024-01-10revised

2Q 2024 annual review: DTC language clarified to reference oncocytic (Hürthle cell) carcinoma; MTC criteria clarified regarding progression on preferred systemic therapy and Gavreto and Retevmo added as examples; AML updated to add FLT3 mutation–positive option.

OpenPayer

Sorafenib (Nexavar) Clinical Policy — coverage criteria

Coverage and Eligibility Criteria

Initial Therapy Requirements

Continuation / Renewal Requirements

Step Therapy / Prior Treatment Expectations

Coding and Dosing Information

Quantity, Dose, and Packaging

Provider Requirements and Actions

Administration Setting

Background and Drug Description

Definitions and Terms

Policy Revision History