CurrentCignaPolicy N/A

Oncology - Temozolomide Capsules Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of temozolomide capsules (Temodar and generics) across FDA-approved and selected evidence-supported oncology indications for affected Cigna health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Temozolomide Capsules Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClinical updates and criteria revisions

Effective DateN/A

Next Review DateJun 18, 2025

Key ActionSubmit prior authorization requests with supporting documentation per the applicable benefit plan; approvals are typically for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

The overview was updated to include the new labeled indication of 'newly diagnosed anaplastic astrocytoma as adjuvant treatment.'

Pheochromocytoma or paragangliomas criterion changed from 'metastatic disease' to 'unresectable or metastatic disease.'

Primary Cutaneous Anaplastic Large Cell Lymphoma was removed from conditions for approval.

Soft tissue sarcoma criterion simplified from 'advanced, unresectable, or metastatic disease and specific diagnoses' to 'advanced or metastatic disease.'

2FDA-approved indications listed (Anaplastic astrocytoma; Glioblastoma)

>=15Other supportive evidence indications listed

1 yeartypical approval duration for indications

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Coverage and Medical Necessity Criteria

inv-01: FDA-Approved Indications

Covered when ALL of the following are met for FDA-approved indications:

FDA-approved indications: Patient has a listed FDA-approved diagnosis: (1) Anaplastic astrocytoma; OR (2) Glioblastoma multiforme (includes glioblastoma and grade IV astrocytoma). Approvals are for 1 year.

Includes newly diagnosed anaplastic astrocytoma as adjuvant treatment per policy update

inv-02: Other Uses with Supportive Evidence

Covered when the indication-specific criteria are met (examples below reflect the policy's structured logic per indication):

Other evidence-supported indications

Bone cancer (Ewing sarcoma or mesenchymal chondrosarcoma): Patient has Ewing sarcoma OR mesenchymal chondrosarcoma; AND patient has tried one chemotherapy regimen (examples include vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide). Approve for 1 year.
Brain metastases: Patient has brain metastases from a solid tumor. Approve for 1 year.
Ependymoma (intracranial or spinal): Patient has intracranial or spinal ependymoma. Approve for 1 year.
Other gliomas: Patient has another type of glioma (examples include pediatric diffuse high‑grade glioma, oligodendroglioma, low‑grade glioma, high‑grade glioma, circumscribed glioma, IDH‑mutant astrocytoma). Approve for 1 year.
For anaplastic astrocytoma and glioblastoma, refer to FDA‑approved criteria.
Gliosarcoma: Patient has gliosarcoma. Approve for 1 year.
Medulloblastoma (recurrent or progressive): Patient has recurrent or progressive medulloblastoma. Approve for 1 year.
Melanoma (unresectable or metastatic): Patient has unresectable or metastatic melanoma; AND (a) patient has tried one systemic regimen (examples include pembrolizumab, nivolumab, ipilimumab, dabrafenib, trametinib, vemurafenib, cobimetinib, encorafenib, binimetinib) OR (b) patient is not a candidate for a systemic regimen. Approve for 1 year.
Mycosis fungoides / Sézary syndrome with CNS involvement: Patient has mycosis fungoides or Sézary syndrome with central nervous system involvement; AND patient has tried at least one prior therapy (examples include topical carmustine, topical corticosteroids, topical imiquimod, topical retinoids, brentuximab vedotin, gemcitabine). Approve for 1 year.
Neuroblastoma (high risk): Patient has high‑risk neuroblastoma; AND temozolomide will be used in combination with chemoimmunotherapy (examples include irinotecan, dinutuximab, sargramostim, naxitamab). Approve for 1 year.
Neuroendocrine tumors: Patient has one of the listed neuroendocrine tumor subtypes (carcinoid or GI/lung/thymus; islet cell/pancreatic NET; extrapulmonary poorly differentiated NEC; large or small cell carcinoma; mixed neuroendocrine‑non‑neuroendocrine neoplasm; or well‑differentiated grade 3 NET). Approve for 1 year.
Pheochromocytoma or paraganglioma: Patient has unresectable or metastatic pheochromocytoma or paraganglioma. Approve for 1 year.
Primary central nervous system lymphoma: Patient has primary central nervous system lymphoma. Approve for 1 year.
Small cell lung cancer: Patient has small cell lung cancer AND has tried one systemic regimen (examples include cisplatin, etoposide, carboplatin, atezolizumab, durvalumab, irinotecan). Approve for 1 year.
Soft tissue sarcomas: Patient has advanced or metastatic soft tissue sarcoma. Approve for 1 year.
Uterine sarcomas: Patient has uterine sarcoma AND has tried a chemotherapy regimen (examples include doxorubicin, docetaxel, epirubicin, gemcitabine, ifosfamide, dacarbazine, vinorelbine). Approve for 1 year.
Uveal melanoma: Patient has unresectable or metastatic uveal melanoma. Approve for 1 year.

Temodar® (temozolomide capsules) is considered not medically necessary for any uses other than those explicitly listed in this policy. The policy’s coverage criteria will be updated as new published data become available; until such updates are made, requests for indications not described in the FDA‑approved or evidence‑supported sections do not meet medical necessity.

Any use that is not explicitly listed in the FDA‑Approved Indications or the Other Uses with Supportive Evidence sections of this policy is considered not medically necessary and is not covered under the described criteria.

Examples of Required or Concomitant Regimens

Indication / Context	Examples of prior chemotherapy or systemic regimens / concomitant agents
Bone cancer (Ewing sarcoma or mesenchymal chondrosarcoma)	Examples of chemotherapy regimens include one or more of: vincristine; doxorubicin; cyclophosphamide; ifosfamide; etoposide.
Melanoma (unresectable or metastatic)	Examples of systemic regimens include one or more of: pembrolizumab (Keytruda); nivolumab (Opdivo); ipilimumab (Yervoy); dabrafenib (Tafinlar); trametinib (Mekinist); vemurafenib (Zelboraf); cobimetinib (Cotellic); encorafenib (Braftovi); binimetinib (Mektovi).
Mycosis fungoides / Sézary syndrome with CNS involvement	Examples of prior therapies include topical carmustine, topical corticosteroids, topical imiquimod, topical retinoids, brentuximab vedotin (Adcetris), gemcitabine.
Neuroblastoma (high‑risk) — used in combination with chemoimmunotherapy	Example chemoimmunotherapy agents include irinotecan; dinutuximab (Unituxin); sargramostim (Leukine); naxitamab (Danyelza).
Small cell lung cancer	Examples of systemic regimens include one or more of: cisplatin; etoposide; carboplatin; atezolizumab (Tecentriq); durvalumab (Imfinzi); irinotecan.
Uterine sarcomas (when prior chemotherapy is required)	Examples of chemotherapy regimens include one or more of: doxorubicin; docetaxel; epirubicin; gemcitabine; ifosfamide; dacarbazine; vinorelbine.
Other indications (general note)	Policy lists additional systemic or chemotherapy regimen examples per indication (see individual criteria for specifics).

Drug and Billing Codes

Covered NDCNDCCovered

00006-0037-01	Temodar (temozolomide) capsules 5 mg - Merck NDC example
00006-0037-02	Temodar (temozolomide) capsules 20 mg - Merck NDC example
00006-0037-03	Temodar (temozolomide) capsules 100 mg - Merck NDC example
00006-0037-04	Temodar (temozolomide) capsules 250 mg - Merck NDC example

Relevant CPT/HCPCSmixed

J3490	Unclassified drugs (use if no specific HCPCS exists)
C9399	Unclassified drugs or biologicals (not otherwise classified)

Provider Requirements, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Recommended

Prior Authorization Recommended. Prior authorization (PA) is recommended for prescription benefit coverage of temozolomide capsules. Typical approvals are granted for the duration listed in the policy criteria (commonly 1 year for approved indications). Providers should request PA before initiating therapy when possible to avoid claim denials or delays in coverage.

Typical approval duration: 1 year for most indications listed in the policy

Documentation Required

Submission and Documentation Expectations

Providers must submit clinical documentation supporting the requested indication and prior treatments when applicable. Include relevant medical records, pathology reports, imaging, treatment history (including prior chemotherapies or systemic regimens), and any notes demonstrating disease status (e.g., recurrent, metastatic, unresectable) or CNS involvement when required by the criteria.

Document prior chemotherapy or systemic regimens when the criteria require "has tried one chemotherapy/systemic regimen" (examples listed in policy).

Key Definitions

inv-11: Temozolomide — key value

Agent classOral alkylating chemotherapy agent (temozolomide)

Primary FDA‑approved indicationsAnaplastic astrocytoma (including newly diagnosed as adjuvant and refractory) and glioblastoma (newly diagnosed: with radiotherapy then maintenance).

Typical approval durationApprovals are commonly provided for 1 year when criteria are met.

Clinical guidance sourceNCCN Drugs & Biologics Compendium supports use for listed FDA and evidence‑supported indications.

Formulation referencedTemodar® (temozolomide capsules) and generics (capsules).

Line-of-Therapy Rules

inv-12: mixed

Line of therapy specifics: Policy specifies prior therapy requirements for certain indications (for example: must have tried one chemotherapy regimen or one systemic regimen) but does not uniformly define first‑line vs subsequent‑line numbering. Individual indication nodes list the required prior regimens or prior therapies.

Examples of what constitutes a chemotherapy or systemic regimen are provided in the policy (see indication details).

Background and Drug Information

Temozolomide is an oral alkylating agent used in oncology primarily for high‑grade gliomas. The agent is FDA‑indicated in adults for anaplastic astrocytoma (including newly diagnosed as adjuvant treatment) and for glioblastoma multiforme when given concomitantly with radiotherapy and as maintenance therapy. The National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium supports temozolomide use for these FDA and additional evidence‑based indications listed in this policy.