CurrentCignaPolicy N/A

Temozolomide (Temodar) prior authorization for capsules

Defines Cigna's prior authorization requirements and coverage criteria for temozolomide capsules (Temodar and generics) across FDA‑approved indications and other oncology uses with supportive evidence for affected members and providers.

Policy Summary

PayerCigna

PolicyTemozolomide (Temodar) prior authorization for capsules

Policy CodePolicy N/A

Change TypeMultiple material updates (added, revised, removed, clarified)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with supporting clinical rationale and covered diagnosis codes; approvals are commonly authorized for 1 year.

SourceLink

POLICY UPDATE CHANGES

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

Pheochromocytoma/paraganglioma criterion changed from 'metastatic disease' to 'unresectable or metastatic disease.'

Primary Cutaneous Anaplastic Large Cell Lymphoma was removed as a condition for approval.

Glioma examples list was expanded (circumscribed glioma added) and various glioma-related notes updated.

17+distinct covered indications listed (FDA and Other Uses with Supportive Evidence)

1 yeartypical approval duration for covered indications

Prior Authorizationcoverage action recommended for temozolomide capsules

NCCN cited

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Coverage Criteria for Temozolomide (Temodar) Capsules

inv-01: FDA-Approved Indications

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

FDA-Approved Indications: 1) Patient has a diagnosis of an FDA‑approved indication: Anaplastic astrocytoma OR Glioblastoma multiforme (includes glioblastoma and grade IV astrocytoma); AND 2) Prior authorization is requested per policy; AND 3) Approval duration: 1 year.

Approvals for FDA indications are provided for 1 year per the policy.

inv-02: Other Uses with Supportive Evidence

Covered when ALL/conditional criteria are met for Other Uses with Supportive Evidence (each indication has its own conditional requirements):

Bone Cancer: A) Patient has tried one chemotherapy regimen; AND B) Patient has a diagnosis of Ewing sarcoma OR mesenchymal chondrosarcoma.

Examples of chemotherapy regimens include vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide.

Brain Metastases from Solid Tumors: Patient has brain metastases from a solid tumor.

Approve for 1 year.

Ependymoma: Patient has intracranial or spinal ependymoma.

Approve for 1 year.

Glioma, Other Types: Patient has another type of glioma (examples: 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: Patient has recurrent or progressive medulloblastoma.

Approve for 1 year.

Melanoma: A) Patient has unresectable or metastatic melanoma; AND B) Either i) patient has tried one systemic regimen OR ii) patient is not a candidate for a systemic regimen.

Examples of systemic regimens include pembrolizumab, nivolumab, ipilimumab, BRAF/MEK agents; approve for 1 year.

Mycosis Fungoides/Sézary Syndrome: A) Patient has tried at least one prior therapy; AND B) Patient has central nervous system (CNS) involvement.

Approve for 1 year. Examples of prior therapies include topical carmustine, topical corticosteroids, topical imiquimod, topical retinoids, brentuximab vedotin, gemcitabine.

Neuroblastoma: A) Patient has high‑risk neuroblastoma; AND B) Temozolomide will be used in combination with chemoimmunotherapy.

Examples of chemoimmunotherapy include irinotecan, dinutuximab (Unituxin), sargramostim (Leukine), naxitamab (Danyelza). Approve for 1 year.

Neuroendocrine Tumors: Patient has one of the specified neuroendocrine tumor types (carcinoid or GI/lung/thymus NET; 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/Paraganglioma: Patient has unresectable or metastatic pheochromocytoma or paraganglioma.

Approve for 1 year.

Primary Central Nervous System Lymphoma: Patient has primary CNS lymphoma.

Approve for 1 year.

Small Cell Lung Cancer: Patient has small cell lung cancer and has tried one systemic regimen.

Approve for 1 year. Examples of systemic regimens include cisplatin, etoposide, carboplatin, atezolizumab, durvalumab, irinotecan.

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 of chemotherapy regimens 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 not medically necessary for uses that are not listed in this policy. Requests for temozolomide for indications outside the FDA‑approved indications and the "Other Uses with Supportive Evidence" section will be denied as not covered unless and until the policy is updated to include new, published supportive data.

Any indication that is not explicitly listed in the FDA‑approved indications or the "Other Uses with Supportive Evidence" section of this policy is considered not medically necessary. Coverage decisions are based on the listed indications and will be revised only when new published evidence is incorporated into the policy.

Covered Regimens and Example Combinations

Indication	Example regimen(s)	Coverage status
Neuroblastoma (high‑risk) to be used in combination with chemoimmunotherapy	Examples include irinotecan plus Unituxin (dinutuximab), Leukine (sargramostim), and Danyelza (naxitamab)	Covered

Indication	Example prior systemic regimens	Coverage status
Melanoma (unresectable or metastatic) when patient has tried one systemic regimen or is not a candidate for systemic therapy	Examples of systemic regimens include pembrolizumab (Keytruda), nivolumab (Opdivo), ipilimumab (Yervoy), and BRAF/MEK agents such as dabrafenib (Tafinlar) + trametinib (Mekinist), vemurafenib (Zelboraf), cobimetinib + encorafenib (Cotellic, Braftovi), binimetinib + encorafenib (Mektovi, Braftovi); other systemic examples: cisplatin, etoposide, carboplatin, atezolizumab, durvalumab, irinotecan	Covered

Coding and Drug Codes

Drug codes (NDC)NDC

NDC	National Drug Codes for temozolomide capsules (product-specific codes not enumerated in document)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for prescription benefit coverage of temozolomide capsules. All approvals are provided for the durations specified in the policy (commonly 1 year for approved indications and other uses with supportive evidence).

Prior authorization required for Temodar® (temozolomide capsules) — approvals typically granted for 1 year for listed indications.
FDA‑approved indications (e.g., anaplastic astrocytoma, glioblastoma multiforme) and specified "other uses with supportive evidence" are covered when criteria are met.

Denial Risk

Denial Triggers

Claims submitted for services that are not accompanied by covered diagnosis or procedure codes consistent with this policy and the applicable benefit plan will be denied as not covered. Temozolomide will be considered not medically necessary for any uses not listed in the policy (see "Conditions Not Covered").

Line of Therapy Specifications

inv-12: first-line

First-line Therapy (Glioblastoma): Temozolomide is indicated as first‑line therapy for newly diagnosed glioblastoma when used concomitantly with radiotherapy and then continued as maintenance therapy.

Approval duration per policy: 1 year.

Background and Drug Information

Temozolomide is an oral alkylating chemotherapeutic agent used in adult patients for high‑grade gliomas, including anaplastic astrocytoma and glioblastoma. It is indicated for use concomitant with radiotherapy for newly diagnosed glioblastoma and for maintenance therapy thereafter. The NCCN Drugs & Biologics Compendium and the product prescribing information are cited as supporting references for both labeled and selected off‑label oncology uses.

Temozolomide (Temodar) — definition

Mechanism of actionOral alkylating agent (temozolomide)

Common FDA‑approved indicationsAnaplastic astrocytoma (including newly diagnosed as adjuvant and refractory) and glioblastoma (newly diagnosed, used concomitantly with radiotherapy then as maintenance)

Typical route and formulationOral capsules (Temodar and generics)

Use with radiotherapyApproved for concomitant use with radiotherapy for newly diagnosed glioblastoma followed by maintenance therapy

Use in combination regimens