CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Temozolomide (Temodar) — Indications and Authorization Criteria

Defines covered indications and authorization periods for temozolomide (Temodar) including FDA-approved and compendial uses, and continuation/reauthorization conditions for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTemozolomide (Temodar) — Indications and Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for covered indications; approvals may be granted for up to 12 months and reauthorization requires no unacceptable toxicity or disease progression.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization period for most indications

FDA-approved + compendialIndications considered covered if criteria met

MultipleCancer types specifically listed

Coverage Criteria for Temozolomide (Temodar)

inv-01: Initial therapy — Covered indications

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Indication is FDA-approved or compendial: The requested use is an FDA-approved indication (newly diagnosed glioblastoma concomitant with radiotherapy and then as maintenance; adjuvant treatment of newly diagnosed anaplastic astrocytoma; or treatment of refractory anaplastic astrocytoma) OR a compendial use listed in Section II (e.g., Ewing sarcoma; CNS cancers; neuroendocrine tumors; extrapulmonary poorly differentiated neuroendocrine carcinoma; pheochromocytoma/paraganglioma; cutaneous melanoma; uveal melanoma; mycosis fungoides/Sezary syndrome; small cell lung cancer; soft tissue sarcoma; uterine sarcoma; neuroblastoma).

See compendial list for included tumor types.

inv-02: Authorization duration and combination requirements — Authorization duration and special combination conditions

Authorization duration and special combination conditions

Authorization period: Authorization of 12 months may be granted for treatment of listed indications including CNS cancers, Ewing sarcoma, neuroendocrine tumors, extrapulmonary poorly differentiated neuroendocrine carcinoma, pheochromocytoma/paraganglioma, cutaneous melanoma, uveal melanoma, mycosis fungoides/Sezary syndrome, small cell lung cancer, soft tissue sarcoma, uterine sarcoma, and neuroblastoma (when used in specified combination).12 months

Neuroblastoma requires use in combination with irinotecan, dinutuximab, and sargramostim.

inv-03: Continuation of therapy — Continuation/reauthorization

Continuation/reauthorization

Reauthorization criteria: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Provider must document lack of progression or unacceptable toxicity.

All indications for temozolomide that are not specifically listed as FDA-approved uses or as compendial uses in this policy are considered experimental/investigational and are not medically necessary. Providers should ensure the requested use corresponds to one of the FDA-approved indications or a compendial tumor type enumerated in the policy before submitting an authorization request.

Regimen	Indication	Authorization Duration	Coverage Status
Temozolomide in combination with irinotecan, dinutuximab, and sargramostim
Neuroblastoma
12 months
Covered when used in the specified combination

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization and reauthorization — 12 month approvals

Prior authorization may be granted for up to 12 months for listed indications; reauthorization requires no unacceptable toxicity or disease progression while on the current regimen.

Authorization of up to 12 months may be granted for CNS cancers, Ewing sarcoma, neuroendocrine tumors, and other listed compendial indications.
Reauthorization (continuation of therapy) allowed for 12 months when there is no evidence of unacceptable toxicity or disease progression.

Prior Authorization

Combination requirement for neuroblastoma

For neuroblastoma, authorization of up to 12 months is specified when temozolomide is used in combination with irinotecan, dinutuximab, and sargramostim.

Combination therapy required for authorization: temozolomide + irinotecan + dinutuximab + sargramostim.

Documentation Required

Indication and exclusion documentation

Provider must document that the indication is an FDA‑approved or compendial use and that all approval criteria are met; the member must have no exclusions to the prescribed therapy. All other indications not listed are considered experimental/investigational and not medically necessary and may be denied.

Indications covered include FDA‑approved labeled uses (e.g., newly diagnosed glioblastoma, anaplastic astrocytoma) and listed compendial uses (e.g., Ewing sarcoma, CNS cancers, neuroendocrine tumors, neuroblastoma, melanoma, sarcomas).
Document the specific indication and confirm it is included in the covered FDA or compendial lists.
Requests for indications not expressly listed should be considered experimental/investigational and will be denied as not medically necessary.

Denial Risk

Non-covered indications

All other indications not listed in the FDA‑approved or compendial uses are considered experimental/investigational and not medically necessary; authorization should not be granted for those indications.

Requests for unlisted indications may be denied as not medically necessary.
Ensure chart documentation supports a listed indication before submitting an authorization request.

Definitions and Indication Categories

FDA-approved indications — Temozolomide (Temodar)

FDA-approved indicationsNewly diagnosed glioblastoma (concomitant with radiotherapy and then as maintenance); anaplastic astrocytoma — adjuvant for newly diagnosed and for refractory disease

Patient populationAdults — temozolomide indicated for adult patients in the above settings

Setting for glioblastomaConcomitant with radiotherapy followed by maintenance treatment

Anaplastic astrocytoma usesAdjuvant treatment for newly diagnosed disease and treatment for refractory disease

Compendial uses (examples)

Compendial tumor typesEwing sarcoma; central nervous system (CNS) cancers; neuroendocrine tumors (pancreas, GI, lung, thymus); well-differentiated grade 3 neuroendocrine tumors; extrapulmonary poorly differentiated (high-grade) neuroendocrine carcinoma/large or small cell carcinoma; pheochromocytoma/paraganglioma; cutaneous melanoma; uveal melanoma; mycosis fungoides/Sezary syndrome; small cell lung cancer; soft tissue sarcoma; uterine sarcoma; neuroblastoma

Coverage noteCompendial uses are additional cancer types listed in recognized compendia (e.g., NCCN) for which temozolomide may be covered when policy criteria are met

Non-covered indicationsAll other indications not listed in the FDA-approved or compendial sections are considered experimental/investigational and not medically necessary

Line of Therapy Specifications

inv-14: first-line — 1 top-level node

Glioblastoma setting: Temodar is indicated for adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.

FDA-approved use.

inv-15: second-line — 1 top-level node

Anaplastic astrocytoma settings: Temodar is indicated as adjuvant treatment for newly diagnosed anaplastic astrocytoma and for treatment of refractory anaplastic astrocytoma.

FDA-approved uses.

Background

Temozolomide (Temodar) is an oral alkylating chemotherapeutic agent with primary use in central nervous system malignancies and broader compendial use across several solid tumors and sarcomas. The compendial list in this policy includes malignancies such as Ewing sarcoma, central nervous system (CNS) cancers, various neuroendocrine tumors, pheochromocytoma/paraganglioma, uveal and cutaneous melanoma, mycosis fungoides/Sezary syndrome, small cell lung cancer, soft tissue and uterine sarcomas, and neuroblastoma. Uses outside these FDA-approved or compendial indications are considered experimental/investigational and not medically necessary.