CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Temozolomide (Temodar) — Coverage Criteria

Policy governs coverage and authorization durations for temozolomide (Temodar) for FDA‑approved and compendial oncology indications for members of Neighborhood Health Plan of Rhode Island, subject to approval criteria and member benefit exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTemozolomide (Temodar) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for temozolomide; authorization may be granted for up to 12 months when approval criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

2FDA‑approved indications

13compendial indications

Coverage and Medical Necessity Criteria for Temozolomide

Coverage criteria for Temozolomide

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

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General coverage prerequisites: The indication is listed as an FDA‑approved indication or a compendial use in this policy AND all approval criteria are met AND the member has no exclusions to the prescribed therapy.

Supported by chunks 0,1,2

FDA‑approved indications: Newly diagnosed glioblastoma (concomitant with radiotherapy and maintenance) OR anaplastic astrocytoma (adjuvant for newly diagnosed or for refractory disease).

Chunk 1 lists FDA approvals

Compendial indications: Temozolomide use for listed compendial indications (central nervous system cancer; Ewing sarcoma; neuroendocrine tumors of the pancreas, gastrointestinal tract, lung, and 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/Sézary syndrome; small cell lung cancer; soft tissue sarcoma; uterine sarcoma; neuroblastoma).

Chunk 2 enumerates compendial uses

Authorization duration: Authorization may be granted for up to 12 months for the listed indications, including for continuation when there is no unacceptable toxicity or disease progression.12 months

Chunk 15 describes continuation authorization of 12 months

Regimen	Indication	Coverage status
Temozolomide in combination with irinotecan, dinutuximab, and sargramostim
Neuroblastoma
Covered when used in combination with irinotecan, dinutuximab, and sargramostim; authorization may be granted for up to 12 months

Indication	Regimen	Authorization duration	Coverage status
Neuroblastoma
Temozolomide in combination with irinotecan, dinutuximab, and sargramostim
Authorization of 12 months may be granted when used in this combination
Covered

Prior Authorization, Approval Requirements, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of 12 months may be granted for FDA‑approved and compendial oncology indications when the approval criteria are met and the member has no exclusions to the prescribed therapy.

Authorization period: up to 12 months for covered indications
Covered indications include FDA‑approved uses and listed compendial uses (see Section II: Indications)

Denial Risk

Experimental / Investigational Exclusions

Use of temozolomide for indications not listed as FDA‑approved or in recognized compendia is considered experimental and investigational and is not medically necessary.

All indications not in Section II (FDA‑approved or compendial uses) are non‑covered
Requests for non‑listed indications will be denied as not medically necessary

Documentation Required

Approval Criteria and References

Coverage is approved only when all approval criteria are met and the member has no exclusions to the prescribed therapy. References used to develop these criteria include product labeling and recognized compendia.

Approval requires documented indication consistent with Section II
Approval requires absence of contraindications or plan exclusions
Continuation requests: authorization of 12 months may be granted if no unacceptable toxicity or disease progression on current regimen

Key Definitions

Compendial Uses

Compendial uses (summary)Indications supported by recognized compendia (e.g., NCCN) considered for coverage when approval criteria are met.

Enumerated compendial indicationsCentral nervous system (CNS) cancer; Ewing sarcoma; Neuroendocrine tumors (pancreas, GI tract, lung, thymus); Well-differentiated grade 3 neuroendocrine tumors; Extrapulmonary poorly differentiated neuroendocrine carcinoma; Pheochromocytoma/paraganglioma; Cutaneous melanoma; Uveal melanoma; Mycosis fungoides/Sézary syndrome; Small cell lung cancer; Soft tissue sarcoma; Uterine sarcoma; Neuroblastoma.

Coverage conditionThese compendial uses are considered covered when all policy approval criteria are met.

Background and Clinical Context

Temozolomide is a chemotherapeutic agent used for certain primary central nervous system tumors and for multiple malignancies supported by recognized compendia. This policy lists the FDA‑approved indications (see Section II) and numerous compendial uses, including central nervous system (CNS) cancer, Ewing sarcoma, neuroendocrine tumors (pancreas, gastrointestinal tract, lung, thymus), pheochromocytoma/paraganglioma, cutaneous and uveal melanoma, mycosis fungoides/Sézary syndrome, small cell lung cancer, soft tissue and uterine sarcoma, and neuroblastoma. Coverage is limited to these FDA‑approved or compendial indications when all approval criteria are met.