ModifiedHealth NetPolicy N/A

Temozolomide (Temodar) coverage

Defines medical necessity criteria, dosing limits, and authorized indications (FDA and NCCN-supported off‑label) for temozolomide for Health Net lines of business (HIM, Medicaid). Applies to providers requesting prior authorization for temozolomide.

Policy Summary

PayerHealth Net

PolicyTemozolomide (Temodar) coverage

Policy CodePolicy N/A

Change TypeCoverage criteria and authorization requirements revised (generic requirement, off-label additions, dosing clarification)

Effective DateSep 1, 2011

Next Review DateN/A

Key ActionObtain prior authorization with documentation that the member meets listed approval criteria and that generic temozolomide is used unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Anaplastic glioma was added as an off-label NCCN-supported category 2A indication.

Requirement changed from medical justification for inability to use generic temozolomide to a 'must use' requirement and added to continued therapy criteria.

Dosing requirements per FDA label clarified: maintenance doses should only be administered on days 1-5 of each 28-day cycle.

Generic temozolomide was added to the policy/criteria section given formulary and authorization status.

Multiple off-label NCCN Compendium indications were added or revised (examples: low-grade recurrent/progressive glioma, mucosal melanoma, neuroendocrine tumor of the lung, unresectable uveal melanoma, neuroblastoma combinations, pediatric medulloblastoma, well-differentiated grade 3 neuroendocrine tumors).

6 monthsinitial approval duration

12 monthscontinuation approval duration

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Coverage Criteria for Temozolomide

Initial Approval (FDA‑approved diagnoses)

Covered when ALL of the following are met:

Initial approval for FDA‑approved diagnoses: 1) Diagnosis of glioblastoma or IDH‑mutant astrocytoma (see Appendix D); 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years unless pediatric indication specified separately; 4) Member must use generic temozolomide unless contraindicated or clinically significant adverse effects occur; 5) Dose and regimen conform to FDA‑approved dosing: glioblastoma concomitant phase 75 mg/m2 daily x 42 days with focal radiotherapy followed by maintenance starting ~4 weeks after RT with Cycle 1: 150 mg/m2 daily days 1-5 of a 28-day cycle (escalate to 200 mg/m2 in Cycle 2 if tolerated) and subsequent cycles 200 mg/m2 days 1-5 (maximum 200 mg/m2/day); for IDH‑mutant astrocytoma adjuvant: begin ~4 weeks after RT with Cycle 1: 150 mg/m2 days 1-5 and escalate to 200 mg/m2 if tolerated (recommended up to 12 cycles); 6) Prescribed regimen must be FDA‑approved or recommended by NCCN;see dosing nodes

Approval duration: 6 months

NCCN Compendium Supported Off‑Label Uses

Covered when ALL of the following are met:

NCCN category 1 or 2A indications (off‑label compendium supported): 1) Prescribed for an indication recommended by the NCCN Drugs & Biologics Compendium (category 1 or 2A), examples include Ewing sarcoma (with irinotecan for relapsed/progressive disease), cutaneous or mucosal melanoma as specified by NCCN, neuroendocrine tumors (including well‑differentiated grade 3 and extrapulmonary poorly differentiated neuroendocrine carcinoma), solitary fibrous tumor (when used in combination with bevacizumab), pediatric medulloblastoma and diffuse high‑grade gliomas, oligodendroglioma, brain metastases, primary CNS lymphoma, and other NCCN‑listed tumors; 2) Prescribed by or in consultation with an oncologist; 3) Member must use generic temozolomide unless contraindicated or clinically significant adverse effects occur; 4) Age ≥ 18 years for adult indications (exceptions apply for pediatric indications such as diffuse high‑grade gliomas and medulloblastoma); 5) Dose does not exceed 200 mg/m2 on days 1-5 of each 28‑day cycle or, if higher or different dosing is requested, the dose is supported by practice guidelines or peer‑reviewed literature with supporting evidence from the prescriber;

Prescribed regimen must be NCCN‑recommended. Approval duration: 6 months.

Continuation Therapy

Covered when ALL of the following are met:

Continuation therapy: 1) Member is currently receiving temozolomide via the benefit or documentation shows at least 30 days of recent use for a covered indication; 2) Member is responding to therapy as documented in the medical record; 3) Member must use generic temozolomide unless contraindicated or clinically significant adverse effects occur; 4) Any requested dose increase must not exceed 200 mg/m2 days 1-5 of each 28‑day cycle unless the new dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence);

Approval duration: 12 months.

Coverage criteria (high-level changes and examples)

Policy covers FDA‑approved and NCCN‑compendium supported off‑label indications when specified criteria are met and dosing/generic requirements are followed.

Generic requirement: Must use generic temozolomide unless contraindicated; requirement changed from medical‑justification language to mandatory 'must use' and was added to continuation criteria.

Applies to initial and continued therapy per formulary/authorization updates.

Dosing adherence: Maintenance dosing must be administered on days 1-5 of each 28‑day cycle per FDA label; maximum maintenance dose 200 mg/m2/day.days 1-5 of 28; max 200 mg/m2/day

Dosing clarification added to policy.

Off‑label NCCN examples and companion therapy requirements: Multiple off‑label indications were added, removed, or reclassified to align with NCCN (examples include addition of anaplastic glioma as NCCN category 2A; inclusion of mucosal melanoma, neuroendocrine tumors, solitary fibrous tumor with required bevacizumab combination, unresectable uveal melanoma, neuroblastoma combinations, pediatric medulloblastoma, and well‑differentiated grade 3 NETs). Use for indications removed or downgraded by NCCN (e.g., primary cutaneous anaplastic large cell lymphoma; angiosarcoma) is not supported by this policy.

Requests for uses that are not FDA‑approved and are not specifically listed in this policy will not be authorized unless the provider supplies sufficient supporting documentation per the applicable off‑label use policy: HIMPA.154 for health insurance marketplace lines of business or CP.PMN.53 for Medicaid. Prior authorization requires submission of clinical documentation (chart notes, labs, etc.) that demonstrates the requested use meets off‑label policy standards and any applicable formulary or non‑formulary requirements.

The policy was updated to remove certain off‑label indications that are no longer supported by the NCCN Compendium. Examples include removal of primary cutaneous anaplastic large cell lymphoma. Additional adjustments reflect NCCN reclassifications (for example, mucosal melanoma was downgraded and removed from off‑label coverage in a later review). These removals mean requests for these indications will not meet authorization criteria under this policy.

Per recent NCCN guidance incorporated into the policy, temozolomide use for certain tumor types such as angiosarcoma is now not recommended and has been removed from supported off‑label indications. Uses that are downgraded or explicitly not recommended by NCCN are considered not supported by the compendium and therefore are not consistent with this coverage policy.

Dosing Regimens and Combination Therapies

Phase	Dose / Schedule	Notes	Coverage
Concomitant (with focal radiotherapy)	75 mg/m2 orally once daily for 42 days (concurrent with focal RT; 60 Gy in 30 fractions)	Start concomitant dosing during radiotherapy course; see RT schedule for fractionation	covered
Maintenance (begin ~4 weeks after completing RT)	Cycle 1: 150 mg/m2 orally once daily on days 1–5 of each 28‑day cycle; if tolerated, escalate to 200 mg/m2 in Cycle 2	Cycles 2–6: 200 mg/m2 once daily on days 1–5 of each 28‑day cycle if escalated at Cycle 2; if not escalated in Cycle 2, do not escalate in later cycles	covered
Maximum per‑day maintenance dose	Maximum maintenance dose: 200 mg/m2 per day	Do not exceed 200 mg/m2/day; adjust for toxicity per label	covered

Setting	Initial Dose	Escalation / Duration	Coverage
Adjuvant (IDH‑mutant astrocytoma)	Begin ~4 weeks after completion of radiotherapy: Cycle 1 dose 150 mg/m2 orally once daily on days 1–5 of a 28‑day cycle	Increase to 200 mg/m2/day in subsequent cycles if Cycle 1 tolerated; recommended up to 12 cycles for adjuvant therapy	covered
Refractory (IDH‑mutant astrocytoma)	Initial dose 150 mg/m2 orally once daily on days 1–5 of a 28‑day cycle	Escalate to 200 mg/m2/day if tolerated; continue until disease progression or unacceptable toxicity (clinical trials permitted up to 2 years)	covered
Maximum per‑day maintenance dose	200 mg/m2 per day	Do not exceed 200 mg/m2/day; monitor blood counts and toxicity	covered

Indication / Combination	Required Companion Therapy / Note	Authorization Implication	Coverage
Solitary fibrous tumor	Temozolomide used in combination with bevacizumab per updated off‑label criteria	Use with bevacizumab is required by updated NCCN‑aligned off‑label criteria; documentation should support regimen selection	covered

Indication	Example Combination Regimens	Notes	Coverage
Neuroblastoma	Temozolomide in combination with irinotecan, dinutuximab (dinutuximab‑containing regimen), and sargramostim	Regimens reflect NCCN‑aligned off‑label combinations added to policy; ensure documentation of indication and combination agents	covered

Coding and Dose Limits

HCPCS Codes referencedHCPCS

J8700	Temozolomide, oral, 5 mg
J9328	Temozolomide (code listed but description truncated in document)

Affected/Consolidated Codesmixed

affected codes

Placeholder referenced in document for codes impacted by prior authorization consolidation

inv-10: Maximum maintenance dose — numeric limit

Maximum maintenance dose200 mg/m2/day

Glioblastoma maintenance regimen noteMaintenance dosing: Cycle 1 = 150 mg/m2 daily days 1-5 then escalate to 200 mg/m2 in Cycle 2 if tolerated; subsequent cycles 200 mg/m2 days 1-5

IDH‑mutant astrocytoma maintenance noteAdjuvant/refractory: Cycle 1 = 150 mg/m2 days 1-5; increase to 200 mg/m2 if tolerated; continue until progression or unacceptable toxicity

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for temozolomide (and brand Temodar) requests. Provider must obtain prior authorization and submit documentation that the member meets all approval criteria (diagnosis, prescriber specialty/consultation, age, dosing regimen, and other clinical criteria) before therapy is authorized.

Prior authorization required for initial and continuation requests
Prescriptions should be by or in consultation with an oncologist when specified in criteria

Prior Authorization

Authorization Duration

Initial authorizations are granted for up to 6 months. Continuation/renewal requests should document ongoing clinical benefit (response to therapy) and adherence to dosing schedule. Per policy history, initial approval duration was consolidated to 6 months; some continuation approvals previously allowed up to 12 months when criteria were met.

Initial approval duration: 6 months
Continuation approvals: documentation of response and adherence to dosing; duration per clinical review

Line of Therapy Designations

first-line | subsequent

Line of therapy per indication: Used as concomitant with radiotherapy and maintenance for newly diagnosed glioblastoma; adjuvant treatment for newly diagnosed IDH‑mutant astrocytoma; and as subsequent or later‑line therapy for various NCCN‑supported off‑label indications as specified by NCCN (line of therapy—first‑line vs subsequent—varies by indication).

first-line | second-line | subsequent

Line‑specific requirements: Some indications specify prior therapies or specific line placement (e.g., cutaneous melanoma modified from second‑line to subsequent therapy; other indications require disease refractory/progressive despite prior alkylator or specified systemic therapies). Line of therapy is applied per the NCCN‑aligned indication criteria.

Biomarker and Diagnostic Requirements

inv-24: IDH (isocitrate dehydrogenase) — biomarker requirement / note

Biomarker required for astrocytoma designationIDH (isocitrate dehydrogenase) mutation status used to define IDH‑mutant astrocytoma for coverage

WHO grade specificationFor IDH‑mutant astrocytoma, disease is WHO grade 2, 3, or 4 per initial approval criteria

Appendix referenceIDH acronym defined in Appendix A (IDH = isocitrate dehydrogenase)

Definitions and Terminology

inv-20: IDH / terminology note — defines IDH and notes NCCN terminology updates

DefinitionIDH = isocitrate dehydrogenase

NCCN terminology updateNCCN CNS guideline no longer uses the term 'anaplastic' and replaced it with tumor‑specific terminology (e.g., IDH‑mutant astrocytoma)

Implication for policy languagePolicy uses tumor‑specific IDH/WHO designations consistent with NCCN updates

inv-21: NCCN category 2A definition — consensus-based category description

NCCN category 2A meaningIndicates uniform NCCN consensus in favor of the intervention based on lower‑level evidence

Policy change exampleAnaplastic glioma was added as an off‑label NCCN‑supported category 2A indication (2Q 2021 review)

Background

Temozolomide is an oral imidazotetrazine alkylating agent primarily used in the management of central nervous system tumors. It is indicated for adults with newly diagnosed glioblastoma given concomitantly with radiotherapy and then as maintenance, and it is used for IDH‑mutant (formerly anaplastic) astrocytoma in adjuvant or refractory settings. For glioblastoma, the concomitant regimen is 75 mg/m2 daily for 42 days with focal radiotherapy, followed by maintenance beginning approximately 4 weeks after radiotherapy with 150 mg/m2 daily on days 1–5 of a 28‑day cycle, escalating to 200 mg/m2 if tolerated (maximum 200 mg/m2/day).

Policy Summary

PayerHealth Net

PolicyTemozolomide (Temodar) coverage

Policy CodePolicy N/A

Change TypeCoverage criteria and authorization requirements revised (generic requirement, off-label additions, dosing clarification)

Effective DateSep 1, 2011

Next Review DateN/A

Key ActionObtain prior authorization with documentation that the member meets listed approval criteria and that generic temozolomide is used unless contraindicated.

SourceLink

On This Page

Documentation Required

Generic Drug Requirement

Member must use generic temozolomide unless there is a documented contraindication or clinically significant adverse reaction to the generic formulation. The policy requires use of generic product; inability to use generic must be justified in the medical record and submitted with the request when brand is requested.

Generic-first requirement: generic temozolomide must be used when available
If brand is requested, submit clinical justification (allergies, intolerance, or other documented contraindication)

Denial Risk

Non‑Covered / Off‑Label Indications Risk

Requests for indications that are non‑FDA approved and not addressed within this policy will be denied unless the prescriber provides sufficient off‑label documentation demonstrating efficacy and safety per applicable off‑label use policies and NCCN support. Provider should include citations to practice guidelines or peer‑reviewed literature when requesting off‑label dosing or indications supported by NCCN.

Non‑covered indications: non‑FDA uses not addressed in policy will be denied without sufficient off‑label evidence
Off‑label requests should reference NCCN compendium category and supporting literature

Documentation Required

Required Documentation

Required documentation must be submitted with the prior authorization request. Providers should include chart notes, relevant laboratory results, pathology reports, imaging, prior treatment history, and evidence that the member meets the specific criteria (diagnosis, age, prescriber specialty, dosing regimen consistent with FDA label or NCCN recommendation). When requesting brand product or doses outside standard FDA dosing, include justification and supporting literature. Documentation should demonstrate adherence to the approved dosing schedule (maintenance dosing on days 1–5 of each 28‑day cycle when applicable) or provide rationale for deviations.

Submit chart notes, labs, pathology/imaging, prior therapy history, and rationale for off‑label use if applicable
If requesting brand Temodar, include documentation justifying inability to use generic
When dosing deviates from standard FDA schedule, include supporting literature or guideline references