mhn Topotecan (Hycamtin) Coverage Prior Auth

Coverage Criteria

Initial Approval — Ovarian Cancer

Covered when ALL of the following are met

ALL of the following

Diagnosis of ovarian cancer (including serous epithelial carcinoma, mucinous neoplasms, clear cell carcinoma, endometrioid carcinoma, low-grade serous carcinoma, and carcinosarcoma), fallopian tube cancer, or primary peritoneal cancer
Formulation: Request is for topotecan for injection
Prescriber: Prescribed by or in consultation with an oncologist
Age ≥ 18 years
Prior therapy: Disease progression on or after initial or subsequent chemotherapy (see Appendix B)
Regimen: Prescribed as a single agent or in combination with bevacizumab or sorafenib (off-label)
Generic preference: For Hycamtin injection requests, member must use generic topotecan, unless contraindicated or clinically significant adverse effects are experienced
Dose limit: Dose does not exceed 1.5 mg/m2 per day for 5 consecutive days every 21 days, or dose supported by guidelines/literature for off-label use with supporting evidence

Initial Approval — Small Cell Lung Cancer

Covered when ALL of the following are met

ALL of the following

Diagnosis of small cell lung cancer
Prescriber: Prescribed by or in consultation with an oncologist
Age ≥ 18 years
Prior therapy: Member has received prior chemotherapy (see Appendix B)
Generic preference: For Hycamtin requests, member must use generic topotecan if available, unless contraindicated or clinically significant adverse effects are experienced

Initial Approval — Cervical Cancer

Covered when ALL of the following are met

ALL of the following

Diagnosis of cervical cancer
Formulation: Request is for topotecan for injection
Prescriber: Prescribed by or in consultation with an oncologist
Age ≥ 18 years
Regimen: Prescribed in combination with cisplatin or paclitaxel, or as a single agent as second-line or subsequent therapy

Initial Approval — Off-Label NCCN Compendium Recommended Indications

Covered when ALL of the following are met

ALL of the following

Indication list: Request is for topotecan for injection for one of the following NCCN‑recommended indications: Ewing sarcoma (with cyclophosphamide), osteosarcoma (with cyclophosphamide), leptomeningeal metastases (intrathecal route), non-pleomorphic rhabdomyosarcoma (single agent or with cyclophosphamide), endometrial carcinoma (second-line, single agent), neuroblastoma (with cyclophosphamide), pediatric medulloblastoma (with temozolomide), or vaginal cancer (single agent or with paclitaxel/cisplatin)
Merkel cell provision: Diagnosis of Merkel cell carcinoma with progression on checkpoint immunotherapy (e.g., avelumab, pembrolizumab, nivolumab)
Prescriber: Prescribed by or in consultation with an oncologist

Coverage with criteria

Covered for specific oncology indications when FDA-labeled or when supported by NCCN/off-label policy criteria and payer formulary guidance:

FDA-approved and NCCN-supported uses: Coverage applies for listed indications (e.g., ovarian cancer, small cell lung cancer, cervical cancer) per dosing regimens and combinations described in the policy; includes single-agent and combination uses where specified.

See dosing section for regimen specifics and Appendix B for therapeutic alternatives

Handling recent label changes: If the drug label has changed within 6 months and the policy is not updated, providers must follow the payer's formulary or non-formulary policy for the relevant line of business as directed (see related policies).

Off-label uses: Non-FDA approved indications not covered by this policy require evidence per the off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) to be considered for coverage or may be redirected to those policies.

Specific off-label NCCN recommendations have been added/updated in annual reviews (see revision history).

Requests for non‑FDA approved indications that are not addressed in this policy will not be authorized for coverage unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or supported by an evidence of coverage document.

Non‑FDA approved indications that fall outside the uses listed in this policy are excluded from coverage unless the request is accompanied by adequate clinical evidence per the payer’s off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) demonstrating the requested use’s efficacy and safety.

Uses that are non‑FDA approved and lack sufficient supporting documentation of efficacy and safety as required by the applicable off‑label use policy are considered not authorized for coverage and may be denied.

Initial Therapy Criteria by Indication

Initial therapy

Initial therapy criteria by indication

Ovarian cancer initial

Small cell lung cancer initial

Cervical cancer initial

NCCN-off-label initial

Recommended dosing by indication

Dosing regimens provided for initial/standard use by indication

Ovarian cancer dosing: IV: 1.5 mg/m2 IV over 30 minutes daily x5 days every 21 days; Maximum IV dose 4 mg/dose. Use as single agent or in combination with bevacizumab or sorafenib as specified in policy.

Small cell lung cancer dosing: IV: 1.5 mg/m2 IV over 30 minutes daily x5 days every 21 days; OR oral: 2.3 mg/m2/day orally once daily x5 days every 21 days; Maximum IV dose 4 mg/dose.

Continuation Therapy Criteria

Continued Therapy

Continued coverage when ALL of the following are met

ALL of the following

Current therapy: Currently receiving medication via Centene benefit or documentation shows member has received Hycamtin for a covered indication for at least 30 days
Response: Member is responding positively to therapy
Generic preference: For Hycamtin requests, member must use generic topotecan if available, unless contraindicated or clinically significant adverse effects are experienced

Coding and Dosing Limits

Referenced HCPCS CodesHCPCS

J8705	Topotecan, oral, 0.25 mg
J9351	Injection, topotecan, 0.1 mg

Dose limits

Ovarian cancer (IV)1.5 mg/m2 per day IV for 5 consecutive days every 21 days (maximum IV single dose 4 mg)

Small cell lung cancer (IV)1.5 mg/m2 per day IV for 5 consecutive days every 21 days (maximum IV single dose 4 mg)

Small cell lung cancer (oral)2.3 mg/m2 per day orally for 5 consecutive days every 21 days

Cervical cancer (IV)0.75 mg/m2 per day IV on Days 1–3 every 21 days (when used per policy combinations)

Off-label usesDoses may be permitted if supported by practice guidelines or peer-reviewed literature with prescriber-submitted evidence

Maximum single IV dose

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must obtain prior authorization per the clinical policy and submit documentation that the member meets the indication‑specific criteria in this policy.

PA governed by clinical policy
Billing/coding for requests should reference HCPCS: J8705 and J9351

Documentation Required

Documentation and Denial Risk

Provider must submit supporting documentation (e.g., office chart notes, lab results, imaging, pathology, prior therapy records) showing the member meets ALL applicable approval criteria. Failure to provide adequate documentation may result in denial.

Documentation examples: office chart notes, lab results, imaging, pathology, prior chemotherapy records
Requests for non‑FDA approved indications not listed in this policy require sufficient documentation per off‑label use policies (see below)

Step Therapy and Product Preference

Requirement	Details
Preferred formulation
Generic topotecan for injection is required when available; for Hycamtin (brand) injection requests the member must use generic topotecan unless contraindicated or clinically significant adverse effects are experienced.
Prescriber responsibility
Prescriber must provide supporting clinical documentation when requesting brand Hycamtin instead of generic topotecan (e.g., evidence of contraindication to generic product or documented clinically significant adverse effects to generic).
Coverage label
Coverage follows the policy criteria for each indication when generic preference is met or appropriate justification for brand use is provided.

Therapeutic alternative	Notes / PA implications
Paclitaxel
Listed as an example therapeutic alternative for ovarian and other gynecologic malignancies; formulary status may determine preference and prior authorization may be required for topotecan vs alternatives.
Carboplatin/cisplatin
Common alternatives for ovarian and small cell lung cancer regimens; selection may depend on prior therapies and formulary coverage; PA rationale may be requested.
Etoposide/irinotecan
Examples for small cell lung cancer; registries and formulary may prefer alternatives and require documentation of why topotecan is chosen.
Bevacizumab
Listed as combination option for ovarian cancer; formulary guidance may affect preferred combinations and prior authorization may require supporting rationale.
Other agents (e.g., pembrolizumab, docetaxel, gemcitabine, vinorelbine)
Provided in Appendix as examples across indications; alternatives may be preferred based on formulary status and PA may require documentation justifying use of topotecan instead of listed alternatives.

Site of Care Considerations

Note

IV dosing implies infusion center/hospital outpatient or office infusion; oral is outpatient

IV administration regimens in this policy indicate treatment should be provided in an infusion center or hospital outpatient/office infusion setting; oral capsule formulations may be administered in an outpatient setting.

IV dosing examples (e.g., 1.5 mg/m2 IV daily x5 days q21) imply infusion center or outpatient infusion administration.
Oral capsule dosing (e.g., 2.3 mg/m2 PO x5 days q21) is administered outpatient.

Definitions

Topotecan (Hycamtin) — Product summary

Drug class and generic nameTopotecan — a topoisomerase inhibitor (generic: topotecan; brand: Hycamtin)

FormulationsOral capsules (e.g., 0.25 mg, 1 mg) and injection for IV administration (vial) — IV infusion and oral dosing regimens described in policy and prescribing information

FDA indicationsCapsules: relapsed small cell lung cancer; Injection: metastatic ovarian cancer after progression, small cell lung cancer with platinum-sensitive disease, and in combination with cisplatin for certain cervical cancers

NCCN

NCCN definitionNCCN refers to the National Comprehensive Cancer Network — the source for guideline and compendium recommendations used to support covered off-label indications

Use in policy

Background

Topotecan is included in this policy with defined FDA‑approved and selected NCCN‑recommended off‑label indications. For indications not specified here, coverage determinations depend on submission of evidence per the off‑label use policies named above; without that documentation, non‑listed uses are generally not authorized.