CurrentCentenePolicy CP.PHAR.64

Topotecan (Hycamtin) (PDF)

Defines medical necessity, initial and continued approval criteria, dosing limits, covered indications (FDA and NCCN off-label recommended), approval durations by line of business, product availability, contraindications/boxed warnings, and coding/billing implications for topotecan (Hycamtin) across Commercial, HIM/ICHRA, and Medicaid lines.

Policy Summary

PayerCentene

PolicyTopotecan (Hycamtin) (PDF)

Policy CodePolicy CP.PHAR.64

Change TypeAnnual review updates (2022-2026) including added indications and duration changes

Effective DateJun 1, 2011

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

2Q 2026 annual review: extended Medicaid and HIM initial approval duration from 6 months to 12 months and revised neuroblastoma to include non-induction therapy; added ICHRA line of business.

2Q 2025 annual review: added pediatric medulloblastoma and vaginal cancer to off-label NCCN recommendations; references updated.

2Q 2024 annual review: revised mucinous carcinoma to mucinous neoplasms; added generic redirection for all indications; added neuroblastoma per NCCN; revised Merkel cell carcinoma criteria.

2Q 2022 annual review: expanded ovarian cancer coverable diagnoses; added requirements for ovarian and cervical uses; modified commercial approval duration for capsules; removed primary CNS lymphoma from off-label uses and added several sarcoma-related requirements.

3FDA-approved primary indications (ovarian, SCLC, cervical)

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Coverage Summary

Policy number CP.PHAR.64 defines medical necessity, initial and continued approval criteria, dosing limits, covered indications (FDA and NCCN off-label recommended), approval durations by line of business, product availability, contraindications/boxed warnings, and coding/billing implications for topotecan (Hycamtin). The policy coverage stance is covered_with_criteria and applies to the lines of business: Commercial, HIM/ICHRA, and Medicaid.

The policy covers the FDA-approved primary indications: metastatic ovarian cancer (Hycamtin injection), small cell lung cancer (Hycamtin capsules and injection), and Stage IV-B/recurrent/persistent cervical carcinoma in combination with cisplatin (injection) per the FDA label. NCCN compendium recommended off-label uses are also included when criteria are met.

Approval durations differ by line of business: for Medicaid/HIM/ICHRA initial and continued approvals are 12 months; for Commercial initial and continued approvals are generally 6 months or to the member's renewal date, whichever is longer for injections, with capsule-specific commercial duration provisions noted separately.

Initial Therapy Criteria

Continuation Therapy Criteria

Continued Therapy

Continued therapy is authorized when all criteria are met:

Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving topotecan for a covered indication and has received this medication for at least 30 days
Member is responding positively to therapy
For Hycamtin requests, member must use generic topotecan if available, unless contraindicated or clinically significant adverse effects are experienced
Dose increase request (must meet one)
- i: New dose does not exceed the following: Ovarian cancer: 1.5 mg/m2 per day IV for 5 consecutive days every 21 days
- ii: New dose does not exceed the following: Small cell lung cancer: 1.5 mg/m2 per day IV or 2.3 mg/m2/day orally for 5 consecutive days repeated every 21 days

Diagnoses / Indications Not Authorized

Diagnoses/Indications not authorized

Non-FDA approved indications which are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to the off-label use policy CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace/ICHRA), and CP.PMN.53 (Medicaid), or evidence of coverage documents

Provider Actions & Prior Authorization

Prior Authorization

Documentation submission required

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria for topotecan (Hycamtin).

Prior Authorization

Prescriber specialty requirement

Prescriptions must be written by or in consultation with an oncologist for all covered indications of topotecan (Hycamtin).

Documentation Required

Support for off-label dosing

For doses or regimens outside the specified limits, the prescriber must submit supporting practice guidelines or peer‑reviewed literature demonstrating support for the off‑label use. The prescribed regimen must be FDA‑approved or recommended by NCCN.

Applicable Codes

Drug HCPCS/J-codeHCPCSCovered

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

Clinical Evidence & References

Evidence sources referenced in the policy include the FDA prescribing information and NCCN compendium/guidelines. The primary FDA reference listed is: Hycamtin for Injection Prescribing Information, Novartis; October 2019.

The policy also cites the NCCN Drugs and Biologics Compendium and disease-specific NCCN guidelines (2025-2026 versions) for ovarian cancer, small cell lung cancer, and cervical cancer and relies on those recommendations to support coverage and off-label compendium uses.

The policy explicitly incorporates the FDA label and NCCN recommendations and includes off-label NCCN compendium recommended uses when the policy criteria are met.

Background

Topotecan (Hycamtin) is a topoisomerase inhibitor.

FDA-approved indications per the policy and labels distinguish formulations: Hycamtin capsules are indicated for relapsed small cell lung cancer in patients with prior response and at least 45 days from the end of first-line chemotherapy; Hycamtin injection is indicated for metastatic ovarian cancer after progression on or after chemotherapy, for small cell lung cancer with platinum-sensitive disease who progressed ≥60 days after initiation of first-line chemotherapy, and in combination with cisplatin for Stage IV-B/recurrent/persistent cervical carcinoma not amenable to curative treatment.

The policy incorporates the FDA label and NCCN recommendations and includes NCCN compendium off-label recommended uses when the policy criteria are satisfied.

Product availability noted in the policy: capsules (0.25 mg, 1 mg) and lyophilized powder for injection (4 mg vial).

Revision History

2Q 2022revised

2Q 2022 annual review: expanded ovarian cancer coverable diagnoses (included fallopian tube and primary peritoneal cancer), added requirement for ovarian use as single agent or with bevacizumab/sorafenib; for cervical cancer, added requirement for use in combination with cisplatin or paclitaxel or as single agent second-line; removed primary CNS lymphoma from off-label uses and added specific sarcoma-related requirements; modified commercial approval duration for capsules. P&T Approval Date = 05.22.22

2Q 2024revised

2Q 2024 annual review: revised mucinous carcinoma to mucinous neoplasms per NCCN; added neuroblastoma to off-label NCCN recommendations; revised Merkel cell carcinoma criteria to require progression on checkpoint immunotherapy; added redirection to generic topotecan for all indications. P&T Approval Date = 05.24