CurrentUnitedHealthcarePolicy N/A

Hycamtin (topotecan hydrochloride) prior authorization

Prior authorization and notification criteria for Hycamtin (topotecan hydrochloride) for UnitedHealthcare members, including initial and reauthorization rules and special provisions for members under 19 and NCCN-recommended uses.

Policy Summary

PayerUnitedHealthcare

PolicyHycamtin (topotecan hydrochloride) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateNov 1, 2025

Key ActionObtain prior authorization; prescriptions for members under 19 automatically process without coverage review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period issued

under 19auto-process <19

SCLC, Merkel cellcovered indications

1/2A/2BNCCN regimens

Coverage Criteria for Hycamtin (topotecan hydrochloride)

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inv-02: Initial Authorization - SCLC

Covered when ALL of the following are met

SCLC initial authorization: (1) Diagnosis of small cell lung cancer (SCLC); AND (2) Patient has experienced a relapse of disease after initial first-line chemotherapy (e.g., cisplatin with etoposide)

inv-04: Initial Authorization - Merkel cell carcinoma

Covered when ALL of the following are met

Merkel cell carcinoma initial authorization: (1) Diagnosis of Merkel cell carcinoma; AND (2) Patient has a contraindication to or disease has progressed on anti-PD-L1 or anti-PD-1 therapy; AND (3) One of: (i) Disease is regional N+ OR (ii) Disease is M1 disseminated

inv-05: NCCN Recommended Regimens

Covered when recognized by NCCN with specified categories

NCCN recognized regimens: Drug recognized for treatment by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

Authorization will be issued for 12 months

Coverage of Hycamtin (topotecan hydrochloride) is subject to member-specific benefit plan terms and any applicable state mandates. Some states mandate benefit coverage for off-label use or require use of particular compendia; where those mandates apply, they supersede the language in this policy. In addition, member-specific utilization management programs and other plan provisions may impact coverage and prior authorization requirements.

Initial Therapy Criteria

inv-14: Initial Therapy

Initial authorization criteria

Initial therapy nodes: See specific indication nodes: SCLC requires relapse after initial first-line chemotherapy; Merkel cell carcinoma requires contraindication or progression on anti-PD-1/PD-L1 therapy and regional N+ or M1 disease

Step	Requirement	Notes
1	Prior first-line chemotherapy required: patient must have experienced relapse of small cell lung cancer (SCLC) after initial first-line chemotherapy (e.g., cisplatin with etoposide).	This requirement applies to initial authorization for SCLC; authorization issued when criteria met per policy.

Reauthorization and Continuation Criteria

inv-03: Reauthorization

Reauthorization covered when the following are met

Reauthorization: Patient does not show evidence of progressive disease while on Hycamtin therapy

Applies to SCLC and Merkel cell carcinoma reauthorization; reauthorization approved for 12 months when met

inv-15: Reauthorization/Continuation

Reauthorization rule

Continuation therapy: Patient does not show evidence of progressive disease while on Hycamtin therapy

Reauthorization approved for 12 months when met

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Hycamtin for most members. For members under 19 years of age, prescriptions will automatically process without a coverage review and an authorization will be issued for 12 months.

Authorization period for members <19: 12 months

Prior Authorization

SCLC Prior Therapy Requirement

For small cell lung cancer (SCLC) indications, initial authorization requires documented relapse after completion of initial first-line chemotherapy (for example, cisplatin with etoposide). Ensure medical record documents prior first-line chemotherapy and evidence of relapse.

SCLC initial authorization requires prior first-line chemotherapy and documented relapse (e.g., cisplatin + etoposide)

Note

Automated Approval Logic and Limits

UnitedHealthcare may approve initial authorizations and reauthorizations automatically using prior claim/medication history, diagnosis codes (ICD-10), and other claim logic. Automated approval and re-approval processes vary by program and therapeutic class. Supply limits may apply.

Automated approval may use prior claims/medication history, ICD-10 codes, and claim logic
Program-specific variation applies to automated processes
Be aware of potential supply limits that may affect approvals

Denial Risk

Coverage Criteria Required

Members must meet the documented coverage criteria for the requested indication. Absent meeting the specified criteria (including age-based automatic processing, SCLC prior therapy requirements, or other listed criteria), a claim or authorization may be denied.

Claims lacking required documentation of criteria (e.g., prior therapy for SCLC) risk denial
For members <19, automatic processing occurs but clinical criteria and authorization duration still apply

Definitions and Clinical Terms

Relapsed SCLC — definition including prior first‑line chemotherapy

DefinitionSmall cell lung cancer (SCLC) with disease recurrence (relapse) after initial first-line chemotherapy (example regimen: cisplatin with etoposide)

ContextHycamtin (topotecan hydrochloride) is indicated for relapsed SCLC and may be considered for certain M1 or regional disease per NCCN

Authorization noteInitial authorization for SCLC requires documentation of relapse following initial first-line chemotherapy

Merkel cell carcinoma criteria — contraindication/progression on anti‑PD‑L1/PD‑1 and regional or metastatic disease

DefinitionMerkel cell carcinoma in patients who have a contraindication to, or disease progression on, anti‑PD‑L1 or anti‑PD‑1 therapy

Disease extent requirementDisease must be either regional (N+) or M1 (disseminated)

Clinical contextNCCN recognizes single‑agent use in certain circumstances when anti‑PD‑1/PD‑L1 is contraindicated or ineffective; Hycamtin initial authorization requires documented criteria be met

Background

Hycamtin (topotecan hydrochloride) is a topoisomerase inhibitor indicated for the treatment of patients with relapsed small cell lung cancer (SCLC). The clinical background supports use as single-agent therapy in relapsed SCLC and recognizes additional contexts where NCCN guidance or other clinical circumstances (for example, select regional or disseminated disease) inform use. Providers should reference the policy criteria for specific covered indications and authorization requirements.