Melanoma Vaccines (Imlygic/talimogene laherparepvec)
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Defines medical necessity and prior authorization criteria for use of Imlygic (talimogene laherparepvec) and other melanoma vaccines under the medical benefit for members; applies to coverage decisions for melanoma and select Merkel cell carcinoma indications.
Updated per NCCN 2A for Merkel cell carcinoma intralesional treatment for primary N+ M0 disease or recurrent N+ regional disease if curative surgery and curative RT are not feasible.
Wording and formatting criteria updates; criteria aligned with NCCN 2A language and inclusion of oligometastatic and widely disseminated disease per NCCN.
Removed HCPCS NOC J3590 from coding list.
Coverage Criteria for Imlygic and Melanoma Vaccines
Initial Therapy — Requests for Imlygic may be approved when the following criteria are met:
Requests for Imlygic may be approved when ALL of the following are met:
Age or diagnosis
- Melanoma intralesional indication: Individual is using for limited resectable or unresectable disease as intralesional treatment for one of: A. Stage III disease with clinical satellite/in-transit metastases; OR B. Stage III clinically positive node(s); OR C. Local satellite/in-transit recurrence of disease; OR D. Nodal recurrence of disease
NCCN 2A; efficacy greater in less advanced, treatment-naïve patients
- Advanced disease indications: Individual is using as intralesional treatment of accessible lesions in oligometastatic disease OR as intralesional treatment of limited extracranial lesions in widely disseminated distant metastatic disease
NCCN 2A
- Merkel cell carcinoma indications: Individual has a diagnosis of Merkel cell carcinoma AND meets one of: A. Intralesional treatment for primary N+, M0 regional disease or recurrent N+ regional disease if curative surgery and curative radiation therapy (RT) are not feasible, but not M1 disseminated disease; OR B. Intralesional treatment for in-transit primary N+ regional disease if curative surgery and/or RT are not feasible
NCCN 2A; added per 02/20/2026 update
- Agent and exclusions: Individual is using Imlygic (talimogene laherparepvec) as a single agent; Exclusions: all other indications not included above; immunocompromised individuals; pregnant individuals
Imlygic is contraindicated in immunocompromised and pregnant patients per package insert
Policy specifies single-agent use
Requests for Imlygic (talimogene laherparepvec) should not be approved for indications outside those specified in the policy. Specifically, coverage is excluded for: (1) all other indications not included above; (2) individuals who are immunocompromised; and (3) individuals who are pregnant.
Use of melanoma vaccines other than talimogene laherparepvec is not approved and is considered not medically necessary under this policy.
Covered Regimens and Dosing
| Regimen | Indication | Billing HCPCS | Coverage |
|---|---|---|---|
| Imlygic (talimogene laherparepvec) intralesional injections | Intralesional single-agent therapy for specified melanoma and Merkel cell carcinoma indications: unresectable or borderline resectable stage III disease with clinical satellite/in-transit metastases or clinically positive node(s); limited resectable or unresectable local/regional recurrence; nodal recurrence; intralesional treatment of accessible lesions in oligometastatic disease or limited extracranial lesions in widely disseminated metastatic disease; Merkel cell carcinoma primary N+, M0 regional disease or recurrent N+ regional disease or in-transit primary N+ regional disease when curative surgery and/or radiation are not feasible (not for M1 disseminated disease). See coverage criteria for full details and exclusions (immunocompromised or pregnant individuals excluded). | J9325 — Injection, talimogene laherparepvec, per 1 million plaque forming units | Covered |
Billing and Diagnosis Codes
| J9325 | Injection, talimogene laherparepvec, per 1 million plaque forming units [Imlygic] |
| C43.0-C43.9 | Malignant melanoma of skin |
| C4A.0-C4A.9 | Merkel cell carcinoma |
Provider Actions: Prior Authorization, Documentation, and Denial Risks
Prior Authorization Required
Prior authorization required: Requests for Imlygic (talimogene laherparepvec) must be prior authorized and meet the plan's clinical criteria for approved indications. Approval is limited to the specific covered indications and patient populations; requests for all other indications will not be approved.
- Imlygic (talimogene laherparepvec) prior authorization required
- Approval limited to covered indications and populations; see documentation requirements below
- Requests for Imlygic will be denied if patient is immunocompromised or pregnant
Step Therapy
No step therapy (no requirement to try other systemic agents before Imlygic) is imposed by this policy. The policy references clinical trial comparators (e.g., subcutaneous GM-CSF) for context but does not mandate trials of other agents prior to Imlygic use.
- No prerequisite trial of other systemic therapies required prior to Imlygic under this policy
- Clinical-trial comparators are informational only and not step therapy requirements
Required Documentation
Required documentation for prior authorization: submit diagnosis (melanoma or Merkel cell carcinoma), disease stage, description of lesion accessibility and location, statement that Imlygic will be used as intralesional single-agent therapy, and justification that surgery and/or radiation are not feasible when applicable. Also document age if <19 years (pediatric approval pathway) and confirm patient is not immunocompromised or pregnant.
- Diagnosis: melanoma or Merkel cell carcinoma
- Disease stage and clinical scenario (e.g., stage III with in-transit/satellite metastases, nodal recurrence, oligometastatic or limited extracranial lesions)
- Lesion accessibility and intralesional treatment plan
- Confirmation Imlygic used as single agent
- If applicable, documentation that curative surgery and/or radiation are not feasible
- Patient not immunocompromised and not pregnant
- Age documentation if patient is <19 years
Common Denial Triggers
Common denial triggers: requests for melanoma vaccines other than Imlygic, use in immunocompromised or pregnant patients, use for indications not listed in the coverage criteria (including M1 disseminated disease outside the limited extracranial/oligometastatic contexts), or use in combination with other systemic agents.
- Requests for non‑Imlygic melanoma vaccines — not approved
- Use in immunocompromised patients — contraindicated and will be denied
- Use in pregnant patients — contraindicated and will be denied
- Use for indications not enumerated in the coverage criteria (e.g., general metastatic M1 disease not meeting limited lesion criteria)
- Requests for Imlygic in combination with other systemic anticancer agents — not approved under this policy
Definitions and Key Terms
Background
Therapeutic melanoma vaccines are intended to stimulate anti-tumor immune responses by presenting tumor-associated antigens to the immune system. Imlygic (talimogene laherparepvec) is an FDA-approved intralesional oncolytic herpes simplex virus type 1 engineered to express GM-CSF for local treatment of unresectable cutaneous, subcutaneous, and nodal melanoma lesions that recur after surgery. Clinical trials demonstrated an improvement in durable response rate (DRR) but not overall survival, with greater benefit observed in less advanced, treatment‑naïve disease. Definitions relevant to interpretation include in-transit metastasis (intralymphatic tumor in skin or subcutaneous tissue more than 2 cm from the primary tumor but not beyond the nearest regional lymph node basin) and DRR (complete or partial responses lasting > 6 months and beginning within the first 12 months).
Line of Therapy
Line of Therapy
Line of therapy decision:
NCCN 2A recommendations
Revision History
Wording and formatting updates to criteria; added NCCN 2A recommendation for intralesional Merkel cell carcinoma for primary N+ M0 or recurrent N+ regional disease when curative surgery and curative RT are not feasible; coding reviewed and HCPCS NOC J3590 removed.
Added NCCN recommendation for use in Merkel cell carcinoma; coding reviewed and ICD-10-CM C4A.0-C4A.9 added.
Updated criteria to align with NCCN wording and to include oligometastatic and widely disseminated disease per NCCN; coding reviewed with no changes.
Annual review documented with no clinical changes and coding reviewed with no changes.
Annual review documented with no clinical changes and coding reviewed with no changes.
Annual review documented with no clinical changes and coding reviewed with no changes.
Wording and formatting changes for clarity; added 'may not be approved' criteria for immunocompromised and pregnant patients; coding reviewed with no changes.
First review of Melanoma Vaccines clinical criteria; no clinical changes and coding reviewed with no changes.
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