CurrentAvMedPolicy Pub. 100-2

Talimogene laherparepvec (Imlygic) prior authorization

Prior authorization and step-edit request form and clinical criteria for outpatient (medical) use of talimogene laherparepvec (Imlygic) for melanoma lesions; applies to AvMed members and prescribing clinicians submitting authorization requests.

Policy Summary

PayerAvMed

PolicyTalimogene laherparepvec (Imlygic) prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must sign the prior authorization request form and submit required documentation including NDC selection, dosing, and recent chart notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial auth

6 monthsReauth

4 mLMax vol/visit

J9325HCPCS

2 listedNDCs

Coverage Criteria for Imlygic (talimogene laherparepvec)

Initial Authorization

Covered when ALL of the following are met

Initial Authorization: Member is 18 years of age or older; prescribed by or in consultation with a hematologist/oncologist; for female members of reproductive potential pregnancy has been excluded prior to initiation and acceptable contraception will be used with monthly pregnancy monitoring; member is not immunocompromised (e.g., history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of HIV infection, or receiving immunosuppressive therapy); treatment (talimogene laherparepvec) will be administered only via intralesional injection; diagnosis of melanoma with cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound (submit recent chart notes/progress notes documenting diagnosis workup and current status, lesion size); diagnosis meets one of the following disease status options: unresectable distant metastatic disease OR unresectable or incomplete resection of nodal recurrence OR limited resectable or unresectable stage III disease with clinical satellite or in-transit metastases OR limited resectable or unresectable disease with local satellite and/or in-transit recurrence; provider will limit intralesional injectable volume to a maximum of 4 mL per treatment visit and will follow the per-lesion maximum volume guidance based on lesion size (if >5 cm up to 4 mL; >2.5–5 cm up to 2 mL; >1.5–2.5 cm up to 1 mL; >0.5–1.5 cm up to 0.5 mL; ≤0.5 cm up to 0.1 mL).

All supporting documentation must be submitted; approval duration 6 months.

Reauthorization

Policy Summary

PayerAvMed

PolicyTalimogene laherparepvec (Imlygic) prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must sign the prior authorization request form and submit required documentation including NDC selection, dosing, and recent chart notes.

SourceLink

On This Page

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Reauthorization: Patient continues to have injectable lesions that meet the initial approval criteria (submit recent chart notes documenting lesion size and current status); member is not experiencing unacceptable toxicity from talimogene laherparepvec (examples include herpetic infection; injection site complications such as necrosis, ulceration, cellulitis, or systemic bacterial infection; immune-mediated events; plasmacytoma at injection site; obstructive airway disorder); disease response has been observed with treatment as demonstrated by stabilization of disease or decrease in tumor size or spread (submit recent chart notes recording medical status and lesion size).

Reauthorization duration 6 months; provide all documentation including lab results, diagnostics, and chart notes or request may be denied.

Lesion size (largest diameter)	Recommended maximum volume to inject per lesion	Notes
≤0.5 cm
Up to 0.1 mL
Document lesion size in chart notes submitted for authorization

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Imlygic (HCPCS J9325). The prescribing physician must sign and clearly print their name on the prior authorization request (preprinted stamps are not valid). Fax completed form and all supporting documentation to 1-877-535-1391. Incomplete, incorrect, or illegible information may delay or result in denial of authorization.

Drug: Imlygic (talimogene laherparepvec) — HCPCS J9325
Fax: 1-877-535-1391
Prescriber signature required (no preprinted stamps)

Step Therapy

Step-edit / Sample Policy

Use of samples to initiate therapy does not meet step-edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes; prior sample use does not substitute for required step-therapy or documentation of prior treatments.

Samples do NOT satisfy step-therapy requirements
Previous therapies verified via pharmacy claims or chart notes

Documentation Required

Required Supporting Documentation

Submit recent chart notes, documentation of lesion measurements and assessment, treatment plan, toxicity assessments, pregnancy status/contraception documentation for females of reproductive potential, and any other supporting records requested on the form. All documentation must be legible and complete to avoid delays or denials.

Recent chart/progress notes documenting diagnosis workup and current status
Lesion size measurements and intralesional volume calculations
Toxicity / adverse event assessments
Pregnancy exclusion and contraception documentation (when applicable)

Denial Risk

Incomplete or Inadequate Documentation

Authorization may be delayed or denied if the information provided is incomplete, incorrect, or illegible. The prescribing physician must sign and clearly print their name on the request. For urgent reviews, contact AvMed Pre-Authorization Department per the plan's urgent review definition.

Incomplete/incorrect/illegible forms can delay or deny authorization
Prescriber signature and printed name required
For urgent reviews, call AvMed Pre-Authorization Department

55513-0078-01	Imlygic 10^6 PFU/mL single-use vial NDC
55513-0079-01	Imlygic 10^8 PFU/mL single-use vial NDC

OpenPayer

Talimogene laherparepvec (Imlygic) prior authorization

Coverage Criteria for Imlygic (talimogene laherparepvec)

Coding and Billing

Provider Actions and Authorization Requirements

Background

Definitions

Line of Therapy