CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Imlygic (talimogene laherparepvec) coverage

Defines clinical indications, exclusion criteria, coding, and utilization management approval authority for Imlygic requests submitted to the payer; applies to providers submitting medication requests for members covered by Neighborhood Health Plan of Rhode Island via Evolent UM processes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImlygic (talimogene laherparepvec) coverage

Policy CodePolicy N/A

Change TypeMinor / administrative (no material clinical changes)

Effective Date01/31/2025

Next Review DateN/A

Key ActionSubmit prior authorization; continuation requests are exempt only if no progression, prior use within the last year without >30-day lapse, and no added medications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4max dose mL

J9325HCPCS

01/08/25committee approval

01/31/25effective

Coverage Criteria for Imlygic (talimogene laherparepvec)

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inv-01: Initial and Neoadjuvant Therapy

Covered when ALL of the following are met

Melanoma - single agent intralesional: Member has unresectable cutaneous, subcutaneous, or nodal melanoma lesions, or is receiving neoadjuvant (preoperative) therapy for resectable stage IIIB-IVM1a melanoma

Imlygic used as single-agent intralesional therapy

Evidence support: Use is supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

See Purpose and references

inv-02: Continuation Therapy

Continuation requests exempt when ALL of the following are met

No progression: Member has not experienced disease progression on the requested medication

Continuation criterion

Recent authorized use: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization

Continuation criterion

No added medications: Additional medication(s) are not being added to the continuation request

Continuation criterion

The policy excludes use of Imlygic when there is disease progression while on talimogene laherparepvec, when the target lesions are visceral or otherwise not amenable to intralesional injection (for example, lesions that are not visible and palpable), or when Imlygic is administered concurrently with checkpoint inhibitors such as ipilimumab, nivolumab, or pembrolizumab. The policy also sets a procedural limit of 4 mL maximum volume per intralesional injection. These exclusion criteria are grounds for denial of requests when documented in the clinical record.

Investigational or off‑label uses are excluded unless supported by sufficient evidence. The policy defines sufficient evidence as being supported by FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature that adequately represents the patient population and regimen, demonstrates clinically meaningful outcomes (for example hazard ratios and survival benefits consistent with ASCO guidance), and is derived from appropriately designed studies. Case reports and meeting abstracts without a full peer‑reviewed article are explicitly noted as generally insufficient to establish coverage.

Requests for Imlygic that propose investigational or off‑label indications will be denied unless the indication is supported by recognized evidence sources (FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS manual standards). The policy specifies that evidence must adequately represent the clinical characteristics of the patient and regimen, report clinically meaningful outcomes, and be derived from suitably designed studies; uncontrolled case reports and abstracts without full peer‑reviewed publication are not adequate to establish medical necessity.

Initial Therapy Criteria

inv-12: Initial therapy criteria

Initial coverage when supported by recognized evidence sources

Indication: Used as single-agent intralesional therapy for unresectable cutaneous, subcutaneous, or nodal melanoma or as neoadjuvant therapy for resectable stage IIIB-IVM1a melanoma

See Indications section

Evidence requirement: Supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

See Purpose

Continuation Criteria

inv-13: Continuation criteria

Continuation requests are eligible for exemption from new authorization when the following ALL apply

No disease progression: Member has not experienced disease progression on Imlygic

Continuation requirement

Recent authorization without lapse: Imlygic was used within the last year without a lapse greater than 30 days of active authorization

Continuation requirement

No additional meds: No additional medications are being added to the continuation request

Continuation requirement

Coding

Covered HCPCS CodeHCPCSCovered

J9325

Injection, talimogene laherparepvec, per 1 million plaque forming units

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Continuation requests are exempt from new policy review only if all continuation criteria are met (no disease progression on the requested medication; medication used within the last year without a lapse >30 days of active authorization; no additional medications being added to the continuation request).

Continuation exemption criteria: member has not experienced disease progression on the requested medication; requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; additional medication(s) are not being added to the continuation request.

Documentation Required

Evidence and Continuation Documentation

Use must be supported by one or more of the following: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards (see CMS Medicare Benefit Policy Manual Chapter 15). For continuation requests, documentation must also demonstrate the member has not had disease progression while on Imlygic and that prior authorization continuity criteria are met.

Acceptable evidence sources: FDA labeling; CMS-recognized compendia; NCCN/ASCO guidelines; acceptable peer-reviewed literature meeting CMS requirements.
Continuation documentation: evidence of prior authorization within last year without >30 day lapse; clinical documentation showing no disease progression on Imlygic.

Denial Risk

Combination Therapy Restriction

Combination use with ipilimumab (Yervoy) or other checkpoint inhibitors is not supported. Policy disallows concurrent use with checkpoint inhibitors (e.g., ipilimumab, nivolumab, pembrolizumab) due to lack of Level 1 evidence demonstrating superior outcomes.

Imlygic in combination with Yervoy (ipilimumab) is not supported due to lack of randomized clinical trial / meta-analysis evidence.
Concurrent use with checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab) is an exclusion and may trigger denial.

Denial Risk

Denial Triggers and Exclusions

Requests may be denied for the following reasons: disease progression while on Imlygic; use for visceral lesions or absence of visible/palpable injectable lesions; concurrent use with checkpoint inhibitors; investigational/off-label uses lacking sufficient evidence; exceeding maximum intralesional dose volume of 4 mL per injection.

Denial triggers: disease progression on Imlygic; visceral lesions or lack of injectable visible/palpable lesions; concurrent checkpoint inhibitor therapy; investigational/off-label indications without adequate evidence; dose volume >4 mL per injection.

Site of Care / Administration

Note

Intralesional injections only — not for visceral or non‑injectable lesions

Imlygic is only authorized as intralesional injections for visible and palpable cutaneous, subcutaneous, or nodal lesions; it is not authorized for visceral (non-injectable) lesions or lesions that are not visible and palpable.

Site of care: office or infusion center for intralesional injection only.
Do not submit requests for visceral lesions or non‑visible/non‑palpable lesions.

Quantity Limits

Imlygic (talimogene laherparepvec) — maximum dose volume

Maximum dose volume per intralesional injection4 mL per intralesional injection

Quantity limit scopeLimit applies per intralesional injection (per course documentation reflects limit of 4 mL)

Exclusion if exceededRequests exceeding 4 mL per injection may be denied as outside policy maximum dose volume

Definitions

Imlygic use for unresectable cutaneous, subcutaneous, and nodal melanoma lesions — Intralesional single‑agent use

Indication (single‑agent intralesional)Used as a single agent intralesional injection for unresectable cutaneous, subcutaneous, and nodal melanoma lesions

Neoadjuvant useMay be used as single‑agent neoadjuvant (preoperative) therapy for resectable stage IIIB‑IVM1a melanoma

Combination use restrictionNot supported in combination with ipilimumab (Yervoy) per policy due to lack of Level 1 evidence

Step Therapy / Restrictions

Restriction	Details
Combination with checkpoint inhibitors (example: ipilimumab [Yervoy])	Imlygic (talimogene laherparepvec) in combination with Yervoy (ipilimumab) is not supported by this policy due to lack of Level 1 evidence demonstrating superior outcomes compared with Evolent-recommended alternatives.

Background

Talimogene laherparepvec (Imlygic) is an intralesional oncolytic viral therapy indicated for treatment of certain cutaneous, subcutaneous, and nodal melanoma lesions. The policy emphasizes intralesional single‑agent use and permits neoadjuvant (preoperative) therapy for select resectable stage IIIB–IVM1a disease when supported by the listed evidence sources. Administration is limited to visible, palpable, injectable lesions in the outpatient setting (office or infusion center), with a maximum of 4 mL per intralesional injection.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImlygic (talimogene laherparepvec) coverage

Policy CodePolicy N/A

Change TypeMinor / administrative (no material clinical changes)

Effective Date01/31/2025

Next Review DateN/A

Key ActionSubmit prior authorization; continuation requests are exempt only if no progression, prior use within the last year without >30-day lapse, and no added medications.

SourceLink

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