Last Review Date: 05/02/2024

Date of Origin: 04/26/2016

Dates Reviewed: 04/25/2017, 04/2018, 05/2019, 05/2020, 05/2021, 05/2022, 05/2023, 05/2024

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC unit]:

• Imlygic 10⁶ (1 million) PFU per mL single-use vial: 4 mL one time only
• Imlygic 10⁸ (100 million) PFU per mL single-use vial: 4 mL three weeks after initial treatment followed by 4 mL every two weeks thereafter

2. Max Units (per dose and over time) [HCPCS Unit]:

Initial treatment:                  4 billable units

Second treatment:                 400 billable units occurring 3 weeks after initial treatment

All subsequent treatments: 400 billable units occurring 2 weeks after previous treatment

3. Initial Approval Criteria^1,2

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria

• Patient is not pregnant (Note: Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment); AND
• Patient is not immunocompromised (i.e., patients with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy); AND
• Treatment will be administered via intralesional injection; AND

Cutaneous Melanoma † ‡ Ф

• Used for unresectable recurrent disease †; OR
• Used as primary treatment for unresectable or borderline resectable stage III disease with clinically positive node(s); OR  
• Used for oligometastatic disease with accessible lesions; OR
• Used for widely disseminated distant metastatic disease for symptomatic extracranial disease; OR
• Patient has limited resectable or unresectable/borderline resectable disease; AND

• Used for stage III disease with clinical satellite/in-transit metastases; OR
• Used for local satellite/in-transit recurrence

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria^1,2

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Patient continues to have injectable lesions; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: herpetic infection, injection site complications (e.g., necrosis, ulceration, cellulitis, systemic bacterial infection, etc.), immune-mediated events, plasmacytoma at injection site, obstructive airway disorder, etc.

5. Dosage/Administration¹

6. Billing Code/Availability Information

HCPCS Code:

• J9325 – Injection, talimogene laherparepvec, per 1 million plaque forming units; 1 billable unit = 10⁶ (1 million) PFU

NDC(s):

• Imlygic 10⁶ (1 million) PFU per mL single-use vial: 55513-0078-xx
• Imlygic 10⁸ (100 million) PFU per mL single-use vial: 55513-0079-xx

7. References

1. Imlygic [package insert]. Thousand Oaks, CA; Amgen Inc.; February 2023. Accessed April 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for talimogene laherparepvec. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2024.
3. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33:2780-2788.
4. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33 (suppl Clinical Study Protocol):doi:10.1200/JCO.2014.58.3377.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): N/A