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Imlygic™ (talimogene laherparepvec) Intralesional
Policy Number: VP-0274
Intralesional
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
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
Coverage will be provided for 6 months and may be renewed.
- Dosing Limits
- 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
- 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
- Initial Approval Criteria1,2
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
- Renewal Criteria1,2
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.
- Dosage/Administration1
Indication |
Dose |
Cutaneous Melanoma |
Initial Treatment
|
Second Treatment
|
|
All subsequent treatments (including reinitiation)
|
|
The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined. It may not be possible to inject all lesions at each treatment visit or over the full course of treatment. Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits. |
Lesion size (longest dimension) |
Intralesional Injection Volume |
> 5 cm |
up to 4 mL |
> 2.5 cm to 5 cm |
up to 2 mL |
> 1.5 cm to 2.5 cm |
up to 1 mL |
> 0.5 cm to 1.5 cm |
up to 0.5 mL |
≤ 0.5 cm |
up to 0.1 mL |
- 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
- References
- Imlygic [package insert]. Thousand Oaks, CA; Amgen Inc.; February 2023. Accessed April 2024.
- 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.
- 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.
- 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
ICD-10 |
ICD-10 Description |
C43.0 |
Malignant melanoma of lip |
C43.111 |
Malignant melanoma of right upper eyelid, including canthus |
C43.112 |
Malignant melanoma of right lower eyelid, including canthus |
C43.121 |
Malignant melanoma of left upper eyelid, including canthus |
C43.122 |
Malignant melanoma of left lower eyelid, including canthus |
C43.20 |
Malignant melanoma of unspecified ear and external auricular canal |
C43.21 |
Malignant melanoma of right ear and external auricular canal |
C43.22 |
Malignant melanoma of left ear and external auricular canal |
C43.30 |
Malignant melanoma of unspecified part of face |
C43.31 |
Malignant melanoma of nose |
C43.39 |
Malignant melanoma of other parts of face |
C43.4 |
Malignant melanoma of scalp and neck |
C43.51 |
Malignant melanoma of anal skin |
C43.52 |
Malignant melanoma of skin of breast |
C43.59 |
Malignant melanoma of other part of trunk |
C43.60 |
Malignant melanoma of unspecified upper limb, including shoulder |
C43.61 |
Malignant melanoma of right upper limb, including shoulder |
C43.62 |
Malignant melanoma of left upper limb, including shoulder |
C43.70 |
Malignant melanoma of unspecified lower limb, including hip |
C43.71 |
Malignant melanoma of right lower limb, including hip |
C43.72 |
Malignant melanoma of left lower limb, including hip |
C43.8 |
Malignant melanoma of overlapping sites of skin |
C43.9 |
Malignant melanoma of skin, unspecified |
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
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |