Talimogene laherepvec (Imlygic) Form

Talimogene laherepvec (Imlygic®) is genetically modified oncolytic viral therapy. FDA Approved Indication(s) Imlygic is indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitation(s) of use: Imlygic has not been shown to improve overall survival or have an effect on visceral metastases.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Imlygic is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Melanoma (must meet all):

1. Diagnosis of unresectable or limited resectable melanoma;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Administered as single agent;
   5. Documentation of the following (a and b): a. Lesions are cutaneous, subcutaneous, or nodal; b. Quantity and sizes of lesions;

2. Request meets one of the following (a, b, or c): a. For initial dose: Dose does not exceed 4 mL of 106 plaque-forming units (PFU)/mL (see Appendix D); b. For all subsequent doses (starting 3 weeks after initial dose): Dose does not exceed 4 mL of 108 PFU/mL every 2 weeks (see Appendix D); c. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN
   Approval duration: 6 months
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   CLINICAL POLICY Talimogene laherepvec B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Melanoma (must meet all):
5. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Imlygic for a covered indication and has received this medication for at least 30 days;
6. Member is responding positively to therapy;
   3. Documentation supports quantity and sizes of lesions that remain to be treated;
   4. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 4 mL of 108 PFU/mL every 2 weeks (see Appendix D); b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND Page 2 of 5

   CLINICAL POLICY Talimogene laherepvec criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration PFU: plaque-forming units NCCN: National Comprehensive Cancer Network Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): immunocompromised patients, pregnancy • Boxed warning(s): none Appendix D: Determination of Imlygic Injection Volume Based on Lesion Size Lesion Size (longest dimension)

   5 cm 2.5 cm to 5 cm 1.5 cm to 2.5 cm 0.5 cm to 1.5 cm ≤ 0.5 cm When lesions are clustered together, they should be injected together as a single lesion according to this table. Injection Volume up to 4 mL up to 2 mL up to 1 mL up to 0.5 mL up to 0.1 mL V. Dosage and Administration
   Indication Dosing Regimen Melanoma Recommended starting dose for injection into cutaneous, subcutaneous, and/or nodal lesions is up to 4 mL at a concentration of 106 (1 million) PFU per mL, followed by up to 4 mL of 108 (100 million) PFU/mL administered 3 weeks later; thereafter, subsequent doses of up to 4 mL of 108 PFU/mL are administered every 2 weeks Maximum Dose 4 mL at a concentration of 108 PFU/mL per treatment (all lesions combined) VI. Product Availability
   Single-use vials: 106 (1 million) PFU/mL, 108 (100 million) PFU/mL Page 3 of 5

   CLINICAL POLICY Talimogene laherepvec VII.