Medical Policy
Effective Date:01/01/2022 Title:Imlygic (talimogene laherparepvec)
Revision Date: Document:BI688:00
CPT Code(s):J9325
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Imlygic (talimogene) requires prior authorization.

2)    Imlygic is used to treat melanoma.

3)    Imlygic is a specialty medication covered under the medical benefit.
Medical Statement

Imlygic (talimogene laherparepvec) is considered medically necessary for members meeting the following criteria:

 

Melanoma

 

1)    Diagnosis of unresectable or limited resectable melanoma; AND

2)    Prescribed by or in consultation with an oncologist; AND

3)    Age > 18 years; AND

4)    Administered as a single agent; AND

5)    Documentation of the following (a and b);

a.    Lesions are cutaneous, subcutaneous, or nodal;

b.    Quantity and size of lesions;

6)    Request meets one of the following (a, b, or c):*

a.    For initial dose: Dose does not exceed 4mL of 106 plaque-forming units (PFU)/mL;

b.    For all subsequent doses (starting 3 weeks after initial dose): Dose does not exceed 4mL of 108 PFU/mL every 2 weeks;

c.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regiment must be FDA-approved or recommended by NCCN.

 

Initial Approval Duration: 6 months

 

Reauthorization (Duration: 12 months)

1)    Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Imlygic for a covered indication and has received this medication for at least 30 days;

2)    Member is responding positively to therapy;

3)    Documentation supports quantity and size 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 4mL of 108 PFU/mL every 2 weeks;

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.

 

Codes Used In This BI:

 

J9325 Injection, talimogene laherparepvec, per 1 million plaque forming units
Limits
Intentially left empty
Reference

1)    Imlygic Prescribing Information. Thousand Oaks, CA: Amgen; October 2019.

2)    NCCN Drugs and Biologics Compendium. Accessed online May 25, 2021.

3)    NCCN. Cutaneous Melanoma Version 02.2021. Accessed May 25, 2021.

 

Addendum:

Effective 01-01-2022: New Policy
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.