BlueCross BlueShield of Tennessee Medical Policy Manual

Talimogene Laherparepvec

NDC CODE(S)

55513-0078-XX Imlygic 1000000 UNIT/ML SUSP (AMGEN)

 

55513-0079-XX Imlygic 100000000 UNIT/ML SUSP (AMGEN)

DESCRIPTION

Talimogene laherparepvec is a live, attenuated herpes simplex virus-1 for intralesional injection.  It has been genetically modified to replicate within tumors and produce the immune stimulatory protein GM-CSF.  This causes lysis of tumors followed by release of tumor-derived antigens.  Together with the virally-derived GM-CSF, this may promote an antitumor immune response, but the exact mechanism of action is not known.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

 

Melanoma

Initial Treatment

·       Imlygic 106 (1 million) plaque-forming units (PFU)  per mL

·       Inject largest lesion(s) first

Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated

Second Treatment

·       Imlygic 108 (100 million) PFU per mL

·       3 weeks after initial treatment

·       Inject any new lesion(s) (lesions that have developed since initial treatment) first

Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated

All subsequent Treatments (including reinitiation)

·       Imlygic 108 (100 million) PFU per mL

·       2 weeks after previous treatment

·       Inject any new lesion(s) (lesions that have developed since previous treatment) first

Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated

  • Store and transport at −90°C to −70°C (−130°F to −94°F), thaw immediately prior to administration

  • Protect from light, store in the carton until use.

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

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of talimogene laherparepvec for the treatment or prevention of other conditions or diseases.

SOURCES

Lexicomp Online. (2017). AHFS DI. Talimogene laherparepvec. Retrieved July 12, 2017 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, June). Talimogene laherparepvec. Retrieved July 12, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Talimogene laherparepvec. Retrieved July 12, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2015, October). Center for Biologics Evaluation and Research. Imlygic® (talimogene laherparepvec) suspension for intralesional injection. Retrieved July 12, 2017 from https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM469575.pdf.

ORIGINAL EFFECTIVE DATE:  11/10/2015

MOST RECENT REVIEW DATE:  9/14/2017

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Talimogene Laherparepvec (Imlygic ®)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, go to question #6

  1. Is the individual ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Will administration of the agent be intralesionally?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the diagnosis melanoma with disease that is ANY ONE of the following?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the dosage request for the appropriate treatment stage, with maximum billable units as listed for an authorization period of 6 months with a possible renewal as listed below?

INDICATION(S)

DOSAGE & ADMINISTRATION

 

Melanoma

Initial Treatment

·       Imlygic 106 (1 million) plaque-forming units (PFU)  per mL

·       Inject largest lesion(s) first

Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated

Second Treatment

·       Imlygic 108 (100 million) PFU per mL

·       3 weeks after initial treatment

·       Inject any new lesion(s) (lesions that have developed since initial treatment) first

Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated

All subsequent Treatments (including reinitiation)

·       Imlygic 108 (100 million) PFU per mL

·       2 weeks after previous treatment

·       Inject any new lesion(s) (lesions that have developed since previous treatment) first

Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated

  • Store and transport at −90°C to −70°C (−130°F to −94°F), thaw immediately prior to administration

  • Protect from light, store in the carton until use.

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

 

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet all of the initial criteria in questions 2 through 5?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent, e.g., pain at the injection site, nausea, flu-like illness, fatigue, fever, shivering, cell-mediated immune reaction, HSV infection, impaired wound healing, necrosis, and plasmacytoma?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is tumor response evident with stabilization of disease or decrease in size of tumor or tumor spread?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there continued presence of injectable lesions for treatment?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.