Subject:
Imlygic (Talimogene Laherparepvec)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Imlygic (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF). Imlygic causes cell lysis, or death, which ruptures tumors, releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response.
The safety and efficacy of Imlygic were evaluated in a multicenter study of 436 participants with metastatic melanoma that could not be surgically removed. The participants’ melanoma lesions in the skin and lymph nodes were treated with Imlygic or a comparator therapy for at least six months, or until there were no remaining injectable lesions. The study showed that 16.3 percent of the study participants who received Imlygic experienced a decrease in size of their skin and lymph node lesions, lasting for a minimum of six months, compared to 2.1 percent of the study participants receiving the comparator therapy. However, Imlygic has not been shown to improve overall survival or to have an effect on melanoma that has spread to the brain, bone, liver, lungs, or other internal organs.
The most common side effects observed in clinical study participants were fatigue, chills, fever, nausea, flu-like symptoms and pain at the injection site. Because Imlygic is a modified live oncolytic herpes virus therapy, herpes virus infection can also occur. Therefore, Imlygic is contraindicated in immunocompromised patients, including those 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, due to the risk of life-threatening disseminated herpetic infection. It also should not be given to pregnant women.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
The requirements of the Horizon BCBSNJ Imlygic (Talimogene Laherparepvec) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
1. Imlygic (talimogene laherparepvec) is medically necessary for the treatment of melanoma in adults (18 years and older) that meet ALL of the following criteria:
a. Member has unresectable cutaneous, subcutaneous, or nodal lesions that are recurrent after initial surgery; AND
b. The member is not immunocompromised OR pregnant; AND
c. The prescriber is a specialist in the area of the patient’s diagnosis (e.g. oncologist) or has consulted with a specialist in the area of the patient’s diagnosis
[INFORMATIONAL NOTE: Imlygic is contraindicated in immunocompromised patients, including those 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, due to the risk of life-threatening disseminated herpetic infection.]
2. Imlygic (talimogene laherparepvec) is considered medically necessary for the following off label indications that have in effect a rating of 'Category 1' or 'Category 2A' in the current recommendations in the National Comprehensive Cancer Network (NCCN) compendium. Refer to National Comprehensive Cancer Network: Drugs and Biologics Compendium - talimogene laherparepvec. Available at: [https://www.nccn.org/professionals/drug_compendium/content/].
3. When Imlygic (talimogene laherparepvec) is medically necessary, therapy will be approved for 6 months based on FDA recommendations:
a. Administered by injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance.
b. The initial recommended dose is up to 4 mL at concentration a of 106 (1 million) PFU per mL.
c. For subsequent administrations up to 4 mL at a concentration of 108 (100 million) PFU per mL
d. The recommended dosing schedule is shown in Table 1
e. The recommended dosing volume is shown in Table 2
Table 1
Treatment | Treatment Interval | Maximum injection volume per treatment visit (all lesions combined) | Dose Strength | Prioritization of Lesions to be Injected |
Initial | - | 4 mL | 106 (1 million) 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 | 3 weeks after initial treatment | 4 mL | 108 (100 million) PFU per mL | · 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) | 2 weeks after previous treatment | 4mL | 108 (100 million) PFU per mL | · 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. |
Table 2
Lesion Size
(Longest dimension) | 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 1mL |
> 0.5 cm to 1.5 cm | Up to 0.5 mL |
< 0.5 cm | Up to 0.1mL |
[INFORMATIONAL NOTE: Imlygic treatment is to be continued for at least 6 months unless other treatment is required or until there are no injectable lesions to treat]
4. Continued therapy with Imlygic (talimogene laherparepvec) will be approved every 12 months based on treatment response, member continues to have injectable lesions to treat, and absence of intolerable toxicity
5. Imlygic (talimogene laherparepvec) for the treatment of other conditions/diseases is considered investigational.
Medicare Coverage
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon Policy.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Imlygic (Talimogene Laherparepvec)
Talimogene Laherparepvec (Imlygic)
References:
1. Imlygic® [package insert]. BioVex, Inc. Thousand Oaks, CA October 2019.
2. Andtbacka R, Kaufman H, Collichio F, et al. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377
3. FDA News Release: FDA approves first-of-its-kind product for the treatment of melanoma. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469571.htm
4. ClinicalTrials.gov accessed March 21,2019 at https://clinicaltrials.gov/ct2/results?term=Talimogene+laherparepvec&Search=Search
5. Amgen New Releases: FDA Approves Imlygic (talimogene laherparepvec) As First Oncolytic Viral Therapy in the US. Available at: https://www.amgen.com/media/news-releases/2015/10/fda-approves-imlygic-talimogene-laherparepvec-as-first-oncolytic-viral-therapy-in-the-us/
6. National Comprehensive Cancer Network: Drugs and Biologics Compendium. 2019. Available at https://www.nccn.org/professionals/drug_compendium/content/. [Accessed 3/21/2019]
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
J9325
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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