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089

Indications

(1) Individual is ≥ 18 years of age; AND 2. Has a diagnosis of unresectable or stage IV metastatic melanoma; AND 3. Must have progressive disease following at least one prior systemic therapy from the following categories: a. PD-1/PDL-1 blocking antibody; OR b. If BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor in combination with a MEK inhibitor; AND 4. Individual has an ECOG PS of 0 or 1; AND 5. Individual at least one partially resectable lesion or aggregate of lesions of a minimum 1.5 cm in diameter post-resection to generate tumor-infiltrating lymphocyte (TIL); AND 6. Has not previously received tumor-derived autologous T cell immunotherapy (including lifileucel) and is not being considered for treatment with any other adoptive cellular immunotherapy; AND 7. Does not have any of the following: a. Absolute neutrophil count (ANC) ≤1,000/mm3; OR b. Hemoglobin < 9.0 g/dL; OR c. Platelets ≤ 100,000/mm3; OR 2 d. Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 times the upper limit of normal (ULN); OR e. Creatinine clearance < 40mL/min; OR f. Left ventricular ejection fraction (LVEF) < 45% or NYHA functional classification > Class 1; OR g. Has a forced expiratory volume in one second (FEV1) of ≤ 60% of predicted; OR h. Symptomatic and/or untreated brain metastases; OR i. Primary melanoma was of ocular/uveal origin; OR j. History of another primary malignancy that has not been in remission for at least 3 years prior to consideration of Amtagvi; OR k. Has a clinically significant active infection (e.g. requiring IV or long-term oral antimicrobial therapy); OR l. Has a primary immunodeficiency, or is on immunosuppressive medications (including but not limited to organ transplant) including systemic steroids; OR m. Will be pregnant or breastfeeding a child at the time of Amtagvi treatment; AND 8. Treatment is being administered at a certified TIL treatment center. NOTE: Lifileucel (Amtagvi) has a BOXED WARNING: TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT. See full prescribing information for complete Boxed Warning. The safety and effectiveness of repeat administration of Lifileucel (Amtagvi) has not been evaluated. Repeat treatment of Lifileucel (Amtagvi) is considered INVESTIGATIONAL. Therefore, coverage will be limited to once per lifetime. Lifileucel (Amtagvi) is considered INVESTIGATIONAL when the above criteria are not met. Lifileucel (Amtagvi) is considered INVESTIGATIONAL for all other indications. Policy Guidelines Recommended Dose: A single dose of 7.5 x 109 to 72 x 109 viable cells Dosing Limits: 1 injection per lifetime Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient. Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient. Outpatient Commercial Managed Care (HMO and POS) This is not a covered service in the outpatient setting. This procedure is performed only in the inpatient setting. Commercial PPO and Indemnity This is not a covered service in the outpatient setting. This procedure is performed only in the inpatient setting. Medicare HMO BlueSM This is not a covered service in the outpatient setting. This procedure is performed only in the inpatient setting. Medicare PPO BlueSM This is not a covered service in the outpatient setting. This procedure is performed only in the inpatient setting. 3 Requesting Prior Authorization Using Authorization Manager Providers will need to use Authorization Manager to submit initial authorization requests for services. Authorization Manager, available 24/7, is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter. For commercial members, the requests must meet medical policy guidelines. To ensure the request is processed accurately and quickly: • Enter the facility’s NPI or provider ID for where services are being performed. • Enter the appropriate surgeon’s NPI or provider ID as the servicing provider, not the billing group. Authorization Manager Resources • Refer to our Authorization Manager page for tips, guides, and video demonstrations. For out of network providers: Requests should still be faxed to 888-973-0726. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: HCPCS Codes HCPCS codes Code Description C9399 Unclassified drugs or biologicals J3490 Unclassified drugs J3590 Unclassified biologics ICD-10 Procedure Codes ICD-10 PCS Procedure Codes Code Description XW033L7 Introduction of Lifileucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7 XW043L7 Introduction of Lifileucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7 Description Melanoma Malignant melanoma is a common skin cancer that occurs due to the uncontrolled growth of the melanin cells (melanocytes) within the upper layer of the skin (epidermis) or from similar cells that may be found in moles (nevi). Melanoma is less common than other skin cancers such as basal cell carcinoma and squamous cell carcinoma. However, melanomas have high metastatic potential and utilize the host microenvironment to promote tumor growth and spread to other organs. Of note, melanoma cells are highly immunogenic, yet they manage to evade host immune surveillance, contributing to unrestricted tumor development. According to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute, the rates of melanoma have been increasing over the past few decades. Melanoma is the fifth most common type of cancer, representing 5.6% of all new cancer cases in the United States. 4 Melanoma is more common in males overall, but the rates are higher in females among people under 50 years of age, and the risk of developing melanoma increases with age (the average age at diagnosis is 65 years). Additionally, the condition is over 20 times more common in White people than in Black people. Individuals with darker pigmented skin may have a lower risk of malignant melanoma, and individuals with blue eyes and lighter pigmented skin have a higher risk of developing the condition. The exact cause of malignant melanoma is unknown. However, excessive exposure to the sun, particularly before puberty, and living at higher elevation increases the risk of developing skin cancer. In the early stages, melanomas may not have specific symptoms, but in the later stages, they may appear as lesions that do not heal properly or a mole (nevus) that changes in size, color, or shape. Although most melanomas are detected at an early stage, a proportion of patients have metastatic disease at the time of diagnosis or develop metastasis at a later stage. The most common sites of metastasis include skin and subcutaneous tissue, followed by the lungs, liver, bones, and brain. About one-half of all melanomas have mutations in the BRAF gene; melanoma cells with these mutations make an altered BRAF protein that helps them grow. The MEK (mitogen-activated protein kinase kinase) and BRAF proteins work together, so drugs that inhibit MEK can be used to treat melanomas with BRAF mutations. Advanced Melanoma Advanced melanoma encompasses tumors that cannot be surgically treated and those that have metastasized. Current primary treatment options include immunotherapy using immune checkpoint inhibitors (specifically anti-programmed cell death protein 1/programmed cell death ligand 1 [PD-1/PD-L1] agents) or targeted therapy involving BRAF/MEK inhibitors, particularly if the melanoma carries a BRAF V600 mutation. Immunotherapies have shown an initial response rate of around 40%–45%, with a 10% relapse rate among those who initially respond. On the other hand, BRAF/MEK inhibitors are effective in significantly reducing tumor size for most patients but have a higher relapse rate due to the development of resistance. For patients who do not respond to or experience a relapse after receiving immunotherapy or targeted therapy, alternative immunotherapies or targeted therapies with different mechanisms of action can be considered. In cases of continued disease progression, chemotherapy is an option, but its efficacy is limited, with response rates reported at only 4% to 12% and a relatively short median overall survival rate of 7 months. Currently, there are no approved treatments for patients with metastatic melanoma whose condition worsens while on or after treatment with immune checkpoint inhibitors and BRAF/MEK inhibitors, assuming they have a BRAF V600 mutation. Summary of Evidence The efficacy and safety of a single treatment with Amtagvi was assessed in the C-144-01 trial (NCT02360579), which included patients with unresectable or metastatic melanoma who had previously received one or more systemic therapies, including anti-PD-1/PD-L1 and a BRAF inhibitor with or without a MEK inhibitor for those with a BRAF V600 mutation. The trial included a total of 153 patients who were treated with Amtagvi (full analysis set [FAS]); of those patients, 111 underwent tumor resection, of whom 22 (19.8%) patients did not receive Amtagvi due to the following reasons: inability to manufacture Amtagvi (n = 6), disease related death (n = 3), meeting exclusion criteria (n = 5), disease progression (n = 3), starting new anti-cancer therapy or consent withdrawal (n = 3), or adverse events (AEs) from lymphodepletion including one death (n = 2). Among 89 patients who underwent tumor resection and received Amtagvi, two patients were excluded because the product did not meet specification and five patients were excluded due to product comparability. The primary efficacy analysis set included 82 patients who received Amtagvi. Among these, nine patients received Amtagvi at a dose less than 7.5 × 109 viable cells and did not achieve an objective response. The recommended Amtagvi dosing range was set at 7.5 × 109 to 72 × 109 viable cells (73 patients received this dosing range). The median time from tumor tissue procurement to the end of the manufacturing process was 23 days and to infusion was 34 days. Lesion origin of Amtagvi products included most commonly skin, lymph nodes, liver, lung, peritoneal, musculoskeletal, breast, and less 5 often other anatomic sites including chest wall, abdominal wall, adrenal gland, abdominal-peritoneal, paraesophageal, axillary, thigh, back, supraclavicular, and soft tissue. All 73 (100%) patients who underwent tumor resection and received the recommended dose of Amtagvi received prior anti-PD-(L)1 therapy, 63 (86.3%) received prior anti-CTLA-4 therapy, 42 (57.5%) received anti-PD1/anti-CTLA-4 combination therapy and 20 (27.4%) received a BRAF inhibitor or combination therapy with BRAF and MEK inhibitors. Results In the C-144-01 study, the median time to initial response to Amtagvi was 1.5 months (min, max: 1.3, 4.2). Among the primary efficacy analysis set of 73 patients in Cohort 4 who received Amtagvi at the recommended dose, the objective response rate (ORR) was 31.5% and the median duration of response (DOR) was not reached at 18.6 months follow-up. Among a pooled efficacy set of 153 patients from Cohorts 2 and 4 who received the recommended Amtagvi dose, the ORR was 31.4% and the median DOR was not reached at 21.5 months follow-up. Efficacy Summary Table Endpoint Efficacy Set (N=73) Objective Response Rate ORR, % (95% CI) 31.5 (21.1, 43.4) Complete response rate, n (% 3 (4.1) Partial response rate, n (%) 20 (27.4) Duration of Response Median DOR in months (95% CI) NR (4.1, NR) Range (1.4+, 26.3+) Patients with DOR ≥6 months, n (%) 13 (56.5) Patients with DOR ≥9 months, n (%) 11 (47.8) Patients with DOR ≥12 months, n (%) 10 (43.5) Sources: Amtagvi Prescribing Information; NCT02360579; J Immunother Cancer, 2022 Policy History Date Action 8/2024 New medical policy describing medically necessary and investigational indications. Policy created with evidence review. Effective 8/1/2024. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References 1. Amtagvi Prescribing Information. Accessed, 6/2024 2. American Cancer Society. Key statistics for melanoma skin cancer. January 17, 2024. Accessed February 20, 2024. https://www.cancer.org/cancer/types/melanoma-skin-cancer/about/key- statistics.html 3. American Cancer Society. What is melanoma skin cancer? October 27, 2023. Accessed February? 

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Medical Policy Adoptive Cell Therapies for Melanoma Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 089 BCBSA Reference Number: N/A NCD/LCD: N/A Related Policies
Prior Authorization Request Form for Lifileucel (Amtagvi), #096 Adoptive Immunotherapy, #455

Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Lifileucel (Amtagvi®)

Lifileucel (Amtagvi) may be considered MEDICALLY NECESSARY and may be covered for individuals with unresectable or metastatic melanoma when ALL the following criteria are met:

  1. Individual is ≥ 18 years of age; AND
  2. Has a diagnosis of unresectable or stage IV metastatic melanoma; AND
  3. Must have progressive disease following at least one prior systemic therapy from the following categories: a. PD-1/PDL-1 blocking antibody; OR b. If BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor in combination with a MEK inhibitor; AND
  4. Individual has an ECOG PS of 0 or 1; AND
  5. Individual at least one partially resectable lesion or aggregate of lesions of a minimum 1.5 cm in diameter post-resection to generate tumor-infiltrating lymphocyte (TIL); AND
  6. Has not previously received tumor-derived autologous T cell immunotherapy (including lifileucel) and is not being considered for treatment with any other adoptive cellular immunotherapy; AND
  7. Does not have any of the following: a. Absolute neutrophil count (ANC) ≤1,000/mm3; OR b. Hemoglobin < 9.0 g/dL; OR c. Platelets ≤ 100,000/mm3; OR

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d. Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 times the upper limit of normal (ULN); OR e. Creatinine clearance < 40mL/min; OR f. Left ventricular ejection fraction (LVEF) < 45% or NYHA functional classification > Class 1; OR g. Has a forced expiratory volume in one second (FEV1) of ≤ 60% of predicted; OR h. Symptomatic and/or untreated brain metastases; OR i. Primary melanoma was of ocular/uveal origin; OR j. History of another primary malignancy that has not been in remission for at least 3 years prior to consideration of Amtagvi; OR k. Has a clinically significant active infection (e.g. requiring IV or long-term oral antimicrobial therapy); OR l. Has a primary immunodeficiency, or is on immunosuppressive medications (including but not limited to organ transplant) including systemic steroids; OR m. Will be pregnant or breastfeeding a child at the time of Amtagvi treatment;
AND

  1. Treatment is being administered at a certified TIL treatment center.

    NOTE: Lifileucel (Amtagvi) has a BOXED WARNING: TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT. See full prescribing information for complete Boxed Warning.

    The safety and effectiveness of repeat administration of Lifileucel (Amtagvi) has not been evaluated. Repeat treatment of Lifileucel (Amtagvi) is considered INVESTIGATIONAL. Therefore, coverage will be limited to once per lifetime.

    Lifileucel (Amtagvi) is considered INVESTIGATIONAL when the above criteria are not met.

    Lifileucel (Amtagvi) is considered INVESTIGATIONAL for all other indications.

    Policy Guidelines

    Recommended Dose: A single dose of 7.5 x 109 to 72 x 109 viable cells

    Dosing Limits: 1 injection per lifetime

    Prior Authorization Information
    Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
    Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

    Outpatient Commercial Managed Care (HMO and POS) This is not a covered service in the outpatient setting. This procedure is performed only in the inpatient setting. Commercial PPO and Indemnity This is not a covered service in the outpatient setting. This procedure is performed only in the inpatient setting. Medicare HMO BlueSM This is not a covered service in the outpatient setting. This procedure is performed only in the inpatient setting. Medicare PPO BlueSM This is not a covered service in the outpatient setting. This procedure is performed only in the inpatient setting.

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Requesting Prior Authorization Using Authorization Manager Providers will need to use Authorization Manager to submit initial authorization requests for services. Authorization Manager, available 24/7, is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter. For commercial members, the requests must meet medical policy guidelines.

To ensure the request is processed accurately and quickly: • Enter the facility’s NPI or provider ID for where services are being performed. • Enter the appropriate surgeon’s NPI or provider ID as the servicing provider, not the billing group.

Authorization Manager Resources • Refer to our Authorization Manager page for tips, guides, and video demonstrations.

For out of network providers: Requests should still be faxed to 888-973-0726. CPT Codes / HCPCS Codes / ICD Codes
Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

HCPCS Codes HCPCS codes

Code Description C9399 Unclassified drugs or biologicals J3490 Unclassified drugs J3590 Unclassified biologics

ICD-10 Procedure Codes ICD-10 PCS Procedure Codes Code Description XW033L7 Introduction of Lifileucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7 XW043L7 Introduction of Lifileucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7

Description
Melanoma
Malignant melanoma is a common skin cancer that occurs due to the uncontrolled growth of the melanin cells (melanocytes) within the upper layer of the skin (epidermis) or from similar cells that may be found in moles (nevi). Melanoma is less common than other skin cancers such as basal cell carcinoma and squamous cell carcinoma. However, melanomas have high metastatic potential and utilize the host microenvironment to promote tumor growth and spread to other organs. Of note, melanoma cells are highly immunogenic, yet they manage to evade host immune surveillance, contributing to unrestricted tumor development. According to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute, the rates of melanoma have been increasing over the past few decades. Melanoma is the fifth most common type of cancer, representing 5.6% of all new cancer cases in the United States.

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Melanoma is more common in males overall, but the rates are higher in females among people under 50 years of age, and the risk of developing melanoma increases with age (the average age at diagnosis is 65 years). Additionally, the condition is over 20 times more common in White people than in Black people. Individuals with darker pigmented skin may have a lower risk of malignant melanoma, and individuals with blue eyes and lighter pigmented skin have a higher risk of developing the condition. The exact cause of malignant melanoma is unknown. However, excessive exposure to the sun, particularly before puberty, and living at higher elevation increases the risk of developing skin cancer.

In the early stages, melanomas may not have specific symptoms, but in the later stages, they may appear as lesions that do not heal properly or a mole (nevus) that changes in size, color, or shape. Although most melanomas are detected at an early stage, a proportion of patients have metastatic disease at the time of diagnosis or develop metastasis at a later stage. The most common sites of metastasis include skin and subcutaneous tissue, followed by the lungs, liver, bones, and brain.
About one-half of all melanomas have mutations in the BRAF gene; melanoma cells with these mutations make an altered BRAF protein that helps them grow. The MEK (mitogen-activated protein kinase kinase) and BRAF proteins work together, so drugs that inhibit MEK can be used to treat melanomas with BRAF mutations.

Advanced Melanoma
Advanced melanoma encompasses tumors that cannot be surgically treated and those that have metastasized. Current primary treatment options include immunotherapy using immune checkpoint inhibitors (specifically anti-programmed cell death protein 1/programmed cell death ligand 1 [PD-1/PD-L1] agents) or targeted therapy involving BRAF/MEK inhibitors, particularly if the melanoma carries a BRAF V600 mutation. Immunotherapies have shown an initial response rate of around 40%–45%, with a 10% relapse rate among those who initially respond. On the other hand, BRAF/MEK inhibitors are effective in significantly reducing tumor size for most patients but have a higher relapse rate due to the development of resistance.

For patients who do not respond to or experience a relapse after receiving immunotherapy or targeted therapy, alternative immunotherapies or targeted therapies with different mechanisms of action can be considered. In cases of continued disease progression, chemotherapy is an option, but its efficacy is limited, with response rates reported at only 4% to 12% and a relatively short median overall survival rate of 7 months. Currently, there are no approved treatments for patients with metastatic melanoma whose condition worsens while on or after treatment with immune checkpoint inhibitors and BRAF/MEK inhibitors, assuming they have a BRAF V600 mutation.

Summary of Evidence The efficacy and safety of a single treatment with Amtagvi was assessed in the C-144-01 trial (NCT02360579), which included patients with unresectable or metastatic melanoma who had previously received one or more systemic therapies, including anti-PD-1/PD-L1 and a BRAF inhibitor with or without a MEK inhibitor for those with a BRAF V600 mutation. The trial included a total of 153 patients who were treated with Amtagvi (full analysis set [FAS]); of those patients, 111 underwent tumor resection, of whom 22 (19.8%) patients did not receive Amtagvi due to the following reasons: inability to manufacture Amtagvi (n = 6), disease related death (n = 3), meeting exclusion criteria (n = 5), disease progression (n = 3), starting new anti-cancer therapy or consent withdrawal (n = 3), or adverse events (AEs) from lymphodepletion including one death (n = 2). Among 89 patients who underwent tumor resection and received Amtagvi, two patients were excluded because the product did not meet specification and five patients were excluded due to product comparability.

The primary efficacy analysis set included 82 patients who received Amtagvi. Among these, nine patients received Amtagvi at a dose less than 7.5 × 109 viable cells and did not achieve an objective response. The recommended Amtagvi dosing range was set at 7.5 × 109 to 72 × 109 viable cells (73 patients received this dosing range). The median time from tumor tissue procurement to the end of the manufacturing process was 23 days and to infusion was 34 days. Lesion origin of Amtagvi products included most commonly skin, lymph nodes, liver, lung, peritoneal, musculoskeletal, breast, and less

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often other anatomic sites including chest wall, abdominal wall, adrenal gland, abdominal-peritoneal, paraesophageal, axillary, thigh, back, supraclavicular, and soft tissue.

All 73 (100%) patients who underwent tumor resection and received the recommended dose of Amtagvi received prior anti-PD-(L)1 therapy, 63 (86.3%) received prior anti-CTLA-4 therapy, 42 (57.5%) received anti-PD1/anti-CTLA-4 combination therapy and 20 (27.4%) received a BRAF inhibitor or combination therapy with BRAF and MEK inhibitors.

Results In the C-144-01 study, the median time to initial response to Amtagvi was 1.5 months (min, max: 1.3, 4.2). Among the primary efficacy analysis set of 73 patients in Cohort 4 who received Amtagvi at the recommended dose, the objective response rate (ORR) was 31.5% and the median duration of response (DOR) was not reached at 18.6 months follow-up. Among a pooled efficacy set of 153 patients from Cohorts 2 and 4 who received the recommended Amtagvi dose, the ORR was 31.4% and the median DOR was not reached at 21.5 months follow-up.

Efficacy Summary Table Endpoint Efficacy Set (N=73) Objective Response Rate ORR, % (95% CI) 31.5 (21.1, 43.4) Complete response rate, n (% 3 (4.1) Partial response rate, n (%) 20 (27.4) Duration of Response Median DOR in months (95% CI) NR (4.1, NR) Range (1.4+, 26.3+) Patients with DOR ≥6 months, n (%) 13 (56.5) Patients with DOR ≥9 months, n (%) 11 (47.8) Patients with DOR ≥12 months, n (%) 10 (43.5) Sources: Amtagvi Prescribing Information; NCT02360579; J Immunother Cancer, 2022

Policy History Date Action 8/2024 New medical policy describing medically necessary and investigational indications.
Policy created with evidence review. Effective 8/1/2024.
Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References

  1. Amtagvi Prescribing Information. Accessed, 6/2024
  2. American Cancer Society. Key statistics for melanoma skin cancer. January 17, 2024. Accessed February 20, 2024. https://www.cancer.org/cancer/types/melanoma-skin-cancer/about/key- statistics.html
  3. American Cancer Society. What is melanoma skin cancer? October 27, 2023. Accessed February 20, 2024. https://www.cancer.org/cancer/types/melanoma-skin-cancer/about/what-is-melanoma.html
  4. Chesney J, et al. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. J Immunother Cancer. 2022;10(12):e005755. doi:10.1136/jitc-2022-005755

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  1. Replimune shares initial primary analysis results from CERPASS clinical trial in advanced cutaneous squamous cell carcinoma and presents new data from IGNYTE clinical trial of RP1 in anti-PD1 failed melanoma and non-melanoma skin cancers. News release. Replimune Group, Inc. December 5,
  2. Accessed February 27, 2024. https://ir.replimune.com/news-releases/news-release- details/replimune-shares-initial-primary-analysis-results-cerpass
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