Metastatic Melanoma denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for cell therapy in the expanded access treatment protocol titled “IOV-EAP401 An Expanded Access Program of Lifileucel, Autologous Tumor Infiltrating Lymphocytes (TIL; Ln-144)”.For patients with metastatic melanoma whose cancer progresses while on immune checkpoint inhibitors, effective treatment options are limited, and novel therapies should be considered. In a randomized trial, patients with advanced unresectable or metastatic cutaneous melanoma who were treated with personalized adoptive cell therapy with tumor-infiltrating lymphocytes showed improved progression-free survival over patients who were treated with single-agent ipilimumab.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for (1) transfer of inpatient hospital level of care services to a tertiary level of care hospital and/or (2) delivery of immunotherapy at the inpatient level of care. In this case, the patient presented with acute intracranial hemorrhage and underwent craniotomy. His neurosurgeon states that further surgery is not indicated, and the patient is awaiting placement in a skilled nursing facility. The patient appears to have significant neurological deficits, possibly due to intracranial hemorrhage, vasogenic edema, and metastatic tumors. The next question is whether the patient is a candidate for further therapy of the metastatic tumors which may include whole brain radiation therapy and systemic agents against melanoma.

Where the denial was upheld

Physician 1:The patient is a 51-year-old woman with a history of melanoma presenting in 2003 as a pulmonary mass, which was resected. No primary site was found. She received brief adjuvant alpha interferon, which was discontinued for poor tolerance. She suffered an isolated brain recurrence, which was resected in May 2004. She received post-operative whole brain irradiation and is currently without evidence of disease and in good clinical condition. The patient’s provider has recommended the patient undergo immune treatment on a Phase II clinical trial. The Health Plan has denied authorization for this treatment on the basis that it is considered investigational.Metastatic melanoma lacks good therapy. To date, chemotherapy, alpha interferon, and IL-2 have offered benefit to a minority of patients.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for FoundationOne testing for evaluation of the enrollee’s metastatic melanoma. Findings: Two of the three physician reviewers found that FoundationOne is a molecular assay that explores the mutations of an individual’s cancer cells. The hope is that the assay will identify a specific mutation or target, which could inform the provider as to which chemotherapeutic drug would be useful. However, there is a lack of convincing evidence that the assay adds to the decision making ability or yields a result that is reliably clinically beneficial. There are a variety of non-randomized studies exploring the value of molecular provider. One study noted this ongoing research as well as the serious limitations of such studies.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving metastatic melanoma, then check the rights and deadlines that apply to your plan.