Mekinist 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 Mekinist tablets once a day. Findings: The physician reviewer found that AVM is a rare, congenital vascular growth that progresses throughout life, causing complications that include bleeding, functional deficits, deformity, and high-output cardiac failure. Traditional management with embolization or surgical resection, with or without embolization, carries a high recurrence rate. Currently, there are no approved treatments by the U.S. Food and Drug Administration (FDA) for AVMs. Couto and colleagues have found that mitogen-activated protein kinase 1 (MAP2K1) somatic mutations have been implicated in the development of extracranial AVMs.

Nature of Statutory Criteria/Case Summary: The parent of a 12-year-old enrollee has requested Mekinist for treatment of the enrollee’s ependymoma. Findings: The physician reviewer found that patients with refractory or relapsed cancer that have exhausted standard treatments are usually considered for clinical trials. This may be particularly relevant for very rare cancers where even phase II studies may be not be effectively conducted due to poor accrual. Recently, it has become important to identify mutations that may be amenable to targeted therapy. A study of 86 patients was conducted by Von Hoff and colleagues. The authors reported progression-free survival on a regimen selected by molecular profiling was compared to progression free survival rate on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Mekinist. This patient has metastatic non-small cell lung cancer with EGFR deletion. In this case, there is a lack of clear evidence of acquired BRAF mutation which would confer resistance to standard EGFR treatment and potentially predict response to combination of osimertinib (Tagrisso) and trametinib (Mekinist). There is also a lack of clinical trial data supporting the use of combination of Tagrisso and Mekinist in this patient’s clinical setting. Finally, combination of Tagrisso and Mekinist is not supported in the recent guidelines as an option to treat metastatic non-small cell lung cancer.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Tafinlar and Mekinist for treatment of the enrollee’s adenocarcinoma of the mullerian origin. Findings: The physician reviewer found that there is a lack of support for the requested medication regimen in this clinical setting. Patients with refractory or relapsed cancer that have exhausted standard treatments are usually considered for clinical trials. This may be particularly relevant for very rare cancers where even phase II studies may be not be effectively conducted due to poor accrual. Recently, it has become important to identify mutations that may be amenable to targeted therapy. This patient’s tumor had mutational profiling which revealed a gain of function BRAF mutation, v600e, which has been described in melanoma, colon cancer, lung cancer, and hairy cell leukemia, among others.

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 Mekinist, then check the rights and deadlines that apply to your plan.