Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bipolar II Disorder.
Treatment: Vraylar 6MG OR CAPS.
The insurer denied the Vraylar 6MG OR CAPS.
The denial is overturned.

This case involves an adult male diagnosed with bipolar II disorder The patient has been prescribed Vraylar capsule (cariprazine) six milligrams daily to address the symptoms of the bipolar mood disorder and to achieve mood stabilization with better functioning. The health plan has denied coverage of Vraylar indicating that the requested medication is being prescribed for a non-approved use.


 Appeal: The patient's prescribing clinician indicates that Vraylar was started  with a favorable response, as the patient is "responding well."  The patient's prescribing clinician asserts that a change from Vraylar to another medication would result in decompensation with increased risk for hospitalization. Moreover, the prescribing clinician indicates that Vraylar was initially covered by the health plan, and that the health plan's pharmacy benefit manager, Caremark, is now denying continued coverage.

Reason for denial: The denial of coverage for Vraylar is on the basis of medical necessity indicating that the requested benefit of Vraylar in this case is for bipolar II disorder which is not an approved use of the drug.

Yes, the proposed and requested health service/treatment of Vraylar six milligrams capsule is medically necessary for this patient.
In this case scenario, the requested benefit of Vraylar is clinically indicated and appropriate in keeping with prevailing standards of medical practice and the scientific literature and published guidelines pertaining to the evaluation and treatment of bipolar disorders. Vraylar has a unique mechanism of action and is the best choice in this case scenario. Vraylar, titrated to a six milligram dose, has been providing reasonable clinical benefit and the patient is "responding well." Thus, medical necessity is met for the requested benefit of Vraylar at the current dose of six milligrams. The appeal reasonably argues and asserts that a change from Vraylar to another medication would result in decompensation with increased risk for hospitalization. Moreover, the prescribing clinician indicates that Vraylar was initially covered by the health plan, and that the health plan's pharmacy benefit manager, is now denying continued coverage. 

In this case, the use of Vraylar for the treatment of bipolar disorder is consistent with product labeling and prevailing standards of medical practice. The health plan's assertion is not valid in this case indicating that the use of Vraylar for bipolar II disorder is not approved; the health plan's assertion is not reasonable, as bipolar I disorder is essentially a less severe form of bipolar disorder, and, published treatment guidelines (referenced below) indicate that treatment for bipolar I and II disorder is essentially the same with regard to the use of medications and clinical management. Thus, the medical necessity for Vraylar in this case is supported by the scientific literature and guidelines, referenced below.

In this case, the use of Vraylar for the treatment of bipolar disorder is consistent with product labeling and prevailing standards of medical practice. The health plan's assertion is not valid in this case indicating that the use of Vraylar for bipolar II disorder is not approved; the health plan's assertion is not reasonable, as bipolar I disorder is essentially a less severe form of bipolar disorder, and, published treatment guidelines (referenced below) indicate that treatment for bipolar I and II disorder is essentially the same with regard to the use of medications and clinical management. Thus, the medical necessity for Vraylar in this case is supported by the scientific literature and guidelines, referenced below. 

The health plan's determination that the requested benefit of Vraylar is not medically necessary is not reasonable or in the best interest of the patient. The health plan's determination of medical necessity should be overturned.

This answer is consistent with the scientific literature and published guidelines, referenced below, and with prevailing standards of medical practice with respect to the treatment of the condition under review, and, consistent with New York State instruction for medical necessity reviews.