Appeal type: Step Therapy
Decision: Overturned

Diagnosis:  Central Nervous System/Neuromuscular Disorder. 
Treatment:  Pharmacy/Prescription Drugs. 

The insurer denied Ingrezza.  The denial is overturned in whole.

The patient is a female with a history of major depressive disorder, moderately severe and recurrent; generalized anxiety disorder; akathisia-resolved; and tardive dyskinesia (TD).  The patient has a history of past exposure to antipsychotic medication and is diagnosed with tardive dyskinesia.  The patient is prescribed Ingrezza (valbenazine) titrated as clinically appropriate. 

The health plan denied coverage for the requested Ingrezza with recommendation of a formulary alternative, tetrabenazine (Xenazine). 

The requested health service of Ingrezza is medically necessary for this patient.

The Ingrezza is prescribed as appropriately indicated for the treatment of tardive dyskinesia, and the clinical provider has documented the rationale for the requested benefit of Ingrezza at the current dosage of one 80 mg capsule daily.  Moreover, the clinical provider has provided documentation and a treatment plan that reflects sound medical judgment including a clinically appropriate diagnostic evaluation and rationale for the use of Ingrezza in this case scenario.  Thus, the requested benefit of Ingrezza in this case is considered medically necessary.  In considering the following questions:
a)  The required prescription drug(s) (those referenced on formulary) are not contraindicated or likely to cause an adverse reaction by or physical or mental harm to the insured, though there is risk of suicidality with the alternative suggested by the health plan; b)  The required prescription drugs(s) (those on formulary) are not expected to be ineffective based on the known clinical history and conditions of the patient and the patient's prescription drug regimen, but the likelihood of a response to other agents is 50 percent at best compared to Ingrezza that is effective and tolerated in this case; c)  The patient has not tried the required prescription drug(s) (those on formulary) while under their current or previous plan or another prescription drug(s) in the same pharmacologic class or with the same mechanism of action and such prescription drug(s) were discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event-as indicated by the health plan with respect to the alternative agent, tetrabenazine; d)  The patient is stable on the prescription drug(s) selected by their health care provider for the medical condition under consideration, and the clinical provider has provided documentation and a treatment plan that reflects sound medical judgment including a clinically appropriate diagnostic evaluation and rationale for the use of Ingrezza in this case scenario; e)  The required prescription drug(s) (those on formulary) are not in the best interest of the patient because it will more likely cause a significant barrier to the patient's adherence to or compliance with the patient's plan of care, or will likely decrease the patient's ability to achieve or maintain reasonable functional ability in performing daily activities-as the prescribing physician reasonably argues that the patient is stable on the current treatment with Ingrezza 80 mg daily, and that discontinuation of a medication that is effective and tolerated would be detrimental to the patient.  The risk of adverse effects and contraindications to the use of the alternative agent, tetrabenazine, was also referenced by the prescribing clinician indicating that there is a relative contraindication to its use in patients with depression and suicidality, even though the patient's depressive disorder is currently stable and effectively treated.  Moreover, the alternative agent is primarily indicated for the treatment of chorea in Huntington or Parkinson disease and not FDA indicated for the treatment of Tardive Dyskinesia.