Page 1 of 5 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Prime Therapeutics will review Prior Authorization requests Prior Authorization Form: https://www.bcbsks.com/customerservice/forms/pdf/priorauth-6514ks-ingr.pdf Link to Drug List (Formulary): https://www.bcbsks.com/drugs/ Professional Institutional Original Effective Date: May 2, 2017 Original Effective Date: May 2, 2017 Revision Date(s): May 2, 2017; November 15, 2017 Revision Date(s): May 2, 2017; November 15, 2017 Current Effective Date: November 15, 2017 Current Effective Date: November 15, 2017 State and Federal mandates and health plan member contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. To verify a member's benefits, contact Blue Cross and Blue Shield of Kansas Customer Service. The BCBSKS Medical Policies contained herein are for informational purposes and apply only to members who have health insurance through BCBSKS or who are covered by a self-insured group plan administered by BCBSKS. Medical Policy for FEP members is subject to FEP medical policy which may differ from BCBSKS Medical Policy. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents of Blue Cross and Blue Shield of Kansas and are solely responsible for diagnosis, treatment and medical advice. If your patient is covered under a different Blue Cross and Blue Shield plan, please refer to the Medical Policies of that plan. DESCRIPTION The intent of the prior authorization (PA) requirement for is to encourage appropriate selection of patients for treatment according to product labeling and/or clinical studies and/or guidelines and according to dosing recommended in product labeling. Target Drugs
Page 2 of 5 Ingrezza (valbenazine) FDA Approved Indication and Dosage 1 Indication: is indicated for the treatment of adults with tardive dyskinesia Dosing: The initial dose for is 40 mg once daily. After one week, increase the dose to the recommended dose of 80 mg once daily. Continuation of 40 mg once daily may be considered for some patients. POLICY Initial Prior Authorization Criteria and Quantity Limits for Approval The requested agents will be approved when the following are met: 1. The patient is an adult ( 18 years old) 2. The patient has a diagnosis of tardive dyskinesia 3. ONE of the following: a. The prescriber is a specialist in the area of the patient s diagnosis (e.g., psychiatrist, neurologist) b. The prescriber has consulted with a specialist in the area of the patient s diagnosis 4. ONE of the following: a. The prescriber has reduced the dose or discontinued any medications known to cause tardive dyskinesia (i.e., dopamine receptor blocking agents) b. The prescriber has provided clinical rationale indicating that a reduced dose or discontinuation of the offending agent is not appropriate 5. The prescriber has documented the patient s baseline Abnormal Involuntary Movement Scale (AIMS) score 6. The patient does NOT have any FDA labeled contraindications to therapy with the requested agent 7. ONE of the following:
Page 3 of 5 a. The requested quantity (dose) is NOT greater than the program quantity b. ALL of the following: i. The requested quantity (dose) is greater than the program quantity ii. The requested quantity (dose) is less than or equal to the FDA labeled dose iii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the Length of Approval: 2 months Renewal Evaluation This agent will be approved for renewal when the following criteria are met: 1. The patient has been previously approved for therapy with the requested agent through Prime Therapeutics PA process 2. ONE of the following: a. The prescriber is a specialist in the area of the patient s diagnosis (e.g., psychiatrist, neurologist) b. The prescriber has consulted with a specialist in the area of the patient s diagnosis 3. The patient has had an improvement from baseline in Abnormal Involuntary Movement Scale (AIMS) score 4. The patient does NOT have any FDA labeled contraindications to therapy with the requested agent 5. ONE of the following: a. The requested quantity (dose) is NOT greater than the program quantity b. ALL of the following
Page 4 of 5 i. The requested quantity (dose) is greater than the program quantity ii. The requested quantity (dose) is less than or equal to the FDA labeled dose iii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the Length of Approval: 12 months Agent Contraindications None Program Quantity Limits Brand (generic) Quantity Limit 40 mg capsule 2 capsules/day RATIONALE Prolonged use of dopamine receptor blocking agents (e.g., antipsychotic drugs, metoclopramide) can cause a delayed onset of a hyperkinetic movement disorder called tardive dyskinesia (TD). Onset of TD is insidious and often occurs while on the offending drug, such as an antipsychotic. Manifestations also commonly present when there is a dose reduction of the antipsychotic, when the antipsychotic is switched to a less potent one, or when the antipsychotic is discontinued. Typical clinical symptoms can include oral, facial, and lingual dyskinesias (e.g., protruding / twisting movements of the tongue, pouting/puckering/smacking movements of the lips, bulging of the cheeks, chewing movements, retraction of the corners of the mouth). To assess the severity of TD symptoms and impact of treatment, the Abnormal Involuntary Movement Scale (AIMS) * has been used in clinical and research settings. Treatment recommendations have been developed by the American Psychiatric Association and the American Academy of Neurology. Therapy for TD has primarily focused on decreasing and then stopping the offending agent, and switching to a different antipsychotic if one is still needed. It is often not possible to stop the antipsychotic immediately because TD symptoms can worsen upon withdrawal. Though patients with TD symptoms may improve with these changes, complete resolution of symptoms is rare, and long-lasting or permanent symptoms can be seen, even if the patient is taken off antipsychotics completely. Prior to the approval of valbenazine, there was no FDA approved drug to treat TD. A randomized, double-blind, placebo-controlled trial of valbenazine (published: KINECT-33) was conducted in patients with moderate to severe TD as determined by clinical observation. The Abnormal Involuntary Movement Scale (AIMS) was the primary efficacy measure for the assessment of TD
Page 5 of 5 severity. The primary efficacy endpoint was the mean change from baseline in the AIMS dyskinesia total score at the end of Week 6. The change from baseline in the AIMS total dyskinesia score in the 80 mg valbenazine group was statistically significantly different from the change in the placebo group. Changes from baseline to week 6 in AIMS dyskinesia score were - 3.2 for the 80 mg/day group and -0.1 for the placebo group (p<0.001), corresponding to an effect size of 0.90. A supportive analysis in the per-protocol population also showed a difference in favor of valbenazine at 80 mg/day for AIMS dyskinesia score reduction at week 6 (-3.7, vs. - 0.1 for placebo; p<0.001). A validated minimal clinically important difference has not been established for change in AIMS dyskinesia score, partly because of the lack of comparability between multiple versions of the AIMS used in previous studies in TD. *The AIMS is a 12-item scale; items 1 to 7 assess the severity of involuntary movements across body regions and these items were used in this study. Each of the 7 items was scored on a 0 to 4 scale, rated as: 0=no dyskinesia; 1=low amplitude, present during some but not most of the exam; 2=low amplitude and present during most of the exam (or moderate amplitude and present during some of the exam); 3=moderate amplitude and present during most of exam; or 4=maximal amplitude and present during most of exam. The AIMS dyskinesia total score (sum of items 1 to 7) could range from 0 to 28, with a decrease in score indicating improvement. Safety 1 Valbenazine does not have any contraindications. REVISIONS 05-02-2017 Policy published in New to Market Drugs policy on 05-10-2017. Policy retroeffective to 05-02-2017. 11-15-2017 Policy published as a stand-alone policy on 11-15-2017. Effective 11-15-2017. REFERENCES 1. Ingrezza prescribing information. Neurocrine Biosciences, Inc. 04/2017. 2. UpToDate. Tardive dyskinesia. Literature review current through: March 2017. Accessed April 2017. 3. Vijayakumar D, Jankovic J. Drug-induced dyskinesia, part 2: Treatment of Tardive Dyskinesia. Drugs 2016;76:779 787. 4. Institute for Clinical and Economic Review (ICER). Vesicular Monoamine Transporter 2 Inhibitors for Tardive Dyskinesia: Effectiveness and Value. Draft Background and Scope. May 8, 2017. 5. Hauser R, Factor S, Marder S, et al. KINECT 3: A Phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J Psychiatry 2017;174:476 484.