Texas Standard Prior Authorization Form Addendum Molina Healthcare of Texas Ingrezza (Marketplace) This fax machine is located in a secure location as required by HIPAA Regulations. Complete / Review information, sign, and date. Fax signed forms to Molina Pharmacy Prior Authorization Department at 1-888-487-9251. Please contact Molina Pharmacy Prior Authorization Department at 1-855-322-4080 with questions regarding the prior authorization process. When conditions are met, we will authorize the coverage of Ingrezza (Marketplace). Drug Name (select from list of drugs shown) Ingrezza Patient Name: Patient ID: Patient Group No.: Patient DOB: Physician Name: Physician Phone:, Physician Fax: Physician Address: City, State, Zip: Diagnosis: Patient Information Prescribing Physician ICD Code: ***Please include all relevant clinical notes, lab work, medication history and any other applicable documentation. Please circle the appropriate answer for each question. 1. Is the request for Ingrezza for a non-fda approved indication? Y N NOTE TO MOLINA REVIEWER: Refer to Medical Clinical Policy for off-label use of drugs and biologic agents. If the answer to this question is no, go to question 2.
2. Does the patient have ANY of the following contraindications/exclusions to Ingrezza? Y N A) Hypersensitivity to valbenazine or any component of the formulation [inactive ingredients (mannitol, partially pregelatinized starch, fumed silica, magnesium stearate, gelatin, candurin silver fine, FD&C Red No. 40, and FD&C Blue No. 1)], B) Serious untreated or undertreated psychiatric illness, such as depression, C) A history of significant suicidal thoughts or behavior, D) Congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval, E) Severe renal impairment (creatinine clearance 30 ml/min or less) NOTE: Members with congenital long QT syndrome or arrhythmias associated with prolonged QT interval, or members at risk of prolonged QT interval: An EKG may be required prior to therapy and before increasing the dosage. Peer-to-Peer and/or additional documentation may be requested at the discretion of the Pharmacy/Medical Director. NOTE: Members with a history of renal impairment, appropriate labs and/or additional documentation may be requested at the discretion of the Pharmacy/Medical Director. If the answer to this question is no, go to question 3. 3. Does the patient have a documented diagnosis of schizophrenia, schizo-affective disorder, or a Y N Mood disorder FOR AT LEAST 3 MONTHS? If the answer to this question is yes, go to question 4. 4. Is the patient in a STABLE psychiatric status? If yes, submit supporting documentation. Y N If the answer to this question is yes, go to question 5. 5. Is the patient currently on maintenance medication(s) for schizophrenia or schizoaffective disorder, Y N or mood disorders? If the answer to this question is yes, go to question 6. If the answer to this question is no, go to question 7. 6. Has the patient been receiving stable medication doses and therapy? If yes, submit supporting Y N documentation. If the answer to this question is yes, go to question 7. 7. Does the patient have a documented diagnosis of antipsychotic-induced moderate to severe Y N tardive dyskinesia as indicated by a score of 3 or 4 on item 8 (severity of abnormal movement overall) of the Abnormal Involuntary Movement Scale (AIMS)? If yes, submit supporting documentation. Note: 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. If the answer to this question is yes, go to question 8.
8. Has the patient received baseline evaluation of tardive dyskinesia by an Abnormal Involuntary Y N Movement Scale (AIMS) score greater than or equal to 10? If yes, submit documentation of the member s current AIMS score from items 1-7 (results range from 0 to 28, with higher scores indicating more severe involuntary movements). If the answer to this question is yes, go to question 9. 9. Is Ingrezza prescribed by or in consultation with a board-certified psychiatrist or neurologist OR Y N physician experienced in the treatment of tardive dyskinesia? Submit consultation notes if applicable. Note: Consultation notes must be submitted at least ONCE annually for continuation of treatment requests. If the answer to this question is yes, go to question 10. 10. Is the patient 18 years of age or older? Y N If the answer to this question is yes, go to question 11. 11. Does the patient have prior medical history of, or significant risk for, any of the following: Y N suicidal ideation, violent behavior, or unstable psychiatric symptoms? If no, submit supporting documentation. If the answer to this question is no, go to question 12. 12. Has the prescriber reduced the dose or discontinued medication(s) known to cause tardive Y N dyskinesia? If the answer to this question is yes, go to question 14. If the answer to this question is no, go to question 13. 13. Has the prescriber switched the patient s medication from a first-generation (e.g., Chlorpromazine, Y N fluphenazine, perphenazine, thioridazine, thiothixene, trifluoperazine, haloperidol, loxapine, pimozide) to a second-generation antipsychotic (e.g., aripiprazole, brexpiprazole, asenapine, cariprazine, clozapine, quetiapine, iloperidone, lurasidone, ziprasidone, olanzapine, paliperidone, risperidone)? If the answer to this question is yes, go to question 14. 14. Has this change failed to achieve and maintain improvement in tardive dyskinesia symptoms? Y N If yes, submit supporting documentation. If the answer to this question is yes, go to question 16. If the answer to this question is no, go to question 15. 15. Is it clinically inappropriate or contraindicated for the patient to have a trial of dose reduction, Y N tapering, switching or discontinuation of the offending medication? If yes, submit supporting documentation. If the answer to this question is yes, go to question 16. 16. Does the patient have a documented inadequate response or clinical intolerance to at least ONE Y N (1) medication used to reduce tardive dyskinesia symptoms [i.e. benzodiazepines (clonazepam)]? Note: Inadequate response is defined as failure to achieve and maintain improvement in TD s symptoms after a compliant trial on the recommended dose for a sufficient period. If yes, submit supporting documentation. If the answer to this question is yes, go to question 18. If the answer to this question is no, go to question 17.
17. Is it clinically inappropriate or contraindicated for the patient to have a trial of at least ONE (1) Y N medication used to reduce tardive dyskinesia symptoms [i.e. benzodiazepines (clonazepam)]? If yes, submit supporting documentation. If the answer to this question is yes, go to question 18. 18. Does the patient have a documented inadequate response or clinical intolerance to tetrabenazine Y N (generic or brand Xenazine) at up to 100 mg/day? Note: Inadequate response is defined as failure to achieve and maintain improvement in TD symptoms after a compliant trial on the recommended dose for a sufficient period. If yes, submit supporting documentation. Note: For coverage requirements for Xenazine, please refer to Xenazine Molina Clinical Policy (MCP-075). If the answer to this question is yes, go to question 20. If the answer to this question is no, go to question 19. 19. Is it clinically inappropriate or contraindicated for the patient to have a trial of tetrabenazine Y N (Xenazine) at up to 100 mg/day? If yes, submit supporting documentation. If the answer to this question is yes, go to question 20. 20. Does the patient have a documented inadequate response to Austedo (deutetrabenazine) Y N therapy after at least 12 weeks of treatment on the labeled dose for tardive dyskinesia or have a documented clinical intolerance to Austedo (deutetrabenazine)? If yes, submit supporting documentation. If the answer to this question is yes, go to question 22. If the answer to this question is no, go to question 21. 21. Is it clinically inappropriate or contraindicated for the patient to have a trial of Austedo Y N (deutetrabenazine) at the labeled dose for tardive dyskinesia for at least 12 weeks? If yes, submit supporting documentation. If the answer to this question is yes, go to question 22. 22. Is/will Ingrezza be prescribed or intended for use in combination with any of the following therapies: Y N A) Other VMAT2 inhibitors: tetrabenazine (Xenazine), dueterabenazine (Austedo), B) MAOI (monoamine oxidase inhibitors): selegiline (Emsam), isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), or C) QTc-prolonging agents such as antipsychotic agents (e.g., chlorpromazine, haloperidol), antibiotics (e.g., moxifloxacin), class IA and III antiarrhythmic agents. If the answer to this question is no, go to question 23. 23. Does/will the prescribed dose exceed any of the following: 80 mg or two capsules per day? Y N If the answer to this question is no. go to question 24. 24. Does the patient have moderate to severe hepatic impairment? Y N NOTE: Members with a history of hepatic impairment, appropriate labs and/or additional documentation may be requested at the discretion of the Pharmacy/Medical Director. If the answer to this question is yes, go to question 25. If the answer to this question is no, go to question 26.
25. Will the patient receive Ingrezza at reduced doses? Y N If the answer to this question is yes, go to question 26. 26. Will Ingrezza be administered by the patient or a caregiver? Y N If the answer to this question is yes, go to question 27. 27. Will Ingrezza be discontinued if any of the following occurs: A) Hypersensitivity to Y N valbenazine or any component of the formulation [inactive ingredients (mannitol, partially pregelatinized starch, fumed silica, magnesium stearate, gelatin, candurin silver fine, FD&C Red No. 40, and FD&C Blue No. 1)], B) Serious untreated or undertreated psychiatric illness, such as depression, C) Significant suicidal thoughts or behavior, D) arrhythmias associated with a prolonged QT interval, E) Severe renal impairment (creatinine clearance 30 ml/min or less), F) Concurrent therapy with a) another VMAT2 inhibitors: tetrabenazine (Xenazine) or dueterabenazine (Austedo), b) MAOI (monoamine oxidase inhibitors): selegiline (Emsam), isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), or c) QTc-prolonging agents such as antipsychotic agents (e.g., chlorpromazine, haloperidol), antibiotics (e.g., moxifloxacin), class IA and III antiarrhythmic agents? If the answer to this question is yes, go to question 28. 28. Will the patient have an office visit and reassessment for this condition to determine if Y N continuation of treatment is medically necessary? Note: Submission of chart notes will be required for continuation. If the answer to this question is yes, go to question 29. 29. Is the request for continuation of therapy? Y N If the answer to this question is yes, go to question 31. If the answer to this question is no, go to question 30. 30. Has the medication authorization been set up with the appropriate specialty pharmacy? Y N NOTE: If member meets all criteria and approval for therapy is granted, medication will be dispensed by a specialty pharmacy vendor at the discretion of Molina Healthcare. Selfadministered medications may not be dispensed for self-administration and billed through the medical benefit by a provider; they must be dispensed through a participating pharmacy. If the answer to this question is yes, approved for 3 months, quantity limit 2 capsules per day, Dispensing limit one 1 month supply per fill.
31. Has the member been adherent to therapy at least 85% of the time as verified by Prescriber Y N and member s medication fill history? (Review Rx history for compliance.) NOTE: Therapy may be discontinued due to poor adherence upon recommendation of the Molina Medical Director when adherence less than 85% has been demonstrated in at least two months during the course of therapy NOTE TO MOLINA STAFF: MOLINA MEDICAL/PHARMACY REVIEWER TO VERIFY. History of non-compliance or non-adherence as verified by member s medication fill history or prescription drug profile may result in continuation of therapy request not being authorized. member s medication fill history or prescription drug profile may result in continuation of therapy request not being authorized If the answer to this question is yes, go to question 32. 32. Has the member experienced intolerable adverse effects or drug toxicity to Ingrezza? Y N If the answer to this question is no, go to question 33. 33. Has the patient experienced improvement in TD symptoms due to Ingrezza therapy as Y N documented by AIMS score (items 1-7): decrease from baseline by at least 2 points? If yes, submit supporting documentation. If the answer to this question is yes, go to question 34. 34. Does any of the following apply to the patient? A) The patient has a history of depression Y N and/or suicidal thoughts or behaviors or B) the patient receiving a current treatment for depression and/or suicidal thoughts or behaviors? If no, submit supporting documentation. If the answer to this question is yes, go to question 35. If the answer to this question is no, go to question 37. 35. Has the patient had regular follow-up office visits and recent evaluation for this condition Y N by the Prescriber (neurologist or psychiatrist) or behavioral health provider? If yes, submit supporting documentation. If the answer to this question is yes, go to question 36. 36. Is the patient experiencing suicidal thoughts or behaviors? If no, submit supporting documentation. Y N If the answer to this question is yes, go to question 37. 37. Has the medication authorization been set up with the appropriate specialty pharmacy? Y N NOTE: If member meets all criteria and approval for therapy is granted, medication will be dispensed by a specialty pharmacy vendor at the discretion of Molina Healthcare. Selfadministered medications may not be dispensed for self-administration and billed through the medical benefit by a provider; they must be dispensed through a participating pharmacy. If the answer to this question is yes, approved for 6 months, quantity limit 2 capsules per day, Dispensing limit one 1 month supply per fill.
Comments: I affirm that the information given on this form is true and accurate as of this date. Prescriber (or Authorized) Signature Date