Prior Authorization. Drug Name (select from list of drugs shown) Gilenya (fingolomid) Quantity Frequency Strength. Physician Name:

Transcription

1 06/01/2016 Prior Authorization Aetna Better Health Michigan Gilenya This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign and date. Fax signed forms to Aetna Better Health of Michigan at Please contact Aetna Better Health of Michigan at with questions regarding the Prior Authorization process. When conditions are met, we will authorize the coverage of Gilenya. Please note that all authorization requests will be reviewed as the AB rated generic (when available) unless states otherwise. Drug ame (select from list of drugs shown) Gilenya (fingolomid) Quantity Frequency Strength Route of Administration Patient Information Patient ame: Patient ID: Patient Group o.: Patient DOB: Patient Phone: Prescribing Physician Expected Length of therapy Physician ame: Specialty: PI umber: Physician Fax: Physician Phone: Physician Address: City, State, Zip: Diagnosis: ICD Code: Please circle the appropriate answer for each question. Question 1. Has this plan authorized this medication in the past for this patient (i.e., previous authorization is on file under this plan)? Circle es or [If no, skip to question 8.] 2. Has the patient been compliant with therapy as verified by the prescriber?

2 3. Has the patient demonstrated a positive response to Gilenya (fingolimod) and stabilization of MS disease as evidenced by ALL of the following? A) Decrease in frequency and/or severity of relapses, B) Improvement in MRI measures of disease severity (decrease in number or volume of gadolinium-enhancing lesions, T2 hyperintense lesions and/or T1 hypointense lesions) Circle es or 4. Is the patient s Expanded Disability Status Scale (EDSS) score less than or equal to 5.5 OR has the patient demonstrated stabilization/improvement in routine neurological observation, mobility, or ability to perform activities of daily living? 5. Has a validated patient reported outcome measure (i.e. Fatigue Impact Scale [FIS], Medical Outcome Study SF-36, etc) been completed and reviewed by the prescriber? If yes, provide scale used and score or submit documentation with request: 6. Has documentation for the following labs been submitted with the request? A) Complete blood count (CBC), B) LFTs and bilirubin levels, C) egative pregnancy test for female patients, D) EKG evaluation, and E) Ophthalmic examination 7. Does the patient have any of the following exclusions to therapy? A) Myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure experienced within the past 6 months, B) History or presence of Mobitz Type II seconddegree or third-degree atrioventricular (AV) block or sick sinus syndrome, without a functioning pacemaker, C) QTc interval greater than or equal to 500 msec, D) Treatment with Class Ia or Class III anti-arrhythmic drugs, E) Steady progression of disability, F) Toxicity or serious adverse reaction to Gilenya [o further questions.]

3 8. Does the patient have a definitive diagnosis of a relapsing form of multiple sclerosis, including relapsing-remitting multiple sclerosis (RRMS), secondary-progressive multiple sclerosis (SPMS) with relapses, or progressive-relapsing multiple sclerosis (PRMS), as defined by the McDonald criteria? Circle es or 9. Does the patient have an Expanded Disability Status Scale (EDSS) score of 5 or less (disability severe enough to impair full daily activities) OR is there documentation supporting the disability within this range? 10. Has the patient had a documented inadequate response (to at least 6 months of therapy) to an interferon beta product (Avonex, Rebif, Betaseron, or Extavia) as defined as meeting TWO of the following? A) Increase in frequency (at least two clinical relapses within the past 12 months), severity and/or sequelae of relapses, B) CS lesion progression as measured by MRI (increased number or volume of gadolinium-enhancing lesions, T2 hyperintense lesions and/or T1 hypointense lesions), C) Sustained worsening of EDSS score, routine neurological observation, mobility, or ability to perform activities of daily living. [If yes, then skip to question 12.] 11. Has the patient had a documented intolerance or hypersensitivity to an interferon beta product (Avonex, Rebif, Betaseron, or Extavia) or contraindication(s) to ALL interferon beta products? (ote: eedle phobia or needle fatigue is not considered an intolerance or contraindication.)

4 12. Has the patient had a documented inadequate response (to at least 6 months of therapy) to glatiramer acetate (Copaxone) as defined as meeting TWO of the following? A) Increase in frequency (at least two clinical relapses within the past 12 months), severity and/or sequelae of relapses, B) CS lesion progression as measured by MRI (increased number or volume of gadolinium-enhancing lesions, T2 hyperintense lesions and/or T1 hypointense lesions), C) Sustained worsening of EDSS score, routine neurological observation, mobility, or ability to perform activities of daily living. Circle es or [If yes, then skip to question 14.] 13. Has the patient had a documented intolerance, FDA labeled contraindication, or hypersensitivity to glatiramer acetate (Copaxone)? (ote: eedle phobia or needle fatigue is not considered an intolerance or contraindication.) 14. Is Gilenya being prescribed by a board-certified neurologist, board-certified multiple sclerosis physician specialist, or in consultation with one of these specialists? (Please submit consultation notes.) 15. Is the patient currently being treated with another diseasemodifying agent for MS that will OT be discontinued when Gilenya is initiated (i.e., patient will remain on the other agent after Gilenya is initiated)? [If yes, then no further questions.] 16. Has documentation for the following labs or exams from within the last 6 months been submitted with the request? A) Complete blood count (CBC), B) LFTs and bilirubin levels, C) egative pregnancy test for female patients, D) EKG evaluation, and D) Ophthalmic examination. 17. Has the patient had a documented history of chicken pox OR has had varicella zoster vaccination OR has evidence of immunity to varicella (positive antibodies)?

5 Circle es or 18. Is the patient 18 years of age or older? 19. Does the patient have any of the following exclusions to therapy? A) Myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure experienced within the past 6 months, B) History or presence of Mobitz Type II seconddegree or third-degree atrioventricular (AV) block or sick sinus syndrome, without a functioning pacemaker, C) QTc interval greater than or equal to 500 msec, D) Treatment with Class Ia or Class III anti-arrhythmic drugs, E) Steady progression of disability Comments: I affirm that the information given on this form is true and accurate as of this date. Prescriber (Or Authorized) Signature Prescriber (Or Authorized) Signature Date Date