Requests by the FDA. For authorization of a brand name medication, please submit a copy of the FDA MedWatch form detailing trial and failure of, or intolerance/adverse side effect to generic formulations made by 2 different manufacturers. The completed form should also be submitted to the FDA. The FDA MedWatch form is available at: Indefinite Medication Authorization Guidelines/Criteria ADHD Medication Age Limits Last reviewed: 06/01/15 Amphetamine mixed salts IR/LA Daytrana Dextroamphetamine IR/LA methylin methylphenidate IR/CR/ER dexmethylphenidate IR/ER Vyvanse Methamphetamine PA is required for members who are <6 years old and >18 years old. Criteria for < 6 years old: Diagnosis of ADHD AND Documentation stating that psychosocial issues and non-medical interventions are being addressed by the clinical team AND The requested dose is NOT greater than FDA recommended maximum daily dosage Patients who are >18 years old must have ONE of the following diagnoses: ADHD Narcolepsy (for methylphenidate, amphetamine/dextroamphetamine, or dextroamphetamine) Cancer-related fatigue (for methylphenidate) Fatigue due MS (for methylphenidate) Idiopathic hypersomnia (for methylphenidate, amphetamine/dextroamphetamine, or dextroamphetamine) Initial year Advair Last reviewed: 06/24/15 Advair Diskus will process for children 4-11 years old without PA. Prescriptions for patients outside of this age range will require a PA and documented failure or intolerance to Symbicort. Initial
Last reviewed: 04/08/15 Lumigan Travoprost Travatan Z The patient has failed latanoprost Oral Platelet Inhibitors Last reviewed: 07/1/15 Effient Brilinta Zontivity Effient or Brilinta can be approved for patients who meet the following: Diagnosis of ACS (unstable angina, STEMI, NSTEMI) Failure or contraindication/intolerance to clopidogrel, including patients identified as CYP2C19 poor metabolizers No active pathological bleeding, history of intracranial hemorrhage, or planned CABG In addition, for Effient: Age <75 unless patient is considered high thromboembolic risk Taking concomitant 75-325mg/day aspirin No history of TIA or stroke In addition, for Brilinta: Taking concomitant 75-100mg/day aspirin No severe hepatic impairment No concomitant use with medications known to interact with Brilinta (i.e., potent CYP3A4 inhibitors/inducers and simvastatin or lovastatin in doses >40mg/day) without provider documentation that benefit outweighs the risk Zontivity can be approved for patients who meet the following: Prescribed for the secondary prevention of atherothrombosis in patients with PAD or history of MI (drug NOT indicated for ACS) Must be used with aspirin and/or clopidogrel according to the standard of care for the patient’s diagnosis No evidence of contraindications: history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH); or active pathological bleeding Initial and 12 be a Initial 12 Orencia[viii] Last reviewed: 10/22/2015 General authorization criteria for all indications: Prescribed by a rheumatologist Patient is NOT on another biological DMARD Patient is up to date with all recommended vaccinations Patient has been screened for latent TB and hepatitis B Initial
Children with cystic fibrosis (unless the child has clinical evidience of CLD and/or nutrional compromise in the first year of life) or Down Syndrome (unless qualifying heart disease or prematuity) Tarceva Last reviewed: 10/01/14 Can be authorized for patients who meet ONE the following: Locally advanced, unresectable or metastatic pancreatic cancer when used in combination with gemcitabine (Gemzar) for the first-line treatment First-line treatment of advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test (e.g. cobas® EGFR Mutation Test) Locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen Maintenance therapy in locally advanced or metastatic NSCLC where disease has not progressed after 4 cycles of first-line chemotherapy Initial: benefit growth of report Topical NSAIDs Voltaren gel Pennsaid Flector patch Criteria for Approval: A. Age 18 or older B History of or high risk for adverse GI effects associated with oral NSAID use AND trial and failure of celecoxib; OR C High risk for other adverse effects associated with oral NSAID use (i.e., CHF, renal failure, concomitant use of lithium); OR D. Failure on TWO formulary NSAIDs E. Diagnosis of OA of knee or hand for Voltaren gel F. Diagnosis of OA of knee for Pennsaid Note: Flector patch is only FDA approved for acute pain. Requests for Flector patch for chronic pain should be denied. If patient meets all other criteria above, offer Voltaren Gel or Pennsaid as an alternative. The risk factors that correlate strongly to adverse GI effects of oral NSAID use are: History of GERD, GI bleed, or ulcer Chronic oral use Current anticoagulant or antiplatelet use Age 65 or greater Initial Flector All Flector All