Changes By Action Taken: Following additions are recommended approved by Committee. Additions Comments Effective Date

Transcription

1 Pharmacy Update: P&T Highlight The following is a summary of the actions taken at the Aetna Medicaid Pharmacy & Therapeutics Committee meeting(s) in 4 th Quarter Changes By Action Taken: Following additions are recommended approved by Committee Additions Comments Effective Date Olopatadine 0.1% soln Add with ST via ketotifen gtts/ 2/1/2017 QLL #1 bottle /25days Savella Add with Step via duloxetine 2/1/2017 Chlorzoxazone QLL 2/1/2017 Orphenadrine QLL 2/1/2017 Imbruvica PA/ QLL 4 caps/day 2/1/2017 Gilenya PA 2/1/2017 Tecfidera PA 2/1/2017 Auryxia Step via calcium acetate 2/1/2017 Apriso 2/1/2017 Viokace 2/1/2017 Xarelto PA 2/1/2017 Zarxio PA 2/1/2017 Breo Ellipta QLL 2/1/2017 Zepatier PA 2/1/2017 PA Prior Auth Required QLL Quantity Limit Applies ST Step Therapy Requirements exist Deletions Comments Effective Date Diltiazem ER/LA Tablets GF existing users, keep capsules 2/1/2017 Clomipramine GF existing users 2/1/2017 Imipramine CAPS* No GF, keep tabs as alternative 2/1/2017 Trazodone 300mg tab* No GF, permit 2 x 150mg tab 2/1/2017 Metaxalone 400mg and No GF 2/1/ mg* Carisoprodol 250mg* No GF 2/1/2017 Tizanidine GF existing users 2/1/2017 Clindamycin Aerosol* No GF 2/1/2017 Clindamysin/Benzoyl Peroxide No GF 2/1/2017 combo* Erythromycin/Benzoyl Peroxid combo* No GF 2/1/2017 Remove Sulfacetamide/Sulfur* Sulfacetamide 10% Lotion 2/1/2017 /Suspension Claravis No GF, Zenatane and Myorisan 2/1/2017 alts. TRETINOIN EM CRE 0.05%* No GF 2/1/2017 SALICYLIC AC GEL 6% * No GF, SALICYLIC AC CREAM 6% or Lotion 2/1/ Benzoyl Peroxide products:* No GF 2/1/2017

2 BP WASH LIQ 7% BPO CREAMY KIT 4% WASH and BPO GEL 4 Copaxone 20mg* No GF, use glatopa 20mg 2/1/2017 Farxiga* No GF 2/1/2017 Renvela/Renagel* No GF 2/1/2017 Delzicol, Dipentum, Pentasa GF existing users 2/1/2017 Amitiza GF existing users 2/1/2017 Pancreaze GF existing users 2/1/2017 Advair * No GF 2/1/2017 Symbicort* No GF 2/1/2017 Spiriva GF existing users 2/1/2017 Tudorza* No GF 2/1/2017 GF grandfathering PA Prior Auth Required ST Step Therapy Requirements exist Clinical Edit Changes Comments Date IUD Add QLL to 1 every 3 yrs 2/1/2017 Celecoxib Change step, remove tramadol 2/1/2017 as qualifying drug Elidel and Tacrolimus oint Remove smart Edit for auto-pa 2/1/2017 children, keep step for 2 corticosteroids Zenatane and Myorisan Step via oral abx/ QLL #60/30 2/1/ mg, 20mg, 30mg, (excludes 40mg, #03/30) TD Hard Edit on combo with topical retinoid PA Prior Auth Required QLL Quantity Limit Applies ST Step Therapy Requirements exist TD Therapeutic Duplication Classes Reviewed WITHOUT Changes Recommendations: Somatostatin Analogs Growth Hormone Synagis Cytokines and CAM Antagonists Viscosupplements

3 Summary of the Coverage Guidelines Changes: Guideline Summary of Changes Ampyra Updated age restriction and added QLL Cambia No changes Celecoxib Clarified duration to avoid use after CABG (within 14 days of CABG due to increased risk of MI/stroke) Removed history of ACS from exclusions (not a true contraindication) Removed NSAID-induced verbiage for gastritis (gastritis itself is a highrisk factor for GI events) Daraprim No changes Growth Hormone Added intrauterine growth as a non-covered indication Modafanil No changes Armodafanil Non-Stimulant No changes ADHD Ranexa No changes Somatostatin Added QLL s Analogs Synagis No changes Viscosupplements Added 3 new agents Hymovis, Genvisc and Gelsyn Anti-TNF s IL-17 Antagonists Integrin Antagonists Orencia Stelara Actemra Kineret Ilaris Xeljanz Combined all guidelines into 1 new guideline titled Cytokines and CAM Antagonists using previous anti-tnf guideline Criteria for RA: Removed criteria for patients with Early RA, high disease activity, and poor prognostic factors. Significant change to the 2015 ACR guideline for RA. DMARD s are recommended for all patients as the initial strategy. Criteria for AS: Removed requirement to use sulfasalazine first for patients with peripheral arthritis Updated AS guideline recommends anti- TNF s for all patients who have failed NSAIDs. Criteria for PsA: Removed MTX requirement for patients with active enthesitis or dactylitis EULAR updated PsA guideline recommends that patients with enthesitis or dactylitis should be progressed to an anti- TNF if they have not responded to NSAIDs (same recommendation as those with predominantly axial disease) Criteria for UC: Steroid-dependent: Removed mesalamine, balsalazide, and sulfasalazine as treatment requirements for patients who

4 have contraindications to 6-MP or azathioprine. If patients cannot take 6-MP or azathioprine, they should be allowed to receive an anti-tnf Criteria for Crohn s: Added Stelara (newly approved indication) Criteria for Hidradenitis: Added requirement that patients with severe disease must also failed an antibiotic per 2015 NICE guidelines. Previous version only required that patients with moderate disease have trial of antibiotics. Patients enrolled in the clinical trials for Humira had all previously received oral antibiotics. Added criteria for new indication: Uveitis: Patient is at least 18 years old Patient has intermediate, posterior, or panuveitis that is not caused by an infection Patient is currently taking an oral corticosteroid or has a contraindication to corticosteroids. (Humira has only been studied with prednisone for Uveitis.) Patient has had an inadequate response or intolerable side effects with at least 2 different steroid-sparing immunosuppressive medications such as methotrexate, azathioprine, mycophenolate, cyclosporine, or tacrolimus, or has contraindications to these agents. Added quantity limits Otezla Updated PsA criteria to be the same as the Cytokine/CAM Antagonist criteria Anticoagulants Injectable Agents Updated to align with CHEST update in February Added indication for treatment of patients who have recurrent VTE on oral anticoagulants Updated criteria for Fragmin and enoxaparin for acute VTE treatment in non-cancer patients LMWH should be used AFTER trial and failure of warfarin AND a target specific anticoagulant (e.g., Xarelto, Pradaxa, or Eliquis) Botulinum Toxins Updated criteria for Anal Fissures: Colony Stimulating Factors Trial of nitroglycerin ointment for 3 weeks AND one additional treatment Previously only required 1 treatment Added cumulative dose restriction for Botox based on package insert Added Zarxio as preferred agent Consolidated all of the key contraindications and requirements under the general authorization criteria for all agents and indications For primary prophylaxis of chemotherapy-induced neutropenia: Clarified the risk factors considered for patients receiving intermediate risk chemotherapy Added dosing table for all of the CSF agents

5 Erythropoiesis Stimulating Agents (ESA s) Added verbiage about preferred agents (Epogen will be preferred effective February 2017) Removed off-label indication for use in PEG/RBV induced anemia. AASLD no longer recommends PEG/RBV regimens for any genotype GnRH Analogs Added indication and criteria for Ovarian Cancer based on NCCN Hepatitis C Injectable Osteoporosis Prescribed by or in consultation with an oncologist Patient has failed or is intolerant to chemotherapy OR GnRH is used as post-operative management For CPP: removed age restriction; can be given as early as 1 year Added Zepatier as the formulary preferred and Epclusa as the non-formulary preferred Removed evidence of portal hypertension by MRI as exception to liver staging, no longer included on the AASLD Added clinical detail for cryoglobulinemia as it pertains to Hep C Moved Monitoring/Treatment plan to the top section with additional details regarding readiness and compliance and adherence, provider will need to attest on Fax form Consolidated Hep C table by each drug in the additional criteria section Zepatier Section Clarified for gt 1a with NS5A polymorphism 16 weeks of treatment is required Added Epclusa Section Covered for gt 2, 3, 5, and 6 without or with compensated cirrhosis Covered for gt 1-6 with decompensated cirrhosis (Zepatier is not indicated for decompensated cirrhosis) Included non-coverage for specific DDI s and for GFR < 30ml/min Harvoni Section Removed all other indications except for gt 1 and 4 with post liver transplant Sovaldi Section Removed all other indications except for HCC Daklinza section removed Added All other regimens will be considered on a case by case bases Non-Coverage Criteria Viekira/XR, Technivie, and Zepatier in patients with Child Pugh (B or C) Olysio, Daklinza, and Sovaldi used as monotherapy Use in combination with other DAA s unless indicated Any contraindications to any of the agents Removed the Peg-ineligible criteria, since Peg IFN is no longer recommended for treatment Updated clinical definition of osteoporosis to include fragility fracture Removed requirement for osteolytic lesions or high fracture risk for myeloma. All patients with MM should be offered zoledronic acid to prevent bone lesions Add QLL s

6 Interferons For hepatitis B: For Hairy-Cell Leukemia: Changed the ALT requirement from elevated to >2x ULN per the 2016 AASLD guideline update Changed initial approval duration for children from 16 weeks to 24 weeks per package insert Changed ANC value from <1000 to <1500 per NCCN Added discontinuation recommendation for nonresponders For Osteopetrosis: Removed age requirement per package insert For Condylomata: Added Alferon N product and it s appropriate approval durations Lyrica Spinal cord injury Post-herpetic neuralgia Removed all clinical criteria except diagnosis since there are no formulary alternatives for this indication Additional criteria failure of 3 months on gabapentin Multiple Sclerosis Updated to reflect formulary changes Weight Reduction Medications For non-preferred agents: Clarified that of the 2 formulary agents tried, at least one of the trials was with a preferred injectable Added new drug, Zinbryta to guideline Requires trial and failure of 2 formulary alternatives, one of which must be a preferred injectable Applicable to AZ and VA only (all other plans exclude weight loss drugs from coverage) Medical necessity clinical requirements remained the same to be eligible to receive any weight loss meds Identified preferred agents Sympathomimetics and OTC Alli are the first-preferred agents Belviq, Qsymia, and Contrave are the second-preferred agents Saxenda and Xenical are non-preferred Updated drug specific criteria For Belviq, Qsymia, and Contrave: Patient meets ONE of the following: Had an inadequate response, intolerable side effects, or a contraindication to Alli OR a sympathomimetic (e.g., phentermine, diethylpropion, benzphetamine); OR Had a good response to a

7 HIV For IL and NJ pilot Oncology Antineoplastic Agents New Guideline For Saxenda: For Xenical: sympathomimetic, however has taken the medication for the maximum recommended duration Patient has had inadequate efficacy or intolerable side effects with trials of at least 3 formulary agents OR has contraindications to all formulary agents Patient has had inadequate efficacy or intolerable side effects with a trial of Alli OTC at a dose of 120mg three times daily AND at least TWO other formulary agents OR has contraindications to all formulary agents Assures that HIV medications are prescribed to patients with an HIV diagnosis Formulary preferred medications require diagnosis only. Authorization Criteria for Truvada for pre-exposure prophylaxis (PrEP ) Patient is at continuous high risk for HIV infection Current (within 2 weeks) negative HIV antibody test Creatinine clearance > 60ml/min Patient is at least 18 years of age Authorization Criteria for Truvada for post-exposure prophylaxis (PeP) Exposure to HIV positive fluids within the last 72 hours Initial Authorization Durations: Renewal: Confirmed HIV dx: indefinite Truvada for PrEP: 14 weeks Truvada for PEP: 30 days only PrEP: 14 weeks and requires: Negative HIV antibody test result Creatinine clearance > 60ml/min Adherence confirmed by claims Member is under the care of an Oncologist Medication is prescribed for an FDA-approved indication OR for a medically accepted indication as noted in the following Compendia: o NCCN Drugs and Biologic Compendium or NCCN Clinical Practice Guidelines, category 1, 2a, or 2b. o Micromedex DrugDex o Clinical Pharmacology

8 The dose prescribed is within the FDA-approved range for the indication and patient specific factors (e.g., age, weight or BSA, renal function, liver function, drug interactions, etc) Requested medication is formulary preferred. Requests for non-preferred or non-formulary antineoplastics must meet ONE of the following: o Trials of formulary preferred agents for an adequate duration were not effective or were poorly tolerated o All other formulary preferred alternatives are contraindicated based on the member s other medical conditions or drug interactions o There are no formulary preferred medications for the patient s indication o Member has a genetic mutation that is resistant to the formulary preferred agents Medical records, lab results, test results, and clinical markers supporting the diagnosis and treatment are submitted with the request Member does not have any contraindications to the medication Member is not taking other medications that should be avoided with the requested drug based on the FDA-approved labeling Request is not for experimental/investigational use or for a clinical trial