Prior Authorization Medications Requiring Review – Criteria for Use The Medicare Part D formulary does not allow prior authorization or criteria restrictions on medications; this document applies to the Commercial, Triple Tier, Multi-Choice, and Qualified Health Plans formularies. * The Pharmacy Consult Service reviews criteria restrictions for Diabetes, Hepatitis C, Multiple Sclerosis Medications, and PCSK9 Inhibitors Brand Name and/or Generic Name J-Code Medicare Status Notes Therapeutic Class Acthar® Corticotropin gel J0800 Medicare Part D Reviewed by the Pharmacy Consult Service for Mutiple Sclerosis indication only Aimovig™ Erenumab-aooe Medicare Part D Ampyra™ Dalfampridine Medicare Part D Reviewed by the Pharmacy Consult Service Arcalyst™ Rilonacept powder for solution J3490 Medicare Part D Aubagio® Teriflunomide Medicare Part D Reviewed by the Pharmacy Consult Service Berinert® Human C1 Inhibitor Medicare Part D Botulinum Toxin: Medicare Part D Botox® (P) Botulinum Toxins Type A J0585 (type Dysport™ (N) Botulinum Toxins Type B A) Myobloc® (N) J0587 (type Xeomin® (N) B) Cerdelga™ Eliglustat Medicare Part D Cholbam® cholic acid Medicare Part D Last Revised: August 22, 2018 CONFIDENTIAL: FOR INTERNAL KAISER PERMANENTE USE ONLY Page 1 of 91 Brand Name and/or Generic Name J-Code Medicare Status Notes Therapeutic Class Cinqair® Reslizumab Medicare Part B or D Daklinza® Daclatasvir Medicare Part D Reviewed by the Pharmacy Consult Service Dipeptidyl peptidase 4 (DPP- Medicare Part D Reviewed by the IV) inhibitors*: Pharmacy Januvia™ Sitagliptin Consult Service Sitagliptin and metformin Janumet™ Linagliptin and metformin Jentadueto® XR Alogliptin Nesina™ Saxagliptin Onglyza™ Alogliptin and metformin Kazano™ Saxagliptin and metformin ER Kombiglyze™ XR Alogliptin and pioglitazone Oseni™ Linagliptin and empagliflozin Glyxambi™ Saxagliptin and dapagliflozin Qtern® Sitagliptin and ertugliflozin Steglujan™ Last Revised: August 22, 2018 CONFIDENTIAL: FOR INTERNAL KAISER PERMANENTE USE ONLY Page 2 of 91 Brand Name and/or Generic Name J-Code Medicare Status Notes Therapeutic Class Dupixent® Dupilumab Medicare Part D Eloctate® Antihemophilic Factor Medicare Part B (Recombinant) Emflaza® Deflazacort Medicare Part D Entyvio® Vedolizumab Medicare Part B or D Enzyme replacement therapy: Velaglucerase Alfa Vpriv® (P) Imiglucerase Cerezyme® (N) Taliglucerase Alfa Elelyso® (N) Epclusa® sofosbuvir and velpatasvir Medicare Part D Reviewed by the Pharmacy Consult Service Exondys 51™ Eteplirsen Fabrazyme Agalsidase Beta Fasenra Benralizumab Medicare Part B or D Firazyr® (N) Icatibant Medicare Part D Gattex® (N) Teduglutide Medicare Part D Gilenya™ (N) Fingolimod Medicare Part D Reviewed by the Pharmacy Consult Service Glatiramer acetate Medicare Part D Reviewed by the Copaxone® Glatiramer acetate Pharmacy Glatiramer acetate Consult Service GLP-1 Receptor Agonists*: Medicare Part D Reviewed by the Bydureon™ (P) Exenatide Extended-Release Pharmacy Consult Victoza® (N) Liraglutide injection Service Byetta™ (N) Exenatide SQ solution Trulicity (N) Dulaglutide Adlyxin (N) Lixisenatide Soliqua (N) Insulin glargine/lixesenatide Xultophy (N) Insulin degludec/liraglutide Ozempic (N) Semaglutide Growth Hormones: Somatropin (Growth hormone) J2940-J2941 Medicare Part D Omnitrope® (P) injectable Genotropin® (N) Humatrope® (N) Norditropin® (N) Nutropin AQ (N) Saizen® (N) Last Revised: August 22, 2018 CONFIDENTIAL: FOR INTERNAL KAISER PERMANENTE USE ONLY Page 3 of 91 Brand Name and/or Generic Name J-Code Medicare Status Notes Therapeutic Class Serostim® (N) Zorbtive® (N) Harvoni® Ledipasvir and sofosbuvir Medicare Part D Reviewed by the Pharmacy Consult Service Hemlibra Emicizumab-kxwh Medicare Part D Human C1 Esterase Human C1 Esterase Inhibitor Medicare Part B or Inhibitors: D Cinryze® Haegarda® Hetlioz® Tasimelteon Medicare Part D Hyaluronic Acid Derivatives Hyaluronic Acid Injections J7321-J7322 Medicare Part B (viscosupplements): Supartz® (P) Synvisc® (2) Euflexxa® (N) Hyalgan® (N) Orthovisc® (N) Synvisc-One® (N) Hyzentra Immune globulin (subcutaneous) Medicare Part B Hyqvia Immune globulin and recombinant Medicare Part D or human hyaluronidase B Ilaris® Canakinumab Medicare Part D Ingrezza® Valbenazine Medicare Part D Interleukin (IL) Antagonists: Stelara® (P) Ustekinumab Taltz® Ixekizumab Medicare Part D Tremfya Guselkumab Siliq™ Brodalumab Impavido® Miltefosine Medicare Part D Interferons: Reviewed by the Avonex® (P) Interferon beta-1a Pharmacy Medicare Part D Rebif® (P) Interferon beta-1a Consult Service Plegridy® (N) Peginterferon beta-1a Last Revised: August 22, 2018 CONFIDENTIAL: FOR INTERNAL KAISER PERMANENTE USE ONLY Page 4 of 91 Brand Name and/or Generic Name J-Code Medicare Status Notes Therapeutic Class Jetrea® Ocriplasmin Juxtapid™ Lomitapide Medicare Part D Kalbitor® Ecallantide Medicare Part D Kalydeco™ Ivacaftor Medicare Part D Keveyis® Dichlorphenamide Medicare Part D Korlym™ Mifepristone Medicare Part D Kuvan™ Sapropterin tablets J3490 Medicare Part D Kynamro™ Mipomersen sodium Medicare Part D Lemtrada® Alemtuzumab Medicare Part B Reviewed by the Pharmacy Consult Service MavyretTM Glaceprevir and Pibrentasvir Medicare Part D Reviewed by the Pharmacy Consult Service Natpara® Parathyroid hormone Medicare Part D Nucala® Mepolizumab Medicare Part B or D Ocrevus™ Ocrelizumab Medicare Part B Reviewed by the Pharmacy Consult Service Olysio® Simeprevir Medicare Part D Reviewed by the Pharmacy Consult Service Orkambi® lumacaftor and ivacaftor Medicare Part D Parathyroid Hormone Medicare Part D Analogs: Forteo® (P) Teriparatide Tymlos® Abaloparatide PCSK-9 Inhibitors: Medicare Part D Reviewed by the Repatha® Evolocumab Pharmacy Praluent® Alirocumab Consult Service Procysbi™ Cysteamine delayed-release Medicare Part D Prolia® Denosumab Medicare Part B or D Provenge® Sipuleucel-T Q2043 Medicare Part B Radicava® Endavarone Medicare Part B or D Ravicti® Glycerol phenylbutyrate Medicare Part D Ruconest® C1 inhibitor (recombinant) Medicare Part B or D Sabril® Vigabatrin Medicare Part D Last Revised: August 22, 2018 CONFIDENTIAL: FOR INTERNAL KAISER PERMANENTE USE ONLY Page 5 of 91 Brand Name and/or Generic Name J-Code Medicare Status Notes Therapeutic Class Sodium-Glucose Medicare Part D Reviewed by the Cotransporter 2 (SGLT2) Pharmacy Consult Inhibitors*: Service Synjardy™ Empagliflozin and metformin Invokana™ Canagliflozin Farxiga™ Dapagliflozin Steglatro™ Ertugliflozin Glyxambi™ Empagliflozin and linagliptin Invokamet™ Canagliflozin and metformin Invokamet XR Canagliflozin and metformin Xigduo XR™ Dapagliflozin and metformin Segluromet™ Ertugliflozin and metformin Somavert® Pegvisomant Medicare Part D Sovaldi® Sofosbuvir Medicare Part D Reviewed by the Pharmacy Consult Service Spinraza™ Nusinersen Supprelin® LA Histrelin implant J9226 Medicare Part D Symdeko Tezafactor/Ivacaftor Medicare Part D Symlin*® Pramlintide SQ solution J3490 Medicare Part D Reviewed by the Pharmacy Consult Service Tecfidera™ Dimethyl fumarate Medicare Part D Reviewed by the Pharmacy Consult Service Technivie® Ombitasvir/paritaprevir/ ritonavir Medicare Part D Reviewed by the Pharmacy Consult Service Last Revised: August 22, 2018 CONFIDENTIAL: FOR INTERNAL KAISER PERMANENTE USE ONLY Page 6 of 91 Brand Name and/or Generic Name J-Code Medicare Status Notes Therapeutic Class Tysabri® Natalizumab IV solution J2323 Medicare Part B Reviewed by the Pharmacy Consult Service for Mutiple Sclerosis indication only Viberzi® Eluxadoline Medicare Part D Viekira Pak® Ombitasvir, Paritaprevir, Ritonavir, Medicare Part D Reviewed by the Viekira XR® and Dasabuvir Pharmacy Consult Service VMAT2 Inhibitors: Medicare Part D Austedo® Deutetrabenazine Xenazine® Tetrabenazine Vosevi® Sofosbuvir/velpatasvir/voxilaprevir Medicare Part D Reviewed by the Pharmacy Consult Service Xgeva® Denosumab Medicare Part B Xiaflex™ Collagenase clostridium J0775 Medicare Part B histolyticum injection Xolair® Omalizumab injectable J2357 Medicare Part D Zavesca® Miglustat Zepatier® Elbasvir and Grazoprevir Medicare Part D Reviewed by the Pharmacy Consult Service P- Preferred when criteria met 2-2nd line (if preferred failed) NP- Non-preferred Last Revised: August 22, 2018 CONFIDENTIAL: FOR INTERNAL KAISER PERMANENTE USE ONLY Page 7 of 91 Medications Requiring Review – Criteria for Use Drug Prior Authorization Criteria Acthar® Candidates for treatment with Acthar® should meet the following pertinent criteria: (Corticotropin (gel)) Acthar® gel will not be covered in patients with any of the following diagnoses: • Congestive heart failure • Uncontrolled Hypertension • Osteoporosis • History of or presence of peptic ulcer • Primary adrenocortical insufficiency or adrenocortical hyperactivity • Scleroderma • Hypersensitivity to porcine protein • Pancreatitis • Thromboembolic disorder • Ocular herpes simplex • Systemic fungal infections Criteria for use for diagnosis of infantile spasms: 1. Diagnosis of infantile spasms 2. Less than 2 years of age 3. Prescribed by pediatric neurologist or neurologist Criteria for use for Nephritic Syndrome: 1. A diagnosis of idiopathic nephritic syndrome 2. Prescriber must be a nephrologist 3. Patient failed to achieve a sustained partial or complete remission of nephritic syndrome after 6 months of therapy with first line therapy (i.e., corticosteroids) AND after 6 months of therapy with second line therapies with demonstrated efficacy (i.e., cyclosporine, tacrolimus, rituximab, and mycophenolate mofetil). Patient is expected to continue therapy for at least 3 months and is able to afford