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Medicare Model Guidelines Draft v8.0 1 of 97

USP Category USP Class Example Drugs Combination Track Changes Drug Product Analgesics Cat Nonsteroidal Anti-inflammatory Class Drugs Celecoxib no Potassium no Diclofenac Epolamine no Diflunisal no Etodolac no Fenoprofen Calcium no Flurbiprofen no no Indomethacin no Ketoprofen no Ketorolac Tromethamine no Meclofenamate no no Meloxicam no Nabumetone no Naproxen no Oxaprozin no Piroxicam no Sulindac no Tolmetin Sodium no Analgesics, Long-acting Class

Buprenorphine no Fentanyl no Fentanyl Citrate no Fentanyl Hydrochloride no Manufacturer Discontinued

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 2 of 97

Hydrocodone Bitartrate no Hydrochloride no

Levorphanol Tartrate no Hydrochloride no Sulfate no Oxycodone Hydrochloride no Oxymorphone Hydrochloride no Hydrochloride no Hydrochloride no Opioid Analgesics, Short-acting Class

Butorphanol Tartrate no Codeine Phosphate no Fentanyl Citrate no Hydromorphone Hydrochloride no

Meperidine Hydrochloride no Morphine Sulfate no Additional Placement Nalbuphine Hydrochloride no Oxycodone Hydrochloride no Oxymorphone Hydrochloride no Lactate no Manufacturer Discontinued Tapentadol Hydrochloride no Tramadol Hydrochloride no Analgesics Combinations Class New class to include analgesic combination drug products

Acetaminophen/ Codeine yes Phosphate Benzhydrocodone/ yes At i h

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 3 of 97

Hydrocodone Bitartrate/ yes Acetaminophen Hydrocodone Bitartrate/ Ibuprofen yes

Morphine Sulfate/ yes Hydrochloride Oxycodone Hydrochloride/ yes Acetaminophen Oxycodone Hydrochloride/ yes

Oxycodone Hydrochloride/ yes Ibuprofen Tramadol Hydrochloride/ yes Acetaminophen

Butalbital/ Acetaminophen yes / Acetaminophen/ yes Butalbital/ Acetaminophen/ yes Caffeine/ Codeine Phosphate Butalbital/ Aspirin/ Caffeine yes Butalbital/ Aspirin/ Caffeine/ yes Codeine Anesthetics Cat Local Anesthetics Class Hydrochloride no Lidocaine/ Epinephrine yes Lidocaine/ yes Lidocaine/ yes

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 4 of 97

Anti-/ Substance Cat Abuse Treatment Agents Deterrents/Anti-craving Class

Acamprosate Calcium no no Naltrexone Hydrochloride no Opioid Dependence Treatments Class Renamed class to "Opioid Dependence" to avoid redundancy Opioid Dependence in category name, since the concept of "treatment agents" is already included no Buprenorphine/ yes Hydrochloride no Naltrexone Hydrochloride no Opioid Reversal Agents Class Naloxone Hydrochloride no Smoking Cessation Agents Class Hydrochloride no Polacrilex no Tartrate no Antibacterials Cat Antibacterials Aminoglycosides Class Antibacterials Amikacin Sulfate no Antibacterials Gentamicin Sulfate no Antibacterials Neomycin Sulfate no Antibacterials Paromomycin Sulfate no Antibacterials Plazomicin no Antibacterials Streptomycin Sulfate no Antibacterials Tobramycin Sulfate no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 5 of 97

Antibacterials Beta-lactam, Class Antibacterials Antibacterials Cefadroxil no Antibacterials Cefazolin no Antibacterials Cephalexin no Antibacterials Antibacterials Cefaclor no Antibacterials Cefoxitin Sodium no Antibacterials Cefprozil no Antibacterials Cefuroxime Axetil no Antibacterials Sodium no Antibacterials Antibacterials Cefdinir no Antibacterials Cefixime no Antibacterials Cefotaxime Sodium no Antibacterials Cefpodoxime Proxetil no Antibacterials Ceftazidime no Antibacterials Ceftazidime/ Avibactam yes Antibacterials Ceftibuten Dihydrate no Manufacturer Discontinued Antibacterials Ceftriaxone Sodium no Antibacterials Antibacterials Cefepime Hydrochloride no Antibacterials Antibacterials Ceftaroline Fosamil no Antibacterials Ceftolozane Sulfate/ Tazobactam yes

Antibacterials Beta-lactam, Class Antibacterials Antibacterials Amoxicillin no Antibacterials Amoxicillin/ Clavulanate yes Antibacterials Ampicillin no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 6 of 97

Antibacterials Ampicillin Sodium/ Sulbactam yes Antibacterials Sdi Antibacterials Piperacillin Sodium/ Tazobactam yes Sodium Antibacterials Antibacterials G Benzathine no Antibacterials Penicillin G Potassium no Antibacterials Penicillin G no Antibacterials Penicillin G Sodium no Antibacterials Penicillin G Benzathine/ Penicillin yes G Procaine Antibacterials Penicillin V Potassium no Antibacterials Antibacterials Dicloxacillin Sodium no Antibacterials Nafcillin Sodium no Antibacterials Oxacillin Sodium no Antibacterials Beta-lactam, Other Carbapenems Class Renamed class to add specification

Antibacterials Aztreonam no Moved example drug to USP Class, "Antibacterials, Other"

Antibacterials Doripenem no Manufacturer Discontinued Antibacterials Ertapenem Sodium no Antibacterials / Cilastatin Sodium yes Imipenem/ Cilastatin/ Relebactam yes New FDA approved drug, 7/16/19

Antibacterials Meropenem no Antibacterials Meropenem/ Vaborbactam yes Antibacterials Macrolides Class Antibacterials Azithromycin no Antibacterials no Antibacterials no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 7 of 97

Antibacterials Erythromycin Ethylsuccinate no Antibacterials Erythromycin Lactobionate no Antibacterials Erythromycin Stearate no Antibacterials Fidaxomicin no Antibacterials Quinolones Class Antibacterials Besifloxacin Hydrochloride no Antibacterials no Antibacterials Delafloxacin no Antibacterials Finafloxacin no Manufacturer Discontinued Antibacterials Gatifloxacin no Antibacterials Gemifloxacin Mesylate no Antibacterials no Antibacterials Moxifloxacin Hydrochloride no Antibacterials no Antibacterials Sulfonamides Class Antibacterials Sulfacetamide Sodium no Antibacterials Sulfadiazine no Antibacterials Sulfamethoxazole/ yes

Antibacterials Tetracyclines Class Antibacterials Demeclocycline Hydrochloride no

Antibacterials Doxycycline Calcium no Antibacterials Doxycycline Hyclate no Eravacycline no Antibacterials Minocycline Hydrochloride no Antibacterials Omadacycline no Antibacterials Sarecycline no Antibacterials Tetracycline Hydrochloride no Antibacterials Antibacterials, Other Class Antibacterials

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 8 of 97

Antibacterials Silver Sulfadiazine no Antibacterials Antibacterials Trimethoprim no Antibacterials Dalbavancin no Antibacterials Vancomycin Hydrochloride no Antibacterials Antibacterials Clindamycin Hydrochloride no Antibacterials Clindamycin Palmitate no Hydrochloride Antibacterials Lincomycin Hydrochloride no Antibacterials Antibacterials Nitrofurantoin no Antibacterials Antibacterials no Antibacterials Tedizolid Phosphate no Antibacterials Antibacterials no Aztreonam no Moved example drug from USP Class, "Beta-lactam, Other"

Antibacterials Bacitracin no Antibacterials Chloramphenicol Sodium no Antibacterials SitDaptomycin no Antibacterials Fosfomycin Tromethamine no Antibacterials Mafenide Acetate no Antibacterials Methenamine Hippurate no Antibacterials no Antibacterials Mupirocin Calcium no Antibacterials Polymyxin B Sulfate no Antibacterials Retapamulin no Antibacterials Rifaximin no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 9 of 97

Antibacterials Secnidazole no Antibacterials no Antibacterials Tigecycline no Cat Anticonvulsants Modifying Agents Class

Anticonvulsants no Anticonvulsants Methsuximide no Anticonvulsants Gamma-aminobutyric Acid (GABA) Class Augmenting Agents Anticonvulsants Anticonvulsants no Anticonvulsants no Anticonvulsants Dipotassium no Anticonvulsants no Anticonvulsants no Anticonvulsants Anticonvulsants no Anticonvulsants no Anticonvulsants Anticonvulsants no Anticonvulsants no Anticonvulsants no Anticonvulsants no Glutamate Reducing Agents Class Removed class due to multiple mechanism of actions of example drugs. Example drugs with multiple mechanism of actions moved to USP Class, "Anticonvulsants, Other.“ Examples drugs moved to USP Class, "Anticonvulsants, Other."

Anticonvulsants Agents Class Anticonvulsants no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 10 of 97

Anticonvulsants Eslicarbazepine no no Anticonvulsants no Anticonvulsants no Anticonvulsants no Anticonvulsants no Anticonvulsants no Anticonvulsants no Anticonvulsants Anticonvulsants, Other Class Anticonvulsants no Anticonvulsants Anticonvulsants no Anticonvulsants no Anticonvulsants Anticonvulsants Divalproex no Anticonvulsants no Anticonvulsants no Anticonvulsants no Anticonvulsants Stiripentol no Anticonvulsants no Anticonvulsants Valproic Acid no Antidementia Agents Cat Antidementia Agents Inhibitors Class Antidementia Agents Hydrochloride no Antidementia Agents Galantamine Hydrobromide no Antidementia Agents Rivastigmine no Rivastigmine Tartrate no Antidementia Agents N-methyl-D-aspartate (NMDA) Class Antagonist Antidementia Agents Hydrochloride no Antidementia Agents Antidementia Agents, Other Class

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 11 of 97

Antidementia Agents Memantine/ Donepezil yes Antidementia Agents HErgoloid d hl Mesylates id no Cat Antidepressants Inhibitors Class Antidepressants no Gap drug found on FRF Antidepressants Sulfate no Antidepressants no Antidepressants Sulfate no Antidepressants SSRIs/SNRIs (Selective Class Reuptake Inhibitors/ Serotonin and Reuptake Inhibitors)

Antidepressants Hydrobromide no Antidepressants no Antidepressants Desvenlafaxine Succinate no Antidepressants Hydrochloride no Antidepressants Oxalate no Antidepressants Hydrochloride no Antidepressants Maleate no Antidepressants Hydrochloride no

Antidepressants Hydrochloride no Example drug moved to USP Class, "Antidepressants, Other."

Antidepressants Hydrochloride no Antidepressants Hydrochloride no Antidepressants Hydrochloride no Antidepressants Hydrochloride no Antidepressants Hydrochloride no Antidepressants Hydrochloride no Antidepressants Hydrobromide no Antidepressants Tricyclics Class

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 12 of 97

Antidepressants Hydrochloride no Antidepressants no Antidepressants Hydrochloride no Antidepressants Hydrochloride no Antidepressants Hydrochloride no Antidepressants Hydrochloride no Antidepressants Imipramine Pamoate no Antidepressants Hydrochloride no Antidepressants Hydrochloride no Antidepressants Maleate no Antidepressants Antidepressants, Other Class Antidepressants Bupropion Hydrochloride no Antidepressants no Antidepressants Antidepressants no Antidepressants Fumarate no

Esketamine Hydrochloride no New FDA approved drug, 3/5/19 Antidepressants Antidepressants / Amitriptyline yes Hydrochloride Antidepressants / Fluoxetine yes Antidepressants / Amitriptyline yes Hydrochloride Antiemetics Cat Antiemetics Emetogenic Therapy Adjuncts Class Antiemetics Antiemetics Rolapitant no Antiemetics Antiemetics Dolasetron Mesylate no Manufacturer Discontinued Antiemetics Granisetron Hydrochloride no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 13 of 97

Antiemetics Ondansetron no Antiemetics Ondansetron Hydrochloride no Antiemetics Palonosetron Hydrochloride no Antiemetics Antiemetics Aprepitant no Fosnetupitant/ Palonosetron no New FDA approved drug 4/19/18 Antiemetics Netupitant/ Palonosetron yes Antiemetics Antiemetics Dronabinol no Antiemetics Nabilone no Antiemetics Antiemetics, Other Class Antiemetics Hydrochloride no

Antiemetics Hydrochloride no

Antiemetics Succinate/ Pyridoxine yes Hydrochloride Antiemetics Hydrochloride no Antiemetics Hydrochloride no Antiemetics no Antiemetics Perphenazine no Antiemetics Edisylate no Antiemetics Prochlorperazine Maleate no Antiemetics Hydrochloride no Antiemetics no Antiemetics Trimethobenzamide Hydrochloride no

Antifungals Cat Antifungals Antifungals Naftifine Hydrochloride no Antifungals Terbinafine Hydrochloride no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 14 of 97

Antifungals Antifungals Butoconazole Nitrate no Antifungals Clotrimazole no Antifungals Econazole Nitrate no Antifungals Efinaconazole no Antifungals Fluconazole no Antifungals Isavuconazonium Sulfate no Antifungals Itraconazole no Antifungals no Antifungals Luliconazole no Antifungals Miconazole Nitrate no Antifungals Oxiconazole Nitrate no Antifungals Posaconazole no Antifungals Sertaconazole Nitrate no Antifungals Sulconazole Nitrate no Antifungals Terconazole no Antifungals Voriconazole no Antifungals Antifungals Anidulafungin no Antifungals Caspofungin Acetate no Antifungals Micafungin Sodium no Antifungals Antifungals Amphotericin B no Antifungals Natamycin no Removed placement. Placement exists under USP Class, "Ophthalmic Anti-Infectives." Antifungals Nystatin no Antifungals Antifungals Butenafine Hydrochloride no Antifungals Ciclopirox Olamine no Antifungals Flucytosine no Antifungals no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 15 of 97

Antifungals Tavaborole no Antigout Agents Cat Antigout Agents Antigout Agents Probenecid no Antigout Agents Antigout Agents Allopurinol no Antigout Agents Febuxostat no Antigout Agents Antigout Agents Colchicine no Antigout Agents Lesinurad no Manufacturer Discontinued Antigout Agents Pegloticase no Antigout Agents Antigout Agents Lesinurad/ Allopurinol yes Manufacturer Discontinued Antigout Agents Probenecid/ Colchicine yes Anti-inflammatory Agents Cat

Anti-inflammatory Agents Glucocorticoids Class

Anti-inflammatory Agents Nonsteroidal Anti-inflammatory Class Drugs Anti-inflammatory Agents Celecoxib no

Anti-inflammatory Agents Diclofenac Potassium no

Anti-inflammatory Agents Diclofenac Epolamine no

Anti-inflammatory Agents Diclofenac Sodium/ Misoprostol yes

Anti-inflammatory Agents Diflunisal no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 16 of 97

Anti-inflammatory Agents Etodolac no

Anti-inflammatory Agents Fenoprofen Calcium no

Anti-inflammatory Agents Flurbiprofen no

Anti-inflammatory Agents Ibuprofen no

Anti-inflammatory Agents Ibuprofen/ Famotidine yes

Anti-inflammatory Agents Indomethacin no

Anti-inflammatory Agents Ketoprofen no

Anti-inflammatory Agents Ketorolac Tromethamine no

Anti-inflammatory Agents Meclofenamate Sodium no

Anti-inflammatory Agents Mefenamic Acid no

Anti-inflammatory Agents Meloxicam no

Anti-inflammatory Agents Nabumetone no

Anti-inflammatory Agents Naproxen Sodium no

Anti-inflammatory Agents Naproxen/ Esomeprazole yes Anti-inflammatory Agents Oxaprozin no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 17 of 97

Anti-inflammatory Agents Piroxicam no

Anti-inflammatory Agents Sulindac no

Anti-inflammatory Agents Tolmetin Sodium no

Antimigraine Agents Cat Antimigraine Agents Ergot Alkaloids Class Antimigraine Agents Mesylate no Antimigraine Agents Tartrate no Antimigraine Agents Serotonin (5-HT) 1b/1d Receptor Class Antimigraine Agents Malate no Antimigraine Agents Hydrobromide no Antimigraine Agents Succinate no Antimigraine Agents Hydrochloride no Antimigraine Agents Benzoate no Antimigraine Agents no Antimigraine Agents Sumatriptan/ Naproxen Sodium yes

Antimigraine Agents no Antimigraine Agents Prophylactic Class Antimigraine Agents Antimigraine Agents Erenumab no Antimigraine Agents no Antimigraine Agents no Antimigraine Agents Antimigraine Agents Maleate no Antimigraine Agents Antimigraine Agents Divalproex Sodium no Antimigraine Agents Topiramate no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 18 of 97

Antimigraine Agents Valproic Acid no Antimyasthenic Agents Cat Antimyasthenic Agents Parasympathomimetics Class Antimyasthenic Agents Guanidine Hydrochloride no Antimyasthenic Agents Pyridostigmine no Antimycobacterials Cat Antimycobacterials Antituberculars Class Antimycobacterials Aminosalicylic Acid no Antimycobacterials Fumarate no Antimycobacterials Capreomycin Sulfate no Antimycobacterials Cycloserine no Antimycobacterials Ethambutol Hydrochloride no Antimycobacterials Ethionamide no Antimycobacterials no Antimycobacterials Pyrazinamide no Antimycobacterials Rifampin no Antimycobacterials Rifapentine no Antimycobacterials Rifampin/ Isoniazid yes Antimycobacterials Rifampin/ Isoniazid/ Pyrazinamide yes

Antimycobacterials Antimycobacterials, Other Class Antimycobacterials Dapsone no Antimycobacterials Rifabutin no Antineoplastics Cat Antineoplastics Alkylating Agents Class Antineoplastics Antineoplastics Altretamine no Manufacturer Discontinued Antineoplastics Antineoplastics Chlorambucil no Antineoplastics Mechlorethamine Hydrochloride no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 19 of 97

Antineoplastics Melphalan no Antineoplastics Antineoplastics Lomustine no Antineoplastics Antineoplastics Busulfan no Antineoplastics Cyclophosphamide no Antineoplastics Hydrochloride no Antineoplastics Temozolomide no Antineoplastics Trabectedin no Antineoplastics Antiandrogens Class Antineoplastics Antineoplastics no Daroflutamide New FDA approved, 7/30/19 Antineoplastics no Antineoplastics Bicalutamide no Antineoplastics Flutamide no Antineoplastics no Antineoplastics Antineoplastics Abiraterone Acetate no Antineoplastics Antiangiogenic Agents Class Antineoplastics Lenalidomide no Antineoplastics Pomalidomide no Antineoplastics Thalidomide no Antineoplastics Antiestrogens/Modifiers Class Antineoplastics Antineoplastics Estramustine Phosphate Sodium no

Antineoplastics Fulvestrant no Antineoplastics Antineoplastics Tamoxifen Citrate no Antineoplastics Toremifene Citrate no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 20 of 97

Antineoplastics Antimetabolites Class Antineoplastics Antineoplastics Capecitabine no Antineoplastics Mercaptopurine no Antineoplastics Thioguanine no Antineoplastics Antineoplastics Hydroxyurea no Antineoplastics Aromatase Inhibitors, 3rd Class Generation Antineoplastics Anastrozole no Antineoplastics Exemestane no Antineoplastics Letrozole no Antineoplastics Inhibitors Class Antineoplastics Etoposide no Antineoplastics Topotecan no Antineoplastics Molecular Target Inhibitors Class

Antineoplastics no Antineoplastics Antineoplastics no Antineoplastics Fumarate no Antineoplastics Antineoplastics no Antineoplastics no Antineoplastics no Antineoplastics no no New FDA approved drug, 11/2/18 Antineoplastics Antineoplastics Mesylate no Antineoplastics no Antineoplastics Dimethyl Sulfoxide no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 21 of 97

Antineoplastics no Antineoplastics Antineoplastics no New FDA approved drug,10/31/17 Antineoplastics no Antineoplastics Antineoplastics no New FDA approved drug, 09/28/17 Antineoplastics no Antineoplastics no New FDA approved drug, 3/13/17 Antineoplastics Antineoplastics no Antineoplastics Antineoplastics Dimaleate no Antineoplastics no Antineoplastics Hydrochloride no no New FDA approved drug, 7/17/17 Antineoplastics Mesylate no

Erdafitinib no New FDA approved drug, 4/12/19 Antineoplastics no New FDA approved drug, 11/21/18 Antineoplastics Phosphate no Antineoplastics no Antineoplastics Antineoplastics no New FDA approved drug, 7/20/18 Antineoplastics Antineoplastics Phosphate no New FDA approved drug, 05/24/19 Antineoplastics Cabazitaxel no Antineoplastics

Antineoplastics no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 22 of 97

Antineoplastics Antineoplastics Monohydrate no Antineoplastics no Antineoplastics Mesylate no Antineoplastics Hydrochloride no Monohydrate Antineoplastics Hydrochloride no Antineoplastics Antineoplastics Ditosylate no Antineoplastics no Antineoplastics S-Malate no Antineoplastics Mesylate no New FDA approved drug 8/2/19 Antineoplastics Hydrochloride no Antineoplastics no Antineoplastics Tosylate no Antineoplastics Malate no Antineoplastics no Antineoplastics no New FDA approved drug, 11/28/18 Antineoplastics no

Larotrectinib no New FDA approved drug, 11/26/18 Antineoplastics Alpelisib no New FDA approved drug, 05/24/19 Antineoplastics Copanlisib no New FDA approved drug, 09/14/17 Antineoplastics Duvelisib no New FDA approved drug, 09/24/18 Antineoplastics Idelalisib no Antineoplastics Antineoplastics Niraparib no New FDA approved drug, 03/27/17

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 23 of 97

Antineoplastics Olaparib no Antineoplastics Rucaparib no New FDA approved drug, 12/19/16 Antineoplastics Talazoparib no New FDA approved drug, 10/16/18 Antineoplastics Antineoplastics no Antineoplastics Antineoplastics Belinostat no Antineoplastics Panobinostat Lactate no Antineoplastics /Antibody- Class Antineoplastics D Cjt no New FDA approved drug, 9/13/18 Antineoplastics Antineoplastics no

Mogamulizumab no New FDA approved drug 8/8/19 Antineoplastics Antineoplastics no Antineoplastics Antineoplastics no Antineoplastics Antineoplastics no Antineoplastics Antineoplastics no Antineoplastics Antineoplastics no Antineoplastics Antineoplastics no / Hyaluronidase no New FDA approved drug, 02/28/19 Antineoplastics Antineoplastics no Antineoplastics

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 24 of 97

Antineoplastics no Antineoplastics Antineoplastics no Antineoplastics no Antineoplastics no Antineoplastics no Antineoplastics no Antineoplastics no Antineoplastics Antineoplastics no Antineoplastics no Antineoplastics no Antineoplastics Rituximab/ Hyaluronidase yes Antineoplastics Antineoplastics Ado- no Antineoplastics no no New FDA approved drug, 09/01/17 Antineoplastics no no New FDA approved drug, 06/10/19 Antineoplastics Retinoids Class Antineoplastics Alitretinoin no Antineoplastics Bexarotene no Antineoplastics Tretinoin no Antineoplastics Treatment Adjuncts Class Antineoplastics Allopurinol no Antineoplastics Mesna no Antineoplastics Rasburicase no Antineoplastics Antineoplastics, Other Class

Methotrexate no Additional placement Pemetrexed Disodium no New FDA approved drug, 5/23/19

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 25 of 97

Antineoplastics Aldesleukin no Antineoplastics Asparaginase-erwinia no Calaspargase Pegol no New FDA approved drug, 12/20/18 Antineoplastics no Antineoplastics no New FDA approved drug, 08/01/17 Antineoplastics Fludarabine Phosphate no Antineoplastics Ixazomib Citrate no Antineoplastics Letrozole/ Ribociclib yes New FDA approved drug, 05/04/17 Antineoplastics Leucovorin no Levoleucovorin Calcium no New FDA approved drug 10/19/18 Antineoplastics Mitoxantrone Hydrochloride no Permetrexed Disodium new FDA approved drug, 5/23/19 Antineoplastics Pegaspargase no Selinexor no New FDA approved drug, 7/3/19 Tagraxofusp no New FDA approved drug, 12/21/18 Antineoplastics Trifluridine/ Tipiracil yes New FDA approved drug, 02/22/19 Antineoplastics no Antiparasitics Cat Antiparasitics Anthelmintics Class Antiparasitics Albendazole no Antiparasitics no Antiparasitics Mebendazole no Antiparasitics Moxidectin no Antiparasitics Praziquantel no Triclabendazole no New FDA approved drug 11/9/18 Antiparasitics Antiprotozoals Class Antiparasitics Antiparasitics Miltefosine no Antiparasitics

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 26 of 97

Antiparasitics Artemether/ Lumefantrine yes Antiparasitics Atovaquone/ Proguanil yes Hydrochloride Antiparasitics Chloroquine Phosphate no Antiparasitics Hydroxychloroquine Sulfate no Antiparasitics Hydrochloride no Antiparasitics Primaquine Phosphate no Antiparasitics Quinine Sulfate no Antiparasitics Tafenoquine Succinate no New FDA approved drug, 7/20/2018 Antiparasitics Antiparasitics Atovaquone no Antiparasitics no Antiparasitics Nitazoxanide no Antiparasitics Pentamidine Isethionate no Antiparasitics Pyrimethamine no Antiparkinson Agents Cat Antiparkinson Agents Class Antiparkinson Agents Benztropine Mesylate no Antiparkinson Agents Diphenhydramine Hydrochloride no

Antiparkinson Agents Hydrochloride no Antiparkinson Agents Agonists Class Antiparkinson Agents Hydrochloride no Antiparkinson Agents Mesylate no Antiparkinson Agents Dihydrochloride no Antiparkinson Agents Hydrochloride no Antiparkinson Agents no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 27 of 97

Antiparkinson Agents Dopamine Precursors/ L-Amino Class Renamed class to add specification Acid Decarboxylase Inhibitors Dopamine Precursors and/or L- Decarboxylase Inhibitors

Antiparkinson Agents no Antiparkinson Agents Carbidopa/ Levodopa yes Levodopa no New FDA approved drug, 12/21/18 Antiparkinson Agents (MAO-B) Class Inhibitors Antiparkinson Agents Mesylate no Antiparkinson Agents no New FDA approved drug, 3/21/17 Antiparkinson Agents Selegiline Hydrochloride no Antiparkinson Agents Antiparkinson Agents, Other Class Antiparkinson Agents Carbidopa/ Levodopa/ yes Antiparkinson Agents EtCarbidopa/ Levodopa/ Gap drug to include combination Antiparkinson Agents Entacapone no Antiparkinson Agents no Antiparkinson Agents Antiparkinson Agents Hydrochloride no Cat Antipsychotics 1st Generation/Typical Class Antipsychotics Chlorpromazine Hydrochloride no

Antipsychotics Hydrochloride no Antipsychotics Fluphenazine Decanoate no Antipsychotics no Antipsychotics no Antipsychotics Succinate no Antipsychotics Perphenazine no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 28 of 97

Antipsychotics no Antipsychotics Prochlorperazine Edisylate no Antipsychotics Prochlorperazine Maleate no Antipsychotics Hydrochloride no Antipsychotics Thiothixene Hydrochloride no Antipsychotics Hydrochloride no Antipsychotics 2nd Generation/Atypical Class Antipsychotics Aripiprazole no Antipsychotics no Antipsychotics no Antipsychotics Cariprazine Hydrochloride no Antipsychotics no Antipsychotics Hydrochloride no Antipsychotics Olanzapine no Antipsychotics Olanzapine Pamoate no Antipsychotics Pimavanserin Tartrate no Antipsychotics Quetiapine Fumarate no Antipsychotics no Antipsychotics Paliperidone Palmitate no Antipsychotics no Antipsychotics Hydrochloride no Antipsychotics Ziprasidone Mesylate no Antipsychotics Treatment-Resistant Class Antipsychotics no Antispasticity Agents Cat Antispasticity Agents no Antispasticity Agents Dantrolene Sodium no Antispasticity Agents Hydrochloride no Antivirals Cat Antivirals Anti-cytomegalovirus (CMV) Agents Class

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 29 of 97

Antivirals Cidofovir no Antivirals Foscarnet Sodium no Antivirals Ganciclovir Sodium no Letermovir no New FDA approved drug,11/08/17 Antivirals Valganciclovir Hydrochloride no Antivirals Anti-hepatitis B (HBV) Agents Class Antivirals Adefovir Dipivoxil no Antivirals Entecavir no Antivirals Lamivudine no Antivirals Ribavirin no Antivirals Tenofovir Alafenamide no New FDA approved drug, 11/10/16 Antivirals Tenofovir Disoproxil Fumarate no Interferon Alfa-2b, Recombinant no

Interferon Alfa-n3 no Peginterferon Alfa-2a no Peginterferon Alfa-2b no Antivirals Anti-hepatitis C (HCV) Agents, Class Other Ribavirin no

Interferon Alfa-2b, Recombinant no

Interferon Alfa-n3 no Peginterferon Alfa-2a no Peginterferon Alfa-2b no Anti-hepatitis C (HCV) Agents Direct Class Acting Agents Ribavirin no

Antivirals Daclatasvir no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 30 of 97

Antivirals Sofosbuvir no Antivirals Antivirals Dasabuvir/ Ombitasvir/ yes Paritaprevir/ Antivirals Elbasvir/ Grazoprevir yes Antivirals Glecaprevir/ Pibrentasvir yes New FDA approved drug, 08/03/17 Antivirals Ledipasvir/ Sofosbuvir yes Antivirals Ombitasvir/ Paritaprevir/ Ritonavir yes

Antivirals Sofosbuvir/ Velpatasvir/ yes Antivirals VilVelpatasvir/ i Sofosbuvir yes Antivirals Antiherpetic Agents Class Antivirals Acyclovir no Antivirals Famciclovir no Antivirals Foscarnet Sodium no Antivirals Idoxuridine no Manufacturer Discontinued Antivirals Penciclovir Sodium no Antivirals Valacyclovir Hydrochloride no Antivirals Anti-HIV Agents, Non-nucleoside Class Reverse Transcriptase Inhibitors (NNRTI)

Antivirals Delavirdine Mesylate no Antivirals Doravirine no Antivirals no Antivirals Etravirine no Antivirals Nevirapine no Antivirals Rilpivirine Hydrochloride no Antivirals Anti-HIV Agents, Nucleoside and Class Nucleotide Reverse Transcriptase Inhibitors (NRTI)

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 31 of 97

Antivirals Abacavir Sulfate no Antivirals Didanosine no Antivirals Emtricitabine no Antivirals Lamivudine no Antivirals Stavudine no Antivirals Tenofovir Disoproxil Fumarate no Antivirals Zidovudine no Antivirals Anti-HIV Agents, Protease Inhibitors Class (PI) Antivirals Atazanavir Sulfate no Antivirals Darunavir no Antivirals Fosamprenavir Calcium no Antivirals Indinavir Sulfate no Antivirals Nelfinavir Mesylate no Antivirals Ritonavir no Antivirals Saquinavir Mesylate no Antivirals Tipranavir no Antivirals Anti-HIV Agents, Integrase Class Inhibitors (INSTI) Antivirals Dolutegravir Sodium no Antivirals Raltegravir Potassium no Antivirals Anti-HIV Agents, Other Class Antivirals Ibalizumab no Antivirals Antivirals Cobicistat no Antivirals Enfuvirtide no Antivirals Maraviroc no Antivirals Anti-HIV Combinations Class New class to add Anti-HIV combination drug products Antivirals Abacavir Sulfate/ Lamivudine yes Antivirals Abacavir Sulfate/ Lamivudine/ yes Zidovudine

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 32 of 97

Antivirals Abacavir/ Dolutegravir/ yes Antivirals LAtazanavir/ i di Cobicistat yes Antivirals Bictegravir/ Emtricitabine/ yes Tenofovir Alafenamide Antivirals Darunavir/ Cobicistat yes Antivirals Darunavir/ Cobicistat/ yes Emtricitabine/ Tenofovir Alafenamide Fumarate Dolutegravir/ Lamivudine yes New FDA approved drug, 4/8/19

Antivirals Dolutegravir/ Rilpivirine yes Antivirals Doravirine/ Lamivudine/ Tenofovir yes Disproxil Fumarate Antivirals Efavirenz/ Emtricitabine/ Tenofovir yes Disoproxil Fumarate

Antivirals Efavirenz/ Lamivudine/ Tenofovir yes Disoproxil Fumarate Antivirals Elvitegravir/ Cobicistat/ yes Emtricitabine/ Tenofovir Alafenamide Fumarate Antivirals Elvitegravir/ Cobicistat/ yes Emtricitabine/ Tenofovir Disoproxil Fumarate Antivirals Emtricitabine/ Rilpivirine / yes Tenofovir Disoproxil Fumarate Antivirals Emtricitabine/ Rilpivirine/ yes Tenofovir Alafenamide Fumarate

Antivirals Emtricitabine/ Tenofovir yes Alafenamide Fumarate Antivirals Emtricitabine/ Tenofovir Disoproxil yes Fumarate

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 33 of 97

Antivirals Lamivudine/ Tenofovir Disoproxil yes Fumarate Antivirals Lamivudine/ Zidovudine yes Antivirals Lopinavir/ Ritonavir yes Antivirals Anti-influenza Agents Class Antivirals Amantadine Hydrochloride no Antivirals Baloxavir Marboxil no Antivirals Oseltamivir Phosphate no Antivirals Peramivir no Antivirals Hydrochloride no Antivirals Zanamivir no Anxiolytics Cat Anxiolytics SSRIs/SNRIs (Selective Serotonin Class Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)

Anxiolytics Duloxetine Hydrochloride no Anxiolytics Escitalopram Oxalate no Anxiolytics Paroxetine Hydrochloride no Anxiolytics Sertraline Hydrochloride no Anxiolytics Venlafaxine Hydrochloride no Anxiolytics Class Anxiolytics no Anxiolytics Chlordiazepoxide no Anxiolytics Clonazepam no Anxiolytics Clorazepate Dipotassium no Anxiolytics Diazepam no Anxiolytics Lorazepam no Anxiolytics no Anxiolytics Anxiolytics, Other Class

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 34 of 97

Anxiolytics Hydrochloride no Anxiolytics Doxepin Hydrochloride no Anxiolytics Hydroxyzine Hydrochloride no Anxiolytics Hydroxyzine Pamoate no Anxiolytics no Bipolar Agents Cat Bipolar Agents Mood Stabilizers Class Bipolar Agents Carbamazepine no Bipolar Agents Divalproex Sodium no Bipolar Agents Lamotrigine no Bipolar Agents Lithium Carbonate no Bipolar Agents Valproic Acid no Bipolar Agents Bipolar Agents, Other Class Bipolar Agents Aripiprazole no Bipolar Agents Asenapine no Bipolar Agents Olanzapine no Bipolar Agents Olanzapine Pamoate no Bipolar Agents Quetiapine Fumarate no Bipolar Agents Risperidone no Bipolar Agents Ziprasidone Hydrochloride no Bipolar Agents Ziprasidone Mesylate no Blood Glucose Regulators Cat

Blood Glucose Regulators Antidiabetic Agents Class

Blood Glucose Regulators

Blood Glucose Regulators Metformin Hydrochloride no

Blood Glucose Regulators

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 35 of 97

Blood Glucose Regulators Alogliptin no

Blood Glucose Regulators Linagliptin no

Blood Glucose Regulators Saxagliptin no

Blood Glucose Regulators Sitagliptin Phosphate no

Blood Glucose Regulators Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators

Blood Glucose Regulators Canagliflozin no

Blood Glucose Regulators Dapagliflozin no

Blood Glucose Regulators Ertugliflozin no New FDA approved drug 12/19/17

Blood Glucose Regulators Empagliflozin no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 36 of 97

Blood Glucose Regulators

Blood Glucose Regulators no Manufacturer Discontinued

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators Glyburide no

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators

Blood Glucose Regulators Pioglitazone Hydrochloride no

Blood Glucose Regulators Rosiglitazone Maleate no

Blood Glucose Regulators

Blood Glucose Regulators Acarbose no

Blood Glucose Regulators Miglitol no

Blood Glucose Regulators

Blood Glucose Regulators no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 37 of 97

Blood Glucose Regulators no

Blood Glucose Regulators Acetate no

Blood Glucose Regulators Colesevelam Hydrochloride no

Blood Glucose Regulators Bromocriptine Mesylate no

Blood Glucose Regulators Antidiabetic Combinations Class New class to add antidiabetic combination drug products

Blood Glucose Regulators Alogliptin Benzoate/ Pioglitazone yes Hydrochloride Blood Glucose Regulators Alogliptin/ Metformin yes Blood Glucose Regulators HCanagliflozin/ d hl id Metformin yes Hydrochloride Blood Glucose Regulators Dapagliflozin/ Metformin yes Hydrochloride Blood Glucose Regulators Dapagliflozin/ Saxagliptin yes Dapagliflozin/ Saxagliptin/ yes New FDA approved drug, 5/2/19 Metformin Hydrochloride Blood Glucose Regulators Empagliflozin/ Linagliptin yes Blood Glucose Regulators Empagliflozin/ Metformin yes New FDA approved drug,12/9/16 Hydrochloride Blood Glucose Regulators Ertugliflozin/ Metformin yes New FDA approved drug,12/19/17 Blood Glucose Regulators HErtugliflozin/ d hl id Sitagliptin yes New FDA approved drug, 12/19/17 Blood Glucose Regulators Glipizide/ Metformin Hydrochloride yes Blood Glucose Regulators Glyburide/ Metformin yes Blood Glucose Regulators HInsulin d hlDegludec/ id Liraglutide yes Blood Glucose Regulators Glargine/ Lixisenatide yes

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 38 of 97

Blood Glucose Regulators Linagliptin/ Metformin yes Blood Glucose Regulators HPioglitazone d hl id Hydrochloride/ yes Glimepiride Blood Glucose Regulators Pioglitazone Hydrochloride/ yes Metformin Hydrochloride Blood Glucose Regulators Repaglinide/ Metformin yes Hydrochloride Blood Glucose Regulators Saxagliptin/ Metformin yes Blood Glucose Regulators HSitagliptin/ d hl idMetformin yes Blood Glucose Regulators Glycemic Agents H d hl id Class

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators Class

Blood Glucose Regulators

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators

Blood Glucose Regulators Insulin Human (Regular) no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 39 of 97

Blood Glucose Regulators

Blood Glucose Regulators Isophane Insulin (Human) no

Blood Glucose Regulators

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators no

Blood Glucose Regulators

Blood Glucose Regulators Insulin Aspart/ Insulin Degludec yes

Blood Glucose Regulators Insulin Aspart Rapid-acting/ yes Insulin Aspart Protamine Blood Glucose Regulators Insulin Lispro Rapid-acting/ Insulin yes Lispro Protamine Blood Glucose Regulators Insulin Human Regular/ Isophane yes Insulin Blood Products/ Modifiers/ Cat Renamed category to remove, "Volume Expanders" since Volume Expanders Blood drugs that are volume expanders also modify blood products. Products and Modifiers

Blood Products and Anticoagulants Class Modifiers Blood Products and Modifiers Blood Products and Dabigatran Etexilate Mesylate no M difi

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 40 of 97

Blood Products and Desirudin no Manufacturer Discontinued Modifiers Blood Products and Modifiers Blood Products and Apixaban no Modifiers Blood Products and Betrixaban no N Modifiers Blood Products and Rivaroxaban no Modifiers Blood Products and Edoxaban Tosylate no Modifiers Blood Products and Modifiers Blood Products and Fondaparinux Sodium no Modifiers Blood Products and Modifiers Blood Products and Heparin, porcine no Modifiers Blood Products and Modifiers Blood Products and Dalteparin Sodium no Modifiers Blood Products and Enoxaparin Sodium no Modifiers Blood Products and Modifiers Blood Products and Vorapaxar Sulfate no Modifiers

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 41 of 97

Blood Products and Modifiers Blood Products and Warfarin Sodium no Modifiers Blood Products and Hemostasis Agents Class Modifiers Blood Products and Modifiers Blood Products and Tranexamic Acid no Modifiers Blood Products and Modifiers Blood Products and 6-Aminocaproic Acid no Modifiers Blood Products and Platelet Modifying Agents Class Modifiers Blood Products and Modifiers Blood Products and Clopidogrel Bisulfate no Modifiers Blood Products and Prasugrel Hydrochloride no Modifiers Blood Products and Ticlopidine Hydrochloride no Modifiers Blood Products and Ticagrelor no Modifiers

Aspirin no Avatrombopag no New FDA approve drug, 05/21/18 no New FDA approved drug, 02/06/19 Cilostazol no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 42 of 97

Dipyridamole no Aspirin/ Dipyridamole yes Fostamatinib no New FDA approved drug, 04/17/2018 Blood Formation Modifiers Blood Class Renamed class to "Blood Products and Modifiers, Other" to Products and Modifiers, Other encompass additional drugs

Filgrastim no no no

Darbepoetin Alfa no Epoetin Alfa no Methoxy polyethylene glycol- no epoetin beta

Anagrelide no

Eltrombopag Olamine no Lusutrombopag no New FDA approved drug, 07/31/2018 Romiplostim no

Plerixafor no Cardiovascular Agents Cat Alpha- Agonists Class Hydrochloride no no Hydrochloride no no Methyldopate Hydrochloride no Manufacturer Discontinued Hydrochloride no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 43 of 97

Phenylephrine Hydrochloride no Alpha-adrenergic Blocking Agents Class

Doxazosin Mesylate no Hydrochloride no

Prazosin Hydrochloride no Hydrochloride no Angiotensin-converting Enzyme Class (ACE) Inhibitors Benazepril Hydrochloride no Captopril no Enalapril Maleate no Fosinopril Sodium no Lisinopril no Moexipril Hydrochloride no Perindopril Erbumine no Quinapril Hydrochloride no Ramipril no Trandolapril no Angiotensin II Receptor Antagonists class

Azilsartan Medoxomil no Candesartan Cilexetil no Eprosartan Mesylate no Irbesartan no Losartan Potassium no Olmesartan Medoxomil no Telmisartan no Valsartan no Antiarrhythmics class

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 44 of 97

Disopyramide Phosphate no Acetate no Hydrochloride no Hydrochloride no Sulfate no

Acebutolol no Added example drug due to antiarrhythmic indication no Added example drug due to antiarrhythmic indication

Amiodarone Hydrochloride no no no Hydrochloride no

Diltiazem no Added example drug due to antiarrhythmic indication no Added example drug due to antiarrhythmic indication

Digoxin no Added example drug due to antiarrhythmic indication Beta-adrenergic Blocking Agents class

Atenolol no Hydrochloride no Fumarate no Succinate no Metoprolol Tartrate no Hydrochloride no

Nadolol no Propranolol Hydrochloride no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 45 of 97

Timolol Maleate no

Acebutolol Hydrochloride no no Removed example drug due to dosage form, ophthalmic solution. Additional placement in USP Category, "Ophthalmic Agents" no Phosphate no Hydrochloride no Calcium Channel Blocking Agents class Removed class and replaced with 2 new USP Classes, "Calcium Channel-Blocking Agents, Dihydropyridines," and "Calcium Channel Blocking Agents, Nondihydropyridines"

Amlodipine Besylate no no no Hydrochloride no no no no

Diltiazem Hydrochloride no Verapamil Hydrochloride no Calcium Channel Blocking Agents, class New Class to provide therapeutic distinction Dihydropyridines Besylate no Felodipine no Isradipine no Nicardipine Hydrochloride no Nifedipine no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 46 of 97

Nimodipine no Nisoldipine no Calcium Channel Blocking Agents, class New Class to provide therapeutic distinction Nondihydropyridines Diltiazem Hydrochloride no Verapamil Hydrochloride no Diuretics, Carbonic Anhydrase class Removed class due to limited relevance to cardiovascular Inhibitors agents. Sodium no Moved example drug to USP Class, "Cardiovascular Agents, Other". Additional placment in USP Category, "Ophthalmic Agents" no Removed example drug due to indication. Additional placement in USP Category, "Ophthalmic Agents" Diuretics, Loop class no Ethacrynate Sodium no Ethacrynic Acid no no Torsemide no Diuretics, Potassium-sparing class Hydrochloride no Eplerenone no Spironolactone no no Diuretics, class Bendroflumethiazide no Manufacturer Discontinued Chlorothiazide Sodium no Chlorthalidone no Hydrochlorothiazide no Indapamide no Methyclothiazide no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 47 of 97

Metolazone no Dyslipidemics, Fibric Acid class Derivatives Fenofibrate no Fenofibrate no Fenofibric Acid no Gemfibrozil no Dyslipidemics, HMG CoA Reductase class Inhibitors Atorvastatin Calcium no Fluvastatin Sodium no Lovastatin no no Sodium no Rosuvastatin Calcium no Simvastatin no Dyslipidemics, Other class Cholestyramine no Colesevelam Hydrochloride no Colestipol Hydrochloride no Ezetimibe no Icosapent Ethyl no Lomitapide Mesylate no Mipomersen Sodium no Manufacturer Discontinued no Omega-3-acid Ethyl Esters no Omega-3 Carboxylic Acids no Manufacturer Discontinued

Ezetimibe/ Simvastatin yes Removed PG

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 48 of 97

Alirocumab no Example drug moved to new USP Class, "Dyslipidemics, PCSK9 Inhibitor." no Example drug moved to new USP Class, "Dyslipidemics, PCSK9 Inhibitor." Dyslipidemics, PCSK9 Inhibitor class New Class to provide therapeutic distinction no Evolocumab no Vasodilators, Direct-acting Arterial class Removed class, replaced with new USP Class, "Vasodilators"

Hydralazine Hydrochloride no no Vasodilators, Direct-acting class Removed class, replaced with new USP Class, "Vasodilators" Arterial/Venous Isosorbide Dinitrate no Isosorbide Mononitrate no Nitroglycerin no Vasodilators class New USP class to consolidate two removed USP classes," Vasodilators, Direct-acting Arterial," and "Vasodilators, Direct- acting Arterial/Venous"

Hydralazine Hydrochloride no Minoxidil no

Isosorbide Dinitrate no Isosorbide Mononitrate no Nitroglycerin no Cardiovascular Agents, Other Class

Acetazolamide no Moved from deleted USP Class, "Diuretics, Carbonic Anhydrase Inhibitors." Aliskiren Fumarate no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 49 of 97

Digoxin no Ivabradine Hydrochloride no Hydrochloride no Pentoxifylline no no Cardiovascular Combinations Class New Class to add specification Aliskiren Hemifumarate/ yes Hydrochlorothiazide Amiloride Hydrochloride/ yes Hydrochlorothiazide Amlodipine Besylate/ Atorvastatin yes Calcium Amlodipine/ Benazepril yes Hydrochloride Amlodipine Besylate/ Celecoxib yes New FDA approved drug, 05/31/18

Amlodipine/ Olmesartan yes Medoxomil Amlodipine/ Valsartan yes Amlodipine/ Valsartan/ yes Hydrochlorothiazide / Chlorthalidone yes Azilsartan Kamedoxomil/ yes Chlorthalidone Benazepril Hydrochloride/ yes Hydrochlorothiazide Bisoprolol Fumarate/ yes Hydrochlorothiazide Candesartan Cilexetil/ yes Hydrochlorothiazide Captopril/ Hydrochlorothiazide yes

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 50 of 97

Enalapril Maleate/ yes Hydrochlorothiazide Ezetimibe/ Simvastatin yes Placed in Dyslipedmics, Other Fosinopril Sodium/ yes Hydrochlorothiazide Hydralazine Hydrochloride/ yes Isosorbide Dinitrate Irbesartan/ Hydrochlorothiazide yes

Lisinopril/ Hydrochlorothiazide yes Losartan Potassium/ yes Hydrochlorothiazide Methyldopa/ Hydrochlorothiazide yes

Metoprolol Succinate/ yes Hydrochlorothiazide Metoprolol Tartrate/ yes Hydrochlorothiazide Moexipril Hydrochloride/ yes Hydrochlorothiazide Nadolol/ Bendroflumethiazide yes Nebivolol Hydrochloride/ Valsartan yes

Olmesartan Medoxmil/ yes Hydrochlorothiazide Olmesartan Medoxomil/ yes Amlodipine Besylate/ Hydrochlorothiazide Perindopril Arginine/ Amlodipine yes Besylate

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 51 of 97

Propranolol Hydrochloride/ yes Hydrochlorothiazide Quinapril Hydrochloride/ yes Hydrochlorothiazide / Valsartan yes Spironolactone/ yes Hydrochlorothiazide Telmisartan/ Amlodipine yes Telmisartan/ Hydrochlorothiazide yes

Trandolapril/ Verapamil yes Hydrochloride Triamterene/ Hydrochlorothiazide yes

Valsartan/ Hydrochlorothiazide yes Central Nervous System Cat Agents Central Nervous System Attention Deficit Hyperactivity Class Agents Disorder Agents,

Central Nervous System no Agents Central Nervous System Dextroamphetamine Sulfate no Agents Central Nervous System Dextroamphetamine Saccharate/ yes Agents Amphetamine Aspartate/ Dextroamphetamine Sulfate/ Amphetamine Sulfate

Central Nervous System Agents

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 52 of 97

Central Nervous System Lisdexamfetamine Dimesylate no Agents Central Nervous System Hydrochloride no Agents Central Nervous System Attention Deficit Hyperactivity Class Agents Disorder Agents, Non- amphetamines Central Nervous System Hydrochloride no Agents Central Nervous System Clonidine Hydrochloride no Agents Central Nervous System no Agents Hydrochloride Central Nervous System Guanfacine Hydrochloride no Agents Central Nervous System Hydrochloride no Agents Central Nervous System Fibromyalgia Agents Class Agents Central Nervous System Duloxetine Hydrochloride no Agents Central Nervous System Hydrochloride no Agents Central Nervous System Pregabalin no Agents Agents Class

Interferon Beta-1a no Interferon Beta-1b no Peginterferon Beta-1a no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 53 of 97

Dalfampridine no

Teriflunomide no

Fingolimod Hydrochloride no Siponimod no New FDA approved drug, 3/26/19

Alemtuzumab no Cladribine no New FDA approved drug, 3/29/19 Dimethyl fumarate no Glatiramer Acetate no Mitoxantrone Hydrochloride no Natalizumab no Ocrelizumab no Daclizumab no Manufacturer Discontinued Central Nervous System, Other Class Phosphate no New FDA approved drug, 11/28/18 Carbamazepine no no New FDA approved drug, 04/03/17 Hydrobromide/ yes Quinidine Sulfate

Central Nervous System Edaravone no Agents Central Nervous System Gabapentin no Agents Central Nervous System no Agents Central Nervous System no Agents

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 54 of 97

Central Nervous System no Agents Central Nervous System no Agents Dental and Oral Agents Cat Dental and Oral Agents Hydrochloride no Dental and Oral Agents Chlorhexidine Gluconate no Dental and Oral Agents Doxycycline Hyclate no Dental and Oral Agents Minocycline Hydrochloride no Dental and Oral Agents no Dental and Oral Agents Pilocarpine Hydrochloride no Dental and Oral Agents Prilocaine Hydrochloride no Dental and Oral Agents Triamcinolone Acetonide no Dermatological Agents Cat Dermatological Agents Acne and Rosacea Agents Class New class to add acne and rosacea agents Dermatological Agents Dermatological Agents Acitretin no Dermatological Agents Adapalene no Dermatological Agents Isotretinoin no Dermatological Agents Tazarotene no Dermatological Agents Tretinoin no Dermatological Agents Dermatological Agents Azelaic Acid no Dermatological Agents Tartrate no Dermatological Agents no Dermatological Agents Dermatological Agents Adapalene/ Benzoyl Peroxide yes Dermatological Agents Clindamycin/ Benzoyl Peroxide yes

Dermatological Agents Clindamycin/ Tretinoin yes

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 55 of 97

Dermatological Agents Erythromycin/ Benzoyl Peroxide yes

Dermatological Agents Dermatitis and Pruritus Agents Class New class to add dermatitis and pruritus agents Dermatological Agents Dermatological Agents Alclometasone Dipropionate no Dermatological Agents Clocortolone Pivalate no Dermatological Agents Desonide no Dermatological Agents Hydrocortisone no Dermatological Agents Dermatological Agents Betamethasone Valerate no Dermatological Agents Desoximetasone no Dermatological Agents Fluocinolone Acetonide no Dermatological Agents Flurandrenolide no Dermatological Agents Fluticasone Propionate no Dermatological Agents Hydrocortisone Butyrate no Dermatological Agents Hydrocortisone Probutate no Dermatological Agents Hydrocortisone Valerate no Dermatological Agents Mometasone Furoate no Dermatological Agents Triamcinolone Acetonide no Dermatological Agents Dermatological Agents Amcinonide no Dermatological Agents Betamethasone Dipropionate no Dermatological Agents Desoximetasone no Dermatological Agents Diflorasone Diacetate no Dermatological Agents Fluocinolone Acetonide no Dermatological Agents Fluocinonide no Dermatological Agents Halcinonide no Dermatological Agents Triamcinolone Acetonide no Dermatological Agents Dermatological Agents Betamethasone Dipropionate no Dermatological Agents Clobetasol Propionate no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 56 of 97

Dermatological Agents Diflorasone Diacetate no Dermatological Agents Halobetasol Propionate no Dermatological Agents Dermatological Agents Ammonium Lactate no Dermatological Agents Crisaborole no New FDA approved drug, 12/14/16 Dermatological Agents Doxepin Hydrochloride no Dermatological Agents Pimecrolimus no Dermatological Agents Selenium Sulfide no Tacrolimus no Dermatological Agents Topical Anti-infectives Class New class to add topical anti-infectives Dermatological Agents Dermatological Agents Clindamycin Phosphate no Dermatological Agents Erythromycin no Dermatological Agents Benzoyl Peroxide no Dermatological Agents Dapsone no Dermatological Agents Ozenoxacin no New FDA approved drug, 12/11/17 Dermatological Agents Dermatological Agents Butenafine Hydrochloride no Dermatological Agents Ciclopirox Olamine no Dermatological Agents Efinaconazole no Dermatological Agents Ketoconazole no Dermatological Agents Tavaborole no Dermatological Agents Terbinafine Hydrochloride no Dermatological Agents Dermatological Agents Acyclovir no Dermatological Agents Penciclovir no Dermatological Agents Pediculicides/Scabicides Class USP Class moved from USP Category, "Antiparasitics." Dermatological Agents no Dermatological Agents Ivermectin no Dermatological Agents no Dermatological Agents no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 57 of 97

Dermatological Agents Spinosad no Dermatological Agents Dermatological Agents, Other Class New class to add miscellaneous dermatological agents Dermatological Agents Dermatological Agents AbobotulinumyoxinA no Dermatological Agents no Dermatological Agents Deoxycholic Acid no Dermatological Agents Eflornithine no Dermatological Agents Finasteride no Dermatological Agents Glycopyrronium no Dermatological Agents OnabotulinumtoxinA no PrabotulinumtoxinA no New FDA approved drug, 02/01/19 Dermatological Agents Dermatological Agents Anthralin no Dermatological Agents Apremilast no Dermatological Agents Calcipotriene no Dermatological Agents Calcitriol no Dermatological Agents Methoxsalen no Dermatological Agents Dermatological Agents Diclofenac Sodium no Dermatological Agents Fluorouracil no Dermatological Agents Imiquimod no Dermatological Agents Ingenol mebutate no Dermatological Agents Podofilox no Dermatological Agents Sinecatechins no Dermatological Agents Dermatological Agents no Dermatological Agents Collagenase no Dermatological Agents Silver Sulfadiazine no Dermatological Agents Dermatological Agents Acyclovir/ Hydrocortisone yes

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 58 of 97

Dermatological Agents Calcipotriene/ Betamethasone yes Dipropionate Dermatological Agents Clotrimazole/ Betamethasone yes Dipropionate Dermatological Agents Fluocinolone Acetonide/ yes Hydroquinone/ Tretinoin Dermatological Agents Hydrocortisone Acetate/ yes Pramoxine Hydrochloride Dermatological Agents Neomycin/ Polymyxin B Sulfates/ yes Bacitracin Zinc/ Hydrocortisone

Dermatological Agents Neomycin Sulfate/ Fluocinolone yes Acetonide Dermatological Agents Nystatin/ Triamcinolone Acetonide yes

Electrolytes/Minerals/Metal Cat s/ Vitamins Electrolytes/Minerals/Metal Electrolyte/Mineral/Metal Modifiers Class s/ Electrolytes/Minerals/Metal s/ Electrolytes/Minerals/Metal Deferasirox no s/ Electrolytes/Minerals/Metal Deferiprone no s/ Electrolytes/Minerals/Metal s/ Electrolytes/Minerals/Metal Penicillamine no s/ Electrolytes/Minerals/Metal Succimer no s/

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 59 of 97

Electrolytes/Minerals/Metal Tolvaptan no s/ Electrolytes/Minerals/Metal Trientine Hydrochloride no s/ Electrolytes/Minerals/Metal s/ Electrolytes/Minerals/Metal Prussian Blue no s/ Electrolytes/Minerals/Metal Zinc Acetate no s/ Electrolytes/Minerals/Metal Electrolyte/Mineral Replacement Class s/ Electrolytes/Minerals/Metal Ammonium no s/ Electrolytes/Minerals/Metal Carglumic Acid no s/ Electrolytes/Minerals/Metal Chromic Chloride no s/ Electrolytes/Minerals/Metal Citric Acid/ Potassium Citrate/ yes s/ Sodium Citrate Electrolytes/Minerals/Metal Fluoride Sodium no s/ Electrolytes/Minerals/Metal Fluoride Stannous no s/ Electrolytes/Minerals/Metal Magnesium Chloride no s/ Electrolytes/Minerals/Metal Magnesium Sulfate no s/ Electrolytes/Minerals/Metal Manganese Chloride no s/

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 60 of 97

Electrolytes/Minerals/Metal Potassium Acetate no s/ Electrolytes/Minerals/Metal Potassium Bicarbonate no s/ Electrolytes/Minerals/Metal Potassium Chloride no s/ Electrolytes/Minerals/Metal Potassium Citrate no s/ Electrolytes/Minerals/Metal Potassium Gluconate no s/ Electrolytes/Minerals/Metal Potassium Phosphates no s/ Electrolytes/Minerals/Metal Potassium Citrate/ Citric Acid yes Electrolytes/Minerals/Metal/ Potassium Citrate/ Sodium Citrate yes Electrolytes/Minerals/Metal/ Potassium Phosphate/ Sodium yes s/ Phosphate Electrolytes/Minerals/Metal Sodium Acetate no s/ Electrolytes/Minerals/Metal Sodium Bicarbonate no s/ Electrolytes/Minerals/Metal Sodium Lactate no s/ Electrolytes/Minerals/Metal Sodium Chloride no s/ Electrolytes/Minerals/Metal Sodium Ferric Gluconate Complex no s/

Electrolytes/Minerals/Metal Phosphate Binders Class s/ Electrolytes/Minerals/Metal Calcium Acetate no s/

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 61 of 97

Electrolytes/Minerals/Metal Ferric Citrate no s/ Electrolytes/Minerals/Metal Lanthanum Carbonate no s/ Electrolytes/Minerals/Metal Sevelamer Hydrochloride no s/ Electrolytes/Minerals/Metal Sodium Zirconium Cyclosilicate no s/ Electrolytes/Minerals/Metal Sucroferric Oxyhydroxide no s/ Electrolytes/Minerals/Metal Potassium Binders Class s/ Electrolytes/Minerals/Metal Patiromer Sorbitex Calcium no s/ Electrolytes/Minerals/Metal Sodium Polystyrene Sulfonate no s/ Electrolytes/Minerals/Metal Vitamins Class s/ Electrolytes/Minerals/Metal Prenatal no s/ Gastrointestinal Agents Cat

Gastrointestinal Agents Anti-Diarrheal Agents Class New class to add anti-diarrheal agents

Gastrointestinal Agents Alosetron Hydrochloride no

Gastrointestinal Agents no

Gastrointestinal Agents Eluxadoline no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 62 of 97

Gastrointestinal Agents Hydrochloride no

Rifamycin no New FDA approved drug, 11/16/18 Gastrointestinal Agents Rifaximin no

Gastrointestinal Agents no New FDA approved drug, 02/28/17

Gastrointestinal Agents

Gastrointestinal Agents Difenoxin/ Sulfate yes

Gastrointestinal Agents Diphenoxylate Hydrochloride/ yes Atropine Sulfate Gastrointestinal Agents Antispasmodics, Gastrointestinal Class

Gastrointestinal Agents Dicyclomine Hydrochloride no

Gastrointestinal Agents Glycopyrrolate no

Gastrointestinal Agents Bromide no Manufacturer Discontinued

Gastrointestinal Agents Methscopolamine Bromide no

Gastrointestinal Agents Scopolamine no

Gastrointestinal Agents Anti- Agents Class New class to add anti-constipation agents

Gastrointestinal Agents

Gastrointestinal Agents Lactulose no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 63 of 97

Gastrointestinal Agents Polyethylene Glycol 3350 NF no

Te Tenaparor New FDA approved drug, 09/12/19 Gastrointestinal Agents

Gastrointestinal Agents Lubiprostone no

Gastrointestinal Agents Methylnaltrexone no

Gastrointestinal Agents Naloxegol Oxalate no

Gastrointestinal Agents Naldemedine no

Gastrointestinal Agents

Gastrointestinal Agents Linaclotide no

Gastrointestinal Agents Plecanatide no New FDA approved drug,1/19/17

Prucalopride no New FDA approved drug, 12/14/18 Gastrointestinal Agents Histamine2 (H2) Receptor Class Antagonists Gastrointestinal Agents Cimetidine Hydrochloride no

Gastrointestinal Agents Famotidine no

Gastrointestinal Agents Nizatidine no

Gastrointestinal Agents Ranitidine Hydrochloride no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 64 of 97

Irritable Bowel Syndrome Agents Class Removed class due to broaden class name to effect rather than disease state. Example drugs moved to new classes, Anti-Diarrheal agents and Anti-Constipation Agents.

Laxatives Class Removed class to broaden class name to Anti-Constipation Agents. Gastrointestinal Agents Protectants Class

Gastrointestinal Agents Misoprostol no

Gastrointestinal Agents Sucralfate no

Gastrointestinal Agents Proton Pump Inhibitors Class

Gastrointestinal Agents Dexlansoprazole no

Gastrointestinal Agents Esomeprazole Magnesium no

Strontium no Gastrointestinal Agents Lansoprazole no

Gastrointestinal Agents Omeprazole no

Gastrointestinal Agents Omeprazole/ Sodium Bicarbonate yes

Gastrointestinal Agents Pantoprazole Sodium no

Gastrointestinal Agents Rabeprazole Sodium no

Gastrointestinal Agents Gastrointestinal Agents, Other Class

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 65 of 97

Gastrointestinal Agents Alvimopan no

Gastrointestinal Agents Bezlotoxumab no

Gastrointestinal Agents Chenodiol no

Gastrointestinal Agents Metoclopramide no

Gastrointestinal Agents no

Gastrointestinal Agents Rifaximin no

Gastrointestinal Agents Ursodiol no

Moved PG Bismuth Subcitrate Potassium/ yes Example drug incorporated to account for combinations Metronidazole/ Tetracycline Hydrochloride Lansoprazole/ Amoxicillin/ yes Example drug incorporated to account for combinations Clarithromycin Omeprazole/ Clarithromycin/ yes Example drug incorporated to account for combinations Amoxicillin Gastrointestinal Agents

Gastrointestinal Agents no

Gastrointestinal Agents Somatropin no

Gastrointestinal Agents no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 66 of 97

Gastrointestinal Agents

Gastrointestinal Agents Polyethylene Glycol 3350/ Sodium yes Chloride/ Potassium Chloride/ Sodium Bicarbonate/ Sodium Sulfate Gastrointestinal Agents Polyethylene Glycol 3350/ Sodium yes Chloride/ Sodium Bicarbonate/ Potassium Chloride

Gastrointestinal Agents Polyethylene Glycol 3350/ Sodium yes Chloride/ Sodium Bicarbonate/ Potassium Chloride/ Bisacodyl

Gastrointestinal Agents Polyethylene Glycol 3350/ Sodium yes Sulfate/ Sodium Chloride/ Potassium Chloride/ Ascorbic Acid/ Sodium Ascorbate

Gastrointestinal Agents Sodium Picosulfate/ Magnesium yes Oxide/ Anhydrous Citric Acid

Genetic or Enzyme Cat Disorder: Replacement, Modifiers, Treatment Genetic or Enzyme Disorder Genetic or Enzyme no Disorder Genetic or Enzyme Patisiran no Disorder

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 67 of 97

Tafamidis no New FDA approved drug, 5/3/19 Meglumine no New FDA approved drug, 5/3/19 Genetic or Enzyme Disorder Genetic or Enzyme no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Alpha-1 Proteinase Inhibitor, no GeneticDi d or Enzyme H Disorder Genetic or Enzyme Cerliponase alfa no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Cholic Acid no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Cysteamine Bitartrate no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Eteplirsen no Disorder

Genetic or Enzyme Disorder Genetic or Enzyme Agalsidase Beta no Disorder

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 68 of 97

Genetic or Enzyme Migalastat Hydrochloride no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Imiglucerase no Disorder Genetic or Enzyme Taliglucerase Alfa no Disorder Genetic or Enzyme Velaglucerase Alfa no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Eliglustat no Disorder Genetic or Enzyme Miglustat no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Disorder Genetic or Enzyme Nitisinone no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Betaine Hydrochloride no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Idursulfase no Disorder

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 69 of 97

Genetic or Enzyme Disorder Genetic or Enzyme Dichlorphenamide no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Asfotase Alfa no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Sebelipase Alfa no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Disorder Genetic or Enzyme Galsulfase no Disorder Genetic or Enzyme Laronidase no Disorder Genetic or Enzyme Elosulfase Alfa no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Pancrelipase no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Pegvaliase no New FDA approved drug, 05/24/18 Disorder

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 70 of 97

Genetic or Enzyme Sapropterin Dihydrochloride no Disorder

Genetic or Enzyme Disorder Genetic or Enzyme Elapegademase no New FDA approved drug, 10/05/18 Disorder Genetic or Enzyme Pegademase Bovine no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Glutamine no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Sacrosidase no Disorder Genetic or Enzyme Disorder Genetic or Enzyme Sodium Phenylbutyrate no Disorder Genetic or Enzyme Glycerol Phenylbutyrate no Disorder Genetic or Enzyme Obeticholic Acid no Disorder Genitourinary Agents Cat Genitourinary Agents Antispasmodics, Urinary Class Genitourinary Agents Genitourinary Agents no New FDA approved drug, 10/12/18 Genitourinary Agents Genitourinary Agents Hydrobromide no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 71 of 97

Genitourinary Agents Fumarate no Genitourinary Agents Hydrochloride no Genitourinary Agents Chloride no Genitourinary Agents Succinate no Genitourinary Agents Tartrate no Genitourinary Agents no Genitourinary Agents Benign Prostatic Hypertrophy Class Agents Genitourinary Agents Genitourinary Agents Hydrochloride no Genitourinary Agents Mesylate no Genitourinary Agents Hydrochloride no Genitourinary Agents no Genitourinary Agents Hydrochloride no Genitourinary Agents Terazosin Hydrochloride no Genitourinary Agents Genitourinary Agents Dutasteride no Genitourinary Agents Dutasteride/ Tamsulosin yes Hydrochloride Genitourinary Agents Finasteride no Genitourinary Agents Genitourinary Agents Tadalafil no Genitourinary Agents Genitourinary Agents, Other Class Genitourinary Agents no Genitourinary Agents Penicillamine no Genitourinary Agents Pentosan Polysulfate Sodium no Hormonal Agents, Cat Stimulant/ Replacement/ Modifying (Adrenal)

Hormonal

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 72 of 97

Hormonal Corticotropin no Hormonal Hormonal Betamethasone Acetate/ yes Betamethasone Sodium Phosphate Hormonal Budesonide no Hormonal Cortisone Acetate no Hormonal Deflazacort no New FDA approved drug, 2/9/17 Hormonal Acetate no Hormonal Dexamethasone Sodium no Phosphate Hormonal Hydrocortisone Acetate no Hormonal Hydrocortisone Sodium Succinate no Hormonal Methylprednisolone Acetate no Hormonal Methylprednisolone Sodium no Hormonal SitPrednisolone Acetate no Hormonal Prednisolone Sodium Phosphate no

Hormonal Prednisone no Hormonal Triamcinolone Acetonide no Hormonal Triamcinolone Diacetate no Manufacturer Discontinued Hormonal Triamcinolone Hexacetonide no Hormonal Hormonal Fludrocortisone Acetate no Hormonal Agents, Cat Stimulant/Replacement/ Modifying (Pituitary) Hormonal Hormonal Chorionic Gonadotropin no Hormonal Choriogonadotropin Alfa no Hormonal

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 73 of 97

Hormonal Somatropin, Recombinant no Hormonal Tesamorelin Acetate no Hormonal Hormonal Rinfabate no Hormonal Hormonal Desmopressin Acetate no Hormonal no Hormonal Agents, Cat Stimulant/ Replacement/ Modifying ()

Hormonal Alprostadil no Hormonal Carboprost Tromethamine no Hormonal Misoprostol no Hormonal Agents, Cat Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers)

Hormonal Anabolic Steroids Class Hormonal Oxandrolone no Hormonal Oxymetholone no Hormonal Androgens Class Hormonal Danazol no Hormonal Fluoxymesterone no Hormonal Methyltestosterone no Hormonal Cypionate no Hormonal Testosterone Enanthate no Hormonal Class Hormonal Acetate no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 74 of 97

Hormonal Estradiol Cypionate no Hormonal Estradiol Valerate no Hormonal Conjugated Estrogens no Hormonal Esterified Estrogens no Hormonal Estropipate no Hormonal Ethinyl Estradiol no Agonists/Antagonists Class Removed class, example drug not FRF eligible

Ulipristal Hormonal Progestins Class Hormonal Hydroxyprogesterone Caproate no

Hormonal Levonorgestrel no Hormonal Medroxyprogesterone Acetate no Hormonal Megestrol Acetate no Hormonal Norethindrone Acetate no Hormonal Progesterone no Hormonal Selective Receptor Class Hormonal M dif i A t Conjugated Estrogens/ yes Hormonal B d if no Hormonal Raloxifene Hydrochloride no Hormonal Ospemifene no Hormonal Hormonal Agents, Stimulant/ Class New class to add combination drug products Replacement/ Modifying (Sex Hormones/ Modifiers), Other Hormonal Estradiol/ yes Hormonal Estradiol/ Levonorgestrel yes Hormonal Estradiol/ Norethindrone Acetate yes

Estradiol/ Progesterone no New FDA approved drug, 10/28/18

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 75 of 97

Hormonal Agents, Cat Stimulant/Replacement/ Modifying (Thyroid) Hormonal Levothyroxine Sodium no Hormonal Liothyronine Sodium no Hormonal Liotrix no Manufacturer Discontinued Hormonal Agents, Cat Suppressant (Adrenal) Hormonal Mitotane no Hormonal Agents, Cat Suppressant (Pituitary) Hormonal Hormonal Bromocriptine Mesylate no Hormonal no Hormonal Hormonal Goserelin Acetate no Hormonal Leuprolide Acetate no Hormonal Nafarelin Acetate no Hormonal Triptorelin Pamoate no Hormonal Hormonal Degarelix Acetate no Hormonal Elagolix no Hormonal Hormonal Pegvisomant no Hormonal Hormonal Lanreotide Acetate no Hormonal Octreotide Acetate no Hormonal Pasireotide Diaspartate no Hormonal Pamoate no Hormonal Agents, Cat Suppressant (Thyroid)

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 76 of 97

Hormonal Antithyroid Agents Class Hormonal Methimazole no Hormonal Propylthiouracil no Immunological Agents Cat Immunological Agents Angioedema Agents Class Immunological Agents Immunological Agents Acetate no Immunological Agents Immunological Agents C1 esterase inhibitor (human) no Immunological Agents C1 esterase inhibitor no Immunological Agents ( bi t) Immunological Agents Lanadelumab no Immunological Agents Immune Suppressants Class Immunological Agents Immunological Agents Mycophenolic Acid no Immunological Agents Immunological Agents Tacrolimus no Immunological Agents Cyclosporine no Immunological Agents Immunological Agents no New FDA approved drug, 05/31/18 Immunological Agents Tofacitinib Citrate no Immunological Agents Immunological Agents no Immunological Agents Immunological Agents Mercaptopurine no Immunological Agents Abatacept no Immunological Agents Anakinra no Immunological Agents Belatacept no Immunological Agents Everolimus no Immunological Agents Sodium no Immunological Agents Pimecrolimus no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 77 of 97

Immunological Agents Immunological Agents Azathioprine no Immunological Agents Immunological Agents Adalimumab no Immunological Agents Certolizumab Pegol no Immunological Agents Etanercept no Immunological Agents Golimumab no Immunological Agents Infliximab no Class

Anti-thymocyte Globulin no Immune Globulin Intramuscular no (Human) Immune Globulin Intravenous no (Human) Class Immunological Agents Immunological Agents Belimumab no Immunological Agents Immunological Agents Interferon Gamma-1b, no Recombinant Immunological Agents Immunological Agents Brodalumab no New FDA approved drug, 02/15/19 Immunological Agents Canakinumab no Immunological Agents Dupilumab no Immunological Agents Guselkumab no Immunological Agents Ixekizumab no Immunological Agents Rilonacept no Immunological Agents Risankizumab no New FDA approved drug, 04/23/19 Immunological Agents Sarilumab no Immunological Agents Secukinumab no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 78 of 97

Immunological Agents no Tildrakizumab no New FDA approved drug, 03/20/18 Tocilizumab no

Auranofin no Apremilast no Eculizumab no Immunological Agents Emapalumab no New FDA approved drug, 11/20/18 Immunological Agents Leflunomide no Immunological Agents Natalizumab no Immunological Agents Omalizumab no Immunological Agents Ravulizumab no New FDA approved drug, 12/21/18 Immunological Agents Vedolizumab no Immunological Agents Immunological Agents Sweet Vernal/ Orchard/ Perennial yes Rye/ Timothy/ Kentucky Blue Grass Mixed Pollens Allergen Extract

Immunological Agents Vaccines Class Immunological Agents Immunological Agents Adenovirus Type 4 and Type 7 yes Vaccine Live Oral

Immunological Agents Anthrax Vaccine Adsorbed no Immunological Agents Immunological Agents Cholera Vaccine Live Oral no Immunological Agents Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed (DTaP)

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 79 of 97

Immunological Agents Tetanus and Diphtheria Toxoids yes Adsorbed (Td) Immunological Agents Diphtheria and Tetanus Toxoids yes Adsorbed (DT) Immunological Agents Tetanus Toxoid, Reduced yes Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)

Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Absorbed and Inactivated Poliovirus (DTaP- IPV) Vaccine

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine (DTaP-HepB- IPV)

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) (DTaP-IPV/Hib)

Immunological Agents Haemophilus B Conjugate no Vaccine (Tetanus Toxoid Conjugate)

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 80 of 97

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) (DTaP-IPV/Hib)

Immunological Agents Immunological Agents Hepatitis A Vaccine no Immunological Agents Hepatitis A and Hepatitis B yes (Recombinant) Vaccine Immunological Agents Immunological Agents Hepatitis B Virus Vaccine no Recombinant Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine (DTaP-HepB- IPV)

Immunological Agents Hepatitis A and Hepatitis B yes (Recombinant) Vaccine Immunological Agents Immunological Agents Human Papillomavirus yes Quadrivalent (types 6, 11, 16 and 18) Vaccine Recombinant

Immunological Agents Immunological Agents Influenza Vaccine no Influenza Vaccine Live no Immunological Agents

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 81 of 97

Immunological Agents Japanese Encephalitis Virus, no Inactivated, Adsorbed Immunological Agents Immunological Agents Measles, Mumps, and Rubella yes Virus Vaccine Live Immunological Agents Measles, Mumps, Rubella, and yes Varicella Virus Vaccine Live

Immunological Agents Immunological Agents Meningococcal Groups (A, C, Y, yes and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Immunological Agents Meningococcal Group B Vaccine no

Immunological Agents Immunological Agents Measles, Mumps, and Rubella yes Virus Vaccine Live Immunological Agents Measles, Mumps, Rubella, and yes Varicella Virus Vaccine Live

Immunological Agents Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed (DTaP)

Tetanus Toxoid, Reduced yes Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 82 of 97

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Absorbed and Inactivated Poliovirus (DTaP- IPV) Vaccine

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine (DTaP-HepB- IPV)

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) (DTaP-IPV/Hib)

Immunological Agents Pneumococcal 13-Valent no Conjugate Vaccine Immunological Agents Pneumococcal Vaccine Polyvalent no

Immunological Agents Immunological Agents Poliovirus Vaccine Inactivated no Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Absorbed and Inactivated Poliovirus (DTaP- IPV) Vaccine

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 83 of 97

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine (DTaP-HepB- IPV)

Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) (DTaP-IPV/Hib)

Immunological Agents Immunological Agents Rabies Vaccine no Immunological Agents Immunological Agents Rotavirus Vaccine Live no Immunological Agents Immunological Agents Measles, Mumps, and Rubella yes Virus Vaccine Live Immunological Agents Measles, Mumps, Rubella, and yes Varicella Virus Vaccine Live

Immunological Agents Immunological Agents Zoster Vaccine Live no Immunological Agents Zoster Vaccine Recombinant, no Adjuvanted

Immunological Agents Varicella Virus Vaccine Live no Immunological Agents

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 84 of 97

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed (DTaP)

Tetanus and Diphtheria Toxoids yes Adsorbed (Td) Immunological Agents Diphtheria and Tetanus Toxoids yes Adsorbed (DT) Immunological Agents Tetanus Toxoid, Reduced yes Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Absorbed and Inactivated Poliovirus (DTaP- IPV) Vaccine

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine (DTaP-HepB- IPV)

Immunological Agents Diphtheria and Tetanus Toxoids yes and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) (DTaP-IPV/Hib)

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 85 of 97

BCG vaccine no

Typhoid Vaccine Live Oral no Typhoid Vi Polysaccharide no Vaccine

Varicella Virus Vaccine Live no Measles, Mumps, Rubella, and yes Varicella Virus Vaccine Live

Immunological Agents Yellow Fever Vaccine no Inflammatory Bowel Cat Disease Agents Inflammatory Bowel Glucocorticoids Class Inflammatory Bowel Budesonide no Inflammatory Bowel Cortisone Acetate no Inflammatory Bowel Dexamethasone Acetate no Inflammatory Bowel Dexamethasone Sodium no Phosphate Inflammatory Bowel Hydrocortisone Sodium Succinate no Inflammatory Bowel Methylprednisolone Acetate no Inflammatory Bowel Methylprednisolone Sodium no Inflammatory Bowel SitPrednisolone Acetate no Inflammatory Bowel Prednisolone Sodium Succinate no Inflammatory Bowel Prednisone no Inflammatory Bowel Triamcinolone Acetonide no Inflammatory Bowel Triamcinolone Diacetate no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 86 of 97

Inflammatory Bowel Aminosalicylates Aminosalicylates Class Renamed Class to add specification and/ or Prodrugs

Inflammatory Bowel Balsalazide Disodium no Inflammatory Bowel Mesalamine no Inflammatory Bowel Olsalazine Sodium no Sulfasalazine no Added example drug from removed USP Class, "Sulfonamides." Inflammatory Bowel Sulfonamides Class Removed USP Class, example drug moved to renamed USP Class, "Aminosalicylates and/or Prodrugs." Inflammatory Bowel Sulfasalazine no Example drug moved to renamed USP Class, "Aminosalicylates and/or Prodrugs" Metabolic Disease Cat MetabolicAt Bone Disease

Metabolic Bone Disease Alendronate Sodium no

Metabolic Bone Disease Alendronate Sodium/ yes Gap drug incoporated to include combination Cholecalciferol Metabolic Bone Disease Etidronate Disodium no

Metabolic Bone Disease Ibandronate Sodium no

Metabolic Bone Disease Pamidronate Disodium no

Metabolic Bone Disease Risedronate Sodium no

Metabolic Bone Disease Zoledronic Acid no

Metabolic Bone Disease

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 87 of 97

Metabolic Bone Disease no New FDA approved drug 04/28/17

Metabolic Bone Disease , Salmon no

Metabolic Bone Disease no

Metabolic Bone Disease no

Metabolic Bone Disease

Metabolic Bone Disease Cinacalcet Hydrochloride no

Metabolic Bone Disease Etelcalcetide no

Metabolic Bone Disease

Metabolic Bone Disease no

Metabolic Bone Disease

Metabolic Bone Disease Calcifediol no

Metabolic Bone Disease Calcitriol no

Metabolic Bone Disease Doxercalciferol no

Metabolic Bone Disease Paricalcitol no

Romosozumab no New FDA approved drug, 4/9/19 Ophthalmic Agents Cat

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 88 of 97

Ophthalmic Agents Ophthalmic Anti- Agents Class

Ophthalmic Agents Ophthalmic Agents Azelastine Hydrochloride no Ophthalmic Agents Cetirizine Hydrochloride no Ophthalmic Agents Emedastine Difumarate no Ophthalmic Agents Epinastine Hydrochloride no Ophthalmic Agents Hydrochloride no Ophthalmic Agents Ophthalmic Agents Alcaftadine no Ophthalmic Agents Bepotastine Besilate no Ophthalmic Agents Ophthalmic Agents Cromolyn Sodium no Ophthalmic Agents Lodoxamide Tromethamine no Ophthalmic Agents Nedocromil Sodium no Ophthalmic Agents Ophthalmic Antiglaucoma Agents Class Renamed class to broaden class name to effect rather than Lowering disease state. Agents Ophthalmic Agents no Ophthalmic Agents Ophthalmic Agents Hydrochloride no Ophthalmic Agents Brimonidine Tartrate no Ophthalmic Agents Ophthalmic Agents Betaxolol Hydrochloride no Ophthalmic Agents Carteolol Hydrochloride no Ophthalmic Agents Hydrochloride no Ophthalmic Agents Hydrochloride no Ophthalmic Agents Timolol Maleate no Ophthalmic Agents Ophthalmic Agents Acetazolamide no Ophthalmic Agents no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 89 of 97

Ophthalmic Agents Hydrochloride no Ophthalmic Agents Methazolamide no Ophthalmic Agents Ophthalmic Agents no Ophthalmic Agents Iodide no Ophthalmic Agents Pilocarpine Hydrochloride no Ophthalmic Agents Pilocarpine Nitrate no Ophthalmic Agents Ophthalmic Agents Bimatoprost no Ophthalmic Agents no Ophthalmic Agents Latanoprostene Bunod no New FDA approved drug, 11/02/17 Ophthalmic Agents no Ophthalmic Agents no Ophthalmic Agents Ophthalmic Agents Ophthalmic Anti-Infectives Class New class to add ophthalmic anti-infectives Ophthalmic Agents Ophthalmic Agents Azithromycin no Ophthalmic Agents Bacitracin no Ophthalmic Agents Besifloxacin Hydrochloride no Ophthalmic Agents Ciprofloxacin no Ophthalmic Agents Erythromycin no Ophthalmic Agents Gatifloxacin no Ophthalmic Agents Gentamicin Sulfate no Ophthalmic Agents Levofloxacin no Ophthalmic Agents Moxifloxacin Hydrochloride no Ophthalmic Agents Ofloxacin no Ophthalmic Agents Sulfacetamide Sodium no Ophthalmic Agents Tobramycin no Ophthalmic Agents Ophthalmic Agents Ophthalmic Agents Natamycin no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 90 of 97

Ophthalmic Agents Ophthalmic Agents Ganciclovir Sodium no Ophthalmic Agents Trifluridine no Ophthalmic Agents Ophthalmic Anti-inflammatories Class

Ophthalmic Agents Ophthalmic Agents Dexamethasone no Ophthalmic Agents Difluprednate no Ophthalmic Agents Fluorometholone Acetate no Ophthalmic Agents Loteprednol Etabonate no Ophthalmic Agents Prednisolone Acetate no Ophthalmic Agents Sodium Phosphate no Ophthalmic Agents Rimexolone no Ophthalmic Agents Triamcinolone no Ophthalmic Agents Ophthalmic Agents Bromfenac Sodium no Ophthalmic Agents Diclofenac Sodium no Ophthalmic Agents Flurbiprofen Sodium no Ophthalmic Agents Ketorolac Tromethamine no Ophthalmic Agents Nepafenac no Ophthalmic and Class Removed class. Example drugs moved to new USP Class, Prostamide Analogs "Intraocular Pressure Lowering Agents." Ophthalmic Agents Ophthalmic Agents, Other Class Ophthalmic Agents no New FDA approved drug, 08/22/19 Ophthalmic Agents Ophthalmic Agents Hydrochloride no Ophthalmic Agents Ophthalmic Agents Hydroxypropyl Cellulose no Ophthalmic Agents Ophthalmic Agents no Ophthalmic Agents

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 91 of 97

Cyclosporine no

Ophthalmic Agents Ophthalmic Combinations Class New class to add ophthalmic combination drug products

Ophthalmic Agents Cyclopentolate Hydrochloride/ yes Hydrochloride Ophthalmic Agents Gentamicin Sulfate/ Prednisolone yes Acetate Ophthalmic Agents Hydroxyamphetamine yes Hydrobromide/ Ophthalmic Agents Loteprednol Etabonate/ yes Ophthalmic Agents TbNeomycin/ i Polymyxin B Sulfates/ yes Bacitracin Zinc/ Hydrocortisone Acetate Ophthalmic Agents Neomycin/ Polymyxin B Sulfates/ yes Dexamethasone Ophthalmic Agents Neomycin/ Polymyxin B Sulfates/ yes Hydrocortisone Ophthalmic Agents Phenylephrine/ Ketorolac yes Ophthalmic Agents Sulfacetamide Sodium/ yes Prednisolone Acetate Ophthalmic Agents Tobramycin/ Dexamethasone yes

Netarsudil Mesylate/ Latanoprost yes New FDA approved drug, 03/12/19

Otic Agents Cat Otic Agents Class New class to add otic anti-infectives Otic Agents Ciprofloxacin no Otic Agents Ofloxacin no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 92 of 97

Otic Agents Class New class to add otic glucocorticoids Otic Agents Fluocinolone Acetonide no Otic Agents Otic Combinations Class New class to add otic combination drug products Otic Agents Ciprofloxacin/ Dexamethasone yes

Otic Agents Ciprofloxacin/ Fluocinolone yes Acetonide Otic Agents Ciprofloxacin Hydrochloride/ yes Hydrocortisone Otic Agents Hydrocortisone/ Acetic Acid yes Otic Agents Neomycin/ Polymyxin B Sulfates/ yes Hydrocortisone Respiratory Tract/ Cat Pulmonary Agents Respiratory Tract Class Respiratory Tract Respiratory Tract Azelastine Hydrochloride no Respiratory Tract Levocetirizine Dihydrochloride no Respiratory Tract Olopatadine Hydrochloride no Respiratory Tract Respiratory Tract Maleate no Respiratory Tract Fumarate no Respiratory Tract Hydrochloride no Respiratory Tract Diphenhydramine Hydrochloride no

Respiratory Tract Hydroxyzine Hydrochloride no Respiratory Tract Hydroxyzine Pamoate no Respiratory Tract Promethazine Hydrochloride no Respiratory Tract Respiratory Tract Azelastine Hydrochloride/ yes Fluticasone Propionate

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 93 of 97

Respiratory Tract Anti-inflammatories, Inhaled Class Corticosteroids Respiratory Tract Beclomethasone Dipropionate no

Respiratory Tract Budesonide no Respiratory Tract Ciclesonide no Respiratory Tract Flunisolide no Respiratory Tract Fluticasone Propionate no Respiratory Tract Fluticasone Furoate no Respiratory Tract Mometasone Furoate no Respiratory Tract Triamcinolone Acetonide no Respiratory Tract Antileukotrienes Class Respiratory Tract Sodium no Respiratory Tract Zafirlukast no Respiratory Tract Zileuton no Respiratory Tract Bronchodilators, Class

Respiratory Tract no Respiratory Tract Glycopyrrolate no Respiratory Tract no no New FDA approved drug, 11/9/18 Respiratory Tract no Respiratory Tract Umeclidinium no Respiratory Tract Bronchodilators, Sympathomimetic Class

Respiratory Tract Albuterol Sulfate no Respiratory Tract Tartrate no Epinephrine no outpatient drug to reflect auto injection use Respiratory Tract Epinephrine Bitartrate no Removed due to OTC status Respiratory Tract Fumarate Dihydrate no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 94 of 97

Respiratory Tract Maleate no Respiratory Tract Levalbuterol Hydrochloride no Respiratory Tract Tartrate no Respiratory Tract Metaproterenol Sulfate no Respiratory Tract Xinafoate no Respiratory Tract Sulfate no Respiratory Tract Olodaterol no Respiratory Tract Bronchodilator Combinations Class New class to add combination bronchodilator drug products

Aclidinium Bromide/ Formoterol yes Fumarate Respiratory Tract Budesonide/ Formoterol Fumarate yes Dihydrate Respiratory Tract Fluticasone Furoate/ yes Trifenatate Respiratory Tract Fluticasone Propionate/ yes Respiratory Tract SlMometasone t l Furoate/ Formoterol yes Fumarate Dihydrate Respiratory Tract Indacaterol/ Glycopyrrolate yes Respiratory Tract / Vilanterol yes Trifenatate

Respiratory Tract Fluticasone Furoate/ yes Umeclidinium Bromide/ Vilanterol Trifenatate Respiratory Tract Glycopyrrolate/ Formoterol yes Respiratory Tract FtIpratropium Bromide/ Albuterol yes Sulfate Respiratory Tract Tiotropium Bromide/ Olodaterol yes Respiratory Tract Agents Class Respiratory Tract Respiratory Tract no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 95 of 97

Respiratory Tract / Ivacaftor yes Respiratory Tract / Ivacaftor yes Respiratory Tract Respiratory Tract Tobramycin no Respiratory Tract Aztreonam no Respiratory Tract Respiratory Tract Dornase Alfa no Respiratory Tract Mast Cell Stabilizers Class Respiratory Tract Cromolyn Sodium no Respiratory Tract Phosphodiesterase Inhibitors, Class Airways Disease Respiratory Tract Aminophylline no Respiratory Tract no Respiratory Tract Respiratory Tract Roflumilast no Respiratory Tract Pulmonary Antihypertensives Class Respiratory Tract Respiratory Tract no Respiratory Tract no Respiratory Tract no Respiratory Tract Respiratory Tract Sildenafil Citrate no Respiratory Tract Tadalafil no Respiratory Tract Respiratory Tract Epoprostenol no Respiratory Tract Iloprost no Respiratory Tract Treprostinil no Respiratory Tract Respiratory Tract Riociguat no Respiratory Tract Respiratory Tract Selexipag no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 96 of 97

Respiratory Tract Respiratory Tract Agents, Other Class

Respiratory Tract Acetylcysteine no Respiratory Tract Respiratory Tract Benralizumab no New FDA approved drug, 11/14/17 Respiratory Tract Mepolizumab no Respiratory Tract Pulmonary Fibrosis Agents Class Respiratory Tract no Respiratory Tract Pirfenidone no Skeletal Muscle Relaxants Cat

Skeletal Muscle Relaxants Hydrochloride no

Skeletal Muscle Relaxants Metaxalone no

Skeletal Muscle Relaxants Methocarbamol no

Skeletal Muscle Relaxants Citrate no

Skeletal Muscle Relaxants no

Skeletal Muscle Relaxants Carisoprodol/ Aspirin yes

Skeletal Muscle Relaxants Carisoprodol/ Aspirin/ Codeine yes Phosphate Skeletal Muscle Relaxants no

Skeletal Muscle Relaxants Orphenadrine Hydrochloride no

Skeletal Muscle Relaxants Orphenadrine Citrate/ Aspirin/ yes Caffeine

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage. Medicare Model Guidelines Draft v8.0 97 of 97

Skeletal Muscle Relaxants

Skeletal Muscle Relaxants Abobotulinum Toxin A no

Skeletal Muscle Relaxants Incobotulinum Toxin A no

Skeletal Muscle Relaxants Rimabotulinum Toxin B no

Sleep Disorder Agents Cat Sleep Disorder Agents GABA Receptor Modulators Class Sleep Disorder Agents Sleep Disorder Agents no Sleep Disorder Agents no Sleep Disorder Agents no Sleep Disorder Agents no Sleep Disorder Agents Sleep Disorder Agents no Sleep Disorder Agents no Sleep Disorder Agents Tartrate no Sleep Disorder Agents Sleep Disorders, Other Class Sleep Disorder Agents no Sleep Disorder Agents Doxepin Hydrochloride no Sleep Disorder Agents no Pitolisant Sleep Disorder Agents no no New FDA approved drug, 03/20/19 Sleep Disorder Agents Sleep Disorder Agents no Sleep Disorder Agents Sleep Disorder Agents Tasimelteon no Sleep Disorder Agents Ramelteon no

* This list is illustrative of Part D eligible drugs only, and does not infer CMS coverage.