Pharmacy and Therapeutics Committee

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1 Michigan Department of Health and Human Services Pharmacy and Therapeutics Committee September 12, 2017 Minutes - Final Attendees: Vickie Tutag Lehr, Andrew Mac, James Miller, Brian Peltz, Anthony Ognjan, Steve Hadesman, Jayne Courts, Venkat Rao, James Matthews, Brad Uren, David Neff. A quorum was met. Absent: Margo Farber The MDHHS P & T committee was called to order at 6:05 pm by the chair, Dr. Vicki Tutag Lehr. The agenda was reviewed and accepted. Introductions were made and quorum established. Conflict of interest statement was reviewed. Annual attestations were signed. None of the members had COI to report. Review of the June meeting minutes were reviewed and accepted. MDHHS Updates: Recent FDA Drug Approvals since the last meeting were reviewed New Drugs 1. AIRDUO RESPICLICK (FLUTICASONE/SALMETEROL) a fixed dose combination product containing a corticosteroid (fluticasone) and a long-acting beta agonist (LABA) (salmeterol) indicated for the treatment of asthma in patients ages 12 years and older. [PDL class: Inhaled Corticosteroids; added to the PDL as non-preferred] 2. AUSTEDO TABLET (DEUTETRABENAZINE) - a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington s disease. [Not a PDL class - Added to the MPPL with PA required] 3. DUPIXENT SYRINGE (DUPILUMAB) - an interleukin-4 receptor alpha antagonist indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. [PDL class: Immunomodulators: Atopic Dermatitis; added to the PDL as nonpreferred]

2 4. ELLZIA PAK (TRIAMCINOLONE/DIMETHICONE) - indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. [PDL class: Steroids, Topical High; added to the PDL as non-preferred] 5. FLONASE SENSIMIST NASAL SPRAY (FLUTICASONE FUROATE- OTC) a low volume version of Flonase Nasal Spray designed for patients who are reluctant to use nasal sprays. Flonase is approved for the treatment of seasonal and perennial allergic rhinitis. [PDL class: Nasal Corticosteroids; added to the PDL as non-preferred] 6. INGREZZA CAPSULE (VALBENAZINE) - a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia. [Not a PDL class - Add to MPPL with PA required] 7. RHOFADE CREAM (OXYMETAZOLINE) - an alpha1a adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. [Not a PDL class - Add to MPPL with PA required] 8. RYVENT TABLET (CARBINOXAMINE) an H1 receptor antihistamine indicated for the symptomatic relief of seasonal and perennial allergic rhinitis. [Not a PDL class - Add to MPPL with PA required] 9. SILIQ 210 MG/1.5 ML SYRINGE (BRODALUMAB) - is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. [PDL class: Biologics: Agents to Treat Plaque Psoriasis; added to the PDL as non-preferred] 10. SYNJARDY XR TABLET (EMPAGLIFLOZIN/METFORMIN) - a once-daily extended release formulation of Synjardy (empagliflozin and metformin) for adults with type 2 diabetes along with diet and exercise to improve glycemic control. [PDL class: Oral Hypoglycemics: Combinations; added to the PDL as non-preferred] 11. TRULANCE 3 MG TABLET (PLECANATIDE) - a guanylate cyclase-c (GC-C) agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adult patients. [New PDL class: GI Motility, Chronic; added to the PDL as non-preferred] 12. VYVANSE CHEWABLE TABLET (LISDEXAMFETAMINE) - chewable tablet formulation of Vyvanse, a CNS stimulant indicated for the treatment for ADHD and moderate to severe binge eating disorder. [PDL class: Drugs for ADHD: Stimulants; added to the PDL as preferred] 13. MAVYRET TABLET (GLECAPREVIR/PIBRENTASVIR) - indicated for the treatment of HCV genotypes 1 to 6 in adult patients without cirrhosis or with compensated cirrhosis (Child-Pugh

3 A). It is also indicated to treat HCV in patients who have genotype 1 and have been treated previously with regimens containing either an HCV NS5A inhibitor or an HCV NS3/4A PI, but not both. [PDL class: Hepatitis C, Direct-Acting Antivirals; added to the PDL as preferred] 14. VOSEVI TABLET (SOFOSBUVIR/VELPATASVIR/VOXILAPREVIR) - indicated for the treatment of chronic HCV infection in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have genotypes 1-6 infection and previously received treatment with an NS5A inhibitor, or who have genotype 1a or 3 HCV infection and have been treated previously with sofosbuvir without an NS5A inhibitor. [PDL class: Hepatitis C, Direct-Acting Antivirals; added to the PDL as preferred] Review of Preferred Drug List Classes Diabetes: 1. Amylin Analogs 2. Incretin Mimetics a. Move Victoza (liraglutide) to preferred b. Move Tanzeum (albiglutide) to non-preferred 3. Incretin Mimetic Combinations 4. Insulins: Basal 5. Insulins: Rapid Acting a. Move Apridra (insulin glulisine) to preferred 6. Insulin Mixes 7. Insulins: Traditional 8. Oral Hypoglycemics: Alpha-Glucosidase Inhibitors 9. Oral Hypoglycemics: Biguanides 10. Oral Hypoglycemics: Combinations a. Move Jentadueto XR to non-preferred (linagliptin/metformin) to non-preferred 11. Oral Hypoglycemics: Dopamine Receptor Agonists

4 12. Oral Hypoglycemics: DPP4 Inhibitors 13. Oral Hypoglycemics: Meglitinides 14. Oral Hypoglycemics: 2 nd Generation Sulfonylureas 15. Oral Hypoglycemics: SGLT2 Inhibitors 16. Oral Hypoglycemics: Thiazolidineiones Gastrointestinal: 1. Antiemetics 2. Bile Salts new class a. Add ursodiol tablets as preferred b. Add the following as non-preferred i. Actigall (ursodiol) ii. Urso/Urso Forte (ursodiol) iii. ursodiol capsules 3. GI Motility, Chronic new class a. Add the following as preferred i. Amitiza (lubriprostone) ii. Linzess (linaclotide) iii. Movantik (naloxegol) b. Add the following as non-preferred i. Lotronex (alosetron) ii. Relistor (methylnaltrexone) iii. Trulance (plecanatide) iv. alosetron (generic for Lotronex) v. Viberzi (eluxadoline) 4. H. pylori Treatment new class a. Add Pylera (bismuth subcitrate potassium, metronidazole, tetracycline) as preferred b. Add the following as non-preferred i. Omeclamox-PAK (omeprazole, amoxicillin, clarithromycin) ii. lansoprazole/amoxicillin/clarithromycin (generic for Prevpac) iii. Prevpac (lansoprazole/amoxicillin/clarithromycin)

5 5. Pancreatic Enzymes 6. Progestins for Cachexia 7. Proton Pump Inhibitors a. Move Nexium OTC to non-preferred 8. Ulcerative Colitis a. Move Lialda (mesalamine) to preferred b. Move Pentasa (mesalamine) to non-preferred c. Move sulfazalazine DR (generic for Azulfidine DR) to preferred Miscellaneous: 1. Biologic Immunomodulators a. Agents to Treat Rheumatoid Arthritis b. Agents to Treat Anlylosing Spondylitis c. Agents to Treat Juvenile Idiopathis Arthritis d. Agents to Treat Plaque Psoriasis i. Add Siliq ((brodalumab) as non-preferred e. Agents to Treat Psoriatic Arthritis f. Agents to Treat Crohn s Disease g. Agents to Treat Ulcerative Colitis. 2. Androgenic Agents (topical) 3. BPH Agents 4. Electrolyte Depleters a. Move calcium acetate tablets to non-preferred b. Move Fosrenal (lanthanum) chewable tablets to non-preferred 5. Epinephrine Injectable a. Move epinephrine injection (generic for Adrenaclick) to non-preferred. 6. Growth Hormones 7. Hematopoietic Agents

6 8. Osteoporosis Agents: Bisphosphonates 9. Osteoporosis Agents: Other 10. Osteoporosis Agents: SERMS 11. Urinary Tract Antispasmodics Public Comments: 1. Jeff Martin, PharmD, MPA, Amgen, re. Enbrel and Repatha 2. Paul Miner, PharmD, Gilead Sciences, re. HCV 3. Luciano Kolodny, MD, Merck & Co., re. Zepatier and Hep C/Januvia 4. Aaron Sheppard, PhD, Pfizer, re. Eucrisa 5. David Freilich, PhD, Impax Specialty Pharmaceuticals, re. Zomig Nasal Spray 6. Ashley Polce, PharmD, Abbvie, re. HCV 7. Cari Holzhei, Allergan PLC, re. Dalbavancin 8. Dr. Ali Norbash, Neurocrine Biosciences, re. Ingrezza 9. Ramesh Candadai, PhD, Sanofi Genzyme, re. Dupilumab/Dupixent 10. Shefali Mihelich, Boehringer Ingelheim Pharmaceuticals, re. Pradaxa and Spiriva 11. Ndidi Yaucher, Novartis, re. Gilenya Next Meeting: Tuesday, December 12, 2017 Location: Kellogg Center Drug Classes: Analgesics, CNS Agents and Dermatologics

Michigan Pharmacy and Therapeutics Committee September 11, Minutes

Michigan Pharmacy and Therapeutics Committee September 11, 2018 Minutes Attendees: Vickie Tutag Lehr, Brian Peltz, Jayne Courts, Rony Foumia, Andrew Mac, Andrew Adair, Margo Farber, David Neff, Brad Uren