Michigan Pharmacy and Therapeutics Committee
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1 Michigan Pharmacy and Therapeutics Committee June 14, 2016 at 6:00 PM Kellogg Center, East Lansing, Michigan Agenda: I. Introductions II. Conflict of Interest Statement III. Approval of the Agenda IV. Approval of Minutes of March 8, 2016 Meeting V. P & T Business a) Population b) Legislation/Budget VI. Old Business: Follow up from previous meetings: a. Review of the oral anticoagulants b. Metabolic surveillance during treatment with antipsychotic agents New Drugs with monographs: 1. Aptensio XR (methylphenidate) an extended-release methylphenidate capsule approved for attention deficit disorder with hyperactivity. [PDL class: Stimulants; non-preferred] 2. Belbuca (buprenorphine) a new buccal film dosage form of buprenorphine approved for the management of pain severe enough to require daily, around-the-clock, longer-term opioid treatment and for which alternative treatment options are inadequate. [PDL class: Analgesics, Narcotics Long; non-preferred] 3. Durlaza (aspirin extended-release) an extended-release formulation of aspirin indicated to reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease and for risk reduction in patients with history of ischemic stroke or transient ischemic attack. [PDL class: Platelet Aggregation Inhibitors; non-preferred] 4. Seebri Neohaler (glycopyrrolate) an anticholinergic indicated for the long-term maintenance treatment of ariflow obstruction in patients with chronic obstructive pulmonary disease (COPD). [PDL class: COPD; non-preferred] MDHHS P & T JUNE 14,
2 5. Utibron Neohaler (indacaterol/glycopyrrolate) indacaterol, a long acting beta adrenergic agonist (LABA), with glycopyrrolate (Utibron Neohaler) is indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD. [PDL class: COPD; non-preferred] 6. Strensiq (asfotase alfa) a tissue-nonspecific alkaline phosphatase approved for the treatment of patients with perinatal/infantile-and juvenile-onset hypophosphatasia (HPP). [Not a PDL class - Add to MPPL with PA required] 7. Ticanase (fluticasone propionate) corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. [PDL class; Nasal Steroids; non-preferred] 8. Tivorbex (indomethacin, submicronized) a non-steroidal anti-inflammatory drug (NSAID) approved for the treatment of mild to moderate acute pain in adults. [PDL class: NSAIDS; nonpreferred] 9. Vivlodex (meloxicam) - a non-steroidal anti-inflammatory agent (NSAID) indicated for the management of osteoarthritis (OA) pain. [PDL class: NSAIDS; non-preferred] 10. Tresiba Flextouch (insulin degludec) a long-acting basal human insulin analog, is indicated to improve glycemic control in adults with diabetes mellitus. It is not recommended to treat diabetic ketoacidosis. [PDL class: Hypoglycemics, Insulin and Related Agents; non-preferred] 11. Uptravi (selexipag) an oral selective prostacyclin receptor (IP receptor) agonist, is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. [NEW PDL Class: PAH Agents; nonpreferred] 12. Varubi (rolapitant) a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy (HEC). [PDL class: Antiemetic/Antivertigo Agents; non-preferred] 13. Veltassa (patiromer calcium sorbitex) - a potassium binder indicated for the treatment of hyperkalemia. Due to its delayed onset of action, patiromer should not be used as an emergency treatment during life-threatening hyperkalemia. [Not a PDL class - Add to MPPL with PA required] 14. Viberzi (eluxadoline) a mu-opioid receptor agonist and also a kappa opioid agonist and a delta opioid antagonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). [Not a PDL class - Add to MPPL with PA required] MDHHS P & T JUNE 14,
3 15. Praluent (alirocumab) a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). It is indicated as an adjunct to diet and maximally-tolerated statin therapy for the treatment of adults with HeFH or clinical ASCVD, who require additional lowering of LDL-C. [PDL class: Lipotropics, Other; Non-preferred; Clinical PA required] 16. Repatha (evolucumab) a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). It is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical ASCVD, who require additional lowering of LDL-C. Additionally, evolocumab is FDA-approved as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with HoFH who require additional lowering of LDL-C. [PDL class: Lipotropics, Other; Non-preferred; Clinical PA required] NEW PDL CLASSES a. Pulmonary arterial hypertension Review of Preferred Drug List Classes Antibiotics/Anti-Infectives: 1. Antibiotics- Inhaled 2. Antifungals Oral a. Move Gris-Peg to non-preferred 3. Antifungals Topical a. Move econazole to non-preferred 4. Antivirals Herpes a. Move acyclovir suspension to non-preferred b. Move Zovirax (acyclovir) suspension to preferred 5. Antivirals Influenza 6. Antivirals Topical 7. Cephalosporin 1 st Generation 8. Cephalosporin 2 nd Generation MDHHS P & T JUNE 14,
4 9. Cephalosporin 3 rd Generation a. Move cefixime suspension to non-preferred b. Move Suprax (cefixime) chew tabs to preferred 10. Macrolide 11. Oxalodinones a. Move Zyvox (linezolid) tablets and suspension to non-preferred b. Keep linezolid tablets and suspension as preferred 12. Quinolones 13. Ophthalmic Fluoroquinolones 14. Ophthalmic Macrolides 15. Otic Quinolones a. Move ofloxacin to non-preferred 16. Topical Antibiotics 17. Gastrointestinal Antibiotics a. Move Vancocin (vancomycin) to preferred b. Move vancomycin to non-preferred Asthma/Allergy/COPD: 1. COPD Agents 2. Antihistamines 2 nd Generation 3. Antihistamines Nasal 4. Beta Adrenergics Short Acting 5. Beta Adrenergics Long Acting MDHHS P & T JUNE 14,
5 6. Beta Adrenergics for Nebulizers 7. Beta Adrenergic/ Corticosteroid Inhaler Combinations 8. Inhaled Glucocorticoids 9. Leukotriene Inhibitors 10. Nasal Steroids a. Move mometasone (generic for Nasonex) to non-preferred. Public Comment: 1. Gerard Buonpane, PharmD, MBA, R.Ph, TRIS Pharma: Dyanavel XR Extended Release Oral Suspension for the Treatmetn of ADHD. 2. Domenic Mantella, PharmD, MBA, NovoNordisk: Norditropin 3. Steve Woods, Medical Science Director, Relypsa: Veltassa 4. Paul McDermott, Medical Science Liaison, Celgene Corporation, Otezla (Apremilast) for use in Psoriasis and Psoriatic Arthritis. 5. Rick Detloff, Pharm.D, Pfizer, Xeljanz 6. Jeff Hurd, MS, PhD, Astra Zeneca, Brilenta ( ticagrelor) 7. Swarup Mehta, PharmD. Medical Affairs Director, Virology, Merck : Zepatier 8. Jenene Hunkele, Sr. Medical Science Liaison, Mid-West, Alexion Pharmaceuticals: Strensiq Next Meeting: September 13, 2016, 6 pm, Kellogg Center Drug Classes: Diabetes/GI/Misc. MDHHS P & T JUNE 14,
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Drug Discovery, Vol. 11, No. 27, February 1, 2016 COMMUNICATION COMMUNICATION ISSN 2278 540X EISSN 2278 5396 Drug Discovery An International Journal FDA Approved Drugs October 2015 Vidhya V Publication
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