Pharmacy and Therapeutics Committee Meeting April 16, 2015 Draft Minutes

Transcription

1 Draft Minutes Members Present: Tim Jennings, Pharm.D., Chair Krishna Madiraju M.D., Gill Abernathy, M.S., R.Ph. Avtar Dhillon, M.D Sue Cantrell, M.D. Nathan Charlton, M.D Barbara Exum, Pharm.D. Mariann Johnson, M.D. Jack Barber, M.D. Jason Vourlekis, M.D. Absent: Mark Oley, R.Ph. Rachel M. Selby-Penczak, M.D. A quorum was present DMAS Staff: Cynthia Jones, Agency Director Cheryl Roberts, Agency Deputy Director Bryan Tomlinson, Director, Division of Health Care Services Donna Proffitt RPh. Pharmacy Manager Keith Hayashi, RPh., Pharmacist Jennifer Gobble, Counsel to the Committee, Office of the Attorney General Staff: Provider Synergies/Magellan Medicaid Administration Debbie Moody, R.Ph., Clinical Account Manager, Virginia Nancy Eldin Pharm.D., Clinical Manager, Virginia Doug Brown, R.Ph., MBA, VP, Drug Rebate Manager Medicaid Guests: 73 representatives from pharmaceutical companies, providers, advocates, associations, etc. Welcome and Comments from Cynthia Jones, Agency Director Cynthia Jones welcomed the members of the Committee and thanked them for their participation in the PDL program. Ms. Jones noted that it has been twelve (12) years since the inception of the Virginia Medicaid Pharmacy and Therapeutics Committee and that over the past twelve (12) years, this Committee has done extremely important work that has helped to transform the FFS Medicaid pharmacy program. Medicaid members are receiving high quality prescription medications based on sound clinical criteria at substantially reduced costs to the Commonwealth. Ms. Jones noted the Governor s Access Plan for the Seriously Mentally Ill, which was approved by CMS and began enrolling members beginning January 1, To date, the program has 2,259 individuals enrolled. These members have access to outpatient services including comprehensive pharmacy coverage. Call to Order Tim Jennings, Pharm.D., Chairman called the meeting to order. Comments from Tim Jennings, Pharm.D., Chairman Dr. Jennings welcomed and thanked the members for their continued participation in the PDL program. Dr. Jennings noted that at the last meeting the Committee reviewed and approved several new drug classes on the PDL, including anticonvulsants, antidepressants and antipsychotics. DMAS is pleased to share that there have been no issues with the implementation of these new classes on the PDL. The Magellan Call Center reports the following stats for the three months after the drugs were added to the PDL (January 1- March 31, 2015): Anticonvulsants 541 service authorization (SA) requests from a total of 29,014 claims for these medications Antipsychotics 46 SA requests from a total of 16,209 claims for these medications Antidepressants SA requests from a total of 14,203 claims for these medications

2 Page 2 DMAS Drug Utilization Review (DUR) Board Update: Dr. Dhillon noted that since the last P&T Committee meeting, the DUR Board met in November At that meeting, the Board conducted its review of new drugs and approved both prospective and retrospective clinical edits on ten new drugs. The Board approved SA criteria for several drugs in therapeutic classes not subject to the PDL including: Cerdelga (eliglustat) used for the treatment of Gaucher disease Type 1 Kerydin (tavaborole) topical antifungal for toenails Northera (droxidopa) used for the treatment of orthostatic dizziness in patients with NOH Triumeq (abacavir/dolutegravir/lamivudine) - used for the treatment of HIV Zydelig (idelalisib) oral antineoplastic agent At its January 2014 meeting, the Board voted to extend the service authorization requirement for antipsychotics to all children under the age of 18. On July 1, 2014, a service authorization was required for all antipsychotics prescribed for children under the age of 13. The service authorization requirement was extended to members under the age of 18 effective March 1, DMAS service authorization contractor grandfathered 657 members ages on antipsychotic therapy with an appropriate diagnosis by entering Service Authorizations for six months of therapy. The expanded age requirement has resulted in a significant increase in the number of SA requests received. Previously, Magellan received an average of 16 requests per week. After adding ages to the SA requirement, the average number of requests per week is 110. Approval of Minutes from October 16, 2014 meeting Dr. Jennings asked if there were any corrections, additions or deletions to the draft meeting minutes. With no revisions or corrections, the Committee members approved the minutes as written. PDL Management Potential New Therapeutic Class Review (PDL Category) 1. Gastrointestinal (Antibiotic-Anti-Infective): Dr. Nathan Charlton presented the Gastrointestinal Antibiotic-Anti-Infective clinical information. Dr. Charlton motioned that the Gastrointestinal Antibiotic-Anti-Infective Class be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this class as PDL eligible. 2. Pancreatic Enzymes (Endocrine and Metabolic Agents: Dr. Charlton presented the Pancreatic Enzymes clinical information. Dr. Charlton motioned that the Pancreatic Enzymes Class be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this class as PDL eligible. 3. Antifungals: Topical (Dermatologic): Dr. Barbara Exum presented the Antifungals: Topical clinical information. Dr. Exum motioned that the Antifungals: Topical Class be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this class as PDL eligible. 4. Cytokine and CAM Antagonists and Related Agents (Expansion of the Class to Include All Indications) (Immunological Agents) Pallav Raval, PharmD, Regional Account Scientific Director, Novartis (Cosentyx TM ) Vanessa Castellano, PhD, Field Medical Director, Pfizer (Xeljanz ) Oliva Lee, PharmD, Medical Outcomes Science Liaison, Abbvie (Humira ) 2

3 Page 3 Dr. Barbara Exum presented the Cytokine and CAM Antagonists and Related Agents clinical information. Dr. Exum motioned that the Cytokine and CAM Antagonists and Related Agents Class be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this class as PDL eligible. PDL Phase I New Drug Review (Therapeutic Class) 1. Akynzeo (Antiemetics/Antivertigo Agents): Dr. Charlton presented the clinical information on Akynzeo (netupitant/palonosetron). Dr. Charlton motioned that Akynzeo be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 2. amlodipine/valasartan/hctz (Angiotensin Modulator Combinations): Dr. Charlton noted the new generic amlodipine/valasartan/hctz, the generic for Exforge HCT. Dr. Charlton motioned that amlodipine/valasartan/hctz be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 3. amlodipine/valsartan (Angiotensin Modulator Combinations): Dr. Charlton noted the new generic amlodipine/valasartan, the generic for Exforge. Dr. Charlton motioned that amlodipine/valasartan be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 4. Arnuity Ellipta (Inhaled Corticosteroids): Dr. Vourlekis presented the clinical information on Arnuity Ellipta (fluticasone). Dr. Vourlekis motioned that Arnuity Ellipta be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 5. Asmanex HFA (Inhaled Corticosteroids): Dr. Vourlekis presented the clinical information on Asmanex HFA (mometasone furoate). Dr. Vourlekis motioned that Asmanex HFA be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 6. Belsomra (Sedatives/Hypnotics): Dr. Cantrell presented the clinical information on Belsomra (suvorexant). Dr. Cantrell motioned that Belsomra be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 7. fexofenadine suspension (Second Generation Antihistamines): Dr. Vourlekis noted the new generic fexofenadine suspension, the generic for Allegra Suspension. Dr. Vourlekis motioned that fexofenadine suspension be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 8. Flonase OTC (Intranasal Rhinitis Agents): Dr. Vourlekis noted Flonase is now available overthe-counter as Flonase Allergy Relief. Dr. Vourlekis motioned that Flonase Allergy Relief OTC be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 9. Children s QNASL (Intranasal Rhinitis Agents): Dr. Vourlekis motioned that Children s QNASL be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 3

4 Page 4 Tyson Park, PharmD, Managed Care Medical Science Liaison, Teva (Children s QNASL ) 10. olopatadine (Intranasal Rhinitis Agents): Dr. Vourlekis noted the new generic olopatadine, the generic for Patanase. Dr. Vourlekis motioned that olopatadine be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 11. Incruse Ellipta TM (COPD): Dr. Vourlekis presented the clinical information on Incruse Ellipta TM (umeclidinium). Dr. Vourlekis motioned that Incruse Ellipta TM be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 12. Spiriva Respimat (COPD): Dr. Vourlekis presented the clinical information on Spiriva Respimat (tiotropium). Dr. Vourlekis motioned that Spiriva Respimat be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 13. Striverdi Respimat (Long Acting Beta Adrenergic Agents): Dr. Vourlekis presented the clinical information on Striverdi Respimat (olodaterol). Dr. Vourlekis motioned that Striverdi Respimat be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. 14. tacrolimus (Atopic Dermatitis: Topical): Dr. Vourlekis noted the new generic tacrolimus, the generic for Protopic. Dr. Vourlekis motioned that tacrolimus be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible. PDL Phase II Annual Review 1. Barbiturate & Non-Salicylate Analgesics (and combinations): Dr. Cantrell motioned that the Barbiturate & Non-Salicylate Analgesics Class be removed from the PDL due to the limited size of the class. With the motion seconded, the Committee voted unanimously to remove this class from the PDL. 2. Long Acting Narcotics: Maribeth Kowalski, PharmD, Medical Science Liaison, Purdue Pharma (Oxycontin ) Dr. Cantrell presented the Long Acting Narcotics clinical information. Dr. Cantrell motioned that Long Acting Narcotics continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 3. Short Acting Narcotics (includes combinations, and lozenges): Dr. Cantrell presented the Short Acting Narcotics clinical information. Dr. Cantrell motioned that Short Acting Narcotics continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible. 4. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (includes Cox-2 inhibitors): Dr. Cantrell presented the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) clinical information. Dr. Cantrell motioned that Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 4

5 Page 5 5. Opioid Analgesics & Dependency: George Bright, MD, Practicing Physician, Orexo (Zubsolv ) Jane Ruby, PhD, EdD, MS, Medical Affairs Manager, Rickett Benckiser (Suboxone ) David W. Byram, Vice-President of Market Access (Zubsolv ) Dr. Cantrell presented the Opioid Analgesics & Dependency clinical information. Dr. Cantrell motioned that Opioid Analgesics & Dependency drugs continueto be PDL eligible. With the motion seconded, the Committee voted unanimously to 6. Topical Agents & Anesthetics: Dr. Cantrell motioned that Topical Agents & Anesthetics continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible nd and 3 rd Generation Cephalosporins: Dr. Madiraju motioned that 2nd and 3rd Generation Cephalosporins continueto be PDL eligible. With the motion seconded, the Committee voted unanimously to 8. 2 nd and 3 rd Generation Quinolones (systemic): Dr. Madiraju presented the 2nd and 3rd Generation Quinolones clinical information. Dr. Madiraju motioned that 2nd and 3rd Generation Quinolones 9. Ketolides & Macrolides (adult and pediatric): Dr. Madiraju motioned that Ketolides & Macrolides 10. Oral Antifungals: Dr. Madiraju motioned that Oral Antifungals continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 11. Otic Quinolones: Dr. Madiraju motioned that Otic Quinolones continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 12. Topical Antibiotics: Dr. Madiraju motioned that Topical Antibiotics continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 13. Hepatitis C, Antivirals: Ali Toumadj, PharmD, Associate Director, Medical Science, Gilead (Harvoni ) Olivia Lee, PharmD, Medical Outcomes Science Liaison, Abbvie (Viekira Pak TM ) Ms. Abernathy presented the Hepatitis C, Antivirals clinical information. Ms. Abernathy motioned that Hepatitis C, Antivirals continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 5

6 Page Herpes, Antivirals: Ms. Abernathy presented the Herpes, Antivirals clinical information. Ms. Abernathy motioned that Herpes, Antivirals continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 15. Influenza, Antivirals: Ms. Abernathy presented the Influenza, Antivirals clinical information. Ms. Abernathy motioned that Influenza, Antivirals continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 16. Topical Antivirals: Ms. Abernathy presented the Topical Antivirals clinical information. Ms. Abernathy motioned that Topical Antivirals continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 17. Bone Resorption Suppression and Related Agents (includes Bisphosphonates, Calcitonins and Others): Ms. Abernathy presented the Bone Resorption Suppression and Related Agents clinical information. Ms. Abernathy motioned that Bone Resorption Suppression and Related Agents 18. Anticoagulants (includes low molecular weight heparins, Factor XA inhibitors and oral anticoagulants): Phillip Wiegand, PharmD, Health Economics & Outcomes Liaison, Janssen (Xarelto ) Cherie Robertson, PharmD, Medical Outcomes Specialist, Pfizer (Eliquis ) Eric Wittbrodt, PharmD, Principal Health Outcomes Liaison, Daiichi Sankyo (Savaysa TM ) Ms. Abernathy presented the Anticoagulants clinical information. Ms. Abernathy motioned that Anticoagulants continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 19. Platelet Inhibitors: Anthony Wheeler, PhD, Regional Outcomes Liaison, Eli Lilly (Effient ) Ms. Abernathy presented the Platelet Inhibitors clinical information. Ms. Abernathy motioned that Platelet Inhibitors continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 20. Antihyperkinesis/CNS Stimulants: Sonia Murphy, PhD, Medical Science Liaison, Shire (Vyvanse ) Dr. Madiraju presented the Antihyperkinesis/CNS Stimulants clinical information. Dr. Madiraju motioned that Antihyperkinesis/CNS Stimulants continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 6

7 Page Antimigraine: Dr. Charlton presented the Antimigraine clinical information. Dr. Charlton motioned that Antimigraine Agents continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 22. Non-Ergot Dopamine Receptor Agonists: Dr. Charlton presented the Non-Ergot Dopamine Receptor Agonists clinical information. Dr. Charlton motioned that Non-Ergot Dopamine Receptor Agonists continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 23. Skeletal Muscle Relaxants: Dr. Cantrell motioned that Skeletal Muscle Relaxants continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible. 24. Smoking Cessation: Earl Ward, PharmD, Field Medical Director, Pfizer (Chantix ) Dr. Madiraju motioned that Smoking Cessation Agents continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 25. Acne Agents (includes benzoyl peroxide, clindamycin, topical retinoids & combinations): Dr. Madiraju presented the Acne Agents clinical information. Dr. Madiraju motioned that Acne Agents 26. Topical Agents For Psoriasis: Dr. Madiraju presented the Topical Agents for Psoriasis clinical information. Dr. Madiraju motioned that Topical Agents for Psoriasis continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 27. Androgenic Agents: Olivia Lee, PharmD, Medical Outcomes Science Liaison, Abbvie (Androgel ) Dr. Charlton presented the Androgenic Agents clinical information. Dr. Charlton motioned that Androgenic Agents continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 28. Antihyperuricemics: Dr. Charlton presented the Antihyperuricemics clinical information. Dr. Charlton motioned that Antihyperuricemics continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 29. Contraceptives (oral, vaginal & transdermal): Dr. Cantrell presented the Contraceptives clinical information. Dr. Cantrell motioned that Contraceptives continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 30. Erythropoiesis Stimulating Proteins: Dr. Charlton presented the Erythropoiesis Stimulating Proteins clinical information. Dr. Charlton motioned that Erythropoiesis Stimulating Proteins 7

8 Page Hypoglycemics Insulins: Dr. Johnson presented the Hypoglycemics, Insulins clinical information. Dr. Johnson motioned that Hypoglycemics, Insulins class continues to be PDL eligible. With the motion seconded, the Committee voted unanimously to 32. Hypoglycemics (includes Incretin Enhancers/Mimetics/GLP-1receptor agonists/ DPP-IV inhibitors and combinations): Anthony Wheeler, PhD, Regional Outcomes Liaison, Eli Lilly (Trulicity TM ) Nicole Kesty, PhD, Senior Medical Science Liaison, Astra Zeneca (Bydureon ) Dr. Johnson presented the Hypoglycemics (includes Incretin Enhancers/Mimetics/GLP-1receptor agonists/ DPP-IV inhibitors and combinations) clinical information. Dr. Johnson motioned that Hypoglycemics (includes Incretin Enhancers/Mimetics/GLP-1 receptor agonists/ DPP-IV Inhibitors and combinations) continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 33. Oral Hypoglycemics, alpha-glucosidase inhibitors: Dr. Johnson motioned that Oral Hypoglycemics, alpha-glucosidase inhibitors continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 34. Oral Hypoglycemics, meglitinides: Dr. Johnson motioned that Oral Hypoglycemics, meglitinides 35. Oral Hypoglycemics, metformins: Dr. Johnson motioned that Oral Hypoglycemics, metformins 36. Oral Hypoglycemics, sulfonylureas: Dr. Johnson motioned that Oral Hypoglycemics, sulfonylureas 37. Oral Hypoglycemics, SGLT2 Inhibitors: Phillip Wiegand, PharmD, Health Economics & Outcomes Liaison, Janssen (Invokana ) Nicole Kesty, PhD, Medical Science Liaison, Astra Zeneca (Farxiga TM and Xigduo XR TM ) Dr. Johnson presented the Oral Hypoglycemics, SGLT2 Inhibitors clinical information. Dr. Johnson motioned that Oral Hypoglycemics, SGLT2 Inhibitors continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 38. Oral Hypoglycemics, thiazolidinediones: Dr. Johnson motioned that Oral Hypoglycemics, thiazolidinediones continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 8

9 Page Progestational Agents: Dr. Exum motioned that Progestational Agents continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 40. Vaginal Estrogens: Dr. Exum motioned that Vaginal Estrogens continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to 41. Multiple Sclerosis Agents: Gregg Morrow, PharmD, MS Medical Science Liaison, Genzyme (Aubagio ) Gregg Morrow, PharmD, MS Medical Science Liaison, Genzyme (Lemtrada TM ) Kendra Davies, PharmD, Medical & Outcomes Science Liaison, Biogen (Plegridy ) Tyson Park, PharmD, Managed Care Medical Science Liaison, Teva (Copaxone ) Dr. Exum presented the Multiple Sclerosis Agents clinical information. Dr. Exum motioned that Multiple Sclerosis Agents continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to Comments from the Office of the Attorney General Ms. Jennifer Gobble from the Attorney General s office stated that under the Virginia Freedom of Information Act (FOIA), specifically Virginia Code section , a public body such as the P&T Committee, may go into a closed session for any one of the 45 reasons listed in that statute. The discussion of manufacturer and wholesaler prices is not one of the 45 reasons listed. She stated the Attorney General strongly supports the principles of open government embodied by the FOIA and believes in the opportunity of the Commonwealth s citizens to witness the operation of government to the fullest extent. Federal Law 42 U.S.C. 1396r-8(b) (3) (D) requires such pricing information to be kept confidential. On this point, federal law supersedes the Virginia FOIA. Since the P&T Committee must discuss this pricing information as part of its duties, pursuant to federal law a confidential meeting must occur for the consideration of this pricing information she cautioned only this confidential pricing information should be discussed. Dr. Madiraju made a motion for the P&T Committee to resume the meeting in another room to discuss this confidential information regarding prices charged by the manufacturers and wholesalers of the drug classes discussed at this P&T Committee meeting. This confidential meeting is authorized by Federal Law at 42 U.S.C. 1396r-8(b) (3) (D) that requires this information be kept confidential. The motion was seconded and unanimously approved by the Committee. Following the Confidential Session, the Committee members re-assembled in the 7 th floor conference room. Dr. Jennings confirmed that to the best of each of the Committee member s knowledge the only information discussed at the confidential meeting was information regarding prices charged by the manufacturers and wholesalers of the drug classes discussed at this P&T Committee meeting. As authorized by Federal Law at 42 U.S.C. 1396r-8(b) (3) (D) that requires this information to be kept confidential. A motion was made to resume the meeting. The motion was seconded and unanimously approved by the Committee. 9

10 Page 10 PDL Changes Effective July 1, 2015 New Therapeutic Class Review: Dr. Madiraju made the following motions that were seconded and approved unanimously by the Committee. 1. Pancreatic Enzymes: The following drugs are preferred: pancrelipase (AG); Zenpep, Creon 2. Antifungals, Topical: The following drugs are preferred: ciclopirox solution miconazole spray (OTC) clotrimazole cream (OTC & RX) nystatin cream, ointment, powder clotrimazole solution (OTC) nystatin-triamcinolone cream & oint clotrimazole-betamethasone cream terbinafine cream (OTC) ketoconazole cream tolnaftate Aero Powder (OTC) ketoconazole Shampoo tolnaftate cream, powder, soln (OTC ) miconazole cream, oint, powder (OTC) tolnaftate spray (OTC) miconazole nitrate (OTC) 3. Antibiotics, GI: The following drug is preferred: metronidazole tablets (oral) New Drugs Phase I: Dr. Madiraju motioned that all products presented remain non-preferred. The motion was seconded and unanimously approved by the Committee. Phase II Annual Review Dr. Madiraju made the following motions that were seconded and approved unanimously by the Committee (note the motions are for changes to the current PDL status): 1. Oral Contraceptives: Falmina, Gianvi, Gildess Fe, Levonest, Minastrin 24 Fe, Necon Monophasic, Nora-Be, Syeda, Vestura, and Viorele are preferred. Enpresse, Gildess 24 Fe, Loestrin, Micronor, Mircette, Norinyl, Nor-Q-D, Yasmin, and Yaz are non-preferred. 2. Dermatologic Agents (Combination Benzoyl Peroxide & Clindamycin for Acne): Benzaclin W/Pump and Benzaclin are preferred. Benzoyl peroxide gel and clindamycin/benzoyl peroxide (Generic Benzaclin ) are non-preferred. Benzoyl peroxide cleanser continues to be non-preferred. 3. Dermatologic Agents (Topical Retinoids/Combinations for Acne): tretinoin microsphere gel continues to be non-preferred. 4. Antivirals Topical: Zovirax Cream is preferred and Zovirax Ointment is non-preferred. 5. Multiple Sclerosis Agents: Betaseron and Gilenya are preferred. Extavia Kit and Vial are nonpreferred. 6. Antihyperuricemics: colchicine tablet is preferred and colchicine capsule is non-preferred. 7. Oral Hypoglycemics SGLT2: Farxiga TM and Xigduo TM XR are preferred. 8. Narcotics Short Acting (Lozenges-Narcotic): fentanyl buccal continues to be non-preferred. 10

11 Page Anticoagulants (Low Molecular Weight Heparin includes Factor XA Inhibitor): Arixtra continues to be non-preferred. 10. Anticoagulants (Oral Anticoagulants): Savaysa TM is non-preferred. 11. Antimigraine Agents: rizatriptan tablet continues to be preferred. 12. Hepatitis C Agents (NS5A, NS3/4A Inhibitor Combinations): Viekira Pak TM is preferred. 13. Non-Ergot Dopamine Receptor Agonist: pramipexole ER is non-preferred. 14. Cytokine and CAM Antagonist: Cosentyx TM Pen and Syringe are non-preferred. 15. Oral Hypoglycemics DPP-IV Inhibitors and Combinations: Glyxambi is non-preferred. Dr. Madiraju made the following motion to make no changes to the following PDL drug classes, which was seconded and approved unanimously by the Committee: Androgenic Agents (Testosterone Topical) Antibiotics Topical Antivirals (Herpes Oral) Antivirals (Influenza) Bone Resorption Suppression and Related Agents (Bisphosphonates, Calcitonins, Others) Contraceptives Other (Etonogestrel/Ethinyl Estradiol Vaginal Ring) Contraceptives Other (Norelgestromin/Ethinyl Estradiol Transdermal) Diabetes Hypoglycemics (Injectable Amylin Analogs) Diabetes Hypoglycemics (Injectable Incretin Mimetics) Diabetes Hypoglycemics: Injectable Insulins (Insulin Mix) Diabetes Hypoglycemics: Injectable Insulins (Insulin N) Diabetes Hypoglycemics: Injectable Insulins (Insulin R) Diabetes Hypoglycemics: Injectable Insulins (Long-Acting Insulins) Diabetes Hypoglycemics: Injectable Insulins (Rapid-Acting Insulins) Erythropoiesis Stimulating Proteins Hepatitis C Agents (Interferon) Hepatitis C Agents (NS5A-NS5B polymerase inhibitor combination) Hepatitis C Agents (Nucleotide Analog NS5B Polymerase Inhibitor) Hepatitis C Agents (Protease Inhibitor) Macrolides/Ketolides Narcotics Long Acting Neuropathic Pain Non-Steroidal Anti-Inflammatory Drugs Opioid Dependency Buprenorphine Products Oral Antifungals Oral Cephalosporins (second and third generation cephalosporins) Oral Hypoglycemics - biguanides, biguanide combinations, meglitinides, thiazolidinediones Oral Quinolones (second & third generation quinolones) 11

12 Page 12 Otic Quinolones Platelet Inhibitors Progestational Agents Short-Acting Narcotics Skeletal Muscle Relaxants Smoking Cessation Stimulants/ADHD Agents (amphetamine, methylphenidate and miscellaneous) Topical Agents for Psoriasis Vaginal Estrogens Clinical Criteria Dr. Madiraju, Dr. Jennings, Dr. Dhillon, Dr. Charlton, Ms. Abernathy, Dr. Cantrell, Dr. Exum, Dr. Vourlekis, Dr. Barber, and Dr. Johnson discussed the proposed clinical criteria. Dr. Madiraju made the following motion to implement clinical criteria for the following drugs and drug classes, which was seconded and approved unanimously by the Committee: Cytokine and CAM Antagonists and Related Agents Gastrointestinal Antibiotics (Dificid, Xifaxan, neomycin, and Alinia ) Hepatitis C Irritable Bowel Syndrome (Movantik ) Multiple Sclerosis (Gilenya ) Oral Anticoagulants (Xarelto and Savaysa TM ) Pancreatic Enzymes Stimulants/ADHD Medications clinical criteria edit for patients greater than 18 years of age to have a diagnosis of ADHD or diagnosis from the FDA approved labeling. Topical Antifungals (ciclopirox/penlac, CNL-8 TM, Jublia, Kerydin TM, and Luzu ) Opioid Dependency Buprenorphine Products (buprenorphine tablets): the criteria were discussed and the Committee will follow up on the criteria for pregnancy and/or allergy to naloxone at the next meeting. The next P&T Committee Meeting is tentatively scheduled for October 15, Dr. Jennings adjourned the meeting. 12