Virginia's Department of Medical Assistance Services Pharmacy and Therapeutics Committee Meeting
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Virginia’s Department of Medical Assistance Services Pharmacy and Therapeutics Committee Meeting Thursday, September 17, 2020 - 10:00 a.m. Please click on this link to join the WebEx Audio Access: 866-692-4530; Pin 161 535 7780 This is an electronic public meeting held pursuant to Items 4-0.01(g) in House Bill 29 and House Bill 30. The FOIA Councils “Electronic Meetings Public Comment” form for submitting feedback on this electronic meeting may be accessed at http://foiacouncil.dls.virginia.gov/sample%20letters/welcome.htm Welcome and Comments from DMAS’ Director Karen Kimsey Virginia’s Secretary of Health & Human Resources Daniel Carey, MD, MHCM Call to Order Chethan Bachireddy, MD, CMO, Chair Approval of Minutes from April 20, 2020 Meeting P&T Committee Members Drug Utilization Review (DUR) Board Update Rachel Cain, PharmD PDL Management P&T Committee Members PDL Phase II – New Drug Review (Therapeutic Class) Brand Drugs Arazlo® (Acne Agents, Topical) AvsolaTM (Cytokine & Cam Antagonists) (Closed class) Licart Patch (topical NSAIDS) LyumjevTM (Hypoglycemics, Insulin & Related Agents) Nurtec® ODT (Antimigraine Agents, Other) Trijardy® XR (Hypoglycemics, SGLT2) (Closed class) Zeposia® (Multiple Sclerosis Agents) ZilxiTM Foam (Rosacea Agents, Topical) Generics Drugs and New Dosage Forms (additional information on P&T Committee web site) Antipsoriatic, Topical TCR calcipotriene 0.005% foam & calcipotriene/betamethasone suspension new generic for Sorilux and Taclonex susp Hypoglycemics, Metformin new generic for Riomet Solution NSAIDS TCR: naproxen-esomeprazole DR new generic for Vimovo, ketorolac tromethamine new generic for SPRIX, indomethacin new generic for TIVORBEX Opiate Dependence Treatments TCR naloxone HCL new a generic for EVZIO Stimulants & Related Agents TCR methylphenidate ER new generic for Aptensio XR PDL Phase I – Annual Review (Therapeutics Classes with Updates for P&T Committee Review) Antibiotics/Anti-Infectives Antibiotics, Vaginal Antivirals Hepatitis C Agents (Closed Class) September 17, 2020 P&T Committee Agenda Page 2 Cardiac Medications Angiotensin Modulators (includes ACEs, ARBs, & CCB combination products) Lipotropics, Other (includes Bile Acid Sequestrants, Cholesterol Absorption Inhibitor agents, Fibric Acid derivatives, Microsomal Triglyceride Transfer Protein Inhibitors, Niacin derivatives, Oligonucleotide Inhibitors and Omega 3 agents) Pulmonary Arterial Hypertension Agents, Oral/Inhaled/Injectable (includes Endothelin-1 agents, PDE-5 Inhibitors; Prostacyclin analogues, Prostacyclin Vasodilator, Soluble Guanylate Cyclase Stimulators) Central Nervous System Anticonvulsants Antipsychotics (includes oral and long-acting injectables) (Closed Class – LA injectables only) Sedative Hypnotics Dermatitis Immunomodulators, Atopic Dermatitis Gastrointestinal Antiemetic/Antivertigo Agents H. pylori Agents Histamine-2 Receptor Antagonists (H-2RA) Proton Pump Inhibitors Ulcerative Colitis Genitourinary Bladder Relaxants Ophthalmics Allergic Conjunctivitis (includes Ophthalmic Antihistamines & Mast Cell Stabilizers) Respiratory Anti-Allergens, Oral Bronchodilators, Long Acting Beta Adrenergics Bronchodilators, Short Acting Beta Adrenergics COPD (includes Anticholinergics, Bronchodilators and Phosphodiesterase 4 (PDE4) Inhibitors) (Closed Class) Glucocorticoids (includes nebulized solutions, metered dose inhalers and combinations) (Closed Class) Leukotriene Modifiers PDL Phase I – Annual Review (Therapeutics Classes without Significant Updates since Last Annual Review – Reviewed by the Department) Blood Modifiers Bile Salts Phosphate Binders Cardiac Medications Angiotensin Modulators II (includes Direct Renin Inhibitors & combination products) Antihypertensives, Sympatholytics (Closed Class) Beta Blockers (includes combination products) Calcium Channel Blockers (includes dihydropyridine and non-dihydropyridine agents) Lipotropics, Statins Central Nervous System Alzheimer’s Agents Antidepressants, SSRI Antidepressants, Other September 17, 2020 P&T Committee Agenda Page 3 Dermatitis Steroids, Topical Endocrine & Metabolic Agents Glucocorticoids, oral Growth Hormones (Closed Class) Hereditary Angioedema (HAE) Progestins for Cachexia Gastrointestinal GI Motility, Chronic Genitourinary BPH Agents (includes Alpha Blockers, Androgen Hormone Inhibitors and Phosphodiesterase (PDE) 5 Inhibitors for BPH treatment) Ophthalmics Antibiotics Antibiotic/Steroid Combinations Anti-Inflammatory Agents (includes Ophthalmic NSAIDS & Corticosteroids) Glaucoma Agents (includes Alpha-2 Adrenergics, Beta-blockers, Carbonic Anhydrase Inhibitors, Prostaglandin Inhibitors) Respiratory Antibiotics, Inhaled (Closed Class) Antihistamines Minimally Sedating Cough & Cold Agents (Legend) Epinephrine, Self-injected Intranasal Rhinitis (includes antihistamines and corticosteroids) Confidential Meeting (Pricing Information Discussion) P&T Committee, DMAS & MMA Staff Pursuant to 42 USC §1396r-8 PDL Recommendations and Vote P&T Committee Members Criteria Discussion of Phase II New Drugs* P&T Committee Members Criteria Discussion of PDL Phase I Drug Classes* P&T Committee Members Next Meeting - tentatively scheduled for March 18, 2021 *Criteria discussions will be held for classes only if deemed PDL eligible by the P&T Committee during Drug Class Discussions. VIRGINIA FREEDOM OF INFORMATION ADVISORY COUNCIL COMMONWEALTH OF VIRGINIA ELECTRONIC MEETINGS PUBLIC COMMENT FORM WE NEED YOUR HELP--Please give us your feedback regarding how meetings using electronic communications technology compare to traditional meetings where everyone is present in the same room at the same time. 1. Name of the public body holding the meeting: _VA Dept of Medical Assistance Services Pharmacy & Therapeutics Committee Meeting 2. Date of the meeting: ____Thursday, September 17, 2020 3. What are your overall thoughts or comments about this meeting? ______________________________ _________________________________________________________________________________________ 4. Where did you attend this meeting -- main meeting location OR from a remote location? (circle one) 5. Technology used for the meeting (audio only or audio/visual, devices and/or software used--please be as specific as possible--for example, speakerphone, iPad, Skype, WebEx, Telepresence, etc.): ________________________________________________________________________________________ 6. Were you able to hear everyone who spoke at the meeting (members of the body and members of the public)? Poor Excellent 1 2 3 4 5 COMMENT______________________________________________________________________ 7. How easy was it for you to obtain agenda materials for this meeting? Easy Difficult 1 2 3 4 5 COMMENT______________________________________________________________________ 8. Could you hear/understand what the speakers said or did static, interruption, or any other technological problems interfere? Easy Difficult 1 2 3 4 5 COMMENT________________________________________________________________________ 9. If the meeting used audio/visual technology, were you able to see all of the people who spoke? Poorly Clearly 1 2 3 4 5 COMMENT_______________________________________________________________________ 10. If there were any presentations (PowerPoint, etc.), were you able to hear and see them? Poorly Clearly 1 2 3 4 5 COMMENT____________________________________________________________________ 11. Were the members as attentive and did they participate as much as you would have expected? Less More 1 2 3 4 5 COMMENT____________________________________________________________________ 12. Were there differences you noticed in how the members interacted? With the other members present: Very Different No Difference 1 2 3 4 5 With members participating from other locations: Very Different No Difference 1 2 3 4 5 With the public: Very Different No Difference 1 2 3 4 5 COMMENT_____________________________________________________________________ 13. Did you feel the technology was a help or a hindrance? Hindered Helped 1 2 3 4 5 COMMENT_____________________________________________________________________ 14. How would you rate the overall quality of this meeting? Poor Excellent 1 2 3 4 5 COMMENT_____________________________________________________________________ THANK YOU. Please send your completed form by mail, facsimile or electronic mail to the FOIA Council using the following contact information: Virginia Freedom of Information Advisory Council General Assembly Building, Second Floor 201 North 9th Street, Richmond, Virginia 23219 [email protected]/Fax: 804-371-8705/Tele: 866-448-4100 2 Virginia Medicaid Pharmacy & Therapeutics Committee Meeting Debbie Moody, R.Ph., Director, Clinical Account Services Nancy Eldin, Pharm.D., Pharmacist Account Executive Jeni Hodzic, Lead Formulary Analyst September 17, 2020 PDL Phase II – New Drug Review (Therapeutic Class) Brand Drugs • ARAZLO™ (Acne Agents, Topical) • AVSOLA™(Cytokine and CAM Antagonists) (Closed Class) • LICART™ Patch (Topical NSAIDs) • LYUMJEV™ (Hypoglycemics, Insulin & Related Agents) • NURTEC™ ODT (Antimigraine Agents, Other) • TRIJARDY™ XR (Hypoglycemics, SGLT2) (Closed class) • ZEPOSIA®, BAFIERTAM™ (Multiple Sclerosis Agents) • ZILXI™ Foam (Rosacea Agents, Topical) 2 ARAZLO™ (Acne Agents, Topical) ARAZLO™ (tazarotene) • A retinoid approved for the topical treatment of acne vulgaris in patients 9 years of age and older. • It is approved as a 0.045% lotion to be applied as a thin layer to the affected areas once daily. • The eyes, mouth, paranasal creases, and