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Xifaxan® (Rifaximin) Wednesday, October 14, 2015 4 p.m. Oklahoma Health Care Authority 4345 N. Lincoln Blvd. Oklahoma City, OK 73105 The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review Board Members FROM: Bethany Holderread, Pharm.D. SUBJECT: Packet Contents for Board Meeting – October 14, 2015 DATE: October 1, 2015 NOTE: The DUR Board will meet at 4:00 p.m. The meeting will be held at 4345 N Lincoln Blvd. Enclosed are the following items related to the October meeting. Material is arranged in order of the agenda. Call to Order Public Comment Forum Action Item – Approval of DUR Board Meeting Minutes – Appendix A Action Item – Vote on 2016 Meeting Dates – Appendix B Update on Medication Coverage Authorization Unit/Bowel Preparation Medication Post-Educational Mailing – Appendix C Action Item – Vote to Prior Authorize Tykerb® (Lapatinib), Halaven® (Eribulin), Ixempra® (Ixabepilone), Kadcyla® (Ado-Trastuzumab), Afinitor® (Everolimus), & Perjeta® (Pertuzumab) – Appendix D Action Item – Vote to Prior Authorize Orkambi™ (Lumacaftor/Ivacaftor) – Appendix E Action Item – Vote to Prior Authorize Savaysa® (Edoxaban) – Appendix F Action Item – Vote to Prior Authorize Epanova® (Omega-3-Carboxylic Acids), Praluent® (Alirocumab), & Repatha™ (Evolocumab) – Appendix G Annual Review of Constipation and Diarrhea Medications and 30-Day Notice to Prior Authorize Movantik™ (Naloxegol), Viberzi™ (Eluxadoline), & Xifaxan® (Rifaximin) – Appendix H 30-Day Notice to Prior Authorize Daraprim® (Pyrimethamine) – Appendix I Annual Review of Allergy Immunotherapies and 30-Day Notice to Prior Authorize Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, & Kentucky Blue Grass Mixed Pollens Allergen Extract) – Appendix J Annual Review of Non-Steroidal Anti-Inflammatory Drugs and 30-Day Notice to Prior Authorize Dyloject™ (Diclofenac Sodium) – Appendix K ORI-4403 • P.O. BOX 26901 • OKLAHOMA CITY, OKLAHOMA 73126-0901 • (405) 271-9039 • FAX: (405) 271-2615 Annual Review of Targeted Immunomodulator Agents and 30-Day Notice to Prior Authorize Cosentyx® (Secukinumab) – Appendix L Annual Review of Inhaled Tobramycin Products and Pulmozyme® (Dornase Alfa) and 30-Day Notice to Prior Authorize Cayston® (Aztreonam Inhalation) & Kitabis™ Pak (Tobramycin Inhalation) – Appendix M Annual Review of Xolair® (Omalizumab) – Appendix N FDA and DEA Updates – Appendix O Future Business Adjournment ORI-4403 • P.O. BOX 26901 • OKLAHOMA CITY, OKLAHOMA 73126-0901 • (405) 271-9039 • FAX: (405) 271-2615 Oklahoma Health Care Authority Drug Utilization Review Board (DUR Board) Meeting – October 14, 2015 @ 4:00 p.m. Oklahoma Health Care Authority 4345 N. Lincoln Blvd. Oklahoma City, Oklahoma 73105 AGENDA Discussion and Action on the Following Items: Items to be presented by Dr. Muchmore, Chairman: 1. Call To Order A. Roll Call – Dr. Cothran Items to be presented by Dr. Muchmore, Chairman: 2. Public Comment Forum A. Acknowledgment of Speakers and Agenda Items Items to be presented by Dr. Muchmore, Chairman: 3. Action Item – Approval of DUR Board Meeting Minutes – See Appendix A A. September 9, 2015 DUR Minutes – Vote B. September 9, 2015 DUR Recommendations Memorandum C. Veripred™ and Millipred™ Prior Authorization Memorandum D. Correspondence Items to be presented by Dr. Muchmore, Chairman: 4. Action Item – Vote on 2016 Meeting Dates – See Appendix B A. 2016 DUR Board Meeting Dates – Vote Items to be presented by Dr. Holderread, Dr. Muchmore, Chairman: 5. Update on Medication Coverage Authorization Unit/Bowel Preparation Medication Post- Educational Mailing – See Appendix C A. Medication Coverage Activity for September 2015 B. Pharmacy Help Desk Activity for September 2015 C. Bowel Preparation Medication Post-Educational Mailing Items to be presented by Dr. Schmidt, Dr. Borders, Dr. Medina, Dr. Muchmore, Chairman: 6. Action Item – Vote to Prior Authorize Tykerb® (Lapatinib), Halaven® (Eribulin), Ixempra® (Ixabepilone), Kadcyla® (Ado-Trastuzumab), Afinitor® (Everolimus), & Perjeta® (Pertuzumab) – See Appendix D A. Recommendations Items to be presented by Dr. Teel, Dr. Muchmore, Chairman: 7. Action Item – Vote to Prior Authorize Orkambi™ (Lumacaftor/Ivacaftor) – See Appendix E A. College of Pharmacy Recommendations Items to be presented by Dr. Hsu, Dr. Muchmore, Chairman: 8. Action Item – Vote to Prior Authorize Savaysa® (Edoxaban) – See Appendix F A. College of Pharmacy Recommendations Items to be presented by Dr. Adams, Dr. Muchmore, Chairman: 9. Action Item – Vote to Prior Authorize Epanova® (Omega-3-Carboxylic Acids), Praluent® (Alirocumab), & Repatha™ (Evolocumab) – See Appendix G A. College of Pharmacy Recommendations B. Attachment A: Diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH) C. Attachment B: Framingham Heart Study and Framingham Risk Score D. Draft PCSK9 Inhibitor Prior Authorization Form Items to be presented by Dr. Adams, Dr. Muchmore, Chairman: 10. Annual Review of Constipation and Diarrhea Medications and 30-Day Notice to Prior Authorize Movantik™ (Naloxegol), Viberzi™ (Eluxadoline), & Xifaxan® (Rifaximin) – See Appendix H A. Current Prior Authorization Criteria B. Utilization of Constipation and Diarrhea Medications C. Prior Authorization of Constipation and Diarrhea Medications D. Market News and Updates E. Product Summaries F. College of Pharmacy Recommendations G. Utilization Details of Constipation and Diarrhea Medications Items to be presented by Dr. Adams, Dr. Muchmore, Chairman: 11. 30-Day Notice to Prior Authorize Daraprim® (Pyrimethamine) – See Appendix I A. Toxoplasmosis Background Information B. Daraprim® (Pyrimethamine) Product Summary C. Daraprim® (Pyrimethamine) Cost Update D. Utilization Details of Daraprim® (Pyrimethamine) E. College of Pharmacy Recommendations Items to be presented by Dr. Teel, Dr. Muchmore, Chairman: 12. Annual Review of Allergy Immunotherapies and 30-Day Notice to Prior Authorize Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, & Kentucky Blue Grass Mixed Pollens Allergen Extract) – See Appendix J A. Current Prior Authorization Criteria B. Prior Authorization of Allergy Immunotherapies C. Oralair® (Allergen Extract) Product Summary D. College of Pharmacy Recommendations Items to be presented by Dr. Hsu, Dr. Muchmore, Chairman: 13. Annual Review of Non-Steroidal Anti-Inflammatory Drugs and 30-Day Notice to Prior Authorize Dyloject™ (Diclofenac Sodium) – See Appendix K A. Current Prior Authorization Criteria B. Utilization of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) C. Prior Authorization of NSAIDs D. Market News and Updates E. Dyloject™ (Diclofenac Sodium) Product Summary F. NSAID Price Trends G. College of Pharmacy Recommendations H. Utilization Details of NSAIDs Items to be presented by Dr. Holderread, Dr. Muchmore, Chairman: 14. Annual Review of Targeted Immunomodulator Agents and 30-Day Notice to Prior Authorize Cosentyx® (Secukinumab) – See Appendix L A. Current Prior Authorization Criteria B. Utilization of Targeted Immunomodulator Agents C. Prior Authorization of Targeted Immunomodulator Agents D. Market News and Updates E. Cosentyx® (Secukinumab) Product Summary F. Hidradenitis Suppurativa Summary G. College of Pharmacy Recommendations H. Utilization Details of Targeted Immunomodulator Agents Items to be presented by Dr. Holderread, Dr. Muchmore, Chairman: 15. Annual Review of Inhaled Tobramycin Products and Pulmozyme® (Dornase Alfa) and 30-Day Notice to Prior Authorize Cayston® (Aztreonam Inhalation) & Kitabis™ Pak (Tobramycin Inhalation) – See Appendix M A. Introduction B. Current Prior Authorization Criteria C. Utilization of Inhaled Tobramycin Products, Dornase Alfa, & Aztreonam Inhalation D. Prior Authorization of Inhaled Tobramycin Products and Dornase Alfa E. Market News and Updates F. Product Summaries G. College of Pharmacy Recommendations H. Utilization Details of Inhaled Tobramycin Products, Dornase Alfa, & Aztreonam Inhalation Non-Presentation, Questions Only: 16. Annual Review of Xolair® (Omalizumab) – See Appendix N A. Current Prior Authorization Criteria B. Utilization of Xolair® (Omalizumab) C. Prior Authorization of Xolair® (Omalizumab) D. Market News and Updates E. College of Pharmacy Recommendations Items to be presented by Dr. Keast, Dr. Muchmore, Chairman: 17. FDA and DEA Updates – See Appendix O Items to be presented by Dr. Holderread, Dr. Muchmore, Chairman: 18. Future Business* (Upcoming Product and Class Reviews) A. Ophthalmic Anti-Inflammatories/Omidria™ (Phenylephrine/Ketorolac Injection) B. Topical Corticosteroids C. Xiaflex® (Collagenase Clostridium Histolyticum) D. Xgeva® (Denosumab) E. Erythropoietin Stimulating Agents F. Prialt® (Ziconotide) G. Tetracycline and Ofloxacin 400mg Tablets H. Keveyis™ (Dichlorophenamide) I. Ibrance® (Palbociclib) *Future business subject to change. Items to be presented by Dr. Muchmore, Chairman: 19. Adjournment Appendix A OKLAHOMA HEALTH CARE AUTHORITY DRUG UTILIZATION REVIEW BOARD MEETING MINUTES OF MEETING OF SEPTEMBER 9, 2015 BOARD MEMBERS: PRESENT ABSENT Theresa Garton, M.D. x Carla Hardzog-Britt, M.D. x Anetta Harrell, Pharm.D. x Ashley Huddleston, Pharm.D. x John Muchmore, M.D., Ph.D.; Chairman x James Osborne, Pharm.D. x Paul Louis Preslar, D.O., MBA x James Rhymer, D.Ph. x Bruna Varalli-Claypool, MHS, PA-C x Eric Winegardner, D.Ph. x COLLEGE OF PHARMACY STAFF: PRESENT ABSENT Terry Cothran, D.Ph.; Pharmacy Director x Michyla Adams, Pharm.D.; Clinical Pharmacist x Karen Egesdal, D.Ph.; SMAC-ProDUR Coordinator/OHCA Liaison x Erin Ford, Pharm.D.; Clinical Pharmacist
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