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«DRUG UTILIZATION REVIEW BOARD MEETING Department of Community Health 2 Peachtree Street - 5th Floor Board Room Atlanta, Georgia 30303 June 6, 2013 ...»

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Georgia Department of

Community Health

DRUG UTILIZATION REVIEW BOARD MEETING

Department of Community Health

2 Peachtree Street - 5th Floor Board Room

Atlanta, Georgia 30303

June 6, 2013

This page intentionally left blank

DRUG UTILIZATION REVIEW BOARD MEETING

AGENDA

2 Peachtree Street - 5th Floor DCH Board Room

Atlanta, Georgia 30303

June 6, 2013 – 10:00 a.m. to 2:00 p.m.

CALL TO ORDER Laurel Ashworth, PharmD, Chair COMMENTS FROM THE DEPARTMENT Linda Wiant, PharmD, Director MINUTES FROM PREVIOUS MEETING Chair CONSUMER COMMENTS SESSION Chair ADJOURNMENT OF OPEN SESSION Chair

EXECUTIVE SESSION

RECONVENING OF OPEN SESSION Chair CLINICAL REVIEW AND DURB VOTES Emily Baker, PharmD, BCPS, MBA, MHA Tara R. Cockerham, PharmD  Manufacturers’ Forum  New Drug Reviews ●Aubagio™ ●Stivarga™ ●Bosulif™ ●Synribo™ ●Linzess™ ●Tudorza™ ●Myrbetriq™ ●Xeljanz™  Follow-Up Review ●High-Level Analysis of Human Immunodeficiency Virus Agents  Class Reviews – Clinical Updates  Utilization Trends Review  Drug Information Review ●Drug Update Newsletter ●Patent Expiration Report ●Horizon Watch Report ●Clinical Compass Newsletter FUTURE AGENDA ITEMS Chair REVIEW OF DURB RECOMMENDATIONS Chair ADJOURNMENT OF MEETING Chair This page intentionally left blank Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, March 19, 2013 Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, March 19, 2013

MEMBERS PRESENT MEMBERS ABSENT

Laurel E. Ashworth, Pharm.D., Chair Paul D. Boyce, M.D.

Joseph R. Bona, M.D., MBA, Vice-Chair Melissa D. Carter, J.D, Karen L. Carter, M.D.

Ann R. Damon, Pharm.D.

Carl Ellis, R.Ph.

Deborah W. Fincher, M.S., R.Ph.

Thomas B. Gore, M.D.

John Greeson, M.D., MBA Rondell C. Jaggers, Pharm.D.

Edwina L. Jones, Pharm.D.

Robyn Lorys, Pharm.D.

J. Russell May, Pharm.D.

Osgood (Drew) A. Miller, R.Ph.

Donald A. Paul, M.D.

Matthew Perri, III, R.Ph., Ph.D.

Sandra L. White, M.D., MBA, FACR Mary Virginia "Ginny" Yates, Pharm.D.

Staff Linda Wiant, Pharm.D., Pharmacy Director, Pharmacy Services Turkesia Robertson-Jones, Pharm.D., Pharmacy Operations Manager, Pharmacy Services Gilletta Gray, R.Ph., Clinical Manager, Pharmacy Services Lori Garner, MHS, MBA, R.Ph., Pharmacist, Pharmacy Services Rose Marie Duncan, MBA, Program Associate, Pharmacy Services Matthew Leigh, Pharm.D. Candidate NorthStar HealthCare Consulting Tara R. Cockerham, Pharm.D., Clinical Programs Director Elizabeth Flores, Pharm.D., Clinical Pharmacist Catamaran Susan McCreight, Sr. Director, Public Sector Account Management Mark Hall, MBA, PMP, Account Manager Talmahjia “Tami” Sweat, Pharm.D., Clinical Systems Product Manager Christopher Hamilton, R.Ph., Clinical Consultant, Account Management Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, March 19, 2013 Goold Health Services Steve Liles, Pharm.D., Sr. Director, Pharmacy Services Doug Martin, Pharm.D., Pharmacy Project Manager University of Georgia Pharmacy School Erin Masarello, Pharm.D. Candidate Leigh Perri, Pharm.D. Candidate Call to Order The Drug Utilization Review Board (DURB/DUR Board/Board) held its first meeting for the calendar year on March 19, 2013. The Chair, Laurel E. Ashworth, Pharm.D., called the meeting to order at 9:01am.

Comments from the Department Linda Wiant, Pharm.D., Pharmacy Director, Pharmacy Services, commented on the following

items:

1. Pharmacy Students –UGA students, Erin Massarello and Leigh Ann Perri, and Mercer student, Matthew Leigh, were welcomed.

2. Resignations – Arvind Gupta, M.D., has resigned from the DUR Board. Appreciation for his service to the Board was expressed.

3. DUR Board – The Department is seeking nominations for the DUR Board. Nominations can be emailed to DCH.

4. Medicaid Snapshot: Year in Review – A presentation was given to provide an overview of Medicaid expenditures/growth, pharmacy expenditures, specialty drug trending, DUR initiatives and DURB recommendations (see Attachment A).

Minutes from the Previous Meeting Dr. Ashworth asked for comments regarding the minutes from the December 11, 2012 meeting.

There were no corrections. A motion was made, seconded, and carried to approve the minutes as written.

Manufacturers’ Forum Tara Cockerham, Pharm.D., reviewed information regarding the Manufacturers’ Forum that was provided in the Manufacturer Information section in the DUR Board binder. A total of twentytwo (22) manufacturers participated and provided information regarding the following drugs

discussed at the March 2013 DURB meeting:

Questions and comments were made on the following: Manufacturer restrictions on data provided, pharmacoeconomic data; budget-impact models. The next forum will be held on Thursday, May 2, 2013 from 9am-5pm at the NorthStar Healthcare Consulting office: 1121 Alderman Drive, Suite 112, Alpharetta, GA 30005.

New Drug Reviews Clinical information for the following new drugs, in the market six months or more, was presented for discussion and recommendations. The complete detailed drug summary is in the New Drugs for Review section of the DUR Board binder.





The Board discussed the drug information, provided comments, and raised questions on the

following:

 Sklice – pregnancy testing to rule out pregnancy; exclusion of pregnant patients in the clinical trial; local resistant patterns Therapeutic Class Review Clinical information for the following therapeutic class was presented for discussion by Dr. Tara Cockerham. The complete detailed therapeutic class review was provided in the Therapeutic Class Review section of the DUR Board binder.

Therapeutic Class Name Oral Nonsteroidal Antiinflammatory Drugs (NSAIDs) Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, March 19, 2013 Comments were provided on usage in older patients and in Coronary Artery Disease (CAD) patients. The Department noted there were no current issues from providers that have come up with this drug class.

Supplemental Rebate Drugs – New Clinical Information Review Clinical updates to the Supplemental Rebate categories were listed in the Supplemental Rebate

section of the DURB binder. The following therapeutic categories had updates:

Drug Class/Name Anticonvulsants – Second Generation Antiinfectives - Miscellaneous Beta Adrenergics – Short-Acting Inhalers Gastrointestinal – Digestive Enzymes Insulin Nasal Steroids Nonsteroidal Antiinflammatory Agents Ophthalmic Quinolones Osteoporosis Agents Platelet Aggregate Inhibitors/Combinations - Miscellaneous Pulmonary Antihypertensives Topical – Corticosteroids Topical – Scabicides and Pediculicides Adrenergic Combinations Alzheimer - Cholinomimetics Androgen/Anabolics Angiotensin II Receptor Antagonist (ARBs) and Combinations Anticoagulants Antidepressants – Selective Norepinephrine Reuptake Inhibitors Antiemetic Drugs Antihemophilic Products Antihistamines - Nasal Antihistamines – Non-Sedating Antihyperkinesis Agents Antimanic Agents Antineoplastics and Adjunct Therapies Antiparkinson Agents Asthma & Bronchodilator Agents Atypical Antipsychotics Cardiac – Other Cephalosporins Cholesterol Bile Acid Sequestrants Diabetic – Dipeptidyl Peptidase IV (DPP-IV) Inhibitors Diabetic – Non-Insulin Injectables Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, March 19, 2013 Drug Class/Name - continued Direct Renin Inhibitors and Combinations Gastrointestinal – Inflammatory Bowel Agents Gastrointestinal – Proton Pump Inhibitors Growth Hormones Hematopoietic Agents Hepatitis C Lipid – Niacin Lipid-Other Migraine – Selective Serotonin Agents Multiple Sclerosis (MS) Agents Ophthalmic – Antiallergic Ophthalmic – Antiinflammatory/Steroid Agents Ophthalmic – Beta Blockers Ophthalmic Nonsteroidal Antiinflammatory Agents Ophthalmic Prostaglandins Opioid Agonists Opioid Partial Agonists Progestins Prostatic Hypertrophy Agents Topical – Immunomodulators Triglyceride Lowering Agents Tumor Necrosis Factor (TNF) Agents There were no comments or questions from the Board.

DCH Decisions DCH Decisions from the December 2012 DUR Board meeting were provided in the DCH Decision section of the DUR Board binder.

Utilization Trend Review Utilization trends for Georgia Medicaid Fee-for-Service were provided in detail in the Utilization Trends section of the DUR Board binder.

Drug Information Information from the following was provided in detail in the Drug Information section of the

DUR Board binder used for this meeting:

 Drug Update Newsletter  Horizon Watch Report  Patent Expiration Report  Clinical Compass Newsletter Future Agenda Items

The following future agenda items were noted:

 Utilization Review Activities Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, March 19, 2013 Consumer Comments Session Dr. Bona conducted the Consumer Comments Session. Consumer comments were presented to

the Board from the following:

 Camden Pace, Consumer – consider open access for all atypical antipsychotics  Dr. Tara Cockerham read a consumer comment (received after last meeting) from the Georgia AIDS Coalition, Cathalene Teahan, RN, MSN Disclosure forms were completed by Camden Pace and Cathalene Teahan and were reviewed by the Department.

Upcoming Meetings

The following upcoming meetings were published in the DURB binder:

Disclosure Forms Disclosure forms were received and reviewed by the Department for completeness for all Board members attending the meeting.

Dr. Donald Paul disclosed program support from a manufacturer and abstained from voting for products or classes of medications from this manufacturer.

Adjournment of Open Session The DUR Board voted to close the open meeting pursuant to the Open Meeting Act of Georgia Section 50-14-1 – 50-14-6 and pursuant to Federal Law Section 1396R-8B3D. The individuals recorded in attendance from the Department of Community Health, Goold Health Services, NorthStar HealthCare Consulting, Catamaran and University of Georgia and Mercer pharmacy students attended the closed session with the Board members. A motion was made by Rusty May, Pharm.D., and seconded by Karen Carter, M.D., to adjourn the open session and approve the closed session. There was a unanimous vote approving the closed session. The Chairman, Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, March 19, 2013 Dr. Laurel Ashworth, adjourned the open session at approximately 10:47 am, at which time members took a break then reconvened for the executive (closed) session.

Executive SessionThe executive session was held from 11:04am to 1:15pm.

Board’s Recommendations to the Department After all clinical and financial evaluations and discussions, the DUR Board reconvene ed in the open session, voted, and presented the Department with the following recommendations for changes to the Preferred Drug List (PDL). All motions and votes are noted in Attachment B.

New Drug Reviews Antiparkinson Agent The DUR Board recommended Non-Preferred status with Prior Authorization for Neupro™.

Gastrointestinal – Bowel Evacuation Preparation The DUR Board recommended Non-Preferred status with Prior Authorization for Prepopik™.

Topical – Scabicides and Pediculicides The DUR Board recommended Non-Preferred status with Prior Authorization for Sklice™.

Antineoplastics The DUR Board recommended Preferred status with Prior Authorization for Xtandi.

The DUR Board recommended Non-Preferred status with Prior Authorization for Butalbital-Aspirin-Caffeine Capsule, Butalbital-Acetaminophen-Caffeine Capsule, Bupap®, Zebutal®, Dolgic® Plus and Phrenilin® Forte.

Anticonvulsants The DUR Board recommended Non-Preferred status with Prior Authorization for Banzel, Vimpat® and Lamotrigine Chewable Tablet.

® Antiinfective - Miscellaneous The DUR Board recommended Non-Preferred status with Prior Authorization for Metronidazole 375mg Capsule.

Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, March 19, 2013 Beta Adrenergics – Short-Acting Inhalers The DUR Board recommended Non-Preferred status with Prior Authorization for Ventolin® HFA and ProAir® HFA.

Gastrointestinal – Digestive Enzymes The DUR Board recommended Non-Preferred status with Prior Authorization for Ultresa® and Zenpep® Gastrointestinal - Laxatives The DUR Board recommended Non-Preferred status with Prior Authorization for Kristalose®.

Hyperparathyroid Treatment – Vitamin D Analogs and Calcimimetics The DUR Board recommended Non-Preferred status with Prior Authorization and Grandfathering for Zemplar®.

Insulins The DUR Board recommended Preferred status for Humulin® R Vial, Humulin® N Vial and Levemir® Vial, and Preferred status with Prior Authorization for Levemir® Flexpen.

Non-Steroidal Antiinflammatory Agents The DUR Board recommended Non-Preferred status with Prior Authorization for Diclofenac Sodium Extended-Release Tablet, Etodolac Extended-Release Tablet, Fenoprofen Calcium Tablet, Indomethacin Extended-Release Capsule, Ketoprofen Capsule, Ketoprofen Extended-Release Capsule, Meclofenamate Sodium Capsule, Naproxen Delayed-Release Tablet, Oxaprozin Tablet and Tolmetin Sodium Capsule and Tablet.

Ophthalmic Quinolones The DUR Board recommended Non-Preferred status with Prior Authorization for Besivance® and Ofloxacin.

Ophthalmic Selective Alpha Adrenergic Agonists The DUR Board recommended Non-Preferred status with Prior Authorization for Alphagan® P 0.1%.

Opioid Combinations The DUR Board recommended Preferred status for Ibudone® 10mg-200mg Tablet and Non-Preferred status with Prior Authorization for Hydrocodone-Ibuprofen 5mgDepartment of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, March 19, 2013 200mg and 7.5mg-200mg Tablets.

Phosphate Binders The DUR Board recommended Non-Preferred status with Prior Authorization for Renvela® 800mg Tablet.



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