Meeting of the Pharmacy and Therapeutics Committee October 20, 2011 Draft Minutes

Members Present: DMAS Staff: Randy Axelrod, M.D., Chair Cynthia Jones, Agency Director Mark Oley, R.Ph., Vice Chair Bryan Tomlinson, Director, Division of Health Care Services Tim Jennings, Pharm.D. Usha Koduru, Counsel to the Board, Office of the Attorney General Gill Abernathy, M.S., R.Ph. Donna Proffitt R.Ph, Pharmacy Manager Rachel M. Selby-Penczak, M.D. Keith Hayashi, R.Ph., Clinical Pharmacist Avtar Dhillon, M.D. Rachel Cain, Pharm.D., Clinical Pharmacist Mariann Johnson, M.D. Maryanne Paccione, Information Management Consultant Michele Thomas, Pharm.D. Scott Cannady, Senior Policy Analyst alternate for James Stewart III, Commissioner DBHDS Henry Ivey, M.D. Krishna Madiraju M.D.

Members Absent: Staff: Provider Synergies/Magellan Medicaid Administration Sue Cantrell, M.D. Debbie Moody, R.Ph., Clinical Account Manager, Virginia Renita Driver, Pharm.D. Nancy Eldin Pharm.D., Clinical Manager, Virginia

A quorum was present Guests: 66 representatives from pharmaceutical companies, providers, advocates, associations, etc. were in attendance

Welcome and Comments from DMAS’ Agency Director: Cynthia Jones welcomed the members of the Committee and thanked them for their continued participation in the PDL program.

Call to Order: Randy Axelrod, M.D., Chairman called the meeting to order.

Update DMAS’ Drug Utilization Review (DUR): Dr. Avtar Dhillon, who is also a member of the DMAS Drug Utilization Review Board (DUR), provided the Committee with a brief update on the activities of DMAS’ Drug Utilization Review (DUR) Board. Dr. Dhillon discussed a new service authorization process for atypical antipsychotics in children under the age of six that DMAS plans to implement on December 1, 2011. Dr. Dhillon also informed the P&T Committee that a service authorization requirement was implemented for Synagis® this past July.

PDL Contract Vendor Update: Debbie Moody, from Provider Synergies an affiliate of Magellan Medicaid Administration, provided the Committee with an update on PDL related issues. Prilosec OTC® was made non-preferred and the generic omeprazole OTC preferred as of October 19, 2011. Mrs. Moody also indicated that the P&T Committee meeting agenda was revised as a result of DMAS’ decision to review the Erythropoiesis Stimulating Proteins at the Spring 2012 P&T meeting.

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Approval of minutes from April 28, 2011 meeting: Dr. Axelrod asked if there were any corrections, additions or deletions to the draft meeting minutes. With no revisions or corrections from the Committee members, the minutes were approved as written.

Dr. Axelrod noted that some clinical materials received by Provider Synergies are copyright protected. These copyrighted documents cannot be reproduced and are distributed to the P&T Committee members for their review.

Old Business:

Polypharmacy and Butrans®: A report completed by Provider Synergies showed no current issues concerning polypharmacy and the use of Butrans®.

Cough and Cold Medication – quantity limits for pseudoephedrine products: Reports provided by Ms. Moody indicated that overuse of pseudoephedrine by Medicaid patients who have received prescriptions is not of concern in Virginia at this time. The P&T Committee agreed to monitor this issue and revisit it after one year. Gill Abernathy mentioned that the Virginia General Assembly is looking at the pseudoephedrine issue with the possibility of the implementation of electronic monitoring program.

Dr. Krishna Madiraju mentioned that the American Academy of Pediatrics does not recommend the use of OTC cough and cold medication in children. He expressed concern that if Medicaid covers even a 10-day supply of a cough and cold medication that physicians may prescribe these products more in children. He recommended that Medicaid not cover pseudoephedrine in the pediatric population.

Dr. Axelrod suggested that the Committee evaluate the use of cough and cold medicine in general at the next P&T meeting and to specifically look at the utilization of cough and cold products in patients ages zero to 6, six to 12, and 12 and above.

Effient® utilization by physician specialty: An analysis of claims data indicates that most of the physicians prescribing Effient® were cardiologists with some family medicine and nurse practitioners. The Committee proposed no changes to Effient® coverage, which is currently preferred on Virginia’s PDL..

Pradaxa® Utilization: Dr. Axelrod expressed concerns about “indication creep” with Pradaxa®. Dr. Jennings cited a recent article published by the Institute for Safe Medication Practices (ISMP) that mentioned several adverse events being reported associated with Pradaxa® use. The Committee decided to maintain the current status for Pradaxa®.

Review of Smoking Cessation Programs: Reports completed by Provider Synergies showed a spike in 3rd quarter 2011 utilization with Chantix® since the removal of the criteria edit in 2nd quarter 2011. The utilization for nicotine replacement products remained the same during this period. Donna Proffitt informed the Committee that the Virginia Department of Health has a free counseling program that is telephonic for all Virginia citizens. The DUR Board will distribute an educational letter to prescribers of smoking cessation drugs informing them of this program and encouraging them to have all their recipients participate in this free program. In addition, DMAS currently provides coverage of smoking cessation counseling for pregnant women.

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Rosiglitazone REMS Update: Utilization of rosiglitazone has dramatically decreased since the introduction of the REMS program. Ms. Moody explained that there are strict restrictions to the prescribing and use of rosiglitazone products because of this REMs program. Since rosiglitazone can only be prescribed by physicians enrolled in the REMS program and the drug can only be obtained through specialty pharmacies, the Committee suggested that rosiglitazone products not be subject to additional DMAS SA criteria. Dr. Axelrod motioned that rosiglitazone containing products be non- PDL eligible. With the motion seconded, the Committee voted unanimously to consider all rosiglitazone-containing products as non-PDL eligible.

Ampyra® Adverse Events: Dr. Jennings noted that Ampyra® was mentioned in the ISMP quarterly review on adverse drug events. Citing that there have been several reports of adverse events such as altered mental status and confusion, Dr. Jennings requested a complete evaluation on Ampyra® utilization for the next P&T meeting.

PDL Management

PDL Phase II – New Drug Review (Therapeutic Class)

1. Axiron® (Androgenic Agents, Topical): Dr. Jennings noted Axiron® is indicated for replacement therapy in males with deficiency or absence of endogenous testosterone. There is a Black Box Warning that virilization has been reported in children who were secondarily exposed to transdermal testosterone. Children should avoid contact with unwashed or unclothed application sites in men using transdermal testosterone. Patients should be advised to wash their hands with soap and water immediately following application. Axiron® should not be used in men with carcinoma of the breast or prostate. Testosterone may cause fetal harm and should not be used by pregnant or breastfeeding women. Dr. Jennings motioned that Axiron® be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

™ 2. Brilinta (Platelet Aggregation Inhibitors): Mrs. Abernathy noted ticagrelor is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina, non–ST-elevation myocardial infarction, or ST-elevation myocardial infarction). Ticagrelor has been shown to reduce the rate of a combined end-point of cardiovascular (CV) death, myocardial infarction (MI), or stroke compared to clopidogrel. It does carry a Black Box Warning for potential for significant, sometimes fatal, bleeding. Maintenance doses of aspirin above 100 mg reduce the effectiveness of ticagrelor and should be avoided. After any initial ticagrelor dose, use with aspirin 75-100 mg per day. A Risk Evaluation and Mitigation Strategy (REMS) for ticagrelor includes a Medication Guide available for distribution with each prescription and a communication plan to healthcare providers to inform of the serious risks associated with ticagrelor. Ticagrelor does have some of the same drug interactions as other agents in this class. Ms. Abernathy motioned that Brilinta™ be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

3. Bromfenac 0.09% ophthalmic solultion (Ophthalmic, Anti-Inflammatory): Mr. Oley stated that bromfenac, is a new first time generic for the brand name drug, Xibrom® which has no significant advantages over other products in the class. Mr. Oley motioned that bromfenac 0.09% ophthalmic solution be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

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4. Cyclobenzaprine ER (Skeletal Muscle Relaxants): Mr. Oley noted that cyclobenzaprine ER is a new first time generic for the brand name drug, Amrix® that has no significant advantages over other products in the class. Mr. Oley motioned that cyclobenzaprine ER be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

5. Epinastine 0.05% ophthalmic solution (Ophthalmics for Allergic Conjunctivitis): Mr. Oley stated that epinastine 0.05% ophthalmic solution is a new first time generic for the brand name drug, Elestat® which has no significant advantages over other products in the class. Mr. Oley motioned that epinastine 0.05% ophthalmic drops be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

6. Levofloxacin tablet/suspension (Oral Quinolones): Mr. Oley noted that levofloxacin is a new first time generic for the brand name drug, Levaquin® that has no significant advantages over other products in the class. Mr. Oley motioned that levofloxacin be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

7. Methylphenidate ER (Stimulants and Related Agents): Mr. Oley stated that methylphenidate ER is a new first time generic for the brand name drug, Concerta® that has no significant advantages over other products in the class. Mr. Oley motioned that methylphenidate ER be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

8. Orencia® (Self-Administered Drugs for Rheumatoid Arthritis): Dr. Jennings stated a subcutaneous formulation of Orencia®, which is used for the treatment of rheumatoid arthritis (RA), has recently entered the marketplace. Orencia® (abatacept) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Following a single intravenous (IV) loading dose, the first 125 mg subcutaneous injection of abatacept should be given within a day, followed by 125 mg subcutaneously once weekly. Dr. Jennings motioned that the subcutaneous formulation of Orencia® be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

9. Sprix® Nasal Spray (Non-Steroidal Anti-Inflammatory Drug): Mr. Oley noted that Sprix® is ketorolac tromethamine nasal spray, an intranasal non-steroidal anti-inflammatory drug (NSAID) that is indicated for short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level. Mr. Oley motioned that Sprix® be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

10. Syeda™, Zeosa™, Amethia™, and Camrese™ (Oral Contraceptives): Mr. Oley noted that there are no significant advantages over other products in the class. Mr. Oley motioned that Syeda™, Zeosa™, Amethia™, and Camrese™ be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

11. Tradjenta™ (Hypoglycemics/DPP-IV Inhibitors):

Speaker: Niteen Jamdar, MD, Johnston-Willis Hospital, discussed Tradjenta™, a Hypoglycemics/DPP-IV Inhibitors

Gill Abernathy motioned that Tradjenta® be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

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12. Xarelto™ (Oral Anticoagulants): Mrs. Abernathy noted rivaroxaban, a direct factor Xa inhibitor, is indicated for the prevention of deep vein thrombosis (DVT) which may lead to pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery. Rivaroxaban has some of the same drug interactions as other oral anticoagulants. Mrs. Abernathy noted that it does appear to have good efficacy relative to Lovenox®. It is not recommended in patients with severe renal impairment (CrCL <30 mL/min). It should be used with caution in patients with moderate renal impairment (CrCL 30 mL/min to 49 mL/min). The recommended dosage of rivaroxaban is 10 mg orally once daily without regard to food, starting six to ten hours post-op, after hemostasis has been established. Mrs. Abernathy motioned that Xarelto™ be PDL eligible. With the motion seconded, the Committee voted unanimously to consider this product as PDL eligible.

PDL Phase I – Annual Review

1. Antivirals – Hepatitis C

Speaker Dan Petty, PharmD, Managed Care Liaison, Vertex Pharmaceuticals (Incivek™)

Speaker Christiane Arserver, MD, Senior Medical Director, Merck (Victrelis™)

Dr. Jennings discussed the addition of the protease inhibitors to the cocktail of hepatitis C drugs provides a superior outcome. He stressed the importance of having all the drugs utilized together and discontinuing any of the drugs could lead to potential resistance. Incivek™ has a short and defined duration whereas Victrelis™ has a variant duration depending on response or if patient is naïve or not. Dr. Jennings recommended the following clinical criteria edit for the protease inhibitors used in the treatment of hepatitis C:

With Incivek™: Confirm diagnosis of HCV with genotype 1 AND Concurrent therapy with ribavirin and peginterferon AND no previous protease inhibitor treatment for Hepatitis C. Contraindicated and must go for a peer to peer review if have a diagnosis of HIV, HBV, organ transplant, or pregnancy With Victrelis™: Confirm diagnosis of HCV with genotype 1 AND No previous protease inhibitor treatment for Hepatitis C AND Completed ribavirin and peginterferon for at least 4 weeks AND Concurrent therapy with ribavirin and peginterferon Contraindicated and must go for a peer to peer review if have a diagnosis of HIV, HBV, organ transplant, or pregnancy For cirrhosis approve for 44 weeks For previous treatment with peginterferon and ribavirin approve for 44 weeks If neither of the above then look at lab analysis for duration o Treatment naïve patients: . If week 8 and 24 are both undetectable – triple therapy is completed. Discontinue Victrelis™ therapy. . If week 8 results are detectable and week 24 results are undetectable – then approve Victrelis™ for 8 more weeks.

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. If week 24 results are detectable, discontinue all 3 therapies (Victrelis™ and peginterferon/ ribavirin). o Previously treated or relapsed patients: . If week 8 and 24 are both undetectable – approve for 8 more weeks for Victrelis™ and peginterferon/ribavirin (then discontinue all 3) . If week 8 results are detectable and week 24 results are undetectable – then approve Victrelis™ for 8 more weeks. . If week 24 results are detectable, discontinue all 3 therapies (Victrelis™ and peginterferon/ribavirin).

Dr. Jennings motioned that Incivek™ and Victrelis™ be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

2. Angiotensin Modulators which includes angiotensin-converting enzyme inhibitors (and combination products), angiotensin II receptor antagonists (and combination products), and direct renin inhibitors (and combination products): Mrs. Abernathy noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain these classes as PDL eligible.

3. Beta Blockers (and combination products): Mrs. Abernathy noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

4. Calcium Channel Blockers (includes dihydropyridine and non-dihydropyridine): Mrs. Abernathy noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

5. Lipotropics – Statins

Speaker Ahmed Nessar, PharmD, Regional Scientific Manager, Astra Zeneca (Crestor)

Mrs. Abernathy discussed the new FDA safety restrictions for high-dose simvastatin. The FDA recommendations include the following:

. Maintain patients on simvastatin 80 mg or Vytorin® 10/80 mg ONLY if they have been taking this dose chronically (for 12 months or more) without evidence of muscle toxicity. . Do not start new patients on simvastatin 80 mg or Vytorin® 10/80 mg. . Place patients who do not meet their LDL-C goal on simvastatin 40 mg or Vytorin® 10/40 mg on alternative LDL-C lowering treatment(s) that provides greater LDL-C lowering. . Follow the recommendations in the simvastatin-containing medicines labels regarding drugs that may increase the risk for muscle injury when used with simvastatin. . Switch patients who need to be initiated on a drug that interacts with simvastatin to an alternative statin with less potential for the drug-drug interaction.

Mrs., Abernathy recommended to include the FDA’s warning information in the simvastatin criteria. She motioned that the Lipotropics - Statins class be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

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6. Lipotropics – Other (includes Fibric Acid derivatives, Omega 3 fatty acid, Niacin, Bile Acid Sequestrants,CAI agent and combinations): Mrs. Abernathy noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

7. Pulmonary Arterial Hypertension (PAH) Agents:

Speaker Russ Bowes, Gilead Sciences (Letairis®) Speaker Joan Zhang, PharmD, Medical Science Liaison, United Therapeutics (Tyvaso®)

PDE-5 Inhibitors: Mrs. Abernathy noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

Endothelin-1 agents: Mrs. Abernathy noted that reports demonstrate that these drugs are being used appropriately by experts in pulmonary arterial hypertension. She motioned that this class be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

Prostacyclin analogues: Mrs. Abernathy noted that reports demonstrate that these drugs are being used appropriately by experts in pulmonary arterial hypertension. She motioned that this class be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

8. Sedative Hypnotics and Other Hypnotics: Mrs. Abernathy noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

9. Growth Hormones:

Speaker: Donna King, PhD, Director, Regional Medical and Research Specialist, Pfizer (Genotropin®) Speaker: Chuck DiPaula, PharmD, Medical Liaison, Novo Nordisk (Norditropin® Flexpen)

Dr. Jennings noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

10. Progestins for Cachexia: Dr. Jennings noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

11. Histamine-2 Receptor Antagonists: Dr. Jennings noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

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12. Proton Pump Inhibitors: Dr. Jennings shared the FDA alert on prescription proton pump inhibitor (PPI) drugs which states that PPIs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures). Dr. Jennings motioned to remove the current step edit and add new criteria requiring both of the following to be true to approve:

If there has been a therapeutic failure of no less than a three-month* trial of at least two different medication within the same class not requiring service approval (*Dr. Jennings read 30 day trial, however the written criteria presented to the Committee requires a three-month trial). The requested medications corresponding generic (if a generic is available and covered by the State) has been attempted and failed or is contraindicated.

Dr. Jennings motioned that this class continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

13. Ulcerative Colitis (oral and rectal):

Speaker: Michael Steidle, PharmD, Medical Science Liaison, Salix Pharmaceuticals (Apriso™) Speaker: Marsha Walkup, Senior Medical Science Liaison, Shire (Lialda®)

Dr. Jennings noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

14. Bladder Relaxants:

Speaker: Peter Snyder, PhD, Regional and Medical Research Specialist, Pfizer (Toviaz®)

Dr. Jennings requested to add criteria on oxybutynin ER and Ditropan XL® that would allow PDL exceptions for children ages 6 - 18 with a diagnosis of neurogenic bladder. Dr. Jennings motioned that this class continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

15. Benign Prostatic Hyperplasia(BPH) Agents:

Alpha Blockers for BPH: Dr. Jennings noted that alfuzosin is a new first time generic for the brand name drug Uroxatral® that has no significant advantages over other products in the class.

Androgen Hormone Inhibitors for BPH: Dr. Jennings shared that FDA had revised the alert in the warnings and precautions section of the labeling for the 5-alpha reductase inhibitor (5-ARI) drug class to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).

Phosphodiesterase-5 Inhibitors for BPH: Dr. Jennings discussed the new mechanism of action to treat BPH, phosphodiesterase-5 inhibitors. Cialis® has been approved by the FDA on October 6, 2011 to treat the signs and symptoms of BPH. He recommended to include Cialis® for the indication of BPH under a step edit. Both Alpha Blockers for BPH and Androgen Hormone Inhibitors for BPH need to be tried and failed before Cialis® can be approved. Cialis® should not

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be approved if the recipient is currently taking nitrates or alpha blockers. The recipient must not be on the state's list of sex offenders. A fax form will be created that must be signed by the physician attesting to the fact the recipient is not on the state's list of sex offenders. Dr. Jennings motioned that BPH Agents class be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

16. Phosphate Binders: Dr. Jennings mentioned a new product in the class, Phoslyra® - generic name calcium acetate. Phoslyra® is a 667mg/5mL oral solution of calcium acetate. Dr. Jennings motioned that this class continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

17. Topical Immunomodulators: Dr. Jennings noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

18. Antihistamines – 2nd generation (include combination products): Mark Oley noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

19. Bronchodilators, Beta Adrenergic (Long and Short Acting): Mark Oley stated that there have been no significant changes for the Short Acting Beta Adrenergic Bronchodilators; however, a new Long Acting Beta Adrenergic Bronchodilator, Arcapta Neohaler® - generic name indacaterol has recently been FDA approved. Arcapta Neohaler® is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Mr. Oley motioned that this class continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

20. COPD: Bronchodilators

Speaker: Alan Blau, PhD, Senior Therapeutic Specialist, Forest Research Institute (Daliresp®)

Mark Oley discussed the new drug Daliresp®. Roflumilast (Daliresp®) and its active metabolite, roflumilast N-oxide, are selective inhibitors of phosphodiesterase 4 (PDE4), an enzyme in lung tissue that metabolizes cyclic-3’,5’-adenosine monophosphatase (AMP). The mechanism of action is thought to be related to the effects of increased intracellular cyclic AMP in lung cells. Roflumilast is indicated to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Mr. Oley motioned that this class continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

21. Inhaled Corticosteroids

Speaker Erin Drew, PharmD, Senior Medical Liaison, Glaxo Smith Kline (Advair®)

Speaker Christy Cappelletti, PharmD, Medical Affairs, Sr. Regional Scientific Manager, Astra Zeneca (Symbicort®)

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Dr. Madiraju expressed his concerns with the long-term use of long acting beta agonist (LABAs) in children. He asked the Committee to consider adding a time limit for theses products. Provider Synergies agreed to research the utilization and report to the P&T Committee at the next meeting in April 2012. Mark Oley noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

22. Intranasal Rhinitis Agents Intranasal Steroids: Mark Oley noted that triamcinolone acetonide is a new first time generic for the brand name drug Nasacort AQ® which has no significant advantages over other products in the class. He motioned that this class continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

Intranasal Antihistamines: Mark Oley noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

Intranasal Anticholinergics: Mark Oley noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

23. Self-Injectable Epinephrine: Mark Oley noted that there have been no significant changes in this class since the last review and motioned that they continue to be PDL eligible. With the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible.

Comments from the Office of the Attorney General

Ms. Usha Koduru from the Attorney General’s office stated that under the Virginia Freedom of Information Act (FOIA), specifically Virginia Code section 2.2-3711, 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.

Mark Oley 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 to be kept confidential.

The motion was seconded and unanimously approved by the Committee.

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Following the Confidential Session, the Committee members re-assembled in the 13th floor conference room. Dr. Axelrod 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.

PDL Changes Effective January 1, 2012

Generic Watch - Brands preferred over Generics

Dr. Axelrod noted there were no new changes to the Generic Watch and requested a motion that there be no changes to the PDL. Mr. Oley provided the motion and with the motion seconded, the Committee voted unanimously to maintain this class as PDL eligible. The drugs on the “Generic Watch” currently include: Differin® (Acne Agents, Topical Retinoids), Concerta® (ADHD Stimulants), Lovenox® (Anticoagulants), Famvir® and Valtrex® (Antivirals), Miacalcin® (Calcitonin), Phoslo® (Phosphate Binders, formerly Electrolyte Depleters), Pulmicort® Respules (Inhaled Corticosteroid), Astelin® (Intranasal Antihistamine), Accolate® (Leutoterien Receptor Antagonist), Duragesic® (Long Acting Narcotics), Nasacort AQ (Intranasal Steroid), Alphagan® P (Ophthalmic Alpha2 Adrenergic), Starlix® (Oral Hypoglycemics, Meglitinides), Spectracef® (3rd Generation Cephalsporins).

New Drugs in Phase II

Mark Oley motioned the following products would continue their non-preferred status and there would be no changes to the associated classes: Axiron® (Androgenic Agents, Topical) Brilinta™(Platelet Aggregation Inhibitors) bromfenac 0.09% ophthalmic solution (Ophthalmics, Anti-inflammatory) cyclobenzaprine ER (Skeletal Muscle Relaxants) epinastine 0.05% ophthalmic solution (Ophthalmics, Allergic Conjunctivitis) levofloxacin tablet/suspension (Quinolones, systemic) methylphenidate ER (Stimulants and Related) Orencia® 125mg/ml syringe (Cytokine and Cam Antagonists, Self-injectable) Sprix® (NSAIDS) Syeda™, Zeosa™, Amethia™, and Camrese™ (Oral Contraceptives) Xarelto™(Anticoagulants)

With the motion seconded for New Drugs in Phase II, the Committee voted unanimously to incorporate the changes into the PDL as noted.

Mark Oley motioned that Tradjenta™ be preferred. With the motion seconded, the Committee voted unanimously to approve the addition of Tradjenta™ to the PDL.

Phase I Annual Review

Mark Oley made the following motions that were seconded and approved unanimously by the Committee (note that Mr. Oley only read the changes to the current PDL):

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1. Sedative Hypnotics (Benzodiazepine). The following products change to a non-preferred status: triazolam estazolam temazepam 7.5 mg and 22.5 mg

2. Sedative Hypnotics (Non-Benzodiazepine). The following product changes to a non-preferred status: Somnote®

3. Bronchodilators - Beta Adrenergic Agents Short Acting Nebulizers. No changes to the class.

4. Bronchodilators - Beta Adrenergic Agents Short Acting. The following products change to a non- preferred status: Proair® HFA Ventolin® HFA

5. Bronchodilators - Beta Adrenergic Agents Long Acting. No changes to the class.

6. Intranasal Steroids and Intranasal Anticholinergics. No changes to these classes.

7. Intranasal Antihistamines. The following products change to a non-preferred status Astepro® 0.15% Patanase®

8. Bladder Relaxants. The following product changes to preferred status: Toviaz™ And the following products change to a non-preferred status: Vesicare® Detrol® LA Sanctura®

9. Histamine-2 Receptor Antagonists. The following product changes to a preferred status: Acid Reducer OTC And the following product changes to a non-preferred status: ranitidine capsules

10. Lipotropics - Bile Acid Sequestrants. The following products change to a non-preferred status: cholestyramine light (the motion was read as “cholestyramine” but should have been read a cholestyramine “light) Questran® Questran® Light colestipol HCl Granules Welchol® Packets Colestid® Granules

11. Lipotropics - Fibric Acid Derivatives. The following product changes to a preferred status: Tricor® And the following products changes to a non-preferred status

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Antara®

12. Lipotropics - Omega 3 Fatty Acid Agents. No changes to the class

13. Lipotropics - Niacin Derivatives. No changes to the class

14. Lipotropics - Niacin Derivatives & HMG CoA Reductase Inhibitors (Statins) Combination. No changes to the class

15. Lipotropics – CAI. No changes to the class.

16. Alpha-Blockers for BPH. No changes to the class

17. Androgen Hormone Inhibitors for BPH. The only change to this class is the addition of a step edit which require a trial of a generic product before the preferred agent, Avodart®

18. Phosphodiesterase (PDE) type 5 Inhibitor for BPH. The following product is non-preferred Cialis®

19. Beta Blockers and Beta Blockers + Diuretic Combinations. The following products change to non- preferred status: acebutolol bisoprolol fumarate pindolol timolol maleate metoprolol/HCTZ

20. Second Generation Antihistamines and Combinations. The following product changes to preferred status: cetirizine tablet OTC And the following products changes to a non-preferred status: Claritin® OTC syrup Claritin® OTC Claritin-D® 12 hr OTC Claritin® tablets - Rapids OTC loratadine D Claritin-D® 24 hr OTC

21. Non-Dihydropyridine Calcium Channel Blockers. The following products change to non-preferred status: verapamil capsule verapamil 360 mg capsule

22. Dihydropyridine Calcium Channel Blockers. The following products change to non-preferred status: Dynacirc CR® nicardipine felodipine ER

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23. Antivirals: Hepatitis C - Pegylated Interferon. No changes to the class

24. Antivirals: Hepatitis C - Protease Inhibitors Pending Contract Clarification

25. Growth Hormones. The following product changes to non-preferred status: Nutropin® vial

26. Lipotropics - HMG CoA Reductase Inhibitors and Combinations (High Potency Statins). No changes to the class

27. Lipotropics - HMG CoA Reductase Inhibitors (Statins). No changes to the class

28. PAH Agents - PDE5 Inhibitor. No changes to the class

29. PAH Agents - Endothelin-1 Agents. This new class will be added to the PDL and the following products will be preferred: Letairis® Tracleer®

30. PAH Agents - Prostacycline Analogues. This new class will be added to the PDL and the following products will be preferred: Tyvaso® Ventavis®

31. Proton Pump Inhibitors (PPIs). All step edits will be removed from the drugs in this class except for the age edit for Prevacid ® suspension.

32. ACE Inhibitors and ACE Inhibitors + Diuretic Combinations. No changes to the class.

33. ACE Inhibitors + Calcium Channel Blocker Combinations. No changes to the class.

34. Angiotensin II Receptor Blockers and Angiotensin II Receptor Blockers + Diuretic Combinations. No changes to the class.

35. Direct Renin Inhibitors. No changes to the class.

36. Angiotensin II Receptor Blockers + Calcium Channel Blocker Combinations. No changes to the class.

37. COPD: Bronchodilators. No changes to the class

38. Self Injectable Epinephrine. No changes to the class

39. Inhaled Corticosteriods (includes Metered Dose Inhalers, Nebulizer Solution, and Combination Products - Glucocorticoid and Beta Adrenergic). No changes to the class.

40. Topical Immunomodulators (Atopic Dermatitis). No changes to the class.

41. Phosphate Binders. No changes to the class.

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42. Progestins Used for Cachexia. No changes to the class.

43. Ulcerative Colitis (Oral and Rectal). No changes to the class.

Criteria

Dr. Axelrod led the Committee in a review of criteria changes or additions for Phase I annual review. Mr. Oley made the following motions that were seconded and approved unanimously by the Committee:

Lipotropics – Omega3 fatty acids require a failure for one other Lipotropics Lipotropics – Niacin derivatives + HMG CoA Reductace Inhibitors require history of niacin or simvastatin product within the past 90 days. Lipotropics - prefer atorvastatin (generic for Lipitor®) and make Lipitor® non-preferred once the price is favorable to DMAS Lipotropics - add the FDA warning to the criteria in reference to the simvastatin 80 mg dose Sedative Hypnotics - eliminate the current step edits and add clinical indication criteria for approval. Prescriber must document clinical reason as to why preferred medications are not appropriate (i.e. patient has history of substance abuse, patient on another benzodiazepine for another disorder). The criteria that requires patients age 65 and older, to fail a trial of trazodone (duration of at least one month) before Rozerem®, Ambien®, or Lunesta® may be approved will be maintained. It is not necessary for patients ≥ 65 to try a benzodiazepine if they have had a trial of trazodone. Proton Pump Inhibitors - modify duration of therapy to 12 weeks, unless recipient meets an exception that allows a 1-year approval. Proton Pump Inhibitors - remove previous step edits and special considerations and add criteria stating that if both of the following are true then approve: o If there has been a therapeutic failure of no less than a three-month trial of at least two different medications within the same class not requiring service approval o The requested medications corresponding generic (if a generic is available and covered by the State) has been attempted and failed or is contraindicated. Long Acting Beta Adrenergic Agonists (LABAs) – The Committee discussed placing a 90-day limit on all initial treatments with LABAs in children. The Committee requested that the American Academy of Pediatrics guidelines for the use of LABAs in children be reviewed at the next meeting in April 2012 before a final recommendation is made.

The next P&T Committee Meeting is tentatively scheduled for April 19, 2012.

Dr. Axelrod adjourned the meeting.

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