Pharmacy and Therapeutics Committee Meeting Summary - May 9, 2007

Agenda and Introduction

The Medicaid Pharmacy & Therapeutics Committee met on Friday, May 9^th, 2007 from 8:00 a.m. to 4:00 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

Linda Jones, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP), introduced Jeffrey Dubitsky, R.Ph., NYC Health & Hospital Corporation, as a new Committee member.

A. Background Materials Provided:

The Committee was provided copies of written materials submitted by interested parties in advance of the meeting.

B. Public Comment Period:

The following speakers provided comment to the committee:

1. Preston, Rachel, PharmD, Scientific Manager, Procter & Gamble Pharmaceuticals, Washington, DC
2. Gueye, Mouhamed, PharmD, Roche Pharmaceuticals, Nutley, NJ
3. Baran, Daniel, MD, Medical Director, Merck & Co, Shrewsbury, MA
4. Gonzalez, Edwardo, PharmD, Interim Director & Clinical Coordinator, Mary Washington Hospital, King Pharmaceuticals, Fredericksburg, VA
5. Amin, Shima, PharmD, Medical Liaison, Daiichi Sankyo Inc., Parsippany, NJ
6. Karish, Sarah, PharmD, Regional Medical Scientist, Boehringer Ingelheim, Jamaica Plain, MA
7. Sachdeva, Amisha, PharmD, Regional Cardiovascular Medical Science Liaison, Schering-Plough, Kenilworth, NJ
8. Govaker, David, MD, Medical Director, Pfizer Inc., Arlington VA
9. Solomon, Henry, MD, FACP, FACC, Medical Director, Pfizer Global Pharmaceuticals, US Cardiovascular and Metabolic Group, New York, NY
10. Tang, David, PharmD, Senior Therapeutic Brand Leader, Cardiovascular, AstraZeneca, Wilmington, DE
11. deLeon, Dennis, President of the Latino Commission on AIDS, New York, NY
12. Thomson, Heather, MS, Endo Pharmaceuticals, Norfolk, CT
13. Lane, Lisa, RPh, Regional Manager, Tap Pharmaceuticals, Vernon Hills, IL
14. Phelan, Ted, MS, Senior Regional Scientific Manager, AstraZeneca, Wilmington, DE
15. Clift, Richard, MD, Albany Gastroenterology Consultants, Albany, NY
16. Birner, Timothy, PharmD, MBA, Director of Health Outcomes Strategy, Sanofi-Aventis, Beverly, MA
17. Candaras, Michael, MD, Lake Shore Medical Specialty, Irving, NY
18. Konev, Anton, for Honorable Peter M. Rivera, New York State Assembly, Albany, NY
19. Jacob, Patricia, PharmD, Regional Medical Scientist, GlaxoSmithKline, Research Triangle Park, NC
20. Kucherov, Misha, MD, Private Practice, Poughkeepsie, NY
21. Gall, Rebecca, MD, Medical Science Liaison, Schering-Plough, Hopedale, MA
22. Singh, Binoy, MD, FACC, Attending Cardiologist, Center for Interventional Vascular Therapy, Yorktown Heights, NY
23. Sill, Bruce, PharmD, Clinical & Outcomes Manager, Takeda Pharmaceuticals, Glastonbury, CT
24. Brekke, Johan Fredrik, MSc, PhD, Medical Science Liaison, Dept. of Medical Affairs, Reliant Pharmaceuticals Inc., Liberty Corner, NJ
25. Espaillat, Ramon, MD, Medical Science Liaison, Abbott Labs, Latham, NY
26. Price, Arlene, PharmD, Senior Scientific Affairs Liaison, Ortho McNeil Janssen, Randolph, NJ
27. Meister, Fred, PharmD, Medical Science Liaison-Infectious Disease, Schering Plough Corp., Fountain Valley, CA
28. D'Arienzo, Peter A., MD, Manhasset Eye Physicians, P.C., Alcon Labs, Manhasset, NY
29. Fiscella, Richard, RPh, MPH, Clinical Professor, University of Illinois at Chicago, Chicago, IL

C. Key issues raised by interested parties and the Pharmacy and Therapeutics Committee pertaining to the clinical re-review of the following therapeutic classes:

Public comments:

Bisphosphonates:

• The Committee was asked to consider information regarding clinical trial results (indications, dosing regimens, efficacy in the prevention and treatment of osteoporosis, safety, tolerability, and adherence).

Angiotensin Converting Enzyme (ACE) Inhibitors:

• The Committee was asked to consider information regarding clinical trial results (indications, efficacy in special populations, and post-marketing studies).

Angiotensin Receptor Blockers (ARB) and ARB/Diuretic Combinations:

• The Committee was asked to consider information regarding clinical trial results (efficacy as monotherapy or in combination with a diuretic, indications, pharmacokinetics, dosing interval, and adverse reactions).

Beta Blockers:

• The Committee was asked to consider information regarding clinical trial results (mechanism of action, efficacy post myocardial infarction and in the treatment of heart failure, benefits in morbidity and mortality, and adherence).

HMG-CoA Reductase Inhibitors (Statins):

• The Committee was asked to consider information regarding clinical trial results (new indications, mechanism of action, use in diabetes, stroke, and heart failure, the importance of treating to goal, use in special populations and use in combination with ezetimibe and amlodipine).

Long Acting Narcotics:

• The Committee was asked to consider information regarding clinical trial results (indications, metabolism, dosing, drug interactions, and adverse effects), and education and monitoring as tools to prevent misuse of these medications.

Proton Pump Inhibitors (PPIs):

• The Committee was asked to consider information regarding clinical trial results (use in pediatric patients, dosing, dosage forms and administration options, the relationship between intragastric pH and healing, new indications, and pharmacokinetics).

Sedative Hypnotics/Sleep Agents:

• The Committee was asked to consider information regarding clinical trial results (efficacy in sleep onset and maintenance, safety, and duration of use), and the treatment of insomnia with comorbidities, including generalized anxiety and major depressive disorder.

Serotonin Receptor Agonists (Triptans):

• The Committee was asked to consider information regarding clinical trial results (dosing including formulations and ease of administration, efficacy including onset and duration of action, adverse events, use in different types of migraine headaches, and tolerability).

Intranasal Steroids:

• The Committee was asked to consider information regarding clinical trial results (indications and use in pediatric patients).

Thiazolidinediones (TZDs):

• The Committee was asked to consider information regarding clinical trial results (mechanism of action, safety, efficacy in glycemic control, use in patients with cardiovascular and cerebrovascular disease, and use in special populations).

Triglyceride Lowering Agents:

• The Committee was asked to consider information regarding clinical trial results for both omega-3 fatty acids and the fibric acids (indications, efficacy, safety, composition, tolerability, and dosing).

Ophthalmic Quinolones:

• The Committee was asked to consider information regarding clinical trial results (efficacy in the coverage of gram positive and gram negative bacteria, susceptibility of resistant bacteria, ocular penetration, dosing, safety, tolerability and the inclusion of preservative in ocular products), as well as appropriate use of the drugs in this class.

Ophthalmic Antihistamines:

• The Committee was asked to consider information regarding clinical trial results (safety, efficacy, indications, adverse reactions, antihistaminic and mast cell stabilizing properties, tolerability, use in pediatrics, and onset of action).

Oral Fluoroquinolones:

• The Committee was asked to consider information regarding clinical trial results (efficacy, indications, spectrum of activity, adverse reactions, duration of therapy, and antimicrobial resistance), as well as appropriate fluoroquinolone use, and the Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults.

Pharmacy and Therapeutics Committee Comments:

• A committee member inquired about osteonecrosis of the jaw related to bisphosphonate therapy and the presenter indicated that the majority of cases have occurred in cancer patients receiving therapy via the intravenous route.
• A committee member clarified that the monthly bisphosphonate adherence data presented was obtained in conjunction with a patient support program while the weekly adherence data was not, the presenter concurred.
• A committee member asked if there was data to support a decrease in mortality with a decrease in fracture rate, the presenter indicated that while there is data showing an increase in mortality within the first year after hip fracture, this has not been studied as an endpoint in a clinical trial with bisphosphonates.
• A committee member asked if the presenter was stating that atorvastatin had a different mechanism of action from other statins, and the presenter responded that atorvastatin has clinical outcomes data published in its prescribing information that are not in the prescribing information of other statins. The committee member also commented that the cost of heart failure hospitalizations in New York State may be impacted by more than merely the use of statins, and that evidence should be provided to support all claims that are made.
• A committee member commented on a potential correlation between HIV, cardiac disease and diabetes, which is still being investigated.
• A committee member commented that with regard to proton pump inhibitor (PPI) bioavailability, a faster onset of action does not necessarily mean a greater PPI effect, which is dependent upon the inhibition of an enzyme system.
• A committee member voiced concern with the direct-to-consumer advertising of the newer, non-benzodiazepine drugs for insomnia, noting that, in his opinion, patients with insomnia can often be managed without these medications. He also noted that judicious use of the generic anxiolytic sleep agents may be considered a safe and effective treatment option in certain circumstances.
• A committee member noted that it is important not to underemphasize the effect of TZDs on lipids and edema.
• A committee member asked if the 45% decrease in triglyceride levels associated with the prescription strength omega-3 fatty acid is clinically significant. The presenter indicated that it is not the percent decrease, but achieving triglyceride levels below 500mg/dL that reduces the risk of acute pancreatitis and cardiovascular disease.
• A committee member wished to clarify that there are also reports of levofloxacin, as well as the other fluoroquinolones, being associated with clostridium difficile infections.

D. Clinical Presentation and Discussion

Susan Carson, MPH, Oregon Health & Sciences University, Evidence-based Practice Center (OHSU EPC); Steve Liles, PharmD, Provider Synergies; Robert Correia, PharmD, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP)

1. Re-review of the Bisphosphonates therapeutic class

Drugs Affected: Actonel (risedronate), Actonel with Calcium (risedronate with calcium carbonate), Boniva (ibandronate), Fosamax (alendronate), Fosamax Plus D (alendronate plus cholecalciferol)

Dr. Liles noted a new indication and new monthly dosing for risedronate. He mentioned the FACT extension trial which compared the surrogate marker hip trocanter bone mineral density of participants taking alendronate or risedronate.

Dr. Correia provided the Department's clinical review of new information for this category. He addressed the issue of dosing frequency and adherence, noting data from several European studies which indicate that reducing frequency of dosing on its own will not increase compliance. He noted that the FDA labeling states that serious adverse events for ibandronate were almost 50% higher for monthly versus daily dosing. He concluded that there has not been adequate new clinical evidence to indicate any of these drugs offer an overall advantage.

A committee member asked if the FDA could ask for additional information from the manufacturers on the higher rate of adverse reactions with monthly dosing, and another commented that the higher potency drugs in this class will cause more adverse events. Drs. Liles and Correia knew of no FDA requirement to address this.

2. Re-review of the Nasal Calcitonins therapeutic class

Drugs Affected: Fortical (calcitonin-salmon), Miacalcin (calcitonin-salmon)

Dr. Lilies indicated that he found no new clinical information since the last review of this therapeutic class.

Dr. Correia noted that no new information was presented to support an overall advantage for either drug in this class.

3. Re-review of the ACE Inhibitors and ACE Inhibitor/Diuretic Combinations therapeutic classes

ACE Inhibitors

Drugs Affected: Accupril (quinapril), Aceon (perindopril erbumine), Altace (ramipril), benazepril, Capoten (captopril), captopril, enalapril maleate, fosinopril, lisinopril, Lotensin (benazepril), Mavik (trandolapril), moexipril, Monopril (fosinopril), Prinivil (lisinopril), quinapril, trandolapril, Univasc (moexipril), Vasotec (enalapril maleate), Zestril (lisinopril)

ACE Inhibitor/Diuretic Combinations

Drugs Affected: Accuretic (quinapril/hctz), benazepril/hctz, Capozide (captopril/hctz), captopril/hctz, enalapril maleate/hctz, fosinopril/hctz, lisinopril/hctz, Lotensin HCT (benazepril/hctz), moexipril/hctz, Monopril HCT (fosinopril/hctz), Prinzide (lisinopril/hctz), Quinaretic (quinapril/hctz), quinapril/hctz, Uniretic (moexipril/hctz), Vaseretic (enalapril maleate/hctz), Zestoretic (lisinopril/hctz)

Dr. Liles noted the addition of two new generic medications to these classes: trandolapril and moexipril/hctz. He noted the DREAM trial, HOPE Extension, and a new Meta-Analysis of seven studies.

Dr. Correia provided the Department's clinical review of new information for this category. He indicated that ongoing outcomes evidence continues to support the benefit of ACE inhibitors as well as ACE inhibitors with diuretics for a range of clinical indications. He stated that at this time there is no new comparative evidence to justify preferential availability of any one product.

4. Re-review of the Dihydropyridine (DHP) Calcium Channel Blockers (CCB) therapeutic class

Drugs Affected: Adalat CC (nifedipine CC), Afeditab CR (nifedipine CR), amlodipine, Cardene (nicardipine), Cardene SR (nicardipine SR), DynaCirc (isradipine), DynaCirc CR (isradipine CR), felodipine ER, isradipine, nicardipine HCl, Nifediac CC (nifedipine CC), Nifedical XL (nifedipine XL), nifedipine, nifedipine ER, nifedipine SA, Norvasc (amlodipine), Plendil (felodipine ER), Procardia (nifedipine), Procardia XL (nifedipine XL), Sular (nisoldipine)

Dr. Liles noted the addition of two new generic medications to this class: isradipine and amlodipine.

Dr. Correia noted that the calcium channel blockers continue to be recognized as valuable for a range of clinical indications, however, at this time, there is no new comparative evidence to justify preferential availability of any one product.

5. Re-review of the ACE Inhibitor/Calcium Channel Blocker therapeutic class

Drugs Affected: Lexxel (enalapril maleate/felodipine ER), Lotrel (benazepril/amlodipine besylate), Tarka (trandolapril/verapamil ER)

Dr. Liles presented an overview of two new clinical trials: EXPLORE (amlodipine/benazepril versus amlodipine) and INVEST (addition of trandolapril to verapamil).

Dr. Correia stated that at this time, there is no new comparative evidence to justify preferential availability of any one product.

6. Re-review of the Angiotensin Receptor Blockers (ARB) and ARB/Diuretic Combinations therapeutic classes

Angiotensin Receptor Blockers (ARB)

Drugs Affected: Atacand (candesartan cilexetil), Avapro (irbesartan), Benicar (olmesartan medoxomil), Cozaar (losartan), Diovan (valsartan), Micardis (telmisartan), Teveten (eprosartan mesylate)

ARB/Diuretic Combinations

Drugs Affected: Atacand HCT (candesartan cilexetil/hctz), Avalide (irbesartan/hctz), Benicar HCT (olmesartan medoxomil/hctz), Diovan HCT (valsartan/hctz), Hyzaar (losartan/hctz), Micardis HCT (telmisartan/hctz), Teveten HCT (eprosartan/hctz)

Dr. Liles discussed several new clinical trials which compared efficacy of an ARB versus its ARB/diuretic combination product. He also discussed a new pediatric study of candesartan, noting that losartan is the only ARB with a pediatric indication at this time. Lastly, he spoke about forced titration data between olmesartan, losartan and valsartan, which indicated that at equivalent doses (with losartan dosed twice a day), the three drugs showed equivalent blood pressure lowering effects.

Dr. Correia provided the Department's clinical review of new information for this category. He spoke about the February 2006 Final Report on ARBs from Oregon Health & Science University. He noted new information pertaining to ARBs' expanded recommendations in various guidelines from the American College of Cardiology/American Heart Association as well as the National Kidney Foundation, indicating evidence of potential benefits in heart failure, post-MI, and kidney disease for the ARBs as a drug class. The report researched comparative efficacy or safety of ARBs for hypertension, high cardiovascular risk, recent MI, heart failure, and nephropathy as well as efficacy and tolerability in special populations. He noted there are no head to head comparisons for any of these outcomes. He noted that there is no new evidence to justify preferential availability of any one ARB or ARB/diuretic combination.

In response to a question from a Committee member, Dr. Liles noted that there is no good comparative data for ARBs in the treatment of heart failure.

7. Re-review of the Beta Blockers and Beta Blocker/Diuretic Combinations therapeutic classes

Beta Blockers

Drugs Affected: acebutolol, atenolol, betaxolol, bisoprolol fumarate, Blocadren (timolol), Coreg (carvedilol), Coreg CR (carvedilol CR), Corgard (nadolol), Inderal (propranolol), Inderal LA (propranolol LA), Innopran XL (propranolol XL), Kerlone (betaxolol), labetalol, Levatol (penbutolol), Lopressor (metoprolol tartrate), metoprolol succinate XL, metoprolol tartrate, nadolol, pindolol, propranolol, Sectral (acebutolol), Tenormin (atenolol), timolol maleate, Toprol XL (metoprolol succinate XL), Trandate (labetalol), Zebeta (bisoprolol fumarate)

Beta Blocker/Diuretic Combinations

Drugs Affected: atenolol/chlorthalidone, bisoprolol fumarate/HCTZ, Corzide (nadolol/bendroflumethiazide), Inderide (propranolol/HCTZ), Lopressor HCT (metoprolol tartrate/HCTZ), metoprolol tartrate/HCTZ, propranolol/HCTZ, Tenoretic (atenolol/chlorthalidone), Ziac (bisoprolol fumarate/HCTZ)

Dr. Liles discussed Coreg CR, a once-a day dosage form of Coreg. He indicated the approval for the CR formulation was based on Coreg data, and it has the same indications as Coreg. A generic version of Coreg is expected in Fall 2007.

Dr. Correia provided the Department's clinical review of new information for this category. He discussed new labeling for carvedilol indicating no adverse effect on glycemic control when used in well-controlled Type 2 diabetics for hypertension only. The label carries warnings to monitor for hyperglycemia in Type 2 diabetics with heart failure. He mentioned the American Association of Clinical Endocrinologists (AACE) guidelines, which identify drugs that block both alpha and beta receptors as being preferential for use in diabetics to cause vasodilation and increase insulin sensitivity. He noted that labetalol as well as carvedilol possess alpha and beta blocking properties. He also noted there is no clinical outcomes data for the sustained release carvedilol, it is all for the original immediate release formulation. He discussed a study which indicated that it was as safe to initiate therapy for heart failure with bisoprolol as with an ACE inhibitor. On the topic of beta blocker/diuretic combinations, he noted that they are only indicated for hypertension and there is no new information for this subgroup. He concluded by noting there is no new evidence of overall clinical superiority to justify preferential availability of any one product.

A Committee member clarified the chemical difference between labetalol and carvedilol and indicated that while labetalol would be appropriate for use in hypertension in diabetics, he wouldn't recommend its use in heart failure. Dr. Correia reiterated that his statement was with regard to the treatment of hypertension, not heart failure, in Type 2 diabetics.

A Committee member noted that the last time the Committee reviewed this therapeutic class, the recommendation to the Commissioner was not unanimous.

8. Re-review of the HMG-CoA Reductase Inhibitors (Statins) therapeutic class

Drugs Affected: Advicor (lovastatin/niacin extended-release), Altoprev (lovastatin extended-release), Caduet (atorvastatin/amlodipine), Crestor (rosuvastatin), Lescol (fluvastatin), Lescol XL (fluvastatin XL), Lipitor (atorvastatin), lovastatin, Mevacor (lovastatin), Pravachol (pravastatin), pravastatin, Pravigard PAC (pravastatin/buffered aspirin), simvastatin, Vytorin (simvastatin/ezetimibe), Zocor (simvastatin)

Ms. Carson presented an overview of the OHSU DERP Drug Class Review on HMG-CoA Reductase Inhibitors (Statins), Update #4 dated May, 2006. She noted six new head-to-head trials of LDL-c lowering with results consistent with previous evidence. New evidence in the Update addressing raising HDL-c did not change previous conclusions. She identified three new trials with health outcomes, and five new subgroup analyses of trials. The summary of this evidence was consistent with previous conclusions about health outcomes. She noted that there is no evidence that one statin is safer than another in women, the elderly, African-Americans, or Hispanics. She indicated again that there is insufficient evidence to determine which statin or statins are safer with regard to muscle toxicity or elevated liver enzymes. In summary, Ms. Carson concluded that new evidence in Update #4 is consistent with existing evidence and does not change previous conclusions.

Dr. Liles discussed new indications for fluvastatin, simvastatin and atorvastatin. He discussed the SPARCL trial, TNT analysis, a new meta-analysis of adverse event data, and a new observational study from the National Lipid Association Statin Safety Task Force showing no significant difference in safety among statins.

Dr. Correia provided the Department's clinical review of new information for this category. He discussed the combination product containing a statin and a calcium channel blocker noting that the large body of research continues to reinforce the concept that there are many factors which affect compliance and adherence, and with potentially greater impact than frequency of dose. He also indicated that there is no evidence of enhanced efficacy of these drugs by combining them into a single tablet. He noted the benefits shown from even low doses of statins, and mentioned the risk of using surrogate markers versus actual outcomes as raised in one study which demonstrated no correlation between magnitude of LDL lowering and reduction in ambulatory ischemia. In closing, he stated new evidence submitted is consistent with previous evidence and does not change previous conclusions.

A Committee member asked if there was any new data relevant to raising HDL and lowering triglycerides for the statins.

Ms. Carson, Dr. Correia, and Dr. Liles indicated that they had not seen any new data in this area.

9. Re-review of the Long Acting Narcotics therapeutics class

Drugs Affected: Avinza (morphine sulfate ER), Duragesic (fentanyl), fentanyl, Kadian (morphine sulfate SR), morphine sulfate SR, MS Contin (morphine sulfate CR), Opana ER (oxymorphone ER), Oramorph SR (morphine sulfate SR), oxycodone CR, Oxycontin (oxycodone CR)

Dr. Liles discussed the new medication in this class, Opana ER (oxymorphone ER). He noted the indication, clinical trial information, dosing, and adverse events, noting similar efficacy, safety and analgesia when compared to equivalent doses of oxycodone ER.

Dr. Correia noted that oxymorphone has been historically associated with relatively higher incidences of constipation, respiratory depression, emesis, and physical dependence than other drugs in this class. He also noted comparative metabolism with other drugs in this class with regard to drug interactions. He stated there is no new clinical evidence to indicate any of these drugs offers an overall advantage.

10. Re-review of the Proton Pump Inhibitors (PPI) therapeutic class

Drugs Affected: Aciphex (rabeprazole), Nexium (esomeprazole), omeprazole, Prevacid (lansoprazole), Prevacid NapraPAC (lansoprazole/naproxen), Prilosec (omeprazole), Prilosec OTC (omeprazole), Protonix (pantoprazole), Zegerid (omeprazole)

Ms. Carson presented an overview of the OHSU DERP Drug Class Review on Proton Pump Inhibitors (PPI) Update #4 dated July, 2006. New information presented to the Committee included head to head trials for the treatment and prevention of relapse of erosive and non-erosive esophagitis. She also discussed the limited comparative evidence regarding effectiveness and adverse events in children. She presented new evidence for the treatment of gastric ulcer, NSAID induced ulcer, and Helicobacter pylori. In the above studies, the new evidence does not change conclusions, or in the case of use in children, is too limited to make conclusions about comparisons. She indicated that new evidence supports a lack of a difference between PPIs based on H.pylori genotype when dose is taken into account, and new evidence on exposure to PPIs in pregnancy does not support clear differences between PPIs and risk of malformations.

Dr. Liles presented information on the new indication for esomeprazole in children aged 12 years and older, and the new capsule form of omeprazole/sodium bicarbonate. He discussed new head-to-head clinical trials in erosive esophagitis and GERD. He also discussed use in pediatrics, and a new case control study of the risk of hip fracture and duration of PPI therapy.

Dr. Correia indicated that new information presented either does not change previous conclusions, or supports previous evidence regarding a lack of difference in PPIs when dose is taken into account. He concluded there is no clinical basis to justify preferential availability of any one product.

11. Re-review of the Sedative Hypnotics/Sleep Agents therapeutics class

Drugs Affected: Ambien (zolpidem), Ambien CR (zolpidem CR), chloral hydrate, Dalmane (flurazepam), Doral (quazepam), estazolam, flurazepam, Halcion (triazolam), Lunesta (eszopiclone), Prosom (estazolam), Restoril (temazepam), Rozerem (ramelteon), Somnote (chloral hydrate), Sonata (zaleplon), temazepam, triazolam, zolpidem

Ms. Carson presented an overview of the OHSU DERP Drug Class Review on Newer Drugs for Insomnia Update #1 dated July, 2006. Two new drugs were added to the update, ramelteon and zolpidem extended release. The scope of the report was expanded to include children; however the literature search yielded no evidence in children. She noted no new head-to-head trials for this update. Ms. Carson briefly discussed the details of placebo controlled trials for both zolpidem extended release and ramelteon. She discussed a summary of direct comparative evidence for short term efficacy, as well as indirect evidence of effectiveness, efficacy and safety, including efficacy and safety in older adults. A systematic review and meta-analysis of safety in older adults also included benzodiazepines and over-the-counter medications.

Dr. Liles spoke about the new Food and Drug Administration (FDA) warning regarding severe allergic reactions and sleep related behaviors. He also mentioned the new guidelines from the National Sleep Foundation indicating the need for clinical trials to evaluate safety and efficacy of sedative hypnotics in pediatric patients.

Dr. Correia provided the Department's clinical review of new information for this category. He clarified that the FDA warning mentioned above applies to all drugs in this class. He noted no new comparative evidence to change previous conclusions about relative efficacy or safety of these drugs. He noted that it is important that data be more than merely detectable as statistically significant, it must also demonstrate clinically relevant improvement, citing a Canadian meta-analysis of sedative-hypnotic use in the elderly as appeared in the British Medical Journal, which concludes that the modest (at best) effects may not justify the risks of these drugs in high risk elderly populations. He concluded that there is no new evidence to change the previous recommendations pertaining to this drug class.

12. Re-review of the Serotonin Receptor Agonists (Triptans) therapeutic class

Drugs Affected: Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Imitrex (sumatriptan) tablet/nasal/injection, Maxalt (rizatriptan) tablet/MLT, Relpax (eletriptan), Zomig (zolmitriptan) tablet/nasal/ZMT

Dr. Liles mentioned the new FDA Public Health Advisory pertaining to serotonin syndrome and the use of triptans in combination with selective serotonin reuptake inhibitors (SSRI) or serotonin/norepinephrine reuptake inhibitors (SNRI). He noted a new rapid release system for sumatriptan. He presented an overview of three new clinical trials, including two for pediatric patients.

In response to public testimony, Dr. Correia indicated that there are actually four triptans that have evidence of effectiveness in the treatment of menstrual migraines. He noted that information reviewed revealed no new clinical information since the previous review which would change the previous comparative evaluation of the drugs in this class.

13. Re-review of the Intranasal Steroids therapeutic class

Drugs Affected: Beconase AQ (beclomethasone dipropionate), Flonase (fluticasone propionate), flunisolide, fluticasone propionate, Nasacort AQ (triamcinolone acetonide), Nasarel (flunisolide), Nasonex (mometasone furoate), Rhinocort Aqua (budesonide)

Dr. Liles mentioned one placebo controlled study in prepubertal children showing no significant difference in growth velocity with the use of budesonide.

Dr. Correia noted no new clinical information since the previous review which would change the previous comparative evaluation of the drugs in this class.

14. Re-review of the Thiazolidinediones (TZDs) therapeutic class

Drugs Affected: Actos (pioglitazone), Actoplus met (pioglitazone/metformin), Avandia (rosiglitazone), Avandamet (rosiglitazone/metformin), Avandaryl (rosiglitazone/glimepiride), Duetact (pioglitazone/glimepiride)

Dr. Liles noted the new pioglitazone/glimepiride combination product. He spoke about a new precaution for increased risk of bone fractures in women taking rosiglitazone. He included, for informational purposes, ADA Guidelines: Management of Hyperglycemia in Type 2 Diabetics which lists the TZDs as additional therapy (versus initial therapy).

Dr. Correia clarified that the new FDA warning relative to an increased risk of fractures in women taking TZDs applies to both drugs in the class (rosiglitazone, pioglitazone) as a result of findings in clinical trials of each. He noted no new clinical information since the previous review which would change previous evaluation of the drugs in this class.

A Committee member asked if there was a difference in fluid retention between rosiglitazone and pioglitazone, and Dr. Correia indicated he had not seen comparative information on this.

15. Re-review of the Triglyceride Lowering Agents therapeutic class

Drugs Affected: Antara (fenofibrate), fenofibrate, gemfibrozil, Lofibra (fenofibrate), Lopid (gemfibrozil), Omacor (Omega-3 acid ethyl esters), Tricor (fenofibrate), Triglide (fenofibrate)

Dr. Lilies indicated that he found no new clinical information since the last review of this therapeutic class.

Dr. Correia provided the Department's clinical review of new information for this category. He commented that in this class, only gemfibrozil has FDA approval for reducing coronary risk, and has outcomes data including cardiovascular and all-cause mortality. He indicated that information reviewed revealed no significant new clinical or comparative information since the previous review and there are no changes from the previous comparative evaluation of the drugs in this class.

16. Re-review of the Ophthalmic Quinolones therapeutic class

Drugs Affected: Ciloxan solution/ointment (ciprofloxacin), ciprofloxacin, Ocuflox (ofloxacin), ofloxacin, Quixin (levofloxacin), Vigamox (moxifloxacin), Zymar (gatifloxacin)

Dr. Lilies indicated that he found no new clinical information since the last review of this therapeutic class.

Dr. Correia provided the Department's clinical review of new information for this category. He reiterated there is an identified overall differential in spectrum of activity between second generation fluoroquinolones versus the third and fourth generation drugs, and it is the State's recommendation to have both of these groups represented on the Preferred Drug List. He also reiterated that there is currently a lack of evidence to show that extent of corneal penetration of these drugs affects clinical outcomes. He concluded information revealed no significant new clinical or comparative information since the last review five months ago and there are no changes from the previous comparative evaluation of the drugs in this class.

17. Re-review of the Ophthalmic Antihistamines therapeutic class

Drugs Affected: Elestat (epinastine), Emadine (emedastine), ketotifen, Optivar (azelastine), Patanol (olopatadine), Pataday (olopatadine), Zaditor (ketotifen)

Dr. Liles noted the new over-the-counter status for the ketotifen products Zaditor and Alaway. A new once-a-day formulation of olopatadine, effective in placebo-controlled studies, received FDA approval.

Dr. Correia stated that other than availability of a new olopatadine product, information reviewed revealed no significant comparative new clinical information since the last review five months ago. He reiterated that the subtleties in differences in FDA labeled indications in terms of specifically treating itching versus other signs and symptoms are not as relevant as the evaluation of clinical evidence, with any of the six products effective for the treatment of allergic conjunctivitis.

18. Re-review of the Oral Fluoroquinolones therapeutic class

Drugs Affected: Avelox (moxifloxacin), Cipro (ciprofloxacin), Cipro XR (ciprofloxacin ER), ciprofloxacin, ciprofloxacin ER, Factive (gemifloxacin), Floxin (ofloxacin), Levaquin (levofloxacin), Maxaquin (lomefloxacin), Noroxin (norfloxacin), ofloxacin, Proquin XR (ciprofloxacin), Tequin (gatifloxacin)

Dr. Liles noted a new indication for gemifloxacin. He mentioned the Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia (CAP). He also mentioned that due to high, and rapidly increasing levels of resistance, fluoroquinolones are no longer recommended by the Centers for Disease Control and Prevention (CDC) in the treatment of Neisseria gonorrhoeae.

Dr. Correia provided the Department's clinical review of new information for this category. He pointed out there are several fluoroquinolones with a five day indication for CAP, and others with a seven day indication, and that there is concern with overuse of these drugs for this indication. He also spoke about the observational study and outbreak report relating to emergence of clostridium difficile infections and a proposed advantage of one fluoroquinolone over another. He noted that the observational study involved a change in antibiotic simultaneously accompanied by other infection control interventions and only included a very select patient population (hematology/oncology with neutropenia). The second report involved an inpatient outbreak of a specific resistant strain of c. difficile (resistant to levofloxacin as well as moxifloxacin and gatifloxacin). He reiterated the overall differential in spectrum of activity between second and third generation fluoroquinolones and recommended to have both generations represented as preferred drugs.

E. Executive Session:

The Committee recessed the public session at 12:30 P.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Bisphosphonates, Nasal Calcitonins, ACE Inhibitors, ACE Inhibitors/Diuretic, DHP CCB, ACE Inhibitors/CCB, ARBs, ARBs/Diuretic, Beta Blockers, Beta Blockers/Diuretic, Statins, Long Acting Narcotics, PPI, Sedative Hypnotics/Sleep Agents. No official action was taken in the executive session. The executive session was recessed at 2:10 P.M.

The Committee recessed the public session at 2:45 P.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Triptans, Nasal Steroids, TZDs, Triglyceride Lowering Agents, Ophthalmic Quinolones, Ophthalmic Antihistamines, Oral Fluoroquinolones. No official action was taken in the executive session. The executive session was recessed at 3:30 P.M.

F. Recommendations of the Pharmacy and Therapeutics Committee:

The following recommendations developed by the P&T Committee are to be submitted to the Commissioner of Health for final determination.

Description of Recommendations	Commissioner's Final Decision
Proposal: Identification of preferred drugs in the category of Bisphosphonates A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Fosamax (alendronate), Fosamax Plus D (alendronate plus cholecalciferol), Fosamax (alendronate) solution Non-preferred Drugs Actonel (risedronate), Actonel with Calcium (risedronate with calcium carbonate), Boniva (ibandronate) B. The Committee unanimously recommended the following standard clinical questions be used as the basis for approving use of the non-preferred drug: Q: Has your patient experienced treatment failure with preferred drugs in the class? Q: Has your patient experienced an adverse drug reaction with preferred drugs in the class? Q: Is there a documented history of successful therapeutic control with a non-preferred drug and transition to a preferred drug is medically contraindicated?	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Calcitonins A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drug Miacalcin (calcitonin-salmon) Non-preferred Drug Fortical (calcitonin-salmon) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of ACE Inhibitors A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Altace (ramipril), benazepril, captopril, enalapril, lisinopril, moexipril, trandolapril Non-preferred Drugs Accupril (quinapril), Aceon (perindopril erbumine), Capoten (captopril), fosinopril, Lotensin (benazepril), Mavik (trandolapril), Monopril (fosinopril), Prinivil (lisinopril), quinapril, Univasc (moexipril), Vasotec (enalapril maleate), Zestril (lisinopril) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of ACE Inhibitor/Diuretic Combinations A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs benazepril/hctz, captopril/hctz, enalapril/hctz, lisinopril/hctz, moexipril/hctz Non-preferred Drugs Accuretic (quinapril/hctz), Capozide (captopril/hctz), fosinopril/hctz, Lotensin HCT (benazepril/hctz), Monopril HCT (fosinopril/hctz), Prinzide (lisinopril/hctz), Quinaretic (quinapril/hctz), quinapril/hctz, Uniretic (moexipril/hctz), Vaseretic (enalapril maleate/hctz), Zestoretic (lisinopril/hctz) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Dihydropyridine Calcium Channel Blockers A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Afeditab CR (nifedipine CR), amlodipine besylate, DynaCirc (isradipine), DynaCirc CR (isradipine CR), felodipine ER, isradipine, nicardipine, Nifediac CC (nifedipine CC), Nifedical XL (nifedipine XL), nifedipine, nifedipine ER, nifedipine SA, Sular (nisoldipine) Non-preferred Drugs Adalat CC (nifedipine CC), Cardene (nicardipine), Cardene SR (nicardipine SR), Norvasc (amlodipine besylate), Plendil (felodipine ER), Procardia (nifedipine), Procardia XL (nifedipine XL) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of ACE Inhibitor/Calcium Channel Blockers A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Lotrel (benazepril/amlodipine besylate), Tarka (trandolapril/verapamil ER) Non-preferred Drugs Lexxel (enalapril maleate/felodipine ER) B.The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Angiotensin Receptor Blockers A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Avapro (irbesartan), Benicar (olmesartan medoxomil), Cozaar (losartan), Diovan (valsartan), Micardis (telmisartan) Non-preferred Drugs Atacand (candesartan cilexetil), Teveten (eprosartan mesylate) B.The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Angiotensin Receptor Blockers/Diuretic Combinations A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Avalide (irbesartan/hctz), Benicar HCT (olmesartan medoxomil/hctz), Diovan HCT (valsartan/hctz), Hyzaar (losartan/hctz), Micardis HCT (telmisartan/hctz) Non-preferred Drugs Atacand HCT (candesartan cilexetil/hctz), Teveten HCT (eprosartan/hctz) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Beta Blockers A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs acebutolol, atenolol, betaxolol, bisoprolol, Coreg (carvedilol), labetalol, metoprolol tartrate, nadolol, pindolol, propranolol, propranolol solution, propranolol ER, timolol maleate Non-preferred Drugs Coreg CR (carvedilol CR), Corgard (nadolol), Inderal (propranolol), Inderal LA (propranolol LA), Innopran XL (propranolol XL), Kerlone (betaxolol), Levatol (penbutolol), Lopressor (metoprolol tartrate), metoprolol succinate XL, Sectral (acebutolol), Tenormin (atenolol), Toprol XL (metoprolol succinate XL), Trandate (labetalol), Zebeta (bisoprolol fumarate) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process, removing the additional clinical question regarding heart failure.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Beta Blocker/Diuretic Combinations A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs atenolol/chlorthalidone, bisoprolol/hctz, metoprolol/hctz, propranolol/hctz Non-preferred Drugs Corzide (nadolol/bendroflumethiazide), Inderide (propranolol/hctz), Lopressor/HCT (metoprolol tartrate/hctz), Tenoretic (atenolol/chlorthalidone), Ziac (bisoprolol fumarate/hctz) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of HMG-CoA Reductase Inhibitors (Statins) A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Advicor (lovastatin/niacin extended-release), Altoprev (lovastatin extended-release), Crestor (rosuvastatin), Lescol (fluvastatin), Lescol XL (fluvastatin XL), Lipitor (atorvastatin), pravastatin, simvastatin, Vytorin (simvastatin/ezetimibe) Non-preferred Drugs lovastatin, Mevacor (lovastatin), Pravachol (pravastatin), Zocor (simvastatin), Caduet (atorvastatin/amlodipine) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Long Acting Narcotics A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Duragesic (fentanyl), fentanyl patch, Kadian (morphine sulfate SR), morphine sulfate SR, Oramorph SR (morphine sulfate SR) Non-preferred Drugs Avinza (morphine sulfate ER), MS Contin (morphine sulfate CR), Opana ER (oxymorphone ER), oxycodone CR, Oxycontin (oxycodone HCL CR) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Proton Pump Inhibitors A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Nexium (esomeprazole), Prevacid Capsule (lansoprazole), Prilosec OTC (omeprazole) Non-preferred Drugs Aciphex (rabeprazole), Nexium Packet (esomeprazole), omeprazole, Prevacid Suspension (lansoprazole), Prevacid Solutab (lansoprazole), Prevacid NapraPAC (lansoprazole/naproxen), Prilosec (omeprazole), Protonix (pantoprazole), Zegerid Capsule (omeprazole), Zegerid Packet (omeprazole) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Sedative Hypnotics/Sleep Agents A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Ambien CR (zolpidem CR), chloral hydrate syrup, estazolam, flurazepam, temazepam, triazolam, zolpidem Non-preferred Drugs Ambien (zolpidem), Dalmane (flurazepam), Doral (quazepam), Halcion (triazolam), Lunesta (eszopiclone), Prosom (estazolam), Restoril (temazepam), Rozerem (ramelteon), Somnote (chloral hydrate), Sonata (zaleplon) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Serotonin Receptor Agonists (Triptans) A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Imitrex (sumatriptan) tablet/nasal/injection, Maxalt (rizatriptan) tablet/MLT, Relpax (eletriptan) Non-preferred Drugs Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Zomig (zolmitriptan) tablet/nasal/ZMT B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Intranasal Steroids A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Nasacort AQ (triamcinolone acetonide), Nasonex (mometasone furoate), Non-preferred Drugs Beconase AQ (beclomethasone dipropionate), Flonase (fluticasone propionate), flunisolide, fluticasone propionate, Nasarel (flunisolide), Rhinocort Aqua (budesonide) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Thiazolidinediones (TZDs) A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Actos (pioglitazone), Actoplus met (pioglitazone/metformin), Avandia (rosiglitazone), Avandamet (rosiglitazone/metformin), Avandaryl (rosiglitazone/glimepiride), Duetact (pioglitazone/glimepiride) Non-preferred Drugs None B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process, should the Commissioner's final decision include a non-preferred drug.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Triglyceride Lowering Agents A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs fenofibrate, gemfibrozil, Lofibra (fenofibrate), Tricor (fenofibrate) Non-preferred Drugs Antara (fenofibrate), Lopid (gemfibrozil), Omacor (Omega-3 acid ethyl esters), Triglide (fenofibrate) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Ophthalmic Quinolones Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs ciprofloxacin drops, ofloxacin drops, Vigamox (moxifloxacin) Non-preferred Drugs Ciloxan solution/ointment (ciprofloxacin), Ocuflox, Quixin (levofloxacin), Zymar (gatifloxacin) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Ophthalmic Antihistamines A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Patanol (olopatadine), Pataday (olopatadine) Non-preferred Drugs Elestat (epinastine), Emadine (emedastine), ketotifen, Optivar (azelastine) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Oral Fluoroquinolones A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Avelox ABC Pack (moxifloxacin), Avelox (moxifloxacin), ciprofloxacin, Cipro Suspension, ofloxacin Non-preferred Drugs Cipro (ciprofloxacin), Cipro XR (ciprofloxacin ER), ciprofloxacin ER, Factive (gemifloxacin), Floxin (ofloxacin), Levaquin tablet/solution (levofloxacin), Maxaquin (lomefloxacin), Noroxin (norfloxacin), Proquin XR (ciprofloxacin ER), Tequin (gatifloxacin) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended

G. Additional Discussion:

Dr. Martin (Chairperson) reminded the public that all drugs currently covered by Medicaid remain available under the Preferred Drug Program and the determination of preferred and non-preferred drugs does not prohibit a prescriber from obtaining any of the medications covered under Medicaid.

The meeting adjourned at 3:45 PM.

Meeting Summary Posted 6/8/07

H. Final Determinations:

The Commissioner has determined that the Medicaid program will require prior authorization under the Preferred Drug Program (PDP) for non-preferred drugs, as listed above, in the following classes: Bisphosphonates, Nasal Calcitonins, ACE Inhibitors, ACE Inhibitors/Diuretic, DHP CCB, ACE Inhibitors/CCB, ARBs, ARBs/Diuretic, Beta Blockers, Beta Blockers/Diuretic, Statins, Long Acting Narcotics, PPI, Sedative Hypnotics/Sleep Agents, Triptans, Nasal Steroids, TZDs, Triglyceride Lowering Agents, Ophthalmic Quinolones, Ophthalmic Antihistamines and Oral Fluoroquinolones.

Preferred drugs will not require prior authorization.

The impact of this final determination is as follows:

1. State Public Health Population:

• Minimal effect on Medicaid enrollees as a large majority currently utilize the preferred products.
• Non-preferred products remain available when prior authorized.

2. Program Providers:

• No impact on prescribers or pharmacies when ordering the preferred product. Prescribers, or their agents, will need to initiate the prior authorization process when ordering a non-preferred product. Pharmacies will need to complete the prior authorization process for non-preferred products.

3. Fiscal Impact to State Health Program:

• Annual gross savings associated with these therapeutic classes under the Preferred Drug Program are estimated at $143 M. The savings are achieved through changes in utilization to more cost effective drugs, and the receipt of supplemental rebates from pharmaceutical manufacturers based on product utilization.

Final Determinations Posted 7/24/2007