Pharmacy and Therapeutics Committee Meeting Summary - June 12, 2008

Agenda and Introduction

The Medicaid Pharmacy & Therapeutics Committee met on Thursday, June 12, 2008 from 8:45 a.m. to 4:30 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

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. Chouhdry, Umar, MD, MBA, Field Medical Director, Sanofi-Aventis, Bridgewater, NJ
  2. DaJusta, Rehana, Pharm.D., Senior Regional Medical Scientist, GlaxoSmithKline, Hillsborough, NJ
  3. Hoffman, Sharon, Pharm.D., Regional Clinical Executive, Abbott Laboratories, Abbott Park, IL
  4. Beacker, Mark, Medical Liaison, Roche Pharmaceuticals, Nutley, NJ
  5. Krauter, Eric, Ph.D. Medical Science Liaison, P&G Pharmaceuticals, Skaneateles, NY
  6. Bruno, Marianna, Pharm.D. Medical Outcomes Specialist, Pfizer, Inc. New York, NY
  7. Torosoff, Mikhail, MD, Assistant Professor of Medicine, Albany Medical College, Albany, NY
  8. Green, Mark, MD, Director of Headache Medicine, Clinical Professor of Neurology in Neurology, Anesthesiology, and Dentistry, Columbia University, New York, NY
  9. Baran, Daniel, MD, Senior Medical Director, Merck & Co., Inc., Shrewsbury, MA
  10. Berner, Todd, MD, Clinical Affairs Manager, Migraine, Endo Pharmaceuticals, Chadds Ford, PA
  11. Korenda, Brian, Pharm.D., Regional Medical Scientist, GlaxoSmithKline, Sturbridge, MA
  12. Kucherov, Misha, MD, Neurologist, Poughkeepsie, NY
  13. Price, Arlene, Pharm.D., Senior Scientific Affairs Liaison, Ortho McNeil Janssen, Randolph, NJ
  14. Malenbaum, Susan, Ph.D., Medical Science Liaison, Global Medical Affairs, Schering-Plough, Kenilworth, NJ
  15. Sill, Bruce, Pharm.D., MS, Clinical & Outcomes Manager, Takeda Pharmaceuticals America, Inc., Glastonbury, CT
  16. Busch, Robert, MD, The Endocrine Group, Albany, NY
  17. Forte, Kenton, MD, Clinical Assistant Professor of Medicine at SUNY Buffalo, Buffalo, NY
  18. Condon, Edward, MD, Private Practice, Commack, NY
  19. Leibowitz, Jonas, MD, Endocrinology, Diabetes and Osteoporosis Consultants, LLP, Yonkers, NY
  20. Beach, Amy, Pharm.D., Senior Regional Medical Scientist II, Medical Services/R&D, GlaxoSmithKline, Saint James, NY
  21. Russell, David, MD, Senior Director, Regional Medical and Research Specialist, Pfizer, Inc., Albany, NY
  22. Mack, Alicia, Pharm.D., Senior Medical Scientific Manager, Allergan, Irvine, CA
  23. Van Zile, Peter, Pharm.D., Senior Regional Medical Scientist, GlaxoSmithKline, Research Triangle Park, NC

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

Public comments:

Injectable Anticoagulants:

  • The Committee was asked to consider information regarding clinical trial results including indications, efficacy, mechanism of action, safety, dosing, risk/benefit profile, coagulation monitoring, inpatient and outpatient use, incidence of heparin induced thrombocytopenia with low molecular weight heparins (LMWH) compared to heparin, use in special populations such as severe renal disease patients, pregnancy, and pediatrics, as well as the American College of Chest Physicians (ACCP) Guidelines for Antithrombotic Therapy for Venous Thromboembolic Disease.

Niacin Derivative:

  • The Committee was asked to consider information regarding clinical trial results for Niaspan (extended release niacin) including effects on high density lipoproteins (HDL), low density lipoproteins (LDL), very low density lipoproteins (VLDL) and triglycerides (TG), dosing, tolerability, and adverse events, especially flushing.

Bisphosphonates:

  • The Committee was asked to consider information regarding clinical trial results including indications, efficacy, annual cumulative exposure, fracture risk reduction (vertebral and nonvertebral), time point to statistically significant fracture reduction, dosing, tolerability, and safety, as well as persistence with therapy.

Cyclooxygenase II (COX II) Inhibitor:

  • The Committee was asked to consider information regarding clinical trial results for Celebrex (celecoxib) including indications, efficacy, cardiovascular profile compared to nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and the black box warning for all prescription NSAIDS including Celebrex, safety, tolerability, adverse events, and use with aspirin.

Serotonin Receptor Agonists (Triptans):

  • The Committee was asked to consider information regarding clinical trial results including efficacy, safety, tolerability, adverse events, pharmacokinetics including the pharmacokinetics of a combination triptan/NSAID tablet, drug interactions, headache recurrence, half life, sustained pain-free response, redosing, use in menstrual migraine, the flexibility of an orally disintegrating tablet, speed of headache relief and pain relief at different time points, and use of rescue medication.

Oral Fluoroquinolones:

  • The Committee was asked to consider information regarding clinical trial results including indications, treatment regimens, patient compliance, safety, efficacy, adverse events, pathogen coverage, and resistance, as well as the Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults.

Thiazolidinediones (TZD):

  • The Committee was asked to consider information regarding clinical trial results including safety and efficacy, especially with regard to cardiovascular health, boxed warnings and contraindications, adverse events, combination therapy with a TZD and metformin or a sulfonylurea, as well as the importance of protecting beta-cells, lowering HgA1c, and avoiding complications of diabetes. The Committee was also asked to consider the results of several meta-analyses of trials for drugs in this class.

Urinary Tract Antispasmodics:

  • The Committee was asked to consider information regarding clinical trial results including indications, efficacy in men and women, dosing, safety, mechanism of action, adverse events, drug interactions, contraindications, onset of action, pharmacology, and adherence.

Pharmacy and Therapeutics Committee Comments:

  • A Committee member clarified that there is controversy with regard to the incidence of heparin-induced thrombocytopenia (HIT) with enoxaparin and fondaparinux, and also that Protamine does not completely reverse the effects of enoxaparin.
  • A Committee member and a presenter discussed the use of selective versus non-selective NSAIDs with aspirin in patients with known cardiovascular disease and those at risk for cardiovascular events as well as the importance of understanding the interaction between the non-selective NSAIDs with aspirin and how it can be overcome with proper timing of doses.
  • A Committee member asked if the concern with self dosing of naproxen and a triptan has been proven clinically and the presenter indicated it has not been studied. Another Committee member inquired about the triptan dosing in the combination tablet and the presenter indicated that pharmacokinetics as well as tablet size were taken into consideration.
  • A Committee member asked with so much patient variability in response to triptan therapy was there a way to predict which triptan might be most efficacious for a particular patient. The presenter indicated there was no way to predict, and one way to choose therapy was for a patient to keep a headache diary.
  • In response to a comment made by a presenter comparing moxifloxacin and levofloxacin, a Committee member wished to clarify that C. difficile may occur with levofloxacin therapy as well as moxifloxacin therapy.
  • A Committee member and a presenter discussed the QT prolongation that may occur with fluoroquinolones and broader spectrum antibiotics, channel polymorphism, and the CAPRIE study.
  • A Committee member commented on the decreased utility of the TZD class in terms of targeting insulin resistance in certain patient populations. The Committee also discussed treatment options for pre-diabetes or impaired glucose tolerance.
  • The Committee discussed the effect of over active bladder on certain aspects of quality of life.

D. Clinical Presentation and Discussion

Barbara Rogler, PharmD, MS, First Health Services Corporation; Robert Correia, PharmD, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP)

Proposal to identify preferred drugs in the therapeutic class of Anticoagulants - Injectable

Drugs Affected: Arixtra (fondaparinux sodium), Fragmin (dalteparin sodium), Innohep (tinzaparin sodium), Lovenox (enoxaparin sodium)

Dr. Rogler presented an overview of unfractionated heparin (UFH), LMWH, the selective Factor Xa inhibitor, and venous thromboembolism (VTE), including the risk factors for and incidence of VTE. She described the mechanism of action for the drugs in the class and provided a description of the human coagulation cascade to explain where in that process the injectable anticoagulants provide their effect. She discussed the American College of Chest Physicians (ACCP) Guidelines for Antithrombotic Therapy for Venous Thromboembolic Disease: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. She discussed primarily the outpatient indications for the drugs, and also mentioned the inpatient cardiac indications. She mentioned use of these agents in special populations such as pediatrics, pregnancy and in patients with renal impairment. She noted that the agents are not indicated for intramuscular (IM) administration, listed the contraindications, and also noted that the agents cannot be used interchangeably. She concluded that although the products differ in their FDA-indications, the ACCP makes no distinction between the products for orthopedic surgery prophylaxis or treatment of VTE.

Dr. Correia provided the Department's clinical review for this category. He noted the drugs in this class are generally comparable in uses and clinical effects, and that all except tinzaparin are used for prevention of deep vein thrombosis (DVT), with various surgical procedures or other specific etiologies identified in their labeling. He noted all are used for treatment of DVT, and all may be used with pulmonary embolism (PE), again with some variation in labeling relative to DVT etiology as well as inpatient and outpatient settings. He mentioned the ACCP guidelines recommend use of LMWHs for pregnant women at risk of PE or VTE, with no distinction between dalteparin and enoxaparin for this use, and noted all four agents are Pregnancy Category B. He discussed product dosing, pharmacokinetics in terms of time to peak anti-Factor Xa activity, adverse effect profiles and the use of Protamine sulfate intravenously (IV) to reverse the effects of enoxaparin and dalteparin, but not fondaparinux. He noted that fondaparinux has a significantly longer half-life in the body than the LMWHs, which may be a consideration depending on clinical situations and patient co-morbidities. He also noted fondaparinux was associated in some studies with increased efficacy or increased bleeding in comparison to LMWH which is relevant to the timing between the procedure and dosing. He concluded that no distinction between these products was identified in treatment guidelines discussed for orthopedic surgical prophylaxis or VTE, and none of these products demonstrates an overall advantage in all situations.

Several committee members discussed the risks and benefits of the long half-life of fondaparinux and the distinction between half-life and duration of action.

Review of the Niacin Derivative therapeutic class for inclusion to the Preferred Drug Program (PDP)

Drugs Affected: Niaspan (niacin extended release)

Dr. Rogler described the possible mechanisms of action, indications, and dosing and administration for niacin extended release (Niaspan). She discussed the Arbiter 2 Study comparing the effects of niacin ER 1000 mg/day with placebo on carotid intima-media thickness (CIMT) over 12 months. She summarized noting that niacin has been on the market for over 4 decades, it remains the single most effective agent for raising HDL, and can safely be used in combination with statin therapy for the reduction of total cholesterol (TC), LDL and TG.

Dr. Correia provided the Department's clinical review for this category. He noted there is no basis for a comparative review as there is only one drug in the class. He indicated Niaspan (niacin extended release) is currently covered by Medicaid both as an individual drug and also as part of a combination product with simvastatin in the HMG-CoA Reductase Inhibitors (Statins) therapeutic class. He explained that establishing the niacin derivative class in the PDP minimizes any uncertainty with regard to the availability of niacin ER for use alone or in combination with any statin drug, and will allow the Committee to address any newly approved drugs that fall into this therapeutic class.

Re-review of the Preferred Drug Program therapeutic classes

1. Re-review of the Oral Bisphosphonates therapeutic class

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

Dr. Rogler noted two new product formulations for risedronate and a new generic alendronate, in this class. She mentioned the Food & Drug Administration (FDA) Alert from 1/7/2008, highlighting the possibility of severe and sometimes incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates, noting information related to musculoskeletal pain is included as a potential adverse effect in all the bisphosphonates prescribing information. She also noted the FDA Early Communication of an Ongoing Safety Review (10/1/2007) which states the FDA is continuing to study the question about the association of atrial fibrillation (AF) with the use of bisphosphonates.

Dr. Correia provided the Department's clinical review of new information for this category. He noted the new once monthly dose for risedronate indicating that this dose was associated with almost double the incidence of diarrhea compared to the daily dose. He also noted that in clinical trials, ibandronate and risedronate efficacy with monthly dosing is not inferior to daily dosing, but both drugs are associated with a higher incidence of acute phase reactions such as fever and influenza-like symptoms at the higher monthly dose, and FDA labeling identifies the incidence of serious adverse events for both drugs as almost 50% higher in the monthly regimens.

With regard to adherence to therapy, Dr. Correia explained that retrospective and observational database reviews, which may not adequately account for potential confounding factors, could affect study population selection bias or adherence rates. He reiterated from previous reviews of this drug class that adherence was addressed in 2 studies involving over 13,000 women discussed at the 5th European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis held in Rome, and the data presented indicated that reducing frequency of dosing on its own will not increase compliance. He also noted that it has been widely identified that other factors such as patient support, identification of clinical benefit, and belief that therapy produces benefit, are more significant factors. He concluded that there has been no new clinical evidence found to indicate overall clinical superiority for any of these drugs.

Dr. Rogler reiterated that the Agency for Healthcare Research and Quality (AHRQ) supported the adherence data that Dr. Correia presented.

A Committee member asked the significance of the term "faster" with regard to bisphosphonate therapy, and Dr. Correia indicated this refers to the speed of effect and is based on once daily dosing.

2. Re-review of the Nasal Calcitonins therapeutic class

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

Dr. Rogler indicated that she found no new clinical information pertaining to this drug class since the last review.

Dr. Correia provided the Department's clinical review of new information for this category. He reiterated both intranasal calcitonins are FDA approved for treatment of osteoporosis in post-menopausal women, and the active drug in both products is chemically identical. He noted the only difference is in the method by which the chemical is synthesized and inert ingredients present, and there is no evidence that either of these factors impacts clinical efficacy. He concluded there is still no evidence to indicate either of these drugs offers an overall advantage.

3. Re-review of the Cyclooxygenase II (COX II) Inhibitor therapeutic class

Drug Affected: Celebrex (celecoxib)

Dr. Rogler indicated that she found no new clinical information pertaining to this drug class since the last review.

Dr. Correia provided the Department's clinical review of new information for this category. He indicated this therapeutic class is included to allow the Pharmacy and Therapeutics Committee to address any newly approved drugs that fall into this class and concluded there is still only one drug in the class; therefore there is no comparative analysis, and no new recommendations.

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

Drugs Affected: Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Imitrex (sumatriptan), Maxalt (rizatriptan), Relpax (eletriptan), Treximet (sumatriptan/naproxen sodium), Zomig (zolmitriptan)

Dr. Rogler discussed a new sumatriptan/naproxen sodium combination tablet, including dosing, and also mentioned an expected patent expiration date for the brand name sumatriptan product.

Dr. Correia provided the Department's clinical review of new information for this category. He mentioned the new combination product which adds naproxen to sumatriptan, and noted combining both of these drugs in a single tablet may be more convenient for those patients whose migraine responds to this specific combination, or may be a disadvantage if the patient currently has or later acquires other medical conditions or takes other medications which are a problem with concomitant NSAID use. He noted previously discussed complications in comparing overall efficacy for this drug class including response rates, sustained relief, and sustained pain free outcomes. He also mentioned that in crossover studies, patients switched from one triptan to another when response wanes obtained benefit by changing to a new drug. He concluded there was no new comparative clinical evidence found or provided to suggest overall advantage for any one drug in this class.

5. Re-review of the Anti-Emetics therapeutic class

Drugs Affected: Anzemet (dolasetron), granisetron, Kytril (granisetron), ondansetron, Zofran (ondansetron)

Dr. Rogler noted granisetron as a new generic in this class.

Dr. Correia provided the Department's clinical review of new information for this category noting the new generic, and indicated now two of the three drugs in the class are available generically. He concluded no new comparative evidence was found to differentiate effectiveness between the three drugs, and all three are effective with none demonstrating an overall advantage.

6. 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), Noroxin (norfloxacin), ofloxacin, Proquin XR (ciprofloxacin), Tequin (gatifloxacin)

Dr. Rogler noted levofloxacin received FDA approval for the indication of the treatment of inhalational anthrax (post-exposure) in children >6 months of age. She also reiterated the Update to CDC's Sexually Transmitted Diseases Treatment Guidelines 2006: Fluoroquinolones No Longer Recommended for Treatment of Gonococcal Infections, which was issued due to widespread fluoroquinolone resistant Neisseria gonorrhoeae in the United States.

Dr. Correia provided the Department's clinical review of new information for this category. He noted all of the available oral fluoroquinolones are effective, although their utility is being eroded through resistance due to overuse, as evidenced by removal from federal recommendations for treatment of gonorrhea. He noted previous discussion surrounding variation in doses and lengths of therapy, with various different drugs having shorter lengths of therapy for certain indications. He concluded that while the drugs in this class may have differences as groups or subtle differences individually for particular pathogens or patient populations, there is no new evidence that any of these drugs demonstrate an overall advantage. He also noted that there is an identified overall differential in spectrum of activity between second and third generation fluoroquinolones and recommended that both generations be represented as preferred drugs.

A Committee member asked if they were aware of changes in any other clinical guidelines with regard to this class, and Drs. Correia and Rogler indicated they were not aware of any other changes.

7. Re-review of the Third Generation Cephalosporins therapeutic class

Drugs Affected: Cedax (ceftibuten), cefdinir, cefpodoxime proxetil, Omnicef (cefdinir), Suprax (cefixime), Spectracef (cefditoren), Vantin (cefpodoxime proxetil)

Dr. Rogler noted cefixime (Suprax) 400 mg tablets were made available again and are indicated for the treatment of uncomplicated gonorrhea infections.

Dr. Correia provided the Department's clinical review of new information for this category. He noted cefixime is being brought back because fluoroquinolones are no longer recommended for uncomplicated gonorrhea due to bacterial resistance. He also noted both cefixime and cefpodoxime have one-time single dosing for uncomplicated gonorrhea. He concluded that no new comparative evidence was found to differentiate effectiveness between the products, and none of the drugs demonstrate an overall advantage. He also noted that this drug class may be grouped according to relative gram-positive or gram-negative bacterial activity, and recommended having drugs from both bacterial spectrum groups represented as preferred drugs.

A Committee member asked if they were aware of changes in any clinical guidelines with regard to this class, and Drs. Correia and Rogler indicated they were not aware of any changes.

8. Re-review of the Otic Fluoroquinolones therapeutic class

Drugs Affected: Cipro HC (ciprofloxacin/hydrocortisone), Ciprodex (ciprofloxacin/dexamethasone), Floxin (ofloxacin), ofloxacin

Dr. Correia and Dr. Rogler indicated that they found no new clinical information pertaining to this drug class since the last review, and Dr. Correia noted all the products are effective with none demonstrating an overall advantage.

9. Re-review of the Thiazolidinediones (TZD) therapeutic class

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

Dr. Rogler presented an update of clinical information pertaining to pioglitazone and rosiglitazone. She discussed several clinical trials including PROactive, PERISCOPE, and the Interim Analysis of the RECORD trial as well as several meta-analyses. She also discussed the increased fracture risk with TZDs. She noted the boxed warning for rosiglitazone pertaining to an increased risk of myocardial ischemic events, which concluded that in their entirety, the available data on the risk of myocardial ischemia are inconclusive.

Dr. Correia provided the Department's clinical review of new information for this category. He discussed the PERISCOPE study, noting the significant differences in baseline demographic risks between the study populations. He noted that controversy remains about the potential adverse effect profiles, especially cardiovascular adverse events, and how they relate to pioglitazone, rosiglitazone, or class effect for both. He indicated the controversy is primarily based on meta-analyses of drug trials, and he discussed the weaknesses inherent to meta-analyses. He noted that after concerns were raised by results of a meta-analysis of rosiglitazone studies, the FDA conducted their own meta-analysis which indicated a one-half percent higher incidence of any myocardial ischemic event, but no statistically significant difference in serious ischemia, or for the endpoint of myocardial infarction, cardiovascular death, or stroke.

He discussed another meta-analysis of 19 clinical trials of pioglitazone which showed benefit for the combined secondary endpoint of death, MI, or stroke, but no statistically significant difference in the endpoints individually, and over eighty percent of the events contributing to the combined endpoint came from the PROactive study. He noted the benefit was only significant when placebo controlled trials were included; there was no statistically significant benefit when only trials with active comparator drugs were used. This review also again showed an increased risk for serious heart failure with pioglitazone.

He reiterated pioglitazone and rosiglitazone have the same boxed warning in their labeling for heart failure, and both drugs have warnings about fluid retention, weight gain, edema, and for an increased risk of bone fractures in women. He noted rosiglitazone has an additional boxed statement addressing the risk of myocardial ischemic events, but the FDA ultimately concluded that: "In their entirety, the available data on risk of myocardial ischemia are inconclusive."

He mentioned that the FDA Advisory Committee met in May 2007 to review the TZDs, and specifically focused on the data pertaining to rosiglitazone and ischemic and thrombotic risks, and commented that the data may suggest that the difference between the two TZDs may not be as great as claims that have been made based on information from observational studies. Dr. Correia concluded that at this time, there is still no comparative evidence which clearly demonstrates an advantage of either of these products overall, and the FDA has determined that the available data concerning safety issues is inconclusive.

10. Re-review of the Selective Alpha Adrenergic Blockers therapeutic class

Drugs Affected: Flomax (tamsulosin), Uroxatral (alfuzosin)

Dr. Correia and Dr. Rogler indicated that they found no new clinical information pertaining to this drug class since the last review, and Dr. Correia reiterated the American Urological Association's statement regarding this drug class, noting that both drugs are comparably clinically effective.

11. Re-review of the Urinary Tract Antispasmodics therapeutic class

Drugs Affected: Detrol (tolterodine), Detrol LA (tolterodine LA), Ditropan (oxybutynin), Ditropan XL (oxybutynin XL), Enablex (darifenacin), oxybutynin, oxybutynin ER, Oxytrol (oxybutynin), Sanctura (trospium), Sanctura XR (trospium), Vesicare (solifenacin)

Dr. Rogler mentioned the new extended release trospium (Sanctura XR) including product dosing.

Dr. Correia provided the Department's clinical review of new information for this category. He also mentioned the new once a day version of trospium. He noted clinical trials demonstrated similarity in efficacy between immediate and sustained release dosage forms. He did indicate that sustained release dosage forms may have a slight advantage of less adverse effects, although this was not reflected in discontinuation rates of the drugs with the possible exception of the transdermal patch which did cause some contact dermatitis, resulting in more adverse events and higher withdrawal rates in clinical data. He concluded clinical evidence reviewed indicates any of these drugs provide comparable symptomatic relief, with none demonstrating an overall advantage.

The Committee discussed the difference between the tertiary and quaternary amines with regard to adverse effects, and noted there were no head to head trials between the drugs in this class that fall within those two classifications.

E. Executive Session:

The Committee recessed the public session at 12:00 P.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Injectable Anticoagulants, Niacin Derivatives, Oral Bisphosphonates, Nasal Calcitonins, COX II Inhibitors, Triptans, Anti-Emetics, Oral Fluoroquinolones, Third Generation Cephalosporins, Otic Fluoroquinolones, TZDs, Selective Alpha Adrenergic Blockers, and Urinary Tract Antispasmodics. No official action was taken in the executive session. The executive session was recessed at 1:50 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 RecommendationsCommissioner's Final Determination
Proposal: Identification of preferred drugs in the category of Anticoagulants - Injectable

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
Arixtra (fondaparinux sodium), Fragmin (dalteparin sodium), Innohep (tinzaparin sodium), Lovenox (enoxaparin sodium)

Non-preferred Drugs
None

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

  • 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 Niacin Derivatives

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
Niaspan (niacin extended release)

Non-preferred Drugs
None

B. The Committee unanimously recommended the standard clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.

Approved as Recommended
Proposal: Identification of preferred drugs in the category of Bisphosphonates - Oral

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
alendronate, Fosamax (alendronate), Fosamax Plus D (alendronate plus cholecalciferol)

Non-preferred Drugs
Actonel (risedronate), Actonel with Calcium (risedronate with calcium carbonate), Boniva (ibandronate)

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 Calcitonins - Nasal

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 Drugs
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 Cyclooxygenase II (COX II) 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 Drug
Celebrex (celecoxib)

Non-preferred Drugs
None

B. The Committee unanimously recommended the standard clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.

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), Maxalt (rizatriptan), Relpax (eletriptan)

Non-preferred Drugs
Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Treximet (sumatriptan/naproxen sodium), Zomig (zolmitriptan)

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 Anti-Emetics

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
ondansetron

Non-preferred Drugs
Anzemet (dolasetron), granisetron, Kytril (granisetron), Zofran (ondansetron)

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 Fluoroquinolones - Oral

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 (moxifloxacin), Cipro Suspension (ciprofloxacin), ciprofloxacin, ofloxacin

Non-preferred Drugs
Cipro tablets (ciprofloxacin), Cipro XR (ciprofloxacin ER), ciprofloxacin ER, Factive (gemifloxacin), Floxin (ofloxacin), Levaquin (levofloxacin), Noroxin (norfloxacin), Proquin XR (ciprofloxacin), Tequin (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 Cephalosporins - Third Generation

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
Cedax (ceftibuten), cefdinir, cefpodoxime proxetil, Suprax (cefixime)

Non-preferred Drugs
Omnicef (cefdinir), Spectracef (cefditoren), Vantin (cefpodoxime proxetil)

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 Fluoroquinolones - Otic

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
Ciprodex (ciprofloxacin/dexamethasone), ofloxacin

Non-preferred Drugs
Cipro HC (ciprofloxacin/hydrocortisone), Floxin (ofloxacin)

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 as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.

Approved as Recommended
Proposal: Identification of preferred drugs in the category of Selective Alpha Adrenergic Blockers (used for BPH)

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
Flomax (tamsulosin), Uroxatral (alfuzosin)

Non-preferred Drugs
None

B. The Committee unanimously recommended the standard clinical questions be used as a basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.

Approved as Recommended
Proposal: Identification of preferred drugs in the category of Urinary Tract Antispasmodics

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
Detrol LA (tolterodine LA), Enablex (darifenacin), oxybutynin, Oxytrol (oxybutynin patch), Sanctura (trospium), Sanctura XR (trospium), Vesicare (solifenacin)

Non-preferred Drugs
Detrol (tolterodine), Ditropan (oxybutynin), Ditropan XL (oxybutynin XL), oxybutynin ER

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

Approved as Recommended

G. Additional Discussion:

The DUR Update on Ophthalmic NSAID usage was tabled.

H. Election of Committee Chair and Co-Chair:

The Committee voted and elected a Committee Chair and Vice-Chair. The following members were re-elected:

  • Chairperson: Glenn Martin, MD
  • Vice Chairperson: William Scheer, RPh

The meeting adjourned at 2:00 PM.

Meeting Summary Posted 7/7/08

I. 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: Anticoagulants-injectable, Niacin Derivatives, Bisphosphonates, Calcitonins, Cox II Inhibitors, Serotonin Receptor Agonists, Anti-emetics, Fluoroquinolones-oral, Cephalosporins-third generation, Fluoroquinolones-otic, Thiazolidinediones, Selective Alpha Adrenergic Blockers and Urinary Tract Antispasmodics.

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 of enrollees currently utilize preferred products.
    • Non-preferred products remain available when prior authorized.
  2. Program Providers:
    • No impact on prescribers or pharmacies when utilizing preferred products. Prescribers, or their agents, will need to initiate the prior authorization process when ordering non-preferred products. Pharmacies will need to complete the prior authorization process for non-preferred products.
  3. State Health Program:
    • Annual gross savings associated with these therapeutic classes under the PDP are estimated at $25.9 M. The savings are achieved through changes in utilization to equally effective and less expensive drugs through the receipt of supplemental rebates from pharmaceutical manufacturers.

Final Determinations Posted 8/29/2008