Pharmacy and Therapeutics Committee Meeting Summary - April 24, 2009
Agenda and Introduction
The Medicaid Pharmacy & Therapeutics Committee met on Friday, April 24, 2009 from 8:15 a.m. to 4:30 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.
Dr. Martin (Chairperson) announced that Dr. Johnson, MD and Dr. Satloff, MD are no longer with the Committee and thanked them for their service.
Dr. Mary Lee Wong MD, Dr. Andrew T. Cheng MD, and Dr. Sara E. Dugan, PharmD were introduced as new Committee members.
Dr. Martin asked that the focus of the comments and presentations for the re-reviewed classes be on new, evidence-based information since the last review of the therapeutic classes.
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:
- Khan, Arsalan, PharmD, MBA, Senior Manager Health Economics and Outcomes Research, Centocor Ortho-Biotech LLC, Piscataway, NJ
- Musaji, Naomi, Director, Medical Affairs, Strativa Pharmaceuticals, Woodcliff Lake, NY
- McEntee, James, PharmD, Medical Science Liaison, Shire Pharmaceuticals, Wayne, PA
- Price, Arlene, PharmD, Senior Scientific Affairs Liaison, Ortho McNeil Janssen, Randolph, NJ
- McGrath Brodeur, Jean, PharmD, Medical Liaison II, Daiichi Sankyo, Parsippany, NJ
- Baran, Daniel, MD, Region Medical Director, Merck & Co., Inc., North Wales, PA
- Gasinu, Koku, MD, Cardiologist, Bronx, NY
- Forte, Kenton, MD, Assistant Clinical Professor, SUNY Buffalo, Heart Beat Center of Western NY, Buffalo, NY
- Miura, Dennis, MD, PhD, FACC, FACP, Bronx Westchester Medical Group, Assistant Clinical Professor of Medicine Albert Einstein College of Medicine, Bronx, NY
- Vichiendilokkul, Aungkana, PharmD, MS, Regional Medical Scientist, GlaxoSmithKline, Research Triangle Park, NC
- Schmitt, Laurie, PharmD, Forest Pharmaceuticals
- Krauter, Eric, PhD, Medical Liaison, Roche, Nutley, NJ
- Leonard, Thomas, RPh, PhD, Regional Medical Scientist, GlaxoSmithKline, Philadelphia, PA
- Birner, Timothy, PharmD, MBA, Director, Medical Managed Care, Sanofi-Aventis, Beverly, MA
- Winther, Marisa, PharmD, BCPS, Regional Scientific Manager-Cardiovascular, AstraZeneca Pharmaceuticals, Wilmington, DE
- Kerstein, Joshua, MD, Cardiologist, Cardiology Associates of Brooklyn, Brooklyn, NY
- Frankel, Perry, MD, Private Practice, Lake Success, NY
- Dietrich, Gary, MD, Senior Medical Director, External Medical & Scientific Affairs, Merck/Schering-Plough, North Wales, PA
- Zuckerman, Andrea, MD, Senior Director, Regional Medical and Research Specialist, Pfizer, Inc, Mt. Kisco, NY
- Pollack, Cary, MD, Cardiologist, Bronx, NY
- Clarke, Sherwanna, PharmD, Government Regional Clinical Executive, Abbott Laboratories, Marietta, GA
- Posta, Linda, RPh, MBA Scientific Liaison, Astellas Pharma US, Milford, CT
- Russell, David, MD, Senior Director, Regional Medical & Research Specialists, Pfizer Inc., New York, NY
- Zak, Michelle, Medical Science Liaison, ProStrakan, Bedminster, NJ
- Hawranko, Alyssa, PhD, Senior Regional Scientific Manager-Gastrointestinal Division, AstraZeneca Pharmaceuticals, Wilmington, DE
- Muslim, Arif, MD, FACG, FAGA, FASGE, GI Associates, New Windsor, NY
- Martin, Ubaldo, MD, Associate Director, Clinical Research, AstraZeneca LP, Wilmington, DE
- Mavumkal, Romy, PharmD, Senior Regional Medical Scientist, GlaxoSmithKline, New York, NY
- Goldstein, Stanley, MD, Director of Allergy & Asthma Care of Long Island, Rockville Centre, NY
- Gall, Rebecca, MD, Medical Science Liaison, Schering-Plough, Uxbridge, MA
- Konev, Anton, Senior Legislative Assistant to Honorable Peter M. Rivera, New York State Assembly, Albany, NY
- Dube, Christine, PharmD, PAHM, Director, Medical Sciences, MedImmune LLC, Gaithersburg, MD
C. Key issues raised by interested parties and the Pharmacy and Therapeutics Committee pertaining to the clinical review of the following therapeutic classes/drugs:
Public comments:
Erythropoiesis Stimulating Agents (ESAs):
- The Committee was asked to consider recent safety information pertaining to the class including a Medication Guide, Risk Evaluation and Mitigation Strategies (REMS), communications to health care providers, and changes to the product label.
Progestins (for Cachexia):
- The Committee was asked to consider information regarding clinical trial results including indications, bioavailability in the fed and unfed state, effectiveness, dosing, and product viscosity.
Central Nervous System Stimulants:
- The Committee was asked to consider information regarding clinical trial results including indications, efficacy in children, adolescents and adults, tolerability, dosing, onset and duration of action, drug interactions, pharmacokinetics and drug delivery systems, adherence and persistence to therapy, and abuse liability.
Angiotensin Receptor Blockers (ARBs) and ARB/Diuretic Combinations:
- The Committee was asked to consider information regarding indications, dosage strengths, efficacy, combination products and their efficacy versus monotherapy, adverse reactions, black box warnings, titration of dose, safety, product label updates and patent expiration.
Beta Blockers:
- The Committee was asked to consider information regarding clinical trial results including indications, efficacy, tolerability, mechanism of action, adverse effects, drug interactions, pharmacokinetics, adherence, beta-1 selectivity, immediate release and controlled release formulations, and use in the African American population and the elderly.
Bisphosphonates - Oral:
- The Committee was asked to consider information regarding clinical trial results including efficacy data for non-vertebral fractures, bone mineral density gains, dosing, adverse events, adherence, and long term safety and efficacy data.
Anticoagulants - Injectable:
- The Committee was asked to consider information regarding clinical trial results including indications, safety during pregnancy, efficacy and safety across age subgroups, dosing, and contraindications, and was also asked to consider the American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines for Antithrombotic and Thrombolytic Therapy.
HMG-CoA Reductase Inhibitors (Statins):
- The Committee was asked to consider information regarding clinical trial results including indications, efficacy and safety (including long term), effect on lipid parameters, apolipoprotein-B, and high-sensitivity C-reactive protein, statins combined with ezetimibe or a calcium channel blocker, use in renal disease including end-stage renal disease, use in patient populations with hypertension, diabetes, coronary artery disease, stroke, and the elderly, dosing, adverse events, adherence and compliance, and use as primary and secondary prevention.
Triglyceride Lowering Agents:
- The Committee was asked to consider information regarding clinical trial results for both omega-3 fatty acids and fenofibric acid including indications, contraindications, efficacy, safety, tolerability, side effects, metabolism, drug interactions, dosing, use in renal impairment, and use with statins as well as use as monotherapy.
Urinary Tract Antispasmodics:
- The Committee was asked to consider information regarding clinical trial results including indications, efficacy, pharmacology, dosing, dose titration, safety, tolerability, adverse events, drug interactions, and use in renal or hepatic impairment.
Anti-Emetics:
- The Committee was asked to consider information regarding clinical trial results including indications, dosing, compliance, adherence, and the use of a transdermal delivery system for the prevention of chemotherapy induced nausea and vomiting.
Proton Pump Inhibitors (PPIs):
- The Committee was asked to consider information regarding clinical trial results including indications, efficacy, healing rates, use in pediatric and adolescent patients, dosing, dosing formulations, short and long term tolerability, and adverse events.
Corticosteroids - Inhaled:
- The Committee was asked to consider information regarding clinical trial results including indications, safety, efficacy, use in adult and pediatric patients, onset of action, dosing, and adverse events, and the Committee was also asked to consider the importance of maintaining access to asthma medications.
Clinical Drug Review Program - palivizumab (Synagis):
- The Committee was asked to consider information regarding clinical trial results including dosing and indications and was also asked to consider the potential variability of the respiratory syncytial virus (RSV) season, and the importance of avoiding delays in or disruption of dosing schedules.
Pharmacy and Therapeutics Committee Comments:
- A committee member asked for confirmation that the labeling changes for the ESAs were for all the drugs in that class.
- A committee member and the presenter discussed the bioavailability of the megestrol preparations.
- A committee member discussed with several presenters the lack of comparative bioequivalence and pharmacodynamics data for ARBs.
- Several committee members and presenters discussed the appropriate use of various beta-blockers in special populations including African Americans, side effects of nebivolol versus other beta blockers, comparison of nebivolol to other vasodilating beta-blockers, the immediate release versus controlled release formulation of carvedilol, the use of beta-blockers in peripheral vascular disease and coronary artery disease, orthostatic hypotension, and the current place in therapy for beta-blockers in general.
- Committee members discussed with presenters the potency of rosuvastatin with regard to efficacy and toxicity, and the simvastatin/ezetimibe combination product with regard to recent clinical trials and lowering LDL with versus without outcomes data.
- A committee member requested clarification regarding the anticoagulant effect of high doses of omega-3 products and any resulting drug-drug or drug-disease interactions.
- A committee member and presenter discussed the pharmacodynamics of tolterodine and fesoterodine.
- Several committee members discussed with the presenter the need for rescue medication when using the granisetron patch versus oral drugs for nausea and vomiting prophylaxis, taking into consideration acute versus delayed symptoms. The presenter referred to the National Comprehensive Cancer Network (NCCN) guidelines.
- A committee member commented on the multiple strengths and dosage forms currently available for inhaled corticosteroids.
- A committee member asked if the presenter had evidence that the current Preferred Drug List has had a negative impact with regard to asthma treatment, and the presenter indicated he did not but was concerned with maintaining access to asthma medications.
D. Clinical Presentation and Discussion
Dana Selover, MD, MPH, Oregon Health & Sciences University, Evidence-based Practice Center (OHSU EPC); Barbara Rogler, PharmD, MS, First Health Services Corporation; Robert Correia, PharmD, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP), Marie Wenzel, PharmD, University of Massachusetts Medical School
Inclusion of palivizumab (Synagis) in the Clinical Drug Review Program (CDRP)
Linda Jones, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP), noted that palivizumab (Synagis) was reviewed for inclusion in the CDRP at the February 20, 2008 P&T Committee meeting, and the Committee recommended at that time not to include palivizumab in the CDRP. Dr. Martin indicated that after considering the information presented at the February 2008 meeting, the Committee determined there was insufficient evidence to recommend inclusion in the CDRP at that time.
Dr. Wenzel presented a clinical review of palivizumab to the Committee. Her presentation also included data specific to the NY Medicaid program and focused on utilization outside of the RSV season and in patients greater than two (2) years of age at onset of the RSV season. She noted palivizumab is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk.
Joseph Paladino, PharmD, State University of New York at Buffalo, and Chairperson of the NYS Medicaid Drug Utilization Review (DUR) Board presented the DUR Board's recommendations regarding palivizumab from their meeting on March 23rd, 2009. He noted that based on a report of palivizumab clinical information and utilization within the NY Medicaid program, the Board determined that palivizumab meets the criteria for inclusion into the CDRP, and recommended that the Medicaid Pharmacy & Therapeutics Committee consider palivizumab for inclusion in the CDRP. The Board also recommended that the Medicaid program implement edits that restrict use of palivizumab to the period of October 16 to March 31 and to children less than two (2) years of age at the onset of the RSV season.
1. Re-review of the ACE Inhibitors and ACE Inhibitor/Diuretic Combinations therapeutic classes
ACE Inhibitors
Drugs Affected: Accupril (quinapril), Aceon (perindopril erbumine), Altace capsule (ramipril), Altace tablet (ramipril), benazepril, Capoten (captopril), captopril, enalapril maleate, fosinopril, lisinopril, Lotensin (benazepril), Mavik (trandolapril), moexipril, Monopril (fosinopril), Prinivil (lisinopril), quinapril, ramipril capsule, 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. Rogler provided ACE Inhibitor label revisions associated with new precautions and potential drug interactions. The 2009 Guideline Focused Update on Heart Failure was also presented. It was noted that no new clinical information was found for the ACE Inhibitor/Diuretic Combinations therapeutic class since the last review.
Dr. Correia noted new product labeling pertaining to class effects. He discussed a study with a fixed-dose regimen of perindopril plus indapamide versus placebo in a highly selected patient population that concluded blood-pressure lowering treatment in type-2 diabetics with atrial fibrillation significantly reduced cardiovascular events and mortality versus placebo. He noted ongoing outcomes evidence continues to support the benefit of ACEIs with or without diuretics for a range of clinical indications, and concluded that at this time there is no new comparative clinical evidence between drugs in either of these classes to justify preferential availability of any one product.
2. Re-review of the Calcium Channel Blockers (CCB) and the ACE Inhibitor/Calcium Channel Blocker Combinations therapeutic classes
Calcium Channel Blockers
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, nisoldipine, Norvasc (amlodipine), Plendil (felodipine ER), Procardia (nifedipine), Procardia XL (nifedipine XL), Sular (nisoldipine)
ACE Inhibitor/Calcium Channel Blocker Combinations
Drugs Affected: benazepril/amlodipine, Lexxel (enalapril maleate/felodipine ER), Lotrel (benazepril/amlodipine), Tarka (trandolapril/verapamil ER)
Dr. Rogler noted that no new clinical information was found for the Calcium Channel Blocker therapeutic class since the last review. With regard to the ACE Inhibitor/Calcium Channel Blocker Combinations, amlodipine/benazepril 5/40mg and 10/40mg are not available generically.
Dr. Correia discussed the results of the ACCOMPLISH trial, which was discussed at the last re-review of the classes, and concluded there is no new comparative evidence between the drugs in either of these classes that favors any product within either of these classes.
3. Re-review of the Angiotensin Receptor Blockers (ARBs) and ARB/Diuretic Combination therapeutic classes
Angiotensin Receptor Blockers (ARBs)
Drugs Affected: Atacand (candesartan cilexetil), Avapro (irbesartan), Azor (olmesartan/amlodipine), Benicar (olmesartan medoxomil), Cozaar (losartan), Diovan (valsartan), Exforge (valsartan/amlodipine), 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. Rogler discussed a new indication for valsartan/amlodipine (Exforge) as first-line treatment in patients who are likely to require multiple drugs to achieve blood pressure goals. Study design, outcomes and results of the I-PRESERVE and PRoFESS studies were also presented.
Dr. Correia noted that comparative evidence submitted was either not new or did not provide additional relevant comparative information in the ARB class. He reiterated Exforge and Diovan HCT have a new modified indication as first-line treatment for a subset of patients. He concluded that his clinical review revealed no significant new evidence demonstrating overall superiority for any of the drugs within either class since the last re-review.
4. Re-review of the Beta Blockers and Beta Blocker/Diuretic Combinations therapeutic classes
Beta Blockers
Drugs Affected: acebutolol, atenolol, betaxolol, bisoprolol fumarate, Bystolic (nebivolol), carvedilol, 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, propranolol SA, 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, nadolol/bendroflumethiazide, propranolol/HCTZ, Tenoretic (atenolol/chlorthalidone), Ziac (bisoprolol fumarate/HCTZ)
Dr. Rogler presented carvedilol label revisions associated with potential drug interactions. The 2009 Focused Update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults were also discussed. Dr. Rogler also presented information regarding the comparative effectiveness of beta-blockers in elderly patients with heart failure. It was also noted that no new clinical information was found for the beta blocker/diuretic combinations therapeutic class since the last review.
Dr. Correia noted that good comparative new clinical information is lacking in these classes. He discussed a study completed in 2007 of carvedilol MR (Modified Release) versus metoprolol succinate that was submitted for Committee review, noting that the study is unpublished, therefore lacked peer review, and the results were neither scientifically nor clinically compelling. He discussed a retrospective review that concluded atenolol, but not metoprolol tartrate, was as effective for heart failure in older patients as the evidence-based beta-blockers bisoprolol, carvedilol, and metoprolol succinate, but noted the review may have been impacted by patient selection bias. He mentioned two warning letters issued by the FDA to the manufacturer of Bystolic (nebivolol) for misleading advertising including unsubstantiated claims for superiority, efficacy, and mechanism of action. He also noted that beta blockers combined with diuretics are only indicated for hypertension, and there is no new relevant information for this subgroup. He concluded that at this time there is no new evidence of overall clinical superiority to justify preferential availability of any one product in these drug classes.
The committee discussed the limitations of the beta-1 selectivity of beta-blockers, the clinical relevance of nitric oxide, the use of various beta-blockers in the African American population and the current place in therapy for beta-blockers.
5. 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, Simcor (simvastatin/niacin extended-release), simvastatin, Vytorin (simvastatin/ezetimibe), Zocor (simvastatin)
Dr. Rogler noted a new indication for rosuvastatin and product insert changes for all statins related to hepatic failure. The American Academy of Pediatrics revised guidelines for lipid screening and cholesterol management in children were also reviewed. Several new studies were discussed including SEAS, JUPITER, AURORA as well as the Dual Target Trial. Dr Rogler also presented information associated with rosuvastatin in the prevention of venous thromboembolism and data associated with cancer rates from three ezetimibe trials.
Dr. Correia discussed the SEAS Trial noting it did not demonstrate a difference in the primary endpoint of composite of major cardiovascular events between simvastastin-ezetimibe and placebo, and he mentioned the increased incidence of cancer, noting the study was not designed to detect this occurrence. Subsequent analysis of a few other trials of this drug combination has not proven or disproven this possibility, but the studies weren't designed to detect this event, and ongoing trials are being monitored to try to clarify the issue.
He discussed the JUPITER trial, and discussed the evaluation of statin therapy in this highly selective patient population beyond cholesterol effects, particularly in the presence of inflammation. He noted that it appears impact on inflammatory mediators and their biomarkers such as C-reactive protein may be an important additional component of statin therapeutic effect, but this may or may not have a significant impact on clinical outcomes depending on the patient population and comorbidities involved. He discussed a systematic review from 2003 that evaluated the five statins available at that time for impact on C-reactive protein and other non-lipid markers which concluded that statin-mediated anti-inflammatory effects do contribute to reduced cardiovascular risks, and that all statins are equally effective at lowering C-reactive protein levels. He noted that benefits have been shown from even low doses of statins, and reiterated the potential risk of using surrogate markers versus actual outcomes.
He stated that there is consistent evidence from a large number of trials that when statins are prescribed at comparable doses, they achieve comparable percent reductions in LDL-c, as well as a similar percent increase in HDL-c. He then reiterated the basic cholesterol lowering effects of the drugs in this class in terms of percent reductions of LDL-c. He noted the current consensus opinion that the attempt to achieve lipid lowering goals should be primarily via use of statins, which have documentation of improved outcomes, and reserve ezetimibe for situations where statins are not tolerated or not tolerated to doses needed to achieve lipid goals. He concluded that new evidence submitted and reviewed is consistent with previous findings that there is no evidence of overall clinical superiority to justify preferential availability of any one product.
6. Re-review of the Triglyceride Lowering Agents therapeutic class
Drugs Affected: Drugs Affected: Antara (fenofibrate), fenofibrate, Fenoglide (fenofibrate), gemfibrozil, Lipofen (fenofibrate), Lofibra (fenofibrate), Lopid (gemfibrozil), Lovaza (Omega-3 acid ethyl esters), Tricor (fenofibrate), Triglide (fenofibrate), Trilipix (fenofibric acid delayed release)
Dr. Rogler discussed a new fenofibrate product, fenofibric acid (Trilipix) including indications, dosage, administration and strengths available. It was noted that fenofibric acid is the active metabolite of fenofibrate. Study results from co-administration of fenofibric acid and statins were presented including the mean percent change from baseline to the final value for HDL-c, TG and LDL-c.
Dr. Correia also discussed the new fenofibric acid product (Trilipix), with labeling allowing concomitant statin therapy. He noted the labeling also states that no incremental benefit has been established for Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy. He also noted that studies so far have been with low to moderate dose statins, and the risk for adverse effects with concomitant fibrate/statin therapy increases with higher statin doses. He concluded that he found no significant new comparative clinical information since the previous review, and at this time there is no evidence of overall clinical superiority for any product in this class.
The Committee discussed the clinical significance of the difference in metabolism for fenofibric acid versus other drugs in this class.
7. Re-review of the 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 described FDA evaluations regarding esophageal cancer potential, musculoskeletal pain and an Early Communication of an Ongoing Safety Review regarding atrial fibrillation. Updated guidelines (Pharmacological Treatment of Low Bone Density or Osteoporosis to Prevent Fractures: A Clinical Practice Guideline from the American College of Physicians) were also provided.
Dr. Correia discussed a retrospective meta-analysis and review information that suggests ibandronate is effective for nonvertebral fractures, however this is not yet recognized in the labeling. He discussed the new AHRQ Clinician's Guide for Fracture Prevention in Postmenopausal Women with Osteoporosis released in June 2008, but noted it does not provide any new clinical information, and is just a review of the 2007 AHRQ report document. He also discussed the American College of Physicians clinical guidelines to prevent fracture in low bone density or osteoporosis, published in September 2008. He noted a higher incidence of adverse reactions reported with monthly dosing regimens. He concluded there has been no new clinical evidence found to indicate overall clinical superiority for any of the drugs in this class.
8. Re-review of the Calcitonins therapeutic class
Drugs Affected: calcitonin-salmon, Fortical (calcitonin-salmon), Miacalcin (calcitonin-salmon)
Dr. Rogler noted that the generic for Miacalcin, calcitonin-salmon, has become available since the previous review of the class. The updated guidelines associated the Pharmacological Treatment of Low Bone Density or Osteoporosis to Prevent Fractures: A Clinical Practice Guideline from the American College of Physicians were also provided in relation to calcitonin and the evidence associated with risk reduction in vertebral and non-vertebral fractures.
Dr. Correia also noted the new generic available for Miacalcin, and reiterated that the active drug in all the products in this class is chemically identical. He concluded he found no new information to indicate any changes in the clinical review of this class and there is still no evidence that any product is better overall.
9. Re-review of the Erythropoiesis Stimulating Agents (ESAs)
Drugs Affected: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa)
Dr. Rogler noted the prescribing information has been updated since the previous review. The information which is now included in the prescribing information was presented during the previous review of the class. No new clinical information was found for the class since the last review.
Dr. Correia noted the new updated product labeling which is the same for all three products in the class. He concluded that either epoetin (both products are identical) or darbepoetin may have advantages or be preferable in specific situations or at different stages of disease progression, but neither demonstrates overall advantages at all stages or in all situations. He also reiterated the updated 2007 clinical practice guidelines from the American Society of Hematology and the American Society of Clinical Oncology which state that epoetin and darbepoetin are equivalent with respect to efficacy and safety.
10. Re-review of the Progestins (for cachexia) therapeutic class
Drugs Affected: megestrol acetate, Megace (megestrol acetate), Megace ES (megestrol acetate)
Dr. Rogler noted that no new clinical information was found for the class since the previous review.
Dr. Correia stated that he found no new information since the original review of these products. He indicated the products in this class are the same drug in different dosage preparations and are all dosed once a day, as either a 5 ml dose or a 20 ml dose depending on product selection. He noted in clinical trials both products were found to be clinically effective. He pointed out that the clinical trial mentioned during the public session was previously reviewed. He concluded there is no evidence of overall clinical superiority between the products.
11. Re-review of Anti-Coagulant therapeutic class
Drugs Affected: Arixtra (fondaparinux sodium), Fragmin (dalteparin sodium), Innohep (tinzaparin sodium), Lovenox (enoxaparin sodium)
Dr. Rogler presented label revisions associated with tinzaparin (Innohep) including administration in special populations (elderly), warning and precautions and adverse reactions. The IRIS study, which lead to the tinzaparin label revisions, was also reviewed.
Dr. Correia also mentioned the additional warnings to the tinzaparin labeling and concluded that he found a lack of new comparative information between the products within this drug class, and none of these products demonstrates an overall advantage in all situations.
12. Re-review of Anti-Emetic therapeutic class
Drugs Affected: Anzemet (dolasetron), granisetron, Granisol (granisetron), Kytril (granisetron), ondansetron, Sancuso (granisetron patch), Zofran (ondansetron)
Dr. Rogler noted the new granisetron patch (Sancuso) and reviewed the indications, dosing and strength available. A granisetron transdermal system study titled A Randomized, Active Control, Double-Blind, Double Dummy, Parallel-Group, Multi-National Study to Assess the Efficacy, Tolerability and Safety of the Granisetron Transdermal System in Chemotherapy-Induced Nausea and Vomiting Associated with the Administration of Moderately or Highly Emetogenic Multi-Day Chemotherapy was reviewed. It was also noted that a new formulation of granisetron oral solution (Granisol) has become available since the previous review.
Dr. Correia reiterated the new liquid and transdermal dosage forms, noting the transdermal patch appears to have efficacy not inferior to the oral form of the drug, but it has not been directly compared to any of the other anti-emetics under review. He also noted that five to seven days of treatment, as provided by the patch, may not always be needed, but this and the oral liquid formulation may provide alternatives for specific patients. He concluded no new comparative evidence was found to differentiate effectiveness between the three drugs in the class, and all three are effective with none demonstrating an overall advantage.
13. Re-review of the Central Nervous System (CNS) Stimulants therapeutic class
Drugs Affected: Adderall (amphetamine salt combo), Adderall XR (amphetamine salt combo XR), amphetamine salt combo, Concerta (methylphenidate), Daytrana (methylphenidate), Desoxyn (methamphetamine), Dexedrine (dextroamphetamine sulfate), Dexedrine Spansule (dextroamphetamine), dexmethylphenidate, dextroamphetamine sulfate, dextroamphetamine sulfate SA, Dextrostat (dextroamphetamine sulfate), Focalin (dexmethylphenidate), Focalin XR (dexmethylphenidate XR), Metadate CD (methylphenidate CD), Metadate ER (methylphenidate ER), Methylin ER (methylphenidate ER), Methylin (methylphenidate), methylphenidate, methylphenidate ER, Procentra (dextroamphetamine sulfate), Provigil (modafinil), Ritalin (methylphenidate), Ritalin SR (methylphenidate SR), Ritalin LA (methylphenidate LA), Vyvanse (lisdexamfetamine dimesylate)
Dr. Rogler noted the new liquid dextroamphetamine product called Procentra, new strength available for lisdexamfetamine and new amphetamine/dextroamphetamine salts extended release generic product. New indications for methylphenidate extended-release (Concerta) and lisdexamfetamine (Vyvanse) for the treatment of ADHD in adults were also reviewed.
Dr. Correia noted the warning letters issued by the FDA in September 2008 to the manufacturers of Concerta (methylphenidate), Adderall XR (amphetamine salt combo XR) and Methylin (methylphenidate) for misleading advertising. He reiterated that overall; there is little good clinical evidence for comparative effectiveness, conflicting evidence for comparative efficacy, and still no real long-term evidence for safety. He concluded there is a lack of evidence to demonstrate overall comparative advantage for any drug for shared indications within the drug class. He also noted it would be preferable to have drugs that are short, intermediate, and long acting represented as preferred drugs.
14. Re-review of the Proton Pump Inhibitors (PPI) therapeutic class
Drugs Affected: Aciphex (rabeprazole), Kapidex (dexlansoprazole), Nexium (esomeprazole), omeprazole, omeprazole OTC, pantoprazole, Prevacid (lansoprazole), Prevacid NapraPAC (lansoprazole/naproxen), Prilosec (omeprazole), Prilosec OTC (omeprazole), Protonix (pantoprazole), Zegerid (omeprazole)
Dr. Rogler presented information related to a new product, dexlansoprazole (Kapidex), a new omeprazole oral suspension and a new generic formulation of omeprazole 40mg. Also discussed was information associated with a new rabeprazole indication for short-term treatment of GERD in adolescents and a safety labeling revision for esomeprazole related to drug interactions with anti-retrovirals. Dr. Rogler reviewed dexlansoprazole including indications, pharmacokinetics and enteric coated granules dissolution characteristics. A study of the Efficacy of Esomeprazole for the Treatment of Poorly Controlled Asthma was also discussed including primary outcomes and results.
Dr. Correia mentioned the new product dexlansoprazole as well, a single isomer of an existing product. He noted that evidence continues to support that there is no significant clinical difference in PPIs in terms of safety or efficacy when dose is taken into account, and there was no new clinical information found to change previous recommendations.
15. Re-review of the Selective Alpha Adrenergic Blocker therapeutic class
Drugs Affected: Flomax (tamsulosin), Rapaflo (silodosin), Uroxatral (alfuzosin)
Dr. Rogler noted the new product silodosin (Rapaflo) and provided an overview of the drug including indication, strengths available, dosing and contraindications. It was also noted that there are no comparative trials available at this time.
Dr. Correia reiterated the new drug in the class, and noted there was no comparative data with the other drugs in the class at this time. He stated there is no new comparative information for safety or effectiveness, and the drugs appear to be comparably clinically effective, with possibly differing adverse effect profiles.
16. Re-review of Urinary Tract Antispasmodic 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), Toviaz (fesoterodine fumarate), Vesicare (solifenacin)
Dr. Selover presented the Oregon Health and Sciences University Drug Class Review for the Agents for Overactive Bladder Update 4. It was noted that there were 44 new studies in Update 4 including four head-to-head trials. New information included comparative efficacy of long acting versus short acting agents (darifenacin vs. oxybutynin IR) and long acting versus long acting agents (solifenacin ER vs. tolterodine ER). A review of clinical studies associated with the new drug trospium was also provided. Dr. Selover concluded with a summary of comparative efficacy, safety and evidence in patient subpopulations.
Dr. Rogler noted the new product fesoterodine fumarate (Toviaz) and provided an overview of the drug including indication, strengths available, dosing, and mechanism of action. A phase 3 clinical trial titled Clinical Efficacy, Safety and Tolerability of One-Daily Fesoterodine in Subjects with Overactive Bladder was also presented.
Dr. Correia discussed the comparison between fesoterodine, tolterodine ER and placebo. He noted there is limited, poor-quality comparative evidence for the drugs in the class. He discussed the warning letter issued by the FDA in January 2009 to the manufacturer of Sanctura (trospium) for misleading advertising due to unsubstantiated superiority claims. He explained the updated Drug Effectiveness Review Report again indicates similarity between the drugs in this class. He also noted that clinical trials have demonstrated similarity in efficacy between immediate and sustained release dosage forms. He concluded that clinical evidence reviewed for this drug class indicates any of these drugs provide comparable symptomatic relief, with none demonstrating an overall advantage.
The Committee discussed patient satisfaction data and one Committee member noted that in her experience, discontinuation rates were similar between the drugs in this class.
17. Re-review of the Inhaled Corticosteroid therapeutic class
Drugs Affected: Advair Diskus (fluticasone/salmeterol), Advair HFA (fluticasone/salmeterol), Aerobid/Aerobid-M (flunisolide), Alvesco (ciclesonide), Asmanex (mometasone), Azmacort (triamcinolone), Flovent Diskus (fluticasone), Flovent HFA (fluticasone), Pulmicort Flexhaler (budesonide), Qvar (beclomethasone), Symbicort (budesonide/formoterol)
Dr. Rogler noted the new product in the class, ciclesonide (Alvesco) and presented the new product information including the indication, strength availability, dosage, contraindications and side effects. Information associated with evaluation of ciclesonide in six randomized double blind, placebo-controlled, parallel-group clinical trials was discussed. Dr. Rogler presented the SHINE study which compared the budesonide/formoterol combination product (Symbicort) to each drug administered individually. The new COPD indication for the budesonide/formoterol combination product was presented. Lastly, the boxed warning associated with inhaled corticosteroid/long-acting beta adrenergic combination products (Symbicort and Advair) was reviewed.
Dr. Correia reiterated the new inhaled corticosteroid, ciclesonide, and the new indication for Symbicort, noting both Advair and Symbicort are now labeled for use in COPD. He noted the FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for Symbicort due to new information submitted from clinical trials which indicated an increased incidence of lower respiratory tract infections in patients with COPD who take Symbicort. He discussed research indicating that there may be an increased risk of pneumonia in COPD patients with use of either Symbicort or Advair. He noted the labeling for Advair Diskus was just updated March 31, 2009 to include information in the warnings and precautions sections about reduction in bone mineral density with fluticasone propionate. He concluded there is little new good quality comparative information in this drug class, and although different products may be more appropriate at different points of disease process or progression, there is not adequate new evidence of clinical superiority of any one of these products to justify preferential availability.
The Committee discussed the differences between the HFA and Diskus dosing systems.
E. Executive Session:
The Committee recessed the public session at 12:30 PM to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: ACE Inhibitors, ACE Inhibitors/Diuretic, CCBs, ACE Inhibitors/CCB, ARBs, ARBs/Diuretic, Beta Blockers, Beta Blockers/Diuretic, and Statins. The Committee also reviewed patient cases related to palivizumab (Synagis) and the CDRP. No official action was taken in the executive session. The executive session was recessed at 2:20 PM.
The Committee recessed the public session at 3:45 PM to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Urinary Tract Antispasmodics, Triglyceride Lowering Agents, Bisphosphonates, Calcitonins, Selective Alpha Adrenergic Blockers, CNS Stimulants, PPIs, Anti-Emetics, ESAs, Anticoagulants, Progestins and Inhaled Corticosteroids. The executive session was recessed at 4:45 PM.
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 Determination |
|---|---|
| Proposal: Inclusion of palivizumab (Synagis) in the Clinical Drug Review Program A. The Committee unanimously recommended that Medicaid include palivizumab (Synagis) in the Clinical Drug Review Program. B. The Committee unanimously recommended the following question be asked in the prior authorization process of palivizumab (Synagis) for utilization outside of the RSV season and in children greater than two (2) years of age at the onset of the RSV season:
|
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 benazepril, captopril, enalapril, lisinopril, moexipril, ramipril capsule, trandolapril Non-preferred Drugs Accupril (quinapril), Aceon (perindopril erbumine), Altace capsule (ramipril), Altace tablet (ramipril), 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 |
| Identification of preferred drugs in the category of 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 CR (isradipine CR), felodipine ER, isradipine, nicardipine, Nifediac CC (nifedipine CC), Nifedical XL (nifedipine XL), nifedipine, nifedipine ER, nifedipine SA Non-preferred Drugs Adalat CC (nifedipine CC), Cardene SR (nicardipine SR), nisoldipine, Norvasc (amlodipine besylate), Plendil (felodipine ER), Procardia (nifedipine), Procardia XL (nifedipine XL), Sular (nisoldipine) 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 amlodipine/benazepril, Lotrel (amlodipine/benazepril), 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), Exforge (valsartan/amlodipine besylate), Micardis (telmisartan) Non-preferred Drugs Atacand (candesartan cilexetil), Azor (olmesartan medoxomil/amlodipine besylate), 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, carvedilol, labetalol, metoprolol tartrate, nadolol, pindolol, propranolol, propranolol ER/SA, timolol maleate Non-preferred Drugs Bystolic (nebivolol), Coreg (carvedilol), Coreg CR (carvedilol CR), Corgard (nadolol), 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 |
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 tartrate/hctz, nadolol/bendroflumethiazide, propranolol/hctz Non-preferred Drugs Corzide (nadolol/bendroflumethiazide), 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 Crestor (rosuvastatin), Lescol (fluvastatin), Lescol XL (fluvastatin XL), Lipitor (atorvastatin), lovastatin, pravastatin, Simcor (simvastatin/niacin extended-release), simvastatin Non-preferred Drugs Advicor (lovastatin/niacin extended-release), Altoprev (lovastatin extended-release), Caduet (atorvastatin/amlodipine), Mevacor (lovastatin), Pravachol (pravastatin), Vytorin (simvastatin/ezetimibe), Zocor (simvastatin) 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 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 gemfibrozil, Lovaza (omega-3 acid ethyl esters), Tricor (fenofibrate), Trilipix (fenofibric acid) Non-preferred Drugs Antara (fenofibrate), fenofibrate, Fenoglide (fenofibrate), Lipofen (fenofibrate), Lofibra (fenofibrate), Lopid (gemfibrozil), 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 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 alendronate, Fosamax (alendronate) solution, Non-preferred Drugs Actonel (risedronate), Actonel with Calcium (risedronate with calcium carbonate), Boniva (ibandronate), Fosamax (alendronate) tablet, Fosamax Plus D (alendronate plus cholecalciferol) 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 Nasal 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 Drugs calcitonin-salmon, 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 Erythropoiesis Stimulating Agents (ESAs) 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 Aranesp (darbepoetin alfa), Procrit (epoetin alfa) Non-preferred Drugs Epogen (epoetin alfa) 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 Central Nervous System (CNS) Stimulants 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 Adderall XR (amphetamine salt combo XR), amphetamine salt combo, Concerta (methylphenidate ER), dexmethylphenidate, dextroamphetamine sulfate, dextroamphetamine sulfate SA, Focalin (dexmethylphenidate), Focalin XR (dexmethylphenidate XR), Metadate ER (methylphenidate ER), Methylin (methylphenidate), Methylin ER (methylphenidate ER), methylphenidate, methylphenidate ER/SA, Vyvanse (lisdexamfetamine dimesylate) Non-preferred Drugs Adderall (amphetamine salt combo), amphetamine salt combo ER, Daytrana (methylphenidate patch), Desoxyn (methamphetamine), Dexedrine Spansule (dextroamphetamine sulfate SR), Dextrostat (dextroamphetamine sulfate), Metadate CD (methylphenidate CD), Procentra (dextroamphetamine sulfate) Provigil (modafinil), Ritalin (methylphenidate), Ritalin LA (methylphenidate LA), Ritalin SR (methylphenidate SR) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process and an additional clinical question for Provigil (modafinil) as follows:
|
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of Progestins (for cachexia) 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 megestrol acetate suspension Non-preferred Drugs Megace suspension (megestrol acetate), Megace ES suspension (megestrol acetate) 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 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 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 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, Granisol (granisetron), Kytril (granisetron), Sancuso (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 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 capsule (esomeprazole), OTC omeprazole products (including Prilosec OTC), Prevacid capsule (lansoprazole) Non-preferred Drugs Aciphex (rabeprazole), Kapidex (dexlansoprazole), Nexium Packet (esomeprazole), omeprazole Rx, pantoprazole, Prevacid NapraPAC (lansoprazole/naproxen), Prevacid Packet (lansoprazole), Prevacid Solutab (lansoprazole), Prilosec Rx (omeprazole), Protonix (pantoprazole), Zegerid (omeprazole sodium bicarbonate) 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 Selective Alpha Adrenergic 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 Flomax (tamsulosin), Uroxatral (alfuzosin) Non-preferred Drugs Rapaflo ( silodosin) 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 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, Toviaz (fesoterodine) 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 Corticosteroids - Inhaled 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 Advair Diskus/Advair HFA (fluticasone/salmeterol), Asmanex (mometasone), Azmacort (triamcinolone), Flovent Diskus (fluticasone), Flovent HFA (fluticasone), Qvar (beclomethasone), Symbicort (budesonide/formoterol) Non-preferred Drugs Aerobid/Aerobid-M (flunisolide), Alvesco (ciclesonide), Pulmicort (budesonide) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process and again recommended one additional clinical question for specific product concerns related to pregnancy:
|
Approved as Recommended |
G. Additional Discussion:
Dr. Martin expressed appreciation to DOH for coordinating efforts between the DUR Board and the P&T Committee for the CDRP discussion.
The meeting adjourned at 5:00 PM
Meeting Summary Posted 5/26/09
H. Final Determinations
The Commissioner has determined that the Medicaid program will require prior authorization under the Clinical Drug Review Program (CDRP) for palivizumab (Synagis).
The impact of this final determination is as follows:
- State Public Health Population:
- A product requiring prior authorization under the CDRP continues to be covered by the Medicaid program. The prior authorization requirement will have a minimal effect on Medicaid enrollees, and will ensure the product is being used in a medically appropriate manner.
- Program Providers:
- There will be a minimal impact on prescribers and pharmacies as they are familiar with the prior authorization process. The prior authorization process is simple to use and available twenty-four hours a day, seven days a week.
- Prescribers will need to initiate the prior authorization process when ordering the product. They will be asked for clinical information to support appropriate use of the product. Pharmacies will need to complete the prior authorization process prior to submitting the claim.
- State Health Program:
- Prior authorization through the CDRP will reinforce appropriate use and will also provide an additional means to detect and deter overuse.
- During SFY 07-08, total expenditure for palivizumab (Synagis) was approximately $60 million. The fiscal impact will depend on changes in utilization associated with assuring the appropriate use of the product. Expenditures will be expected to decrease subsequent to the implementation of the prior authorization requirement.
The Commissioner has determined that the Medicaid program will require prior authorization under the Preferred Drug Program (PDP) for non-preferred drugs in each of the drug classes as listed above.
Preferred Drugs will not require prior authorization
The impact of this final determination is as follows:
- 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.
- 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.
- State Health Program:
- Annual gross savings associated with these therapeutic classes under the PDP are estimated at $125M. The savings are achieved through changes in utilization to equally effective and less expensive drugs including the receipt of supplemental rebates from pharmaceutical manufacturers.
Final Determinations Posted 7/14/09
