Pharmacy and Therapeutics Committee Meeting Summary - March 11, 2010
Agenda and Introduction
The Medicaid Pharmacy & Therapeutics Committee met on Thursday, March 11, 2010 from 8:15 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:
- Kane, Michael, PharmD, Professor, Albany College of Pharmacy, The Endocrine Group, Albany, NY
- Martinez, Joe, RPh, PDE, PPC, Medical Affairs, Amylin Pharmaceuticals Corporation, Plainsboro, NJ
- Leibowitz, Jonas, MD, Private Practice, Yonkers, NY
- O'Brien, Stephen, MD, Medical Scientific Director, Novo Nordisk Inc., Princeton, NJ
- Bennett, Alix, PhD, Senior Cardiovascular Therapeutic Specialist, Forest Research Institute, subsidiary of Forest Laboratories, Jersey City, NJ
- Singh, Varinder, MD, Columbia University, New York, NY
- D'Ambrosio, Beth, PharmD, Regional Scientific Associate Director, Novartis Pharmaceuticals Corporation, Pittsford, NY
- Connell, Doris, PharmD, Director, Field Medical Affairs, Daiichi Sankyo Inc., Parsippany, NJ
- Marshall, Sarah, PharmD, Medical Science Liaison, Boehringer-Ingelheim Pharmaceuticals, Ridgefield, CT
- Baran, Daniel, MD, Region Medical Director, Merck & Co., Upper Gwynedd, PA
- Frankel, Perry, MD, FACC, Private Practice, Lake Success, NY
- Winther, Marisa, PharmD, Regional Scientific Manager, AstraZeneca Pharmaceuticals, Cooperstown, NY
- Wexelman, Warren, MD, Maimonides Medical Center, Brooklyn, NY
- Clarke, Sherwanna, PharmD, Government Regional Clinical Executive, Abbott Laboratories, Marietta, GA
- Trainer, JoAnn, PharmD, Regional Medical and Research Specialist, Pfizer Inc., Yardley, PA
- Reiss, Robert , PharmD, Senior Regional Medical Scientist, GlaxoSmithKline Pharmaceuticals, Research Triangle Park, NC
- Lemanski, Paul, MD, Private Practice, Albany, NY
- Lehman, John, RPh, Regional Scientific Manager, AstraZeneca Pharmaceuticals, Wilmington, DE
- Karyekar, Chetan, MD, Associate Director, Medical Strategy, Metabolics, Bristol-Myers Squibb Co, Princeton, NJ
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:
Glucagon-like peptide-1 (GLP-1) receptor agonists:
- The Committee was asked to consider information regarding indications, mechanism of action, safety, dosing, pharmacokinetics, adverse effects including risk of pancreatitis, contraindications, use in renal and hepatic impairment, and improvements in glycosylated hemoglobin (HbA1C). The Committee was also asked to consider the American Association of Clinical Endocrinologists /American College of Endocrinology (AACE/ACE) Glycemic Control Algorithm and the consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes and the current place in therapy for the GLP-1 receptor agonists.
Beta Blockers:
- The Committee was asked to consider information regarding indications, efficacy, tolerability, mechanism of action, adverse effects, pharmacokinetics, cardioselectivity and vasodilation, and use in the African American population. The Committee was also asked to consider compliance with immediate release versus controlled release formulations.
Angiotensin Receptor Blockers (ARBs) and ARB Combinations:
- The Committee was asked to consider information regarding indications, efficacy, adverse events, dosing, safety, use in special populations including the elderly, pediatrics, use in pregnancy, the African American population, diabetics, and in hepatic impairment, and the use of combination therapy to adequately treat hypertension.
HMG-CoA Reductase Inhibitors/Statins:
- The Committee was asked to consider information regarding indications (primary and secondary prevention), mechanism of action, safety, efficacy, compliance, use in pediatric patients, adverse reactions, and safety and efficacy when combined with niacin.
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, safety (including prescription versus over-the-counter formulations of omega-3 fatty acids), efficacy, tolerability, side effects, drug interactions, dosing, use in renal impairment, data for long term safety and efficacy, and use with statins.
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.
Dipeptidyl Peptidase-4 (DPP- 4) Inhibitors:
- The Committee was asked to consider information regarding indications, effects on lipids and weight, safety, tolerability, adverse events, including post-marketing events, pharmacokinetics, route of elimination, use with insulin, use in the elderly, and place in therapy for the DPP-4 inhibitors (initial therapy versus monotherapy versus adjunct therapy). The presenter also noted the black box warning for the metformin combination product.
Pharmacy and Therapeutics Committee Comments:
- Several Committee members discussed with presenters the place in therapy for the GLP-1 receptor agonists and the DPP- 4 inhibitors, considering product indications, adverse event profiles and safety concerns.
- A Committee member and presenter discussed cardiac output with beta-blocker therapy in heart failure versus hypertension, and the use of beta-blockers in special populations.
- With regard to cholesterol-lowering drugs, a Committee member noted the importance of evaluating clinical outcomes versus the effect of these drugs on surrogate markers.
- A Committee member asked the presenter to comment on the use of omega-3 acid ethyl esters with aspirin and warfarin with regard to bleeding risk.
- A committee member requested clarification regarding the selection of omeprazole doses used in the presented studies and the short term healing rates presented for a fairly chronic disease. The Committee member also asked if CYP2C19 genotyping had been performed.
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); Holly Coe, PharmD, School of Pharmacy & Pharmaceutical Sciences, State University of New York at Buffalo; Fred Doloresco, PharmD, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo; John Naioti, RPh, DOH/OHIP
Clinical Drug Review Program
Inclusion of becaplermin gel (Regranex) in the Clinical Drug Review Program (CDRP)
The Committee was asked to consider a proposal to include becaplermin gel (Regranex) in the Clinical Drug Review Program. As presented, the product would require prior authorization in order to evaluate and address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health and potential for overuse or misuse.
Dr. Coe presented the Committee with a review of becaplermin gel (Regranex) in regard to public health concerns noting an increased risk of death from malignancies with overuse, and use for non-FDA approved indications. She also provided information on prior authorization requirements from comparator state Medicaid programs. Dr. Doloresco presented data specific to the NY Medicaid program and focused on utilization outside of the FDA approved indications. Dr. Coe concluded that adding becaplermin gel (Regranex) to the CDRP would promote appropriate prescribing, and raise awareness to potentially fatal cancer concerns.
Mr. Naioti noted that becaplermin gel (Regranex) was reviewed during the November 12, 2009 Drug Utilization Review (DUR) Board Meeting. The DUR Board agreed that becaplermin gel (Regranex) met the criteria for inclusion into the CDRP, and recommended that the Medicaid P&T Committee consider becaplermin gel (Regranex) for inclusion into the CDRP.
The Committee and presenters discussed the NY Medicaid data with regard to appropriate utilization. There was discussion around the number of tubes that could be considered appropriate utilization taking into consideration the FDA product labeling, including a black box warning, and individual patient/prescriber need. The Committee inquired whether any DUR prescriber outreach had been performed. They asked for more information from the Drug Utilization Review Program with regard to prescribing practices, and asked that prescriber and pharmacy outliers be identified for outreach. The Committee also asked for comparative information regarding how commercial insurers may address becaplermin gel utilization, understanding that the State's ability to obtain that information could be limited.
After considering the information and concerns raised by the membership, the Committee recommended (by a vote of 8 to 3) to table the discussion to a future meeting for additional information as noted above.
Re-review of the glucagon-like peptide-1 (GLP-1) receptor agonist therapeutic class in the CDRP
Drugs affected: exenatide (Byetta), liraglutide (Victoza)
Dr. Rogler presented an overview of liraglutide (Victoza) including indications, dosage, pharmacokinetics, warnings and precautions, the black box warning and use in special populations including geriatric use and use in patients with kidney or liver impairment. She also presented an overview of new information for exenatide (Byetta), including the new indication, warnings and precautions, and the Risk Evaluation and Mitigation Strategy (REMS). She included the American Diabetes Association and the European Association for the Study of Diabetes clinical consensus statement and the 2009 consensus guidelines from the American Association of Clinical Endocrinologists/American College of Endocrinology for Type-2 diabetes.
Dr. Correia stated the NYS Medicaid program proposes to add liraglutide (Victoza) to the CDRP, and presented the background for the proposal. He discussed dosing and noted the mechanisms by which liraglutide improves glycemic control. He noted that the GLP-1 agonists can cause weight loss, although use specifically for weight loss is neither approved by the FDA nor recommended at this time due to safety and efficacy concerns. Dr. Correia also noted that drugs used for weight loss are excludable from coverage under federal law and not reimbursable through the NYS Medicaid program by regulation. He discussed adverse events including pancreatitis and discussed the black box warning specific to liraglutide regarding thyroid C-cell tumors in both rats and mice. He noted liraglutide has the same potential health concerns as exenatide (Byetta), which is currently in the CDRP. Those concerns include use inconsistent with FDA approved indications, use as first line therapy, which is contrary to product labeling and current clinical guidelines, and use specifically for weight loss.
He also discussed the change in the product labeling for exenatide (Byetta) which indicates it can be used as monotherapy. He discussed the 2009 consensus guidelines from the American Association of Clinical Endocrinologists/American College of Endocrinology for Type-2 diabetes and the guidelines from the American Diabetes Association and the European Association for the Study of Diabetes clinical consensus statement which both address the place in therapy for the GLP-1 agonists. He noted in most cases, metformin is the preferred initial agent. He proposed slight modifications to the current CDRP criteria language to reinforce current best practice concepts.
Dr. Doloresco presented data specific to the NY Medicaid program and focused on utilization of Byetta pre- and post CDRP implementation. The Committee discussed the GLP-1 agonist class within the context of the CDRP, reiterating the three CDRP criteria of long-term efficacy and public health, potential for overuse or misuse and appropriate utilization consistent with approved indications. A committee member raised the concerns of using the drugs in non-diabetics for the treatment of obesity, which is not a labeled use, and inappropriate use of liraglutide as monotherapy. It was noted that the change in the approved indications for Byetta may be a reason to remove the class from the CDRP.
After considering the information and concerns raised by interested parties and the membership, the Committee recommended (by a vote of 6 to 4 with 1 abstention) the GLP-1 receptor agonist therapeutic class be removed from the CDRP.
Preferred Drug Program Re-review
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), perindopril erbumine, 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 noted that the generic for Aceon, perindopril erbumine, has become available since the previous review of the ACE Inhibitor class. 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 that one new generic product is available and outcomes evidence continues to support the benefits of ACEIs for a range of clinical indications. He 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. She also noted no new clinical information was found for the ACE Inhibitor/Calcium Channel Blocker Combinations therapeutic class since the last review.
Dr. Correia mentioned that Lexxel has been discontinued and there is no new comparative evidence between the drugs in either of these classes that favors any one product.
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), Twynsta (telmisaratn/amlodipine), Valturna (valsartan/aliskiren)
ARB/Diuretic Combinations
Drugs Affected: Atacand HCT (candesartan cilexetil/hctz), Avalide (irbesartan/hctz), Benicar HCT (olmesartan medoxomil/hctz), Diovan HCT (valsartan/hctz), Exforge HCT (valsartan/amlodipine/hctz), Hyzaar (losartan/hctz), Micardis HCT (telmisartan/hctz), Teveten HCT (eprosartan/hctz)
Dr. Rogler discussed the new ARB combination products valsartan/amlodipine/hydrochlorothiazide (Exforge HCT), telmisartan/amlodipine (Twynsta), and valsartan/aliskiren (Valturna) including indications, dosage, administration, and strengths available. She presented information regarding new indications for telmisartan 80mg and product labeling changes for olmesartan, olmesartan/amlodipine, and candesartan. Dr. Rogler also presented information regarding the HEAAL study.
Dr. Correia noted that candesartan has a new indication for pediatric hypertension to as young as one year of age and there is a new cardiovascular risk reduction indication for telmisartan at the 80mg dose and only recommended for patients unable to take ACEIs. He also mentioned that there are two additional new fixed dose combination products. Dr. Correia concluded that there is 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 information regarding an FDA advisory panel's recommendation not to approve nebivolol (Bystolic) for the treatment of chronic 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 the FDA declined the application for an indication for heart failure for nebivolol. In response to submitted information and statements made again this year, Dr. Correia reiterated information discussed at last year's P&T Committee meeting regarding warning letters issued by the FDA to the manufacturer of Bystolic (nebivolol) for unsubstantiated efficacy and mechanism of action claims, as well as unsubstantiated superiority claims. The FDA stated in the 2008 warning letter that attributes of cardioselective beta blockade and vasodilation were not unique to Bystolic within this drug class, and that its cardioselectivity is actually modest. 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.
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 and product labeling changes for rosuvastatin. Several studies were discussed including the ARBITER 6-HALTS trial, the FDA completing review of the SEAS trial and the review of interim data from the SHARP and IMPROVE-IT trials.
Dr. Correia reviewed the recent FDA approval for rosuvastatin regarding the indication of primary prevention of cardiovascular disease in individuals with no clinically evident heart disease but increased risk of heart disease due to the combined effect of specific risk factors. He noted that atorvastatin, lovastatin, pravastatin and simvastatin also have a labeled indication for primary prevention. New information on rosuvastatin also included an indication for pediatric use down to 10 years of age, similar to other drugs with pediatric indications within the class.
Dr. Correia reiterated some of the pertinent information that was presented during last year's re-review of the class including the SEAS trial relating to the effects on biomarkers like C-reactive protein and the incidence of cancer; and that the FDA has stated that it is unlikely that there is a connection between simvastatin, ezetimibe, or the combination of both and any increased risk of cancer. There is consistent evidence that when statins are utilized at comparable doses, they achieve comparable percentage reductions in LDL-c and elevations in HDL-c. Dr. Correia concluded that new information is consistent with previous findings that there is no evidence of overall clinical superiority to justify preferential availability of any one product within the class.
6. Re-review of the Triglyceride Lowering Agents therapeutic class
Drugs Affected: Antara (fenofibrate), fenofibrate, fenofibric acid, 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 (Fibricor) including indications, dosage, administration and strengths available. It was noted that fenofibric acid is the active metabolite of fenofibrate. Dr. Rogler also presented information regarding a safety label update for gemfibrozil and a Postmarketing Experience section label update for omega-3-acid ethyl esters (Lovaza).
Dr. Correia also discussed the new fenofibric acid product (Fibricor), noting that the new product does not have a labeled indication for use with statins but the labeling does include dosing information for concomitant use with specific statins. Dr. Correia reviewed adverse effects and warnings for the fenofibric acid products. The FDA labeling for the fenofibric acid products was provided, which specifically states that no incremental benefit has been established for either product on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy. Dr. Correia also presented the new labeling for the omega-3 acid regarding pharmacokinetics with statin co-administration, as well as for reports of postmarketing adverse events. No significant new comparative clinical information since the previous review was found, and there is no evidence of overall clinical superiority for any product in this class.
The committee discussed the different metabolic pathways for fenofibrate versus fenofribic acid with regard to drug interactions in general, and specifically with the statins.
7. 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 presented updated guidelines (2010 position statement of the North American Menopause Society) in the management of osteoporosis in postmenopausal women, noting the guidelines do not delineate between the different bisphosphonates.
Dr. Correia reviewed the FDA safety communication from 3/10/2010 regarding oral bisphosphonates and atypical subtrochanteric femur fractures. He noted that the new information presented by Dr. Rogler pertain to drug class effects and 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 Nasal Calcitonins therapeutic class
Drugs Affected: calcitonin-salmon, Fortical (calcitonin-salmon), Miacalcin (calcitonin-salmon)
Dr. Rogler discussed the information relevant to the nasal calcitonins from the updated osteoporosis guidelines noted above.
Dr. Correia noted that the active drug in all products is chemically identical, there is 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 Proton Pump Inhibitors (PPI) therapeutic class
Drugs Affected: Aciphex (rabeprazole), Kapidex (dexlansoprazole), lansoprazole, Nexium (esomeprazole), omeprazole, omeprazole OTC, pantoprazole, Prevacid (lansoprazole), Prevacid OTC (lansoprazole OTC), Prilosec (omeprazole), Prilosec OTC (omeprazole), Protonix (pantoprazole)
Dr. Rogler discussed Prevacid 24-HR 15 mg OTC which was approved for the treatment of frequent heartburn. She noted the new generic, lansoprazole 15mg and 30mg, is now available. Also discussed was the FDA safety information regarding reduction in the effectiveness of clopidogrel (Plavix) when taken concurrently with omeprazole, and the concern with the use of clopidogrel with esomeprazole, and other PPIs.
Dr. Correia mentioned the new generic lansoprazole as well as the new OTC version of lansoprazole. He reviewed the new safety information from the FDA concerning PPI co-administration with clopidrogel and provided the FDA statement recommending the use of an antacid or most H-2 antagonists, except cimetidine, in place of a PPI for patients on clopidrogel and needing a medication to reduce stomach acid. Lastly, 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 which would change previous recommendations.
10. Re-review of the DPP-4 Inhibitors therapeutic class
Drugs Affected: Januvia (sitagliptin), Janumet (sitagliptin/metformin HCL), Onglyza (saxagliptin)
Dr. Rogler reviewed the two DPP-4 inhibitors currently available, sitagliptin (Januvia) and saxagliptin (Onglyza) including indications, mechanism of action, pharmacokinetics, drug interactions, warnings and precautions, contraindications, and use in special populations including pregnancy, nursing mothers, pediatrics and geriatrics. She discussed the label update for Januvia and Janumet regarding use in combination with insulin, and the FDA safety alert regarding post-marketing reports of pancreatitis. She provided a summary of HbA1C (%) reductions from several Onglyza combination studies.
Dr. Correia discussed the availability of a second DPP-4 (saxagliptin) and the update to the sitagliptin labeling regarding use with insulin. Also, sitagliptin labeling changed to include information on the incidence of pancreatitis. The FDA review for approval of saxagliptin also included a recommendation of surveillance for pancreatitis along with the cardiovascular impacts tracking. Neither sitagliptin nor saxagliptin had pancreatitis emerge during clinical trials. Dr. Correia stated that there is little if any comparable information for effectiveness between the two drugs and indirect evidence seems to indicate that they are clinically comparable in efficacy. Specific metabolism and elimination pathways and practical considerations were provided by Dr. Correia. Lastly, it was noted that each drug may introduce specific concerns for patients with certain comorbidities or concomitant therapies but neither drug offers an overall advantage.
The Committee discussed the difference in half life between the two DPP-4 inhibitors and how that relates to dosing of the drugs.
E. Executive Session:
The Committee recessed the public session at 12:15 PM to go into executive session for review of financial information relating to the recommendation of preferred drugs in the following classes: ACE Inhibitors, ACE Inhibitor/Diuretics, Calcium Channel Blockers (CCB), ACEI/CCB, Beta Blockers, Beta Blocker/Diuretics, Angiotensin Receptor Blockers (ARBs), ARB/Diuretics, Oral Bisphosphonates and Nasal Calcitonins. The Committee also reviewed patient cases related to exenatide (Byetta) and the CDRP. No official action was taken in the executive session. The executive session was recessed at 2:15 PM.
The Committee recessed the public session at 3:05 PM to go into executive session for review of financial information relating to the recommendation of preferred drugs in the following classes: Statins, Triglyceride Lowering Agents, PPIs and DPP- 4 Inhibitors. No official action was taken in the executive session. The executive session was recessed at 3:50 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 becaplermin (Regranex) in the Clinical Drug Review Program The Committee recommended (by a vote of 8 to 3) to table the discussion to a future meeting for additional information as noted in Section D above. |
Approved as Recommended |
| Proposal: Re-review of the glucagon-like peptide-1 (GLP-1) receptor agonist therapeutic class in the Clinical Drug Review Program. Drugs affected: exenatide (Byetta), liraglutide (Victoza) The Committee recommended (by a vote of 6 to 4 with 1 abstention) that the glucagon-like peptide-1 (GLP-1) receptor agonist therapeutic class be removed from the Clinical Drug Review Program. |
Approved as Recommended Utilization of the GLP-1 receptor agonists will continue to be monitored. The Drug Utilization Review and Prescriber Education Programs will be utilized to reinforce safe and effective use according to FDA approved indications and treatment guidelines. |
| 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), perindopril, Prinivil (lisinopril), quinapril, Univasc (moexipril), Vasotec (enalapril maleate), Zestril (lisinopril) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.
|
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of ACE Inhibitor/Diuretic Combinations A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs benazepril/hctz, captopril/hctz, enalapril/hctz, lisinopril/hctz, moexipril/hctz Non-preferred Drugs Accuretic (quinapril/hctz), Capozide (captopril/hctz), fosinopril/hctz, Lotensin HCT (benazepril/hctz), Monopril HCT (fosinopril/hctz), Prinzide (lisinopril/hctz), Quinaretic (quinapril/hctz), quinapril/hctz, Uniretic (moexipril/hctz), Vaseretic (enalapril maleate/hctz), Zestoretic (lisinopril/hctz) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of 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 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 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 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 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 Cozaar (losartan), Diovan (valsartan), Exforge (valsartan/amlodipine besylate), Micardis (telmisartan), Valturna (valsartan/aliskiren) Non-preferred Drugs Avapro (irbesartan), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Azor (olmesartan medoxomil/amlodipine besylate), Teveten (eprosartan mesylate), Twynsta (telmisartan/amlodipine) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of 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 Diovan HCT (valsartan/hctz), Hyzaar (losartan/hctz), Micardis HCT (telmisartan/hctz), Exforge HCT (valsartan/amlodipine/hctz) Non-preferred Drugs Avalide (irbesartan/hctz), Benicar HCT (olmesartan medoxomil/hctz), 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 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 recommended the following (by a vote of 7 to 4): Preferred Drugs Crestor (rosuvastatin), 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), Lescol (fluvastatin), Lescol XL (fluvastatin XL), 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, fenofibric acid, Fenoglide (fenofibrate), Fibricor (fenofibric acid), 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 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), omeprazole OTC, omeprazole Rx, Prilosec OTC (omeprazole OTC) Non-preferred Drugs Aciphex (rabeprazole), lansoprazole Rx, Kapidex (dexlansoprazole), Nexium Packet (esomeprazole), pantoprazole, Prevacid Rx (lansoprazole), Prevacid OTC (lansoprazole OTC), Prilosec Rx (omeprazole), Protonix (pantoprazole) 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 Dipeptidyl Peptidase-4 (DPP-4) 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 Januvia (sitagliptin), Janumet (sitagliptin/metformin HCL) Non-preferred Drugs Onglyza (saxagliptin) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
Approved as Recommended |
G. Additional discussion
During the discussion of the Statins therapeutic class, a member stated the position that Lipitor (atorvastatin) be included as a non-preferred drug. The Committee opposed the recommendation (by a vote of 6 to 5).
Dr. Martin (Chairperson) announced Linda Jones has taken a new position within the Medicaid program, and thanked her, on behalf of the Committee, for her service.
The Meeting adjourned at 4:00 PM
Meeting Summary Posted 04/01/10
H. Final Determinations
1. Clinical Drug Review Program
The Commissioner deferred any final determination regarding Regranex (belcaplermin) pending provision of additional information by the Medicaid program as requested by the Committee, to be reviewed by the Committee at a future meeting.
The Commissioner determined that the GLP-1 therapeutic class will be removed from the CDRP as indicated in Section F above.
The impact of this final determination is as follows:
- a. State Public Health Population:
- No impact.
- b. Program Providers:
- No impact.
- c. State Health Program:
- The Drug Utilization Review and Prescriber Education Programs will be used to monitor, evaluate and promote safe and effective use consistent with FDA approved indications, treatment guidelines and applicable regulations.
2. 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 in Section F.
Preferred Drugs will not require prior authorization
The impact of this final determination is as follows:
- a. 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.
- b. 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.
- c. State Health Program:
- Annual gross savings associated with these therapeutic classes under the PDP are estimated at $137M. 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 05/27/2010
