Pharmacy and Therapeutics Committee Meeting Summary - April 30, 2008
Agenda and Introduction
The Medicaid Pharmacy & Therapeutics Committee met on Wednesday, April 30, 2008 from 8:30 a.m. to 4:00 p.m. in Meeting Room 2, Concourse, Empire State Plaza, Albany, New York.
Dr. Martin (Chairperson) emphasized the purpose of the meeting was to review new clinical information since the last review of the therapeutic classes to determine if changes to the Preferred Drug List should be recommended. He asked that the focus be on new, evidence-based information.
Linda Jones, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP) reminded the public that all drugs currently covered by Medicaid remain available under the Preferred Drug Program and the non-preferred drugs require prior authorization.
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:
- Hoy, Christopher, MD, Co-Chair of the Medical Advisory Board, National Kidney Foundation of Northeast NY, Glens Falls, NY
- Argoff, Charles, MD, Professor of Neurology, Albany Medical College, Director, Comprehensive Pain Program, Albany Medical, Albany, NY
- Pinto, Gregory, MD, Private Practice, Saratoga Springs, NY
- D'Ambrosio, Beth, PharmD, Regional Scientific Associate Director, Novartis Pharmaceuticals Corporation, Pittsford, NY
- Rouvelas, Peter, MD, Cardiologist, Brooklyn, NY
- Brodeur McGrath, Jean, Medical Science Liaison, Daiichi Sankyo, Parsippany, NJ
- Baran, Daniel, MD, Regional Medical Director, Merck & Co., West Point, PA
- Vichiendilokkul, Anna, PharmD, MS, BCPS, Regional Medical Scientist, GlaxoSmithKline, Forest Hills, NY
- Singh, Varinder, MD, Columbia University, New York, NY
- Gasinu, Koku, MD, Cardiologist, New York, NY
- Neugarten, Joel, MD, Montefiore Medical Arts, Bronx, NY
- Paeglow, Robert, MD, Koinonia Primary Care, Albany, NY
- Solomon, Henry, MD, FACC, Medical Director, Pfizer Inc., New York, NY
- Bhatia, Sonal, MD, Medical Director, Pfizer Inc., New York, NY
- Clarke, Sherwanna, PharmD, Government Regional Clinical Executive, Abbott Laboratories, Inc., Marietta, GA
- Winther, Marisa, PharmD, Regional Scientific Manager, AstraZeneca, Delmar, NY
- Kane, Michael, PharmD, Professor, Albany College of Pharmacy, The Endocrine Group, Albany, NY
- Basri, Raymond, MD, FACP, Private Practice, Middletown, NY
- Kaiser, Fran, MD, AGSF, FGSA, Regional Medical Director, Merck/Schering-Plough, Dallas, TX
- Frankel, Perry, MD, FACC, Private Practice, Lake Success, NY
- Burky, Christopher, MD, Child Psychiatrist, Schenectady, NY
- Pollack, Cary, MD, Cardiologist, Centro Medico Dominicano, Manhattan, NY
- Winter, Duncan, MD, Surgical Eye Care, Saranac Lake, NY
- Karafilidis, John, PharmD, Senior Director, Medical Information, Sepracor, Marlborough, MA
- DeSilva, Mahendra, PharmD, Regional Scientific Manager, Takeda Pharmaceuticals, Goshen, NY
- Price, Arlene, PharmD, Senior Scientific Affairs Liaison, Ortho McNeil Janssen, Randolph, NJ
- Eggleston, Steven, PharmD, Regional Medical Scientist, GlaxoSmithKline, Albany, NY
- Schroeder, Scott, MD, Albany Medical Center, GlaxoSmithKline, Albany, NY
- Gall, Rebecca, MD, Medical Science Liaison, Schering-Plough, Uxbridge, MA
- Lehman, John, Regional Scientific Manager, AstraZeneca, Westfield, MA
- Schultze, Robert, MD, Associate Professor of Ophthalmology, Albany Medical College, Alcon, Slingerlands, NY
- Lewis, Charles, RPh, MBA, Clinical Coordinator, Jasos Group, Allergan, Lake Mary, FL
- Brevetti, Teresa, MD, Regional Medical Research Specialist, Pfizer, New York, NY
- Marble, Dwight, PharmD, Senior Medical Science Liaison, Bristol-Myers Squibb, Rochester, NY
C. Key issues raised by interested parties and the Pharmacy and Therapeutics Committee pertaining to the clinical review of the following drugs:
Public comments:
Angiotensin Receptor Blockers (ARB), ARB/Diuretic Combinations:
- The Committee was asked to consider information regarding clinical trial results including efficacy as monotherapy or in a combination product with a calcium channel blocker or a diuretic, indications, safety, mechanism of action, adverse reactions, compliance, tolerability, and dose flexibility, as well as the importance of getting to blood pressure goal as quickly as possible, and use of these medications in special populations, such as the elderly and ESRD patients.
Beta Blockers:
- The Committee was asked to consider information regarding clinical trial results including indications, effectiveness, dosing, compliance and adherence, adverse events, the degree of beta-1 receptor selectivity, vasodilating effect, mechanism of action, as well as use in metabolic syndrome and diabetic patients and use in the elderly and African Americans.
HMG-CoA Reductase Inhibitors (Statins):
- The Committee was asked to consider information regarding clinical trial results including indications, efficacy, safety of statins as monotherapy or in a combination product with niacin, ezetimibe, or a calcium channel blocker, use in renal disease, dosing, adverse events, adherence and compliance, the importance of treating to goal, use in heart failure, stroke and ACS, and the effect on cardiovascular morbidity and mortality. The Committee was also asked to consider use in special populations such as African Americans, the Hispanic population, the Asian population, the elderly, and diabetics.
Cholesterol Absorption Inhibitors:
- The Committee was asked to consider information regarding clinical trial results including the effect of ezetimibe on LDL and surrogate markers, and the ENHANCE trial.
Triglyceride Lowering Agents:
- The Committee was asked to consider information regarding clinical trial results for both omega-3 fatty acids and the fibric acids including indications, efficacy, safety, tolerability, side effects, drug interactions, and use in metabolic syndrome and diabetes.
Long Acting Narcotics:
- The Committee was asked to consider recommending a broader choice of preferred drugs in this class.
Sedative Hypnotics/Sleep Agents:
- The Committee was asked to consider information regarding clinical trial results including indications, efficacy in sleep onset and maintenance, adverse events, duration of use, tolerability, safety, and the treatment of insomnia with comorbidities, including anxiety, depression, sleep apnea, COPD, and menopause.
Central Nervous System Stimulants:
- The Committee was asked to consider information regarding clinical trial results including indications, safety, efficacy including long term efficacy, tolerability, dosing, duration of action, adherence to therapy, product formulation, and abuse liability.
Intranasal Steroids:
- The Committee was asked to consider information regarding clinical trial results including indications, efficacy, safety, side effects, nasal and ocular effects, tolerability, adherence, metabolism, and use in pediatric patients down to 2 years of age. The Committee was also asked to consider drug administration and volume of spray delivered per actuation.
Proton Pump Inhibitors (PPIs):
- The Committee was asked to consider information regarding clinical trial results including new dosing and pharmacokinetics in pediatric patients, safety, dosage forms, and administration options.
Ophthalmic Quinolones:
- The Committee was asked to consider information regarding clinical trial results including efficacy in the coverage of gram positive and gram negative bacteria, ocular penetration, dosing, side effects, and the inclusion of preservative in ocular products, as well as appropriate use of the drugs in this class.
Ophthalmic Antihistamines:
- The Committee was asked to consider information regarding clinical trial results including indications, tolerability, side effects, dosing, patient compliance, onset and duration of action, antihistaminic, anti-inflammatory, and mast cell stabilizing properties.
Ophthalmic Prostaglandin Agonists:
- The Committee was asked to consider information regarding clinical trial results including efficacy in lowering intraocular pressure (IOP) and keeping diurnal pressures low, side effects, rates of ocular hyperemia and tolerability, patient compliance and persistency with therapy, and corneal safety.
Pharmacy and Therapeutics Committee Comments:
- A committee member asked if there were adherence studies specifically with Coreg CR, and the presenter indicated there were studies that looked at once a day versus twice a day versus three times a day dosing, but not specifically for Coreg CR.
- A committee member and the presenter discussed the use of beta blockers in hypertension, including comparisons (or lack thereof) of beta blockers with calcium channel blockers, ACE inhibitors, and hydrochlorothiazide in terms of efficacy. They discussed surrogate markers such as vasodilation and the effect of different types of drug metabolizers on drug effectiveness. They discussed JNC VII and the use of beta blockers with compelling indications.
- Several comments were made regarding atorvastatin in comparison to other statins, and regarding the relationship between lowering LDL and progression of chronic kidney disease.
- A committee member and the presenter discussed the results of the ENHANCE trial, including the surrogate marker carotid artery intima-media thickness (CA-IMT), and cholesterol-lowering drugs with (and without) outcomes data that may be used with or in place of a statin.
- A committee member asked if fluticasone furoate had a different "target" than fluticasone propionate, and the presenter indicated the "targets" were the same.
- It was noted that several times during the public comment period, presenters voiced concerns regarding the availability of drugs in the Preferred Drug Program (PDP) and it was clarified that all drugs in the PDP remain available, preferred drugs do not require prior authorization (PA), non-preferred drugs require PA, the PA process is easy and straightforward, and the prescriber prevails.
D. Clinical Presentation and Discussion
Linda Jones (DOH/OHIP) noted that Astellas Pharma Inc. has withdrawn the request to have the Pharmacy & Therapeutics Committee review the Mandatory Generic Drug Program exemption for tacrolimus (Prograf) as the generic is not yet available in the marketplace.
Marian McDonagh, PharmD, 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)
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 noted a new formulation and a new generic for Altace. She spoke about the 2007 Focused Update of the American College of Cardiology/American Heart Association (ACC/AHA) 2004 Guidelines for the Management of Patients with ST-Elevation Myocardial Infarction, and the ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction. She indicated that she found no new clinical information for the ACE Inhibitor/Diuretic Combinations therapeutic class since the last review.
Dr. Correia provided the Department's clinical review of new information for these categories, noting that ongoing outcomes evidence continues to support the benefits of ACEIs as well as ACEI with diuretics for a range of clinical indications. He concluded that he found no new comparative clinical evidence between drugs in the ACEI or ACEI with diuretic classes to justify preferential availability of any one product.
2. Re-review of the Dihydropyridine (DHP) 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, Norvasc (amlodipine), Plendil (felodipine ER), Procardia (nifedipine), Procardia XL (nifedipine XL), Sular (nisoldipine)
ACE Inhibitor/Calcium Channel Blocker Combinations
Drugs Affected: amlodipine/benazepril, Lexxel (enalapril maleate/felodipine ER), Lotrel (amlodipine/benazepril), Tarka (trandolapril/verapamil ER)
Dr. Rogler noted that there are new strengths available for the CCB product Sular and new generics for several of the Lotrel products. She discussed the ACCOMPLISH trial comparing amlodipine/benazepril and benazepril/HCTZ.
Dr. Correia provided the Department's clinical review of new information for these categories. He indicated that the calcium channel blockers continue to be recognized as valuable for a range of clinical indications, and ACE/CCB combination products are indicated only for the treatment of hypertension. He noted new clinical information suggests benefit from combining an ACEI with a CCB and spoke about the comparison of an ACE/CCB to an ACE/diuretic, but indicated he found no new comparative evidence between the drugs in either of these classes to favor of any one product in either class.
3. Re-review of the Angiotensin Receptor Blockers (ARB) and ARB/Diuretic Combinations therapeutic classes
Angiotensin Receptor Blockers (ARB)
Drugs Affected: Atacand (candesartan cilexetil), Avapro (irbesartan), 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 noted two new ARB/CCB combination products, Azor (olmesartan/amlodipine) and Exforge (valsartan/amlodipine). She mentioned the expanded indication for valsartan for the treatment of hypertension in patients 6 to 16 years of age, noting losartan also has this indication. She described a comparative trial between valsartan/amlodipine and lisinopril/hctz and discussed the ONTARGET study.
Dr. Correia provided the Department's clinical review of new information for these categories. He discussed the hypertension indication for the ARBs, ARB/amlodipine combination products and ARB/diuretic products. He also discussed the additional indications, some of which are shared indications, for valsartan, losartan, candesartan and irbesartan. He concluded that 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 discussed the new generics for Coreg and Corzide, and the new beta blocker Bystolic (nebivolol). She discussed the indication, dosing, metabolism and mechanism of action for Bystolic, as well as a clinical trial of nebivolol versus metoprolol in the treatment of hypertension. She also discussed the clinical trial titled The Efficacy and Tolerability of Nebivolol in Hypertensive African American Patients.
Dr. Correia provided the Department's clinical review of new information for this category. He noted that clinical information available on nebivolol to date consists of laboratory studies of isolated cells, study populations which are not comparable to actual treatment populations or inclusive of common comorbidities, or comparisons with less than comparable drugs whether within or outside of this drug class. He noted that other proposed advantages remain theoretical and lack relevant comparative outcomes data. He also noted that nebivolol has been in use in Europe in a large population for a long period of time, yet this clinical experience has not generated any additional demand. He indicated that the beta blocker/diuretic combination products are only indicated for hypertension and he was not aware of any new information for this class. He concluded by noting there is no new evidence of overall clinical superiority to justify preferential availability of any one product in these drug classes.
A Committee member asked if nebivolol fit in to any clinical guidelines as developed in other countries, and Dr. Correia stated not to his knowledge.
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, Pravigard PAC (pravastatin/buffered aspirin), Simcor (simvastatin/niacin extended-release), simvastatin, Vytorin (simvastatin/ezetimibe), Zocor (simvastatin)
Dr. Rogler discussed a new product in this class, Simcor (simvastatin/niacin ER), and a new formulation for simvastatin (oral disintegrating tablets). She discussed product insert changes for Crestor, including a new indication, dosing, drug interactions and use in the Asian population. She discussed four new clinical trials pertinent to the statins (ENHANCE, JUPITER, METEOR, and CORONA). Lastly, she discussed the Update to the American Heart Association/American Stroke Association Recommendations for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack.
Dr. Correia provided the Department's clinical review of new information for this category. He discussed the new statin/niacin combination product, and the new indication for rosuvastatin. He discussed the controversy surrounding the ENHANCE trial, which did not demonstrate the expected change in the surrogate marker intima-media thickness, and noted the study did not provide any information on actual long-term outcomes. He reiterated the consensus opinion that the attempt to achieve lipid lowering goals should be primarily via the use of statins, which have documentation of improved outcomes, and ezetimibe should be reserved for situations where statins are not tolerated or not tolerated to necessary doses to achieve lipid goals. In closing, he stated there is no new evidence of overall clinical superiority to justify preferential availability of any one product.
6. Re-review of the Cholesterol Absorption Inhibitors (CAI) therapeutics class
Drugs Affected: Zetia (ezetimibe)
Dr. Rogler addressed the new indication for ezetimibe in combination with fenofibrate as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia.
Dr. Correia provided the Department's clinical review of new information for this category noting again that ezetimibe should be reserved for situations where statins are not tolerated or not tolerated to necessary doses to achieve lipid goals. He also noted that having the CAI class on the PDP minimizes uncertainty with regard to the availability of ezetimibe for monotherapy or in combination with any statin when needed. He concluded that no new clinical evidence was found to justify any modification in the status of this therapeutic class.
In response to a question from a committee member, Dr. Correia confirmed there are currently no outcomes data for Zetia.
7. Re-review of the Triglyceride Lowering Agents therapeutic class
Drugs Affected: Antara (fenofibrate), fenofibrate, Fenoglide (fenofibrate), gemfibrozil, Lipofen (fenofibrate), Lofibra (fenofibrate), Lopid (gemfibrozil), Lovaza [formerly Omacor] (Omega-3 acid ethyl esters), Tricor (fenofibrate), Triglide (fenofibrate)
Dr. Rogler discussed two new fenofibrate products, Fenoglide and Lipofen, and the name change of omega-3 acid ethyl esters from Omacor to Lovaza. She discussed a new clinical trial, Efficacy and Tolerability of Adding Prescription Omega-3 Fatty Acids 4g/day to Simvastatin 40mg/day in Hypertriglyceridemic Patients: An 8-week, Randomized, Double-Blind, Placebo-Controlled Study. It was also noted that Lovaza is the only fish oil product regulated by the Food & Drug Administration (FDA).
Dr. Correia reiterated the new fenofibrate products and the clinical trial discussed in Dr. Rogler's comments, noting that the study evaluated surrogate serum level endpoints, not clinical outcomes. He also noted that clinical trials indicate the omega-3 acid ethyl esters product is less effective in lowering triglycerides than fibrates overall. He concluded that he found no significant new clinical comparative information since the previous review and there are no changes from the previous comparative evaluation of the drugs in the class.
8. Re-review of the Long Acting Narcotics therapeutic class
Drugs Affected: Avinza (morphine sulfate ER), Duragesic (fentanyl), fentanyl patch, Kadian (morphine sulfate SR), morphine sulfate SR, MS Contin (morphine sulfate CR), Opana ER (oxymorphone ER), Oramorph SR (morphine sulfate SR), oxycodone HCl CR, Oxycontin (oxycodone HCl CR)
Dr. Rogler noted new strengths for OxyContin (oxycodone CR), Opana ER (oxymorphone ER), and Kadian (morphine sulfate SR). She also noted there is no longer a generic product available for Oxycontin.
Dr. Correia provided the Department's clinical review of new information for this category. He stated that as noted last year, oxymorphone has historically been associated with relatively high incidences of constipation, respiratory depression, emesis, and physical dependence when compared to the other drugs in this class, but that overall, the agents in this class demonstrate equivalent efficacy and safety at comparable doses. He discussed a warning issued by the FDA to a manufacturer of a drug in this class regarding promotional materials. He concluded there is no new clinical evidence since the last re-review to indicate any of the drugs in this class offers an overall advantage.
9. Re-review of the Sedative Hypnotics/Sleep Agents therapeutics class
Drugs Affected: Ambien (zolpidem), Ambien CR (zolpidem CR), chloral hydrate, Dalmane (flurazepam), Doral (quazepam), estazolam, flurazepam, Halcion (triazolam), Lunesta (eszopiclone), Prosom (estazolam), Restoril (temazepam), Rozerem (ramelteon), Somnote (chloral hydrate), Sonata (zaleplon), temazepam, triazolam, zolpidem
Dr. Rogler noted a new generic for Sonata (zaleplon).
Dr. Correia provided the Department's clinical review of new information for this category. He stated that he found no changes in this drug class from a clinical standpoint, although there continue to be claims of less adverse cognitive or functional impact for ramelteon. He noted that ramelteon has been associated with changes in prolactin and testosterone levels in some patients, and one published study demonstrated ramelteon was better than placebo only for sleep latency at double the approved dose. He concluded there was no new clinical evidence submitted or found demonstrating overall superiority for any of the drugs in this class since the last re-review.
10. 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, Provigil (modafinil), Ritalin (methylphenidate), Ritalin SR (methylphenidate SR), Ritalin LA (methylphenidate LA), Vyvanse (lisdexamfetamine dimesylate)
Dr. McDonagh (OHSU) presented an overview of the OHSU Drug Effectiveness Review Project (DERP) Drug Class Review on Pharmacologic Treatments in ADHD, dated September, 2007. She noted nine new head to head trials since the last DERP Report Update, including trials in children, adolescents, and adults. She discussed the availability of evidence of major harms, weight and height change in children, other adverse events such as tics, and risk of misuse of drugs in this class. She discussed evidence for use of these drugs based on race/ethnicity, gender, and with such commonly occurring comorbidities as oppositional defiant disorder, conduct disorder, anxiety and depression.
Dr. Rogler noted the new product Vyvanse (lisdexamfetamine dimesylate), and the new generic for Focalin (dexmethylphenidate). She provided an overview for Vyvanse including its indication, pharmacokinetics, dosing, and formulations. She discussed the AHA recommendation for testing for cardiac abnormalities prior to prescribing stimulants to children with ADHD, and the February 21, 2008 FDA press release requiring manufacturers of ADHD drugs to notify patients about cardiovascular and psychiatric adverse events. She also mentioned the Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Methylphenidate Transdermal System in Pediatric Patients with Attention Deficit/Hyperactivity Disorder.
Dr. Correia provided the Department's clinical review of new information for this category. He noted that lisdexamfetamine is a prodrug converted in the body to the active form dextroamphetamine, and that the original FDA review for this drug approval compares it to the extended-release dextroamphetamine/amphetamine salts product (Adderall XR), showing very similar time-concentration curves. He also noted in clinical trials including both Vyvanse and Adderall XR, the primary efficacy outcomes and secondary endpoints (attempted and correct performance) were nearly identical. He discussed the FDA Medical Review which indicates the rationale for lisdexamfetamine, presumably to decrease potential for abuse compared to dextroamphetamine, but noted the drug is still a Schedule II controlled substance and carries the same safety warnings as the other stimulants. He indicated that overall for the drugs in this class; there is still no good comparative clinical evidence for effectiveness, and 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, and noted it would be preferable to have drugs in the short, intermediate, and long-acting ranges represented among the preferred drugs.
11. Re-review of the Second Generation Antihistamines therapeutic class
Drugs Affected: Allegra/Allegra-D (fexofenadine), cetirizine/cetirizine-D OTC, Clarinex/Clarinex-D (desloratadine), Claritin/Claritin-D OTC (loratadine), loratadine/loratadine D OTC, fexofenadine, Semprex-D (acrivastine), Xyzal (levocetirizine), Zyrtec/Zyrtec-D (cetirizine), Zyrtec/Zyrtec-D OTC (cetirizine)
Dr. Rogler noted a new Xyzal (levocetirizine) oral solution and the availability of Zyrtec (cetirizine) as a multi-source generic. She also noted that Zyrtec and Zyrtec D were approved for non-prescription use and were available in several different formulations. She noted Allegra 30mg tablets were discontinued by the manufacturer and Allegra 30mg ODT is now available.
Dr. Correia provided the Department's clinical review of new information for this category. He noted the only significant changes in this class relate to brand/generic or prescription/OTC status. He concluded that clinical information reviewed revealed no significant new clinical evidence demonstrating overall superiority for any of the drugs in this class since the last re-review.
12. Re-review of the Intranasal Steroids therapeutic class
Drugs Affected: Beconase AQ (beclomethasone dipropionate), Flonase (fluticasone propionate), flunisolide, fluticasone propionate, Nasacort AQ (triamcinolone acetonide), Nasarel (flunisolide), Nasonex (mometasone furoate), Rhinocort Aqua (budesonide), Veramyst (fluticasone furoate)
Dr. Rogler noted the new product Veramyst (fluticasone furoate), and the discontinuation of Nasalide 0.025%. She described the indication, dosing, and administration for Veramyst, and noted both Veramyst and Nasonex (mometasone furoate) have indications for patients down to two years of age. She also noted in a non-inferiority trial contained in the product dossier, Veramyst was found to be non-inferior to Flonase (fluticasone propionate).
Dr. Correia concurred with Dr. Rogler's presentation and indicated that information reviewed revealed no new clinical information since the previous review which would justify preferential availability of any one product over another.
13. Re-review of the Proton Pump Inhibitors (PPI) therapeutic class
Drugs Affected: Aciphex (rabeprazole), Nexium (esomeprazole), omeprazole, omeprazole OTC, pantoprazole, Prevacid (lansoprazole), Prevacid NapraPAC (lansoprazole/naproxen), Prilosec (omeprazole), Prilosec OTC (omeprazole), Protonix (pantoprazole), Zegerid (omeprazole)
Dr. Rogler noted the new Nexium (esomeprazole) Delayed-Release Oral Suspension and the approval of Nexium for the short term treatment of gastroesophageal reflux disease (GERD) in children age one to eighteen years. She noted Prilosec (omeprazole) was approved for this indication as well. She also noted new generics for Protonix (pantoprazole) and Prilosec OTC (omeprazole).
Dr. Correia provided the Department's clinical review of new information for this category. He noted that in addition to Nexium and Prilosec, lansoprazole has approval for use in children as young as one year of age. He concluded 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 is no clinical basis to change previous recommendations.
14. Re-review of the Ophthalmic Quinolones therapeutic class
Drugs Affected: Ciloxan solution/ointment (ciprofloxacin), ciprofloxacin, IQUIX (levofloxacin), Ocuflox (ofloxacin), ofloxacin, Quixin (levofloxacin), Vigamox (moxifloxacin), Zymar (gatifloxacin)
Dr. Rogler noted the new product IQUIX (levofloxacin) 1.5% ophthalmic solution and discussed the two randomized, double-masked, multi-center controlled trials that are currently included in the IQUIX product monograph.
Dr. Correia provided the Department's clinical review of new information for this category. He noted IQUIX is indicated for corneal ulcers only, and is the only product in the therapeutic class that is not indicated for conjunctivitis. He reiterated ciprofloxacin and ofloxacin are also indicated for corneal ulcers. He also noted IQUIX is indicated for patients greater than six years of age, and the other drops in this class are indicated for use down to one year of age. He discussed spectrum of activity, tolerability, corneal healing, corneal penetration and aqueous humor concentrations as well as the lack of clinical evidence for outcomes based on corneal penetration or aqueous humor concentrations for drugs in this class. He concluded, information reviewed revealed no significant new clinical or comparative information using approved doses or indications since the last review, and there are no changes from the previous comparative evaluation of the drugs in this class. He also proposed that since there is an identified overall differential spectrum of activity between second generation fluoroquinolones (ciprofloxacin, ofloxacin) versus the third and fourth generation drugs (levofloxacin, moxifloxacin, gatifloxacin), both of these groups should be represented as preferred drugs.
15. Re-review of the Ophthalmic Antihistamines therapeutic class
Drugs Affected: Elestat (epinastine), Emadine (emedastine), ketotifen Rx, Optivar (azelastine), Patanol (olopatadine), Pataday (olopatadine)
Dr. Rogler noted the new generic for Zaditor (ketotifen) 0.025% for prescription use only.
Dr. Correia stated that clinical information reviewed revealed no significant comparative new clinical information since the last time this drug class was reviewed. He noted that any of the six products are effective for the treatment of allergic conjunctivitis with none of these drugs demonstrating overall advantages for all cases.
16. Re-review of the Ophthalmic Prostaglandin Agonists therapeutic class
Drugs Affected: Lumigan (bimatoprost), Travatan (travoprost), Travatan Z (travoprost), Xalatan (latanoprost)
Dr. Rogler found no new clinical information for this therapeutic class.
Dr. Correia provided the Department's clinical review of new information for this category. He stated that clinical practice guidelines from the professional organizations do not give preference to any one of these drugs. He noted that small differences between study results of absolute change in intraocular pressures (IOP) may only be statistically, but not clinically significant. He indicated information reviewed revealed no significantly different new clinical or comparative information since the last review. He concluded marginal differences are claimed by each manufacturer, but continue to balance between slight study variations in change in IOP and tolerability due to adverse effects with none demonstrating an overall advantage.
E. Executive Session:
The Committee recessed the public session at 12:10 P.M. 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, DHP CCB, ACE Inhibitors/CCB, ARBs, ARBs/Diuretic, Beta Blockers, Beta Blockers/Diuretic, Statins, Cholesterol Absorption Inhibitors, Triglyceride Lowering Agents. No official action was taken in the executive session. The executive session was recessed at 1:40 P.M.
The Committee recessed the public session at 2:35 P.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Long Acting Narcotics, Sedative Hypnotics/Sleep Agents, CNS Stimulants, Second Generation Antihistamines, Intranasal Steroids, PPIs, Ophthalmic Quinolones, Ophthalmic Antihistamines, Ophthalmic Prostaglandin Agonists. No official action was taken in the executive session. The executive session was recessed at 3:45 P.M.
F. Recommendations of the Pharmacy and Therapeutics Committee:
The following recommendations developed by the P&T Committee are to be submitted to the Commissioner of Health for final determination.
| Description of Recommendations | Commissioner's Final Determination |
|---|---|
| Proposal: Identification of preferred drugs in the category of ACE Inhibitors A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Altace capsule (ramipril), benazepril, captopril, enalapril, lisinopril, moexipril, ramipril capsule, trandolapril Non-preferred Drugs Accupril (quinapril), Aceon (perindopril erbumine), 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 |
| Proposal: Identification of preferred drugs in the category of Dihydropyridine Calcium Channel Blockers A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Afeditab CR (nifedipine CR), amlodipine besylate, DynaCirc (isradipine), DynaCirc CR (isradipine CR), felodipine ER, isradipine, nicardipine, Nifediac CC (nifedipine CC), Nifedical XL (nifedipine XL), nifedipine, nifedipine ER, nifedipine SA Non-preferred Drugs Adalat CC (nifedipine CC), Cardene (nicardipine), Cardene SR (nicardipine SR), Norvasc (amlodipine besylate), Plendil (felodipine ER), Procardia (nifedipine), Procardia XL (nifedipine XL), 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 (propranolol), Inderal LA (propranolol LA), Innopran XL (propranolol XL), Kerlone (betaxolol), Levatol (penbutolol), Lopressor (metoprolol tartrate), metoprolol succinate XL, Sectral (acebutolol), Tenormin (atenolol), Toprol XL (metoprolol succinate XL), Trandate (labetalol), Zebeta (bisoprolol fumarate) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
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), Inderide (propranolol/hctz), Lopressor/HCT (metoprolol tartrate/hctz), Tenoretic (atenolol/chlorthalidone), Ziac (bisoprolol fumarate/hctz) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of HMG-CoA Reductase Inhibitors (Statins) A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs 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 Cholesterol Absorption Inhibitors (CAIs) A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drug Zetia (ezetimibe) Non-preferred Drugs None |
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of Triglyceride Lowering Agents A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs fenofibrate, gemfibrozil, Tricor (fenofibrate), Lovaza (omega-3 acid ethyl esters) Non-preferred Drugs Antara (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 Long Acting Narcotics A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Duragesic (fentanyl patch), fentanyl patch, Kadian (morphine sulfate SR), morphine sulfate SR, Oramorph SR (morphine sulfate SR), Opana ER (oxymorphone ER) Non-preferred Drugs Avinza (morphine sulfate ER), MS Contin (morphine sulfate CR), oxycodone CR, Oxycontin (oxycodone HCL CR) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of Sedative Hypnotics/Sleep Agents A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs chloral hydrate, estazolam, flurazepam, temazepam, triazolam, zolpidem Non-preferred Drugs Ambien (zolpidem), Ambien CR (zolpidem CR), Dalmane (flurazepam), Doral (quazepam), Halcion (triazolam), Lunesta (eszopiclone), Prosom (estazolam), Restoril (temazepam), Rozerem (ramelteon), Somnote (chloral hydrate), Sonata (zaleplon) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of 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), Daytrana (methylphenidate patch), Desoxyn (methamphetamine), Dexedrine (dextroamphetamine sulfate), Dexedrine Spansule (dextroamphetamine sulfate SR), Dextrostat (dextroamphetamine sulfate), Metadate CD (methylphenidate CD), 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: Q: Is the patient being treated for excessive sleepiness associated with shift work sleep disorder or as an adjunct to standard treatment for obstructive sleep apnea? | Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of Second Generation Antihistamines A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs OTC cetirizine products (i.e. Zyrtec), OTC cetirizine D products (i.e. Zyrtec D), OTC loratadine products (i.e. Claritin), OTC loratadine D products (i.e. Claritin D) Non-preferred Drugs Allegra/Allegra-D (fexofenadine), Clarinex/Clarinex-D (desloratadine), fexofenadine, Semprex-D (acrivastine), Xyzal (levocetirizine), Zyrtec/Zyrtec-D Rx (cetirizine Rx) 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 pediatric indications: Q: Is the patient under twenty-four (24) months of age? |
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of Intranasal Steroids A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs fluticasone propionate, Nasonex (mometasone furoate) Non-preferred Drugs Beconase AQ (beclomethasone dipropionate), Flonase (fluticasone propionate), flunisolide, Nasacort AQ (triamcinolone acetonide), Nasarel (flunisolide), Rhinocort Aqua (budesonide), Veramyst (fluticasone furoate) 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 (i.e. Prilosec OTC), Prevacid capsule (lansoprazole) Non-preferred Drugs Aciphex (rabeprazole), 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 Ophthalmic Fluoroquinolones Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs ciprofloxacin, ofloxacin, Vigamox (moxifloxacin) Non-preferred Drugs Ciloxan solution/ointment (ciprofloxacin), IQUIX (levofloxacin), Ocuflox (ofloxacin), Quixin (levofloxacin), Zymar (gatifloxacin) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of Ophthalmic Antihistamines A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Patanol (olopatadine), Pataday (olopatadine) Non-preferred Drugs Elestat (epinastine), Emadine (emedastine), ketotifen Rx, Optivar (azelastine) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
Approved as Recommended |
| Proposal: Identification of preferred drugs in the category of Ophthalmic Prostaglandin Agonists 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 Travatan (travoprost), Travatan Z (travoprost), Xalatan (latanoprost) Non-preferred Drug Lumigan (bimatoprost) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. |
Approved as Recommended |
G. Additional Discussion:
Dr. Martin (Chairperson) expressed appreciation to the Committee and Staff. He announced that Dr. Bello, MD and Dr. Bruce PharmD have resigned from the Committee to pursue other opportunities and thanked them for their service.
The meeting adjourned at 3:45 PM.
Meeting Summary Posted 06/05/08
H. Final Determinations
The Commissioner has determined that the Medicaid program will require prior authorization under the Preferred Drug Program (PDP) for non-preferred drugs, as listed above, in the following classes: ACE Inhibitors, ACE Inhibitors/Diuretic Combinations, Dihydropyridine Calcium Channel Blockers, ACE Inhibitor/Calcium Channel Blocker Combinations, Angiotensin Receptor Blockers (ARB), ARB/Diuretic Combinations, Beta Blockers, Beta Blocker/Diuretic Combinations, HMG-CoA Reductase Inhibitors (Statins), Cholesterol Absorption Inhibitors, Triglyceride Lowering Agents, Long Acting Narcotics, Sedative Hypnotics/Sleep Agents,Central Nervous System Stimulants, Antihistamines-Second Generation, Intranasal Steroids, Proton Pump Inhibitors, Ophthalmic Quinolones, Ophthalmic Antihistamines and Ophthalmic Prostaglandin Agonists.
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 $104 M. The savings are achieved through changes in utilization to equally effective and less expensive drugs through the receipt of supplemental rebates from pharmaceutical manufacturers.
Final Determinations Posted 7/28/2008
