New york state medicaid pharmacy and therapeutics committee meeting summary june 16, 201
New York State Medicaid Pharmacy and Therapeutics Committee Meeting Summary June 16, 2011 Agenda and Introduction
The Medicaid Pharmacy & Therapeutics Committee met on Thursday, June 16, 2011 from 8:45 AM to4:30 PM 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 advanceof the meeting. B. Public Comment Period:
The following speakers provided public comment to the Committee:
1. McDonald, Eric, Director of Sales, Taro Pharmaceuticals, Hawthorne, NY
2. Cannito, Maria, PharmD, MS, Director, Medical Outcomes Specialists, Pfizer, Pittsford, NY
3. Szabo, Erika, MPH, Global Health Outcomes Liaison, Eli Lilly, Indianapolis, IN
4. Schwartz, Kenneth, MD, Saratoga Family Physicians, Saratoga Springs, NY
5. Eren, Devrim, PhD, Medical Science Liaison, Aptalis Pharma, Yardley, PA
6. Schroeder, Scott, MD, Section Head, Division of Pulmonary & Critical Care, AMC Pediatric
Pulmonary Group, Albany Medical Center, Albany, NY
7. Hoffman, Sharon, Regional Clinical Executive, Abbott Laboratories, Abbott Park, IL
8. Gann, Kathryn L, PhD, Senior Medical Science Liaison, Amylin Pharmaceuticals, San
9. Servera, Soraly, MD, Medical Affairs, Novo Nordisk, Princeton, NJ
10. Fruiterman, Mark L, MD, The Endocrine Group, Albany, NY
11. Braden, Wesley, PhD, Medical Science Liaison, United Therapeutics, Durham, NC12. Kowalski, Maribeth, PharmD, MBA, Medical Liaison, Purdue Pharma, Stamford, CT
13. Khan, Arsalan, Principal Liaison, Johnson and Johnson/Janssen, Piscataway, NJ
14. Strouss, Lisa, PharmD, Senior Area Medical Specialist, Sunovion Pharmaceuticals,
15. Owens, Mark, DO, Medical Director, The League Treatment Center, Brooklyn, NY
16. Roberts, Holly, MD, Director RMRS, Pfizer, NY, NY
17. Self, Rachel L, PhD, Neuroscience Medical Science Liaison, Bristol-Myers Squibb,
18. Dinh, Quinn, MD, Senior Director, Medical Affairs, Azur Pharma, Philadelphia, PA
19. Morris, Adrian, MD, Attending Psychiatrist, Glens Falls Hospital, Glens Falls, NY
20. Shapiro, Matthew, Development and Events Coordinator, National Alliance on Mental
21. Rosenthal, Harvey, Executive Director of the New York Association of Psychiatric
Rehabilitation Services, Albany, NY
22. Liebman, Glenn, CEO, Mental Health Association in NYS, Albany, NY
23. Amyot, Edmond, MD, NYS Psychiatric Association, Saratoga Hospital, Saratoga Springs,
24. Cheema, Sohail, MD, Westbury Therapeutic Medical Services, Westbury, NY
25. Baran, Daniel, MD, Region Medical Director, Merck, Upper Gwynedd, PA
26. Beeman, David R, PharmD, National Clinical Account manager, Astra Zeneca
27. Caminis, John, MD, Vice President, Clinical Development, Warner Chilcott, Rockaway,
28. Heslin, Eugene P, MD, Bridge Street Family Medicine, Saugerties, NY
29. Thomas, Susan, MD, Associate Director, National Medicine-Diabetes, Boehringer
Ingelheim Pharmaceuticals, Ridgefield, CT
30. Dalsania, Amy, PharmD, Medical Science Liaison, Bristol-Myers Squibb, Plainsboro, NJ
31. Prior, Cheryl, PharmD, Medical Liaison-Managed Markets, Norvo Nordisk, Princeton, NJ
32. Lazala, Carmen, MD, Pediatric Endocrinology, Director of Briggs Family Pediatrics,
33. Racicot, Diane, MBA, RD, National Account Manager, Strativa Pharmaceuticals, Division
34. Weiner, Jonathan, Medical Science Liaison, Shire, Wayne, PA
C. Key issues raised by interested parties pertaining to the following therapeutic classes: Public comments:
The Committee was asked to consider information on tapentadol regarding indication, dual
mechanism of action, dosing and administration and adverse reaction profile. TheCommittee was also asked to consider non-inferiority comparative studies with oxycodoneIR in the reduction of pain relief and incidence of nausea and/or vomiting.
The Committee was asked to consider information on desoximetasone, as a class
structure C corticosteroid, which is regarded as hypoallergenic by the North AmericanContact Dermatitis Group.
Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs)
The Committee was asked to consider information regarding major depressive disorder
(MDD) and the American Psychiatric Association recommendations for first line treatment. The Committee was also asked to consider the clinical efficacy, safety andpharmacokinetic profile of desvenlafaxine.
The Committee was asked to consider information on duloxetine including indications,
safety, adherence and persistence. The Committee was also asked to consider placebocontrolled trials measuring pain reduction in patients with chronic musculoskeletal pain.
The Committee was asked to consider information on milnacipran for the treatment of
The Committee was asked to consider information regarding the epidemiology of H. pylori
and the primary causes of treatment failure. The Committee was also asked to considerthe efficacy of bismuth, metronidazole, and tetracycline (a 3-in-1 capsule) that is takenwith omeprazole and the eradication rates achieved with this quadruple therapy.
The Committee was asked to consider information on exocrine pancreatic insufficiency
(EPI). The Committee was also asked to consider clinical studies evaluating the safety andefficacy of pancrealipase in both children and adults with cystic fibrosis (CF).
The Committee was asked to consider information on CF, the importance of nutrition in
these patients and prevention of malnutrition as the primary goal. The Committee was alsoasked to consider the addition of enzyme supplements to help restore the delicate balancein the human body for patients suffering from CF, chronic pancreatitis andpancreatectomy. Additionally, information on clinical efficacy and safety were alsopresented.
The Committee was asked to consider information on exenatide including its place in
treatment algorithms for both the American Association of Clinical Endocrinologists(AACE) and the American Diabetes Association (ADA). The Committee was also asked toconsider efficacy as well as data published in the Journal of Medical Economicscomparing medical costs of patients taking insulin glargine versus exenatide.
The Committee was asked to consider efficacy information on liraglutide including the
LEAD-6 trial and its extension. The Committee was also asked to consider liraglutide withregards to indication and once a day dosing.
Phosphodiesterase type-5 inhibitors (for PAH)
The Committee was asked to consider information on pulmonary arterial hypertension
(PAH) including the 2008 World health Organization (WHO) guidelines and the 2009American Heart Association (AHA)/American College of Cardiology (ACC) consensusdocument. The Committee was also asked to consider information on tadalafil includingindication, dosing and administration, mechanism of action and dose dependent efficacy inclinical trials.
The Committee was asked to consider information regarding transdermal buprenorphine
including indication, dosing and administration and box warning.
The Committee was asked to consider information on olanzapine including safety and cost
effectiveness of olanzapine versus aripiprazole.
The Committee was asked to consider information on lurasidone including indication,
dosing and administration, efficacy and safety profile.
The Committee was asked to consider information on paliperidone including indications,
dosing and administration, adverse reactions and metabolism. The Committee was also
asked to consider information on head to head trials with quetiapine and olanzapine aswell as meta analyses with other oral atypical antipsychotics.
The Committee was asked to consider information on ziprasidone including indications,
metabolic and tolerability profile. The Committee was also asked to consider informationon head to head trials with olanzapine and risperidone as well as the CATIE trial.
The Committee was asked to consider information on aripiprazole including a new
indication and safety data in the pediatric population.
The Committee was asked to consider information on clozapine orally disintegrating
tablets (ODT) with regards to the formulation and availability of new strengths.
The Committee was asked to consider information on asenapine including a new
indication, efficacy data, sublingual formulation and safety and metabolic profile. Apresenter indicated that generic products were inferior in the acutely psychotic or manicpatient.
The Committee was asked to consider open access for all atypical antipsychotics. The
Committee was also asked to consider expanding and strengthening the PSYCKESprogram.
The Committee was asked to consider information on quetiapine including studies done in
children and adolescents evaluating safety, efficacy and tolerability.
The Committee was asked to consider the reduced risk of fractures with risedronate as
well as dosing and administration for risedronate DR.
Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
The Committee was asked to consider information on sitagliptin and sitagliptin/metformin
including indications, adverse reactions and comparative data with sulfonylureas as wellas add on data with other oral antihyperglycemic agents. The Committee was also askedto consider diabetes as the underlying disease as well as comorbidity.
The Committee was asked to consider information on linagliptin including indications,
dosing and administration, efficacy (as well as a non inferiority trial between glimepirideand metformin), contraindications, warnings, adverse reactions and drug interactions.
The Committee was asked to consider information on saxagliptin including indications,
dosing and administration, clinical trial efficacy and safety.
The Committee was asked to consider information on buffers and preservatives used in
somatropin (Norditropin) as well as a new device for the product. The Committee wasalso asked to consider dosing accuracy, ease of use and adherence in relation to the newdevice.
The Committee was asked to consider information on ondansetron oral soluble film
including indications, dosing and administration, and safety.
The Committee was asked to consider information on mesalamine once-daily (Lialda) and
delayed-release (Asacol HD) including indications, dosing and administration, efficacy,adverse reactions and safety. The Committee was also asked to consider differences in
drug delivery systems, extension trials, healing rates (ASCEND I and II) and recurrence ofulcerative colitis (S.I.M.P.L.E. study). Pharmacy and Therapeutics Committee Comments:
A Committee member commented that the treatment of choice for contact dermatitis is not
A Committee member asked the presenter if there were any head to head trials with
A Committee member asked a presenter if there were any studies with duloxetine versus a
tricyclic antidepressant in the treatment of fibromyalgia.
A Committee member asked a presenter what percent of their patients were on Medicaid.
The presenter indicated approximately 10-15%.
A Committee member commented on resistance rates with metronidazole and
clarithromycin and also mentioned that adherence is a problem and may be exacerbatedby having to obtain a proton pump inhibitor separately.
A Committee member asked a presenter for an update on the risk of pancreatitis with
exenatide. The presenter clarified the black box warnings.
A Committee member asked a presenter for an update on the risk of pancreatitis with
liraglutide. The presenter commented there were 8 cases in over 4,000 patients and that itis difficult to relate dosing or duration to the increased incidence of pancreatitis. If there isany risk of pancreatitis, the physician should reconsider GLP-1 therapy.
A Committee member asked a presenter if they have seen any abuse of liraglutide in
obese patients for weight reduction. The presenter answered that they have not seen itand added that a 3mg dose is being tested now for an obesity indication.
A Committee member asked a presenter about protections against extraction and
addiction potential with the buprenorphine patch. A Committee member also commentedon QTc prolongation. A Committee member asked for clarification on why this productwould not be a good candidate for step therapy. The presenter clarified only in opioidexperienced patients the buprenorphine patch may not provide adequate analgesia.
A Committee member commented on tapentadol and that the product is a CII and has
A Committee member asked a presenter about head to head studies with paliperidone and
other products in the class. The presenter clarified there was a six week trial withrisperidone in 2010.
A Committee member commented on a study measuring cost effectiveness of
aripiprazole versus olanzapine and wanted to know if the increase in weight gain witholanzapine attributed to other health problems and actually increased health care costs. Another Committee member asked how they determined total cost effectiveness.
A Committee member commented on QTc prolongation with lurasidone and how that was
A Committee member asked a presenter if they had enough experience with lurasidone to
really determine if it had a better side effect profile since it has only been on the market fora short time. The presenter commented that 10-15% of his patients are using lurasidone.
A Committee member commented on aripiprazole’s indication for use as adjunctive
therapy to antidepressants and expressed concern that aripiprazole was being usedconcomitantly with an antidepressant before an inadequate response was seen. AnotherCommittee member asked about metabolic implications versus other antipsychotics in theclass. The presenter cited a Swedish study which showed a favorable metabolic profile.
A Committee member asked a presenter to comment on open access for primary care
physicians versus psychiatrists. The presenter commented that a psychiatrist has moreexperience and should have open access. A Committee member also asked how thepresenter selected an antipsychotic for a naïve patient. The presenter commented that heuses his experience to tailor therapy to each patient. Another Committee membercommented that more than half of the prescriptions in this class are written by primarycare physicians according to the Office of Mental Health but it is difficult to discern whethera psychiatrist was consulted first. Another Committee member commented on the use ofthis class of drugs off-label.
A Committee member asked a presenter to comment on whether NAMI has an official
stance on open access for atypical antipsychotics for primary care physicians versuspsychiatrists. A presenter commented that it is a challenge just to obtain treatment forthese patients at all.
A Committee member asked a presenter to comment on whether there should be open
access for all medications. The presenter commented that he focuses on his communityand if the patients are prescribed what they need they will cost less.
A Committee member clarified that in Medicaid fee-for-service the provider still prevails
which does not apply to managed care organizations.
A Committee member asked a presenter to comment about other States with more
stringent rules/criteria around mental health drugs and if there was evidence that therewere better outcomes than in NY.
A Committee member cautioned a presenter about their comments on generic products
and stated that bioequivalence data on generic products is robust. A Department of Health(DOH) staff member commented that the Pharmacist can aide in educating patients onbrand to generic recognition.
A Committee member asked a presenter to clarify that quetiapine is not an antidepressant. A Committee member asked a presenter about follow up drug surveillance data regarding
adverse reactions (swollen tongue and angioedema) with asenapine. The presentercommented that there were no post marketing reports and that the adverse reactions wereprobably due to the anesthetic properties of the drug.
A Committee member commented that metformin does not cause renal deterioration. A Committee member asked a presenter if sitagliptin slows gastric emptying time. The
presenter clarified that oral DPP-4 inhibitors do not.
A Committee member asked a presenter if there was any comparative data with
ondansetron oral soluble film and other products in the class. The presenter clarified thatit has only been compared to ondansetron. D. Clinical Presentation and Discussion
Candi Wines, MPH, University of North Carolina at Chapel Hill Evidence based Practice CenterBarbara Rogler, Pharm D, MS, Magellan Medicaid AdministrationRobert Correia, Pharm D, New York State Department of Health, Office of Health InsurancePrograms
Preferred Drug Program: Initial Review
1. Proposal to identify preferred drugs in the therapeutic class of Short Acting Opioids
Dr. Rogler provided background information on the class and gave an overview of theproducts including indications, mechanisms of action, contraindications, warnings, druginteractions, adverse reactions, dosage and administration. Dr. Rogler also presentedinformation from January 2011, by the Food and Drug Administration (FDA), requiring drugmanufacturers to limit the strength of acetaminophen in prescription drug products to 325mg.
Dr Correia concluded that this class of drugs can all be calculated for equianalgesic dosages,although some will reach a ceiling effect or upper limit before others.
A Committee member commented that tapentadol could be more addictive when used for
2. Proposal to identify preferred drugs in the therapeutic class of Topical Anti-Fungals
Drs. Correia and Rogler provided background information on the class and gave an overviewof the products including indications, pharmacology, use in special populations, dosage andadministration. They also presented information on the types of infections treated by thisclass of drug as well as an explanation of the different vehicles used to deliver themedications, noting advantages and disadvantages for each.
Dr. Correia noted that this drug class was previously researched by the University of Buffaloand presented at the February 2010 DUR Board meeting. He reiterated the results of theirliterature review pertinent to effectiveness of agents for various indications. Dr. Correia notedtremendous overlap of indications for these products.
3. Proposal to identify preferred drugs in the therapeutic class of Topical Steroids
Dr. Rogler provided background information on the class and gave an overview of theproducts including indications, pharmacology, contraindications and warnings, druginteractions, adverse effects, use in special populations and dosage and administration. Dr. Rogler also presented information on the grouping of categories in this class based on theirpotency (low, medium, high, very high) and that the concentration of drug and vehicle usedmay affect the level of potency.
Dr. Correia concluded that the relevant issues are to assure there are products available in
each of the potency classifications, and to provide as broad a selection of product types aspossible within those potency classes.
4. Proposal to identify preferred drugs in the therapeutic class of SNRIs
Dr. Rogler provided background information on the class and gave an overview of theproducts including indications, pharmacokinetics, contraindications and warnings, druginteractions, adverse effects, use in special populations and dosage and administration. Dr. Rogler also presented information fibromyalgia and diabetic peripheral neuropathic (DPN)pain and the drugs approved to treat those conditions.
Dr. Correia commented that the Oregon Drug Effectiveness Review Project comparativeeffectiveness report for the second generation antidepressants and another report coveringdrugs in this class used for fibromyalgia was just released this year. Dr. Correia alsoreiterated the products indications and provided information from the 2011 AmericanAcademy of Neurology guidelines that recommended for painful diabetic neuropathy, Level Aevidence indicates that pregabalin be offered first rather than an SNRI. He also commentedthat for fibromyalgia pain, an indirect meta-analysis indicated that duloxetine was better than
milnacipran in short-term trials of 8 to 15 weeks, but no difference existed between the drugsat 28 weeks. Dr. Correia concluded that overall, in evaluating the available evidence,including a systematic review by the U.S. Department of Health and Human Services’Agency for Healthcare Research and Quality, these drugs are very comparable in efficacyand effectiveness.
A Committee member inquired about classifications for antidepressants. They commented ontricyclic antidepressants and how they are still valuable for use in fibromyalgia. They alsomentioned how SNRIs are used if there is a failure to a SSRI in clinical practice.
5. Proposal to identify preferred drugs in the therapeutic class of SSRIs
Dr. Rogler provided background information on the class and gave an overview of theproducts including indications, pharmacology, pharmacokinetics, drug interactions,contraindications and warnings, adverse effects, use in special populations and dosage andadministration. Dr. Rogler concluded that SSRIs are considered first-line treatment for theirFDA approved indications and despite the differences in pharmacokinetic properties of eachagent, the full response time for all of the SSRIs typically takes four to six weeks.
Dr. Correia commented all the drugs inhibit neuronal serotonin reuptake and that variousdrugs within the class are also suggested to have a minor impact on reuptake of otherneurotransmitters such as norepinephrine or dopamine, or agonist effects on serotinergic orcholinergic receptors, which is theorized to impact subtle differences in adverse effectprofiles. Dr. Correia concluded for the indication shared by the drugs in this class, there is noevidence of overall superiority, and significant evidence of similarity in efficacy andeffectiveness.
6. Proposal to identify preferred drugs in the therapeutic class of Helicobacter Pylori Agents
Dr. Rogler provided background information on the class and gave an overview of theproducts including indications and dosage and administration. Dr. Rogler also presentedinformation on H. pylori infection and treatment guidelines from the American College ofGastroenterology. She also provided results from a non-inferiority trial comparing a fixeddose combination capsule versus separate triple therapy for H. pylori eradication.
Dr. Correia reiterated that both of the metronidazole, tetracycline and bismuth combinationtherapies require an additional H2 antagonist or omeprazole to be obtained and taken as partof the regimen so these product packages are not 100% complete therapy. Dr. Correiaconcluded that additionally, there is concern with accelerating development of resistance tometronidazole with more widespread use.
7. Proposal to identify preferred drugs in the therapeutic class of Pancreatic Enzymes
Dr. Rogler provided background information on the class and gave an overview of theproducts including indications and dosage and administration. Dr. Rogler explained how eachenzyme type exerts its effect on the body as well as the significant effects a deficiency of aparticular enzyme may cause.
Dr. Correia concluded all of these products contain the same three enzymes, amylase,lipase, and protease, in comparable ranges of dosages and all the products in this class havelabeling as well as recommendation guidelines for use in infants and children as well asadults.
8. Proposal to identify preferred drugs in the therapeutic class of Glucagon-like Peptide-1
Candi Wines presented the Drug Effectiveness Review Project (DERP) Drug Class Reviewfor Newer Diabetes Medications and Combinations which included a review of the GLP-1Agents.
Dr. Rogler provided background information on the class and gave an overview of theproducts including indications, pharmacokinetics, contraindications and warnings, druginteractions, adverse reactions, use in special populations and dosage and administration. Dr. Rogler also reviewed the LEAD-6 trial which was a non inferiority trial that comparedliraglutide and exenatide.
Dr. Correia commented that GLP-1 agonists are generally not recommended as first-linemonotherapy. He also stated that the 2009 guidelines from the American DiabetesAssociation and the European Association for the Study of Diabetes clinical consensusstatement only identify metformin as step-1 therapy, and that the GLP-1 agonists are onlystep-2 therapy after metformin. Dr. Correia informed the Committee that the FDA sent out anotice that as a requirement of a risk evaluation and mitigation strategy (REMS) forliraglutide, a letter was being sent to healthcare professionals about a potential risk of thyroidC-cell tumors, including medullary thyroid carcinoma (MTC) as well as an increased risk ofacute pancreatitis. The FDA labeling states that liraglutide is not indicated as first-line therapyfor patients who have inadequate glycemic control on diet and exercise. Dr. Correiaconcluded that there is significant concern about development of pancreatitis for bothliraglutide and exenatide, and labeling indicates to use with caution in patients with a historyof pancreatitis.
9. Proposal to identify preferred drugs in the therapeutic class of Phosphodiesterase type-5
Dr. Rogler described pulmonary arterial hypertension (PAH), its affects on the body, how it isdiagnosed and the drugs that are used to treat the disease. Dr. Rogler and Dr. Correiaprovided background information on the class and gave an overview of the products includingindications, pharmacokinetics, contraindications and warnings, drug interactions, adversereactions, use in special populations and dosage and administration. Dr. Correia also statedthat differences in dosing as well as metabolism and elimination could affect drug selectionfor specific patients.
A Committee member commented on drug interactions with alpha blockers and somelimitations associated with older treatments like calcium channel blockers. Preferred Drug Program: Re-review
1. Proposal to identify preferred drugs in the therapeutic class of Long Acting Opioids
Dr. Correia and Dr. Rogler discussed the new buprenorphine transdermal system. Theyfocused on indication, pharmacokinetics, drug interactions and use in special populations forthe product. Dr. Rogler provided updated information on new REMS plan for long actingopioids.
Dr. Correia stated that there is a new 6th update pending to the OHSU/DERP report on Long-Acting Opioids that he was able to review but concluded that there is no new comparativeclinical evidence since the last re-review to indicate any of these drugs offers an overalladvantage within the class.
A committee member questioned value of the buprenorphine transdermal system.
2. Proposal to identify preferred drugs in the therapeutic class of Atypical Antipsychotic
Dr. Rogler discussed a new product in the class lurasidone including indication,pharmacology, pharmacokinetics, use in special populations, contraindications and dosingand administration. She also discussed several new product indications, safety revisions anda labeling update for all products in the class for use during pregnancy and the risk ofabnormal muscle movement and withdrawal syndrome.
Dr. Correia concluded that this is a class of drug where the consideration is balancing efficacyand risk of adverse outcomes between the drugs.
A Committee member asked about original trials conducted for atypical antipsychotics. Dr. Rogler clarified that they were done in Europe with institutionalized patients. AnotherCommittee member commented on the CATIE trials and questioned side effects with newversus older medications. Dr. Rogler commented that more tardive dyskinesia is seen with theolder products but overall adverse effects are more prominent in higher doses across allantipsychotics.
3. Proposal to identify preferred drugs in the therapeutic class of Oral Bisphosphonates
Dr. Correia and Dr. Rogler discussed a new product to the class, risedronate DR, since theprevious review. They provided an updated safety alert for bisphosphonates regardinginformation previously communicated describing the risk of subtrochanteric and diapysealfemur fractures. Dr. Correia and Dr. Rogler also presented the 2010 American Association ofClinical Endocrinologists (AACE) Guidelines for prevention and treatment of postmenopausalosteoporosis that recommend alendronate and risedronate as first-line and ibandronate as asecond-line agent.
4. Proposal to identify preferred drugs in the therapeutic class of Dipeptidyl Peptidase-4
Candi Wines, MPH, UNC at Chapel Hill Evidence based Practice Center presented the DrugEffectiveness Review Project (DERP) Drug Class Review for Newer Diabetes Medicationsand Combinations which included a review of the DPP-4 Inhibitors.
Dr. Correia and Dr. Rogler discussed two new products to the class, linagliptin and acombination product, saxagliptin/metformin ER. Dr. Rogler provided additional information onsitagliptin and sitagliptin/metformin with regards labeling additions about acute renal failure,increasing incidence of pancreatitis and other side effects. Dr. Rogler also presented a non-inferiority trial between sitagliptin and saxagliptin versus glipizide. Dr. Correia also discussedimpact of difference in metabolism and elimination for the three drugs. Dr. Correia concludedthere is little if any comparative information for effectiveness of the three current DPP-4Inhibitors or the combination products, but indirect evidence seems to indicate that they areclinically comparable in efficacy.
A Committee member commented on proper titration in a trial presented. A Committeemember also commented on DPP-4 agents compared to metformin.
5. Proposal to identify preferred drugs in the therapeutic class of Thiazolidinediones (TZDs)
Candi Wines presented the Drug Effectiveness Review Project (DERP) Drug Class Review forNewer Diabetes Medications and Combinations which included a review of theThiazolidinediones (TZDs).
Drs. Correia and Rogler provided updates to the rosiglitazone and pioglitazone labeling. Theypresented an update on the REMS required for the rosiglitazone, that included a restrictedaccess and distribution program in which clinicians and patients must enroll in to prescribeand receive the product. Additionally, Dr. Correia and Dr. Rogler provided a FDA safetycommunication from this week informing the public that use of pioglitazone for more than oneyear may be associated with an increased risk of bladder cancer.
Dr. Correia concluded that there is still no comparative evidence which demonstrates anyadvantage of either of these products overall, in terms of efficacy or harms, although theevidence for increased risk of adverse effects for each of these drugs individually or as a classcontinues to accumulate.
A Committee member commented on lipid abnormalities with the use of these products.
6. Proposal to identify preferred drugs in the therapeutic class of Growth Hormones
Dr. Correia and Dr. Rogler presented new indications for somatropin (Omnitrope) andcommented on new devices available for somatropin (Norditropin). They provided informationon a FDA safety alert stemming from a study in France which stated there was a smallincreased risk of death when recombinant growth hormone was used to treat certain types ofshort stature including GH-deficiency, idiopathic, or gestational age. Dr. Correia concludedthat the endocrine society has stated there are no observable differences in the resultsobtained from the different preparations as long as the appropriate regimen is followed andthat there is no evidence that clinical outcome differs among the various injection systems.
7. Proposal to identify preferred drugs in the therapeutic class of Anti-Emetics
Dr. Correia and Dr. Rogler indicated that there is a new drug in the class, ondansetron oralsoluble film and provided additional safety revisions for ondansetron and dolasetron. Dr. Correia concluded that available dosage forms now include oral film, oral disintegratingtablets, oral liquid and transdermal patch and that ultimately all products are effective withnone of these products demonstrating an overall advantage.
8. Proposal to identify preferred drugs in the therapeutic class of Proton Pump Inhibitors (PPIs)
Dr. Correia and Dr. Rogler indicated there are two new generics in the class,omeprazole/bicarbonate Rx and lansoprazole ODT. They provided additional FDA safetyinformation on PPIs including the possible increased risk of fractures of the hip, wrist andspine, safety announcement related to low serum magnesium levels due to long term use ofPPIs and a reminder warning against concomitant use of clopidogrel and omeprazole.
9. Proposal to identify preferred drugs in the therapeutic class of Sulfasalazine Derivatives
Dr. Correia and Dr. Rogler presented safety labeling revisions for mesalamine (Asacol/AsacolHD) during pregnancy. Dr. Correia summarized the difference between a prodrug anddelayed release formulations as well as active and maintenance treatments for ulcerativecolitis.
10. Proposal to identify preferred drugs in the therapeutic class of Intranasal Corticosteroids
Dr. Correia and Dr. Rogler summarized differences in number of sprays/day, dosing frequencyand usage among pediatric patients. E. Executive Session:
The Committee recessed the public session at 1:00 PM to go into executive session for review offinancial information relating to the Committee's recommendations of preferred drugs in thefollowing classes: Glucagon-like Peptide-1 (GLP-1) Inhibitors, Dipeptidyl Peptidase (DPP-4)Inhibitors and Thiazolidinediones (TZDs). No official action was taken in the executive session. The executive session was recessed at 1:45 PM.
The Committee recessed the public session at 4:00 PM to go into executive session for review offinancial information relating to the recommendation of preferred drugs in the following classes:Helicobacter Pylori Agents, Proton Pump Inhibitors (PPIs), Bisphosphonates-oral, GrowthHormones, Anti-emetics, Sulfasalazine Derivatives, Intranasal Corticosteroids, AtypicalAntipsychotics, SSRIs, SNRIs, Short Acting Opioids, Long Acting Opioids, Topical Steroids,Topical Anti-Fungals, Pancreatic Enzymes and Phospodiesterase type-5 Inhibitors (PDE-5s).
No official action was taken in the executive session. The executive session was recessed at
F. Recommendations of the P&T Committee submitted to the Commissioner of Health for final determination.
Based on the submitted or presented clinical information and on the financial information providedduring the executive session, the Committee unanimously (unless otherwise noted)recommended the following:
Commissioner's Recommendations of Pharmacy and Therapeutics Committee Final Determination The standard clinical questions be used in the prior authorization review process for non-preferred drugs:
Q: Has your patient experienced treatment failure with preferred drugs in the class?
Q: Has your patient experienced an adverse drug reaction with preferred drugs in
Q: Is there a documented history of successful therapeutic control with a non-preferred drug and transition to a preferred drug is medically contraindicated?
Short Acting Opioids
Motion was made to alter the DOH recommendation. The Committee upheld the motion to alter the DOH recommendation as follows: Preferred Drugs codeine/APAP, codeine, hydrocodone/APAP, morphine IR, oxycodone/APAP, oxycodone/ibuprofen, tramadol Non-preferred Drugs
butalbital compound w/codeine, butorphanol NS, Dazidox, Demerol,
dihydrocodeine/APAP/caffeine, Dilaudid, Endocet, Endodan, Hycet,hydrocodone/ibuprofen, hydromorphone, Ibudone, levorphanol, Lorcet, Lorcet Plus,Lortab, Magnacet, Margesic H, Maxidone, meperidine, Norco, Nucynta, Opana,oxycodone, oxycodone/ASA, oxymorphone, OxyIR, Panlor SS, pentazocine/APAP,pentazocine/naloxone, Percocet, Percodan, Primalev, Primlev, Reprexain, Roxicet,Roxicodone, Rybix ODT, Synalgos DC, tramadol/APAP, Trezix, Tylenol #3,Tylenol #4, Tylox, Ultracet, Ultram, Vicodin/Vicodin ES/Vicodin HP, Vicoprofen,Xodol, Xolox, Zamicet, Zydone
Topical Anti-Fungals Preferred Drugs clotrimazole OTC, miconazole OTC, nystatin cream/ointment, nystatin powder, nystatin/triamcinolone, terbinafine OTC, tolnaftate OTC Non-preferred Drugs
clotrimazole Rx, clotrimazole/betamethasone, ciclopirox, econazole, Ertaczo,Exelderm, Extina, ketoconazole, Lamisil AT, Loprox, Lotrisone, Mentax, Naftin,Nyamyc, Nystop, Oxistat, Pedi-Dri, Tinactin, Vusion, Xolegel
Topical Steroids Preferred Drugs Very High Potency halobetasol, clobetasol
High Potencyamcinonide, fluocinonide, fluocinonide emollient, fluocinonide E, triamcinoloneacetonide
Medium Potencyfluocinolone, hydrocortisone valerate
Low Potencyhydrocortisone acetate OTC, hydrocortisone acetate Rx, hydrocortisone/aloe-vera
Non-preferred Drugs Very High Potency Clobex, Cormax, Olux/Olux-E, Temovate/Temovate-E, Ultravate
High PotencyApexicon/Apexicon E, Beta-Val, betamethasone valerate, betamethasonedipropionate, desoximetasone, diflorasone, Diprolene/Diprolene AF, Halog,
Medium PotencyCloderm, Cordran, Cutivate, Dermatop, Elocon, fluticasone proprionate,hydrocortisone butyrate, Locoid Lipocream, Luxiq, mometasone furoate, Pandel,prednicarbate
Low Potencyalclometasone, Aclovate, desonide, Desonate, Derma-Smooth/FS, Texacort,Verdeso, Nucort
Preferred Drugs Cymbalta, Effexor XR, Savella, venlafaxine Non-preferred Drugs Effexor, Pristiq, venlafaxine ER capsules, venlafaxine ER tablets Preferred Drugs citalopram, fluoxetine, fluvoxamine, paroxetine, Paxil suspension, sertraline Non-preferred Drugs Celexa, fluoxetine weekly, Lexapro, Luvox CR, paroxetine CR, Pexeva, Paxil, Paxil CR, Prozac, Sarafem, Selfemra, Zoloft Helicobacter Pylori Agents
Motion was made to alter the DOH recommendation. The Committee upheld the motion to alter the DOH recommendation as follows (vote of 6 to 3): Preferred Drugs Non-preferred Drugs None Pancreatic Enzymes Preferred Drugs Creon, pancrelipase Non-preferred Drugs Pancreaze, Zenpep Glucogon-like Peptide-1 (GLP-1) Agents Preferred Drugs Byetta Non-preferred Drugs Phosphodiesterase type-5 Inhibitors (for PAH) Preferred Drugs Non-preferred Drugs None Long Acting Opioids Preferred Drugs Duragesic, Kadian, morphine sulfate SR, Opana ER, Oramorph SR Non-preferred Drugs Avinza, Butrans, Embeda, Exaglo, fentanyl patch, MS Contin, oxycodone CR, Oxycontin, Ryzolt, tramadol ER, Ultram ER Atypical Antipsychotics Preferred Drugs clozapine, Fanapt, FazaClo, Geodon, risperidone, Saphris, Seroquel, Seroquel XR Non-preferred Drugs
Abilify, Clozaril, Invega, Latuda, Risperdal, Zyprexa
Non-preferred drugs will NOT require prior authorization until systems are in place
which allows patients stabilized on these products to continue therapy withoutobtaining prior authorization. Bisphosphonates – Oral
A motion was made to alter the DOH recommendation. The Committee recommended to uphold the DOH recommendation as follows(vote of 6 to 3):
Preferred Drugs Non-preferred Drugs Actonel, Actonel with calcium, Atelvia, Boniva, Fosamax tablets, Fosamax plus D Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Preferred Drugs Janumet, Januvia, Kombiglyze XR, Onglyza Non-preferred Drugs Tradjenta Thiazolidinediones (TZDs)
The Committee recommended to uphold the DOH recommendation as follows(1 abstention):
Preferred Drugs Actos, Actoplus Met, Duetact Non-preferred Drugs Actoplus Met XR, Avandia, Avandamet, Avandaryl Growth Hormones Preferred Drugs Genotropin, Nutropin, Nutropin AQ Non-preferred Drugs Humatrope, Norditropin, Omnitrope, Saizen, Tev-Tropin, Zorbtive
Continue to use the one additional clinical prior authorization question for specificproduct indications:
Are you using the non-preferred product for an FDA approved indication that isnot listed for a preferred agent?
Anti-Emetics Preferred Drugs ondansetron Non-preferred Drugs Anzemet, granisetron, Granisol, Kytril, Sancuso, Zofran, Zuplenz Proton pump Inhibitors Preferred Drugs Nexium, omeprazole OTC, omeprazole Rx, pantoprazole, Prilosec OTC Non-preferred Drugs Aciphex, Dexilant, lansoprazole Rx, Nexium Packet, omeprazole/sodium bicarbonate Rx, Prevacid OTC, Prevacid Rx, Prilosec Rx, Protonix Sulfasalazine Derivatives Preferred Drugs Apriso, Asacol, Dipentum, Pentasa, sulfasalazine IR, sulfasalazine DR/ER Non-preferred Drugs Asacol HD, Azulfidine, Azulfidine Entab, balsalazide, Colazal, Lialda Intranasal Corticosteroids Preferred Drugs Nasacort AQ Non-preferred Drugs
Beconase AQ, Flonase, flunisolide, fluticasone, Nasonex, Omnaris,Rhinocort Aqua, Veramyst
G. Final Determinations
The Commissioner has determined that the Medicaid program will require prior authorizationunder the Preferred Drug Program (PDP) for non-preferred products in each of the drug classesas listed in Section F.
Preferred Drugs will not require prior authorization
The impact of this final determination is as follows:
Minimal effect on Medicaid enrollees, as a large majority of enrollees currently utilize
Non-preferred products remain available with prior authorization.
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-preferredproducts. Pharmacies will need to complete the prior authorization process as required.
Annual gross savings associated with these therapeutic classes under the PDP are
estimated at $31M. The savings are achieved through changes in utilization to equallyeffective and less expensive products including the receipt of supplemental rebates frompharmaceutical manufacturers.
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