Connecticut Medical Assistance Pharmacy Program Drug Utilization Review (DUR) Program DUR Board Meeting

Transcription

1 December 2011 Minutes ATTENDEES Board Members Present: Kenneth Fisher, R.Ph. (Chair), Keith Lyke R.Ph., Dennis Chapron, M.S., Richard Gannon, Pharm.D., Bhupesh Mangla, M.D., Ram Illindala, M.D., Angela Moemeka, M.D., F.A.A.P, Carol Drufva, R.Ph. Ex-Officio Non-Voting Member Present: Heather L. Kissinger, Pharm. D. (HID DUR Board Coordinator and Secretary), James Zakszewski, R.Ph. (DSS), Ellen Arce, R.Ph. (HP) Guests: Terry Lee (Gilead), Ron Menapace (Sunovion), Cecile Hearult (Astellas Pharma), Pat Cambray (Astellas Pharma) INTRODUCTORY BUSINESS Ken Fisher called the meeting to order at 6:35 p.m. Ken requested to know what constitutes a quorum for the DUR Board meetings and stated that beginning in March 2012, once the number of members that constitutes a quorum was present, the meetings would begin whether or not all members were present. OLD BUSINESS A. Previous Meeting Minutes It was requested to correct the spelling of Dunny to Downey under guests on page one. It was requested to add of to the third bullet point on page six so the sentence would read: Exercise caution when prescribing antipsychotics in patients with a history of seizure disorders. It was requested to change March to September in the last bullet point on page seven. The September 2011 DUR Board meeting minutes were approved with changes by all members. B. Follow-Up from Previous Meeting The Board reviewed section 3 titled Follow-up from the September

2 December 2011 Minutes Follow-up 1, a request was made to know the days supply required for criteria 3179 and what specific antipsychotic medications the patient needed to be on in order for the criteria to flag patients. Heather Kissinger stated that the day supply is 30 days in the most current 90 days and all atypical antipsychotics are flagged. Follow-up 2, a request was made to create a new criterion regarding the therapeutic appropriateness of Ketorolac Nasal Spray in patients diagnosed with renal impairment, moderate to severe or NYHA class III and IV congestive heart failure, and/or ascites. Heather stated that Connecticut has 3 criteria turned on that look at the above: o Criteria 188 NSAIDS / Renal Impairment o Criteria 194 NSAIDS / Heart Failure o Criteria 197 NSAIDS / Hepatic Impairment Follow-up 3, a request was made to know if there are specific ICD-9 codes for the NYHA classifications of heart failure. Heather stated that ICD-9 does not specify the different NYHA classes of heart failure. ( Follow-up 4, a request was made to know why the other strong inducers were not included in Util B of the new criteria below: 24. Ezogabine / Phenytoin & Carbamazepine Alert Message: The concurrent use of Potiga (ezogabine) with phenytoin or carbamazepine may result in reduced ezogabine plasma levels. An increase in dosage of ezogabine should be considered when adding phenytoin or carbamazepine. Drugs/Diseases Util A Util B Util C Ezogabine Phenytoin Carbamazepine Rifampin Ritonavir Efavirenz **Approved as amended with the addition of the other strong inducers Nevirapine Dexamethasone Phenobarbital References: Potiga Prescribing Information, June 2011, Valeant Pharma. 2

3 December 2011 Minutes Heather stated that the interaction between ezogabine and carbamazepine or phenytoin is a UGTmediated interaction not a CYP3A4 interaction. The studies that the manufacturer did conduct with other UGT inducers (topiramate, valproate, phenobarbital, lamotrigine, zonisamide, clonazepam, gabapentin, levetiracetam, oxcarbazepine, pregabalin, and clobazam) showed that UGT inducers decreased ezogabine levels but not to the degree to warrant recommending dosage increases except with carbamazepine and phenytoin. Follow-up 5, a request was made to have the Util categories used for HID s criteria explained. Util A The util must contain a drug and the drug must have a claim in the most current cycle and meet the day supply requirement set for it (x days in most current 90 days). Util B - The util can contain a drug and/or a diagnosis code, the drug must meet the day supply requirement like the drug in util A, there must be 1 occurrence of the diagnosis. For a drug/drug interaction the two drugs must occur within 25 days of each other as well as meet the day supply requirement. Util C The util may include a drug and/or a diagnosis code, it can be coded to be included or excluded (required for criteria to hit or negate a criteria). Day supply must be 1 or more, diagnosis icd-9code of at least 1. C. Criteria Trend Summary Heather Kissinger stated that section 4 is the criteria trend summary, the purpose of this report is to review criteria previously reviewed 6 months after intervention letters are mailed to evaluate if the intervention had an impact on the population. For the Adult reviews: Criteria 1119 (Alert Message: Cyclobenzaprine should be used only for short periods (up to two or three weeks) because adequate evidence for more prolonged use is not available. Muscle spasm associated with acute painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted) had 1,979 hits in April 2011 and increased to 2,016 hits in October Criteria 723 (Alert Message: The concurrent use of tramadol or tramadol-containing products and opioid-type analgesics may result in increased CNS and respiratory depression. The manufacturer recommends that reduced doses of tramadol be used when it is administered with other CNS depressants. This combination may also result in an increased risk of seizures) had 910 hits in May 2011 and decreased to 688 hits in November

4 December 2011 Minutes The polypharmacy Intervention had 763 hits in June 2011 and decreased to 576 hits in December Of those 576 patients in December, only 226 of them were from the original list. Bhupesh Mangla commented that the polypharmacy intervention had a positive impact. Angela Moemeka asked if there was a way we could look at the number of patients who hit on a criteria 6 months post intervention that were from the original list of patients reviewed for all the other criteria, to obtain a more refined view of the patients originally targeted. Heather stated she would look into that request. Jim Zakszewski asked if all prescriptions were counted for the patients who were reviewed for the polypharmacy intervention, even the prescriptions that were taper doses. Heather stated that any single prescription was counted as one when targeting the patients for the polypharmacy intervention. For the Pediatric Reviews: Criteria 5960 (Alert Message: The Connecticut DCF Psychotropic Medication Monitoring Guidelines recommend that all children and adolescents on an SSRI should have follow-up every 3 months for height, weight, BMI, blood pressure and pulse. Consider pregnancy testing in females of child-bearing potential) had 975 hits in April 2011 and decreased to 675 hits in October Criteria 86 (Alert Message: Stimulants may be over-utilized.) had 130 hits in May 2011 and decreased to 80 hits in November Criteria 2783 (Alert Message: Stimulants are contraindicated in patients with marked anxiety, agitation and tension since the drugs may aggravate these symptoms) had 440 hits in May 2011 and decreased to 341 hits in November Criteria 2815 (Alert Message: Particular care should be taken when using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder, such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder and depression) had 168 hits in May 2011 and decreased to 138 hits in November Criteria 5954 (Alert Message: The Connecticut DCF Psychotropic Medication Monitoring Guidelines recommend that, if possible, benzodiazepine therapy should be for short-term therapy 4

5 December 2011 Minutes in children and adolescents. Patients receiving benzodiazepines should be monitored for behavioral disinhibition, drowsiness, dizziness, sedation and cognitive blunting) had 235 hits in May 2011 and decreased to 134 hits in November Criteria 611 (Alert Message: The efficacy of Proton Pump Inhibitors (PPIs) and H-2 antagonists in relieving symptoms of mild to moderate GERD and resolving PUD is essentially equal. If appropriate for this patient, your assistance in changing drug therapy to a less expensive H-2 antagonist would result in significant cost savings per patient per month. Certainly for patients with a more severe level of GERD, PPIs would be indicated) had 677 hits in June 2011 and decreased to 442 hits in December Dennis Chapron requested to know if there was any evidence of a decrease in bone density in pediatric patients who received PPIs as well as any other adverse events associated with the class in the pediatric population. Heather stated she would perform a literature search to obtain information. Ken Fisher asked if new criteria would be developed based on any information found. Heather stated that if there was enough evidence to support new criteria development and if the Board requested it to be created, it could be done. Dennis also stated that 10% of patients develop microscopic colitis while on a PPI and once the PPI is discontinued, the colitis resolves. Retrospective Drug Utilization Review A. Program Summary Review The Board reviewed the program summary for 2 nd and 3 rd quarter 2011 in section 5. Rich Gannon requested to have four quarters of data present in the program summary instead of two. Heather stated that during 3 rd QTR 2011 prescription claims cost decreased, the number of prescriptions filled decreased, the total number of unique recipients receiving a prescription decreased, but the average cost per prescription increased when compared to 2 nd quarter Keith Lyke asked why there was a decrease of about 30,000 patients receiving prescriptions from 2 nd to 3 rd QTR. Jim stated that it may have been from the ConnPACE phase out or more patients becoming dually eligible for both Medicare and Medicaid. 5

6 December 2011 Minutes Angela asked what would make the cost per prescription increase so dramatically from 2 nd to 3 rd quarter if both the prescription claims cost and number of patients receiving prescriptions decreased, were there any new drugs released to the market that would make the cost rise sharply or was there an increase in utilization of more expensive products from 2 nd to 3 rd QTR. Heather stated she would send the members the top 50 drugs by cost list for the past 3 quarters to try and determine if the increase in the average cost per prescription was due to an increase in utilization of any of the top 50 drugs. The Board reviewed page 2 and 3 of the program summary. Heather stated the chart and graphs show the month to month fluctuation in number of recipients, number of prescriptions, prescription claims cost, cost per member per month, and cost per claim. Jim requested that the graphs below the chart begin their Y axes higher up and the points on the graph be closer together to show more detail of the month to month fluctuations. Heather stated she would follow-up. B. Intervention Activity Report The Board reviewed the Intervention Activity report for 3 rd quarter 2011 in section 6. It was stated that the Intervention Activity Report is a monthly summary of the distribution of letters mailed to prescribers and also summarizes the main criteria that were reviewed each month. In July 2011, 2,829 letters were sent. The main interventions reviewed for the adult population were: Therapeutic duplication of NSAID agents and/or COX2 inhibitors may be occurring. (793 Letters) Lock-in criteria (728 letters) The main intervention reviewed for the pediatric population was: The Connecticut DCF Psychotropic Medication Monitoring Guidelines recommend that all children and adolescents on an atypical antipsychotic should have a fasting lipid profile, fasting glucose, and LFTs at 3 months and then every 6 months. (430 Letters) In August 2011, 2,793 letters were sent. The main interventions reviewed for the adult population was: 6

7 December 2011 Minutes Coadministration of bupropion and drugs metabolized by P450 isoenzyme 2D6 should be approached with caution. Bupropion may inhibit the metabolism of 2D6 substrate drugs such as nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline, haloperidol, risperidone, thioridazine, metoprolol, propafenone, and flecainide. Consider using lower doses of these interacting medications if giving bupropion concomitantly. (888Letters) Lock-in criteria (677 letters) The main intervention reviewed for the pediatric population was: The Connecticut DCF Psychotropic Medication Monitoring Guidelines recommend that all children and adolescents on an atypical antipsychotic should have a fasting lipid profile, fasting glucose, and LFTs at 3 months and then every 6 months. (568 Letters) In September 2011, 2,759 letters were sent. The main intervention reviewed for the adult population was: It appears that the patient may be receiving long-term therapy of short-acting opioid pain relievers in the absence of any long-acting analgesics. When treating chronic severe pain, it is typically recommended that a continuous baseline of pain coverage be established by using a long-acting opioid. This is supplemented with the addition of an immediate-release product for breakthrough pain control. If the long-acting opioid is properly adjusted and dosed on a scheduled basis, breakthrough medication should only be necessary 1 or 2 times daily, based on the patient's activity. (683 Letters) Lock-in criteria (713 letters) The main intervention reviewed for the pediatric population was: Inappropriate Pediatric Therapy. (455 Letters) C. RetroDUR Criteria New Criteria Criteria 1, Tapentadol ER / Overutilization was approved as Criteria 2, Indacaterol / Overutilization was approved as Criteria 3, Indacaterol / Long-Acting Beta2-Agonists was approved as Criteria 4, Indacaterol / Adrenergic Drugs was approved as Criteria 5, Indacaterol / Xanthines Derivatives, Steroids & K+ Sparing Diuretics was approved as 7

8 December 2011 Minutes Criteria 6, Indacaterol / Non-Potassium Sparing Diuretics was approved as Criteria 7, Indacaterol / Nonselective Beta Blockers (Oral & Ophthalmic) was approved as Criteria 8, Indacaterol / Cardiovascular, Convulsive Disorders, Thyrotoxicosis & Diabetes was approved as Criteria 9, Indacaterol / MAOIs, TCAs & QT Prolongation Agents was approved as written by Criteria 10, Nelfinavir / Contraindicated Drugs was approved as Criteria 11, Zocor & Vytorin & Juvisync / Diltiazem was approved as AGE RELATED CRITERIA Criteria 1, Fexofenadine Suspension / Overuse (2-11 yoa) was approved as Criteria 2, Fexofenadine Suspension / Overuse (0-1 yoa) was approved as Criteria 3, Fexofenadine Suspension / Renal Impairment (2-11 yoa) was approved as written by Criteria 4, Fexofenadine Suspension / Renal Impairment (< 2 yoa) was approved as written by Criteria 5, Fexofenadine-Pseudoephedrine 24 / Therapeutic Appropriateness (<12 yoa) was approved as Criteria 6, Fexofenadine-Pseudoephedrine 12 / Therapeutic Appropriateness (<12 yoa) was approved as Criteria 7, Cetirizine-Pseudoephedrine 12 / Therapeutic Appropriateness (<12 yoa) was approved as Criteria 8, Cetirizine / Therapeutic Appropriateness (< 2 yoa) was approved as written by the Criteria 9, Cetirizine / Therapeutic Appropriateness ( 77 yoa) was approved as written by the Criteria 10, Desvenlafaxine / Therapeutic Appropriateness (< 19 yoa) was approved as written by Criteria 11, Milnacipran / Therapeutic Appropriateness (< 17 yoa) was approved as written by 8

9 December 2011 Minutes Criteria 12, Venlafaxine XR / Therapeutic Appropriateness (< 19 yoa) was approved as written by Criteria 13, Bupropion / Therapeutic Appropriateness (< 19 yoa) was rejected by Criteria 14, Protopic & Elidel / Therapeutic Appropriateness (<2 yoa) was rejected by Criteria 15, Protopic 0.1% / Therapeutic Appropriateness (2-15 yoa) was approved as written by Criteria 16, Elidel / Immunocompromised Patients was approved as Criteria 17, Protopic / Immunocompromised Patients was approved as Criteria 18, Spinosad / Therapeutic Appropriateness (< 4 yoa) was approved as written by the Criteria 19, Adapalene / Therapeutic Appropriateness (< 12 yoa) was approved as written by the Criteria 20, Tazarotene Cream-Avage / Therapeutic Appropriateness (< 17 yoa) was approved as Criteria 21, Tazarotene Gel 0.05% & 0.1% / Therapeutic Appropriateness (< 12 yoa) was approved as Criteria 22, Tazarotene Cream-Tazorac 0.05 & 0.01 / Therapeutic Appropriateness (< 12 yoa) was approved as Criteria 23, Acitretin / Therapeutic Appropriateness (< 19 yoa) was approved as written by the Criteria 24, Isotretinoin / Therapeutic Appropriateness (< 12 yoa) was approved as written by the Criteria 25, Isotretinoin / Therapeutic Appropriateness (12-17 yoa) was approved as written by Criteria 26, Intuniv / ADHD (6-17 yoa) was rejected by Criteria 27, Intuniv / Therapeutic Appropriateness (< 6 yoa) was approved as written by the Heather stated she would look into the age range for utilization of Intuniv since the recent change in age range for use of stimulant medications in the pediatric population. Criteria 28, Intuniv / Non-adherence was approved as Criteria 29, Intuniv / Guanfacine IR was approved as Criteria 30, Intuniv / Other Antihypertensives was approved as 9

10 December 2011 Minutes Criteria 31, Guanfacine / Strong CYP3A4/5 Inhibitors was approved as Criteria 32, Guanfacine / CYP3A4 Inducers was approved as Criteria 33, Guanfacine / Valproic Acid was approved as Criteria 34, Guanfacine /CNS Depressants was approved as Criteria 35, ADHD Stimulants / High Dose was tabled by Criteria 36, High Dose ADHD Stimulants / Alpha Agonists was tabled by Criteria 37, High Dose ADHD Stimulants / Atypical Antipsychotics was tabled by It was requested to reword criteria 35, 36, and 37 and have the last sentence be placed as the 2 nd sentence for better flow. The Board requested to review these 3 criteria again at the March 2012 meeting. Criteria 38, Alcaftadine / Therapeutic Appropriateness was approved as Criteria 39, Azelastine-Ophthalmic / Therapeutic Appropriateness (< 3 yoa) was approved as Criteria 40, Azelastine-Nasal (Astelin) / Therapeutic Appropriateness (< 5 yoa) was approved as Criteria 41, Azelastine-Nasal (Astepro) / Therapeutic Appropriateness (< 12 yoa) was approved as Criteria 42, Emedastine / Therapeutic Appropriateness (< 3 yoa) was approved as written by the Criteria 43, Epinastine / Therapeutic Appropriateness (< 3 yoa) was approved as written by the Criteria 44, Ketotifen / Therapeutic Appropriateness (< 3 yoa) was approved as written by the Criteria 45, Olopatadine-Ophthalmic 0.1% / Therapeutic Appropriateness (< 3 yoa) was approved as Criteria 46, Olopatadine-Ophthalmic 0.2% / Therapeutic Appropriateness (< 2 yoa) was approved as Criteria 47, Olopatadine-Nasal / Therapeutic Appropriateness (< 6 yoa) was approved as written by Criteria 48, Beclomethasone Intranasal / Therapeutic Appropriateness (< 6 yoa) was approved as 10

11 December 2011 Minutes Criteria 49, Budesonide Intranasal / Therapeutic Appropriateness (< 6 yoa) was approved as Criteria 50, Ciclesonide Intranasal / Therapeutic Appropriateness-Allergic Rhinitis (< 6 yoa) was approved as Criteria 51, Ciclesonide Intranasal / Therapeutic Appropriateness Perennial Rhinitis (< 12 yoa) was approved as Criteria 52, Flunisolide Intranasal / Therapeutic Appropriateness (< 6 yoa) was approved as Criteria 53, Veramyst - Fluticasone Intranasal / Therapeutic Appropriateness (< 2 yoa) was approved as Criteria 54, Flonase-Fluticasone Intranasal / Therapeutic Appropriateness (< 4 yoa) was approved as Criteria 55, Mometasone Intranasal / Therapeutic Appropriateness (< 2 yoa) was approved as Criteria 56, Mometasone Intranasal / Therapeutic Appropriateness (< 18 yoa) was approved as Criteria 57, Triamcinolone Intranasal / Therapeutic Appropriateness (< 2 yoa) was approved as Criteria 58, Intranasal Corticosteroids/ Therapeutic Appropriateness (<19 yoa) was rejected by Criteria 59, Beclomethasone-Inhalation / Therapeutic Appropriateness (< 5 yoa) was approved as Criteria 60, Budesonide Pulmicort Flexhaler / Therapeutic Appropriateness (< 6 yoa) was approved as Criteria 61, Alvesco - Ciclesonide / Therapeutic Appropriateness (< 12 yoa) was approved as Criteria 62, Fluticasone Propionate / Therapeutic Appropriateness (< 4 yoa) was approved as Criteria 63, Mometasone-Asmanex / Therapeutic Appropriateness (< 4 yoa) was approved as Criteria 64, Inhaled Corticosteroids/ Therapeutic Appropriateness (<19 yoa) was rejected by the Board 11

12 December 2011 Minutes Criteria 65, Omalizumab / Therapeutic Appropriateness (< 12 yoa) was approved as written by Criteria 66, Mometasone-Formoterol / Therapeutic Appropriateness (< 12 yoa) was approved as Criteria 67, Advair Diskus / Therapeutic Appropriateness was approved as Criteria 68, Advair HFA / Therapeutic Appropriateness was tabled by A request was made to know why Advair HFA cannot be used in patients < 12 years of age but Advair diskus is not to be used in patients < 4 years of age. Criteria 69, Budesonide-Formoterol / Therapeutic Appropriateness (< 12 yoa) was approved as Criteria 70, Zileuton / Therapeutic Appropriateness (< 12 yoa) was approved as written by the Criteria 71, Zafirlukast / Therapeutic Appropriateness (< 5 yoa) was approved as written by the Criteria 72, Montelukast / Therapeutic Appropriateness (< 2 yoa) was approved as written by the Criteria 73, Montelukast / Therapeutic Appropriateness (< 15 yoa) was rejected by the Board Criteria 74, Zafirlukast / Therapeutic Appropriateness (5-11 yoa) was approved as written by the Criteria 75, Zafirlukast / Therapeutic Appropriateness ( yoa) was approved as written by Criteria 76, Zileuton / Therapeutic Appropriateness ( yoa) was approved as amended by the Board with the addition of daily to the alert message. Criteria 77, Montelukast / Therapeutic Appropriateness ( yoa) was approved as amended by the Board with the addition of daily to the alert message. Criteria 78, Montelukast / Therapeutic Appropriateness (6-14 yoa) was approved as amended by the Board with the addition of daily to the alert message. Criteria 79, Montelukast / Therapeutic Appropriateness (2-5 yoa) was approved as amended by the Board with the addition of daily to the alert message. Criteria 80, Montelukast / Therapeutic Appropriateness (< 2 yoa) was approved as amended by the Board with the addition of daily to the alert message. 12

13 December 2011 Minutes D. Newsletter The Board approved the December 2011 DUR Newsletter with the following modifications: o Page1, add main heading to read: Special Storage and Handling and make Pradaxa (dabigatran) as a sub heading. o Page 2, Change the heading to read: Proper Storage of Reconstituted and Liquid Antibiotics The Board agreed that the newsletter would be approved once those changes were made. Heather stated that DSS was interested in the March 2012 newsletter covering Troubling Patterns of Antibiotic use. The Board agreed that this topic would be good to write about for the upcoming newsletter. Bhupesh suggested the newsletter include information regarding antibiotic cycling and antibiotic freezes. Angela suggested that the newsletter be more specific than just an overview of antibiotic overutilization. Heather stated she would run queries to give a breakdown of antibiotic use specific to the Connecticut population and include this information in the newsletter. NEW BUSINESS Jim stated that there has been a recent push by the Federal Government to begin reviewing psychotropic medication use in the pediatric population and we are ahead of the curve due to the implementation of pediatric Retro DUR in July Heather stated she would send the Board members the letter from the Department of Health and Human Services detailing this effort. Ken requested that the 2012 DUR Board meeting dates be sent to the members. Heather stated she would send the meeting dates to the members and post the dates on the web ( The meeting was adjourned at 8:20 pm. 13