March 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., Charles Caley, Pharm.D. 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: Wendy Pollinger (Eli Lilly), Adam Denman (GlaxoSmithKline) INTRODUCTORY BUSINESS Ken Fisher called the meeting to order at 6:45 p.m. OLD BUSINESS A. Previous Meeting Minutes It was requested to change the fourth bullet point from the bottom on page two, move and so the point reads Ken Fisher and Bhupesh Mangla It was requested to correct the spelling of linked on the sixth bullet point on page three. It was requested to correct the spelling of oxcarbazepine on the fourteenth bullet point on page three. It was requested to change indiacted to indicated on the fourth bullet point on page four. It was requested to change note to noted on the tenth bullet point on page four. I was requested to change that is to if on the thirteenth bullet point on page four. It was requested to change generic to genetic on the fifteenth bullet point on page four. The December 2010 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 2010. Follow-up 1, a request was made for the Pharmacy team at HP to review the Drug-Drug and Therapeutic Duplication ProDUR Alerts. 1
March 2011 Minutes Ellen Arce stated this request would be worked on and followed up with during the June 2011 DUR Board meeting. Follow-up 2, a request was made to know why prenatal vitamins were the top drug class causing the pregnancy precautions alert to set (found on page 38 of the FFY 2009 CMS Report). Ellen Arce stated this request would be worked on and followed up with during the June 2011 DUR Board meeting. Follow-up 3, a request was made to know how many claims for Suboxone were processed for more than 16mg per day during a 3 month period in time. Heather Kissinger stated that from 5/20/2010 through 8/20/2010 there were 4390 claims for Suboxone 8 mg products where patients were receiving more than 16 mg per day. The claims for doses greater than 16 mg/day totaled $1,312,984.64 during the 3 month period. Bhupesh asked to know what percentage of patients were taking more than the recommended 16 mg per day. Heather said she would report back to the Board. Jim Zakszewski asked what the normal duration is for suboxone therapy and Dennis Chapron asked the difference between suboxone treatment and methadone when treating opioid dependence. Rich Gannon stated that some patients may be on Suboxone for extended periods of time and the difference between suboxone and methadone treatments may be that suboxone is used more in private practice settings where methadone is given out at dispensaries. He also added that a new patch form of buprenorphine just came on to the market, Butrans, but the dose is very low. Rich also stated that doses greater than 16 mg/day of suboxone may be necessary in some patients. Charlie Caley stated that when treating substance abuse no available treatment guarantees relapse prevention and sustained psychological treatment programs are necessary to help patients with their addictions. Ram Illindala stated that reimbursement for psychiatric counseling is so low; physicians tend to not perform the counseling. Bhupesh Mangla stated that support for better reimbursement and counseling will offer a better treatment environment for patients and the patients may be more receptive. Jim Zakszewski agreed. 2
March 2011 Minutes Follow-up 4, the board requested the polypharmacy intervention target patients who consecutively received 15 or more medications in a single month over the course of 3 months. Heather Kissinger stated the intervention is set to be performed after the March 2011 meeting and in October 3010 patients received 15 or more medications, in November 3167 patients received 15 or more medications, and in December 3078 patients received 15 or more medications. The polypharmacy intervention will target approximately 3,000 patients over the course of 3 months. Follow-up 5, a request was made to pair the polypharmacy intervention scheduled to follow the March 2011 with a newsletter about medication use in the elderly, the Beers List, and also include a small section recapping the polypharmacy newsletter sent in June 2010. Heather Kissinger stated the newsletter could be found in section eight of the Board meeting packets and would be reviewed later during the meeting. Follow-up 6, a request was made to know if on the patient profiles physicians receive for targeted interventions, are other physician NPIs displayed on the profile. Heather Kissinger stated the other prescriber NPIs are listed on the patient profile that is sent to a physician for a targeted intervention. Follow up 7, a request was made to make the following changes to the fentanyl PA form: o Add (18 years or greater for Onsolis) next to requirement number 2 o Add a sixth requirement for use that states patient may not receive greater than 4 doses per day o Change the PA help desk phone number to the HP PA help desk Once the changes are made the PA form will be send to DSS. Heather stated Abstral was also added to the PA form, Abstral is the newest fentanyl citrate product released to the market a few months ago. Heather passed out the updated PA form along with the notification letter to providers informing them of the PA implementation. The Board requested to bold and underline current in the section of the PA form where it asks the provider to list all current opioid therapy and duration of use. It was also requested to add an additional line for the providers to list the current opioid therapies their patient is receiving. Heather stated the requested changes would be made to the form. 3
March 2011 Minutes Follow up 8, a request was made to know if beta blockers with alpha-1 blocking potential (labetalol and carvedilol) pose a therapeutic duplication risk with alpha-1 blocking drugs. Heather directed the Board to review attachment B; mechanism of action information and drugdrug interaction. The drug information appears to list the interaction as moderate; however, it does not state specifically that the interaction between beta blockers with alpha blocking potential when used with alpha blockers is due to the additive alpha blocking potential. Follow up 9, a request was made to know all criteria turned on for CT with a Problem code 108 - Drug contraindicated in pregnancy. Heather Kissinger directed the Board to review attachment C. The Board requested to have the title of Problem Code 108 changed to read Drugs cautioned or contraindicated in pregnancy. It was also requested to delete any criteria under Problem Code 108 that was pregnancy category B or C. Jim requested the other drugs that cause fetal hydantoin syndrome (phenytoin, primidone, valproate, carbamazepine, and trimethadione) be added to criteria 461. Charlie asked to also add oxcarbamazepine to the alert message. Heather stated she would complete the requests. Jim questioned if criteria 431, regarding nicotine replacement therapy use in pregnancy, be removed from the criteria list due to the recent change in coverage for all smoking cessation products for Medicaid patients. The Board pointed out the criteria states that nicotine is FDA pregnancy category D and is not recommended for use in pregnancy. They did not recommend the removal of criteria 431. Dennis stated that Topamax was recently changed from category C to category D when used in pregnancy. Heather stated she would check with the criteria manager, Pam DeRuiter, to have the current criteria changed. 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: 4
March 2011 Minutes Criteria 1598 (Alert Message: Nonadherence to the prescribed antihypertensive regimen may result in poor blood pressure control, disease progression and additional health care costs) had 1070 hits in April 2010 and increased to 1445 hits in October 2010. Criteria 1073 (Alert message: Therapeutic duplication of antihistamine agents may be occurring) had 886 hits in May 2010 and decreased to 183 hits in November 2010. Criteria 1603, (Therapeutic duplication of salmeterol products may be occurring. Large doses of salmeterol have been associated with increases in heart rate, significant reduction in diastolic pressure, and prolongation of QTc interval which may potentially produce life-threatening arrhythmias.) had 164 hits in May 2010 and decreased to 76 hits in November 2010. Criteria 1679, (Alert message: Therapeutic duplication of intranasal steroids may be occurring) had 52 hit in May 2010 and decreased to 29 hits in November 2010. Criteria 809, (Alert message: The profile history indicates that the patient has a diagnosis of osteoporosis and is receiving sedative/anxiolytic therapy. The use of sedatives and/or anxiolytic therapy may result in increased sedation. In patients with osteoporosis this may increase the risk of falls and fractures. This patient may be at risk since they are not currently receiving treatment for osteoporosis) had 237 hit in June 2010 and decreased to 217 hits in December 2010. Criteria 810, (Alert message: The profile history indicates that the patient has a diagnosis of osteoporosis and is receiving narcotic therapy. The use of narcotic therapy may result in increased sedation. In patients with osteoporosis this may increase the risk of falls and fractures. This patient may be particularly at risk since they are not currently receiving treatment for osteoporosis) had 106 hits in June 2010 and decreased to 70 hits in December 2010. Criteria 811, (Alert message: The profile history indicates that the patient has a diagnosis of osteoporosis and is receiving corticosteroid therapy. Corticosteroid therapy in patients with osteoporosis may increase the risk of fractures due to decreased bone density associated with corticosteroid use. This patient may be particularly at risk since they are not currently receiving treatment for osteoporosis) had 46 hits in June 2010 and decreased to 32 hits in December 2010. Criteria 1262, (Alert message: The profile history indicates that the patient has a diagnosis of osteoporosis and is receiving sedative/anxiolytic therapy. The use of sedative and/or anxiolytic therapy may cause dizziness and grogginess which can put the patient at increased risk for fallrelated injuries) had 419 hits in June 2010 and decreased to 363 hits in December 2010. Criteria 1264, (Alert message: The profile history indicates that the patient has a diagnosis of osteoporosis and is receiving corticosteroid therapy. Corticosteroid therapy may increase the 5
March 2011 Minutes risk of fractures in patients with osteoporosis due to decreased bone density associated with corticosteroid use) had 84 hits in June 2010 and decreased to 69 hits in December 2010. Criteria 113, (Alert message: Diuretic agents may cause or exacerbate hyperuricemia) had 472 hits in July 2010 and decreased to 228 hits in January 2011. Criteria 948, (Alert message: Antibiotics may decrease the effectiveness of oral and transdermal contraceptives by altering intestinal flora and/or estrogen plasma concentrations. When used to prevent pregnancy, it is recommended that additional contraceptive precautions be used for the entire duration of therapy and for 7 days after a short course of any antibiotic) had 96 hits in July 2010 and decreased to 77 hits in January 2011. Criteria 797, (Alert message: Certain medications can cause induction of liver enzymes and speed the metabolism of oral, transdermal and vaginal contraceptives. A partial list includes: barbiturates, phenytoin, carbamazepine, felbamate, oxcarbazine, and St John's Wort. Use caution when using these drugs concomitantly as they may decrease effectiveness of the contraceptives. An alternative method of contraception may be necessary) had 103 hits in July 2010 and decreased to 62 hits in January 2011. Criteria 2959, (Alert message: Anticholinergic agents may cause or worsen dry eye. A patient receiving an anticholinergic drug concurrently with Restasis (ophthalmic cyclosporine) may not experience the optimal therapeutic effect of the ophthalmic cyclosporine) had 48 hits in July 2010 and decreased to 37 hits in January 2011. Criteria 619, (Alert message: Therapeutic duplication of HMG CoA reductase inhibitors may be occurring) had 496 hits in August 2010 and decreased to 281 hits in February 2011. Criteria 631, (Alert message: Therapeutic duplication of beta-blockers may be occurring) had 523 hits in August 2010 and decreased to 392 hits in February 2011. For the Pediatric Reviews: Problem Code 186 (Inappropriate Pediatric Therapy) had 1804 hits in July and August and decreased to 1726 hits in February 2011. Rich asked if HID performed the pediatric intervention warning physicians of metabolic syndrome when using atypical antipsychotics. Heather stated that intervention was performed in November 2010, December 2010, and January 2011. 6
Retrospective Drug Utilization Review March 2011 Minutes A. Program Summary Review The Board reviewed the program summary review for 3 rd and 4 th quarter 2010 in section 5. Heather Kissinger stated that during 3 rd QTR 2010 prescription claims cost, the number of prescriptions filled, the total number of unique recipients, and the cost of recipient per month decreased when compared to the 2 nd quarter 2010. The cost paid per prescription increased when compared to the 2 nd quarter 2010. Charlie asked where Connecticut fell in comparison with other states with regard to per member per month cost. Ellen said that information is published by Kaiser Permanente. Heather Kissinger stated that during the 4 th QTR 2010 the number of prescriptions filled decreased, but prescription claims cost, total number of unique recipients, the cost of recipient per month, and the cost paid per prescription all increased when compared to the 3 rd QTR. Dennis stated that $160,000,000 per quarter was a lot to spend on prescriptions alone. He asked if this was taken into consideration when budgets were discussed. Both Jim and Ellen responded and pointed out that these figures don t take into consideration the amount the State receives from drug rebate. Ellen stated that the State received about $60,000,000 per quarter in rebate dollars. Jim stated that all drugs are covered under Medicaid and on the Preferred Drug List if they are subject to federal rebate. He invited the Board members to the next P&T meeting to show how drugs are added or removed from the PDL. Ken asked if Heather would send an e-mail informing the members of the next P&T meeting as the date gets closer. B. Intervention Activity Report The Board reviewed the Intervention Activity report for 3 rd and 4 th quarter 2010 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 2010, 2969 letters were sent. The main interventions reviewed for the adult population were: 7
March 2011 Minutes Therapeutic duplication of HMG CoA reductase inhibitors may be occurring.( 322 letters) Therapeutic duplication of beta-blockers may be occurring. (283 letters) Lock-in criteria (830 letters) The main intervention reviewed for the pediatric population was: Inappropriate Pediatric Therapy (350 letters) In August 2010, 2692 letters were sent. The main interventions reviewed for the adult population was: The accredited medical literature does not suggest that the COX-2s have an efficacy advantage over the non-selective NSAIDS. Non-selective NSAIDS should remain first line therapy. Cost effectively, COX-2 inhibitors should be reserved for patients in which bleeding is a readily apparent concern and for patients who have demonstrated an inability to tolerate other NSAIDS due to gastrointestinal bleeding or ulceration. COX-2s and NSAIDS should not be used concurrently. The hemorrhagic protective benefit is negated when even small doses of nonselective NSAIDS are utilized. (276 letters) Lock-in criteria (755 letters) The main interventions reviewed for the pediatric population were: Additive Sedation (57 letters) Anticonvulsant Interaction (46 letters) Overutilization (193 letters) Inappropriate Dosing Regimen (215 letters) In September 2010, 2800 letters were sent. The main intervention reviewed for the adult population was: Underutilization of Antidepressants (580 letters) Lock-in criteria (764 letters) The main intervention reviewed for the pediatric population was: The patient is under the age of 18 with a diagnosis of ADHD and is receiving an atypical antipsychotic with no evidence, in their diagnostic history, of a FDA approved indication for use. Atypical antipsychotics have not been shown to be safe and effective for the treatment of ADHD. These agents have significant adverse effects which can be more prevalent and severe in pediatric patients. (491 letters) In October 2010, 2437 letters were sent. The main intervention reviewed for the adult population was: 8
March 2011 Minutes Therapeutic duplication of benzodiazepine therapy may be occurring. (306 letters) Lock-in criteria (1152 letters) The main intervention reviewed for the pediatric population was: The effects of prolonged use of atypical antipsychotics in pediatric patients are unknown. Preliminary evidence suggests that pediatric patients experience more prevalent and severe adverse effects than those reported in adults (e.g., weight gain, extrapyramidal side effects, and insulin resistance). If therapy with these agents is clinically necessary use the lowest effective dose and observe patients closely for adverse events. If adverse effects cannot be controlled consider switching, if clinically possible, to a SGA with a more favorable adverse effect profile. (480 letters) In November 2010, 2031 letters were sent. The main intervention reviewed for the adult population was: Therapeutic duplication of benzodiazepine therapy may be occurring. (384 letters) Lock-in criteria (672 letters) The main intervention reviewed for the pediatric population was: The effects of prolonged use of atypical antipsychotics in pediatric patients are unknown. Preliminary evidence suggests that pediatric patients experience more prevalent and severe adverse effects than those reported in adults (e.g., weight gain, extrapyramidal side effects, and insulin resistance). If therapy with these agents is clinically necessary use the lowest effective dose and observe patients closely for adverse events. If adverse effects cannot be controlled consider switching, if clinically possible, to a SGA with a more favorable adverse effect profile. (472 letters) In December 2010, 3064 letters were sent. The main intervention reviewed for the adult population was: Therapeutic duplication of benzodiazepine therapy may be occurring. (601 letters) Lock-in criteria (723 letters) The main intervention reviewed for the pediatric population was: The effects of prolonged use of atypical antipsychotics in pediatric patients are unknown. Preliminary evidence suggests that pediatric patients experience more prevalent and severe adverse effects than those reported in adults (e.g., weight gain, extrapyramidal side effects, and insulin resistance). If therapy with these agents is clinically necessary use the lowest effective dose and observe patients closely for adverse events. If adverse effects cannot be 9
March 2011 Minutes controlled consider switching, if clinically possible, to a SGA with a more favorable adverse effect profile. (477 letters) C. RetroDUR Criteria New Criteria Criteria 1, Lurasidone /Overutilization was approved as written by the Board. Criteria 2, Lurasidone /Moderate & Severe renal and hepatic impairment was approved as written by the Board. Criteria 3, Lurasidone /Non-Adherence was approved as written by the Board. Criteria 4, Lurasidone /Strong CYP 3A4 Inhibitors was approved as written by the Board. Criteria 5, Lurasidone / Strong CYP 3A4 Inducers was approved as written by the Board. Criteria 6, Lurasidone/ Moderate 3A4 Inhibitors was approved as written by the Board. Criteria 7, Lurasidone/ Therapeutic Appropriateness was approved as written by the Board. Criteria 8, Kapvay/ Overuse was approved as written by the Board. Criteria 9, Kapvay/ Non-adherence was approved as written by the Board. Criteria 10, Kapvay /Therapeutic Duplication was approved as written by the Board. Criteria 11, Silenor/ Overuse was approved as written by the Board. D. Newsletter The Board approved the March 2011 DUR Newsletter with the following modifications: o Insert a table on the first page showing the top 10-15 drugs from the Beers 2003 list currently used by the Medicaid population The Board agreed that the newsletter would be approved once those changes were made. Dennis suggested the next newsletter pertain to top drugs that cause the most emergency room visits. NEW BUSINESS Heather stated Joseph Bordonaro had resigned from the DUR Board and is currently searching for a new member to replace Joe. Ken stated he may have someone who is interested and would e-mail Heather the contact. 10
March 2011 Minutes Ken reminded the members that the next DUR Board meeting is scheduled for Tuesday June 7, 2011 at 6:30 pm. The meeting was adjourned at 9:15 pm. 11