Idaho Medicaid Drug Utilization Review Program 19 April

Idaho Medicaid Drug Utilization Review Program 19 April 2012

Follow-up to Previous Reviews Citalopram High Dose Transdermal Testosterone Intervention Colchicine DUR Ketorolac DUR 2

Citalopram High Dose DUR FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide) On August 24, 2011, the Food and Drug Administration (FDA) released a Safety Announcement addressing the high dose of citalopram and potential adverse effects it can have on the heart. The maximum daily dose is now recommended to be 40 mg per day when it was previously 60 mg per day. A review of Idaho Medicaid Recipients showed that during the previous 3 months 234 recipients had received doses greater than 40 mg per day. 3

Citalopram High Dose DUR Letters were sent out about 235 patients on 10/6/2011 to 186 prescribers with a list of their patients along with the FDA Safety Announcement and Survey Response Form. (see Letter and Announcement in Packet) As of 4/11/2012, 60 responses have been received (32% response rate) 1 additional response since last DUR Meeting 4

Citalopram High Dose DUR: Response Detail as of 4/11/2012 Note that providers may choose more than one selection per response. Will use this information for care of future patients Reviewed info and have modified or plan to modify treatment Found Info clinically useful and plan to monitor patients Reviewed info and do not believe adjustment is necessary Will change dose Very useful to my practice Extremely useful to my practice Somewhat useful to my practice Not useful to my practice 29 28 22 19 19 18 15 10 6 5

Citalopram High Dose DUR: Response Detail as of 4/11/2012 Note that providers may choose more than one selection per response. Previously saw this patient, but no longer in my care 5 Attempted to modify therapy, but the patient response was not favorable Will discontinue medication Patient is under my care, but I am not prescriber for this med I am not the provider for this patient 5 3 2 1 6

Citalopram High Dose DUR: Response Detail as of 4/11/2012 (one additional comment from last meeting) “Pt is no longer on this. It was changed to Effexor when she was hospitalized, thanks. ” 7

Citalopram High Dose DUR Recommendations Decrease the maximum daily dose to the FDA recommended 40 mg. Require a quantity override Prior Authorization for any claims with a dose greater than 40 mg per day. 8

Citalopram High Dose DUR 2 patients currently receiving 60 mg daily Both times pharmacy overrode with: TD – Therapeutic Duplication M 0 – Prescriber consulted 1 G – Filled, prescriber approval Idaho Medicaid Pharmacy Clinical Call Center has been receiving PA requests for 60 mg stating patient is stable on current regimen with no mention of awareness of the new FDA Safety announcement. These requests are being denied. Example of recent PA request (see packet) 9

Citalopram High Dose DUR On March 28, 2012 the FDA sent out a revised Drug Safety Communication with updated recommendations: Recognition that although citalopram use should be avoided, if possible, in patients with certain conditions because of the risk of QT prolongation, ECG monitoring and/or electrolyte monitoring is recommended if citalopram must be used in such patients. Patients with congenital long QT syndrome are at particular risk of Torsade de Pointes, ventricular tachycardia, and sudden death when given drugs that prolong the QT interval. Nevertheless, the labeling recommendation for patients with congenital long QT syndrome has been changed from “contraindicated” to “not recommended, ” because it is recognized that there may be some patients with this condition who could benefit from a low dose of citalopram and who lack viable alternatives. The maximum recommended dose of citalopram is 20 mg per day for patients over the age of 60. Citalopram is recommended to be discontinued in patients who are found to have persistent QTc measurements greater than 500 ms. 10

Citalopram High Dose DUR Report ran looking at data from 1/1/2012 to 3/25/2012 and there were 76 recipients receiving 40 mg of citalopram daily who were over the age of 60. Should a new Retro. Dur activity be done on this patient population? 11

Transdermal Testosterone Intervention The Idaho Medicaid Pharmacy and Therapeutics Committee recommended that therapeutic criteria be set up on this class of medication including testosterone levels as part of the criteria. Retro. Dur activity was completed and new criteria was implemented based on these recommendations. 12

Transdermal Testosterone Intervention 48 prescribers with 52 recipients were identified and letters along with the educational handout and PA form were sent out to the prescribers. (see packet) As of 4/11/2012, 24 completed PA forms (46%) were sent in and 1 returned saying they were not the prescriber. As of 4/11/2012, 3 new PA requests have come in which were not part of the DUR Intervention. 18 out of the 27 PA requests (67%) were approved. 5 recipients are no longer on therapy 22 recipients will have claim deny on next fill at pharmacy. 13

Colchicine DUR Historical Perspective In June 2006, the FDA announced a new drug safety initiative to remove unapproved drugs from the market, including a final guidance entitled “Marketed Unapproved Drugs-Compliance Policy Guide (CPG)”. Notice that any illegally marketed product is subject to FDA enforcement at any time Clarified that the FDA intends to use a risk-based approach to enforcement July 29, 2009: Colcrys® approved for Familial Mediterranean Fever (FMF) July 30, 2009: Colcrys® approved for Acute Gout Flares October 16, 2009: Colcrys® approved for Chronic Gout 14

Colchicine DUR October 1, 2010: FDA sent out a notice that it intends to initiate enforcement action against any marketed and listed unapproved single-ingredient oral colchicine product that is manufactured on or after November 15, 2010, or that is shipped on or after December 30, 2010. Colcrys® colchicine May 2010 May 2011 No Rx’s 8 Rx’s $241. 82/46 tabs 42 Rx’s (7 different NDCs) $23. 25/46 tabs No Rx’s 15

Therapeutic Criteria for Colcrys® Acute Gout 1. • Contra-indication and/or failure to NSAIDS or corticosteroids 2. Chronic Gout • Adjunct to allopurinol AND contra-indication or failure to NSAIDS 16

Colcrys’® Utilization Overview Date Number of Recipients Number of Claims 4/1/11 -6/30/11 Colcrys® 16 29 1/1/12 -3/31/12 Colcrys® 15 23 17

Therapeutic Criteria for Colcrys® The Idaho Medicaid Pharmacy & Therapeutics Committee has recommended that no PA be required for acute cases. Pharmacies do have the ability to use a 3 day emergency override if the prescription falls under the appropriate criteria. 18

Ketorolac DUR Historical Perspective: Discovered that in the drug profiles the Maximum Quantity was set at 10 tablets per day. The Maximum Quantity was immediately changed to 4 tablets per day as recommended by the package insert. Report was generated to see how many patients have actually received doses higher than the recommended amount and based on this report it was felt that a Retrospective DUR would be appropriate. 19

Ketorolac DUR Maximum quantity per day reduced from 10 to 4 tablets on 5/24/2011 Utilization Overview: Date Span Total # of claims >4 per day 2/23/11 -5/23/11 ketorolac 249 39 5/24/11 -8/24/11 ketorolac 213 0 1/1/12 -3/31/12 ketorolac 239 0 DUR letter sent on 6/20/2011 to 9 prescribers 3 patient profiles provided in packet to review 20

Current Interventions/Outcomes Studies P&T Committee Narcotic Analgesic Studies Ophthalmic Antibiotic/Steroid Combinations Atopic Dermatitis Senator Grassley Letter Protease inhibitors and statins Synagis 2010 -2011 Season 21

Narcotic Patterns of Use in Chronic Non-Malignant Pain Intermittent Report 22

Profile Review Generated profiles for the top 150 recipients by total narcotic claim count from the recipients who had at least one narcotic claim in each of the 24 months of the period ending December 2011 Time Period: May 1, 2011 through December 31, 2011 Evaluated thus far 90. Cancer Diagnosis found in 3. All profiles were hand reviewed by Idaho Medicaid Pharmacists Diagnoses were hand searched from electronic records since medical diagnosis codes were unavailable in Retro. DUR database 23

Review Focus Years of opioid use Number of different opioids used Daily morphine equivalents Number of different prescribers Other concurrent potentially addictive drugs Diagnosis or indication for chronic opioid use Average days between refills History of abuse diagnosis Currently in lock-in program? Additional opioid use outside of Medicaid 24

Length of Time for Continuous Opioid Use Number of Years on Opioids 20 18 16 14 Average = 9. 8 years 12 Number of Participants 10 8 6 4 2 0 1 2 Records only back to 1998 3 4 5 6 7 Years 8 9 10 11 12 13 14 25

Number of Different Opioids Includes different drugs or dosage forms May or may not be concurrent, but over course of therapy 35 30 Average = 2. 6 25 20 Number of Participants 15 10 5 0 1 2 3 4 5 6 7 8 9 Number of Different Opioids 26

Daily Morphine Equivalents Lowest = 10 mg Highest = 1080 mg Daily Morphine Equivalents 1000 -1100 900 -999 800 -899 700 -799 Average= 202 mg equivalents 600 -699 Daily Morphine Equivalents 500 -599 (mg) 400 -499 300 -399 200 -299 100 - 199 0 -99 0 5 10 15 20 25 Number of Participants 30 35 27

Number of Prescribers per Participant 50 45 40 Average number of prescribers per participants is 2 35 30 Participants 25 20 15 10 5 0 1 2 3 4 5 6 7 8 9 10 11 12 Number of Prescribers 28

Other Concurrent Potentially Addictive Drugs None Benzodiazepines Only (up to 3) 1 2 2 Muscle relaxants only 1 18 Sedative Hypnotics Only 17 Benzodiazepines plus muscle relaxants Benzodiazepines plus sedative hypnotics 11 24 7 5 Sedative Hypnotics plus muscle relaxants Benzodiazepines plus a stimulant Benzodiazapines plus a stimulant plus a sedative hypnotic For this count temazepam was classified as a sedative hypnotic and diazepam as a benzodiazepine Benzodiazepines plus muscle relaxants plus sedative hypnotics 29

Diagnosis/Indications Most patients had multiples diagnoses Diagnosis Number of Participants (incidence) lumbago: unspecified disorder of back; back pain 62 chronic pain; chronic pain syndrome; other chronic pain 58 intevertebral disc disorder; lumbar disc degeneration; cervicalgia; sciatica; disc degeneration; spondylosis 29 knee injury; shoulder injury; pain in limb; lower leg pain; neck injury; hip and thigh injury; wrist injury 29 hand joint pain; osteoarthritis; rheumatoid arthritis; pain in joint of ankle and foot; ankylosing spondylitis; other disorders of synovium tendon and bursa headache; migraine 28 6 disorders of muscle ligament and fascia; other disease of bone and cartilage; myalgia 5 abdominal pain, generalized pain 4 multiple sclerosis 3 peripheral neuropathy; diabetic peripheral neuropathy 2 Unknown 2 30

Average Days Prior to Refill 45 40 35 30 25 Participants 20 15 10 5 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Average Days Prior to Refill 31

Other Information Gathered Number on Medicaid Pharmacy Lock-In 3 currently on lock-in 1 previously on lock-in, released 1/2011 Non-Medicaid Opioid Fills From Board of Pharmacy Reports 30 of the 87 patients had fills not paid for by Medicaid Extra number of doses ranged from 2 to 1719 32

Summary of Narcotic Study- 1 87 of the top 150 were evaluated for time period of 5/2011 through 12/2011 The average patient evaluated had been receiving narcotic analgesics f 0 r 9. 8 years Each patient was on an average of 2. 6 different narcotic analgesics Daily total morphine equivalents ranged from 10 mg to 1080 mg with average being 202 mg The patients saw an average of 2 different prescribers for their narcotic prescriptions 33

Summary - 2 Most patients were on concurrent potentially addictive drugs Most common were benzodiazepines with or without muscle relaxants or sedative hypnotics The most common diagnoses were lumbago/back pain and chronic pain syndrome Three patients were currently on pharmacy lock-in 34 % of the patients had opioid prescriptions paid outside of Medicaid pharmacy benefit with extra doses up to 1719 for the 8 month period 34

Next Steps 35

Ophthalmic Antibiotic/Steroid Combinations The P&T Committee requested a DUR to evaluate whether the prescribing physicians were specialists (ophthalmologists), primary care, or ER prescribers. Also included in the review will be the age of the recipients. 36

Ophthalmic Antibiotic/Steroid Combinations by Provider Type (see packet) Ophthalmic Antibiotic/Steroid Combo Claims 1/1/2011 – 3/19/2012 Age Range Recipients Claims 0 – 9 yrs old 540 621 10 – 18 yrs old 443 478 > 18 yrs old 471 619 Totals 1454 1718 37

Ophthalmic Antibiotic/Steroid Combinations Ophthalmic Antibiotic/Steroid Products GSN Brand Generic Form # of claims 7986 Tobradex tobra/dex Susp 783 48547 Maxitrol neo/polymyx b/dex Susp 423 48546 Maxitrol neo/polymyx b/dex Oint 202 7985 Tobradex tobra/dex Oint 121 58620 Zylet tobra/lotepred Susp 84 7964 Cortisporin neo/polymyx b/hc Susp 77 66617 Tobradex tobra/dex Susp 23 48543 Cortisporin neo/bacitrac zn/polymyx b/hc Oint 4 7985 Pred-G gent/prednisolone Susp 1 38

Next Steps 39

Atopic Dermatitis The P&T Committee requested a DUR on this drug class to include patterns of use, presence or absence of step up therapy from steroids, specialty of prescribers and geographic region differences of prescribing patterns. The DUR should include an educational piece on risks of these agents compared to risks from steroids since many practitioners seem to be using these agents to spare patients from steroid exposure. 40

Atopic Dermatitis (AD) is a chronic relapsing, pruritic, inflammatory skin condition that most commonly affects children. 60 -65% of patients develop AD before age 1 85 -90% of patients have developed signs of their disease by age 5. Lifetime prevalence is estimated between 10 -20% in children and 1 -3% in adults. It is estimated that close to $2. 6 billion is spent yearly on the disease in the United States. 41

Atopic Dermatitis The cause of AD appears to be a result of interactions between genetics, environment, skin barrier defects, and the immune system. AD persists on average 4. 4 years in children and 18. 2 years in adults. The disease typically improves as children get older; however, up to 40% does not and recurs into adulthood. Triggers may include aeroallergens, climate, emotional stress, hormones, food, irritants, and microbes. 42

Atopic Dermatitis Treatment Emollients are considered mainstay of maintenance therapy Topical corticosteroids are the standard of care which other treatments are compared and are considered first-line treatments for flare-ups. Local side effects include striae, atrophy, and telangiectasia. Systemic side effects including hypothalamic-pituitary-adrenal axis suppression, reduced linear growth in children, and bone density changes in adults are the most worrisome. There is no conclusive evidence that appropriately used topical steroids cause significant systemic adverse effects. Topical corticosteroids should be used for the shortest duration possible to control the flare-up. 43

Atopic Dermatitis Treatment Sedating antihistamines are useful when patients have sleep disturbances and concomitant allergic conditions. Antibiotics should be reserved for patients with acutely infected lesions. Topical calcineurin inhibitors should be second-line treatments for flare-ups and maintenance. Local side effects include skin burning and irritation. Patients should also be counseled on proper sun protection. Black Box Warning – discussed on next slide 44

Atopic Dermatitis 45

Atopic Dermatitis In March 2010, the FDA issued a public health advisory about the potential cancer risk associated with the use of Elidel (pimecrolimus) and Protopic (tacrolimus) products applied to the skin. This was based off of information from animal studies, case reports in a small amount of patients, and how the drugs work. The FDA recommends that healthcare providers, patients, and caregivers consider the following: Use these products only as second-line agents as short term and intermittent treatment. Avoid the use in children under the age of 2. Use for a short period of time, not continuously. Children and adults with a weakened or compromised immune system should not use these products. Use the minimum amount of the products needed to control the patient’s symptoms. 46

Atopic Dermatitis References http: //www. aad. org/skin-conditions/dermatology-a-to-z/atopic-dermatitis. Retrieved March 22, 2012. Hanifin, J. M. , Cooper, K. D. , Ho, V. C. , Kang, S. , et al. Guidelines of care for atopic dermatitis. Journal of the American Academy of Dermatology. 2004; 50: 391 -404. Peterson, J. D. , Chan, L. S. , A Comprehensive Management Guide for Atopic Dermatitis. Dermatology Nursing. 2006; 18(6): 531 -542. Buys, L. M. , Treatment Options for Atopic Dermatitis. Am Fam Physician. 2007; Feb 15; 75(4): 523 -528. http: //www. fda. gov/Drugs/Drug. Safety/Postmarket. Drug. Safety. Informationfor. Patient sand. Providers/ucm 153525. htm. Retrieved March 16, 2012. http: //www. fda. gov/Drugs/Drug. Safety/Postmarket. Drug. Safety. Informationfor. Patient sand. Providers/ucm 153941. htm. Retrieved March 16, 2012. Elidel [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corp. ; July 2010. Protopic [package insert]. Deerfield, IL; Astellas Pharma US, Inc. ; November 2011. 47

Atopic Dermatitis Topical Immunomodulators 2011 Table (see packet) Topical Immunomodulators 2011 Sorted by City Table (see packet) 48

Atopic Dermatitis Region Map Region # of prescribers # of 2011 claims for topical immunomodulators 1 17 38 2 23 68 3 30 90 4 55 186 5 30 90 6 29 110 7 40 187 Out of State 18 31 None noted 2 10 49

Atopic Dermatitis Claims Data from 2011 Brand Strength Form # of Recipients Age Range # of Paid Claims Protopic 0. 03% Oint. 76 0 – 71 125 Protopic 0. 1% Oint. 39 2 – 60 90 Elidel 1% Cream 348 2 – 67 595 Totals 463 0 -71 810 50

Atopic Dermatitis # of recipients with calcineurin inhibitor claims < 2 yrs old 2 112 194 # of claims per age group 150 2 - 6 yrs old 7 - 15 yrs old >= 16 yrs old < 2 yrs old 2 209 363 236 2 - 6 yrs old 7 - 15 yrs old >= 16 yrs old 51

Atopic Dermatitis Claims Data from 2011 # of Recipients Age Range # of Paid Claims Corticosteroid Totals 299 0 – 71 1, 661 52

Atopic Dermatitis # of recipients of calcineurin inhibitors with previous corticosteroids 2 65 128 < 2 yrs old 104 2 - 6 yrs old # of claims per age group of corticosteroids 18 396 744 < 2 yrs old 503 2 - 6 yrs old 7 - 15 yrs old 7 -15 yrs old >= 16 yrs old 53

Next Steps 54

55

Grassley Letter 2010 Premise Federal and State governments spend $317 billion annually on Medicaid programs As ranking member of Senate Committee on Finance he is obligated to ensure that taxpayer dollars are appropriately spent on federal health care Medicaid suffers from systemic weaknesses that lead to fraud, waste, and abuse resulting in higher costs and less health care to those who are in need Purpose of letter: request information on outliers, how Idaho monitors and actions taken 56

2010 Drugs In Review Abilify Geodon Seroquel Zyprexa Risperdal Oxy. Contin Roxicodone Xanax 57

Data Requested List of top ten Medicaid prescribers for listed drugs For each prescriber His/her prescriber identifier Number of prescriptions written per drug per year Total amount billed to Medicaid per drug, separated for each year Note: no information requested on number of Medicaid eligibles or total number of prescriptions for each drug 58

Results See Handout number 1 Reported from Medicaid data unit, no pharmacy input 59

Grassley Letter January 23, 2012 Premise Follow-up from previous letter Pain management and mental health drugs have addictive properties and potential for fraud and abuse by prescribers and patients is extremely high High prescribing rates of mental health drugs Pain management clinics are hotbeds for black market painkillers American people pay the price for over-prescription, abuse, and fraud 60

His Extensive Review of our Data Concern about oversight and enforcement of Medicaid abuse in our state The data we provided is “ quite shocking” The top prescriber of Oxy. Contin wrote nearly double the amount of scripts of next provider and 8 times more than another top 10 prescriber Antipsychotic top prescribers wrote double or triple the others in the top 10 61

Responses to Questions 1 and 2 1. What action, if any, has your agency taken with respect to the prescribers identified to the Committee? A. 2. No action has been taken. If there has been no action taken with respect to these prescribers, please explain why not. A. The number of prescriptions written by these prescribers only shows that these prescribers have relatively higher prescribing of these specific agents compared to other prescribers. It does not necessarily indicate overprescribing or inappropriate prescribing. These numbers must be looked at in context of several factors including total prescriptions for a particular drug in Medicaid overall and the patient mix seen by the specific prescriber. Specialists for mental health or pain management will have more of those patients using those drugs than general practitioners. Almost all of prescribers in both the mental health and pain classes of medication seen here have the majority if not all of their patients fitting that category. 62

Responses to Questions 3 and 4 3. Please identify which of the providers identified to the Committee remain eligible to bill the Medicaid Program. A. 4. All of the providers except for O 0391, PA 724, M 5597, CNS 15 A and MD 00046330 remain eligible to bill the Idaho Medicaid Program. M 5597 is incarcerated for Medicaid billing fraud (not related to drug prescribing) and all of the others listed above have left the state. Please provide the 2010 and 2011 numbers for the top prescribers of these same drugs. A. Attached. Please note that the analysis for 2010 and 2011 includes Risperdal Consta, generic Roxicodone (oxycodone), and generic Xanax (alprazolam) which were not included in the 2008 and 2009 report. 63

Results See Handout #2 64

Responses to Questions 5 and 6 5. Has each of these prescribers been cross-checked for complaints or misconduct with the state medical board or the National Practitioner Data Bank? If not, do you plan to do so? A. Our claims adjudication system does use the National Data Bank for prescribers and no irregularities have come to our attention. We have not checked with the state medical board and would not do so unless we determined that prescribing was inappropriate. 6. Have any of the prescribers identified to this Committee been referred to your state medical board? A. Not by Idaho Medicaid. 65

Responses to Questions 7 and 8 7. Is there any system set up in you state to identify and monitor excessive prescription writing? If not, why not? A. This would come under the responsibility of the state board of pharmacy and resources would have to be designated and funded. 8. Have you received any training or guidance from the Centers for Medicare and Medicaid Studies to help identify potential issues with prescription drugs? A. No 66

Responses to Questions 9 and 10 9. Does your state maintain a database of all prescribed controlled-substance? If so, what entities have access to it? A. Idaho does have a prescription monitoring program. The program is overseen by the Idaho Board of Pharmacy. Information is available to prescribers, pharmacies, and law enforcement. Idaho Medicaid has this information available for review of participants and providers. The Medicaid Pharmacy Program uses this information for its lock-in program. 10. Does your state have any point-of-sale restrictions related to maximum units, prior authorization, therapeutic duplication, or early refill? A. Yes. All individual medications in the Idaho Medicaid drug database have been reviewed and have hard edits on dose/day and maximum units per month as well as age restrictions. We have over 100 drugs requiring prior authorization for preferred drug status, therapeutic use, age, and/ or quantity. We utilize point of sale prospective drug utilization review edits for therapeutic duplication and early refill. 67

Response to Question 11 11. Were any of these top ten prescribers identified in the federalmandated Drug Utilization Review or CMS-base retrospective reviews? A. The Idaho Medicaid Drug Utilization Review Board has looked at or is currently looking at appropriate use of both narcotic analgesics and atypical antipsychotics. In these reviews, we identify specific patients so if one of those patients identified had one of these prescribers as their prescriber they would have received an educational intervention. In 2010 the Board looked at the following: Narcotic use studies looking at multiple short or long-acting agents in one patient. Narcotic use study identifying patients receiving continuous narcotic pain treatment with short acting agents without addition of long-acting agents. Narcotic use study of continued opioid use with dependency and/or abuse diagnosis. 68

Response to Question 11 (cont. ) Currently the DUR Board is doing a very detailed study on narcotic analgesics that includes the following data. If deemed necessary, they will also use information from the Board of Pharmacy Prescription Drug Monitoring Program, legal/arrest databases and hospital discharge medication records. Patient Profiling Number of patients on monthly (chronic) narcotics Number of different agents used by individual patients Total (cumulative) monthly doses of all concurrent narcotics Number of prescribers per patient Analysis of multiple scripts from multiple providers Other addictive drugs prescribed concurrently Diagnosis/indication for narcotic use and data backing that diagnosis Patients with no relevant diagnosis for medication Evaluation for evidence of illicit drug use Relationships of long-acting narcotic use and break through narcotics use (lack of long acting and/or break through narcotics given continuously) Hospital and ER admissions for overdose Prescription fill history, including early refills 69

Response to Question 11 (cont) Provider Profiling • Prescribing pattern for non-pain clinic prescribers Currently the DUR Board is working with the Program Integrity unit to look at use of injectable atypical antipsychotics and ensuring what is paid for by Medicaid is actually administered. The Pharmacy and Therapeutics Committee is also instituting appropriate use guidelines for atypical antipsychotics which will involve prior authorization review of those prescriptions not meeting the guideline criteria. 70

Response to Questions #12 12. Does your state have any programs in place to educate providers about the prescription of antipsychotics to children and adolescents? A. The Idaho Medicaid Pharmacy program utilizes an Academic Detailing (Educational Outreach) program to meet one on one with high use prescribers of mental health medication. The Medicaid pharmacy program is also participating in a project with other areas of Health and Welfare and various community organizations to improve the use of psychotropic drugs in Foster kids. It is anticipated that this will include appropriate consent for treatment, prior authorization when necessary and a set up of red flags to identify potential inappropriate prescribing. 71

Protease inhibitors and statins On March 1, 2012 the U. S. Food and Drug Administration (FDA) issued a safety communication in regards to interactions between protease inhibitors and statins. (see packet) Idaho had one patient on both a protease inhibitor and a statin. His course of Incivek will be complete soon and he has been non-compliant on his lovastatin (fills 9/11/11, 10/10/11, and 1/6/12) so it was decided not to send any correspondence to the prescriber. 72

Impact of using the 2009 revised American Academy of Pediatrics (AAP) recommendations for infants with gestational age between 32 to 35 weeks. The AAP Committee on Infectious Disease updated the recommendations for the use of palivizumab for the prevention of respiratory syncytial virus infections August 2009 2006 Red Book Recommendations 2009 Red Book Recommendations 32 -35 weeks gestation 32 weeks, 0 days - 34 weeks, 6 days Less than 6 months of age at the start of the RSV season Less than 3 months of age at the start of the RSV season Receive 5 doses for prophylaxis per season Receive prophylaxis until 90 days of age or a maximum of 3 doses Must have 2 of 5 risk factors Either of 2 specific risk factors 73

2006 Red Book Risk Factors 2009 Red Book Risk Factors Child care attendance with infants and young toddlers School aged siblings Sibling(s) less than 5 years of age Exposure to environmental air pollutants Congenital abnormalities of the airways Severe neuromuscular disease 74

Information from the American Academy of Pediatrics regarding update to previous recommendations. Optimal balance of benefit and cost from this expensive intervention. Based on the availability of additional data regarding seasonality of RSV disease as well as the limitations in available data on risk factors for identifying children at increased risk of serious RSV lower respiratory tract disease. Cost Considerations of immunoprophylaxis with 5 monthly doses of palivizumab is an effective, though costly, intervention that reduces hospitalization rates by 39% to 82% among high-risk infants. The primary benefit of immunoprophylaxis is a decrease in the rate of RSV -associated hospitalization. No prospective, randomized clinical trial has demonstrated a significant decrease in the rate of mortality attributable to RSV or in the rate of recurrent wheezing following RSV infection among infants who receive prophylaxis. Economic analyses fail to demonstrate overall savings in health care dollars because of the high cost if all at risk infants receive prophylaxis. 75

Incidence of RSV Hospitalization by Treatment Group per prescribing information Med. Immune revision date July 2010 Trial 1 Impact-RSV Trial 2 CHD Placebo Synagis N 500 1002 Hospitalization 53 (10. 6%) 48 (4. 8%) N 648 639 Hospitalization 63 (9. 7%) 34 (5. 3%) Difference Relative Between Reduction Groups p-Value 5. 8% 55% <0. 001 4. 4% 45% 0. 003 76

History of Synagis Season Prior Authorization Requests Total Requests Received Percentage Denied 2007 452 31% 2008 509 30% 2009 472 35% 2010 445 39% Criteria change did not cause fewer prior authorization request submissions. 77

Review Criteria: Specifically looked at 56 infants between 32 weeks, 0 days to 35 weeks gestational age and < 6 months chronological age as of December 1, 2010. Filtered denials based on infants that met criteria per the previous 2006 Red Book recommendations but did not met criteria per the updated 2009 Red Book recommendations. 78

Case studies: One infant was hospitalized Baby 1: DOB 11/3/2010 with the gestational age box 32 -34 weeks, 6 days checked. No other information was provided as well as no discharge summary. The electronic claims profile was not indicative of any risk factors. RSV positive with hospitalization February 2011. Using either the 2006 or the 2009 Red Book recommendations the infant would not have met criteria because no risk factors were provided. 79

Two infants were RSV positive without hospitalization Baby 2 and 3: Twins with DOB 8/7/2010 with gestational age checked 32 -34 weeks, 6 days. Synagis denied because infants > 90 days old upon start of RSV season using 12/1/2010. RSV positive 3/2/11 and 3/8/11 without hospital or emergency department admission. 80

The following Infants were neither hospitalized nor RSV positive: Requests Received Gestational Age 5 32 weeks 23 32 -34 weeks , 6 days 4 33 weeks 2 33 -35 weeks 12 34 weeks 10 35 weeks 81

Summary 445 prior authorizations received and 56 of those did not meet criteria using the new AAP guidelines (13%). Only one of the 56 infants was RSV positive with hospitalization. There was no information submitted and nothing in the electronic claims profile indicative of high risk. Impact of implementing the new AAP guidelines continues to not be significant. 82

Proposed Studies for Next Quarter: P&T Committee Narcotic Analgesic Studies Leukotrienes vs. inhaled corticosteroids in children with asthma Use of Psychotropic Medications in Foster Children Use of Lupron 83

P&T Committee Narcotic Analgesic Studies Committee Recommendation for Drug Utilization Review of Narcotic Analgesics The Committee recommended a comprehensive drug utilization review of short and long-acting narcotics. This was based on concern over the misuse/abuse of these agents that is not addressed through the preferred drug list. Components of the proposed review are outlined below. Patient Profiling Number of patients on monthly (chronic) narcotics Number of different agents used by individual patients Total (cumulative) monthly doses of all concurrent narcotics Number of prescribers per patient Analysis of multiple scripts from multiple providers 84

P&T Committee Narcotic Analgesic Studies Patient Profiling Continued Other addictive drugs prescribed concurrently Diagnosis/indication for narcotic use and data backing that diagnosis Patients with no relevant diagnosis for medication Evaluation for evidence of illicit drug use Relationships of long-acting narcotic use and breakthrough narcotics use (lack of long acting and/or breakthrough narcotics given continuously) Hospital and ER admissions for overdose Prescription fill history, including early refills 85

P&T Committee Narcotic Analgesic Studies Provider Profiling Prescribing pattern for non-pain clinic prescribers They also suggested utilizing several data sources outside Medicaid including outlier reports from the Board of Pharmacy Prescription Drug Monitoring Program, legal/arrest databases and hospital discharge medication records. 86

P&T Committee Narcotic Analgesic Studies Possible policy changes suggested for consideration after collection and analysis of the data Restriction of prescriptions to prescribers and pharmacies within Idaho state borders Stricter refill policies (90% rather than current 75% threshold) Expansion of lock-in program 87

Leukotrienes vs. inhaled corticosteroids in children with asthma Number of recipients < 18 years of age with paid claim for leukotriene: Date # of recipients 7/1/2011 – 9/30/2011 3, 369 1/1/2012 – 3/31/2012 3, 059 Number of recipients < 18 years of age with paid claim for inhaled corticosteroid: Date # of recipients 7/1/2011 – 9/30/2011 1, 595 1/1/2012 – 3/31/2012 2, 156 88

Use of Psychotropic Medications in Foster Children The U. S. Government Accountability Office released the results from a study that they performed examining the rates of psychotropic medications for foster and nonfoster children in 2008. It was determined that HHS Guidance Could Help States Improve Oversight of Psychotropic Prescriptions. 89

Use of Psychotropic Medications in Foster Children Medication Classes included in the report ADHD drugs Anti-anxiety Anticonvulsant Antidepressants Anti-enuretic (just desmopressin acetate) Antiparkinson Antipsychotics Combination anti-anxiety and antidepressant Hypnotic Mood stabilizer (just lithium) Sleep aid (just melatonin) 90

Use of Psychotropic Medications in Foster Children Percentage of children (017 years old) prescribed psychotropic Medications in named State and year Foster Children Nonfoster children Ratio of foster to nonfoster children Florida 2008 22. 0% 8. 2% 2. 7 Massachusetts 2008 39. 1% 10. 2% 3. 8 Michigan 2008 21. 0% 7. 9% 2. 7 Oregon 2008 19. 7% 4. 8% 4. 1 Texas 2008 32. 2% 7. 1% 4. 5 Idaho 2008 38. 8% 14. 8% 2. 6 Idaho 2011 42. 9% 14. 8% 2. 9 91

Psychotropic Medication Use in Foster Children 4/2012 Update 92

AACAP 1 Practice Parameter on the Use of Psychotropic Medication in Children and Adolescents Assessment Development of a treatment and monitoring plan Psychoeducation and assent/consent Implementation of the treatment and monitoring plan 5. Management of complex pharmacological interventions including medication discontinuation 1. 2. 3. 4. 1 Journal of American Academy of Child and Adolescent Psychiatry 48: 9; September 2009 93

Areas For Idaho Medicaid Pharmacy Program to Assist 1. 2. 3. 4. 5. 6. 7. Education of prescribers on the medications – extension of Academic Detailing program Educational information on the medications for persons giving consent Provide medication profiles to case workers Set up guidelines with red flag systems Develop protocols for monitoring medications Develop and provide simple medication guides for foster parents Data 1. 2. 3. Baseline Trending Monitoring the impact of the interventions 94

Guidelines, Prior Authorization, and Red Flags Prior Authorization Diagnosis per P&T recommendations Evidence-based indications for age Age and Quantity per evidence-based information Red Flags Retro. DUR evaluation of patients meeting red flags Quarterly interventions Transition to timely alerts (Pro. DUR) and possible hard edits requiring prior authorization 95

Possible Red Flags Texas Five (5) or more psychotropic medications prescribed concomitantly Two (2) or more concomitant antidepressants Two (2) or more concomitant antipsychotic medications (actual PA on 3 rd) Two (2) or more concomitant stimulant medications (longacting plus an immediate release of same chemical entity not considered concomitant) Three (3) or more concomitant mood stabilizer medications Psychotropic polypharmacy ( 2 or more agents) for a given mental disorder prescribed before utilizing psychotropic monotherapy 96

Texas Red Flags - continued Additionally Diagnosis, age, and dose limitations similar to what Idaho does presently Require specialty training for diagnosis other than ADHD, uncomplicated anxiety disorders or uncomplicated depression *Medication overlap and cross-titration ok when switching psychotropics 97

Possible Other Red Tags • Two (2) or more concomitant anti-anxiety agents • Two (2) or more concomitant sedative/hypnotic agents Split into separate interventions for 1 Vs 2 prescribers for duplicate therapy for antidepressants, stimulants, atypical antipsychotics, anti-anxiety agents, sedative/hypnotics 98

Next Steps 99

Prospective DUR Report History Errors: Non-History Errors: • DD – drug-to-drug • PA – drug-to-age • PG – drug to pregnancy • HD – high dose • TD – therapeutic duplication • LD – low dose • ER – early refill • SX – drug-to-gender • MC – drug-to-disease 100

Prospective DUR Report Idaho Medicaid Program Pro. DUR Message Report March-12 Pro. DUR Message Drug To Gender Drug To Known Disease Drug To Pregnancy Duplicate Therapy Min Max Too Soon Clinical Pro. DUR Severity 1 2 3 9 1 2 3 1 2 A B C D X 0 0 0 Message Count 2, 272 14, 784 65, 365 3 116 53 64, 935 242, 066 289, 788 101 23 3 131 256 36 41 120, 392 37, 330 22, 684 ALL 860, 379 Total Number of Claims with Messages 218, 822 Average Pro. DUR Message Per Claim 3. 93 Message Amount $457, 602. 00 $2, 549, 305. 71 $11, 032, 658. 53 $22. 47 $25, 224. 88 $1, 287. 90 $19, 679, 895. 85 $45, 599, 264. 18 $55, 585, 891. 88 $3, 180. 77 $429. 52 $70. 69 $55, 749. 15 $21, 660. 28 $2, 146. 06 $863. 47 $26, 014, 904. 40 $7, 045, 362. 22 $4, 678, 290. 51 $172, 753, 810. 47 101

DUR Winter Newsletter Copy of Fall Newsletter in packet Brainstorm for new topics (Prescriber emails? ? ? ) 102

Annual American Drug Utilization Review Society (ADURS) Meeting February 23 -25, 2012 Scottsdale, Arizona 103

ADURS 2012 Representatives were present from 43 states State Medicaid employees Drug Utilization Review personnel 104

ADURS 2012 14 hours of Continuing Education Hepatitis C Update “Less Abusable” Opioids New Drugs Pipeline Drugs CMS Update Is it a “Drug” ? 105

ADURS 2012 Round Table – Oral report by representative from each state on DUR projects done in the past year plus challenges and successes. 106

ADURS 2012 Round Table Report Atypical antipsychotics Require psychiatrist to be prescriber for (a) children less than 6 years or (b) children less than 18 years. Signed consent form (by parents or guardians). Baseline metabolic monitoring (blood glucose, Hgb. A 1 c, lipid panel) and then routinely thereafter. Letters sent to prescribers of patients less than 16 years old who are receiving two or more atypicals concurrently. 107

ADURS 2012 Round Table Report Suboxone Therapy Maximum daily dose of 16 mg with enforced reduction to 8 mg after 3 -6 months. Automatic lock-in to one pharmacy. Approvals for only three months at a time, requiring documentation of patient’s attendance at counseling sessions and negative urine drug screen for renewal. Limiting approval to two years per lifetime. 108

ADURS 2012 Round Table Report Polypharmacy – Patients receiving more than 15 medications per month for at least 3 consecutive months. Methadone – No other opioids are allowed without prior authorization Topical Immunomodulators – Requires trial and failure of TWO topical corticosteroids first. Quantity is limited to one tube per 90 days. 109

ADURS 2012 Round Table Report Pain Therapy – Require pain specialist review of any non-cancer patient receiving more than 1000 mg/day of morphine equivalents. Controlled Substances – Refills not allowed until 100% of time has elapsed (pharmacy can override for weekends/holidays to allow early refill by a few days). Twice daily PPI not approved unless patient has first tried and failed once daily PPI plus a bedtime H-2 blocker. 110

Medicaid Update 111