HOW DO FORMULARY RESTRICTIONS AFFECT MEDICATION USE AND COSTS FOR LOW-INCOME SUBSIDY RECIPIENTS IN MEDICARE PART D PLANS?

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ability to select responsive patients. Additionally, pharma and diagnostic companies can negotiate fair revenue distribution and coordinated launch that will ensure appropriate, and timely care for patients. PHP15 ANALYSIS OF PRICE DECLINE OF DRUGS IN MOROCCO IN 2014 Saji K , Belaiche A , Cherrah Y , Ahid S Mohammed V University, Rabat, Morocco .

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Doshi J A 1, Li P 1, Pettit A R 1, Dougherty J S 2 1University of Pennsylvania, Philadelphia, PA, USA, 2PhRMA, Washington, DC, USA .

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Objectives: Medicare Part D beneficiaries who do not qualify for low-income subsidies (LIS) face high and variable cost sharing for specialty drugs during the calendar year. We examined the magnitude of Part D cost sharing and out-of-pocket (OOP) cost patterns among non-LIS specialty drug users.  Methods: Data were extracted from the 2012 Chronic Conditions Data Warehouse 100% Medicare claims. The sample included non-LIS Medicare beneficiaries with 12 months of fee-for-service and stand-alone Part D plan coverage; a diagnosis of rheumatoid arthritis (RA), multiple sclerosis (MS), or selected cancers (i.e., multiple myeloma, chronic myeloid leukemia, advanced renal cell carcinoma); and a prescription fill for a Part D specialty drug indicated for these conditions in January 2012. Annual cumulative OOP costs and OOP costs by calendar month for these specialty drugs were calculated for each disease area and overall.  Results: Our sample consisted of 13,109 specialty drug users (N= 3,826 for RA, N= 3,931 for MS, N= 5,352 for cancer). The mean total annual OOP cost for specialty drugs across all diseases was $4,574 (RA $2,995, MS $4,425, cancer $5,807). A significant proportion of MS (16%) and cancer (69%) specialty drug users had annual OOP costs ≥ $5,000. Overall, specialty drug users had to bear onequarter to nearly one-half of their annual OOP costs in January alone (RA $781 [26%], MS $1,460 [33%], cancer $2,553 [44%]). Even after entering catastrophic coverage, beneficiaries on average paid $2,095 out-of-pocket during the remainder of the year. Sensitivity analyses in a subsample of patients who filled specialty drugs regularly during the entire year indicated even higher OOP burden.  Conclusions: The Part D cost sharing structure creates substantial financial burden for specialty drug users, especially in the beginning of the calendar year. Our findings suggest the need for changes in Part D including creation of annual OOP maximums and greater consistency in monthly OOP costs. PHP17 HOW DO FORMULARY RESTRICTIONS AFFECT MEDICATION USE AND COSTS FOR LOW-INCOME SUBSIDY RECIPIENTS IN MEDICARE PART D PLANS? Shen X 1, Stuart B 1, Powers C 2, Tom S 1, Magder L 3, Perfetto E M 4 1University of Maryland School of Pharmacy, Baltimore, MD, USA, 2Centers for Medicare and Medicaid Services, Baltimore, MD, USA, 3University of Maryland School of Medicine, Baltimore, MD, USA, 4University of Maryland, School of Pharmacy, Baltimore, MD, USA .

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Alkelya M 1, Alsultan M 2, AlJeraisy M 3 International Medical Research Center (KAIMRC), Ryiadh, Saudi Arabia, 2Saudi Food and Drug Authority (SFDA), Riyadh, Saudi Arabia, 3King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS), Ryiadh, Saudi Arabia .

PHP16 MEDICARE PART D OUT-OF-POCKET COST PATTERNS FOR SPECIALTY DRUG USERS DURING THE CALENDAR YEAR: TOO MUCH TOO SOON .

PHP18 DRUG UTILIZATION REVIEW PROGRAM IN SAUDI HOSPITALS: ENABLING FACTORS AND IMPELMENTATION .

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Objectives: The objective of this analysis is to study the profile of medicines that have been the subject of declining prices and to assess the distribution of decrease on all of these drugs and according to several criteria.  Methods: The data base is carried on a fusion between the IMS database and the list of drugs on the Official Bulletin No. 6245 of April 8, 2014.  Results: A total of 4916 drugs were analyzed, 28.9% of drugs has decreased less than 5%. Only 4% of drugs have been affected by a reduction beyond 50%. Drugs with a Moroccan public price (MPP) of less than 10 USD constituted 26% of drugs with reduced prices. only 4% of drugs with a MPP exceeds 302,4 USD experienced the decrease in its prices. declining profiles are similar to the eight classes of the top ten consumed in 2013. For all these classes more than 60% of specialties has not been affected by the decline. For molecules with lots of generic in Morocco, the decline was not equivalent between brand name and generic.  Conclusions: The price decrease was mainly concerned the drugs less than 10 USD, and the most consumed classes have experienced a slight decrease. The decrease is based not only on the consumer test, nor on the price range at which the drug belongs.

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toward generic drugs and has minimal impact on adherence for OHAs, statins and RAS antagonists among LIS recipients in Part D plans.

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Background: Formulary restrictions—non-coverage, prior authorization, and step therapy—are increasingly employed by Medicare Part D plans.  Objectives: To evaluate effects of formulary restrictions on utilization and costs of oral hypoglycemic agents (OHAs), statins, and renin-angiotensin system (RAS) antagonists among low-income subsidy (LIS) recipients who were randomly assigned to Part D plans.  Methods: We chose to study the randomized LIS recipients in order to: 1) remove the confounding effects of plans’ cost-sharing rules on study outcomes (LIS recipients pay the same nominal copays); and 2) take advantage of the random plan assignment to reduce selection bias. The study outcomes included generic dispensing rate (GDR), mean cost per prescription, and proportion of days covered (PDC). A 5% sample of 2012 Medicare administrative data was linked to a customized dataset that captured beneficiaries’ histories of plan assignment, dating back to 2006. Random intercept regression models were estimated.  Results: Three study cohorts were selected, including 28,082 users of OHAs, 53,864 users of statins, and 57,289 users of RAS antagonists. After covariate adjustment, beneficiaries subject to formulary restrictions on brand-name pioglitazone and single-source brandname DDP-4 inhibitors (saxagliptin, sitagliptin, and sitagliptin-metformin) had 3.0 percentage-points higher GDR, $10.8 lower cost per prescription fill but similar PDC compared to those who faced no restrictions. Restricting access to brand-name atorvastatin and single-source brand-name statins (rosuvastatin and ezetimibesimvastatin) was associated with 14.9 percentage-points higher GDR and $29.6 lower cost per prescription fill but had no impact on PDC. Restricting use of single-source brand-name RAS antagonists (olmesartan, valsartan, and valsartan-hydrochlorothiazide) was associated with 15.0 percentage-points higher GDR, $27.2 lower cost per prescription fill, and 1.3 percentage-points lower PDC.  Conclusions: Placing formulary restrictions on single-source brand-name medications shifts utilization

Objectives: Adoption of Drug Utilization Review (DUR) program is essential to optimize the safety and effectiveness of medication use in health care sitting. The aim of the study is to explore the enabling factors to adopt DUR program and to explore DUR program implementation in Saudi Hospitals.  Methods: A cross-sectional survey targeted mangers at hospital pharmacy with in-patient and out-patient pharmacies in Riyadh City in 2014. The survey gathered information about the hospital pharmacy services, pharmacy information system (PIS), Pharmacy & Therapeutics (P&T) Committee activities.  Results: Of the 30 hospital pharmacies, 23 (76.6%) pharmacy managers responded, and only 21(70%) hospital pharmacies met the inclusion criteria. 18(85.7% ) hospitals have Electronic Medical Record (EMR) and 14(66.67%) of them have Computerized Physician Order Entry (CPOE). 12 (57.2 %) of the hospitals have Pharmacy and laboratory integrated information systems, 6 (28.6%) hospitals have Clinical Decision-Support Systems (CDSSs), 7(33.3%) hospital pharmacies provide Patient Discharge Counseling Services (PDCS), 13 (61.9%) provide Inpatient Clinical Pharmacy Services(ICPS), 14 (66.7%) provide Therapeutic Drug Monitoring (TDM) services. 8 (38.1%) hospitals have PIS which can detect incorrect dose and duration, 8 (38.1%) for drug-drug interaction, 6(28.6%) for drug-disease Interaction, 7 (33.3%) for contraindication and 11 (52.3%) for early refill detection. Only 6 (28.6%) hospitals PISs have the capability to generate four types of retrospective reports (ranking physicians by utilization, drug they prescribe, most utilized drug by number of patients, most utilized drug by diagnosis. 18 (85.7%) hospitals ‘ P&T Committee discuss the DUR reports at least once annually. 10 (45.2%) of the hospitals have designated subcommittees for DUR.  Conclusions: The enabling factors for the prospective and concurrent DUR such as CDSSs, PDCS, ICPS, and PIS detection capabilities are not adopted widely as standard process or services in Saudi hospitals, likewise the retrospective DUR. The DUR programs at these hospitals have huge opportunity to improve. PHP19 PLAN FORMULARY COVERAGE AND DRUG CONSUMPTION OF LOW-INCOME SUBSIDY RECIPIENTS IN MEDICARE PART D Zhou B University of Southern California, Los Angeles, CA, USA .

Objectives: To examine the impact of plan formulary coverage on drug consumption and medication adherence of Low-Income Subsidy (LIS) recipients randomly assigned into benchmark standalone Prescription Drug Plans (PDPs) in Medicare Part D.  Methods: Using CMS administrative data on Medicare Part D claims and plan formulary coverage, we simulate out-of-pocket spending in all available plans in her service area among our working population in 2010 (N= 691,681) and 2011 (N= 701,797), and construct a single measure of plan generosity as plan-level Average Simulated Beneficiary Cost Sharing (ASBCS) over all beneficiaries in the service region, assuming that beneficiaries pay CMS defined copay for on-formulary claims and full cost for off-formulary drugs. We identify randomly assigned LIS beneficiaries in our working population, and analyze how plan generosity affect drug consumption and medication possession ratio (MPR) of chronic drugs.  Results: ASBCS has wide variation among benchmark PDP plans, ranging from 7.9% to 33.5% in 2010, and from 8.8% to 30.3% in 2011. LIS beneficiaries enrolled in the bottom quartile ASBCS plans (most generous) has total drug consumption $800 more than beneficiaries in the top quartile ASBCS plans (least generous). After controlling for demographics, health status, state of residence and income, 10 percent increase in average beneficiary cost-sharing leads to decrease in total drug consumption by $310-$430, and 0.7 percent reduction in Medication Possession Ratio of chronic drugs among randomly assigned LIS beneficiaries.  Conclusions: Plan formulary coverage has an important impact on drug consumption and medication adherence among LIS beneficiaries. PHP20 GEOGRAPHIC VARIATION IN ON-LABEL AND OFF-LABEL TESTOSTERONE USE AMONG THE COMMERCIALLY INSURED POPULATION IN THE UNITED STATES Shewale A R , Bhandari N R , Kathe N , Hammond D , Painter J T University of Arkansas for Medical Sciences, Little Rock, AR, USA .

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Objectives: Testosterone sales eclipsed 1.6 billion dollars in 2011; however, the percentage of on-label and off-label use is unknown. Only 5 percent of men with hypogonadism received treatment and additional testosterone use could be attributed to the indications which are not approved. Furthermore, the geographic variation for on-label and off-label testosterone use is undetermined. The aim of our study was to assess the coefficient of variation for on-label and off-label testosterone use.  Methods: We used the IMS Lifelink Plus (2006-2013) claims data, a nationally representative of commercially insured US population to assess the geographic variation in testosterone (T) use. T use was categorised as on-label, offlabel, and conditions other than indicated on label or off label (“indeterminate use”). Weighted coefficient of variation and ratio of highest rate to lowest rate were computed to compare the geographic variation across the states in the US.  Results: The final sample consisted of 47,732 patients with a prescription or a procedure claim for testosterone use. There was a 3-fold difference between the states with lowest utilization compared to the states with highest utilization of testosterone for on-label and off-label use. The coefficient of variation for on-label and off-label use was 21.8% and 26.40%, respectively, and 9.8% for indeterminate use. Most the states with the high off-label testosterone use rate (15-21%) were from the mid-west (Kansas, Nebraska, Iowa, North Dakota, Minnesota and Wisconsin) except Alabama