THE UPTAKE OF BIOSIMILAR INFLIXIMAB BY ENGLISH ACUTE TRUSTS

A265

VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8

female testosterone users.  Methods: Characteristics of male and female testosterone users were retrieved from IMS LifeLink Plus for 2006-2013 and compared. On-label and off-label indications and contraindications were identified using validated ICD-9-CM codes. Demographics, prescriber and payer types, comorbidities, contraindications, and off-label and on-label use were compared between genders using Chi-square tests.  Results: In total, 6187 females and 42306 males used testosterone. Female testosterone users were much younger than male users (46.0% vs. 40.5%, p< 0.0001). The major provider speciality that prescribed testosterone was OB/GYN for females and general practitioner for males (22.5% vs. 10.2%, p< 0.0001). Males were prescribed testosterone for a labeled indication more frequently (29.9% vs. 1.0%, p< 0.0001), whereas females were prescribed testosterone off-label more commonly (22.9% vs. 15.9%, p< 0.0001). The two populations differed significantly on most comorbidities, including a greater proportion of males previously experiencing cardiovascular events (6.3% vs. 3.0%, p< 0.0001). Serum testosterone concentration (TC), were performed more frequently for males compared to females (76.0% vs. 40.2%, p< 0.0001). Prostate specific antigen (PSA) test was performed in only 60% of men prior to testosterone use.  Conclusions: Characteristics of male and female testosterone users significantly differ in the cohort of commercially insured US population. Extensive off-label use of testosterone among females requires further investigation. PHP38 A LITERATURE REVIEW OF FACTORS AFFECTING PRICE AND COMPETITION IN THE GLOBAL PHARMACEUTICAL MARKET Park Y 1, Goto D 1, Yang K F 2, Downton K 2, Lecomte P 3, Olson M 4, Mullins C D 1 1University of Maryland School of Pharmacy, Baltimore, MD, USA, 2University of Maryland Health Sciences and Human Services Library, Baltimore, MD, USA, 3Novartis Pharma AG, Basel, Switzerland, 4Novartis Pharma, Basel, Switzerland .

.

.

.

.

.

.

.

.

Objectives: Rising healthcare costs have driven increased emphasis on demonstrating the cost-effectiveness of new drug products. Cost-effectiveness of a product varies depending on how the price evolves through its life cycle. This literature review summarizes market and regulatory factors that may affect price and competition of brand or generic products in the global market.  Methods: Articles published between January 2000 and February 2015 were identified from PubMed, EMBASE, International Pharmaceutical Abstracts, and EconLit. Search terms were developed for three categories: drug industry, market features, and regulations. We included articles that were published in English and discussed market factors generalizable to multiple drug classes and markets in high-income OECD countries. Each article was evaluated by two reviewers using a stepwise approach.  Results: A total of 66 articles were included after full-text review of 198 articles from 1,947 screened articles. The most commonly studied country was the US (n= 28), followed by the EU (n= 15), multiple countries (n= 11), Canada (n= 5), Japan (n= 2), Australia (n= 1), and South Korea (n= 1). Few discussed non-country specific (n= 3) factors. Factors affecting price and competition varied due to different pricing and regulatory policies in effect. In the US, the market size and revenue of brand-name drugs in the year before patent expiration was the most important factor determining generic competition. The length of exclusivity period, authorized generics, and product extensions also affected brand and generic competition in the US. Reference pricing or price setting policies in Canada and the EU were shown to deter generic entry and increase generic prices in the long run. Moreover, therapeutic reference pricing and strict price regulations could also deter entry of new, innovative brand products, especially in small markets.  Conclusions: This review demonstrates that multitude of market and regulatory factors need to be analyzed in order to evaluate long term cost-effectiveness of pharmaceutical products. PHP39 VARIATION IN DEMAND RESPONSE TO FDA SAFETY ALERTS Ning N 1, Lu Y 2, Gascue L 1, Ding Y 1, Joyce G 1 1University of Southern California, Los Angeles, CA, USA, 2Harbor-UCLA Medical Center, Torrance, CA, USA .

.

.

.

.

Objectives: To understand how patient responses to FDA safety warnings differ by provider type, geography, disease burden, race and socio-economic status (SES) for a nationally representative sample of Medicare beneficiaries.  Methods: We identified 11 widely prescribed chronic medications that received black box warnings (BBW) between 2006-2009. We examined the demand response to the warnings and the extent to which patient, provider and area characteristics affected rates of discontinuation. Multivariate analyses controlled for baseline (pre-alert) rates of medication adherence, as well as a rich set of demographic and area characteristics.  Results: Response to a black box warning varied substantially across products. Medications prescribed by a specialist were more likely to be discontinued (OR= 1.047, p< 0.01), as were medications prescribed to beneficiaries in the Northeast (ORs=  1.37-1.70, p< 0.001). Beneficiaries eligible for low-income subsidies or dualeligible (Medicaid and Medicare) were less likely (ORs= 0.911 and 0.915, p< 0.01, respectively) to discontinue use after a BBW. While Whites and Blacks had similar responses to a safety alert, they were more likely to discontinue use than Hispanics and Asians (ORs= 0.827 and 0.876, respectively, p< 0.001).  Conclusions: Substantial variation in response to FDA-issued safety alerts suggest that BBW content is not reaching all clinician and patients, particularly those of lower socioeconomic status. New approaches are needed to influence patient-clinician deliberation about the risks and benefits of available agents when a black box warning is issued. Increased efforts are needed to inform physicians, low-educated patients, as well as low-SES and minority patients, of safety warnings. PHP40 THE UPTAKE OF BIOSIMILAR INFLIXIMAB BY ENGLISH ACUTE TRUSTS Alnahar S A , Smith M D , Elliott R A University of Nottingham, Nottingham, UK .

.

.

.

.

.

Objectives: In February 2015, two infliximab biosimilars were launched in the United Kingdom, both subsequently recommended for use by the National Institute for Health and Care Excellence1. In November 2015, NHS-England released data on usage of infliximab by Acute Trust and by brand (both biosimilars and the reference product). In this study, we analyse and compare infliximab prescription rates between 157 Acute Trusts across 4 regional areas within England.  Methods: Acute Trusts were categorised according to usage of infliximab brands and geographical location. Data were analysed using descriptive statistics on Excel 2010.  Results: Out of 157 Acute Trusts, 70(45%) prescribed the reference and at least one of the biosimilar brands. 65(41%) prescribed the reference only, while prescription percentages were not reported for 22(14%) Trusts. Of the 70 biosimilar-prescribing Trusts 40(57%) did not have biosimilar prescription rates exceeding 20%, while for 14(20%) rates were between 20-40%, for 7(10%) rates were between 40-60%, and finally for 9(13%) the biosimilar infliximab prescription rate exceeded 60%. The London and South-of-England regions had the highest percentages of biosimilar-prescribing Trusts, with 59%(16/27) and 58%(22/38) respectively. North-of-England had the lowest with only 22%(11/49) of Trusts in this region prescribing biosimilar infliximab.  Conclusions: Although biosimilar infliximab has been available for less than a year, it has been prescribed in 45% of Acute Trusts across England. By providing the latest prescribing trends of biosimilar infliximab, this study provides insight into the widely varying prescribing practices of biosimilars in Acute Trusts. Differences between regions may also reflect differences in offered prices per brands or differences in incidence rate of targeted diseases. Further studies targeting clinical guidelines and formularies may provide in-depth understanding of utilising biosimilars in medical practice. References: 1. NICE (2015) Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy. NICE Technology appraisal guidance 329. Available at: https://www.nice.org.uk/guidance/ta329 PHP41 UNITED STATES GEOGRAPHIC VARIATION OF ANTIPSYCHOTIC USE IN MEDICARE PART D RECIPIENTS Freeman M K , Anthony A , DeGreef R Samford University, Birmingham, AL, USA .

.

.

.

Objectives: Inappropriate antipsychotic use can be associated with serious adverse effects. Several studies have shown that there is a geographic variation in antipsychotic prescribing; however, antipsychotic prescribing practices in the U.S. Medicare population has not been evaluated. The objective of this study was to determine if there is a geographic variation in 10 US divisions among antipsychotic prescribing, based on 2013 Medicare Part D data.  Methods: Data was collected in the Microsoft Excel format from the Medicare Provider Utilization and Payment Data: Part D Prescriber Public Use File (PUF) for 2013 Centers for Medicare and Medicaid Services (CMS) data. Antipsychotics were sorted and downloaded into separate Microsoft Excel formats. The states were separated into 9 geographic divisions and the U.S. territories, according to the US Census Bureau, to identify prescribing trends. The primary endpoint was the rate of antipsychotic prescriptions per number of patients utilizing Medicare Part D within each geographic division. Statistical comparisons were assessed via ANOVA in SPSS (version 19, Armonk, NY).  Results: Antipsychotics comprised 4.75% of the total spending on medications for Medicare Part D in 2013. Antipsychotic brand name medications accounted for $3.5 billion of the cost. Although various healthcare practitioners prescribed these medications, mental health professionals accounted for 47% of the claims. The rates of antipsychotic prescribing in each division were: Pacific (0.51), Mountain (0.46), West South Central (0.53), east South Central (0.58), South Atlantic (0.52), West North Central (0.73), East North Central (0.63), Middle Atlantic (0.62), New England (0.83), and US Territories (0.5) (P< 0.001).  Conclusions: There is a geographic distribution in the number of antipsychotics prescribed in the various divisions. This should be explored further to find causality and to determine if there is inappropriate prescribing of antipsychotics to these patients. PHP42 ANTIMICROBIAL USAGE IN ICU OF A PUBLIC TEACHING HOSPITAL: A PROSPECTIVE OBSERVATIONAL STUDY Nelson N T B 1, Tiwari P 2, Gombar S 3, Anand L 3 1NIPER, mohali, India, 2National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar (Mohali), Punjab, India, 3Government Medical College & Hospital, Chandigarh, India .

.

.

.

.

.

Objectives: The purpose of this study to assess drug utilization using WHO recommended RPM plus indicators in an ICU of a public teaching hospital.  Methods: This 4 month prospective long observational study was conducted at public teaching hospital. It included patients admitted in the ICU at a for at least 24h and having received more than one antimicrobial. All information about the drugs and patients details recorded in case record form. The RPM plus indicators were used to analyze the data so collected.  Results: Of the 118 patients screened, 110 met the inclusion criteria. Average number of medication was 10.6±0.3. Average number of antimicrobials was 3.2±0.2. Out of 358 antimicrobials prescribed 135 were prescribed by generic name. Approx 96% of the antimicrobials were prescribed by parenteral route. Average number of antimicrobials consistent with NLEM was found to be 1.3±0.1. Cephalosporins (80.9%) were frequently prescribed followed by nitroimidazoles (58.2%), penicillins (54.5%) and aminoglycosides (42.7%). Out of 358 antimicrobials, patient prescribed with more than one antimicrobial per hospitalization was found to be 100%. Of 124 culture sensitivity performed, 57 were found to be positive. Pseudomonas aeruginosawas the common microorganism observed in the cultures (16/57).  Conclusions: It was seen that a Variety of drugs from various drug classes were used for a wide spectrum of clinical diagnoses. This drug utilization study can provide a framework for continuous prescription audit in ICU. PHP43 DIETARY SUPPLEMENT USE, KNOWLEDGE, AND PERCEPTIONS AMONGST PHARMACY STUDENTS