When The Outcome of An Appraisal Is Not Nice: A Review Of Nice Appeals

VA L U E I N H E A LT H

PHP236 Knowledge And Attitudes Identifying Victims Of Human Trafficking In The US: A Cross-Sectional Study Patel I1, Perez-Rodriguez S2, Eppes D2, Atta E2, Nord L3, Han Y4 University, Huntington, VA, USA, 2Shenandoah University, Winchester, VA, USA, 3Marshall University, Huntington, WV, USA, 4University of Michigan, Ann Arbor, MI, USA

1Marshall

Objectives: Human trafficking is today’s modern form of slavery and the second largest criminal activity in the world. Trafficking typically originates in disadvantaged areas with high levels of poverty, lack of opportunities and high crime rates but can also exist in communities of any socioeconomic class. The objective of this study was to assess the knowledge and attitudes about identifying victims of human trafficking among US pharmacy students.  Methods: This was a cross-sectional study. A survey was distributed amongst first, second, and third year pharmacy school students in a private university in the US. The questionnaire comprised of 17 questions that was divided into four components: general questions about human trafficking (7), types of human trafficking (4), human trafficking and health (5), and attitude about human trafficking (1). Descriptive analyses were conducted using SPSS version 21.  Results: A total of 219 pharmacy school students participated in the survey. 69.4% participants were females and 30.6% participants were males. Study participants had poor knowledge about the age group (13.24%), race (2.28%), and warning signs (14.16%) of victims of human trafficking respectively. Only 7.31% of participants had accurate knowledge about the disease conditions associated with human trafficking. Approximately 77% participants agreed that 911 should be called upon encountering a human trfficking victim in the pharmacy. 53% participants felt that upon encountering a human trafficking victim, they would inquire about the availability of a friend for emotional support.  Conclusions: Pharmacy students had a positive attitude about treating victims of human trafficking, even though they had poor knowledge about victims of human trafficking. This study stresses the need for implementing education about human trafficking in the pharmacy curricula to raise awareness about this serious issue, both in the US and across the globe. PHP237 Assessment Of Knowledge And Perceived Practices Of Antimicrobial Stewardship Among Malaysian Future Healthcare Professionals Ahmad S1, Sulaiman LH1, Qamar M1, Shaikh FA1, Ismail NE2 University, Bandar Saujana Putra, Malaysia, 2MAHSA University, Bandar Saujana Putra, Jenjarom Kuala Langat, Selangor, Malaysia

1MAHSA

Objectives: The antimicrobial stewardship is currently not mandatory as part of the undergraduate healthcare educational programs. Better understanding of current levels of knowledge and perceived practices can facilitate more effective educational interventions for future healthcare professionals. Therefore, this study was conducted to assess the levels of knowledge and perceived practices of Malaysian final year undergraduate healthcare students towards the antimicrobial stewardship.  Methods: This cross-sectional study was conducted from January to April, 2017, using a self-administered questionnaire in the State of Selangor, Malaysia. The questionnaire consisted of three parts: socio-demographic characteristics of respondents (5 items), knowledge (8 items), and perceived practice (8 items) towards antimicrobial stewardship. A convenience sampling approach was used to recruit undergraduate final year students from the faculties of pharmacy, medicine, dentistry, and nursing in MAHSA University, Malaysia. The descriptive (numbers, and percentages) and inferential (Spearman’s correlation coefficients, and Chi-square test) statistical analyses were conducted by using Statistical Package for the Social Sciences (SPSS), version 23.  Results: Post-oral consent, a total of 180 undergraduate final year healthcare students completed the questionnaire, giving an overall response rate of 81.4%. The majority (n= 107, 59.4%) of the respondents showed good levels of knowledge and (n= 122, 67.8%) perceived practices. There was a statistically significant moderately positive correlation between the overall knowledge and attitude score of the enrolled students (r= 0.450, p< 0.001). No statistically significant association was found between the categories of socio-demographic characteristics and perceived practices; whereas, students’ age (p< 0.040) and nationality (p< 0.025) categories showed the statistically significant associations across the levels of knowledge enrolled students.  Conclusions: The enrolled students possessed good levels of knowledge and perceived practices regarding antimicrobial stewardship. Continuous efforts focusing the principles and practices of appropriate use of antibiotics and antimicrobial stewardship are essentials to sustain these good levels of knowledge and practices for future healthcare providers.

HEALTH CARE USE & POLICY STUDIES – Health Technology Assessment Programs PHP238 The Role of Patient-Reported Outcomes and Patient Engagement In Health Technology Assessments and Reimbursement Decision Making In 10 Countries Lee J1, Kitchen H1, Fletcher-Louis M2 1DRG Abacus, Manchester, UK, 2DRG Abacus, London, UK

Objectives: We evaluated the role of patient-reported outcome (PRO) data and patient testimonial evidence (e.g. patient advocacy) in reimbursement decisions in 10 countries.  Methods: Websites of national/regional health technology assessment (HTA) agencies for the UK (England, Wales, Scotland), Spain, France, Germany, Italy, Canada, Japan, and Brazil were searched for decision documents that included PRO data and/or evidence of patient involvement in a pre-specified list of treatments for three diseases (diabetes, obesity, and haemophilia). HTA guidance for formal patient involvement processes was also identified and national clinical guidelines were reviewed for information regarding patient involvement. Data were compared to identify common themes and inter-country differences.  Results: In total, 155 HTA decisions were reviewed for PRO data and patient involvement. Only

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28% (44) reported use of PRO data in decision making. PRO data were referenced more frequently in HTA decisions from countries that use a cost-utility and/or cost-effectiveness approach to economic evaluation (UK, Canada, and Italy), for which detailed guidance on PRO data expectations exists. Reasons for PRO data not being included were: poor trial design (e.g. no head-to-head data or data from open-label studies), limited generalisability to the population, and lack of clinically or statistically significant differences between interventions. Processes for patient involvement were identified with substantial inter-country variability, from formal patient submissions/consultations and committee involvement (UK, Canada) to limited/unclear patient involvement (France, Japan). Clinical guidelines were largely clinically-led, although patients were formally involved in guideline development in the UK, Spain, and Italy.  Conclusions: Patient involvement had limited influence on HTA decision making in the diseases evaluated, suggesting that formal processes for patient involvement are not fully maximised. PRO data influenced few decisions, potentially due to being insufficiently robust or compelling. Valid, reliable, responsive PROs in well-designed comparative clinical studies are needed to generate data for reimbursement decision making. PHP239 The Use of Real World Data for Nice Decision-Making: A Review of Submissions To Three Treatment Effectiveness Evaluation Programmes In 2015 And 2016 Glen F1, Pulfer A2 1Harvey Walsh, Runcorn, UK, 2pH Associates

(an Open Health company), Marlow, UK

Objectives: Randomised controlled trials (RCTs) are traditionally the ‘goldstandard’ data source for National Institute for Care and Health Excellence (NICE) evidence appraisals, although real world data (RWD) is gradually being accepted alongside RCTs or sometimes as a distinct evidence source. Guidance regarding the appropriate use of RWD is limited and varies across programmes. This audit aimed to quantify the extent to which RWD was considered in submissions and reviews for three NICE evaluation programmes in the previous two years.  Methods: A systematic review of NICE guidance published by the NICE Technology Appraisal (TA), Diagnostic Assessment (DA) and Medical Technologies Evaluation (MTE) programmes in 2015-16 was conducted in May 2017. Key information, including a description of evidence considered, committee comments and recommendations made was extracted and recorded in an electronic database. References to RWD (i.e. data generated from non-comparative, observational studies) were noted.  Results: In 2015-16, 91 TA, 9 DA and 9 MTE submissions were appraised by NICE. Of TA evidence submissions, 10% (9/91) included RWD, compared with 67% (6/9) DA and 89% (8/9) MTE submissions. The reviewing committee identified aspects of real-world study methods or reporting requiring improvement for 56% (5/9) TA, 50% (3/6) DA and 44% (4/9) MTE appraisals involving RWD: key areas of focus included sample size, generalisability to wider population, and potential confounders. Guidance included specific recommendations for further RWD collection for 5% TA, 100% DA and 56% MTE submissions.  Conclusions: The relatively low proportion of RWD in TA submissions suggests a slower uptake for medicine appraisals compared with diagnostics and other technologies. Nevertheless, the thorough evaluations of realworld evidence by NICE, and trend towards specific recommendations for further RWD, indicate increasing prominence of RWD for NICE decision-making. Detailed guidance and collaboration across NICE programmes is needed to enable robust design and consistent critique of real-world studies. PHP240 When The Outcome of An Appraisal Is Not Nice: A Review Of Nice Appeals O’Day K1, Campbell DJ2, Meyer KL1 Harbor, FL, USA, 2Xcenda, Palm Harbor, FL, USA

1Xcenda, LLC, Palm

Objectives: The National Institute for Health and Care Excellence (NICE) provides stakeholders to health technology appraisals the option to appeal the decision. We conducted an analysis of past appeals to review the appraisal appeal process by time, therapeutic area, number and type of appellants, grounds of the appeal, and success of the appeal.  Methods: Appeals starting from the year 2000 were identified on the NICE website. Appeal decision documents were reviewed to obtain date of appeal, therapeutic area, number of appellants, type of appellant, grounds of the appeal, and outcome of the appeal (ie, whether it was dismissed or upheld). Results were tabulated in an Excel spreadsheet and descriptive statistics were compiled.  Results: A total of 87 past appeals were identified and appeal decisions were available for 75 of the appeals. The annual number of appeals peaked between 2006 and 2008. The most common therapeutic areas of appeals were oncology (39%), rheumatology (16%), and endocrinology (12%). There were a mean of 2.4 appellants per appeal. Manufacturers were the most common appellant (47%), followed by professional group (22%), patient group (22%), clinical (5%), and other (3%). The most frequent ground for an appeal was unreasonable evidence (92%), followed by failure to be fair (64%), and exceeded powers (23%). Forty-two (56%) of the appeal decisions were dismissed on all grounds, while the remaining 33 (44%) were upheld on one or more grounds. Failure to be fair was the most common ground for upholding the appeal (38%), followed by unreasonable evidence (34%), and exceeded powers (7%).  Conclusions: Manufacturers are the most common appellant in NICE appeals, with unreasonable evidence being the most common ground for the appeal. However, failure to be fair is the ground for appeal most likely to be upheld. PHP241 How Do Nice Evidence Review Groups Perceive Single Technology Appraisals Presenting Limited Evidence of Comparative Treatment Efficacy? Langford BE, Beaver S, Besford M, Castell A, Dierker Viik A, Eddowes LA Costello Medical Consulting Ltd, Cambridge, UK

Objectives: When determining relative treatment effects, synthesising data from several high-quality randomised controlled trials (RCTs) using conventional