The Evolution of Nice Medtech Innovation Briefings And Their Associated Technologies

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outcomes, 1-year mortality and composited endpoints were extracted from each registry’s publications. No publication time restriction was used.  Results: 20 TAVI registries were identified in our review with an overall sample size of 12,583 patients. 20 TAVI registries used either EuroScore or Society of Thoracic Surgery Risk Score (STS) or both to record patients’ baseline characteristics and case selection. The 30-day all-cause mortality ranged from 0 to 12.7%. 14 registries reported 30-day cardiovascular mortality, and only 11 registries reported 1-year mortality. Myocardial infarction (MI) should be differentiating into periprocedural MI and spontaneous MI, the author only can identify 11 registries who reported periprocedural MI. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation. Of all 20 TAVI registries, 30% reported 9 of 9 complications, and 55% missed 1-2 complications.  Conclusions: VARC and VARC-2 definitions are more and more widely used by TAVI registries. Reporting VARC-2 definitions makes cross-registry comparisons more feasible. Since the introduction of VARC, the number of systematic-review and meta-analysis is dramatically increasing. This transparence will provide better evidence to patients and decision makers such as regulatory bodies, payers and HTA agencies. PMD127 The Evolution of Nice Medtech Innovation Briefings And Their Associated Technologies Bullen M, Hughes T, Marshall JD MAP MedTech Limited, Cambridge, UK

Objectives: A MedTech Innovation Briefing (MIB) is a document produced by the National Institute for Health and Care Excellence (NICE) designed to help NHS commissioners, patients and clinicians make informed decisions about new medical technologies. Our objective was to establish how MIBs have evolved over time since the publication of the first briefing in February 2014, and to identify trends in the technologies evaluated by this process.  Methods: Structured desk research was conducted. The number of MIBs produced per month was quantified and an analysis on the types of technologies included in the briefings was performed. Areas of interest included regulatory details, contributions from patient groups and specialists, and device cost.  Results: The study showed that the number of MIBs produced each year has steadily increased between 2014 and 2016 from 17 to 42. Across all years, devices with a Class IIa or IIb CE mark remained the most common technologies selected for evaluation, as did technologies with a purchasing price between £1,000 and £10,000. Our analysis also revealed that across this timeframe, the majority of MIBs (78%) did not contain comment from patient organisations or carers, however, all briefings contained contributions from three or more specialists.  Conclusions: Whilst the number of MIBs produced each year is increasing, there remains limited patient group involvement in the development process. Due to the absence of a NICE recommendation and NHS funding mandate, MIBs are typically perceived as low profile assessments. This may contribute to the observed limited patient engagement. With the development of MedTechScan to identify technologies suitable for NICE evaluation, the quantity and diversity of MIBs is likely to increase. Implementing the Government’s Accelerated Access Review recommendations to provide funding for medical technologies approved by NICE is expected to raise the status of MIBs. PMD128 HTA Reports In Gene And Cell Therapy Products: A Scoping Review Zhang S, Kolominsky-Rabas PL Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany

Objectives: The approval of Strimvelis from GlaxoSmithKline (GSK) for treatment of “bubble boy syndrome” raised questions in field of gene and cell therapy products (GCT), whether new models of modified HTA assessment methodologies are needed. The objective of our study is to overview HTA reports in GCTs in Europe and United States (US).  Methods: A scoping review was performed on HTA reports in GCTs from exiting HTA agencies in Europe and US. The assessment reports planned to identify limited within 8 approved advanced therapy medicinal products (ATMPs) from European Medicines Agency (EMA) and 13 approved gene and cellular therapy products (GCTs) from US Food and Drug Administration (US FDA). The Language is limited in English and German.  Results: 12 HTA reports have been identified, five from NICE, three from IQWIG, three from HAS and one from LBI. Two reports based on systematic review of clinical studies, which assessed MACI from LBI and NICE. The other assessment reports used methods of experts or committee’s comments on the dossier submitted by the company. Compare to focusing points on safety and efficacy from regulatory bodies, HTA agencies focus on added value and actual benefit comparing to the comparator for current treatment. For example, for assessing a cancer treatment for melanoma called “Imlygic”, both IQWIG and NICE criticized on its comparator, IQWIG needed the company to submit additional three RCTs to prove their added value, NICE also needed one RCT to prove actual benefit, because they suggested the current comparator used in pivotal study is ineffective.  Conclusions: The assessment process for GCTs is similar to other medical products but with more flexibility. For safety concerns, a long-term followup observation in a registry is recommended from different agencies. To assess cost-effectiveness, make appropriate health economic model, early involving payers and HTA in the development of GCTs is necessary. PMD129 Economic Outcomes Of The Attune® Knee System: Analysis Of Real World Length Of Stay In An Italian Hospital Pipino G1, Paragò V2, Corso KA3, Wigham R4, Holy CE3, Do Rego B5 1L.U.de.S Foundation H.E.I. University, Bologna, Italy, 2Johnson & Johnson Medical SpA, Pratica di Mare (Rome), Italy, 3Johnson & Johnson, New Brunswick, NJ, USA, 4Johnson & Johnson Medical Limited, Livingston, West Lothian, UK, 5DePuy Synthes, Leeds, West Yorkshire, UK

Objectives: Total Knee Arthroplasty (TKA) is a successful, widely-used procedure that provides pain relief and improved function for osteoarthritic patients. Given

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the increased demand for TKAs, there is a need for meaningful innovation that improves clinical outcomes and optimises resource utilisation. The DePuy Synthes (DS) ATTUNE® Knee System has been designed to improve patient function and satisfaction. The objective of this study was to compare the length of stay (LOS) for TKA patients who received ATTUNE versus the DS SIGMA® Knee System.  Methods: A single center, retrospective analysis was conducted between 2013 and 2015 at a private Italian hospital. 200 consecutive patients from a single surgeon underwent TKA, representing the last 100 SIGMA cases and first 100 ATTUNE cases (post 20 learning curve cases). The primary endpoint was LOS. Electronic medical records were used to collect patient characteristics: age, gender, marital status, ASA grade, prior TKA, and pre-operative Oxford Knee Scores (OKS). Bivariate analyses to compare patient characteristics by implant were generated and a linear regression model was constructed to evaluate LOS as a function of demographic and clinical variables.  Results: Patients implanted with ATTUNE demonstrated a 4-day reduction in mean LOS (95% CI 3.5 – 4.5 p< 0.0001): ATTUNE: 9.7 (SD: 1.2); SIGMA: 13.7 (SD: 1.9). There were no significant differences in reported characteristics between the two groups. The proportion of females (71%) was similar; there were no significant age differences with most patients between 61 and 70. Most patients were married (ATTUNE: 92%, SIGMA: 85%). All patients (100%) had severe preoperative OKS (ATTUNE: mean= 9.5 (SD: 3.7), SIGMA: mean= 9.4 (SD4.1)), and 22.5% patients had previous contralateral TKA (ATTUNE: 23%, SIGMA: 22%).  Conclusions: Statistically significant differences were noted in the LOS between the two groups. This Real World study demonstrates how the adoption of ATTUNE could potentially benefit providers, payors and patients by reducing LOS. PMD130 Competency Analysis Of Community Pharmacists About Correct Use Of Metered Dose Inhaler Hayat K1, Bukhari NI1, Hussain T2, Saeed H1, Murtaza G3 of the Punjab, Lahore, Pakistan, 2University of Veterinary and Animal Sciences, Lahore, Pakistan, 3Department of Pharmacy, COMSATS Institute of Information Technology, Abbottabad, Pakistan 1University

Objectives: Asthma is one of major respiratory disorders, requiring the use of corticosteroids and bronchodilators for its treatment. These drugs, in the form of inhaler device, provide quick and prompt relief due to the increased bioavailability. It is the integral responsibility of the community pharmacists to guide the patients about the correct technique of using an inhaler device. The present study evaluated the competency of community pharmacists about the rational use of metered dose inhaler (MDI).  Methods: A cross-sectional study was conducted to assess correct use of MDI by utilizing a 10-items criteria after validation in Lahore, Pakistan. A pseudo-patient approach was used in which one person acted as a patient of asthma requiring inhaler device and the second as the first’s caretaker. A total of 100 community pharmacies were targeted by convenient sampling technique. Scoring system was designed based on the critical and noncritical steps.  Results: A total of 60 (60%) community pharmacists agreed to participate in this study. Male was the dominant gender (95%) and most practicing community pharmacists (92%) were bachelor in Pharmacy. Nearly 43% community pharmacists were able to counsel the pseudo-patients about how to exhale completely before using MDI. The instruction that patient should wait for 5 to 10 seconds before second puff was skipped by 60% of the community pharmacists. Majority of the pharmacists (37%) counseled only 6 critical steps correctly. Only 3% of the community pharmacists were able to demonstrate all the selected critical steps of the rational use of MDI.  Conclusions: Community pharmacists are not competent enough to demonstrate correct use of inhaler device. The regular training programs by government is needed to be launched for the rational use of drug delivery devices. This will not merely increase the prognosis rate of disease but also the prestige of pharmacists. PMD131 Cost And Operational Efficiency Comparison Of An Integrated VS. A Multi-Step System For Extracorporeal Photopheresis In Germany Maas C1, Kuchenbecker U1, Kontekakis A2 GmbH, Hannover, Germany, 2Mallinckrodt Pharmaceuticals, Staines-Upon-Thames, UK

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Objectives: Extracorporeal photopheresis (ECP) is a treatment in which the mononuclear cells of a patient are ex vivo exposed to 8-methoxypsoralen, irradiated with ultraviolet A, and then reinfused into the patient. Two approaches exist for delivering ECP: 1) integrated ECP systems, where all procedure steps are fully integrated and the patient remains connected to the system and 2) multi-step procedures, where separate devices are used for cell separation and photoactivation. Aim of this model was to compare the budget impact of delivering photopheresis with both approaches.  Methods: A decision analytic model was developed in Excel to compare the budget impact of an integrated with a multi-step ECP system in different scenarios. Scenarios were adjustable by procedure step times, cost parameters, weekly available time and time horizon. Sensitivity analyses were conducted to assess the results.  Results: Over one year, the application of one unit of each system results in 780 (integrated) vs. 260 (multi-step) treatments with total costs of € 1,152,992 (integrated) vs. € 356,612 (multi-step). One treatment cycle of the integrated system costs € 1,478 compared with € 1,372 for the multi-step system. With an average DRG reimbursement of € 3,492 per treatment cycle, the operating costs would constitute 42% (integrated) and 39% (multi-step) of the compensation. Due to higher treatment volume of the integrated system the budget impact presented with +€ 1,019,461 in net earnings compared to the multi-step system. Varying the cost parameters and procedure step times by +20% (integrated) and -20% (multistep), the budget impact of the integrated system remained beneficial compared to the multi-step system with +€ 197,439.  Conclusions: Due to shorter procedure times, integrated ECP systems can achieve more treatments and higher net earnings per year. By applying these fully integrated systems, hospitals could increase efficiency in healthcare delivery for the relevant patient populations. Sensitivity analysis showed robustness of the model.