THE ASSESSMENT OF VALUE FOR MEDICAL DEVICES- USING REAL WORLD EVIDENCE (RWE) TO QUANTIFY UNMET NEEDS IN DIABETES MANAGEMENT
Author(s)
Charter R1, Yeung A2, Smith M2, Hopley C3
1Becton Dickinson AG, Allschwil, Switzerland, 2Becton Dickinson (BD), Allschwil, Switzerland, 3Becton Dickinson, Oxford, Switzerland
OBJECTIVES: Education and product training are critical but overlooked variables in the value assessment of medical devices. Over 24 million insulin injections occur daily in Europe. Many of these injections occur into undiagnosed Lipohypertrophy (LH). Insulin absorption is significantly reduced when injecting into LH. Using Real World Evidence we aimed to determine whether significant cost savings associated with proper device selection, regimen adherence and outcomes would lower healthcare system costs. METHODS: Using Real World Evidence generated from 18 CCG centres across the UK in an England/Scotland Lipohypertrohy Audit (ESLA) we developed a robust patient and HCP questionnaire that aimed to quantify the important role proper injection technique has in achieving and maintaining optimal glycemic control. A prospective, 3 visit audit study was conducted composed of 3 distinct phases: Study nurse training, patient recruitment, and finish study (patient exit). The primary endpoint was reduction in insulin usage. The secondary endpoint was reduction in HbA1c. These were comparted to baseline as well as modelled against a 13,000+ Injection Technique questionnaire to determine healthcare system savings and cost reductions. RESULTS: The ESLA audits yielded an n of 75, and the ITQ yielded an n of 13,289. The results were comparable across both sample sizes. The prevalence of Lipohypertrophy was 50% on entry to the audit, and was reduced to 33% on exit. Mean insulin reduction related to ESLA ranged from 2 units per person per day to 17 units per person per day. CONCLUSIONS: Medical device value is materially impacted by the level of additional training and HCP support. The higher the training, the more aligned efficacy and effectiveness data become. This makes intuitive sense, as practice replicates the idea setting of a controlled trial. It is therefore highly recommended that additional training and HCP support be a key variable in the value assessment of medical devices.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PMD104
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care
Topic Subcategory
Formulary Development, Pricing Policy & Schemes, Reimbursement & Access Policy, Risk-sharing Approaches
Disease
Diabetes/Endocrine/Metabolic Disorders