1. VHA INNOVATION PROGRAM Innovation #554 Insulin Pen Project VHA ISB Business Case September 25, 2013

2. VETERANS HEALTH ADMINISTRATION Project Background Problem Statement – The traditional vial and syringe method of administering insulin is complex, involving over 15 separate steps. Many patients find the process daunting and are reluctant to start insulin therapy, increasing their risk for diabetes-related complications. Insulin pens offer an easier method for patients to administer insulin injections. Previous research has shown that patients prefer insulin pens and report significantly less fear of self-injecting. They also report improved ease of use/handling with insulin pens, a factor that is particularly important for patients with poor manual dexterity or vision. As a result, many studies have shown improved adherence to recommended insulin regimens with insulin pens as compared to traditional vial and syringe (1,2). The goal of this project is to offer insulin pens in lieu of insulin vials and syringes to Veterans at the VA Montana Health Care System. The anticipated benefits include improvements in clinical outcomes as measured by hemoglobin A1c (HbA1c) levels, reductions in the amount of time clinicians spend training patients to administer insulin therapy, decreased adverse events related to insulin misuse and improvements in patient satisfaction. Description of Proposed Solution – Begin offering insulin pens in lieu of vial and syringes in inpatient settings – Expand use of insulin pen in outpatient settings in select patient populations – Provide training to nursing staff, physicians, pharmacists, and diabetes educators on insulin pen use – Collect outcomes data to evaluate the impact of providing insulin pens as opposed to traditional vial and syringe 1

3. VETERANS HEALTH ADMINISTRATION Execution Status Local deployment in the VA Montana Healthcare System Pharmacy staff was not supportive due to cost concerns – The pharmacy staff was not supportive because cost-effectiveness data are lacking – Previous studies highlight that the overall health care costs are similar or lower with insulin pen as compared to vial and syringe (1-2) The modest increase in the cost of pens versus syringe and vials is usually more than compensated for in cost-savings from reduced utilization of inpatient and outpatient services as a result of better medication adherence and disease management High level, project specific, tasks required for enterprise deployment: – In depth data gathering completed to identify specific number of Veterans currently receiving syringe and vial treatment – Six (6) month pilot at approximately six (6) sites and Class III to Class I verification performed prior to national release 2

4. VETERANS HEALTH ADMINISTRATION ISB Selection Criteria 3 CriteriaSee…Self-Assigned Score ComplianceSlide 41 Five-Year Net Operational Cost ChangeSlide 50 Implementation CostSlide 6-6 Clinical Impact (Broadness)Slide 710 Clinical Impact (Degree)Slide 710 Business Impact (Broadness)Slide 810 Business Impact (Degree)Slide 810 Patient SafetySlide 97 Patient ValueSlide 1010 Healthcare DisparitySlide 111 Summary Value = 1 * (14+38) = 52 Business Value = 0 + (-6) + 10 + 10 = 14 Clinical Value = 10 + 10 + 10 + 1 + 7 = 38

5. VETERANS HEALTH ADMINISTRATION Business Case – Compliance The solution is compliant with regulations, including patient safety 4 Self Assigned Score: 1

6. VETERANS HEALTH ADMINISTRATION Business Case – 5 Year Net Operational Cost Change 5 Self Assigned Score: 0 While the pharmacy costs associated with the insulin pen are greater than with a vial & syringe, reviews of the literature suggesting that replacing traditional vial and syringes with insulin pens is cost-neutral due to reduced utilization of inpatient, outpatient, and ER resources (improved adherence) Cost Element Cost Difference Pharmacy cost differences between insulin pen vs. vial & syringe (anti- hyperglycemic therapy HTs and self – monitoring blood glucose supplies) + $293 Total diabetes-related costs (pharmacy, outpatient, inpatient, and ER) - $296 Cost Element Cost Difference Annual diabetes-related healthcare costs with vial and syringe vs. insulin pens $3970 vs. $4838 Total annual healthcare related costs with vial and syringe vs. insulin pends $13,214 vs. $13212 Authors reported there were no significant changes in health care costs Lee et al., 2011Baser et al., 2010

7. VETERANS HEALTH ADMINISTRATION Business Case - Implementation Costs 6 Year 1Year 2Year 3Year 4Year 5 Pilot Phase$250,000$0 Deployment Phase$0$125,000 Annual Total$250,000$125,000 Cumulative Costs$250,000$375,000$500,000$625,000$750,000 Self Assigned Score: -6 Identified cost based on oversight of deployment at facilities Initiating insulin therapy with a pen device was associated with comparable medication adherence and significant reductions in health care resource utilization and associated costs compared with vial/syringe insulin(3).

8. VETERANS HEALTH ADMINISTRATION Business Case – Clinical Impact Broadness: This solution positively impacts three clinical performance metrics 7 Self Assigned Score, Broadness: 10 Self Assigned Score, Degree: 10 Clinical Performance MetricDegree of Impact Communication about medications 20% improvement Discharge information 15% improvement DM, HbA1 GT9 or not done, poor control (OP) Degree: This solution positively impacts these metrics in the following ways - Improves communication of staff by simplifying process for educating patients - Improves quality of care by preventing medication errors - Improves accuracy of medication profiles - Eliminates Veteran confusion associated with administration of new medication - Limits adverse drug events and decreases patient misuse - Improves hospital admission/discharge communication on medications

9. VETERANS HEALTH ADMINISTRATION Business Case – Business Impact Broadness: This solution positively impacts five business performance metrics 8 Self Assigned Score, Broadness: 10 Self Assigned Score, Degree: 10 Degree: This solution positively impacts these metrics in the following ways - Improves accuracy of medication profiles (medication reconciliation) for clinical decision making -Standardizes and streamlines process for patient instruction -Reduces amount of time clinicians spend providing training to patients on administering self- injections -Reduces Patient confusion/intimidation of new prescription Business Performance MetricDegree of Impact Improved accuracy of decision making (quality of work) 25% improvement Standardization of best practices (quality of work) 10% improvement Reduces program or organizational risk (quality of work) 25% improvement Reduces costs (VA staff efficiency or workflow) 5% improvement Improves the environment of care (Veteran/beneficiary’s experience) 15% improvement

10. VETERANS HEALTH ADMINISTRATION Business Case - Patient Safety This solution demonstratively improves patient safety -Improves accuracy of medication administered by patients due to visual impairment -Improves quality of care by preventing medication errors -Limits adverse drug events and decreases patient misuse -Eliminates Veteran confusion due to ease of use of pens vs. vial and syringe and dosage requirements Evaluation Criteria Scored -10 to 10 where -10 is severe decrease in patient safety, 0 is no change in patient safety and +10 is very strong impact in patient safety 1.Demonstratively reduces preventative harm in this population: 6 2.Reduces mortality and morbidity in this population: 5 3.Improves patient safety by demonstratively reducing the chance of human error: 9 9 Self Assigned Score: 7

11. VETERANS HEALTH ADMINISTRATION Business Case – Patient Value This solution significantly increases patient satisfaction – Decreases Veterans risk of needle stick injuries with the pens as compared to vial and syringe creates a safer environment for clinicians and patients – Improves patient satisfaction with ease of use of pens – Improves training for patients by simplifying process to administer medication – Improves availability/portability of prescriptions – Improves Veteran Satisfaction by reducing needs of refrigeration of vial 10 Self Assigned Score: 10

12. VETERANS HEALTH ADMINISTRATION Business Case – Healthcare Disparity This solution does not address a healthcare disparity 11 Self Assigned Score: 1

13. VETERANS HEALTH ADMINISTRATION References 1.Baser, O., Bouchard, J., DeLuzio, T., Henk, H., & Aagren, M. (2010). Assessment of adherence and healthcare costs of insulin device (FlexPen) versus conventional vial/syringe. Advances in therapy, 27(2), 94–104. 2.Lee, L. J., Li, Q., Reynolds, M. W., Pawaskar, M. D., & Corrigan, S. M. (2011). Comparison of utilization, cost, adherence, and hypoglycemia in patients with type 2 diabetes initiating rapid-acting insulin analog with prefilled pen versus vial/syringe. Journal of medical economics, 14(1), 75–86. 3.Pawaskar MD, Camacho FT, Anderson RT, Cobden D, Joshi AV, Balkrishnan R. (2007)Health care costs and medication adherence associated with initiation of insulin pen therapy in medicaid-enrolled patients with type 2 diabetes: a retrospective database analysis.Health care costs and medication adherence associated with initiation of insulin pen therapy in medicaid-enrolled patients with type 2 diabetes: a retrospective database analysis. 12

14. VETERANS HEALTH ADMINISTRATION Back Up Slides 13

15. VETERANS HEALTH ADMINISTRATION Other Considerations – Environmental Impact Insulin Pen Project will: -Reduce hazardous waste reaching landfills and major water sources -Discarded syringes -Unusable/expired vials on insulin -Decrease availability and misuse of insulin therapy syringes for illegal drug use 14