ORGANIZATION: Veteran Affairs San Diego Healthcare System (VASDHS) is a 242-bed medical facility that provides comprehensive medical, surgical, mental health, rehabilitation, spinal cord injury, and extended care services for over 57,000 veterans. VASDHS is part of the Department of Veterans Affairs which is an integrated health care organization that operates using a national formulary, provides outpatient and inpatient specialty services and uses a comprehensive electronic medical record system. PROBLEM OR ISSUE ADDRESSED: The absence of an accepted system for evaluating appropriate utilization of disposable medical supplies present decision makers with concern for how resources are managed in this category of budget expenditures. There is no current standard in place for technology assessments for durable medical equipment (DME) requiring disposable medical supplies in a pharmacy benefit management (PBM) plan with the potential for extensive budgetary and utilization management challenges to our health care system. With the introduction of CGM to the US market, the American Diabetes Association has recognized CGM as a useful tool for clinicians and patients. Local health care systems are now faced with identifying the specific utility of this new technology for their patient population. GOALS: (1) Develop health technology criteria for use for CGM sensors (2) Assess diabetes outcomes after patients are approved for CGM device and sensors. OUTCOMES ITEMS USED IN THE DECISION: Clinical efficacy/effectiveness included: HbgA1c (pre-post CGM sensors utilization), incidence of hypoglycemia, and Emergency Department and hospital admissions due to hypoglycemia. IMPLEMENTATION STRATEGY: The local Pharmacy and Therapeutics (P&T) committee approved a criterion for use (CFU) for the CGM sensors that required providers to measure clinical efficacy and patient outcomes in order to facilitate the decision making process for authorization. The pharmacy service implemented the P&T committee CFU in conjunction with a medical staff reviewer from our national headquarters for approval of the DME device. RESULTS: Twelve out of 15 patients who received the CGM devices were evaluable at 6 months. All patients were on insulin (100%), most were diagnosed with type I diabetes (92%), 83% had hypoglycemia unawareness, and there was an average reduction of 0.13% HbgA1c following CGM intervention. No incidences of hypoglycemic events requiring hospitalizations occurred following the receipt of CGM, with 67% of patients reporting a reduction in frequency of hypoglycemic episodes. The average time to patient receipt of device was 90 days (d) (SD 76 d, median 73 d) from date of provider request. Fiscal Year 2009 (FY2009) VASDHS Pharmacy budget impact was estimated as $18,480. Annualized cost for CGM device and sensors ranged from $740 to $3520 per patient based on patients refill rates in FY2009. LESSONS LEARNED: There was a gap in communication that was identified within the CGM device approval process. Final decisions by the reviewer were not communicated to the provider who initiated the request for the CGM device in a timely manner. This led to a delay in getting patients the CGM devices. Hypoglycemic events that require hospitalization is a preventable economic burden to the PBM and society. CGM devices showed benefit in eliminating unnecessary hospitalizations due to hypoglycemia and reducing the frequency of hypoglycemic events by alerting patients of the potential danger prior to it evolving in to a major problem.
Christopher, M., Bounthavong, M., Mendes, M., Kazerooni, R., Herbst, K., Mavian, A., & Kung, J. (2010). PCASE2 DEVELOPING CRITERIA FOR USE FOR CONTINUOUS GLUCOSE MONITORING (CGM) SENSORS IN A VETERAN POPULATION. Value in Health, 13(3), A217. https://doi.org/10.1016/s1098-3015(10)73063-1