Economic impact of a novel naloxone autoinjector on third-party payers.

BACKGROUND: Patient overdoses on prescription opioid analgesics in the United States continue to rise, resulting in increased emergency department and hospitalization costs. Opioid overdose is readily reversible with naloxone, a fast-acting opioid antagonist. A new naloxone autoinjector (NAI), Evzio, which does not require medical training to use, was approved by the FDA in April 2014. Payers must decide on reimbursement policies for this product. PURPOSE: To demonstrate to payer decision makers the costs and potential medical resource cost offsets associated with the utilization of a new NAI. DESIGN: A deterministic model using matched controls. METHODOLOGY: An Excel-based cost model was developed for a hypothetical health plan with 1 million adult members. Costs of prescription opioid overdose events for patients appropriately dispensed NAI were compared with matched controls. RESULTS: NAI prescriptions increased from 218 in Year 1 to 2,527 in Year 3. In Year 3, 86 NAI patients (and their matched controls) experienced opioid overdose events. For this period, fatal overdoses in the NAI cohort totaled 11.1 vs. 14.7 for the control group. In Year 3, 2.5 deaths (10.1-7.6) were avoided. NAI acquisition costs rose from $125,000 in Year 1 (PMPM = $0.01) to nearly $1.5 million in Year 3 (PMPM = $0.12).This cost was offset by medical resource savings of approximately $84,000 in Year 1, increasing to $975,000 in Year 3. The total net cost (NAI less offsets) in Year 3, when NAI uptake was assumed to plateau, was $481,000 (PMPM = $0.04). CONCLUSION: A deterministic model demonstrated that NAI acquisition costs can be offset through medical cost reductions with improved timely access to naloxone.

Impact of pen utilization on insulin cost reduction in long-term care facilities.

OBJECTIVE: To determine the impact on insulin acquisition cost of a pharmacy program to convert insulin utilization from multidose vials to pen-delivery systems for long-term care residents covered by Medicare Part A, and managed care plans. DESIGN: Retrospective cost comparison. SETTING: Long-term care facilities. PATIENTS: Residents covered by Medicare Part A and managed care plans. INTERVENTIONS: Policy to replace insulin vials with pen devices, effective July 2009. MAIN OUTCOME MEASURES: Mean insulin cost-per-patient day (total insulin purchases divided by patient admission days) and pen utilization (pen purchases as a percent of total insulin purchases). RESULTS: Insulin purchase data covered 2,405 admissions in 75 facilities over the 12-month period ending June 2010. Pen device purchases increased from less than 1% to almost 35% of total insulin purchases over the study period during which insulin cost per patient-day declined from $10.29 to $4.08. For Medicare Part A patients with admissions of 30 days or fewer, the most frequent visit type, mean cost per patient-day decreased from $13.73 to $9.19 as pen purchases increased from less than 1% to about 32%. For these same patients, mean cost per patient-day for admissions using only pen devices was $7.04, compared with $11.79 for admissions using only vials (P < 0.001). Significant differences in mean cost per patient-day were also found for residents covered by managed care and for longer admissions. CONCLUSION: Total insulin costs can be reduced through higher utilization of pen devices by patients in long-term care facilities.

Impact of final short-fill rule on Medicare Part D costs and long-term care pharmacy dispensing.

OBJECTIVE: To evaluate the impact of the final Centers for Medicare & Medicaid Services' (CMS) "short-fill" rule regarding the appropriate dispensing of prescription drugs in long-term care facilities. DESIGN: A prospective study to determine rates of unconsumed medication and the net-cost impact on Medicare Part D prescription drug plans based on the proposed and final CMS rule and other scenarios under consideration by CMS. SETTING: Four hundred twenty-five long-term care facilities in six states. PATIENTS: Residents covered by Medicare Part D. MAIN OUTCOME MEASURES: Rates of unconsumed medication, average dispensing fees, potential reduction in unconsumed medication, incremental fills, incremental dispensing fees, net cost or savings to Medicare Part D plans, and percentage increase in fills. RESULTS: Total estimates of the cost of unconsumed medication charged to Medicare Part D plans for residents in long-term care facilities are $87 million for brand products and $39 million for generics annually. Based on current dispensing fees, it is likely that implementation of the final rule will result in incremental costs to CMS plans in the range of $30 million annually. The number of Medicare Part D prescription fills will increase by about 20%. A seven-day fill requirement on brand products would raise incremental costs to more than $150 million annually, and inclusion of generic products in a seven-day fill requirement would result in incremental costs in the range of $850 million annually. CONCLUSION: The final CMS rule on short-fills is unlikely to result in savings to Medicare Part D plans. Shorter fill times and inclusion of generic products would significantly raise costs to these plans.

Measurement of unused medication in Medicare Part D residents in skilled nursing facilities.

OBJECTIVE: To determine the cost of unused medication dispensed to Medicare Part D residents in nursing facilities in the United States and to describe the distribution of unused medication based on dispensed prescription cost and unit medication cost. DESIGN: A prospective study in which dispensed and returned prescription data for Medicare Part D residents encompassing the first six months of 2010 were provided by eight long-term care pharmacies servicing approximately 33,700 residents in 425 facilities. SETTING: Nursing facilities. PATIENTS: Residents covered by Medicare Part D. MAIN OUTCOME MEASURES: Unused medication as a percentage of dispensed prescriptions was calculated based on the number of returned prescriptions and the cost of unused medication for all dosage forms and for solid oral forms. RESULTS: For all dosage forms, 6.8% of dispensed prescriptions were returned partially used, representing 3.5% of dispensed cost. For solid oral dosage forms, 6.1% of all dispensed prescriptions were returned partially used, representing 2.9% ± 1% of total dispensed cost. For returned oral solid prescriptions, 24% had a dispensed cost of $50 or more but accounted for 84% of the cost of returned medications; 26% had a unit cost of $1 of more, but accounted for 83% of the cost. The total amount of unconsumed solid oral medication for Medicare Part D residents in skilled nursing facilities was estimated at $125 million annually. CONCLUSION: The estimated cost of unconsumed medications dispensed to Medicare Part D residents in nursing facilities is approximately 3% of dispensed cost, amounting to approximately $125 million across all U.S. nursing facilities.

Economic benefits of improved insulin stability in insulin pumps.

PURPOSE: Insulin pump users discard unused medication and infusion sets according to labeling and manufacturer's instructions. The stability labeling for insulin aspart (rDNA origin] (Novolog) was increased from two days to six. The associated savings was modeled from the perspective of a hypothetical one-million member health plan and the total United States population. DESIGN: The discarded insulin volume and the number of infusion sets used under a two-day stability scenario versus six were modeled. METHODS: A mix of insulin pumps of various reservoir capacities with a range of daily insulin dosages was used. Average daily insulin dose was 65 units ranging from 10 to 150 units. Costs of discarded insulin aspart [rDNA origin] were calculated using WAC (Average Wholesale Price minus 16.67%). The cost of pump supplies was computed for the two-day scenario assuming a complete infusion set change, including reservoirs, every two days. Under the six-day scenario complete infusion sets were discarded every six days while cannulas at the insertion site were changed midway between complete changes. AWP of least expensive supplies was used to compute their costs. PRINCIPAL FINDINGS: For the hypothetical health plan (1,182 pump users) the annual reduction in discarded insulin volume between scenarios was 19.8 million units. The corresponding cost reduction for the plan due to drug and supply savings was $3.4 million. From the U.S. population perspective, savings of over $1 billion were estimated. CONCLUSIONS: Using insulin that is stable for six days in pump reservoirs can yield substantial savings to health plans and other payers, including patients.

Impact of a prior authorization for pregabalin on health plan drug expenditures.

OBJECTIVE: The objective of this study is to examine the financial impact of a prior authorization (PA) intervention for pregabalin in a commercially insured US population via an economic model. METHODS: An Excel-based model was developed to simulate 2 hypothetical scenarios for health plans: one with a PA on pregabalin, and another without a PA. In the PA scenario, a variable percentage of pregabalin prescriptions were assumed to be approved and dispensed, the remainder being denied or a substitute product dispensed (branded or generic alternatives). In the "no PA" scenario, all pregabalin prescriptions were assumed to be filled. The market shares of these products, including pregabalin, were based on secondary prescription data. The model calculated the total drug acquisition cost and cost of PA administration in each scenario for a cohort of 1000 patients over a 1-year period. Patients switching to pregabalin following denial were accounted for in the model. Sensitivity analyses were carried out varying the PA approval rates and prescription share of pregabalin and limiting the range of substituted products. RESULTS: The pregabalin prescribing rate was set to 10.3% in both the PA and "no PA" scenarios, with a denial rate of 50% in the PA scenario, consistent with the IMS prescription volume. The calculated drug acquisition cost for the PA scenario was $885,564 compared with $888,822 for the "no PA" scenario, a difference of 0.4%, after factoring in the cost of PA administration. The calculated PA administration cost was $4121. Eliminating the PA administration cost results in a cost for the PA scenario of $881,443, 0.8% below the "no PA" scenario. Lowering the pregabalin PA approval rate from 50% to 10% decreased the costs of the PA scenario to $879,660, 1.0% lower than the "no PA" scenario. Raising the pregabalin market share to 20% in the "no PA" scenario increased the costs of that scenario to $902,714, 1.9% higher than the PA scenario. Limiting the substituted products for denied pregabalin prescriptions in the PA scenario to the 2 most common products, valproate sodium and gabapentin (both generics), lowered the cost of the PA scenario to $875.412, 1.5% below the "no PA" scenario cost. With half of the denied pregabalin patients switching to pregabalin during the course of the year, the cost of the PA scenario increased to $892,550, 0.4% higher than the "no PA" scenario. CONCLUSION: Potential savings due to PA protocols on pregabalin are low, in the 1% to 2% range across a variety of scenarios, because of the relatively low pregabalin market share (about 10%) in typical health plans and the absence of a significant difference in cost for the most commonly substituted products. Patients who switch to pregabalin after an initial denial will further reduce savings to health plans.

Effect of drug therapy on HEDIS measurements of HbA1c control in diabetes patients.

The purpose of this study was to corroborate an earlier study that explored the relationship between a health plan's Health Plan Employer Data and Information Set (HEDIS) score for glycolated hemoglobin (HbA1c) control in diabetes patients and its utilization of insulin and oral diabetes products. Prescription volumes were tracked for four categories of diabetes drug therapy: analog insulin, human insulin, single-source brand oral products, and multisource generic oral products, for calendar years 2005 and 2006. The prescription shares of each of the four drug categories for each health plan were matched to the health plan's HEDIS measurements of HbA1c control for each year. Univariate and multivariate regression analysis was performed between the health plan's HbA1c -based HEDIS score and its prescription share of each drug category. A favorable and statistically significant (p < 0.01) relationship was found between plan HbA1c HEDIS score and plan prescription share of analog insulin in both 2005 and 2006. The correlation between HEDIS scores and human insulin was not statistically significant. Unfavorable relationships were found between HEDIS scores and both the single-source brand (statistically significant) and the multisource generic oral category prescription shares (not significant). These results corroborate the relationships found in our earlier study, although a cause and effect relationship cannot be confirmed.

Comparison of human growth hormone products' cost in pediatric and adult patients. A budgetary impact model.

We assessed the economic impact to the United States payer of recombinant human growth hormone (rhGH) utilization, comparing the relative dosage efficiency of marketed pen-based and vial-based products in a pediatric and in an adult population. A budgetary impact model calculated drug costs based on product waste and cost. Waste was the difference between prescribed dose, based on patient weight, and actual delivered dose, based on dosing increments and maximum deliverable dose for pens and a fixed-percent waste as derived from the literature for vials. Annual wholesale acquisition costs were calculated based upon total milligrams delivered, using a daily dose of 0.03 mg/kg for pediatric patients and 0.016 mg/kg for adults. Total annual drug costs were compared for two scenarios: 1) a product mix based on national market share and 2) restricting use to the product with lowest waste. Based on the literature, waste for each vial product was 23 percent. Among individual pens, waste was highest for Humatrope 24 mg (19.5 percent pediatric, 14.3 percent adult) and lowest for Norditropin Nordi-Flex 5 mg (1.1 percent pediatric, 1 percent adult). Restricting use to the brand with least waste (Norditropin), compared to national product share mix, resulted in a 10.2 percent reduction in annual pediatric patient cost from $19,026 to $17,089 and an 8 percent reduction in annual adult patient cost from $24,099 to $22,161. We concluded that pen delivery systems result in less waste than vial and syringe. Considering all approved delivery systems, Norditropin resulted in the least product waste and lower annual patient cost for both pediatric and adult populations.

Correlation of HEDIS diabetes health plan score with utilization of diabetes medications.

This study sought to determine the correlation between a health plan's Health Plan Employer Data and Information Set (HEDIS) score for glycated hemoglobin (HbA1c) control in patients with diabetes and its utilization of analog insulin, human insulin, and oral drug therapy as determined by the share of prescriptions of each therapy. Prescription volumes were tracked for four categories of diabetes drug therapy: (1) analog insulin, (2) human insulin, (3) single-source brand oral products, and (4) multisource generic oral products, for the three months ending January 2005 and January 2006 and matched to the 2004 and 2005 HEDIS scores. A correlation analysis conducted between the HbA1c-based HEDIS score and the prescription share of each drug category found a favorable and statistically significant (P < .0001) correlation between plan HbA1c HEDIS score and plan prescription share of analog insulin in both 2004 and 2005. The correlation between HEDIS scores and human insulin was not statistically significant. Unfavorable correlations were found between HEDIS scores and both the single-source brand and the multisource generic oral category prescription shares, although these correlations were found to be significant only for the single-source products in 2005.