Date of Award

2019

Degree Type

Thesis

Degree Name

Master of Science in Pharmaceutical Sciences

Department

Biomedical and Pharmaceutical Sciences

First Advisor

Ami Vyas

Abstract

Background: Abuse deterrent opioids (ADOs) are approved by the US Food and Drug Administration for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Their unique formulations are designed to target recognized or anticipated routes of abuse. Affordability is always a concern with newly formulated medications. ADOs are expensive compared to non-ADOs, however, little is known about the overall cost implications of the widespread adoption of ADOs.

Objectives: The goal of this analysis was to evaluate the financial implications of increased use of novel ADOs in patients with chronic use within a typical commercial health insurance plan.

Methods: A budget impact model was conducted from the payers’ perspective considering a typical commercial health insurance plan. The population (N = 286,417) included patients under the age of 65 and with chronic opioid use. The model used a 2-year timeframe, with 2015 as the base year. It was estimated that a certain percentage of the non-abuse deterrent opioids in the base year would be converted to abuse-deterrent formulations based on drug type and dosage strength. Direct medical costs of prescription opioid overdose, due to increased use of ADOs, were used to calculate the cost-benefit in total spending on ADOs compared to the projected reduction in the cost of opioid overdose (inpatient and outpatient care). A sensitivity analysis was conducted to account for the uncertainty of model parameters.

Results: The total expected 2-year drug cost to the plan population after the conversion of non-ADOs to novel ADOs was $589,544,613 ($169,021,043 in year 1 and $420,523,570 in year 2). Taking into account the cost of non-ADOs still in the mix, in addition to the costs relating to opioid overdose, the total expected budget impact was $1,001,065,419 for the two budget impact years. In terms of per-member per-month (PMPM) spending, the average PMPM cost of novel ADOs was projected to be $2.42 for the 2-year period, with $1.39 in year 1 and $3.45 in year 2. When including costs associated with the continued use of non-ADOs and decreased overdose events, the average budgetary impact was projected to be $4.10 PMPM for the 2 budget impact years, $3.20 in year 1 and $5.00 in year 2. The sensitivity analysis showed that the model was most sensitive to changes in the price of ADOs being introduced into the modeled years. When the price of ADOs was decreased by 50% the total spending decreased by $294,772,306. When the benchmark increased by 50% the total spending increased by $289,116,923. The least sensitive variable was the change in opioid overdose, the only variable within the sensitivity analysis that does not affect prescription opioid use and cost.

Conclusions: The conversion of non-ADOs to ADOs in a population of chronic opioid use would result in a substantial impact to health plan costs. Although the model accounted for reduction in inpatient and outpatient costs related to opioid overdose, the savings do not offset what was spent on increased use of ADOs.

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