Impact of Oxycodone HCl Extended-release Formulary Restrictions on Extended-release Opioid Market Share, Healthcare Resource Utilization and Costs in Commercial and Medicare Plans.

Background: Previous research demonstrated that utilization management (UM) such as prior authorization (PA) or non-formulary (NF) restrictions may reduce pharmacy costs when designed and applied appropriately to certain drug classes. However, such access barriers may also have unintended consequences. Few studies systemically analyzed the impact of major UM strategies to extended-release (ER) opioids on different types of health plans. Objective: This study evaluated, from payer perspective, the impact of formulary restrictions (PA, NF, or step therapy [ST]) for branded oxycodone HCl extended release (OER) on market share, and healthcare resource utilization/costs in ER opioids patients for multiple types of health plans in the United States. Methods: This retrospective, longitudinal case-control study analyzed prescription and outpatient medical claims data (2012 to 2015) for adult ER opioid patients from US plans (commercial,/Medicare, national/regional) that instituted OER PA, NF, or ST. Patients from each restricted plan (cases) were matched to patients in an unrestricted plan (controls) on key patient characteristics. ER opioid market share and healthcare resource utilization/costs for both cases and controls were evaluated for the 6-month period before and after the formulary restriction dates. A difference-in-differences (DiD) approach was utilized to evaluate change in the total per patient per month (PPPM) healthcare utilization and costs. Results: The study comprised 1622 (national commercial PA), 2020 (regional commercial PA), 34 703 (national commercial ST), and 4372 (national Medicare NF) cases and equivalent number of controls. OER market share decreased after the formulary restrictions, with the national Medicare NF plan showing the greatest decrease (9.2%). DiD analyses indicated that PPPM office visit change in the PA and NF plans were non-significant (decreased by 0.1 and 0.2, P>0.05), but significant in the ST plan (increased by 0.1, P=0.0001). For most plans, no significant total monthly cost change was observed; PPPM costs decreased by $48.74 and $59.87 in ST and regional PA plans and increased by $37.90 in national NF plans (all P>0.05). Conclusions: This study observed that despite reducing the market share of OER, OER formulary restrictions had negligible impact on overall ER opioid utilization, and did not result in substantial pharmacy/medical cost savings.

Drivers of excess costs of opioid abuse among a commercially insured population.

OBJECTIVES: To replicate and extend a recently published analysis of the drivers of excess costs of opioid abuse. STUDY DESIGN: Retrospective data analysis using de-identified claims data from the Truven MarketScan Commercial Claims and Encounter database. METHODS: Medical and prescription drug claims from beneficiaries covered by large self-insured US companies were used to select patients with incident diagnoses of opioid abuse between 2012 and 2015. Two cohorts, abusers and nonabusers, were matched using propensity score methods. Excess healthcare costs were estimated over a 6-month baseline period and 12-month follow-up period. Cost drivers were assessed by diagnosis (3-digit International Classification of Diseases, Ninth Revision, Clinical Modification groupings) and place of service. RESULTS: The analysis included 73,714 matched pairs of abusers and nonabusers. Relative to nonabusers, abusers had considerably higher annual healthcare costs of $10,989 per patient, or $1.98 per member per month. Excess costs were similar, yet lower, than the previous analysis using another commercial claims database. In both analyses, a ramp-up in excess costs was observed prior to the incident abuse diagnosis, followed by a decline post diagnosis, although not to baseline levels. Key drivers of excess costs in the 2 studies included opioid use disorders, nonopioid substance misuse, and painful and mental health conditions. From 2010 to 2014, the prevalence of diagnosed opioid abuse doubled, with incidence rates exhibiting an increasing, though flatter, trend than earlier in the period. CONCLUSIONS: Opioid abuse imposes a considerable economic burden on payers. Many abusers have complex healthcare needs and may require care beyond that which is required to treat opioid abuse. These results are robust and consistent across different data sources.

Development and validation of a computer program to design and calculate ROPS.

In Spain, there are more than 250,000 tractors built before 1980, when it became mandatory for all new tractors to be equipped with a rollover protective structure (ROPS). A similar situation is found in the European Union, but the situation is worse in the U.S. and in developing countries. Directive 2003/37/EEC establishes that tractors over 800 kg weight can be homologated by using the OECD standard code for the official testing of protective structures on agricultural and forestry tractors (static test), called Code 4. A ROPS attachable to the rear axle of different tractor models has been designed, and a computer program for the calculation of the ROPS design has been developed. The program, named ESTREMA, is available at: www.cfnavarra.es/insl. Using this program, it has been possible to design a ROPS for the Massey Ferguson model 178 tractor, one of the most common tractor models without a ROPS in Spain. After the tractor was equipped with the designed ROPS, it was tested at the Spanish Authorized Station for testing ROPS and passed the homologation test (OECD Code 4), the main results being a maximum distortion of 21.3 cm when the absorbed energy was 5437 N and the maximum force applied was 34 kN during loading from the side. The ROPS was improved, redesigned, and remounted on the tractor, the tractor was tested in a real overturn, and no part of the structure intruded on the driver's clearance zone during the test. In conclusion, the ESTREMA program worked correctly, and the designed ROPS was able to pass the authorized test and provide adequate protection to the operator during a real overturn.