Dataset Information

Impact of Formulary Restrictions on Antiepileptic Drug Dispensation Outcomes.

ABSTRACT:

Introduction

The aim of this analysis was to assess the relationship between formulary restrictions and antiepileptic drug (AED) dispensation in patients with focal seizure (FS).

Study design

A retrospective cohort analysis was conducted using data from Symphony Health's Integrated Dataverse® (1 April 2015-30 June 2018).

Methods

This study included two patient populations: the overall patient population (N = 54,097) and a pediatric population (< 18 years) (N = 12,610). Cohorts were defined based on approval or rejection of the index AED claim. Study outcomes were prescription life cycle analysis, proportion of patients with dispensation, time to dispensation, and likelihood of successful dispensation. A multivariable Cox proportional hazards model was estimated to study the association between formulary restriction and likelihood of successful AED dispensation.

Results

Among patients in the overall population with a rejected claim (n = 9133), 8.0% did not receive any AED and 77.6% received approval for the index AED following an appeal. Among the pediatric patients with a rejected claim (n = 3081), 6.0% did not receive any AED and 81.7% received approval for the index AED after an appeal. In both populations, formulary restrictions were associated with significant delays in index AED dispensation (6.9 and 5.3 days, respectively; P < 0.0001 for each population), compared to approved AED claims. In the overall and pediatric populations, formulary-related rejections of AEDs were associated with a 35% (hazard ratio [HR] 0.65; 95% confidence interval [CI] 0.64-0.66; P < 0.0001) and 27% (HR 0.73; 95% CI 0.69-0.76; P < 0.0001) lower likelihood of successful dispensation of the index AED, respectively.

Conclusions

Formulary restrictions of AEDs were associated with significant delays in treatment and significantly lower likelihood of successful AED dispensation in patients with FS.

SUBMITTER: Mehta D

PROVIDER: S-EPMC7606428 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Importance:Although there are many pharmacologic alternatives to opioids, it is unclear whether the structure of Medicare Part D formularies discourages use of the alternatives. Objectives:To quantify the coverage of opioid alternatives and prevalence of prior authorization, step therapy, quantity limits, and tier placement for these drugs, and test whether these formulary exclusions and restrictions are associated with increased opioid prescribing to older adults at the county level. Design, Setting, and Participants:County fixed-effect models were estimated using a panel of counties across the 50 US states and the District of Columbia over calendar years 2015 and 2016. Data analysis was conducted from July 1 to September 23, 2019. The sample included 2721 counties in 2015 and 2671 counties in 2016 with sufficient data on Medicare Part D formulary design and opioid prescribing. Main Outcomes and Measures:County-level opioid prescribing rate (number of opioid claims divided by the number of overall claims) and counts of excluded opioid alternatives and opioid alternatives with prior authorization, step therapy, quantity limits, and high-tier placements. Results:A total of 30 nonopioid analgesics were examined across 28 997 Medicare plans in 2015 and 30 390 plans in 2016. Medicare plans did not cover a mean of 7% of these drugs (interquartile range, 10%; lower to upper limit, 0%-23%). Among covered nonopioids, prior authorization and step therapy were uncommon, with fewer than 5% affected by prior authorization and 0% by step therapy. However, 13% of covered nonopioids had quantity limits (interquartile range, 10%; lower to upper limit, 0%-31%) and 22% were in high-cost tiers (interquartile range, 38%; lower to upper limit, 0%-50%). Increases in the number of nonopioids excluded on Medicare plans in a county were associated with increased opioid prescribing (effect size relative to mean, 2.2%-3.7%; P = .004). Conversely, increases in the number of opioids not covered on Medicare plans in a county was found to be associated with decreased opioid prescribing (effect size relative to mean, 0.8%-1.5%; P = .02). None of the utilization management strategies (prior authorization, step therapy, and quantity limits) examined or high-cost tier placements of nonopioids were associated with increased opioid prescribing. Conclusions and Relevance:Lack of Medicare coverage for pharmacologic alternatives to opioids may be associated with increased opioid prescribing.

Project description:IntroductionAntiepileptic drugs, which are also called anticonvulsants, are used in the therapy and prophylaxis of epileptic seizures. The purpose of this paper was to investigate the relevant epidemiological data and to determine which of these drugs was the most frequent cause of intoxication. Another purpose of this study was to determine the neurological, cardiac, and biochemical problems caused by antiepileptics.Material and methodThis retrospective study included 95 consecutive patients under 18 years of age with antiepileptic intoxication, presenting to and being followed-up in, the Toxicology Unit between January 2010 and February 2013. The data were obtained by screening the patient files.ResultsOf the cases, 67 (70.5%) were self-poisoned by first generation antiepileptics (FGAEs) and 28 (29.5%) by second generation antiepileptics (SGAEs). The Glasgow Coma Scale (GCS) scores and the serum lactate levels of the patients poisoned by FGAEs and SGAEs on admission to emergency department were 15 (25th: 12; 75th: 15; 95th: 15; IQR: 3) and 1.9 (25th: 1.4; 75th: 3.1; 95th: 5.6; IQR: 1.7), and 15 (25th: 14.3; 75th: 15; 95th: 15; IQR: 0.75) and 1.07 (25th: 0.9; 75th: 1.6; 95th: 5.5; IQR: 0.71), respectively. The serum lactate levels of patients poisoned by FGAEs were significantly higher (p < 0.001). Among the cases poisoned by carbamazepine, the most frequent cause of intoxication, the GCS score was significantly lower and serum lactate level was significantly higher in the group with high serum levels of carbamazepine (p = 0.004 and p < 0.001, respectively). In cases poisoned by valproic acid (VPA), the second frequent cause of intoxication, there was neither a significant association between the serum VPA level and the GCS score, nor between the serum lactate level and the systolic blood pressure (p = 0.470, p = 0.897, and p = 0.088, respectively). However, there was a positive correlation between the serum VPA level and the serum ammonia level (kk = 0.742, p < 0.001).ConclusionFirst generation antiepileptics are more toxic than SGAEs. In patients with serum carbamazepine level, particularly those over 30 mg/L, serious disorders of consciousness, cardiovascular toxicity, and metabolic disorders may occur. In VPA intoxication, there is a positive correlation between the serum VPA levels and ammonia levels. On account of this finding, one should be more careful about hyperammonemic hepatic encephalopathy as the serum VPA level rises.