Impact of a Linezolid (Zyvox ) Prior Authorization …

1 The study was not randomized. Although the two commercially insured population s baseline member characteristics were similar, we were unable to account for individual differences. A limitation of this study is potential inclusion of miscoded administrative pharmacy and medical claims; additionally, there was no way to validate if a member has completed a full treatment course. Data are limited to commercial populations in the Southern and may not be generalized to Medicare or Medicaid populations or other geographic regions. Members may have obtained Linezolid via samples or by paying cash which would result in over-estimating the number of members without treatment. We did not measure any of the PA administrative costs including those incurred by the health plan or PBM. There may be unmeasured differences in Linezolid prescribing patterns and population sociodemographic characteristics between In this concurrent comparison retrospective administrative claims study, the Linezolid PA program resulted in no increase in hospitalizations, ER visits, or health care costs.

2 The Linezolid PA intervention was associated with significantly lower $ PMPM pharmacy costs due to an average $915 per patient lower antibiotic cost. Total cost of care and medical costs were also lower in the intervention group. These commercially insured findings are similar to the Medicare Advantage retrospective claims analysis findings4 and should be confirmed with a prospective randomized controlled trial, incorporating PA administrative costs. Health plans and pharmacy benefit managers should consider implementing a Linezolid PA program to ensure appropriate use, reduce health care resource consumption, and potentially reduce the risk of Linezolid Linezolid ( zyvox ). Prescribing information. Pharmacia & Upjohn Co. Division of Pfizer, Inc. March FDA Safety Announcement FDA Drug Safety Communication: Updated information about the drug interaction between Linezolid ( zyvox ) and serotonergic psychiatric medications.

3 October 20, Prime Therapeutics LLC, internal data, Ball, , Y. Xu, Sanchez, et al. Nonadherence to oral Linezolid after hospitalization: A retrospective claims analysis of the incidence and consequence of claim reversals . Clin Ther 32 (2010): Deyo, ; et al. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol 45 (1992): 613 design and inclusion criteria This study was retrospective and utilized a cohort of members enrolled in a commercial insurance plan. Members in the Intervention Group were exposed to a Linezolid PA program, while members in the Comparison Group were not. To be included in the study, a member must have been continuously enrolled in the plan for six months and have submitted a claim for Linezolid (index) between January 1, 2011 and June 30, 2011.

4 Members in the Intervention Group must have had the claim for Linezolid rejected, while members in the Comparison Group must have had the claim for Linezolid paid. Members were then followed for 30 days post their index date. All pharmacy and medical claims were queried in the six months Prior to the index date and during the 30-day follow-up period. Medical diagnoses were collected in the six months Prior to index date. International Classification of Diseases Ninth Revision (ICD-9) codes were hierarchically ordered as follows: Group 1: infections with drug resistant organisms specific to vancomycin, methicillin resistant Staphylococcus aureus (MRSA) pneumonia, septicemia or carrier status; Group 2: infections due to undefined organisms; and Group 3: all The following outcomes were assessed during the 30-day follow-up: number of Linezolid claims, other antibiotic claims, hospitalizations, ER visits and all outpatient visits.

5 Total medical and pharmacy costs and total Linezolid costs and all other antibiotic Comparisons between groups were performed with the chi-square test for categorical variables (Fisher s exact test for those with counts less than five), Wilcoxon rank sum test for counts, follow-up time and time to events, and likelihood ratio test for expenditures. A logistic regression model was used to test the difference of hospitalization/ER visit between the intervention and comparison groups, with adjustment for age, gender, Charlson comorbidity Index score (Charlson risk score)5, education and income based on ZIP code census data, existence of baseline hospitalization or ER visit and hierarchical presence of specific ICD-9 coded diagnoses (Table 1). Cost analyses were performed using the generalized linear model with Gamma log link and adjusted for the same covariates listed In the intervention group, 217 (two per 10,000) members had a rejected Linezolid claim during January 1, 2011 to June 30, 2011 and 185 ( ) met continuous enrollment criteria.

6 The comparison group had 77 (one per 10,000) members with a paid Linezolid claim and 69 ( ) met analysis criteria. Ninety-nine ( ) of 185 intervention group members had a Linezolid claim with an average time to first claim of two days (standard deviation [SD] 3). One hundred and fifty-seven ( ) of 185 intervention group members had a Linezolid or other antibiotic claim with an average time to first claim of two (SD 4) days. There were 28 ( ) intervention group members with no antibiotic claims in the 30-day follow-up. All baseline characteristics were similar except the intervention group had a significantly lower percentage of members with a ZIP code derived median income $50,000 (p = ) (Table 1). Group 1: infections with drug resistant organisms specific to vancomycin, MRSA pneumonia, septicemia or carrier status found in 27 percent vs.

7 Percent and Group 2: infections due to undefined organisms found in percent vs. percent, among intervention and comparison groups, respectively. The average total paid per member for Linezolid was $1,303 higher in the comparison group, p = (Table 2). During the 30-day follow-up, average member Linezolid plus all other antibiotic costs were $1,680 in the intervention group and $2,595 in comparison group (p < ), for a per member $915 difference. Net antibiotic savings from the Linezolid PA was $169,275 (185 patients x $915) or $ per member per month (PMPM) ($169,275 divided by [1,167,888 members x six months]). Average per member overall total costs of care after adjusting for covariates were $5,868 lower in the intervention group, p = (Table 4). The logistic regression model found no difference in hospitalization (p = ), ER visits (p = ) or combined hospitalization/ER visits (p = ) between the intervention and comparison groups (Table 3).

8 Generalized linear model showed the intervention group had 37 percent lower pharmacy costs (Relative Cost [RC] , p = ) and 38 percent lower total cost of care (RC , p = ) than the comparison group. There was no difference in medical costs (p = ) between Prime Therapeutics LLC 04/131305 Corporate Center Drive, Eagan, MN 55121 Catherine Starner, , ext. 5073 April 4, 2013, San Diego, CA, USA The purpose of this study was to evaluate the Impact of a Linezolid PA program in a commercially insured population. The primary objective was to evaluate utilization, cost, hospitalization, and emergency room (ER) visits in a population exposed to a PA program for Linezolid and one that was not & Purpose Linezolid ( zyvox ) is a synthetic oxazolidinone antibiotic indicated for gram-positive infections and approved for the treatment of bacterial pneumonia, skin and skin structure infections, and for vancomycin-resistant enterococcal (VRE) infections, including infections due to susceptible organisms which are complicated by Inappropriate use is a concern due to the specificity of this antibiotic for gram-positive organisms only and the potential for resistance to develop.

9 Furthermore, the Food and Drug Administration (FDA) issued an alert about serious central nervous system (CNS) reactions when Linezolid is administered with commonly prescribed serotonergic medications ( , SSRI antidepressants).2 In adults and children over the age of 12, the recommended dose of Linezolid is 600 mg twice daily as either an intravenous infusion or oral tablet. The duration of treatment will vary on indication for use, but a typical regimen may last 14 to 28 days. Based on 2012 average wholesale pricing, a 14-day course of oral Linezolid therapy had a cost of $3,556 ($127 per tablet). Among Prime Therapeutics 2012 book of business, there were 4,188 Linezolid claims resulting in a total paid amount of $9,337,372. The average total paid per claim was $2, A Linezolid Prior Authorization (PA) program could help ensure appropriate use; however, a negative effect could be that members choose to forgo all antibiotic therapy potentially resulting in increased medical care utilization and costs.

10 A 2010 retrospective Medicare Advantage claims analysis evaluated patients with a reversed Linezolid claim and found lower outpatient drug costs, higher medical costs, and no difference in total cost of care during a 60-day There is a paucity of data evaluating medical outcomes associated with PA programs in commercial 1. Baseline member characteristicsIntervention group n = 185 Comparison group n = 69p valueAge categories, n (%) 4063 ( )23 ( )41 5664 ( )27 ( )> 5758 ( )19 ( )Male, n (%)94 ( )34 ( ) , bachelor degree or above, n (%)100 ( )35 ( ) code derived median household income ( $50,000)47 ( )27 ( ) score index categories, n (%) ( )34 ( )1 264 ( )24 ( ) 327 ( )11 ( )Events in pre period* in 6 months Prior to index, n (%)103 ( )39 ( )Emergency room visits in 6 months Prior to index, n (%)24 ( )12 ( )Hierarchy of ICD-9 code in 6 months Prior to indexGroup 1: Infection with vancomycin-resistant microorganisms or MRSA infections or carrier status50 ( )27 ( ) 2: Infections with unknown organism113 ( )35 ( ) 3: All others22 ( )7 ( ) *Events at baseline were defined mutually exclusively.