Disparities in Access to Spasticity Chemodenervation Specialists in the United States: A Retrospective Cross-Sectional Study.

OBJECTIVE: The aim of the study is to explore variations in access to spasticity chemodenervation specialists across several geographical, ethnic, racial, and population density factors. DESIGN: This is a retrospective cross-sectional study on Medicare Provider Utilization and Payment Data. Providers with substantial adult spasticity chemodenervation practices were included. Ratios were assessed across geographical regions as well as hospital referral regions. A multivariate linear regression model for the top 100 hospital referral regions by beneficiary population was created, using backward stepwise selection to eliminate variables with P values > 0.10 from final model. RESULTS: A total of 566 providers with spasticity chemodenervation practices were included. Unadjusted results showed lower access in nonurban versus urban areas in the form of higher patient:provider ratios (83,106 vs. 51,897). Access was also lower in areas with ≥25% Hispanic populations (141,800 vs. 58,600). Multivariate linear regression results showed similar findings with urban hospital referral regions having significantly lower ratios (-45,764 [ P = 0.004] vs. nonurban) and areas with ≥25% Hispanic populations having significantly higher ratios (+96,249 [ P = 0.003] vs. <25% Hispanic areas). CONCLUSIONS: Patients in nonurban and highly Hispanic communities face inequities in access to chemodenervation specialists. The Medicare data set analyzed only includes 12% of the US patient population; however, this elderly national cross-sectional cohort represents a saturated share of patients needing access to spasticity chemodenervation therapy. Future studies should venture to confirm whether findings are limited to this specialization, and strategies to improve access for these underserved communities should be explored.

Cost Efficiency Analysis for Spasticity Management Based on Physician Botulinum Toxin Prescribing Habits.

OBJECTIVE: To estimate differences in botulinum toxin type A (BoNT-A) treatment costs per patient for spasticity-injecting physicians, with a focus on physicians' use of alternative BoNT-A agents other than onabotulinumtoxinA. DESIGN: Retrospective cohort study. SETTING: National Medicare data for fee-for-service beneficiaries in 2017. PARTICIPANTS: A total of 116 physicians, 6829 BoNT-A procedures, and 3051 patients were included in this analysis. Most physicians were physiatrists (84%) and used only onabotulinumtoxinA (82%). INTERVENTIONS: Type of BoNT-A selected by physicians was the independent variable of interest. Included physicians were separated into 2 groups: (1) onabotulinumtoxinA only injectors and (2) abobotulinumtoxinA and/or incobotulinumtoxinA injectors (may still use onabotulinumtoxinA). MAIN OUTCOME MEASURE: Average cost per patient per year. RESULTS: The total average BoNT-A cost per patient per year was significantly less for physicians who used abobotulinumtoxinA and/or incobotulinumtoxinA vs those who used only onabotulinumtoxinA ($3684 vs $4739; P=.01). Patients' average annual out-of-pocket costs also reflected a similar difference ($855 vs $1082; P=.02) between the groups. Doses used and numbers of injections per patient per year were not significantly different between groups. CONCLUSIONS: The present analysis demonstrated lower cost per patient for both the payer and patient when physicians used types of BoNT-A other than onabotulinumtoxinA for spasticity. Nevertheless, most physicians in this spasticity-focused study used exclusively onabotulinumtoxinA, the most expensive BoNT-A available. Reasons for this are complex and include history on the market and approved indications beyond those associated with spasticity. However, future research should continue to identify such issues with a goal of finding solutions to improve cost inefficiencies.

Real-World Six-Year National Cost-Minimization Analysis of IncobotulinumtoxinA and OnabotulinumtoxinA in the VA/DoD Healthcare Systems.

PURPOSE: This study sought to perform a real-world, long-term cost-minimization analysis for incobotulinumtoxinA (Xeomin®) versus onabotulinumtoxinA (Botox®), given the established non-inferiority when utilized at similar doses. METHODS: The Department of Veterans Affairs (VA) and Department of Defense (DoD) national healthcare systems were included in this analysis. Real-world purchase data for incobotulinumtoxinA were used to estimate the direct drug costs between calendar years 2014 and 2019. Publicly available federal pharmaceutical prices (Federal Supply Schedule and Big 4) were used. The primary outcome was the difference in total direct costs nationally for incobotulinumtoxinA (real-world) versus having hypothetically utilized onabotulinumtoxinA (projected) for similar utilization. Sites utilizing ≥100 vials (of 100 Unit equivalents) of incobotulinumtoxinA annually were categorized as "major adopters". IncobotulinumtoxinA 50 Unit vials were assumed to be an alternative to a 100 Unit vial of onabotulinumtoxinA for 50% of such vial purchases in the base case scenario to account for differences in wastage. RESULTS: Over the six-year study time frame, 156 sites (76.8%) utilized incobotulinumtoxinA of the 203 total VA healthcare systems and DoD medical centers. Of these sites, 67 were major adopters for at least one year, with a mean of 3.4 years spent as a major adopter over the study period. Average annual savings per major adopter was $105,782. IncobotulinumtoxinA costs for all VA/DoD sites was $46.39 million for the six-year period versus a projected $71.92 million onabotulinumtoxinA cost-a total savings of $25.53 million (35.5% relative reduction). Approximately, 82.8% of savings stemmed from lower drug acquisition cost ($21.14 million) and 17.2% of savings ($4.39 million) was related to reduced wastage. It was estimated that a total of 9958 extra onabotulinumtoxinA 100 Unit vials would have been wasted during the six-year period, translating to the need for a 5.9% increase in vial purchases versus incobotulinumtoxinA. CONCLUSION: Meaningful cost savings were realized related to incobotulinumtoxinA adoption over a long-term time frame in the VA/DoD healthcare systems.

Comparison of botulinum toxins for treatment of movement disorders: real-world utilization and cost analysis in a national Medicare population.

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) is the single largest payer for health care in the United States and the largest payer by spending globally. Medicare Part B, with more than 50 million beneficiaries, currently has no broad mechanisms in place for promoting cost-effective care of injectable drugs. OBJECTIVE: To conduct a real-world utilization and cost analysis comparing botulinum toxins in movement disorders. METHODS: The 2017 Medicare Provider Utilization and Payment Data: Physician and Other Supplier dataset from CMS was used for this claims level analysis. Neurologists, ophthalmologists, or physiatrists who injected predominantly for movement disorders (defined as blepharospasm, cervical dystonia, sialorrhea, and/or spasticity) were included along with their patients. Botulinum toxins with FDA indications spanning these 3 specialties were included. RESULTS: A total of 891 physicians (406 ophthalmologists, 338 neurologists, and 147 physiatrists) along with their 29,954 botulinum toxin (27,441 onabotulinumtoxinA and 2,513 incobotulinumtoxinA) patients were included in the analysis. The average total drug cost per patient per year (PPPY) was significantly lower for incobotulinumtoxinA versus onabotulinumtoxinA ($2,099 vs. $3,115; P < 0.001), for an average savings of 32.6%. Annual average out-of-pocket costs were also significantly less expensive for incobotulinumtoxinA versus onabotulinumtoxinA ($486 vs. $719; P < 0.001), for an average savings of 32.4%. Across 74,346 total injection visits, there was no significant difference in dosing between the agents, with an average dosing ratio of 0.94 incobotulinumtoxinA to 1.0 onabotulinumtoxinA. Injections PPPY were 2.42 for onabotulinumtoxinA and 2.29 for incobotulinumtoxinA. Average reported wastage was 64% higher for onabotulinumtoxinA than it was for incobotulinumtoxinA. A budget impact analysis estimated that increasing incobotulinumtoxinA use in the movement disorder space to attain an overall 20% botulinum toxin market share would save Medicare $32.9 million over a 3-year period versus current use. CONCLUSIONS: IncobotulinumtoxinA was shown to be a less costly alternative than onabotulinumtoxinA with similar dosing in real-world practice in this large national Medicare population. Policies to increase use of agents that promote cost-effective evidence-based care should be further explored and implemented for this fundamental federal payer. DISCLOSURES: This research received no external funding. Kazerooni was an employee of Merz Pharmaceuticals at the time of the analysis. Watanabe received no compensation or funding for this research project. Watanabe is a member of the National Academies of Sciences, Engineering, and Medicine Forum on Drug, Discovery, Development, and Translation. This information, content, and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by the U.S. government or the National Academies of Sciences, Engineering.

Botulinum Toxin Type A Overdoses: Analysis of the FDA Adverse Event Reporting System Database.

INTRODUCTION: Published literature on overdoses related to botulinum toxin A (BtxA) agents is scarce. OBJECTIVE: The aim of this study was to assess the BtxA drug class' respective agents for associations with overdose. METHODS: United States Food and Drug Administration (FDA) adverse event reporting system (FAERS) database was utilized to search for overdoses. The analysis was conducted on data between second quarter 2014 and third quarter 2017. BtxA cases were included when they were considered the "Primary Suspect" drug. Overdose was defined as presence of 'overdose' being reported as an adverse event. Primary outcome was incidence of 'overdose' compared within the respective agents. Additionally, a disproportionality analysis was conducted utilizing reporting odds ratio (ROR) versus onabotulinumtoxinA as a referent while controlling for confounding variables. RESULTS: A total of 3,837,406 unique adverse events were reported during the study period for all drugs in the FAERS database. Of which, 13,078 were BtxA cases. The rate of adverse events involving overdose for abobotulinumtoxinA (20.2%; 215/1065) was significantly higher than both onabotulinumtoxinA (0.4%; 48/11,323; p < 0.0001) and incobotulinumtoxinA (0.1%; 1/690; p < 0.0001). In the regression analysis, abobotulinumtoxinA (ROR 73.26; 95% CI 51.17-104.90) had a significant association with overdose, whereas incobotulinumtoxinA (ROR 0.73; 95% CI 0.10-5.36) did not, versus the referent onabotulinumtoxinA. CONCLUSION: The present analysis showed adverse events of abobotulinumtoxinA were significantly associated with overdose versus the other two BtxA agents. Overdose can be difficult to research, particularly for in-clinic administered drugs. Future studies should venture to confirm these results in new and novel ways.

Topiramate-Associated Weight Loss in a Veteran Population.

OBJECTIVE: This study aims to see whether patients in a real-world setting taking topiramate for varied indications experience significant weight loss. METHODS: This was a retrospective cohort study from the Veterans Affairs San Diego Healthcare System. Patients were new topiramate users between January 1, 2000 and December 31, 2013 with body mass index > 25 kg/m(2) and medication possession ratio > 0.5. Primary outcome determined if topiramate users experienced significant changes in weight and body mass index. Secondary outcome analyzed predictive factors associated with 5% weight loss using logistic regression models. Patients were followed up 1 year post index date. RESULTS: A total of 767 patients were included in the final analysis. Patients lost an average of 5.6 lbs (216.1 lbs preweight vs. 210.5 lbs postweight) at an average follow-up of 7.8 months. A total of 43.2% (92/213) of females lost 5% of their body weight compared to 29.4% (163/554) of males. Females (odds ratio 1.73; 95% confidence interval 1.21-2.48; p = 0.003), topiramate indication other than headache, and adherent patients (odds ratio 1.78; 95% confidence interval 1.28-2.49; p = 0.001) were more likely to lose 5% of body weight. CONCLUSION: Topiramate should be considered with higher priority in overweight and obese patients for nonweight loss indications for dual benefit.

Predictors of Pregnancy in Female Veterans Receiving a Hormonal Contraceptive Pill, Patch, or Ring.

BACKGROUND: Pregnancy rates in veterans are an understudied phenomenon. OBJECTIVE: The objective of this study was to identify predictors of pregnancy within 1 year of starting hormonal contraception among female veterans. METHODS: This was a retrospective, cohort study of female veterans from Veterans Affairs facilities within Southern California and Nevada, who newly started hormonal contraception (pill, patch, or ring only) between October 2008 and September 2012. Pregnancy was defined as any event corresponding to a pregnant state using ICD-9 codes. Patients were followed for 1 year post-initiation. Multivariate logistic regression analysis was performed. RESULTS: The final analysis included a total of 2166 patients. Approximately 5.9% (n = 127) of patients became pregnant during follow-up. Increased odds of pregnancy were associated with the following: mental health disease (odds ratio [OR] 1.69, 95% confidence interval [CI] 1.15-2.58), lowest socioeconomic quintile (OR 1.50, 95% CI 1.05-2.09), and Christian faith (OR 1.69, 95% CI 1.31-2.41). Age groups 25 to 34 years (OR 0.55, 95% CI 0.38-0.92] and 35 to 44 years (OR 0.32, 95% CI 0.06-0.64) were both associated with decreased odds of pregnancy versus age group 18 to 24 years. CONCLUSION: This study successfully identified several predictors of pregnancy in female veterans starting a pill, patch, or ring form of hormonal contraception. Female veterans in the lowest socioeconomic quintile, aged 18 to 24 years, diagnosed with a mental health disorder, and of Christian faith were found to be at significantly higher odds of a pregnancy. Identification of these at-risk populations may help clinicians and policy makers choose strategies to identify which patients could benefit the most from more effective long-acting reversible contraception therapy.

IncobotulinumtoxinA for Migraine: A Retrospective Case Series.

PURPOSE: IncobotulinumtoxinA is used for treating certain movement disorders but lacks published clinical data on use in chronic migraine. METHODS: This retrospective case series was performed by using electronic chart reviews on patients receiving incobotulinumtoxinA for migraine at the Veterans Affairs San Diego Healthcare System between September 2013 and March 2014. Patients were administered 150 units each, with similar methods used for onabotulinumtoxinA injections. FINDINGS: A total of 21 patients were included in the analysis. Patients were 40 years old on average, 67% white, and 52% female. Patients had trialed an average of 4.19 oral prophylactic agents for migraine with 43% having previous history of onabotulinumtoxinA use and 29% having a history of traumatic brain injury. Patients reported a decrease in headache days per month (19.1 vs 9.1; P < 0.001) and headache intensity (8.3 vs 4.1; P < 0.001) after incobotulinumtoxinA injections. Most patients experienced an improvement in headache frequency and/or intensity (81.8%). The duration of action for these patients averaged 81.9 days (median, 70 days). IMPLICATIONS: Significant improvements in headache frequency and intensity were observed. Chronic migraine is not an indication approved by the US Food and Drug Administration for incobotulinumtoxinA; however, the drug's effectiveness was documented in this small patient population.

New start versus continuing users on aripiprazole: implications for policy.

OBJECTIVES: To evaluate utilization of 90-day-supply prescriptions of aripiprazole. STUDY DESIGN: One year (April 1, 2011, to March 31, 2012) retrospective cohort study from the Veterans Affairs San Diego Healthcare System. METHODS: The primary outcome was to determine the difference in adherence for new starts versus continuing users on aripiprazole, as determined by medication possession ratio (MPR). Secondary outcomes included odds of adherence and refilling at least once associated with being a new start. Adherence was defined as MPR ≥ 0.8. Separate regression models (linear and logistic) were run for the entire population, as well as a subgroup analysis of 90-day prescription patients only. RESULTS: A total of 749 patients, 328 of whom were new starts, were included in the analysis. Both new starts (41.2%) and continuing users (69.1%) had a large portion who received 90-day supplies. New-start patients had significantly lower MPR than continuing users (-0.13; 95% CI, -0.18 to -0.08). Logistic regressions showed that new starts also had lower odds of adherence (odds ratio [OR], 0.46; 95% CI, 0.33-0.65) and of refilling at least once (OR, 0.43; 95% CI, 0.28-0.66) compared with continuing users. CONCLUSIONS: Patients who were continuing users of aripiprazole were more likely to be adherent and refill their medication. Overutilization of 90-day supplies of high-cost agents, particularly in new starts, may lead to waste. It is recommended that patients newly started on high-cost agents should initially be provided a 30-day-supply prescription until it is established that effectiveness and tolerance have been achieved.

Cost-utility analysis of botulinum toxin type A products for the treatment of cervical dystonia.

PURPOSE: A cost-utility analysis of botulinum toxin type A products for the treatment of cervical dystonia (CD) was conducted. METHODS: A cost-utility analysis of botulinum toxin type A products was conducted from the U.S. government perspective using a decision-analysis model with a one-year time horizon. Probabilities of the model were taken from several studies using the three botulinum type A products approved by the Food and Drug Administration for the treatment of CD: onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), and incobotulinumtoxinA (Xeomin). The main outcome measurement was successful treatment response with botulinum toxin type A, measured in quality-adjusted life years (QALYs). Response was defined as a patient who experienced improvement of CD symptoms without a severe adverse event. Probabilistic sensitivity analysis was conducted to test robustness of the base-case results. RESULTS: All three botulinum toxin type A agents were cost-effective at a willingness-to-pay threshold of $100,000 per QALY. Xeomin was the most cost-effective with a cost-effectiveness ratio of $27,548 per QALY. Xeomin was dominant over the alternative agents with equivalent efficacy outcomes and lower costs. Dysport had the second lowest cost-effectiveness ratio ($36,678), followed by Botox ($49,337). The probabilistic sensitivity analysis supported the results of the base-case analysis. Dysport was associated with the lowest wastage (2.2%), followed by Xeomin (10%) and Botox (22.9%). CONCLUSION: A cost-utility analysis found that Xeomin was the more cost-effective botulinum toxin type A product compared with Botox and Dysport for the treatment of CD. Wastage associated with the respective products may have a large effect on the cost-effectiveness of the agents.

Predictors of long-term mortality in new start statin users.

BACKGROUND: Cardiovascular diseases are among the leading causes of death worldwide and studies have found a direct relationship between levels of low-density lipoprotein cholesterol and coronary heart disease. Statins are the most commonly prescribed medications to lower cholesterol, a major controllable risk factor for coronary heart disease. OBJECTIVE: This study aims to find what factors in the first year of statin therapy are predictive of long-term all-cause mortality. METHODS: Data for this retrospective cohort study were collected on patients identified as new statin users between December 1, 2006 and November 30, 2007 at five Veterans Affairs Healthcare Systems from Southern California and Nevada. Multiple independent variables were assessed utilizing a logistic regression model assessing for all cause mortality at 6 years follow-up. The independent variables included race, age, ethnicity, body mass index, socioeconomic status, and baseline comorbidities. Secondary analysis analyzed high-density lipoprotein levels, adherence, total cholesterol, and triglycerides. RESULTS: Increased age, increased medication count, hypertension, diabetes, tobacco use, chronic obstructive pulmonary disease, and congestive heart failure were all associated with an increased risk of mortality. Hispanic ethnicity, Asian race, and increased body mass index were associated with decreased risk of mortality. There were no significant associations between mortality and race, LDL outcomes at 1 year, or annual income level. CONCLUSION: There is clear evidence that statin use is associated with decreased events in cardiovascular disease and total mortality. This study found multiple independent variables as predictors of mortality in new start statin users after a 6 year follow-up, but differences in lipid groups after 1 year were not predictive of long-term mortality in the cohort studied.

Evaluation of Celecoxib Addition to Pain Protocol After Total Hip and Knee Arthroplasty Stratified by Opioid Tolerance.

OBJECTIVE: This study seeks to determine the impact that celecoxib has on patients' postoperative opioid consumption on the basis of whether the patient is opioid naive or opioid tolerant for total hip and knee arthroplasty. METHODS: This was a retrospective study over 1.5 years that encompassed a preperiod and postperiod for adding celecoxib to the pain protocol. Prescriptions for opioids dispensed 6 months before surgery were analyzed to assess for preoperative opioid tolerance. Unadjusted results were presented. Primary outcome measure was change in milligrams of morphine per day associated with celecoxib use as per linear regression analysis. Secondary outcome measures included total opioid dose, average pain score, length of stay, and as-needed opioid doses. RESULTS: Analysis included 142 patients. Unadjusted results showed that opioid-naive patients had greater reductions in opioid dose per day with celecoxib (49.1 vs. 80.8 mg) compared with tolerant patients (86.6 vs. 100.1 mg). Regression results showed similar results, with opioid-naive patients having a 29.9 mg reduction (95% confidence interval, -47.9 to -12.1; P=0.009) in opioid use per day associated with celecoxib use versus 5.5 mg reduction (95% confidence interval, -33.6 to 22.5; P=0.69) for opioid-tolerant group. Opioid-naive patients also had significant reductions in pain scores, as-needed opioid doses, and total opioid dose. Opioid-tolerant patients had significant reductions only in pain scores. CONCLUSIONS: Both opioid-tolerant and opioid-naive patients benefited from celecoxib therapy, although in different ways. Opioid-tolerant patients saw benefits other than reductions in opioid use; opioid-naive patients had similar benefits, but also had significant reductions in opioid use.

Retrospective cohort study of anti-tumor necrosis factor agent use in a veteran population.

Introduction. Anti-tumor necrosis factor (TNF) agents are effective for several immunologic conditions (rheumatoid arthritis (RA), Crohn's disease (CD), and psoriasis). The purpose of this study was to evaluate the efficacy and safety of anti-TNF agents via chart review. Methods. Single-site, retrospective cohort study that evaluated the efficacy and safety of anti-TNF agents in veterans initiated between 2010 and 2011. Primary aim evaluated response at 12 months post-index date. Secondary aims evaluated initial response prior to 12 months post-index date and infection events. Results. A majority of patients were prescribed anti-TNF agents for CD (27%) and RA (24%). Patients were initiated on etanercept (41%), adalimumab (40%), and infliximab (18%) between 2010 and 2011. No differences in patient demographics were reported. Response rates were high overall. Sixty-five percent of etanercept patients, 82% of adalimumab patients, and 59% of infliximab patients were either partial or full responders, respectively. Approximately 16%, 11%, and 12% of etanercept, adalimumab, and infliximab were non-responders, respectively. Infections between the groups were non-significant. Etanercept and adalimumab patients had higher but non-significant odds of being a responder relative to infliximab. Conclusions. Most patients initiated with anti-TNF agent were responders at 12 months follow-up for all indications in a veteran population.

Association of copayment and socioeconomic status with hormonal contraceptive adherence in a female veteran population.

BACKGROUND: There are limited studies available analyzing association between copayment and hormonal contraception adherence. The study was conducted to investigate the association between copayment status and hormonal contraceptive adherence in a female veteran population when stratified by socioeconomic status. METHODS: This 4-year, retrospective, cohort study of women Veterans from the Veterans Integrated Service Network 22, a network of Veterans Affairs facilities that includes Southern California and Nevada, included patients who received a new hormonal contraceptive prescription between October 1, 2008, and September 30, 2012. Patients were split into five quintiles (one having the lowest income and five the highest) dependent on zip code-based median annual household income from the 2007-2011 American Community Survey data. Medication possession ratio difference of copayment versus no copayment group for each respective quintile was the primary outcome. Analysis was done using multiple linear regression models. RESULTS: A total of 3,622 patients met the inclusion criteria and were included in the analysis. Over the entire population, copayment was significantly associated with reduced adherence (-0.034; 95% confidence interval [CI], -0.06 to -0.008). Patients in the highest socioeconomic group, quintile five, had the largest reduction in adherence associated with having a copayment (-0.073; 95% CI, -0.129 to -0.017). Patients in the other four quintiles saw varying levels of decreased adherence respectively, although the differences did not achieve statistical significance. CONCLUSION: The association between adherence and copayment status varied by socioeconomic status. Our findings suggest that even affluent patients may be discouraged from adherence when subject to a copayment. If larger studies substantiate these findings, consideration should be given to a policy that exempts women veterans from copayments for hormonal contraceptives.

Predictors of adherence to hormonal contraceptives in a female veteran population.

OBJECTIVE: The objective was to identify predictors of adherence to hormonal contraceptives in a female veteran population. STUDY DESIGN: This was a retrospective cohort study of female veterans from the VA San Diego Healthcare System. The study period was April 1, 2010, to March 31, 2012. Each patient was followed for 1 year from the index date, defined as the date of first contraceptive prescription in the study time period. Adherence was defined as a medication possession ratio ≥ 0.9. Income was estimated using zip-code-based median household income and split into quintiles (quintile 1 being the lowest-earning group). Logistic regression was used to analyze the association between adherence and the independent variables. RESULTS: A total of 805 patients were included in the final analysis. The majority of the population was white (62.2%) and receiving a 3-month supply of medication (87.6%). The following independent variables were predictive of increased adherence: 3-month supply versus 1-month supply [odds ratio (OR) 1.79, 95% confidence interval (CI) 1.03-3.13], age group 40-45 versus 18-24 (OR 2.57, 95% CI 1.16-5.70) and income quintiles 3 (OR 1.96, 95% CI 1.16-3.29), 4 (OR 1.77, 95% CI 1.06-2.98) and 5 (OR 1.75, 95% CI 1.03-2.98) each versus quintile 1 as reference group. The following were associated with decreased adherence: new start versus continuing user (OR 0.25, 95% CI 0.18-0.37), OB/GYN provider versus primary care provider (OR 0.60, 95% CI 0.38-0.95), and highest weight group versus lowest weight group (OR 0.40, 95% CI 0.17-0.94). CONCLUSION: Hormonal contraceptive adherence in the veteran population is below optimal. Providing 3-month supplies of high-value therapies such as hormonal contraceptives is one strategy that may improve adherence. Initiatives to target lower socioeconomic status or new start populations to increase contraceptive adherence should also be considered. IMPLICATIONS: Adherence to hormonal contraceptives is not as well studied in the literature as some other high-value therapies. Identifying predictive variables for adherence may have implications for establishing possible interventions, or refining benefit structures, in order to increase adherence.

Comparison of an intensive pharmacist-managed telephone clinic with standard of care for tobacco cessation in a veteran population.

PURPOSE: To evaluate the effectiveness of the Pharmacist-Managed Telephone Tobacco Cessation Clinic (PMTTCC) compared to the standard of care (SOC) at the Veterans Affairs San Diego Healthcare System. METHOD: A retrospective cohort study was performed investigating the proportion of veterans who quit smoking at 6 months while enrolled in the PMTTCC. Chart review was performed using the Veterans Affairs Computerized Patient Record System. The PMTTCC group included patients who had received medication and counseling from the tobacco cessation pharmacists. The cohort was compared to a matched SOC group who did not receive counseling, only tobacco cessation medication therapy through a primary care provider. The primary outcome for this study was patient-reported tobacco cessation at 6 months. Secondary outcomes were abstinence at 1 and 3 months. RESULTS: A total of 1,006 patients were included in the analysis, 503 patients from the PMTTCC and 503 patients from SOC. The overall study population was 54 years old on average, 92.5% male, 70.0% Caucasian, 45.5% with history of psychiatric conditions, and had an average smoking history of 33-pack years. Patients in the PMTTCC group had statistically significant improvements in abstinence at 6 months versus the SOC group (81/503, 16.1% vs. 48/503, 9.5%; p < .0001). Quitters were older on average versus non-quitters (56.03 vs. 53.65 years; p = .01). CONCLUSION: Patients enrolled in the PMTTCC had improved tobacco abstinence rates at 6 months compared to SOC. Although the study was not designed to test for causality, the results lend support for using intensive tobacco cessation management in veteran population.

Association of copayment with likelihood and level of adherence in new users of statins: a retrospective cohort study.

BACKGROUND: Statins remain a fundamental component of pharmacologic therapy for hyperlipidemia. Health benefits of statin therapy are jeopardized when adherence is reduced. OBJECTIVES: To (a) assess the association between copayment and copayment type on statin adherence using 2 different thresholds of adherence and (b) identify the incremental change in statin adherence associated with presence of copayment and copayment type. METHODS: We executed a retrospective cohort study of new users of statins with dyslipidemia from the Veterans Health Administration (VHA) within the Veterans Integrated Service Network 22 who initiated a statin between November 30, 2006, and December 2, 2007. We used exposure categories of Any Copayment versus No Copayment, indicating a patient had a copayment or had no copayment in order to obtain medications, respectively. As a separate analysis, we varied the exposures to the standard VHA copayment categories: (a) Service-Connected (SC) Copayment (patients with service-related injury), (b) Non-Service-Connected (NSC) Copayment (patients without a service-related injury), and (c) No Copayment. Using each set of exposures, we conducted separate multiple logistic regression analyses using 2 different adherence outcomes based on medication possession ratio (MPR) threshold: (1) adherence defined as MPR ≥ 0.8 and (2) adherence defined as MPR ≥ 0.9. We then proceeded with multiple linear regression models to determine the incremental change in MPR associated with the 2 sets of exposures. Subjects were required to be enrolled in VHA services for at least 2 years prior to index date and throughout the 1-year study period. RESULTS: A total of 4,886 subjects were identified for analysis based on the inclusion and exclusion criteria. Patients who did not pay a copayment for their statin medications were more likely to have adherence rates of ≥ 0.8 MPR and ≥ 0.9 MPR relative to the No Copayment Group with odds ratios (OR) of 1.19 (95% CI = 1.03-1.37) and 1.28 (95% CI = 1.11-1.48), respectively. The second analysis applied the VHA exposure categories of SC Copayment, NSC Copayment, and No Copayment. Using the 0.8 MPR or greater adherence threshold, the No Copayment group was associated with an increased likelihood of adherence versus the SC Copayment category as reference group with an OR of 1.31 (95% CI = 1.10-1.58). The NSC Copayment was associated with a nonsignificant increase in odds of adherence at the 0.8 MPR level or greater with OR of 1.12 (95% CI = 0.98-1.39). Using the 0.9 MPR level or greater, adherence threshold findings were similar. The No Copayment group produced an OR of 1.42 (95% CI = 1.17-1.71) compared with the SC Copayment group. The NSC Copayment group was associated with a nonsignificant increase in odds of adherence at the 0.9 MPR level or greater with an OR of 1.12 (95% CI = 0.97-1.38).The No Copayment group was associated with an increase in MPR of 0.02 (95% CI = 0.002-0.035) versus the Any Copayment category. Using the VHA copayment categories, we observed an increase in MPR for the No Copayment group versus the SC Copayment group of 0.03 (95% CI = 0.01-0.05). The NSC Copayment group was associated with a nonsignificant increase in MPR versus the SC Copayment group of 0.02 (95% CI = -0.003-0.036). CONCLUSIONS: Patients without out-of-pocket payments for their statins were more likely to adhere to therapy. Patients who pay a copayment for their statin medications were also compared with each other based on whether they (a) received any of their nonstatin prescriptions without a copayment or (b) paid a copayment on all of their prescriptions including statins. Our findings suggest that, among those that pay for their statins, patients are less adherent to their statins if other medications they are prescribed are copayment free. Thus, patient consumption behavior may be influenced by the relative cost of medications in patient prescription lists. Additional counseling on the necessity of adherence should be given to patients paying a copayment for their statin prescriptions.