Healthcare costs for Crohn's disease patients treated with infliximab: a propensity weighted comparison of the effects of treatment adherence.

OBJECTIVE: The objective for the research was to evaluate the direct healthcare costs for Crohn's disease (CD) patients categorized by adherence status. METHODS: Adult patients with ≥1 claim for infliximab and ≥2 claims for CD who were continuously insured for 12 months before and after their first infliximab infusion (index date) were identified in a 2006-2009 US managed care database. Patients were excluded if they had rheumatoid arthritis claims, received infliximab billed as a pharmacy benefit, or received another biologic drug. Patients were categorized as being either adherent or intermittently adherent to infliximab using a pre-defined algorithm. Total and component direct costs, CD-related costs, rates of surgery, and days of hospitalization were estimated for the 360-day post-index period. Propensity weighted generalized linear models were used to adjust the cost estimates for potential confounding variables. RESULTS: The total propensity weighted cost for infliximab adherent patients was $40,425 (95% CI = [$38,686, $42,242]), compared to $41,082 (95% CI = [$38,163, $44,223]) for the intermittently adherent (p = 0.71). However, adherent patients had lower total direct medical costs, exclusive of infliximab, that were $13,097 (95% CI = [$12,141, $14,127]) compared with $20,068 (95% CI = [$17,676, $22,784]) for intermittently adherent patients as a result of substantially lower hospital and outpatient costs (p < 0.0001). CONCLUSIONS: Greater drug-related costs for infliximab adherent patients were offset by lower costs from hospitalization and outpatient visits. These findings indicate that adherent patients have improved clinical outcomes, at a similar aggregate cost, than patients who are only intermittently adherent to therapy.

Complexity of pain management among patients with nociceptive or neuropathic neck, back, or osteoarthritis diagnoses.

BACKGROUND: Approaches to pain management are diverse, requiring prescribers to evaluate an array of clinical issues and potential solutions. In addition to the difficult task of selecting a treatment option, pain treatment may be further complicated by multiple prescribers, multiple medications, and multiple mechanisms of pain origination. OBJECTIVE: To describe patient demographics (e.g., age, gender); comorbidities; office visits (e.g., physician, chiropractor, physical therapy, psychiatry, allergist); number of different prescribers overall prescription use; pain medications as classified by the World Health Organization's (WHO) pain ladder; adjuvant medications; nonpharmacologic procedures; and potential drug interactions in a broad sample of patients with nociceptive or neuropathic neck or back diagnoses, or osteoarthritis diagnoses, in a commercial population. METHODS: This claims-data analysis used a cross-sectional cohort comparison with a fixed 2-year observation period from September 1, 2006, to August 31, 2008, for patients in the PharMetrics national managed care database. The assigned cohorts were neuropathic-related neck/back diagnoses (NEURO); neuropathic and nociceptive neck/back diagnoses (NEURO/NOCI); nociceptive neck/back diagnoses without a neuropathic-related diagnosis (NOCI); and only osteoarthritis (OA) diagnoses. All analyses were conducted by cohort. The analysis included the following patient-descriptive variables: patient demographics, comorbidities, office visits, most frequent medical providers and number of different prescribers, all medications, pain medications as classified by the WHO pain ladder, adjuvant medications, adjuvant procedures and potential drug interactions. The goal for selecting these variables was to describe a range of data that might provide insight into the complexity of pain management decisions faced by clinicians. RESULTS: The study included 85,014 patients, classified as NEURO (n = 2,375), NEURO/NOCI (n = 37,019), NOCI (n = 39,496), and OA (n = 6,124). The most frequently occurring comorbidities (observed in > 40% of patients) included cardiovascular and neuropathic pain conditions. Considering all types of medication claims observed among all cohorts, the overall mean prescription claim count for the 2-year observation period was 57.9 claims (standard deviation 56.2). Weak opioids (WHO pain relief ladder rung 2) accounted for the majority of pain medication claims across all cohorts. Across cohorts, 25.7% of patients had 10 or more days of overlapping drug availability (for inducers or inhibitors of the cytochrome P450 system concomitantly), a measure of potential for drug interactions. CONCLUSIONS: Choosing the appropriate pain treatment involves assessing currently used medications for existing illnesses and deciding on the appropriate types of pain medications. However, potentially serious drug-drug interactions are a consequence of multiple drug use, and such a potential requires thoughtful consideration by those involved in patient care.

Inflammatory bowel disease: healthcare costs for patients who are adherent or non-adherent with infliximab therapy.

OBJECTIVE: Healthcare costs of inflammatory bowel disease are substantial. This study examined the effect of adherence versus non-adherence on healthcare costs in patients with inflammatory bowel disease. METHODS: Adults who started infliximab treatment between 2006 and 2009 and had a diagnosis of inflammatory bowel disease were identified from MarketScan Databases. Medication adherence was defined as an infliximab medication possession ratio of 80% or greater in the first year. Mean treatment effects (adherence versus non-adherence) on costs in adherent patients were estimated with propensity-weighted generalized linear models. RESULTS: A total of 1646 patients were identified. Significant variables in the model used to develop propensity weights were age, year of infliximab initiation, having Medicare coverage, presence of supplementary diagnoses, office as the place of service for infliximab initiation, prior aminosalicylate use, prior outpatient costs, number of prior outpatient visits, and number of prior colonoscopies. Mean total costs in adherent (n = 674) and propensity-weighted non-adherent (n = 972) patients were $41,713 versus $47,411 overall (p < 0.001), including $28,289 versus $14,889 for infliximab drug costs (p < 0.001), $2458 versus $17,634 for hospitalizations (p < 0.001), $7357 versus $10,909 for outpatient visits (p < 0.001), $236 versus $458 for emergency room visits (p < 0.001), and $3373 versus $3521 for other pharmaceuticals costs (p = 0.460). LIMITATIONS: Costs associated with infliximab administration (infusions, adverse events) were captured in healthcare costs (inpatient, outpatient, and emergency room), not in infliximab costs. The influence of adherence on indirect costs (e.g., time lost from work) could not be determined. Reasons for non-adherence were not available in the database. CONCLUSIONS: In patients who were adherent to infliximab treatment (a medication possession ratio of 80% or greater in the first year), adherence versus non-adherence was associated with lower total healthcare costs, supporting the overall value of infliximab adherence in patients with inflammatory bowel disease.

Opioids before and after initiation of pregabalin in patients with diabetic peripheral neuropathy.

OBJECTIVES: To examine opioid prescription claims before and after initiation of pregabalin in patients with a diagnosis of diabetic peripheral neuropathy (DPN). METHODS: This retrospective analysis used a national commercial database of integrated inpatient, outpatient, and prescription claims to identify adults with a DPN diagnosis code within 360 days prior to the first claim for pregabalin between January 1, 2006 and March 31, 2008. Prescription claims for pregabalin or opioids were analyzed in nine consecutive 60-day periods from 180 days before through 360 days after the first pregabalin claim. It was not possible to establish drug administration dates, compliance rates, indications for opioid use, or reasons for treatment discontinuation. RESULTS: Of the 8004 adults who met eligibility criteria, 6080 (76%) received an opioid within the 180 days before and/or 360 days after their first prescription for pregabalin, including 3956 (49%) both before and after, 1580 (20%) after only, and 544 (7%) before only. The percentage of patients with pregabalin claims covering ≥20 of 60 days (within 60-day periods) was 99% (day 1-60), 63% (day 61-120), 50% (day 121-180), 45% (day 181-240), 42% (day 241-300), and 39% (day 301-360). The percentage of patients with opioid claims covering ≥20 of 60 days within the 60-day periods remained stable (range, 25-30%). Among patients with opioid claims, 73-76% received only short-acting opioids, 6-7% received only long-acting opioids, and 18-20% received both short- and long-acting opioids. In the first year, 982 (12%) patients had opioid claims covering ≥20 of 60 days in every 60-day period (i.e., persistent use of opioids). Coexisting musculoskeletal (95%) or neuropathic (61%) pain conditions were frequent. CONCLUSION: A majority of patients with DPN receive an opioid before and/or after their first pregabalin claim. Pregabalin neither interferes with nor replaces opioid use for pain management in patients with DPN. Although nearly 1 in 8 patients received opioids throughout the study period, most claims were for short-acting opioids. The majority of this DPN sample had other pain conditions, including musculoskeletal and neuropathic pain conditions. These results highlight the frequency of opioid use with pregabalin, particularly short-acting opioids.

Development and validation of a patient satisfaction and preference questionnaire for inhalation devices.

INTRODUCTION: The Patient Satisfaction and Preference Questionnaire (PASAPQ) is a multi-item measure of respiratory inhalation device satisfaction and preference designed to be easily understood and administered to patients with asthma and COPD. This study assessed its validity, reliability and responsiveness and explored the between-group difference in PASAPQ scores that is meaningful. METHODS: The field test version was developed using literature, focus groups and expert opinion. Item reduction followed. The assessment of the validity, reliability and responsiveness of the PASAPQ utilized data from two clinical studies comparing devices delivering the same medication, and was performed with pre-specified criteria. A minimally important difference (MID) was estimated using both anchor- and distribution-based approaches. RESULTS: Two factors of the PASAPQ, 'performance' and 'convenience', were consistent across studies. Missing and out-of-range data were minimal (<1%) and respondents used a full range of response options. All items correlated most highly with their hypothesized scale and all exceeded the minimum correlation criteria of 0.40. Cronbach's alfa was high (0.87-0.94), providing support for internal reliability for the PASAPQ. Correlations of the overall satisfaction item with the performance domain ranged from 0.78 to 0.91, the convenience domain ranged from 0.54 to 0.71, and the total score ranged from 0.78 to 0.90. These moderate-to-strong correlations provide substantial support for the validity of the PASAPQ domains and total score. Discriminate validity was assessed by calculating PASAPQ scores for patients' ratings of the device that they preferred compared with the other, non-preferred device. The preferred device was rated higher on all satisfaction measures, supporting the ability of the PASAPQ to discriminate between preferred and non-preferred devices. Although a difference of 3 or 4 points may be sufficient to observe a small effect difference between groups, most of the MID estimates were in the 8-10 point range. DISCUSSION AND CONCLUSION: Our analyses across asthma, COPD and patients with mixed respiratory disease (with features of both COPD and asthma), study designs and data sets lead us to conclude that the PASAPQ is a practical, valid, reliable and responsive instrument for measuring respiratory device satisfaction. Furthermore, a difference in satisfaction scores between treatment groups of 10 points is, conservatively, a difference that is meaningful to patients.