Howard G. Birnbaum

Objective: Allergic rhinitis (AR) is a chronic disease with a substantial clinical and economic burden. This study estimated the potential budget impact (BI) associated with market entry of Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Tablet for Sublingual Use (‘5-grass SLIT tablet’) for patients aged 10–65 with grass pollen-induced AR. Methods: A budget impact model was constructed to estimate the potential BI from a US payer perspective. The model calculated pharmacy, medical, and total (pharmacy + medical) costs per-member-per-month (PMPM) with and without market entry of the 5-grass SLIT tablet, considering a 3-year time horizon. The target population was determined using an epidemiological approach and existing literature. The treatment market shares without 5-grass SLIT tablet entry were derived from an analysis of de-identified insurance claims data. Pharmacy costs and medical utilization rates and costs were obtained from the claims...

The study aims to examine real-world effects of duloxetine treatment for low back pain (LBP). The study identified employees with ≥1 LBP diagnosis and ≥1 duloxetine prescription within a year after LBP diagnosis from a privately insured claims database (2004–2007). Duloxetine-treated employees were propensity score matched to employees initiating another pharmacological/noninvasive treatment in the same month from LBP diagnosis. Treatment patterns and costs were compared over the 6 months following treatment initiation. Relative to controls, duloxetine-treated employees (N = 753) had significantly lower rates of other pharmacological/noninvasive therapies and a similar LBP surgery rate (1.7% vs 2.8%, P = 0.1573). Duloxetine-treated employees, despite higher pharmacy costs, had similar direct (health care) costs ($4,935 vs $5,649, P = 0.2662), and significantly lower indirect (workloss) costs ($1,723 vs $2,198, P = 0.0036). Duloxetine treatment in LBP employees was associated with reduced rates of many nonsurgical therapies and lower indirect costs. The findings are limited by the observational study design and unmeasured potential confounders.

While there are validated patient-reported outcomes (PRO) instruments for use in specific cancer populations, no validated general instruments exist for use in conditions common to multiple cancers, such as muscle wasting and consequent physical disability. The Medicare Current Beneficiary Survey (MCBS), a survey in a nationally representative sample of Medicare beneficiaries, includes items from three well known scales with general applicability to cancer patients: Katz activities of daily living (ADL), Rosow–Breslau instrumental ADL (IADL), and a subset of physical performance items from the Nagi scale.

Prescription opioid abuse and addiction are serious problems with growing societal and medical costs, resulting in billions of dollars of excess costs to private and governmental health insurers annually. Although difficult to accurately assess, prescription opioid abuse also leads to increased insurance costs in the form of property and liability claims, and costs to state and local governments for judicial, emergency, and social services. This manuscript's objective is to provide payers with strategies to control these costs, while supporting safe use of prescription opioid medications for patients with chronic pain. A Tufts Health Care Institute Program on Opioid Risk Management meeting was convened in June 2010 with private and public payer representatives, public health and law enforcement officials, pain specialists, and other stakeholders to present research and develop recommendations on solutions that payers might implement to combat this problem. While protecting access to prescription opioids for patients with pain, private and public payers can implement strategies to mitigate financial risks associated with opioid abuse, using internal strategies such as formulary controls, claims data surveillance, and claims matching; and external policies and procedures that support and educate physicians on reducing opioid risks among patients with chronic pain. Reimbursement policies, incentives, and health technology systems that encourage physicians to use universal precautions, to consult prescription monitoring program (PMP) data, and to implement Screening, Brief Intervention, and Referral to Treatment protocols have a high potential to reduce insurer risks while addressing a serious public health problem.

Objectives: No head-to-head trial has compared the efficacy of adalimumab vs etanercept and infliximab for psoriatic arthritis (PsA). This study implements a matching-adjusted indirect comparison technique to address that gap. Methods: Patient-level data from a placebo-controlled trial of adalimumab (ADEPT) were re-weighted to match average baseline characteristics from pivotal published trials of etanercept and infliximab. ADEPT patients were re-weighted by odds of enrollment in comparator trials, estimated using logistic regression. Matched-on characteristics included PsA duration, age, gender, severity, active psoriasis, and concomitant treatment. After matching, placebo-adjusted treatment arms were compared at weeks 12 (or 14) and 24. Outcomes included ACR20/50/70, PsARC, HAQ, and modified TSS. PASI50/75/90 were compared for patients with active psoriasis. Cost per responder (CPR) was assessed in the US and Germany using matching-adjusted end-points and drug list prices. Statistical significance was assessed using weighted t-tests. Results: After matching, adalimumab-treated patients had greater placebo-adjusted rates of ACR70 and PASI50/75/90 at week 24 compared with etanercept (all p < 0.05). Adalimumab patients had a higher placebo-adjusted rate of ACR70 than infliximab at week 14 (p = 0.034). Adalimumab treatment had lower CPR for ACR70 and PASI50/75/90 compared with etanercept at week 24, in both the US and Germany (all p < 0.02). Adalimumab had lower CPR than infliximab for all outcomes at week 24 (all p < 0.05). Conclusion: Adalimumab is associated with higher ACR70 and PASI50/75/90 response rates than etanercept at week 24 and a higher ACR70 response rate than infliximab at week 14. Adalimumab has significant advantages over etanercept and infliximab in CPR across multiple end-points. Key limitations: The matching-adjusted indirect comparison method cannot account for unobserved differences in patient characteristics across trials, and only a head-to-head randomized clinical trial can fully avoid the limitations of indirect comparisons. CPR findings are limited to the US and German markets, and may not be generalizable to other markets with different relative pricing.

Little is known about the real-world treatment patterns and costs of patients with chronic low back pain (CLBP) who are treated with duloxetine compared with those receiving other non-surgical treatments. Our objective was to compare the real-world treatment patterns and costs between patients with CLBP who initiated duloxetine and matched controls who initiated another non-surgical treatment. The study sample was selected from a US privately insured claims database (2004-8). Selected patients were aged 18-64 years, and had a low back pain (LBP) diagnosis (per Healthcare Effectiveness Data and Information Set [HEDIS] specifications) with a subsequent CLBP-qualifying diagnosis recorded ≥90 days after the initial LBP diagnosis. Duloxetine-treated patients had ≥1 duloxetine prescription within 6 months after CLBP diagnosis, no prior duloxetine claim, and continuous eligibility ≥12 months before first LBP diagnosis and ≥6 months after index duloxetine prescription (study period). Because duloxetine patients had higher rates of co-morbidities, 553 duloxetine-treated patients were matched to 553 control patients who initiated another non-surgical LBP treatment based on propensity score and time from first LBP diagnosis to treatment initiation. A subset (n = 103 each) of matched employees with disability data was also analysed to assess work loss. Main outcomes measures included study period treatment rates and direct (medical and drug) costs from a third-party payer perspective and employee indirect (work-loss) costs. McNemar tests were used to compare LBP treatment rates. Bias-corrected bootstrapping t-tests were used to compare costs. After matching, the two groups had balanced baseline characteristics including demographics, LBP diagnostic categories, co-morbidity profiles, resource use, treatment patterns and mean direct costs. During the 6-month study period, matched duloxetine-treated patients had significantly lower rates of other pharmacological therapy (e.g. 56.2% vs 64.9% narcotic opioids, p = 0.0024; 34.9% vs 49.5% NSAIDs, p < 0.0001) and non-invasive therapy (28.8% vs 38.5% chiropractic therapy, p = 0.0007; 25.5% vs 35.4% physical therapy, p = 0.0004; 17.5% vs 28.4% exercise therapy, p < 0.0001) than controls. Duloxetine-treated patients versus controls had similar back surgery rates (2.2% vs 3.8%; p = 0.1127) and similar direct costs ($US7658 vs $US7439; p = 0.8119). Among CLBP employees, duloxetine-treated employees versus controls had lower rates of other non-surgical therapy, similar back surgery rates (0.0% vs 3.9%; p = 0.1250), lower total direct and indirect costs ($US5227 vs $US7299; p = 0.0418), and similar indirect costs ($US1806 vs $US2664; p = 0.0528). Duloxetine treatment in CLBP patients/employees versus other non-surgical treatment was associated with reduced rates of non-surgical therapies and similar back surgery rates, without increased costs.

Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease that often results in joint pain, inflammation and bone erosions. Perhaps the most notable change in RA treatment during the last...

To compare healthcare costs and resource utilization among patients with post-traumatic stress disorder (PTSD) vs control subjects with major depressive disorder (MDD) in populations covered by Medicaid or private insurance. Retrospective analysis of Medicaid and private insurance administrative claims data. Patients with at least 2 PTSD diagnoses during or after 1999, and at least 1 PTSD diagnosis during or after 2003, were identified from deidentified Medicaid claims from Florida, Missouri, and New Jersey (1999-2007) and from a privately insured claims database (1999-2008). Patients had continuous eligibility 6 months before (baseline) and 12 months after (study period) the index date and were aged 18 to 64 years. Potential control subjects having MDD without PTSD diagnosis were identified using similar selection criteria. Control subjects with MDD were matched to patients with PTSD on age, sex, state or region, employment status (private insurance only), index year, and race/ethnicity (Medicaid only). Study period per-patient utilization and costs, calculated as reimbursements to providers for medical services and prescription drugs, were compared using univariate and multivariate analyses. Patients with PTSD had higher rates of other mental health disorders (eg, anxiety and bipolar disorder) and higher mental health-related resource use and costs than control subjects with MDD in both Medicaid and privately insured populations. The mean study period total direct healthcare costs were higher for patients with PTSD than for control subjects with MDD ($18,753 vs $17,990 for Medicaid and $10,960 vs $10,024 for private insurance, P <.05 for both). The difference in total direct costs was driven by higher mental health-related resource use for patients with PTSD. Patients having PTSD had 4.2% to 9.3% higher mean annual per-patient healthcare costs compared with matched control subjects having MDD among patients covered by Medicaid or private insurance.

Objectives. The objective of this study was to estimate the societal costs of prescription opioid abuse, dependence, and misuse in the United States. Methods. Costs were grouped into three categories: health care, workplace, and criminal justice. Costs were estimated by 1) quantity method, which multiplies the number of opioid abuse patients by cost per opioid abuse patient; and 2) apportionment method, which begins with overall costs of drug abuse per component and apportions the share associated with prescription opioid abuse based on relative prevalence of prescription opioid to overall drug abuse. Excess health care costs per patient were based on claims data analysis of privately insured and Medicaid beneficiaries. Other data/information were derived from publicly available survey and other secondary sources. Results. Total US societal costs of prescription opioid abuse were estimated at $55.7 billion in 2007 (USD in 2009). Workplace costs accounted for $25.6 billion (46%), health care costs accounted for $25.0 billion (45%), and criminal justice costs accounted for $5.1 billion (9%). Workplace costs were driven by lost earnings from premature death ($11.2 billion) and reduced compensation/lost employment ($7.9 billion). Health care costs consisted primarily of excess medical and prescription costs ($23.7 billion). Criminal justice costs were largely comprised of correctional facility ($2.3 billion) and police costs ($1.5 billion). Conclusions. The costs of prescription opioid abuse represent a substantial and growing economic burden for the society. The increasing prevalence of abuse suggests an even greater societal burden in the future.

Background: Published studies indicate that depression in older adults is severely under-recognized and under-treated. Objective: To characterize primary-care physicians’ decisions to prescribe antidepressants to older patients with depression. Methods: Electronic medical record (EMR) notes from office visits of older patients (aged ≥65 years), treated in a central Massachusetts multi-specialty medical group practice, were screened every 2 weeks between August 2007 and July 2008 for mention of depression. Electronic surveys containing questions about depression severity and onset, and antidepressant treatment, were sent to physicians whose EMR notes indicated that they had treated an older patient with depression, until approximately 400 responses had been received. Physicians were asked about whether they prescribed antidepressants or made changes to antidepressant treatment and were asked about the extent to which they agreed with a set of pre-specified reasons for treatment recommendations. Physicians were also allowed to document any other reasons that influenced their decision. Patient characteristics and treatment were identified from administrative claims. Univariate analyses were used to describe patient characteristics and physician survey responses. Results: Physicians responded to the survey and confirmed a depression diagnosis for 396 patients, for whom the average age was 77.1 years and 76.5% were female. Most patients had physician-reported depression onset after age 60 years (72.2%) and moderately severe depression (58.8%). Physicians reported that 62.9% of patients were already being treated with anti-depressants prior to their visit, 28.5% were recommended antidepressant initiation and 8.6% were not prescribed antidepressants. Selective serotonin reuptake inhibitors were most frequently prescribed. Maintaining prior therapy was recommended for 81.1% of treated patients and treatment modification for 18.9%. Almost all physicians (>92%) agreed that experience in use of prescription drugs, safety/tolerability and patient improvement influenced their decision to maintain prior therapy or recommend new therapy. 85.8% of physicians agreed that availability of efficacy data in the elderly influenced their decision to prescribe new therapy. 38.9% of patients who were recommended new therapy initiation did not fill an antidepressant prescription. Conclusions: Despite previous reports of under-treatment of depression in the elderly, this study suggests that physicians are comfortable prescribing anti-depressants to the elderly, and the majority of older patients with depression were prescribed antidepressants. Rather than a physician’s prescribing decision, it may be patient factors, such as refusal to accept diagnosis/treatment and noncompliance, that may lead to under-treatment — approximately 40% of patients who were recommended new antidepressant therapy did not fill an antidepressant prescription.