US Healthcare Claims Research Articles

Adherence to Chronic Hepatitis B Treatment Guideline Recommendations for Laboratory Monitoring of Patients Who Are Not Receiving Antiviral Treatment

BackgroundHepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) levels predict future complications in chronic hepatitis B (CHB) patients. To determine when to initiate antiviral therapy, treatment guidelines recommend monitoring of HBV DNA and ALT levels at least annually. This study aimed to assess adherence to treatment guideline-recommended monitoring of CHB patients not receiving antiviral treatment and to identify predictors of laboratory monitoring and subsequent initiation of antiviral therapy.MethodsThis retrospective cohort study used data from a large US health care claims database over a 5-year period (January 1, 2003 to December 31, 2007). The study population included patients 18–65 years of age with at least two paid medical claims with an ICD-9 code for CHB, at least one positive hepatitis B surface antigen test, and at least 12 months of continuous health plan enrollment after initial diagnosis. Descriptive statistics assessed the proportion of patients with claims for ALT and/or HBV DNA monitoring. Multivariate logistic regression models were used to determine predictors of monitoring and subsequent antiviral therapy.ResultsThe study included 1,168 CHB patients, with a mean follow-up of 728 days (median = 696 days). The proportion monitored at least every 12 months was 53.3% for ALT, 39.0% for HBV DNA, and 35.1% for both. Significant predictors of monitoring were a higher Deyo-Charlson Comorbidity Index (DCCI) score for ALT (OR 1.90, p < 0.001), male gender for HBV DNA (OR 1.49, p < 0.01), and a higher DCCI score (OR 1.10, p < 0.05) and male gender (1.46, p < 0.01) for both. Significant predictors of subsequent initiation of antiviral treatment were HBV DNA monitoring (OR 2.08, p < 0.001), a higher DCCI score (OR 1.24, p < 0.001), and male gender (OR 1.53, p < 0.01).ConclusionsLaboratory monitoring of CHB patients not receiving antiviral treatment is below guideline recommendations, suggesting that initiation of antiviral therapy may also be delayed, leaving patients at risk for disease progression.

Treatment of Newly Diagnosed Ulcerative Proctitis in Community-Based Practice

Purpose: Treatment of ulcerative proctitis (UP) is aimed at controlling inflammation and reducing symptoms. While orally administered 5-aminosalicylates (“5-ASAs”) traditionally have been the mainstay of acute and maintenance therapy for UP, 5-ASA suppositories or enemas are generally considered to be first-line therapy, due to evidence that they are more effective at inducing and maintaining remission. Little is known, however, about how UP is typically treated in community-based practice. Methods: Using a large US healthcare claims database, we identified all persons with evidence of newly diagnosed UP (ICD-9-CM 556.2, 556.3) between 1/1/2005 and 12/31/2007, based on: (1) ≥2 encounters for UP ≤90 days apart; (2) evidence of sigmoidoscopy/colonoscopy within 60 days of first visit for UP (“index date”); and (3) no evidence of receipt of any medication used to treat UP (eg, 5-ASA, glucocorticoid, etc.) in the year preceding index date. All patients were followed for 365 days from their index date. We examined pharmacotherapy for UP over post-index periods of 30 days and 365 days alternatively. Results: We identified a total of 518 patients with newly diagnosed UP. Mean (SD) age was 48 (16) years, and there were equal numbers of men and women. Forty-five percent of patients were seen by a gastroenterologist at initial visit. In the 30-day post-index period, 37% of patients had evidence of receipt of mesalamine suppository; 23%, an oral 5-ASA; 12%, mesalamine enema; 12%, rectal hydrocortisone; and 6%, oral prednisone. Antidiarrheals, antimetabolites, and TNF inhibitors were rarely used. Over the entire 365-day post-index period, the number of patients ever-prescribed 5-ASA suppositories increased to 45%; oral 5-ASAs, 38%; 5-ASA enemas, 18%; and systemic glucocorticoids, 20%. Combination and sequential treatment was frequent. Over 365 days, 24% of patients had evidence of receipt of both oral and rectal 5-ASAs; 11%, rectal 5-ASAs and rectal steroids; 2%, rectal 5-ASAs and budesonide; and 11%, rectal 5-ASAs and systemic steroids. Conclusion: While local therapy is commonly prescribed in patients with newly diagnosed UP, approximately one in four patients receive an oral 5-ASA preparation. In the year following diagnosis, one in five patients receive systemic steroids—a marker of failure of conservative therapy and/or disease progression. Our findings suggest that treatment of newly diagnosed UP by community-based physicians largely conforms to guidelines and recommendations. Support: This research was funded by Axcan Pharma Inc., which manufactures and markets a 5-ASA suppository (Canasa®). Disclosure: This research was funded by Axcan Pharma Inc., which manufactures and markets a 5-ASA suppository (Canasa®).

Medical chart validation of an algorithm for identifying multiple sclerosis relapse in healthcare claims

Objective:Relapse is a common measure of disease activity in relapsing-remitting multiple sclerosis (MS). The objective of this study was to test the content validity of an operational algorithm for detecting relapse in claims data.Methods:A claims-based relapse detection algorithm was tested by comparing its detection rate over a 1-year period with relapses identified based on medical chart review. According to the algorithm, MS patients in a US healthcare claims database who had either (1) a primary claim for MS during hospitalization or (2) a corticosteroid claim following a MS-related outpatient visit were designated as having a relapse. Patient charts were examined for explicit indication of relapse or care suggestive of relapse. Positive and negative predictive values were calculated.Results:Medical charts were reviewed for 300 MS patients, half of whom had a relapse according to the algorithm. The claims-based criteria correctly classified 67.3% of patients with relapses (positive predictive value) and 70.0% of patients without relapses (negative predictive value; kappa 0.373: p < 0.001). Alternative algorithms did not improve on the predictive value of the operational algorithm. Limitations of the algorithm include lack of differentiation between relapsing-remitting MS and other types, and that it does not incorporate measures of function and disability.Conclusions:The claims-based algorithm appeared to successfully detect moderate-to-severe MS relapse. This validated definition can be applied to future claims-based MS studies.

Risk of hospitalization with pegfilgrastim versus filgrastim prophylaxis: A retrospective cohort study

6580 Background: Risk of febrile neutropenia has been reported to be lower with pegfilgrastim (PEG) than filgrastim (FIL) in controlled trials in cancer patients receiving myelosuppressive chemotherapy. It is unknown whether risk of hospitalization for neutropenic complications also differs between these agents in a real-world setting. Methods: A retrospective cohort study was undertaken using a US healthcare claims database. The source population included cancer patients who underwent a course of chemotherapy between January 2002 and December 2005, and who also received PEG or FIL during their first course. For each such patient, each unique cycle of chemotherapy was identified, as was each cycle in which PEG or FIL was administered by cycle day 5 (ie, as prophylaxis). Risk of hospitalization for neutropenia, fever, or infection (“neutropenic complications”) and any reason, respectively, was then examined on a cycle-specific basis, including all patient-cycles in which PEG or FIL was administered as prophylaxis. Unadjusted and adjusted odds of hospitalization were estimated using generalized estimating equations (GEE), the latter controlling for patient and treatment characteristics. Results: A total of 15,763 patient-cycles were identified in which patients received prophylaxis either with PEG (n=14,570) or FIL (n=1,193); mean (SD) number of days of FIL prophylaxis was 4.5 (3.3). Crude risk of hospitalization for neutropenic complications was 4.8% for FIL and 3.1% for PEG; corresponding figures for all-cause hospitalization were 8.7% and 6.3%. Unadjusted and adjusted odds of hospitalization were consistently lower (by 28%-36%) with PEG (vs FIL) (Table). Conclusions: In comparison with FIL, risk of hospitalization appears to be approximately one-third lower with PEG prophylaxis in cancer patients receiving myelosuppressive chemotherapy in a real-world setting. Odds ratios for hospitalization with PEG versus FIL (referent) Hospitalization for Neutropenic Complications Hospitalization for Any Reason Odds Ratio 95% CI p-value Odds Ratio 95% CI p-value Unadjusted 0.64 0.48–0.85 0.002 0.70 0.57–0.87 0.001 Adjusted 0.68 0.51–0.91 0.008 0.72 0.58–0.90 0.003 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Amgen Amgen Amgen

Cost of neutropenic complications of chemotherapy

BackgroundCost of neutropenic complications of myelosuppressive chemotherapy has been reported to be substantial. Prior research, however, has focused on initial hospitalization only and has failed to account for follow-on care. Patients and methodsUsing a US health-care claims database, all adult cancer patients who received a course of chemotherapy were identified. For each such patient, each unique cycle of chemotherapy within the course and each occurrence of neutropenic complications within these cycles were characterized. Patients developing neutropenic complications in a given cycle (neutropenia patients), starting with the first, were matched (1:1) to those who did not develop neutropenic complications in that cycle (comparison patients), and health-care costs (i.e. expenditures) were tallied for each matched pair. ResultsNeutropenia patients (n=373) and comparison patients were similar in terms of baseline characteristics. Costs of neutropenia-related care were $12397 (95% confidence interval $10274–$14754) higher for neutropenia versus comparison patients [$14407 ($12357–$16743) versus $2010 ($1490–$2553)]. Among neutropenia patients, mean cost of initial hospitalization for neutropenic complications was $7813 ($6537–$9379); cost of all subsequent neutropenia-related care averaged $6594 ($5217–$8272). ConclusionsNeutropenic complications of myelosuppressive chemotherapy are costly. Prior research focusing on initial hospitalization only may have underestimated the cost of these complications by as much as 40%.

Assessment of Neuropsychiatric Adverse Events in Influenza Patients Treated with Oseltamivir

After reports from Japan of neuropsychiatric adverse events (NPAEs) in children taking oseltamivir phosphate (hereafter referred to as oseltamivir [Tamiflu; F. Hoffmann-La Roche Ltd, Basel, Switzerland]) during and after the 2004--5 influenza season, Roche explored possible reasons for the increase in reporting rate and presented regular updates to the US FDA and other regulatory authorities. This review summarizes the results of a comprehensive assessment of the company's own preclinical and clinical studies, post-marketing spontaneous adverse event reporting, epidemiological investigations utilizing health claims and medical records databases and an extensive review of the literature, with the aim of answering the following questions: (i) what the types and rates of neuropsychiatric abnormalities reported in patients with influenza are, and whether these differ in patients who have received oseltamivir compared with those who have not; (ii) what levels of oseltamivir and its active metabolite, oseltamivir carboxylate are achieved in the CNS; (iii) whether oseltamivir and oseltamivir carboxylate have pharmacological activity in the CNS; and (iv) whether there are genetic differences between Japanese and Caucasian patients that result in different levels of oseltamivir and/or oseltamivir carboxylate in the CNS, differences in their metabolism or differences in their pharmacological activity in the CNS. In total, 3051 spontaneous reports of NPAEs were received by Roche, involving 2466 patients who received oseltamivir between 1999 and 15 September 2007; 2772 (90.9%) events originated from Japan, 190 (6.2%) from the US and 89 (2.9%) from other countries. During this period, oseltamivir was prescribed to around 48 million people worldwide. Crude NPAE reporting rates (per 1,000,000 prescriptions) in children (aged < or =16 years) and adults, respectively, were 99 and 28 events in Japan and 19 and 8 in the US. NPAEs were more commonly reported in children (2218 events in 1808 children aged < or =16 years vs 833 in 658 adults) and generally occurred within 48 hours of the onset of influenza illness and initiation of treatment. After categorizing the reported events according to International Classification of Diseases (9th edition) codes, abnormal behaviour (1160 events, 38.0%) and delusions/perceptual disturbances (661 events, 21.7%) were the largest categories of events, and delirium or delirium-like events (as defined by the American Psychiatric Association) were very common in most categories. No difference in NPAE reporting rates between oseltamivir and placebo was found in phase III treatment studies (0.5% vs 0.6%). Analyses of US healthcare claims databases showed the risk of NPAEs in oseltamivir-treated patients (n = 159,386) was no higher than those not receiving antivirals (n = 159,386). Analysis of medical records in the UK General Practice Research Database showed that the adjusted relative risk of NPAEs in influenza patients was significantly higher (1.75-fold) than in the general population. Based on literature reports, NPAEs in Japanese and Taiwanese children with influenza have occurred before the initiation of oseltamivir treatment; events were also similar to those occurring after the initiation of oseltamivir therapy. No clinically relevant differences in plasma pharmacokinetics of oseltamivir and its active metabolite oseltamivir carboxylate were noted between Japanese and Caucasian adults or children. Penetration into the CNS of both oseltamivir and oseltamivir carboxylate was low in Japanese and Caucasian adults (cerebrospinal fluid/plasma maximum concentration and area under the plasma concentration-time curve ratios of approximately 0.03), and the capacity for converting oseltamivir to oseltamivir carboxylate in rat and human brains was low. In animal autoradiography and pharmacokinetic studies, brain : plasma radioactivity ratios were generally 20% or lower. Animal studies showed no specific CNS/behavioural effects after administration of doses corresponding to > or =100 times the clinical dose. Oseltamivir or oseltamivir carboxylate did not interact with human neuraminidases or with 155 known molecular targets in radioligand binding and functional assays. A review of the information published to date on functional variations of genes relevant to oseltamivir pharmacokinetics and pharmacodynamics and simulated gene knock-out scenarios did not identify any plausible genetic explanations for the observed NPAEs. The available data do not suggest that the incidence of NPAEs in influenza patients receiving oseltamivir is higher than in those who do not, and no mechanism by which oseltamivir or oseltamivir carboxylate could cause or worsen such events could be identified.

1141 POSTER Evaluation of extended dosing intervals versus weekly dosing of darbepoetin alfa (DA): A phase 2 study in cancer patients (pts) with chemotherapy-induced anemia (CIA)

In 2005, the mean weekly dose ratio of epoetin alfa (EA) to darbepoetin alfa (DA) in clinical practice was estimated to be ∼400 to 1. In 2006, a 500-μg dose and new dosing schedule was approved for DA in the United States. In 2007, the warnings and dosing/administration sections were modified for both agents. All of these factors may have changed the way that physicians use EA and DA. Previous studies of the use of erythropoiesis-stimulating agents (ESAs) in patients with anemia concomitant with chemotherapy may thus not reflect current clinical practice.The goal of this study was to examine the use and costs of ESAs in clinical practice in patients with anemia concomitant with chemotherapy.Using 2 large US health care claims databases, all adults (aged ≥18 years) were identified who received ESAs in 2008 and had evidence of receipt of chemotherapy ≤42 days before initial ESA receipt (ie, the index date). Episodes of care were defined as beginning on the index date and ending on the date of the last ESA claim that was followed by a ≥42-day gap without any receipt of ESAs, to which was added an assumed duration of clinical benefit (in days) based on the ESA and corresponding dose received. DA- and EA-treated patients were matched using propensity scoring. The mean weekly dose and cost of DA and EA during episodes of care was calculated using all information from relevant claims noted during such episodes. Each database was analyzed separately.In the first database, 475 patients with DA episodes of care were matched to an equal number of patients with EA episodes; in the second database, there were 424 matched pairs. In the first database, the mean (95% CI) weekly dose was 37,444 U (35,942 U–39,001 U) during EA episodes and 110 μg (108 μg–113 μg) during DA episodes; the mean weekly EA/DA dose ratio was 340 to 1. In the second database, the mean (95% CI) weekly dose was 37,047 U (35,944 U–38,175 U) during EA episodes and 121 μg (117 μg–125 μg) during DA episodes; the mean weekly EA/DA dose ratio was 306 to 1.The mean weekly EA/DA dose ratio during episodes of ESA care has declined in patients with anemia concomitant with chemotherapy, due at least in part to the availability and use of a new dose/dosing schedule for DA without similar changes for EA.

Acute/Subacute Herpes Zoster

Although there are estimated to be nearly 1 million cases of herpes zoster diagnosed in the US each year, the economic costs associated with herpes zoster in the US have not been well described. To describe the healthcare resource utilisation and costs associated with physician-diagnosed acute/subacute herpes zoster, from a payer perspective, using a large US healthcare claims database. Data for the period 2000-1 were obtained from the Medstat Marketscan healthcare claims database. The duration of acute/subacute herpes zoster was considered to include the 21 days preceding, and 90 days following, the initial herpes zoster diagnosis. Resource utilisation was examined for individuals with newly diagnosed acute/subacute herpes zoster (n = 8741) and compared, through regression analyses, with that observed for control individuals from the same population (n = 50,000). Similar analyses were conducted for costs; the costs included reflected healthcare payments from patients, insurers and other sources. Regression analyses controlled for demographics (age, gender), conditions that have been observed with greater frequency among patients with acute/subacute herpes zoster in prior studies (cancer, HIV infection, organ transplantation, other immunosuppressive conditions and therapies) and the number of billed services within each of seven categories of care that were potentially related to acute/subacute herpes zoster and that were utilised within the 30-180 days prior to the diagnosis for affected patients, and over an analogous period for controls. The acute/subacute phase of herpes zoster was estimated to result in an average of 1.7 (standard error [SE] 0.02) additional physician and hospital outpatient visits, 0.05 (SE 0.003) additional emergency room visits, 0.03 (SE 0.003) additional inpatient hospital admissions, 2.1 (SE 0.03) additional prescriptions filled and $US431 (SE 17.60) in additional healthcare costs per patient. Among patients with acute/subacute herpes zoster, 21.1% had a diagnosis code with a designation for a herpes zoster-related complication, and 9.4% had three or more outpatient visits with a diagnosis code for herpes zoster. The average estimated incremental costs per patient with acute/subacute disease increased with age, ranging from $US258 (SE 37.70) among patients aged < or =19 years to $US805 (SE 106.30) among those aged > or =80 years. The numbers of additional outpatient visits, inpatient admissions, prescriptions filled for pain medications and coded complications were also substantially higher among older than younger patients with acute/subacute herpes zoster. The management of acute/subacute herpes zoster was found to result in substantial healthcare costs, with outpatient care and prescription drugs comprising the majority of the cost burden. To more fully understand the overall cost of herpes zoster disease to society, future studies should examine the healthcare costs associated with post-herpetic neuralgia and productivity losses due to herpes zoster and post-herpetic neuralgia.

Cost of chemotherapy-related febrile neutropenia

6068 Background: Febrile neutropenia (FN) is a serious complication of myelosuppressive chemotherapy that typically necessitates hospitalization. While the costs of FN have been reported to be substantial, previous studies may have underestimated these costs due to failure to account for follow-on care. Methods: A retrospective cohort study was undertaken using a US healthcare claims database. The source population included adult cancer patients who received a course of chemotherapy between 2001 and 2003. For each such patient, each unique cycle of chemotherapy was identified, and patients who developed FN within these cycles were further identified based on hospitalization for neutropenia, fever, and/or infection. Patients with FN in a given cycle (“cases”), starting with the first, were matched–on tumor type, number of cycles, chemotherapy characteristics, and propensity score–to those not experiencing FN in that cycle (“controls”), regardless of occurrence of FN in subsequent cycles; once matched, patients were removed from their respective pools. FN-related healthcare charges–including inpatient, outpatient, and drug treatment for neutropenia, fever, and infection–were tallied for each such pair of patients from the cycle day on which cases developed FN through the last chemotherapy cycle. Healthcare charges were used as a proxy for costs, as the latter were unavailable. Results are reported as means and 95% confidence intervals. Results: The study population consisted of 746 patients; 38% had breast cancer, 21% had lung cancer, and 11% had non-Hodgkin’s lymphoma. Cases and controls were similar in terms of baseline characteristics. FN-related charges totaled $40,928 (95%CI $28,783-$62,586) among cases versus $3,933 ($2,890-$5,119) for controls, a difference of $36,995 ($25,283-$58,776). Non-FN-related charges were similar in the two groups ($32,774 [$28,587-$36,061] vs. $32,253 [$29,248-$36,066]). Care subsequent to initial hospitalization accounted for $9,872 (or 27%) of the higher FN-related charges among cases. Conclusions: Costs of care during chemotherapy are twofold higher among patients who develop FN; follow-on care represents more than one-quarter of the difference. [Table: see text]

Co-occurrence and comorbidities in patients with immune-mediated inflammatory disorders: an exploration using US healthcare claims data, 2001–2002

ABSTRACTObjective: Research in immune-mediatedinflammatory disorders (IMIDs) suggests that several diseases share disruptions in key cytokines. A common pathogenesis may present as similar patterns of disease co-occurrence and comorbidity, which could be observed through the analysis of healthcare claims datasets.Methods: Adult patients continuously enrolled from 2001–2002 were identified in two US healthcare datasets containing medical and drug claims from health plans and self-insured employers. Patients with treatment records indicating an IMID were selected (e.g., rheumatoid arthritis, psoriasis, Crohn's disease); controls for each disorder were matched 3:1 based on age, gender, region, and previous insurance coverage. IMID cohorts and comorbidities were identified using International Classification of Diseases, 9th revision codes. Prevalence relative risk was used to assess co-occurrence and comorbidity rates in IMID cohorts and controls. Medical and drug utilization patterns were also explored.Results: Findings were similar across the two datasets. IMID patients represented about 4% of the population; specific IMID prevalence matched the epidemiology literature. Patients with at least one IMID had a higher risk for another IMID when compared to controls. The risk for infectious, renal, liver, and ulcerative comorbidities was also elevated. Selected drug utilization patterns confirmed comorbidity findings. IMID patients used more healthcare resources compared to controls; findings were robust under sensitivity analyses.Conclusions: IMID patients were generally more likely than controls to have another IMID, supporting the concept that the diseases are related. These patients also had higher comorbidity rates. Findings may be limited by the nature of claims datasets and the confounding effect of current treatments. Prospective studies are needed to determine whether IMIDs have a common pathogenesis.

Are Shorter Courses of Filgrastim Prophylaxis Associated with Increased Risk of Hospitalization?

In clinical trials in patients receiving myelosuppressive chemotherapy, 10-11 days of prophylaxis with filgrastim has been found to reduce the incidence of febrile neutropenia. In clinical practice, however, many patients receive shorter courses of therapy, even though the effectiveness of this regimen is unknown. To examine the relationship between duration of filgrastim prophylaxis and risk of hospitalization in patients receiving chemotherapy for non-Hodgkin's lymphoma (NHL), breast cancer, or lung cancer. Using a large, automated, US healthcare claims database, we identified all adults who received chemotherapy for NHL, breast cancer, or lung cancer between 1998 and 2002. For these patients, we identified their first course of chemotherapy and each unique cycle within that course. We then focused attention on all patient cycles in which filgrastim was administered on or before cycle day 5 (filgrastim prophylaxis). Pooling all such cycles, we examined the relationship between duration of filgrastim prophylaxis and risk of hospitalization for neutropenia or infection and risk of hospitalization for any reason, using generalized estimating equations. Mean +/- SD duration of filgrastim prophylaxis was 6.5 +/- 3.1 days across 332 cycles for 133 NHL patients, 6.1 +/- 2.9 days across 482 cycles for 205 breast cancer patients, and 4.3 +/- 3.1 days across 522 cycles for 260 lung cancer patients. In multivariate analyses, risk of hospitalization for neutropenia or infection was found to decline with each additional day of filgrastim prophylaxis for patients with NHL (OR 0.81; p = 0.003), breast cancer (OR 0.77; p = 0.001), and lung cancer (OR 0.91; p = 0.084). Risk reductions with each additional day of prophylaxis ranged from 15% to 19% for patients with NHL, 17% to 23% for those with breast cancer, and 8% to 9% for those with lung cancer. Similar reductions in risk were noted for all-cause hospitalization. Among patients with NHL, breast cancer, or lung cancer, shorter courses of filgrastim prophylaxis may increase the risk of hospitalization.

Dose Intensification with Infliximab in Patients with Rheumatoid Arthritis

Infliximab, in combination with methotrexate, is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA). While there is anecdotal evidence that many patients beginning infliximab therapy have their dose and/or frequency of infusions increased over time ("dose intensification"), relatively little is known about actual patterns of use in clinical practice. To examine patterns of infliximab use in patients with RA. Using a large US healthcare claims database, all patients with RA who initiated infliximab therapy between January 1, 2000, and September 30, 2001, were identified. The date of each patient's first claim for infliximab was identified and designated as the index date; attention was limited to patients who received infliximab for at least one year. Patterns of infliximab use were then examined over the 12-month period following the index date, based on information on paid claims. Fifty-three patients met all entry criteria; the mean age was 61 years, and 81% were women. Twenty-eight percent of patients received >8 infusions over 12 months. The mean dose of infliximab at initial infusion was 296.2 mg; at final infusion, it was 401.9 mg (36% increase). One-half of study subjects had their dose of infliximab increased by > or =30% between the initial and final infusions; one-third had their dose increased by > or =50%. Many patients with RA beginning treatment with infliximab have their frequency of infusions and/or medication dose increased within the first 12 months.

Retrospective study of the costs of care during the first year of therapy with etanercept or infliximab among patients aged ≥65 years with rheumatoid arthritis

The aim of this work was to retrospectively examine the costs of therapy with etanercept and infliximab, among patients aged > or = 65 years with rheumatoid arthritis (RA), from a health-care system perspective. Data from 2 large, automated US health-care claims databases (Constella COMPASS and Ingenix LabRx) were pooled for the analyses. Each database is comprised of paid facility, professional service, and retail (ie, outpatient) pharmacy claims from participating health plans. Using the 2 databases, all RA patients aged > =65 years were identified who began therapy with etanercept or infliximab between July 1, 1999 (Constella COMPASS), or January 1, 2001 (Ingenix LabRx), and December 31, 2002. Costs of RA-related care (including study drugs, selected medications, and outpatient encounters for RA) and non-RA-related care (all other medications and services) for patients in the 2 treatment groups were assessed, in US dollars, over a 1-year period after therapy initiation. A total of 280 RA patients aged > or = 65 years initiated therapy with etanercept (n = 99) or infliximab (n = 181) and met all other selection criteria. Etanercept patients were younger than infliximab patients (mean [SD] age, 70.5 [4.6] vs 71.8 [4.6] years; P = 0.04), were less likely to be enrolled in a managed care organization (76.7% vs 87.8%; P < 0.01), and had fewer pretreatment rheumatologist visits (mean [SD], 1.3 [2.3] vs 2.2 [3.8]; P = 0.04). Other characteristics, including pretreatment levels of other types of health-care utilization, were generally similar. Mean (95% CI) total cost of RA-related care was lower for etanercept patients in both databases (US 12,159 dollars [US 10,795 dollars-US 13,380 dollars] for etanercept vs US 22,347 dollars [US 20,808 dollars-US 23,912 dollars] for infliximab in one, and US 14,297 [US 12,238 dollars-US 16,326 dollars] for etanercept vs US 22,154 dollars [US 19,688 dollars-US 24,703 dollars] for infliximab in the other), primarily due to lower costs of anti-tumor necrosis factor therapy (US 10,015 dollars [US 8754 dollars-US 11,224 dollars] for etanercept vs US 18,611 dollars [US 17,169 dollars-US 20,023 dollars] for infliximab in one database; US 11,917 dollars [US 10,128 dollars-US 13,480 dollars] for etanercept vs US 16,759 dollars [US 14,551 dollars-US 19,062 dollars] for infliximab in the other). Mean (95% CI) costs of non-RA-related care were similar among etanercept and infliximab patients in both databases (US 13,100 dollars [US 8956 dollars-US 18,377 dollars] for etanercept vs US 11,789 dollars [US 8326 dollars-US 16,001 dollars] for infliximab in one, and US 16,665 dollars [US 10,329 dollars-US 25,690 dollars] for etanercept vs US 13,959 dollars [US 10,216 dollars-US 18,168 dollars] for infliximab in the other). These results suggest that costs of RA-related care during the first year of therapy may be lower among RA patients aged > or =65 years receiving etanercept versus infliximab, a difference attributable primarily to lower costs of drug acquisition.

Therapy switching in patients receiving long-acting opioids.

Patterns of therapy switching in patients receiving long-acting opioids have not been well documented. To compare therapy switching among patients beginning treatment with controlled-release (CR) oxycodone, transdermal fentanyl, or CR morphine sulfate. Using a US healthcare claims database, we identified patients beginning treatment with CR oxycodone, transdermal fentanyl, or CR morphine sulfate between July 1, 1998, and December 31, 1999. We compiled claims for each patient for 6 months following therapy initiation and compared the incidence of therapy switching among the 3 groups. We also estimated total healthcare charges for patients who switched therapy versus those who did not. We identified 1931, 668, and 449 patients beginning therapy with CR oxycodone, transdermal fentanyl, and CR morphine sulfate, respectively; 16.7%, 25.0%, and 35.9%, respectively, had cancer. For patients without cancer, rates of therapy switching at 6 months were 10.6% (CR oxycodone), 19.0% (transdermal fentanyl), and 26.0% (CR morphine sulfate); for those with cancer, rates were 23.8%, 24.6%, and 29.8%, respectively. Multivariate hazard ratios (vs CR morphine sulfate) for therapy switching in patients without cancer were 0.36 (95% CI, 0.27 to 0.47) for CR oxycodone and 0.69 (0.51 to 0.94) for transdermal fentanyl; for those with cancer, corresponding hazard ratios were 0.72 (0.50 to 1.03) and 0.76 (0.50 to 1.16). Total healthcare charges were significantly (p < 0.01) higher for patients who switched therapy than those who did not (23,965 US dollars vs 14,299 US dollars in pts. without cancer; 58,259 US dollars vs 39,618 US dollars for those with cancer). Patients without cancer who receive CR oxycodone or transdermal fentanyl are less likely to switch therapy than those receiving CR morphine sulfate. Total healthcare charges are higher for patients who switch therapy.