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The American Journal of Managed Care Special Issue: Pharmacy Benefits
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Disease-Modifying Antirheumatic Drug Initiation Among Patients Newly Diagnosed With Rheumatoid Arthritis

Machaon Bonafede, PhD, MPH; Barbara H. Johnson, MBA; Neel Shah, PhD, BPharm; David J. Harrison, PhD; Derek Tang, PhD, BSPharm; and Bradley S. Stolshek, PharmD
Only slightly more than half of patients with newly diagnosed rheumatoid arthritis initiated therapy within 1 year.
ABSTRACT

Objectives: To determine the rate of timely disease-modifying antirheumatic drug (DMARD) initiation in patients newly diagnosed with rheumatoid arthritis (RA), as recommended per a quality measure endorsed by the National Quality Forum.

Study Design: Retrospective analysis of claims data from the Truven Health MarketScan commercial and Medicare claims databases.

Methods: Patients newly diagnosed with RA were identified in the claims databases. Outcomes included rate of nonbiologic or biologic DMARD initiation within 12 months of diagnosis; initiation by year (2009-2012), US state, and prescription drug plan; and time to initiation. Multivariate modeling was performed to identify factors associated with initiation or noninitiation.

Results: Of 40,040 newly diagnosed patients, 55.5% initiated RA therapy within 12 months, including 21,154 (52.8%) initiating DMARD therapy and 1051 (2.6%) initiating biologic DMARD therapy. Rates were similar for years 2009 (53.3%), 2010 (55.7%), 2011 (56.3%), and 2012 (56.8%), but they varied widely by US state (range, 33.3%-88.0%) and prescription plan (range, 42.6%-63.5% across 8 largest plans). Mean (SD) time to initiation of any RA therapy was 39 (65) days. Predictors of initiation included point-of-service (odds ratio [OR], 1.18) and consumer-driven/high-deductible (OR, 1.19) plans, comorbid psoriasis (OR, 1.30) or diabetes (OR, 1.17), rheumatoid factor test (OR, 3.02), and diagnosis by a rheumatologist (OR, 3.17). Predictors of noninitiation included female sex (OR, 0.94), preferred provider organization plan (OR, 0.87), higher comorbidity score (OR, 0.94), select comorbidities (OR range, 0.65-0.92), and number of prescriptions for any cause (OR, 0.98).

Conclusions: Only slightly more than half of patients initiated RA therapy within 12 months of diagnosis in this commercially insured population.

Am J Manag Care. 2018;24(Spec Issue No. 8):SP279-SP285
Takeaway Points
  • Early initiation of therapy for rheumatoid arthritis (RA) is important to reduce or delay disease progression.
  • In contrast to the National Quality Forum–endorsed measure and the American College of Rheumatology recommendation for early treatment of RA, this study of commercially insured patients found that only 55.5% of patients initiated disease-modifying antirheumatic drug therapy within 1 year of diagnosis.
  • These results suggest a significant gap in clinical care for newly diagnosed patients with RA, and barriers to therapy initiation need to be identified and addressed.
Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by inflammation of the joints and surrounding tissues. This inflammation leads to destruction of cartilage and bone in affected joints, which can result in substantial pain and disability.1 Bone erosion has been shown to occur as early as 4 months after observation of the first joint symptoms.2 Patients with RA suffer significant impairments in work performance, productivity, and overall quality of life.3 Effective treatment of RA symptoms with disease-modifying antirheumatic drugs (DMARDs) has been shown to increase productivity at work and in the home and to improve health-related quality of life.4,5

Early diagnosis and treatment of RA is important to limit progression of the disease and improve clinical outcomes.6 With treatment, patients with early disease are more likely to achieve optimal outcomes, such as remission, than patients with long-standing disease.7 Importantly, early treatment can reduce long-term radiographic damage, which can be irreversible.6,8 The National Quality Forum (NQF) endorses a quality measure that most patients diagnosed with RA have at least 1 outpatient prescription for a DMARD within 3 months of diagnosis.9 Additionally, the 2015 American College of Rheumatology (ACR) guidelines support early initiation of DMARD therapy for all patients newly diagnosed with RA.10

In our prior analysis covering 2004 through 2008 using the Truven Health MarketScan Research Databases, only 63% of patients with newly diagnosed RA initiated a DMARD within 12 months of diagnosis.11 The objectives of this study were to evaluate DMARD initiation rates for newly diagnosed patients with RA by year (2009-2012), US state, and prescription plan; determine the mean time to DMARD initiation; and explore predictors of DMARD initiation or noninitiation.

PATIENTS AND METHODS

Data Source

This study utilized data from 2 Truven Health MarketScan Research Databases: the Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefits Database. These databases represent more than 35 million patients annually from approximately 200 self-insured employers or commercial health plans across the United States. The databases include fully adjudicated medical and pharmacy claims, inpatient and outpatient diagnoses, and retail and mail order prescription records.

Study Design

This was a retrospective analysis of administrative claims for commercially insured individuals with RA who initiated or did not initiate DMARD therapy after the first RA diagnosis (index date). The preindex period was the 12 months ending the day before the index date. The follow-up period was the 12 months beginning on the index date.

Patient Eligibility

To be included in the analysis, patients had to have at least 1 inpatient or outpatient nondiagnostic claim for RA (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 714.xx) between January 1, 2009, and January 1, 2013; have a second claim for RA within 120 days of the first claim with a more specific RA diagnosis (ICD-9-CM code 714.0 or 714.2); be 18 years or older; have continuous enrollment and pharmacy data availability for 12 months before and after index date; have no pharmacy claim or medical claim for a DMARD or biologic DMARD during the preindex period; and have no diagnosis of RA (ICD-9-CM code 714.xx) during the preindex period.

Outcomes

The percentage of patients initiating DMARD or biologic DMARD therapy was assessed. DMARDs included azathioprine, chloroquine, cyclosporine, cyclophosphamide, gold salts, hydroxychloroquine, leflunomide, methotrexate, minocycline, penicillamine, and sulfasalazine. Biologic DMARDs, administered both subcutaneously and intravenously, included abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab, and tofacitinib. (Tofacitinib is a new nonbiologic DMARD that was analyzed with the biologic DMARDs because it is a second-line therapy and its cost is similar to that of the biologic class of drugs.) Rates of DMARD or biologic DMARD initiation were also analyzed by study year (2009, 2010, 2011, and 2012), US state, and prescription drug carrier plan. Although all prescription drug carrier plans were included in the patient-level and state-level analyses, plans were required to have at least 25 newly diagnosed patients with RA to be included in the plan-level analysis. The time from RA diagnosis to initiation of DMARD or biologic therapy was also assessed. Demographic and clinical characteristics were evaluated as possible predictors of DMARD initiation or noninitiation.

Statistical Considerations

Descriptive analyses included frequency with percentage and interquartile range (IQR) and mean values with SDs for categorical and continuous variables, respectively. Logistic regression models were used to identify indicators of DMARD therapy initiation and noninitiation within 1 year as the outcome predicted and patient demographic (age, gender, region, health plan type) and clinical (Deyo-Charlson Comorbidity Index [CCI] score, select comorbid conditions, oral corticosteroid use, nonsteroidal anti-inflammatory drug [NSAID] use, receipt of a rheumatoid factor [RF] test, diagnosing physician, number of prescriptions for any cause) characteristics at index or preindex as the explanatory effects.

Role of the Sponsor

The study sponsor played no role in the collection of data or in the analysis or interpretation of the data, nor did it have the right to approve or disapprove the publication of the finished manuscript.


 
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