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Supplements Improving Clinical and Managed Care Outcomes in Rheumatoid arthritis: a Focus on Comparative Effecti

Implications for Managed Care and Specialty Pharmacy in Rheumatoid Arthritis

William J. Cardarelli, PharmD
A randomized trial evaluated an intensive treat-to-target outpatient approach for RA versus routine care. This trial was called the TICORA (TIght COntrol for Rheumatoid Arthritis) study.39 The intensive therapy group met with a rheumatologist monthly and had their disease activity calculated at each visit. Disease activity was determined to be high, moderate, or low. At each visit, swollen joints were injected with triamcinolone, unless previously injected in the last 3 months, and DMARD therapy was escalated as needed according to an established protocol. In the routine care group, patients were seen every 3 months by their rheumatologist with no formal composite measure of disease activity or plan of care. The improvement in disease activity was evident within 3 months in the intensive therapy group (P <.0001). At the 18-month follow-up, EULAR remission was achieved in 65% of patients in the intensive therapy group and 16% of those in the routine care group (OR, 9.7; 95% CI, 3.9-23.9; P <.0001), and ACR 20% improvement (91% vs 64%; OR, 5.7; 95% CI, 1.9-16.7; P <.0001), ACR 50% improvement (84% vs 40%; OR, 6.1; 95% CI, 2.5- 14.9; P <.0001) and ACR 70% improvement (71% vs 18%; OR, 11; 95% CI, 4.5-27; P <.0001) were similarly improved, respectively. The intensive therapy group also benefited from less erosion score progression (median, 0.5; interquartile range [IQR], 0-3.375 vs median 3; IQR, 0.5-8.5; P = .002), but no difference in joint space narrowing (median 3.25; IQR, 1.125-7.5 vs median 4.5; IQR, 1.5-9; P = .331) was noted in comparison with the rountine care group. Total direct costs (hospital inpatient and outpatient, medication, travel, healthcare professional visits, and diagnostic test) in 2000-2001 £, were £1427 for intensive care and £1590 for routine care, indicating a cost savings with the intensive therapy regimen.39

Studies have also evaluated a team approach to RA.40-42 One study40 examined patients randomized to a clinical nurse specialist, inpatient team care, or day patient team care in the Netherlands. The nurse provided information about RA, prescribed medical equipment in consultation with a rheumatologist, and referred patients to other healthcare professionals such as occupational therapists, physical therapists, and social workers when needed for a period of 12 weeks. The inpatient team and the day patient team consisted of nurses, a rheumatologist, an occupational therapist, a physical therapist, and a social worker. The team met weekly to discuss treatment goals and modalities. Patients also received written materials and an hour-long educational session on RA. Inpatients and day patients received 9 treatment days. Inpatients stayed overnight for 12 consecutive days with 3 nontreatment days. Day patients stayed 3 days per week for 6 hours and had 1.5 hours of rest for 3 weeks. After the intervention period, all patients were followed as outpatients. In all 3 groups, functional status, quality of life, health utility, and disease activity improved significantly over time (P <.05). There was no significant difference among the groups over time. Patient satisfaction with the nurse specialist care was significantly lower (P <.001) than the other groups.40 An economic analysis was presented in a second publication.41 Based on similar outcomes in the effectiveness of treatment on quality of life and utility instruments, and that other healthcare and non-healthcare costs were similar over the 2-year follow-up, the only differences observed were with the initial cost of care. The cost of initial treatment was €200 for the nurse, €5000 for the inpatient team care, and €4100 for the day patient care. Thus, the societal costs were significantly lower with the nurse specialist.41 This is consistent with how most patients are managed today, as outpatients, but also highlights the importance of a team approach to care.

A national pharmacy benefit manager evaluated a disease therapy management (DTM) program for RA as an enhanced offering for patients receiving specialty pharmacy services.42 Core consultation topics for the DTM program were pathophysiology of RA, laboratory values pertaining to RA and its treatment, optimization of medication therapy, adherence, symptom management, pain management, stress management, importance of a balanced diet, importance of exercise, importance of patient-provider communication, appropriate use of assistive devices, home safety, and additional resources, including financial assistance. Patients with an RA diagnosis and a pharmacy claim for RA who were continuously enrolled in the plan for 4 months before enrollment and 8 months after identification were stratified into 3 groups, DTM program (n = 340), specialty pharmacy (n = 244), and community pharmacy (n = 244), in observational fashion. Patients in the DTM program were further categorized as intent-to-treat (ITT) (all 340 patients in the DTM program) and completers (n = 244). The primary end point was proportion of days covered (PDC), a marker of persistence and adherence to treatment, over the 8-month post-identification period. Patient-reported outcomes (short form [SF]-12, Work Productivity Activity Impairment [WPAI], and Health Assessment Questionnaire-Disability Index [HAQ-DI]) were also collected in 371 patients who completed the 0- and 6-month consultations regardless of enrollment group or requirements. Among specialty pharmacy patients, 14% enrolled in the DTM program. Mean PDC was 0.81 for specialty pharmacy, 0.83 for the DTM program ITT group, 0.89 for the DTM program completers group (P <.001 vs specialty pharmacy), and 0.6 for community pharmacy (P <.001 for both DTM program cohorts). In addition, 10.7% of patients in the DTM program completer group, 20.3% of those in the DTM program ITT group, 22.1% of those in the specialty pharmacy group (P <.001 vs DTM program completers), and 40.6% of those in the community pharmacy group discontinued injectable biologic agents (P <.001 vs DTM program cohorts). In the quality-of-life assessment, the cohort included only 9.4% of patients in the DTM program groups, and the DTM program and non- DTM program groups were not compared. Baseline and 6-month SF-12 scores improved (P = .048), but productivity loss worsened from baseline (12.9% vs 28.3%, P = .045). HAQ-DI scores improved from baseline by 0.08 points (P <.001), including improvements in dressing, grooming, arising, grip, and reach. At month 6, 72.2% rated the program as very helpful in managing their health.

Overall, this study provides promise for improving treatment adherence and, potentially, patient outcomes in RA. It is important to note that this study was observational and that the QOL measures were not specific to the studied groups. In addition, the data were not limited to the first use of injectable medication, and it is uncertain how “late” in the disease patients were at enrollment, and consequently how much benefit they stood to gain, if any. Future studies should evaluate how QOL and productivity are impacted directly by a DTM program when therapies are initiated at the optimal time based on available treatment recommendations, and what effect it has on disease outcome (ie, radiographic progression).2

Conclusion

Rheumatoid arthritis is associated with significant treatment costs; however, in most situations, treatment is costeffective when delivered in a structured and timely manner. Cost-effectiveness primarily stems from prevention of disease progression and improved work productivity associated with disease control. Disease control limits the potential costs associated with surgery and hospitalization, and also has the potential to make patients more productive members of society. Barriers to the success of treatment include lack of education for patients and practitioners about RA, access to specialists, communication, uncertainty regarding which treatments to choose, cost, and lack of treatment adherence. Specialty pharmacy and DTM programs can assist patients by providing structure, education, and mechanisms to improve patient adherence in order to optimize therapy.

Author affiliation: Atrius Health, Harvard Vanguard Medical Associates, Watertown, MA.
Funding source: This activity is supported by an educational grant from Bristol-Myers Squibb.
Author disclosure: Dr Cardarelli has no relevant financial relationships with commercial interests to disclose.
Authorship information: Acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis; and supervision.
Address correspondence to: E-mail: william_cardarelli@vmed.org.
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