Treatment patterns of individualized real-life tapering approaches based on shared decision-making in rheumatoid arthritis.

OBJECTIVE: To provide real-world evidence on patient-individual tapering patterns of disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients in daily clinical practice. METHODS: Data obtained through a controlled prospective cohort study in Germany conducted from July 2018 to March 2021 were analyzed. Participants consist of RA patients in sustained remission who were eligible for DMARD tapering at enrolment. Data from RA patients who experienced tapering of DMARDs at least once during the observational period (n = 200) were used. Descriptive analyses of medical outcomes at baseline and at time of first tapering, time to first tapering, tapering patterns by substance group, and tapering intensity were documented. RESULTS: We did not observe meaningful differences in either disease activity or quality of life measures between substance groups at enrolment, time of first tapering, and at 6 or 12 months after tapering. Median time until first tapering varied between substance groups (csDMARDs: 108 days; bDMARDs: 189 days; combination: 119 days). Most patients received one iteration of tapering only (147/200 patients, 73.5%). Dose reduction was applied for patients treated with csDMARDs (79/86 patients, 91.8%), spacing of interval was the most frequent strategy for patients treated with bDMARDs only (43/48 patients, 89.5%). Necessity for increased DMARD dosage was observed in only 10% of patients (20/200). Tapering intensity by substance was overall heterogenous, indicating high individualization. CONCLUSION: We identify highly heterogeneous tapering patterns between substance groups and within substances. Identification and recognition of patient-individual approaches of tapering will help to further improve the management of RA for both patients and rheumatologists.

Patient-individual tapering of DMARDs in rheumatoid arthritis patients in a real-world setting.

OBJECTIVE: We aim to provide real-world evidence on the effectiveness of patient-individual tapering of DMARDs for patients with RA in daily clinical practice using medical records and claims data. METHODS: We utilize data obtained through a controlled prospective cohort study in Germany conducted from July 2018 to March 2021. Participants consist of RA patients in sustained remission (>6 months) who were eligible for tapering at enrolment. Patients treated with individual tapering based on shared decision making (n = 200) are compared with patients without any dose reduction (n = 237). The risk of loss of remission and the risk of flare is assessed with risk-adjusted Kaplan-Meier estimators and Cox regressions. We evaluate differences in costs 1 year before and after baseline based on claims data for the subgroup of patients insured at one major sickness fund in Germany (n = 76). RESULTS: The risk of flare (hazard ratio 0.88, 95% CI 0.59, 1.30) or loss of remission (hazard ratio 1.04, 95% CI 0.73, 1.49) was not statistically different between the individual tapering group and the continuation group. Minor increases of disease activity and decreases of quality of life were observed 12 months after baseline, again with no statistically significant difference. Drug costs decreased by 1017€ in the individual tapering group while they increased by 1151€ in the continuation group (P < 0.01). CONCLUSION: Individual tapering of DMARDs does not increase the average risk of experiencing flares or loss of remission. Encouraging rheumatologists and patients to apply tapering in shared decision making may be a feasible approach to allow individualization of treatment in RA.

The Effect of Biosimilar Prescription Targets for Erythropoiesis-Stimulating Agents on the Prescribing Behavior of Physicians in Germany.

OBJECTIVES: This study aimed to aid decision makers by analyzing the impact of introducing biosimilar prescription targets on physician prescribing behavior in the prescription of biologic erythropoiesis-stimulating agents in Germany. METHODS: We combined secondary data of regional level biosimilar prescription targets and secondary data of routinely collected claims data of dispensed prescriptions by physicians operating within the statutory health insurance system in ambulatory care across 7 German regions from 2009 to 2015. Two-way fixed-effects regression analysis was used to identify the average treatment effect of introducing biosimilar prescription targets at the physician level. The main outcome of interest was the share of biosimilar prescriptions on all prescriptions within the substance group. We compared 6 regions that introduced biosimilar prescription targets with 1 region without any prescription target policy. RESULTS: Introducing biosimilar prescription targets increased the average share of biosimilars between 6 percentage points (P < .05) in Hamburg and up to 20 percentage points (P < .001) in Saxony-Anhalt. Stratification of specialists by prescription volume and adoption status indicated heterogeneous effects. We identified similar but higher effects for high-volume prescribers. Disentangling of effects with regard to the composition of biosimilar share suggested that the increase in biosimilar share was driven by increased biosimilar use accompanied by a nonsignificant decrease in original biologics prescriptions. CONCLUSIONS: Prescription targets to alter physician prescribing behavior meet their intended goals by increasing biosimilar share. Physicians partly responded to the policy by decreasing overall prescriptions of the target substance. Prescription targets might be a useful tool, but decision makers need to consider all aspects of potential responses.

Cost-utility analysis of de-escalating biological disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis.

OBJECTIVE: Recent guideline updates have suggested de-escalating DMARDs when patients with rheumatoid arthritis achieve remission or low disease activity. We aim to evaluate whether it is cost-effective to de-escalate the biological form of DMARDs (bDMARDs). METHODS: Using a Markov model, we performed a cost-utility analysis for RA patients on bDMARD treatment. We compared continuing treatment (standard care) to a tapering approach (i.e., an immediate 50% dose reduction), withdrawal (i.e., an immediate 100% dose reduction) and tapering followed by withdrawal of bDMARDs. The parametrization is based on a comprehensive literature review. Results were computed for 30 years with a cycle length of three months. We applied the payer's perspective for Germany and conducted deterministic and probabilistic sensitivity analyses. RESULTS: Tapering or withdrawing bDMARD treatment resulted in ICERs of €526,254 (incr. costs -78,845, incr. QALYs -0.1498) or €216,879 (incr. costs -€121,691, incr. QALYs -0.5611) compared to standard care. Tapering followed by withdrawal resulted in a loss of 0.4354 QALYs and savings of €107,969 per patient, with an ICER of €247,987. Deterministic sensitivity analysis revealed that our results remained largely unaffected by parameter changes. Probabilistic sensitivity analysis suggests that tapering, withdrawal and tapering followed by withdrawal were dominant in 39.8%, 28.2% and 29.0% of 10,000 iterations. CONCLUSION: Our findings suggest that de-escalating bDMARDs in patients with RA may result in high cost savings but also a decrease in quality of life compared to standard care. If decision makers choose to implement de-escalation in daily practice, our results suggest the tapering approach.