Background/Purpose:

In the treatment of patients with RA, strategies that include biologics have resulted in a better outcome for patients with regard to disease activity, need for surgery and work participation. Across the countries, reimbursement criteria and/or recommendations/guidelines have been formulated to regulate access to these costly treatments. The objective of this study was to explore clinical eligibility criteria for the start of a first reimbursed biologic in patients with RA and compare them across different European countries.

Methods:

A questionnaire was sent via email to one representative rheumatologist in 49 countries of the European Region to collect data on the eligibility criteria for a first biologic in patients with RA, as of May 2011. First, rheumatologists were asked whether either reimbursement or clinical recommendations or both were mainly regulating prescription in clinical practice. Further information was collected on (a) minimal disease duration required, (b) number of previous DMARDs needed to be failed and (c) requirements for disease activity or severity, mandatory before the start of a biological. A simple score was developed to evaluate the level of restrictions in access to reimbursed biologics across the countries (table). This score varied between 0 and 5, the higher the score, the easier the access. Study results are presented using descriptive statistics.

Results:

Forty-six countries (response rate 96%) provided data. In 10 countries (22%) no biologic was reimbursed. Among the remaining 36, Luxemburg had no regulation of access to reimbursed biologics, in 13 (36%) the reimbursement criteria were the major source of eligibility criteria, while in 7 (19%) the clinical recommendations predominated, and in 15 (42%) both reimbursement criteria and clinical recommendations were used (usually because they were similar).

Among those with at least 1 biologic reimbursed, 21 countries (58%) had no requirement for disease duration in order to initiate a biologic, and for the remaining countries a duration of 3 to 12 months was mandatory. The majority of the countries (47%) required a failure of 2 synthetic DMARDs to qualify for therapy with biologics. Thirty-one out of 36 countries specified a minimum level of disease activity that had to be fulfilled before treatment with biologics (table). Three countries (8%) had the maximum (5) eligibility score (most liberal), 19.5% had a score of 4, 19.5% a score of 3, 22% a score of 2, 28% of 1 and 3% (1 country) a score of 0 (more restrictive). Countries from Eastern Europe and former Soviet Union were more likely to be classified in the more restricted scores.

Criterion	Cut-off	Score for eligibility for biologics	Number of countries (%)
Disease duration	No limitation	1	21(58%)
	Yes	0	15(42%)
Disease activity	No requirement	2	5(14%)
	DAS28≥3.2 or equivalent as major criteria	1	12(33%)
	Stricter requirement than DAS28≥3.2	0	19(53%)
Number of synthetic DMARDs to be failed	≤1	2	15(42%)
	2	1	17(47%)
	>2	0	4(11%)

Conclusion:

Clinical criteria for biologic therapy differ significantly across the countries, suggesting inequalities in access to treatment in RA. These findings should alert stakeholders to further strive for optimal standards of rheumatologic care and implement them across all European countries.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/inequalities-across-46-european-countries-in-clinical-eligibility-criteria-for-the-start-of-a-first-reimbursed-biologic-in-patients-with-rheumatoid-arthritis/