Stimulating development of innovative medicines in the European Union: does a new definition for unmet medical need add value?

The European Commission (EC) has proposed to redefine 'unmet medical need' to steer pharmaceutical innovation and link the definition to incentives and regulatory tools and procedures. A multistakeholder meeting of the Regulatory Science Network Netherlands (RSNN) discussed the impact of this proposal. Four principles were highlighted (flexibility, feasibility, fairness, and sensitivity to risk) that were not considered sufficiently addressed.

Cost-utility analysis of longstanding exercise therapy versus usual care in people with rheumatoid arthritis and severe functional limitations.

Objective: To evaluate the cost-effectiveness of longstanding personalized exercise therapy compared with usual care in people with rheumatoid arthritis (RA) and severe functional disability.

Method: In this cost-utility analysis of a randomized controlled trial (n = 215), with 1 year follow-up, the study population comprised individuals with RA and reported severe difficulties in performing basic daily activities. Assessments were at baseline, 12, 26, and 52 weeks, with measurements of costs including medical and non-medical costs as recorded by patients and healthcare providers.

Work-related support for employed and self-employed people with rheumatoid arthritis or axial spondyloarthritis: a cross-sectional online survey of patients.

Background: Little is known about the provision of work-related support for (self-)employed people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) by healthcare providers (HCPs) or employers.

Objective: This study aims to explore the experiences of (self-)employed people with RA or axSpA regarding work-related support from HCPs and employers in the Netherlands.

Methods: This cross-sectional study concerned an online survey for (self-)employed people, aged ≥ 16 years and diagnosed with RA or axSpA.

One-year effectiveness of long-term exercise therapy in people with axial spondyloarthritis and severe functional limitations.

Objective: To evaluate the effectiveness of long-term, personalized, supervised exercise therapy on functional ability compared with usual care in people with axial spondyloarthritis (axSpA) and severe functional limitations.

Methods: Participants were randomly 1:1 assigned to the intervention(maximal 64 sessions, with 14 additional optional sessions of supervised active exercise therapy(e.g.

Development of a Multimodal, Physiotherapist-Led, Vocational Intervention for People with Inflammatory Arthritis and Reduced Work Ability: A Mixed-Methods Design Study.

Purpose: Work ability of people with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) is reduced, but underexamined as a clinical treatment target. The evidence on vocational interventions indicates that delivery by a single healthcare professional (HCP) may be beneficial. Physiotherapist (PT)-led interventions have potential because PTs are most commonly consulted by RA/axSpA patients in the Netherlands.