To assess the impact of the non-reimbursement policy on vitamin D therapy discontinuation in patients from the general and rheumatic populations.

A cross-sectional study.

Research institute specialised in health research and two outpatient pharmacies in the Netherlands.

Patients from the general and rheumatic population with an active prescription for vitamin D supplementation therapy were included.

Data were collected between April and May 2023 through self-reported questionnaires. Descriptive statistics and logistic regression were performed using STATA V. 17. P value

The primary outcome was the proportion of patients who discontinued vitamin D supplementation therapy following the implementation of the non-reimbursement policy. Secondary outcomes included patient-reported reasons for therapy discontinuation and the association between patient-related characteristics and the risk of therapy discontinuation. In addition, the proportion of patients who switched to an alternative supplement and whether this switch had been made in consultation with a healthcare provider was examined.

Of the 4800 patients, 302 (6.4%) patients discontinued their vitamin D therapy. The three most frequently reported reasons for therapy discontinuation were the inability to afford supplements without reimbursement, not willing to pay for supplements without reimbursement and being unaware of the alternative vitamin D supplements to switch to. Younger age, financial constraints and limited health literacy were significantly associated with vitamin D therapy discontinuation (p

The implementation of the non-reimbursement policy resulted in a small proportion of patients discontinuing their vitamin D therapy. Elevated discontinuation rates were associated with specific patient-related characteristics including patients aged

Rheumatoid arthritis (RA) is a heterogeneous disease, which current treatment guidelines insufficiently accommodate, as they predominantly emphasise the suppression of disease activity. However, a step towards personalised medicine is preferred to further optimise treatment and requires homogeneous subgroups with similarities in pathophysiological mechanisms and treatment responses. Prior research has already demonstrated notable differences in the pathophysiology of patients with autoantibody-positive and autoantibody-negative RA, as well as differences in treatment responses, which may serve as a strong basis for personalised medicine. Additionally, there is evidence suggesting that an early treatment response is indicative of future courses. Based on these findings, we designed a personalised medicine trial in RA that compares the effectiveness and cost-effectiveness of a tailor-made approach with routine care.

The PeRsonalIsed Medicine in RA (PRIMERA) trial is a multicentre, open-label, randomised controlled trial that includes 300 adult patients with newly diagnosed, DMARD-naïve RA, according to 2010 American College of Rheumatology/EULAR criteria. Patients are randomised into either routine care or a tailor-made approach. Both management approaches use a treat-to-target strategy, aiming for low disease activity (LDA, Disease Activity Score using 44 joints (DAS) ≤2.4). In routine care, initial treatment consists of methotrexate along with a single intramuscular dose of glucocorticoids (GCs) and treatment can be intensified after 3, 7 and 10 months if LDA is not reached. Conversely, initial treatment in the tailor-made approach depends on the presence of autoantibodies, with patients with autoantibody-positive and autoantibody-negative RA starting with hydroxychloroquine or methotrexate together with a single intramuscular dose of GCs, respectively. Medication intensifications will be allowed at months 1, 3, 4, 7 and 10. Intensifications at months 1 and 4 depend on whether patients have an early sufficient response to GCs and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively. The tailor-made approach is superior to routine care if no more biological DMARDs (bDMARDs) or tsDMARDs are used after 10 months of treatment, while the mean DAS over time is lower. Our primary outcome is the proportional difference in bDMARD or tsDMARD usage after 10 months of treatment between routine care and the tailor-made approach. Secondary outcomes are DAS over time, time to achieve LDA, cost-effectiveness and patient-reported outcome measurements over time.

Ethical approval has been granted by Erasmus MC Medical Ethics Review Committee (MEC-2020-0825). The results will be disseminated through peer-review journals and medical congresses.

ISRCTN16170070.