The Potential Impact of Inducing a Restriction in Reimbursement Criteria on Vitamin D Supplementation in Osteoporotic Patients with or without Fractures

Abstract

In October 2019, the Italian Drug Agency (AIFA) restricted reimbursement criteria for vitamin D (VD) use outside the osteoporosis setting (Note 96). However, whether this restriction could also have involved patients at risk for or with osteoporotic fractures has not yet been investigated. We retrospectively analyzed databases from five Italian Local Health Units. Patients aged ≥50 years with either at least one prescription for osteoporosis treatment or with fragility fractures and evidence of osteoporosis from 2011 to 2020 were included. The proportion of subjects with an interruption in VD treatment before and after the introduction of the new reimbursement criteria and predictors of this interruption were analyzed. A total of 94,505 patients (aged 69.4 years) were included. Following the introduction of Note 96, a 2-fold (OR 1.98, 95% CI: 1.92–2.04) increased risk of VD discontinuation was observed. These findings were independent of seasonal variation, osteoporosis treatment patterns, as well as other confounding variables. However, a higher rate of interruption was observed in patients without vertebral/femur fracture (37.8%) vs. those with fracture (32.9%). Rheumatoid arthritis, dyslipidemia and previous fracture were associated with a lower risk of VD interruption, while stroke increased the risk of VD interruption. Our results highlight that a possible misinterpretation of newly introduced criteria for reimbursement restrictions in VD outside of osteoporosis have resulted in an inadequate level of VD supplementation in patients with osteoporosis. This undertreatment could reduce the effect of osteoporosis therapies leading to increased risk of negative outcome.

Trabecular Bone Score Significantly Influences Treatment Decisions in Secondary Osteoporosis

“…However, this association was not detectable in the femoral neck region or in the spine region ( Table 3 ). The positive effects of balanced vitamin D levels on bone health are indisputable [ 3 , 18 , 53 , 54 ]. Thus, our results showing an association between DXA T-score and vitamin D are not surprising.…”

Prediction of Vitamin D and Serotonin levels with increased risk Depressive in Adolescent Students

“…It has been shown to protect against a variety of immune system disorders [1]. In addition, it is a micronutrient and an endogenous metabolite acting as a hormone, binding to the vitamin D receptor (VDR) present in many organs and tissues [2], and it is which exerts a crucial role in the maintenance of bone and calcium homeostasis [3]. Vitamin D insufficiency is common worldwide and has been related to a higher risk of depression [4].…”

Reply to Wimalawansa, S.J. Comment on “Bertoldo et al. Definition, Assessment, and Management of Vitamin D Inadequacy: Suggestions, Recommendations, and Warnings from the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS). Nutrients 2022, 14, 4148”

“…The SIOMMMS recommendations are also important in Italy where the regulatory agency for drug reimbursability [ 3 ], as a result of the significant growth in spending on vitamin D, has regulated reimbursability leading to a reduction in prescriptions of 30–34%. This also included a large portion of individuals requiring supplementation [ 4 ]. We hope that in the Italian population, where the prevalence of low vitamin D levels is still very high, our recommendations can make its prescription more appropriate.…”