The intake of vitamin D supplementsis one of the most debated topics in the medical field, a source of controversies and even strongly opposed beliefs. After the “race” for vitamin D caused by the Covid pandemic, in 2019 Aifa established Note 96 to define the reimbursement conditions for vitamin D-based drugs and its analogues (cholecalciferol, calcifediol) classified in band A and therefore reimbursable by the National Health Service.
Now the Italian Medicines Agency has updated Note 96 (AIFA decision no. 48/2023 published in the Official Gazette no. 43 of 20 February 2023) on criteria of prescribing appropriateness of vitamin D supplementationfor the prevention and treatment of deficiency states in adults. Aifa justified the need to proceed with the update « following the publication of new scientific evidence who further clarified the role of vitamin D in the absence of concomitant risk conditions”.
Studies
In particular, Aifa’s decision is based on the results of two large randomized clinical trials, the American VITAL study (LeBoff M et al, NEJM 2022) and the European study DO-HEALTH (Bischoff-Ferrari HA et al, JAMA 2020). “Both studies concluded that supplementation with more than adequate doses of vitamin D (2000 IU day of cholecalciferol) and for several years (over 5 years in the first study and 3 years in the second) is unable to modify the risk of fracture in the healthy population, with no risk factors for osteoporosis. These results were also confirmed among subjects with lower levels of vitamin 25(OH)D. Added to these main studies is the rich literature regarding its use in COVID-19 which has not demonstrated any benefit of vitamin D even in this condition.
The clarifications
Furthermore, as specified in the document, some have been included in the text of the Note improved clarifications on the proposal of clinicians or scientific societies: «introduction of the new risk category “people with severe motor impairments or bedridden who live at home”; 20 to 12 ng/mL (or 50 to 30 nmol/L) decrease in maximum serum vitamin 25(OH)D level, in the presence or absence of specific symptoms and in the absence of other associated risk conditions, necessary for the purposes of reimbursement; sspecification of differentiated levels of serum vitamin 25(OH)D in the presence of certain risk conditions (e.g. malabsorption disease, hyperparathyroidism) already present in the first version of the Note; update of the paragraph relating to the most recent evidence mentioned above and insertion of a short paragraph dedicated to vitamin D and COVID-19; introduction of a paragraph on the potential risks associated with the misuse of vitamin D preparations’.