Cargando…

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

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 retros...

Descripción completa

Detalles Bibliográficos
Autores principales: Esposti, Luca Degli, Perrone, Valentina, Sella, Stefania, Arcidiacono, Gaetano, Bertoldo, Francesco, Giustina, Andrea, Minisola, Salvatore, Napoli, Nicola, Passeri, Giovanni, Rossini, Maurizio, Giannini, Sandro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9105449/
https://www.ncbi.nlm.nih.gov/pubmed/35565842
http://dx.doi.org/10.3390/nu14091877
_version_ 1784708043096719360
author Esposti, Luca Degli
Perrone, Valentina
Sella, Stefania
Arcidiacono, Gaetano
Bertoldo, Francesco
Giustina, Andrea
Minisola, Salvatore
Napoli, Nicola
Passeri, Giovanni
Rossini, Maurizio
Giannini, Sandro
author_facet Esposti, Luca Degli
Perrone, Valentina
Sella, Stefania
Arcidiacono, Gaetano
Bertoldo, Francesco
Giustina, Andrea
Minisola, Salvatore
Napoli, Nicola
Passeri, Giovanni
Rossini, Maurizio
Giannini, Sandro
author_sort Esposti, Luca Degli
collection PubMed
description 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.
format Online
Article
Text
id pubmed-9105449
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-91054492022-05-14 The Potential Impact of Inducing a Restriction in Reimbursement Criteria on Vitamin D Supplementation in Osteoporotic Patients with or without Fractures Esposti, Luca Degli Perrone, Valentina Sella, Stefania Arcidiacono, Gaetano Bertoldo, Francesco Giustina, Andrea Minisola, Salvatore Napoli, Nicola Passeri, Giovanni Rossini, Maurizio Giannini, Sandro Nutrients Article 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. MDPI 2022-04-29 /pmc/articles/PMC9105449/ /pubmed/35565842 http://dx.doi.org/10.3390/nu14091877 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Esposti, Luca Degli
Perrone, Valentina
Sella, Stefania
Arcidiacono, Gaetano
Bertoldo, Francesco
Giustina, Andrea
Minisola, Salvatore
Napoli, Nicola
Passeri, Giovanni
Rossini, Maurizio
Giannini, Sandro
The Potential Impact of Inducing a Restriction in Reimbursement Criteria on Vitamin D Supplementation in Osteoporotic Patients with or without Fractures
title The Potential Impact of Inducing a Restriction in Reimbursement Criteria on Vitamin D Supplementation in Osteoporotic Patients with or without Fractures
title_full The Potential Impact of Inducing a Restriction in Reimbursement Criteria on Vitamin D Supplementation in Osteoporotic Patients with or without Fractures
title_fullStr The Potential Impact of Inducing a Restriction in Reimbursement Criteria on Vitamin D Supplementation in Osteoporotic Patients with or without Fractures
title_full_unstemmed The Potential Impact of Inducing a Restriction in Reimbursement Criteria on Vitamin D Supplementation in Osteoporotic Patients with or without Fractures
title_short The Potential Impact of Inducing a Restriction in Reimbursement Criteria on Vitamin D Supplementation in Osteoporotic Patients with or without Fractures
title_sort potential impact of inducing a restriction in reimbursement criteria on vitamin d supplementation in osteoporotic patients with or without fractures
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9105449/
https://www.ncbi.nlm.nih.gov/pubmed/35565842
http://dx.doi.org/10.3390/nu14091877
work_keys_str_mv AT espostilucadegli thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT perronevalentina thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT sellastefania thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT arcidiaconogaetano thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT bertoldofrancesco thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT giustinaandrea thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT minisolasalvatore thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT napolinicola thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT passerigiovanni thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT rossinimaurizio thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT gianninisandro thepotentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT espostilucadegli potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT perronevalentina potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT sellastefania potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT arcidiaconogaetano potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT bertoldofrancesco potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT giustinaandrea potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT minisolasalvatore potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT napolinicola potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT passerigiovanni potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT rossinimaurizio potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures
AT gianninisandro potentialimpactofinducingarestrictioninreimbursementcriteriaonvitamindsupplementationinosteoporoticpatientswithorwithoutfractures