Impact of Drug Safety Warnings and Cost-Sharing Policies on Osteoporosis Drug Utilization in Spain: A Major Reduction But With the Persistence of Over and Underuse. Data From the ESOSVAL Cohort From 2009 to 2015.

Isabel Hurtado-Navarro,Clara Rodríguez-Bernal,Salvador Peiró,Aníbal García-Sempere,Gabriel Sanfélix-Gimeno,José Sanfélix-Genovés

doi:10.3389/fphar.2019.00768

Abstract

Background: Recent studies in several countries show a significant decrease in the consumption of osteoporosis drugs from a peak around 2009, mainly attributed to bisphosphonate safety warnings issued by regulatory agencies on jaw osteonecrosis, atypical fractures, and esophageal cancer, but no studies have assessed the impact of these warnings by risk of fracture strata. Aim: The aim of this work is to assess changes in the utilization of osteoporosis drugs in the region of Valencia (Spain) after safety warnings from regulatory agencies and cost-sharing changes, according to patient socio-demographic and risk of fracture characteristics. Patients and Methods: We constructed a monthly series of osteoporosis drug consumption for 2009–2015 from the ESOSVAL cohort (n = 11,035; women: 48%; mean age: 65 years old) and used interrupted time series and segmented linear regression models to assess changes in osteoporosis drug utilization while controlling for previous levels and trends after three natural intervention dates: the issue of the Spanish Agency for Drugs and Medical Products (AEMPS) Osteonecrosis Jaw Warning (Sept 2009), the AEMPS Atypical femur Fracture Warning (Apr 2011), and the modification of the cost-sharing scheme (Jul 2012). Results: The AEMPS Osteonecrosis Jaw Warning was not associated with a decline in the consumption of osteoporosis drugs, while the warning on atypical fracture (a downward trend of 0.11% fewer people treated each month) and the increase in the cost-sharing scheme (immediate change level of -1.07% in the proportion of people treated) were associated with a strong decline in the proportion of patients treated, so that by the end of 2015 osteoporosis drug consumption was around half that of 2009. The relative decline was similar in people with both a high and low risk of fracture. Conclusion: The AEMPS Atypical femur Fracture Warning of Apr 2010 was associated with a significant decrease in the number of people treated, reinforced by the increase in the pharmaceutical cost-sharing in 2012. Decreases in treatment affected patients both at a low and higher risk of fracture.

Highlights

Osteoporosis is a common problem, in the elderly population which is more prone to low-impact fragility fractures
Despite the ONJ warming in Sept 2009, trends were rising until the AF warning in Apr 2011, starting a downward trend from that moment until the end of the period only altered by a sudden drop associated with the cost-sharing policy change in Jul 2012
Our study shows that osteoporosis drug utilization in the Valencia region increased until mid-2011 and started to decline, so that by the end of 2015 global consumption was around a half of 2009 and almost two thirds less than the maximum peak in 2010

Summary

Introduction

Osteoporosis is a common problem, in the elderly population which is more prone to low-impact fragility fractures. Notwithstanding, recent studies in several countries show a significant decrease in the consumption of osteoporosis drugs from a peak in around 2009 (Peeters et al, 2014; Jha et al, 2015; van der Velde et al, 2017; Balkhi et al, 2018), including those for secondary prevention after hip fracture (Kim et al, 2016; Desai et al, 2018) This fall has been mainly attributed to safety warnings issued by regulatory agencies on jaw osteonecrosis, atypical fractures, and esophageal cancer (Ruggiero et al, 2004; Wysowski, 2009; Schilcher et al, 2011), and to uncertainty about optimal bisphosphonate treatment duration and recommendations for discontinuation after 3 to 5 years of therapy, as the benefit-risk balance may become negative in the long term, in patients with a low risk of osteoporotic fracture (Whitaker et al, 2012). Recent studies in several countries show a significant decrease in the consumption of osteoporosis drugs from a peak around 2009, mainly attributed to bisphosphonate safety warnings issued by regulatory agencies on jaw osteonecrosis, atypical fractures, and esophageal cancer, but no studies have assessed the impact of these warnings by risk of fracture strata

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