The Impact of Annual Price Revision Based on External Reference Pricing on Medicines Between 2012 and 2023 in Portugal
Author(s)
Inês Teixeira, MSc1, JOSÉ GUERREIRO, BS2, Klara Dimitrovova, PhD3, António Rodrigues, PhD4, Frederico Silva Leal, PhD5, José Zorro Mendes, PhD6.
1Portuguese Pharmaceutical Industry Association - APIFARMA, Lisboa, Portugal, 2Centre for Health Evaluation & Research/Infosaúde, National Association of Pharmacies (CEFAR/IF, ANF), Lisboa, Portugal, 3Centre for Health Evaluation & Research/Infosaúde, National Association of Pharmacies (CEFAR/IF, ANF); Comprehensive Health Research Center, CHRC, NOVA University Lisbon, Lisboa, Portugal, 4Centre for Health Evaluation & Research/Infosaúde, National Association of Pharmacies (CEFAR/IF, ANF); Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Lisboa, Portugal, 5Portuguese Pharmaceutical Industry Association - APIFARMA; ISCAL – Lisbon Accounting and Business School, Polytechnic University of Lisbon, Lisboa, Portugal, 6ISEG-Lisbon School of Economics and Management, University of Lisbon, Lisboa, Portugal.
1Portuguese Pharmaceutical Industry Association - APIFARMA, Lisboa, Portugal, 2Centre for Health Evaluation & Research/Infosaúde, National Association of Pharmacies (CEFAR/IF, ANF), Lisboa, Portugal, 3Centre for Health Evaluation & Research/Infosaúde, National Association of Pharmacies (CEFAR/IF, ANF); Comprehensive Health Research Center, CHRC, NOVA University Lisbon, Lisboa, Portugal, 4Centre for Health Evaluation & Research/Infosaúde, National Association of Pharmacies (CEFAR/IF, ANF); Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Lisboa, Portugal, 5Portuguese Pharmaceutical Industry Association - APIFARMA; ISCAL – Lisbon Accounting and Business School, Polytechnic University of Lisbon, Lisboa, Portugal, 6ISEG-Lisbon School of Economics and Management, University of Lisbon, Lisboa, Portugal.
OBJECTIVES: The Annual Price Revision (APR) is one of the pharmaceutical price control measures implemented in Portugal, based on external reference pricing (ERP). This study aims to evaluate the impact of the APR on branded medicines in the outpatient market in Portugal, between 2012 and 2023.
METHODS: A retrospective longitudinal study with time series was conducted using national sell-out data for branded medicines from the outpatient market subject to the APR between 2012 and 2023. Data was retrieved from a panel of over 82% of community pharmacies and extrapolated to the national level. The impact was measured based on two outcomes: the annual and the cumulative impacts, both analysed at current and constant prices. Both outcomes estimate the isolated effect of retail price variations resulting from changes in the maximum retail price. Additionally, the impact was assessed considering the inclusion of medicines in Homogeneous Groups (HGs) and according to payer segmentation.
RESULTS: The annual impact ranged from a reduction of 128.4 million euros in 2012 and an increase of 2.7 million euros in 2023. Overall, the present value of the total cumulative impact of the APR between 2012 and 2023 amounted to 5,300 million euros of market loss. The impact was more significant in innovative medicines (not included in HGs), and revealed the greatest increase in this segment, reaching 81.7% in 2023. The stratified analysis by payer/financing entity shows that the major effect of APR was observed on the reduction of public expenditure component, with public entities capturing 56.9% of the total price reductions.
CONCLUSIONS: Policymakers should carefully consider the complex trade-offs when implementing ERP systems, balancing benefits and negative effects. This study provides a valuable contribution to the evaluation of price regulation measures based on ERP and can support decision-making by helping to identify and select specific criteria for future price revisions.
METHODS: A retrospective longitudinal study with time series was conducted using national sell-out data for branded medicines from the outpatient market subject to the APR between 2012 and 2023. Data was retrieved from a panel of over 82% of community pharmacies and extrapolated to the national level. The impact was measured based on two outcomes: the annual and the cumulative impacts, both analysed at current and constant prices. Both outcomes estimate the isolated effect of retail price variations resulting from changes in the maximum retail price. Additionally, the impact was assessed considering the inclusion of medicines in Homogeneous Groups (HGs) and according to payer segmentation.
RESULTS: The annual impact ranged from a reduction of 128.4 million euros in 2012 and an increase of 2.7 million euros in 2023. Overall, the present value of the total cumulative impact of the APR between 2012 and 2023 amounted to 5,300 million euros of market loss. The impact was more significant in innovative medicines (not included in HGs), and revealed the greatest increase in this segment, reaching 81.7% in 2023. The stratified analysis by payer/financing entity shows that the major effect of APR was observed on the reduction of public expenditure component, with public entities capturing 56.9% of the total price reductions.
CONCLUSIONS: Policymakers should carefully consider the complex trade-offs when implementing ERP systems, balancing benefits and negative effects. This study provides a valuable contribution to the evaluation of price regulation measures based on ERP and can support decision-making by helping to identify and select specific criteria for future price revisions.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR202
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas