薬経済学: オープンアクセス

Background: Systemic lupus erythematosus (SLE) is a complex, autoimmune disorder with long-term health consequences. Economic evaluation is used by health technology assessment (HTA) bodies to guide drug pricing and reimbursement decisions.
Objective: To conduct a systematic review to identify published economic analyses of pharmacologic treatments for SLE and summaries and critically appraise the modelling techniques used.
Methods: Electronic database searches were performed from January–February 2017. Supplementary searches of conference proceedings and HTA websites were conducted. Reference lists of included papers were examined for relevant studies.
Result: Fifteen relevant economic analyses were identified; all compared belimumab plus standard of care (SOC) with SOC. Most were full economic evaluations (n=13), with two considering a budget impact analysis alone. Eleven used a simulation structure to model interdependencies between multiple dimensions of SLE; one original model and ten country-level adaptations of the same model. Key assumptions were associated with duration of treatment effect for belimumab plus SOC and extrapolated treatment duration.
Conclusion: Limited economic evaluations of pharmacological treatments for SLE were identified. Future economic models in SLE should meet dual aims of transparency and robustness. Key recommendations include that a lifetime model is essential for handling short and long-term complications of SLE, including organ damage and flares, and whilst the simulation model has been shown to be acceptable, for transparency and ease of interpretation the Markov model could be an acceptable and robust modelling approach.

Objective: The pharmacies and wholesalers’ remuneration system for the provision of medicines in Portugal went under structural changes with the Memorandum of Understanding in 2011, which intensified the degree of public pharmaceutical expenditure reduction requirements, in exchange for the financial international assistance. The objectives of the present study were: to provide an overview of the changes, its impact for pharmacies and recent advances towards a more comprehensive system.
Methods: Literature review and identification of changes; market analysis and distribution margins were computed using two nationwide databases with representative pharmaceutical dispensing data from ambulatory care; impact of changes and implications for the sector and pharmacies was accessed. Statistical analysis was performed using Statistical Analysis Software (SAS), Guide v4.1.
Results: The fixed linear remuneration system was replaced in 2012 by a regressive mark-up and minor fees system, per price range, determining the greatest modification to the distribution remuneration system during the last decades. An adjustment was made in 2014.
The pharmaceutical market and the National Health System expenditure were reduced by 876 and 494 million euros, respectively, over the past four years. The loss of pharmacy and wholesaler remuneration was 322.8 million euros, higher than the established objective of 50 million euros.
Conclusion: Policy changes, reinforced with the Memorandum of Understanding, caused a large reduction in the remuneration of pharmacies, directly through cuts in margins and indirectly through decreases in prices. Several studies, published in the meantime, support the difficulties for the sector sustainability.