Access to orphan drugs – comparison across Balkan countries

“…A comparative analysis on the access to orphan drugs in a sample of Balkan countries −5 EU member states (Bulgaria, Croatia, Greece, Romania, Slovenia) and 2 EU candidate countries (Serbia, Montenegro)—was carried out by Pejcic et al ( 2018 ). It revealed significant inequalities among these countries as well as a substantial lack of access to orphan drugs approved for EU market and a need for improvement in accessibility of orphan drugs in the Balkan states.…”

Section: Discussionmentioning

confidence: 99%

Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment

et al. 2018

View full text Add to dashboard Cite

Objective: To assess shares of reimbursed orphan drugs and agreement in reimbursement decision-making in different European Union member states as well as to define odds for reimbursement influenced by the presence of conditional approval or exceptional circumstances granted by the European Medicines Agency (EMA) or by type of the disease.Methods: The list of authorized drugs with current orphan designations was collected from the website of the EMA. For each drug, the information regarding conditional approval or approval under exceptional circumstances was collected. The reimbursement statuses were available on national reimbursement or HTA agencies websites. The agreement for reimbursement decisions between selected countries was assessed using the κ coefficient for the measurement of agreement. The impact of the EMA's conditional approval as well as approval under exceptional circumstances was assessed using the logistic regression and presented as odds ratio.Results: The percentage of reimbursed orphan drugs varied significantly from 27% in Poland to 88% in Denmark, with an average value of 51% (p < 0.0001). Regarding the reimbursement status, the highest, substantial agreement was observed between Spain and Italy, and the lowest agreement was observed between Germany and England, with κ of 0.64 and 0.01, respectively. Conditional approval status significantly decreased the chance for reimbursement in France, Italy, and Spain by 77–80%; however, approval granted under exceptional circumstances had significant impact only in Germany with 85% decrease in chances for reimbursement. The type of the disease (oncology or metabolic) was significantly associated with both conditional approval (p of 0.03—oncology drugs were more likely to be conditionally approved then the rest of analyzed drugs) and exceptional circumstances (p of 0.02—drugs for metabolic diseases were more likely to be approved under exceptional circumstances).Conclusions: Access to reimbursed orphan drugs varies significantly across EU countries. The highest, substantial agreement in reimbursement decisions was observed between Italy and Spain and the lowest between Germany and England. Conditional approval and approval under exceptional circumstances were significant negative predictors of reimbursement in some countries and they were significantly associated with the type of the disease (oncology or metabolic).

show abstract

“…Отражение на това са размерът на конфиденциалните отстъпки, големият брой споразумения за споделяне на риска, дългогодишните регистри за мониторинг на терапии [9][10]. Това е своеобразен лукс, който може да си позволи само един голям и важен за индустрията пазар, но не е опция за малките източноевропейски страни [15].…”

Section: как промените в процедурата по озт в италия ще се отразят в unclassified

“…По-скоро не. Нарастващият интерес към сформиране на регионални групи за съвместни процедури по ОЗТ, ценообразуване и договаряне на реимбурсиране показва на къде се движи този процес [15]. Общоевропейска процедура по ОЗТ за всички страни членки в никакъв случай не е примамлив вариант за страните, които сами по себе си са голям фармацевтичен пазар.…”

Section: как промените в процедурата по озт в италия ще се отразят в unclassified

Започва Ли Глобална Промяна В Парадигмата За Оценка На Здравните Технологии?

Искров¹,

Стефанов²

2020

Редки болести и лекарства сираци

View full text Add to dashboard Cite

От самото си създаване парадигмата на оценката на здравните технологии (ОЗТ) търпи непрекъсната еволюция. Това е съвсем естествен процес предвид развитието на медицинската наука и ускореното навлизане на иновативни здравни технологии. През последните години се наблюдава обаче все по-ясно изразена тенденция за засилване на прозрачността при ценообразуването и обързване на реимбурсната цена на здравните технологии с тяхната ефективност. На 24 юли 2020 г. Италия официално обнародва нова нормативна уредба за ОЗТ, с което освен друго съществено увеличава публичния контрол върху ценообразуването и заплащането с публични средства на всички нови лекарствени продукти. Настоящата статия има за цел да обобщи и анализира критично най-важното от тези промени и значението им за европейската политика и практика в областта на ОЗТ.

show abstract

Access to orphan drugs – comparison across Balkan countries

Cited by 20 publications

References 20 publications

A Review of Rare Disease Policies and Orphan Drug Reimbursement Systems in 12 Eurasian Countries

A Review of Rare Disease Policies and Orphan Drug Reimbursement Systems in 12 Eurasian Countries

Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment

Започва Ли Глобална Промяна В Парадигмата За Оценка На Здравните Технологии?

Contact Info

Product

Resources

About