Availability of Risk Sharing Agreements in the Turkish Pharmaceutical Sector

Abstract

Region to legislate on the matter, supporting the prescription of the biosimilar to the naive patient. The aim of this study was to evaluate the impact of cost-containment policies about biosimilars in Campania between 2009 and 2013. Methods: IMS Health regional database was used to carry out this descriptive retrospective drugutilization for the years 2009 through 2013. Information was retrieved about different distribution channels (retail, direct distribution, hospital). Consumptions are expressed in Counting Units (CU) and trends have been calculated using Compound Average Grow Rate (CAGR). Results: In 2013, a total consumption of 930.859 CU of biosimilar drugs was registered in Italy (CAGR 13/09 68,8%). The penetration rate of biosimilar was 23,9% with regard to expenditure and 25,3% with regard to consumption. Analyzing the consumption of biosimilars by therapeutic category in Italy, the consumption of erythropoietin and filgrastim has an index of annual growth respectively equal to 153.4% and 174.7%. In Campania, the penetration rate of all biosimilars was 31.4% of total expenditure and 35.9% of consumption. Analyzing the trend in consumption for single therapeutic category, it can be seen that penetration is due to erythropoietin (297.5% CAGR); with regard to filgrastim, however, the average annual growth rate is around 54%. ConClusions: The results suggest that Campania Region records an index of market penetration of biosimilars higher than the national. This trend could be attributable to the cost-containment policies implemented in the region.

Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies

“…Multiple authors emphasized that multi-stakeholder agreement between payers and developers on financial terms of the MEA is crucial to enable the use of spread payments ( Brennan and Wilson, 2014 ; Edlin et al, 2014 ; Philipson, 2014 ; Basu, 2015 ; Drummond, 2015 ; Touchot and Flume, 2015 ; Jorgensen and Kefalas, 2015 ; Kleinke and McGee, 2015 ; Carr and Bradshaw, 2016 ; Montazerhodjat et al, 2016 ; Carlson et al, 2017 ; Marsden et al, 2017 ; Jorgensen and Kefalas, 2017 ; Yeung et al, 2017 ; Value in Health, 2017 ; Carr et al, 2018 ; Faulkner et al, 2018 ; Hanna et al, 2018 ; Hampson et al, 2018 ; Lidonnici et al, 2018 ; Sachs et al, 2018 ; Senior, 2018 ; Tuffaha and Scuffham, 2018 ; Salzman et al, 2018 ; Schaffer et al, 2018 ; AMCP, 2019 ; Drummond et al, 2019 ; Jönsson et al, 2019 ; FoCUS, 2019a ; FoCUS, 2019b ; Infante et al, 2019 ; Maes et al, 2019 ; Towse and Fenwick, 2019 ). However, many uncertainties on the ideal duration of spread payments, payment amount per installment and payment linkage to outcomes remain.…”

“…Besides difficulties with reaching agreement on financial terms of spread payments, current financial flows between stakeholders and annual budget cycles could hinder the operationalization of spread payments ( Brennan and Wilson, 2014 ; Kleinke and McGee, 2015 ; Touchot and Flume, 2015 ; Montazerhodjat et al, 2016 ; Proach et al, 2016 ; Carlson et al, 2017 ; Marsden et al, 2017 ; Jorgensen and Kefalas, 2017 ; Spark et al, 2017 ; Yeung et al, 2017 ; Faulkner et al, 2018 ; Hampson et al, 2018 ; Hanna et al, 2018 ; Nevins et al, 2018 ; Sachs et al, 2018 ; Salzman et al, 2018 ; Schaffer et al, 2018 ; Senior, 2018 ; Tuffaha and Scuffham, 2018 ; Alliance for Regenerative Medicine, 2019 ; FoCUS, 2019a ; FoCUS, 2019b ; Jorgensen et al, 2019 ; AMCP, 2019 ; Towse and Fenwick, 2019 ; Barlow et al, 2019 ; Drummond et al, 2019 ; Infante et al, 2019 ; Maes et al, 2019 ). In Europe, therapies are mainly purchased by healthcare providers and subsequently reimbursed by the responsible payer.…”

“…Lastly, during agreements with spread payments over multiple years, payers could consider the possibility that products lose their exclusivity during the course of the agreement or new, possibly better, products enter the market ( Hutton et al, 2007 ; Adamski et al, 2010 ; Menon et al, 2011 ; Goodman et al, 2019 ). Agreements that do not consider market dynamics may reduce the relevance of the evidence generated ( Pauwels et al, 2017 ; Makady et al, 2019 ) and may disincentivise the development of new technologies since conditions stipulated within current agreements may influence future developers ( Trueman et al, 2010 ; Tuffaha and Scuffham, 2018 ). Studies assessing experiences with OBAs emphasized that horizon scanning is crucial to anticipate novel products to inform whether a long-term contract should be concluded or which conditions should be captured within the contract to subject the innovative therapy to the effects of market competition ( Menon et al, 2011 ; Pauwels et al, 2017 ; AMCP, 2019 ; Wenzl and Chapman, 2019 ).…”

“…Furthermore, an increase in payment amount when the therapy performs better than expected could reward manufacturers and incentivize the development of highly effective therapies ( Annemans and Pani, 2017 ; Hettle et al, 2017 ; Cole et al, 2019 ). However, an increase of payment amounts due to better performance and thus a total price increase is currently not possible due to international reference pricing and national legislations in a European context ( Annemans and Pani, 2017 ; Tuffaha and Scuffham, 2018 ; Cole et al, 2019 ).…”

“…Maes et al propose two possible solutions to comply with the ESA: the payer pays for the service of the treatment delivering long-term health outcomes or the payer pays for data services as a delivered data package per year instead of paying for a single treatment administration (Maes et al, 2019). Furthermore, healthcare systems wishing to implement spread payments may face national legal barriers which may require adjustment of country-specific regulations (Carlson et al, 2009;Carlson et al, 2011;Espin et al, 2011;Ferrario and Kanavos, 2013;Tuna et al, 2014;Kleinke and McGee, 2015;Barlas, 2016b;Proach et al, 2016;Montazerhodjat et al, 2016;Kanavos et al, 2017;Nazareth et al, 2017;NEHI, 2017;PWC Health Research Institute, 2017;Spark et al, 2017;Goncalves et al, 2018;Salzman et al, 2018;Infante et al, 2019;Lorente et al, 2019;Mahendraratnam et al, 2019). For instance, the current legislation in Spain only allows long-term spending for certain investments which excludes medicines and Sweden does not allow payments for more than three years for non-investment consumables (that are not purchased to deliver financial return) (Alliance for Regenerative Medicine, 2019).…”