Pgi39 - Darvadstrocel in the Management of Complex Perianal Fistulas: The Role of Patient Registry Data Collection to Support Performance-Based Risk Sharing Agreements

Abstract

OBJECTIVES: The main rationale for using biosimilar medicines is one of cost saving. The market development for biosimilar drugs will therefore depend on the degree to which cost saving measures are required by nations, medical insurers and individuals and the absolute savings that can be gained by switching from originator brands. The aim of this study is to demonstrate the potential cost savings accrued by switching patients from the originator brand, Remicade® to biosimilar infliximab CT-P13 in the treatment of inflammatory bowel disease in a large acute Irish teaching hospital. METHODS: Throughout September 2016 to May 2017, data were collected on 20 patients that were switched from Remicade® to biosimilar infliximab CT-P13. Cost data for these medicines were obtained using exfactory prices available from a national pharmaceutical database. Hypothetical biosimilar pricing scenarios using discount rates of 15%, 30% and 45% were applied to the biosimilar infliximab CT-P13 price. These rates are believed to mimic national current commercially sensitive transactions offered by pharmaceutical manufacturers on biosimilar medicines to Irish Hospitals and are corroborated by the literature. The viewpoint of the study was that of the Irish healthcare payer. RESULTS: With respect to the various hypothetical biosimilar pricing scenarios outlined, potential cost savings from switching these 20 patients can range from V76,638 to V180,099. In addition, assuming no applied discount rate to the publically available ex-factory price, switching this cohort of patients to biosimilar infliximab CT-P13 can result in an immediate cost saving of 25% to the Irish healthcare payer. CONCLUSIONS: Cost savings accrued from biosimilar medicine usage is of benefit to all stakeholders: increased access to medicines for patients, more treatment options for prescribers, sustainable healthcare budgets for payers and more business opportunities for manufacturers. Healthcare policymakers are one body that need to do more to increase biosimilar medicine uptake.OBJECTIVES: Proton pump inhibitors (PPIs) and H2-receptor antagonists are used for antisecretory therapy of acid related diseases. The aim of research -assessment of the volume and structure of consumption of PPIs and H2-receptor antagonists in Ukraine in 2016-2017 and a comparison of their consumption in Ukraine with other countries. METHODS: Assessment of drugs consumption was carried out by ATC/ DDD-methodology. International index of DDDs / 1000 inhabitants / day was calculated at carrying out research. Number of drugs packaging, which were sold for a year in Ukraine, was taken from the information system "Pharmexplorer" of Company "Morion" (September, 2016(September, -2017. Antisecretory drugs DDD are taken from the WHO website (http://www.whocc.no/atc_ddd_index/). The drugs consumption level in Baltic countries (Lithuania, Latvia, Estonia) and Norway was estimated using statistical data of these countries. RESULTS: The largest volumes of consumption in 2016-2017 in all the countries...

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.…”

“…However, many uncertainties on the ideal duration of spread payments, payment amount per installment and payment linkage to outcomes remain. Several publications argue to spread payments over the duration of benefit or effect of the therapy ( Edlin et al, 2014 ; Hettle et al, 2017 ; Jorgensen and Kefalas, 2017 ; Jönsson et al, 2019 ; Maes et al, 2019 ) with a time limit on the payment period (2–5 years) ( Faulkner et al, 2018 ; Hanna et al, 2018 ; Maes et al, 2019 ), while others argue for continued payments as long as the patient is alive ( Schaffer et al, 2018 ; Towse and Fenwick, 2019 ). Although several recommendations exist, no article yet describes a formal method to determine the optimal duration of such spread payments.…”

“…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.…”

“…However, uncertainty exists on which evidence is needed, which outcomes should be selected and from which sources the data should be gathered (Ferrario and Kanavos, 2013;AMCP, 2017). To enable the collection of population-and individual-based data, the use of registries as prospective observational study design has been recommended (Theunissen et al, 2010;Towse and Garrison Jr, 2010;Menon et al, 2011;Vitry and Roughead, 2014;Pritchett et al, 2015;Schmetz et al, 2018;Jönsson et al, 2019). An expert panel reviewing the applicability of current HTA practices to the needs of ATMPs and the evaluation of MEAs by the Belgian healthcare knowledge center recommend registries to consist of standardized data elements and cover the continuity of care, including the primary care setting for possibly cured patients, by being linkable to other databases resulting in the provision of accurate, reliable and complete information (Towse and Garrison Jr, 2010;Ferrario and Kanavos, 2013;Cole et al, 2019).…”

“…Annuity payments, a specific form of spread payments, are paid once every year instead of every few months ( Garrison Jr et al, 2013 ; Edlin et al, 2014 ; Carr and Bradshaw, 2016 ; Marsden et al, 2017 ; Jorgensen and Kefalas, 2017 ; Hettle et al, 2017 ; Kefalas et al, 2018 ; FoCUS, 2019b ). This reimbursement method combines an OBA with spread payments over time which may solve the immediate unaffordable budget impact caused by the high upfront treatment price while the inclusion of an OBA foresees the correction of payments for real-world performance solving both short- and long-term clinical uncertainties ( Jorgensen and Kefalas, 2017 ; Yeung et al, 2017 ; Faulkner et al, 2018 ; Schaffer et al, 2018 ; Jönsson et al, 2019 ; Towse and Fenwick, 2019 ).…”