Outcomes-based Risk-sharing Schemes: Is There a Potential Role in the Asia-Pacific Markets?

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

“…However, spreading payments may conflict with standard financial flows since a link is needed between the medical system and the financial system to allow the initiation of payments when outcomes are achieved and payments have to be tracked over multiple years which may create additional administrative costs (Garrison Jr et al, 2013;Kleinke and McGee, 2015;Slocomb et al, 2017;Richardson and Ling, 2018). These difficulties are similar to the financial challenges experienced by OBAs with upfront payments, such as the OBA for sunitinib in the United Kingdom, where the healthcare provider may need to adjust stock control systems, verify if the cost of the drug is correctly reflected in the financial systems and ensure payments are correctly triggered (Carlson et al, 2009;Lucas et al, 2009;Williamson and Thomson, 2010;Espin et al, 2011;Coulton et al, 2012;Towse et al, 2012;Ferrario and Kanavos, 2013;Navarria et al, 2015;Faulkner et al, 2016;Gerkens et al, 2017;Pauwels et al, 2017;Toumi et al, 2017;Bouvy et al, 2018;Cole et al, 2019;Mahendraratnam et al, 2019;Wenzl and Chapman, 2019). To avoid the burden of current financial flows, payers could directly purchase the therapeutic product from the manufacturer and distribute it to the healthcare provider, as proposed by Spark Therapeutics for the reimbursement of Luxturna (Senior, 2018).…”

“…Lastly, use of data collection systems to collect personal data will require compliance with data privacy regulations such as the General Data Protection Regulation (GDPR) to protect personal data during OBAs (Klemp et al, 2011;Coulton et al, 2012;Franken et al, 2014;Drummond, 2015;Barlas, 2016a;Proach et al, 2016;Van De Vijver et al, 2016;PWC Health Research Institute, 2017;van de Wetering et al, 2017;Duhig et al, 2018;Ernst and Young, 2018a;Ernst and Young, 2018b;EXPH, 2018;Mundy et al, 2019). According to the GDPR, patients may withdraw consent and withdraw their data from the holder files which may increase missing data in registries (Alliance for Regenerative Medicine, 2019; FoCUS, 2019b).…”

“…Furthermore, this framework should entail a clear structure to initiate payments, specify the data collection process with attention to ownership of the data and foreseeing regular data audits, establish a defined management framework, define the funding arrangements of the agreement and clearly state the opportunities for appeal when requirements are not met (Adamski et al, 2010;McCabe et al, 2010;Williamson and Thomson, 2010;Klemp et al, 2011;Ferrario and Kanavos, 2013;Garrison Jr et al, 2013;Annemans and Pani, 2017;Clopes et al, 2017;EXPH, 2018;Wenzl and Chapman, 2019). Most importantly, the governance procedures should indicate the standardised decision-making criteria that are used to support the adjustment of payments based on the outcomes achieved (Coulton et al, 2012;Kornfeld et al, 2013;Gerkens et al, 2017;Kanavos et al, 2017;.…”

“…To enhance trust, several authors propose working with an independent third party such as academic institutions or non-profit, publicly funded organisations to perform all stages of the data collection process (Adamski et al, 2010;McCabe et al, 2010;Stafinski et al, 2010;Menon et al, 2011;Goldenberg and Bachman, 2012;Ferrario and Kanavos, 2013;Drummond, 2015;Thompson et al, 2016;Kanavos et al, 2017;Bouvy et al, 2018;EXPH, 2018;Mahendraratnam et al, 2019;Wenzl and Chapman, 2019). Access to maximum number of treatment options Menon et al (2010) No incentive for robust data collection since cured patients will not be motivated to attend follow-up consultations Coulton et al (2012), Touchot and Flume (2015), AMCP (2019), Maes et al (2019) Make co-pays dependent on patients attending follow-up appointments Coulton et al (2012) The importance of such independence was shown by the decision made by the scientific advisory group, consisting of representatives with high interest in continued access to the medicines, of the United Kingdom multiple sclerosis (MS) agreement to maintain reimbursement even though many patients experienced worse outcomes (Raftery, 2010;Towse et al, 2012;Gibson and Lemmens, 2014). Implementation of OBAs with spread payments will be further complicated by the current experienced cost of implementing and managing OBAs with upfront payment.…”

“…Healthcare professionals, specifically clinicians, nurses, pharmacists and more broadly the hospital administration and finance department, are increasingly burdened with administrative tasks to collect data (Williamson and Thomson, 2010;Franken et al, 2014;Gibson and Lemmens, 2014;Garattini et al, 2015;Kiernan, 2016;Nazareth et al, 2017;Brown et al, 2018;Carr et al, 2018;Schaffer et al, 2018;Antonanzas et al, 2019). They require an increase in staff resources by hiring dedicated healthcare staff or increasing personnel time for management of agreements (Coulton et al, 2012;Goodman et al, 2019;Macaulay and Turkstra, 2019). This was evident from the United Kingdom MS agreement which required hiring approximately 150 additional nurses and an increase in neurology consultations (Sudlow and Counsell, 2003;Garattini and Casadei, 2011).…”