Php32 the Usefulness and Challenges of Patient Access (Risk Sharing) Schemes in the Uk

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

“…Organising and performing data collection are two of the most frequently discussed barriers for implementation of OBAs for payers, developers and healthcare providers ( Sudlow and Counsell, 2003 ; de Pouvourville, 2006 ; Carlson et al, 2010 ; McCabe et al, 2010 ; Raftery, 2010 ; Stafinski et al, 2010 ; Williamson, 2010 ; Jaroslawski and Toumi, 2011b ; Klemp et al, 2011 ; Neumann et al, 2011 ; Cascade et al, 2012 ; Goldenberg and Bachman, 2012 ; Xoxi et al, 2012 ; Bibeau et al, 2014 ; Gibson and Lemmens, 2014 ; Li et al, 2014 ; Garattini et al, 2015 ; Lu et al, 2015 ; Lucas and Wong, 2015 ; Mohseninejad et al, 2015 ; Barlas, 2016b ; Carr and Bradshaw, 2016 ; Malik, 2016 ; Pouwels et al, 2016 ; van de Wetering et al, 2017 ; Duhig et al, 2018 ; Ernst and Young, 2018a ; Ernst and Young, 2018b ; EXPH, 2018 ; Goldenberg et al, 2018 ; Jorgensen et al, 2018 ; Stirnadel-Farrant et al, 2018 ; Urbinati et al, 2018 ; Federici et al, 2019 ; Macaulay and Turkstra, 2019 ; Mundy et al, 2019 ; Pace et al, 2019 ; Kannarkat et al, 2020 ). First, experiences with OBAs in the Netherlands and the United Kingdom highlight that payers should perform a value of information analysis to guide the decision to engage in an OBA to confirm that the benefits from additional evidence collection are higher than the cost of collecting the data ( Ferrario and Kanavos, 2013 ; Pauwels et al, 2017 ; Makady et al, 2019 ; Towse and Fenwick, 2019 ).…”

“…High-quality governance of OBAs is crucial to support financial flows of the agreement, data collection and reinforcement of the relevant legislation. Therefore, several publications, discussing barriers from payer, developer and provider perspective, highlight the current lack of clear governance structures and recommend to build a framework that details every step of the process with specification of every stakeholders’ roles, responsibilities, interests and incentives ( Carlson et al, 2009 ; Trueman et al, 2010 ; Ferrario et al, 2011 ; Jaroslawski and Toumi, 2011a ; Jaroslawski and Toumi, 2011b ; Neumann et al, 2011 ; Goldenberg and Bachman, 2012 ; Xoxi et al, 2012 ; Towse et al, 2012 ; Gottlieb and Carino, 2014 ; Li et al, 2014 ; Vitry and Roughead, 2014 ; Drummond, 2015 ; Lu et al, 2015 ; Lu et al, 2015 ; Lucas and Wong, 2015 ; Lucas and Wong, 2015 ; Polimeni et al, 2016 ; Calabrese et al, 2017 ; Value in Health, 2017 ; Slocomb et al, 2017 ; Toumi et al, 2017 ; Nazareth et al, 2017 ; NEHI, 2017 ; Seeley and Kesselheim, 2017 ; Duhig et al, 2018 ; Ernst and Young, 2018b ; Faulkner et al, 2018 ; Salzman et al, 2018 ; Goncalves et al, 2018 ; Drummond et al, 2019 ; Mahendraratnam et al, 2019 ; Moradi et al, 2019 ; Patel et al, 2019 ). 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 ; …”

“…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).…”

Risk-Sharing Agreements in the EU: A Systematic Review of Major Trends

“…HTA agencies became more important as authors such as McCabe et al [ 4 ], Lucas et al [ 39 ], and Chawla et al [ 40 ] discussed how manufacturers increased their production of drugs that surpassed the acceptable cost-effectiveness measurements (e.g. cost per QALY or ICER) even though the main reasoning behind rejection by NICE was a drug with an ICER >£30,000 per QALY.…”