a2 1. griffin cadth regulatory-reimbursement harmonization 11-apr-16
TRANSCRIPT
Regulatory and Reimbursement HarmonizationAn Industry PerspectiveAdrian Griffin | April 2016
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One Global Development PlanMany geographies, More Stakeholders
Discovery3 yrs
Early Development
2 yrs
Phase II2 yrs
Phase III3 yrs
Regulatory review 1-2yrs
Launch
Need to know evidence requirements 4-7 yrs before launch
InitialPlan
EvidencePlan
‘Locked’
ClinicalUse
Planning the Evidence - Predicting the future
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Need for Regulatory and HTA Agencies to be Aligned
Focus of HTAi Policy Forum, 2011
International Journal of Technology Assessment in Health Care, 27:3 (2011), Page 1 of 8.
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Different Focus, Different DecisionsBoth driving for better outcomes for patients
Regulation HTA Coverage
Role Give market authorisation
Support for clinical and coverage decisions
Decide on coverage or reimbursement
DecisionDo the clinical benefits for patients outweigh the risks?
[HTA supports decisions, often taking into account clinical, financial & other dimensions]
Are the expected health benefits useful and affordable?
EvidenceEfficacy and safety from trials; post launch surveillance
Effectiveness, cost effectiveness and opportunity costs from trials, other studies and modelling
As for HTA; conditional coverage may be used to improve evidence base for re-appraisal
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Regulatory-HTA Interactions have been Increasing
Timing
• Pre-competitive
• During Development– Pre-Phase II / III
• Pre-Market / launch
Type of Interaction
• Disease Specific – Evidence Guidance Documents
• Green Park Collaborative
• Early Scientific Advice– Product specific advice– HTA, Multi-HTA, Parallel Reg-HTA
• Parallel reviews– Regulatory and reimbursement
• Canada, Australia, US
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• Regulator, patient, clinicians call for ‘early access’
– FDA: Breakthrough therapies– EMA: PRIME
• Regulators discussing longitudinal approach to approval
– “Adaptive Licensing”Now Medicines Adaptive Pathways to Patients (MAPPs)
• How will HTA & Reimbursement adapt?– Existing approach to value assessment
needs to evolve
New Challenges for Stakeholders
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Ibrutinib versus Ofatumumab in previously treated CLL: Byrd et al, NEJM, July 2014
The Challenges are here now
Crossover bias
Ofatumumab as single agent CD20 immunotherapy in fludarabine-refractory CLL: Wierda et al, JCO, April 2010
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Ongoing Initiatives
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Ongoing Initiatives (2)
To show how Real World Evidence (RWE) can be adopted
in to medicine development & decision making, and provide the
tools to achieve it
https://www.imi-getreal.eu/
An enabling platform to coordinate MAPPs activities.
Supporting evidence generation, designing the MAPPs pathway, decision-making & sustainability
http://adaptsmart.eu/
Both are multi-stakeholder, including regulators, HTA agencies, patient organisations, academics and industry
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Countries can find ways to deliver access, whilst managing their uncertainty
Scheme type
Rebate for early non-responders
Capped treatment duration
Treatment duration linked rebate
Response scheme
Initiation period costs
Population level cap
Range of Managed Entry Agreement Archetypes in use in Europe, for One Drug in one Disease
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Challenges
• Regulators are Decision-Makers– Able to change their decision-making paradigm
• HTA-agencies provide information & recommendations– Third parties then make Reimbursement decisions
• What flexibility do HTA-agencies have to navigate the reimbursement access model?
– Will a new model be required in the new regulatory environment
• Industry needs to address Regulators, HTAs, Clinicians and Patients