Module 6

03/10/2024

Market access framework for theUK

The UK P&R process can be slow; HTA agencies may recommend against access regardless of regulatory approval.

Source: PRMA Insights: Pricing and Reimbursement Success in NSCLC 2nd edition, 2012

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Across Europe, market access terms are becoming more restrictive

Source: PRMA Consulting

Key market accessthemes

Comment

• Meaningful clinical differentiation against an active and relevant comparator eg head-to-head

• May be significantly smaller than the regulatory population

• Growing importance of subpopulations

• Formal cost-effectiveness requirements at launch

• Growing importance of cost-effectiveness

• Emergence of more complex composite endpoints

• Critical importance of HRQoL

• Increased use of risk-sharingagreements

• Regional stakeholders importance

• Make independant decisions

• Lifecycle market access requirements

• On-going re-assessments

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