Spring Intro 2023

23/03/2023

Route to Market Access – different stakeholders have different questions… Common regulatory stakeholder and payer questions

• Does the product meet necessary quality, safety and efficacy requirements ? • Is there a positive

• Is this product a good use of healthcare resources ? • Is it good value for money ? • Does it provide additional benefit over the current standard of care? • Should we reimburse it in the full targeted population? • At what price should we reimburse it?

• At this cost and level of benefit, should we cover this product under this plan? • If so, in which tier/at what level of patient co-payment?

• Should we fund this product ? • Can we afford it with

our limited budget at the price agreed nationally?

risk–benefit balance ?

• If so, should we restrict use to a

narrower population?

Regulatory stakeholders

National payers

Insurer payers

Regional and local payers

The Organisation for Professionals in Regulatory Affairs

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Key Questions that the Clinical Data alone will not answer…

Not all payers have the same questions – we need bespoke evidence

Does it provide a tangible benefit to patients?

Does it provide value for money over standard of care ?

Is it effective compared to SoC in my market?

Can I afford it?

Do I want to spend money from my limited healthcare budget to fund this new product?

Does it work in real life?

Is there an unmet need?

The Organisation for Professionals in Regulatory Affairs

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