Early Value Definition: A paradigm shift
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The document discusses the importance of defining value early in the drug development process to ensure commercial success, as exemplified by failed products like Exubera and Benlysta due to misunderstood patient needs and insufficient evidence. It outlines a three-step model for achieving this: generating insights, defining value, and delivering on promises, with techniques for gaining deeper understanding of stakeholders' needs. The ultimate goal is to develop products that meet market demands and provide clear value for all stakeholders involved.
Early Value Definition: A paradigm shift
- 1. How to ensure commercial success through early value definition
- 2. The development process is long and it can be hard to see through to what realities will look like at the time of launch Around 12 years from discovery to launch! Executive Insight
- 3. The TPP* is meant to facilitate this process by providing a structure to specify the desired development outcome Executive Insight AG 3 * target product profile Executive Insight
- 4. But all too often, TPPs are technical documents describing attributes of the molecules but not how value will be created Executive Insight
- 5. Famous examples of what can go wrong: Exubera Patient needs not understood Exubera – inhaled insulin: An embarrassing device Failure to gain acceptance of patients and physicians Pfizer pulled the plug less than a year after launch Image sources: images.dailytech.com Executive Insight
- 6. Famous examples of what can go wrong: Benlysta Executive Insight AG 6 Benlysta – Lupus treatment EU payers concluded that GSK failed to provide the relevant data to properly assess the benefit of its medicine Applicability of trials to real world clinical practice not clear Negative reimbursement recommendations Payer perception of therapeutic value not understood Executive Insight
- 7. What needs to happen: an early definition of value for a whole universe of different stakeholders Executive Insight AG 7 Executive Insight
- 8. A three step model how to get there Generate Insights Define Value Deliver on Promise Executive Insight
- 9. Generating insights requires techniques beyond standard market research 9 Need for creative techniques to uncover real needs of stakeholders Moving beyond interviews and questionnaires Putting effort into creating real insights Executive Insight
- 10. Snapshot: Patient Deep Dive Techniques: that go “under the skin” e.g. collaging, associations, metaphorical techniques Result: Gain an emotional understanding of a patient’s feelings, problems, state of mind. Deep Dive: A highly interactive session to understand the patient experience Understanding the why behind the what Executive Insight
- 11. Snapshot: Multi-disciplinary Think Tank Executive Insight AG 11 Early team ideation sessions in clinical development Internal cross-functional teams and/or External stakeholders in a mixed setting (e.g. physician, patient, payer) Design thinking approach Executive Insight
- 12. Defining value: developing a clear idea early on how the product will bring value to all stakeholders Regulators: Why will the product be approved? Payers: Why will the product be paid for? Physicians: Why will the product be prescribed? Patients: Why will the product be used? How will the product be better than what is already there? Executive Insight
- 13. Compelling value stories need to be defined along the dimensions that are relevant for the stakeholder groups Medical importance Therapeutic value Patient benefit Value for money Financial impact Executive Insight
- 14. Deliver on the promise: whether still in development, at launch or in lifecycle management Executive Insight
- 15. Generate evidence that supports the next key step in the process Commercial planning Marketing authorization Value demonstration Benefit-Risk assessment Executive Insight
- 16. Differentiate the product through beyond-the-pill services to capture more value from the market Executive Insight
- 17. The result? Products that have a market and stakeholders that get what they really need Executive Insight
- 18. Want to know more? Get in touch with us! +41 41 710 71 63 [email protected] www.executiveinsight.ch “They have just delivered very strong results consistently” Global Top 5 Pharma, Head of Specialty Care Excellence