Are You Implementation Ready? An Alternative Patient And Healthcare System-Centered Model For Pharma
Author(s)
Melvin Skip Olson, ScD1, Rita Freitas, PhD2.
1Founder, Olson Strategies GmbH, Allschwil, Switzerland, 2Grunenthal, Lisboa, Portugal.
1Founder, Olson Strategies GmbH, Allschwil, Switzerland, 2Grunenthal, Lisboa, Portugal.
OBJECTIVES: The pharmaceutical industry continues working in silos, with development teams focusing on trial completions and commercial teams focusing on launch execution. This process is effective at delivering products to market, but not necessarily to patients. Healthcare system (HCS) and patient needs are typically addressed late in the process, if at all, resulting in suboptimal integration into clinical practice. This abstract introduces the concept of Implementation Readiness (IR), describing the need to deliver a product effectively into the clinical care pathway by launch and beyond.
METHODS: Implementation Readiness is defined as a product’s ability to be used in clinical practice starting from launch, with stakeholder agreement on how, when, and for whom the treatment should be used. It calls for coordinated planning across pharma functions—R&D, medical, commercial, market access—toward a shared IR goal. Key elements include implementation science, treatment optimization studies, and generation of evidence on diagnosis, referral pathways, HCP behaviour, and patient preferences before launch.
RESULTS: IR would require the HEOR function to transform from supporting market access close to launch to identifying and addressing real-world implementation barriers early. While IR involves greater pre-launch investment and risk, it can enable faster uptake and greater patient reach. A simulated analysis shows a 24-50% increase in 10-year area under the curve (AUC) for patient adoption compared to traditional strategies. The IR framework also aligns with the evolving EU HTA Regulation, which demands evidence on real-world clinical practice and system impact, not just regulatory endpoints.
CONCLUSIONS: Implementation Readiness offers a new optimization target for pharma, focused on timely and equitable patient access. It requires organizational change: shared KPIs, early stakeholder co-creation, and cross-functional accountability. By rethinking what it means to be “ready” for launch, IR promotes a more integrated and patient-centric approach—better meeting all stakeholder expectations.
METHODS: Implementation Readiness is defined as a product’s ability to be used in clinical practice starting from launch, with stakeholder agreement on how, when, and for whom the treatment should be used. It calls for coordinated planning across pharma functions—R&D, medical, commercial, market access—toward a shared IR goal. Key elements include implementation science, treatment optimization studies, and generation of evidence on diagnosis, referral pathways, HCP behaviour, and patient preferences before launch.
RESULTS: IR would require the HEOR function to transform from supporting market access close to launch to identifying and addressing real-world implementation barriers early. While IR involves greater pre-launch investment and risk, it can enable faster uptake and greater patient reach. A simulated analysis shows a 24-50% increase in 10-year area under the curve (AUC) for patient adoption compared to traditional strategies. The IR framework also aligns with the evolving EU HTA Regulation, which demands evidence on real-world clinical practice and system impact, not just regulatory endpoints.
CONCLUSIONS: Implementation Readiness offers a new optimization target for pharma, focused on timely and equitable patient access. It requires organizational change: shared KPIs, early stakeholder co-creation, and cross-functional accountability. By rethinking what it means to be “ready” for launch, IR promotes a more integrated and patient-centric approach—better meeting all stakeholder expectations.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR20
Topic
Health Service Delivery & Process of Care, Patient-Centered Research, Real World Data & Information Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas