Assessment of JCA scope and evidence requirements to inform integrated evidence planning

• The client was developing a novel therapy for 2nd  and 3rd  line metastatic colorectal cancer with plans to launch across Europe​
• Following the introduction of the EU JCA, uncertainty existed regarding the range of PICOs likely to be requested within the JCA scoping process and the potential variation in evidence expectations across member states​

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• Complete a detailed evaluation of the predicted PICO requirements for the new therapy for the treatment of 2nd and 3rd  line metastatic colorectal cancer across 10 priority European member states ​
• Analyse predicted member state PICO requirements in the context of the JCA scoping process to inform the predicted minimum viable number of PICOs to address the predicted range of member state evidence requirements ​

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• Comprehensive review of existing clinical guidelines and prior HTA reports for relevant therapies for 2nd /3rd  line metastatic colorectal cancer across scope markets ​
• In-depth KOL interviews across scope markets to define current and evolving practice, relevant subgroups, comparators and outcomes for target patients ​
• Primary research with HTA/payer stakeholders across scope markets to validate evidence requirements, decision drivers and PICO expectations ​
• Definition of country specific and consolidated European PICO requirements for the new therapy for 2nd and 3rd  line metastatic colorectal cancer ​

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• Detailed insights on the predicted JCA scope requirements for the new therapy depending on 2nd /3rd  line positioning for metastatic colorectal cancer ​
• Facilitation of cross-functional planning regarding evidence generation/synthesis requirements to meet clinical/commercial objectives for European launch ​
• Provision of the basis for future Joint Scientific Consultation to consolidate evidence generation planning ​

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