The need for early JCA planning

 

The introduction of the European Joint Clinical Assessment (JCA) is the largest development in European market access in the last decade.

In order for the JCA report to fulfil its objective of accelerating patient access to new treatments across Europe by increasing transparency and reducing duplication of country level Health Technology Assessment (HTA), the scoping process will be critical.

The starting point for any HTA is defining the PICO: Population, Intervention, Comparators and Outcomes.

 

Lightning Health has been closely monitoring how manufacturers will need to prepare in order to navigate the complexity of European healthcare systems to achieve rapid and sustained access. In response to the introduction of the JCA, we have developed PICOScan®.

 

The PICOScan™ process combines AI search and EU stakeholder insights to capture the likely range of PICO requirements for a new therapy across EU member states, and the predicted minimum number of PICOs within the JCA scoping process. The service is powered by Lightning Insights, our global network of stakeholders.

The PICOScan™ process
AI enabled landscape analysis
Understanding previous HTAs and building a PICO reference case
KOL insight
Defining current practice, relevant subgroups, comparators and outcomes
Payer validation
Defining minimum/optimal requirements to support positive national HTA
Defining the minimum number of PICOs
Translating MS needs to the lowest number of PICOs

AI enabled landscape analysis

  • Baseline understanding of the recent HTA landscape in Europe
  • Hypothesis development on key data requirements, including relevant populations(s), outcomes and comparator(s), informed by previous HTAs and clinical literature
  • Benchmarking of analysis against positive/negative reimbursement decisions

KOL insight

  • Current practice for the target population
  • Prediction of patient selection criteria and relevant subgroups
  • KOL validation of potentially relevant comparators (and variation by subgroup)
  • Relevant clinical/ humanistic/safety outcomes
  • Surrogate validation

Payer validation

  • Required PICOs for national level HTA
  • Priority subgroups for analysis
  • Priority clinical/humanistic/ economic outcomes (and validation requirements)
  • Indirect treatment comparison requirements/justification
  • Priority complimentary analysis

Defining the minimum number of PICOs

  • Defining variation in PICOs across scope markets (and the rationale)
  • Mapping divergence across scope members states and benchmarking versus a reference case market (e.g., Germany)
  • Defining the minimum number of PICOs to satisfy member state requirements

Are you prepared for the JCA from 2025?

To avoid the potential challenges associated with multiple PICO requests requiring rapid evidence identification and analytics, contact us today to learn how PICOScan® can support your new product planning, value and access strategy.