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What lessons can pharmaceutical manufacturers learn from the first EUnetHTA joint clinical assessment?

Ally Robert, Associate Director | 9/26/2023

This summary of the first published report of EUnetHTA joint clinical assessment (JCA) highlights two additional factors for evidence requirements that should be considered by pharmaceutical manufacturers; namely the need for aligning trial design parameters with the expected patient/population, intervention, comparison, and outcomes (PICO) frameworks, and the need to ensure sufficient European-level recruitment in the pivotal trial.

This is an extract from an ISPOR Europe 2023 presentation by Ally Robert, Associate Director. Please get in touch for a conversation about leveraging these learnings in your market access strategies.

 

What are EUnetHTA joint clinical assessments?

EUnetHTA JCAs are jointly produced by EUnetHTA partners across Europe with the aim of substituting parallel evaluations of clinical data with a single harmonized process.

In 2025, JCAs of new advanced therapy medicinal products and oncology medicines will commence. While not legally binding, these will affect national health technology assessments – and may present new challenges for pharmaceutical manufacturers.

Analysis of the first published EUnetHTA JCA report provides an opportunity to understand what additional factors should be considered with reference to JCA evidence requirements.

 

When was the first EUnetHTA joint clinical assessment report published and what was its focus?

The first published JCA report assessed the relative clinical effectiveness and safety of Optilume, a paclitaxel-coated urethral balloon for the treatment of urethral strictures in adult males.

The project was managed by Zorginstituut Nederland (ZIN; The Netherlands) and the assessment team consisted of members of Haute Autorité de Santé (HAS; France), and the Austrian Institute for Health Technology Assessment (AIHTA; Austria).

The process began on 4 October 2022 with a scoping phase, followed by an assessment phase beginning on 30 January 2023, and ending with publication of the final report on 6 June 2023.

 

What lessons can be learnt from the first EUnetHTA joint clinical assessment?

The PICO survey resulted in 3 consolidated PICOs that only differed from each other in terms of comparator. The assessment team found that of the three pivotal studies submitted by the manufacturer, no study individually addressed the PICO 1, 2 or 3 question, but one sufficiently addressed elements of PICOs 1 and 2 collectively.

Uncertainties raised by the assessment team included:

  1. the risk of bias which was considered high for all outcomes due to single blinding
  2. concern that the trial wasn’t conducted in Europe
  3. lack of results for drug-related adverse events
  4. lack of clear explanation for handling of missing data.

Outside of methodological or statistical concerns often voiced at national HTA level, drug manufacturers should also be mindful of aligning trial design parameters fully with the expected PICO framework and ensuring sufficient European-level recruitment in the pivotal trial.

 

In 2025, joint clinical assessments of new advanced therapy medicinal products and oncology medicines will commence. While not legally binding, these will affect national health technology assessments – and may present new challenges for pharmaceutical manufacturers.

Ally Robert

Associate Director

avatar for Ally Robert - Associate Director

 

EUnetHTA joint clinical assessments: are you ready?

EUnetHTA JCAs may present new challenges for your organization. How ready is your organization to:

  • understand the process and impact of the PICO scoping at EU and market level
  • generate robust evidence to meet market level vs consolidated PICO level requirements
  • differentiate between market level issues and JCA outcomes to refine market-level strategy
  • manage uncertainty regarding implementation of JCA in practice and the impact on HTA and pricing decisions?

Our Global policy, access, value, and evidence experts at Avalere Health will help you prepare for JCAs. We are experienced in early scientific advice, EUnetHTA submission, and EMA-EUnetHTA 21 Joint Scientific Consultation and have an in-depth understanding of market access and HTA.

Please download our case studies and insights to find out how we can help you map out your JCA strategic and tactical initiatives for the remainder of the year and beyond.

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