Optimizing the Integration of Innovative Therapies into Clinical Practice Guidelines

Key Contextual Factors

• The WP9 started by conducting a mapping of clinical practice guidelines which were including innovative immunotherapies in cancer therapeutic strategies both via literature review and a questionnaire among European countries. The focus was given to the most recent immunotherapies, i.e. checkpoint inhibitors and CAR-T cells.
• Based on the mapping and on the review of the guidelines, difficulties for positioning these innovative therapies in the therapeutic strategies were highlighted as well as off-label recommendations and recommendations associated with biomarkers.
• Then, the WP9 collected feedback from 9 experts of the field (who worked for institution which produce clinical guidelines) to point out methodological considerations and programs which could be implemented in order to surpass these challenges.
• The conclusions were shared with all the WP9 partners.

Key Components/Steps

• WP9 conducted a review of guidelines positioning checkpoint inhibitors and/or CAR-T cells: 120 were identified, including 52 from European organizations. Whereas most countries in Europe have existing organizations in charge of writing clinical practice guidelines in the field of cancer, only half of them had already included innovative immunotherapies within their guidelines at the time of the survey, 7 years after the approval of the first checkpoint inhibitor in Europe (ipilimumab) and 3 years after the introduction of nivolumab and pembrolizumab, showing a delay for integration of innovative therapies into clinical practice guidelines. The main challenges related to the integration of innovative immunotherapies into clinical practice guidelines found were: the difficulty to maintain updated guidelines in the context of very fast evolving indications, especially for checkpoint inhibitors; the lack of data that could lead to uncertainty of recommendations; the limited visibility of existing European clinical practice guidelines in Europe; different levels of acceptance for off-label recommendations.

Main Impacts / Added Value

• The work performed by the WP9 provides a list of clinical practice guidelines providers in Europe and is available in the WP9 task 1 deliverable: innovative cancer therapies in clinical practice guidelines. Although many providers published guidelines, the main challenge is how to update them in view of an emerging therapy. The list of guidelines will be made available.
• Several suggestions were made to optimize integration of innovative immunotherapies into clinical practice guidelines:

• implement strong methodology and Standardized Operational Procedures;
• have dedicated in-house staff with strong methodological expertise;
• reduce the scope of guidelines (or of fields to be updated) could help improving timelines;
• better training on methodological approach for medical doctors and experts involved in the production of guidelines;
• increase financing support;
• implement regular update with agreed timelines (e.g. every year);
• collaborations and methods such as endorsement of existing guidelines could be helpful for improving production and update timelines.

Lessons Learned

• To better identify the place of immunotherapies in therapeutic strategies: the need of additional clinical data.
  A public fund financing studies comparing innovative immunotherapies between them was a proposal with high consensus from experts (90%) to better define the place of innovative therapies in cancer treatment strategies, especially when there is available data comparing the new therapy with standard of care or with other innovative therapies.
• To improve the visibility of guidelines: the need of a dedicated repository.
  When experts were consulted to define the most efficient way to communicate the release of a new or updated guideline, responses were quite various, going from publications on the organization’s website to communication at congresses, scientific publications and emails addressed to professional societies. It was agreed that having a repository including all existing clinical practice guidelines by type of cancer could help improving visibility of existing documents in Europe, like the repository of international guidelines on breast cancer care that has been implemented by the European Commission Initiative on Breast Cancer. A similar initiative will be conducted for colorectal cancer.

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