ADAPT SMART’s Webinar Discusses Positive Developments and Remaining Challenges for 2017

On December 14th, IMI’s ADAPT SMART project heads and WP1-2-3 work package leads hosted an internal year-end webinar, updating on the project’s status and next steps for members of the consortium. Some 70 consortium members were guided through the project’s delivered first-year objectives and explained what will occur over next 12 months, until the end of ADAPT-SMART in December 2017.

Following an EMA hosted multi-stakeholder session on Adaptive Pathways (8 Dec), this webinar addressed both ADAPT SMART’s ongoing project deliverables, as well as the continuing need to included new actions and topics that address the evolving stakeholder concerns around the implementation of Medicine’s Adaptive Pathways to Patients (MAPPs) in Europe.

hans-georg-eichlerHans-Georg Eichler, the EMA’s Senior Medical Officer and ADAPT SMART’s Project Lead, opened the webinar by putting the work of the consortia into context stating, “Adaptive Pathways is now mainstream, everybody is discussing it, and not everybody likes it. This all came in a way to a discussion at the 8 December stakeholder session, and we agree to have several key deliverables ready by next year” to address these concerns.

Dr Eichler outlined that a core deliverable is the Glossary, which should both clarify the terminology around MAPPS in- and externally, as well as align ADAPT SMART’s own messaging. Secondly, the consortium has completed an overview document on engagement criteria (formerly known as “selection criteria” in the original book of works of ADAPT-SMART, D2.03) “the most politically sensitive of all the deliverables that we have finalized so far.”

Both the Engagement Criteria document and the Glossary are made available on ADAPT, the consortium’s public website.

Prof. Eichler also pointed out that the FDA is launching an initiative on evidence generation that will also focus on real-world data, “so we are spot-on with our focus”. He further highlighted that one of the challenges to MAPPs and the ADAPT SMART project in general, is the concern by payers that once a medicine is approved, they will be unable to remove it from the market.

SolangeRohou120x120Solange Rohou of AstraZeneca presented WP1, with the support of ElinHafDavies120x120Elin Haf Davies of CASMI. They highlighted that the WP had completed a report on the knowledge gaps on MAPPs based on a review of the outputs and conclusions of mature IMI projects. Dr. Rohou commented that going forward WP1, “will ask the consortium members define topics of high interest in order to drive the analysis to be performed in 2017, and this input will inform the future deliverables of WP1.”

In addition to the recent WP2 deliverables including the Glossary (D2.02) and report on Selection Criteria (D2.03), Luk Maes, Bristol-Meyers Squibb, outlined several key initiatives including a report of findings from a joint workshop held with MIT’s NewDigs in June 2016, as well as several other key initiatives that the WP is finalising.

LukMaes-1He highlighted that EMA published its report on the Adaptive Licensing Pilot, and the results of that publication will form the basis of a webinar in 2017. The WP (D2.07) has also completed a survey in 12 EU Member States on the tools/systems for appropriate use of “adaptive pathways medicinal products” by the targeted patient groups, this survey will be initially discussed in a workshop that is part of the ADAPT-SMART Annual Meeting on 17-18 Jan 2017. Finally he explained that the D2.08 task “Legal Constraints” had not started yet, while awaiting results/data from other work streams.

However, Luk highlighted that, “The most extensive output from WP2 is the Seamless Pathway document (D2.05). The team is working on an impressive report in partnership with the other WP leads and with other WP groups, but a summary of this is on the website while the final document is worked upon”.

RichardBarker120x120Richard Barker from CASMI led the presentation of the outputs from WP3. “The delivery for the seamless pathway and decision points is very complementary to the deliverables in WP2. By the end of 1Q2017 these complex charts that we’ve been putting together will be synthesized,” he said.

WP3 highlights the challenge that many EU based Health Technology Assessment Bodies (HTAs) are presently not able to participate in early engagement due to resource constraints or prohibitive legislation. “Patients are ready to grapple with the uncertainties around MAPPs,” said Barker, “ but uncertainties for payers perhaps looms larger for us now at the moment.”

sarah-garnerSarah Garner of NICE commented on the team’s work on Manage Entry Agreements (MEAs), highlighting that most that have been implemented are financial, not outcomes based, and payers who have engaged in MEAs have concerns on their practicality. As well, there is continuing ‘push-back’ on the concept of MAPPs by payers, as many HTA’s see it as a way to get inferior therapies into the market, “but we’ve come a long way and we’re building trust, and we’re beginning to explore ways it might be successful by stressing these are therapies for high unmet need”, she said.

The presentation on WP3 concluded with an overview of the upcoming focus in 2017 in Intellectual Property under MAPPs, which will “require additional legal expertise which has been requested and sourced via EFPIA,” said Barker.

AndreBroekmansThe final presentation of the webinar was given by ADAPT SMART’s project coordinator André Broekmans of Lygature, who gave a status of the planning/agenda for ADAPT SMART’s forthcoming Annual Meeting and General Assembly, which will occur on January 17-18 at the EMA. He pointed out that the meeting will be by invitation only, and given space constraints, registrations will only be accepted for each of 3 individual workshops, and it will not be possible for participants to move between each.

Concluding with a reflection of the direction of the project, Prof. Eichler stated, “I think we have addressed in our overall work program all of the key questions of stakeholders in one way or another, so if you ask me if I think we should change course, I would say ‘no’. I think we should accelerate our efforts to ensure we deliver some credible solutions to these issues.”


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