Session report: How to go ahead with pull incentives?
During the third day of the virtual 5th AMR Conference, the important role of governments and policy makers with regard to bring forward pull incentives was stressed.
In the first part of the Briefing Session, current models such as the UK pilot were presented. Colm Leonhard from NICE and David Glover from NHS provided details of the HTA valuation framework developed for this netflix-like subscription model, the selection process and the parameters of the value assessment of the two final products selected. Leonhard and Glover outlined, that from April 2022 this payment model – if it passes through the evaluation process and further commercial discussions until then – could start officially. Particularly SMEs highlighted the difficulties for them to fulfill some of the procurement criteria and Glover said that indeed the problem is recognized by the authorities and that there are already discussions running to see how the situation for smaller companies could be reflected better. Furthermore, the session also provided an overview of further incentives currently underway or in discussion, ranging from the Swedish access pilot, European antibiotic reimbursement reforms to BARDA Project Bioshield contracts, and the proposed US DISARM and PASTEUR acts in the US. As highlighted by Kevin Outterson from Boston University, the positive features of all those are among others, focus on high quality of drugs, delinkage of revenues from sales volumes, transparency of the target product profiles and administration processes. Referring to a recent analysis of market access for novel antibacterials in high-income countries, he demonstrated that there is a high need for change also in these countries as uptake is comparably low. However, he also noticed that it will be key to really design the pull incentives in a way that the right drugs are targeted.
Having only the UK pilot and the Swedish model currently tested, most of the stakeholders expressed high expectations with regard to the PASTEUR Act which was re-introduced in the US Senate in June. “It is not yet done”, said Thomas Cueni from IFPMA. However, he and others representing the AMR Industry Alliance such as Greg Frank, Director Global Public Policy, MSD, emphasized that only with this initiative going forward, the AMR sector may be on an improved path and better market outlook. From their perspective, a pull incentive in the US would provide a profound basis to re-establish further trust for pharma companies and investors so that the now started regained interest in the field has a long-term perspective to grow.
For most of the European-based SMEs represented by BEAM Alliance the European stakeholders are key as well. “We would be pleased to see a further alignment on tools and incentives under the roof of the European Union and Commission to not end up in 27 different complex regulations”, Mark Jones, Head of Project Management Office from Swiss Basilea and Board Member of BEAM Alliance stressed in the closing panel. Expectations are also high that the proposed Health emergency preparedness and response authority (HERA) in Europe and a new Horizon call targeted to pull incentives could also establish a certain spectrum of instruments in Europe for AMR-related policy activities ranging from subscription models to transferable exclusivity extension vouchers. “Any pull incentive be it in Europe or elsewhere must be of sufficient magnitude”, Jones said and underlined that implementation is time-critical now and needs to be appropriately designed in order to be effective. The companies pledged for a process which is transparent so that eligibility is predictable and the process manageable by SMEs as well.
In view of the most recent report of the Global AMR R&D hub which again highlighted the mismatch between global patient needs and commercial potential of AMR innovation (see for more details here) conference participants agreed that the momentum for further action on the G7 and G20 level is also there. Lots of hope was expressed that US and Europe with the UK and German governments in particular will advocate for further tangible measures in the respective countries. “We have seen lots of talks and interest within those policy meetings. All facts and figures have now been put together in many reports as well. Now, it’s time to really come to measurable actions that are of relevance for the sector”, Jeremy Knox, Policy and Advocacy Lead for the Drug-Resistant Infections Programme at Wellcome Trust summarised.