April 2023
Guest editor: Martina Garau | Director
Rapidly evolving and efficient HTA through collaboration
The global Health Technology Assessment (HTA) community faces many challenges from the development and introduction of disruptive innovations to inequities in access to healthcare across and within nations. HTA methods are also constantly being advanced to improve the accuracy of value assessments and the decision-making processes they inform.
The benefits of HTA collaborations, including sharing and developing best practices, have been proclaimed for a long time but how can they help the HTA community to address the most pressing challenges? In this Bulletin I reflect on the main types of collaboration, the problems they aim to solve, and which are most promising.
Probably the most common collaborations are non-binding initiatives among experts and/or HTA agencies to develop new methods, or evolve existing ones, on topics that represent a challenge in HTA processes and, ultimately, in developing appropriate coverage recommendations. When expert-only, they seek to advance methods and introduce new approaches (an example being society groups such as ISPOR Task Forces); when involving HTA agencies from different jurisdictions, their purpose can be to develop shared, voluntary guidance on how to deal with a specific challenge, and ideally to accelerate the endorsement and application of existing approaches.
An example of the latter is the recently started initiative involving the HTAi Global Policy Forum, National Institute for Health and Clinical Excellence (NICE), and other HTA agencies on the use of surrogate endpoints in cost-effectiveness analysis, which is a technical topic with widespread implications on policy and access to innovative treatments, particularly in the oncology space.
One important benefit of this type of initiative, often overlooked, could be shortening or minimising the time gap between method development and real-life implementation. A topic that could significantly benefit from such a collaboration is the value attribution of combination therapies, where proposals have been developed to address the technical challenge of assigning the value generated by the different components of combination therapies to inform value assessment and pricing. Progress towards implementation, however, is hindered by a lack of (joint) engagement by HTA agencies.
Moving across the spectrum of collaborative initiatives in HTA, there are those established to develop joint assessments on individual technologies. They require common and binding guidelines on methods, which can be challenging to agree. Generally, these initiatives start when countries or jurisdictions with similar value assessment processes, or part of a geographical area with strong economic links or similar characteristics, want to harmonise their evidence requirements and avoid duplication of efforts when conducting value assessment. This can make the process from regulatory to patient access more efficient and streamlined. Benefits are potentially captured by countries with less established HTA systems, which can build upon a joint assessment to reach a coverage decision rather than informally having to consult assessments and recommendations published by other agencies.
An example of this type is the EU regulation for the Joint Clinical Assessment (JCA), which comes into force in 2025 for oncology treatments, after over 25 years of efforts towards it. Many challenges remain, particularly around critical areas such as acceptable methods to consider the comparators (or standard of care) that are relevant in all member states. Whether seeking alignment from different jurisdictions could further complicate and delay the evolution of method guidelines, making participating systems less agile than what they currently are, remains a question. The JCA implementation will reveal if these initiatives can deliver the expected benefits.
Another aspect that distinguishes initiatives is the stage of health technologies implementation they are relevant for. Increasingly, a joint collaborative approach throughout the health technology life-cycle is desirable as it could “promote robust evidence generation and transparent communication across all stakeholders” in three key phases (pre-, post-market, disinvestment) (Trowman et al., 2023). An HTAi Task Force initiated by the Global Policy Forum is working on this.
In summary, there is a spectrum of collaborative initiatives in HTA, from voluntary to binding, and affecting different aspects of the HTA process, from methods development and endorsement to joint assessment of specific health technologies. All have specific opportunities and challenges, and the most valuable should be determined based on their impact on specific measures, such as contribution and implementation of method advances and, ultimately, timely access to high-value technologies.
Martina is standing for election to the HTAi Board of Directors - voting closes on 2 May 2023. Find out more at: HTAi candidates for the 2023 Board of Directors
UPCOMING EVENTS
Valuing Vaccines: The Economics of Vaccines & Immunisations
26 April | Virtual
We will be joined by global experts to discuss the value of equity in access to vaccines worldwide, and hear from practitioners in the economic evaluation of vaccines in resource constrained environments.
The free-to-attend webinar will also allow delegates to discover more about the EVIA programme, with tasters of the content and insights from those who have developed the learning materials and provided in-depth interviews on the economics of vaccines and immunisation in Africa.
Cell & Gene Therapies: Can We Find Innovative Ways to Pay?
10 May | In person
As the list of advanced therapy approvals grows, so does the pressure on payers. The record-breaking price tags reflect the savings in medical costs over time, but the sizable upfront costs could create significant challenges.
This event provides an opportunity for those in the Boston area to hear from our experts on innovative approaches to reimbursement, demonstrating the value of cell and gene therapies, and addressing uncertainty whilst providing patient access.
Register for your free ticket today.
Supporting Sustainability in the Era of Green Pharmaceuticals
16 May | Virtual
In this 90-minute webinar, we will build on the results of the “Supporting the Era of Green Pharmaceuticals in the UK” report. Consequent recommendations for industry, the NHS and UK Government as outlined in the report will be explored.
We will hear from a range of perspectives to capture the breadth of challenges and solutions associated with enhancing sustainability in the UK and globally. The session will end with a panel discussion and an opportunity for the audience to ask questions.
Register for your free ticket today.
OHE HIGHLIGHTS
In this Insights series we have paired members of the OHE team with an external collaborator to shed some light and share some insights on HTA around the world.
In our first edition, Dr Laura Vallejo Torres from Universidad de Las Palmas de Gran Canaria and Patricia Cubi-Molla from OHE take us to Spain.
In this report, we describe the design of a globally aligned, value-based, fully-delinked pull incentive, where payers provide manufacturers with a pre-specified subscription fee based on the value of the antibiotic, regardless of the volume used.
We bring together answers to some important remaining questions, such as the size of the incentive, which countries should contribute, and how to assign value to different antibiotics.
In this paper, OHE experts estimate the life-cycle value of risperidone as representative of second-generation antipsychotics (SGA) relative to haloperidol (first-generation antipsychotics).
They found that, in the UK and Sweden, the large majority of the total value generated by risperidone was captured by the payer, both before and after patent expiry.
NEWS HIGHLIGHTS
A new PhRMA report on global trends of patient access to new medicines, shows that new medicines most often launch first in the US.
Meanwhile, across the G20 countries, the US, the UK, Germany, France, Italy, and Japan are the top six countries making available over half of new medicines, reimbursing the largest proportion by their public insurance plans, within the shortest timelines.
A White Paper published by the Institute for Clinical and Economic Review (ICER) explores how HTA can improve health equity for racial, ethnic, and other socially disadvantaged groups.
Recommendations include setting incentives to increase the representation of racial and ethnic populations in clinical trials. But also promoting quantitative frameworks to incorporate equity whilst using deliberative processes to understand potential impact on the value of new technologies and inform policy decisions.
This rolling plan contains a list of key activities that the Commission has carried out or intends to carry out in preparation for the implementation of Regulation 2021/2282
on Health Technology Assessment (the “HTAR”).
The plan is subject to regular review and upcoming milestones include the publication of the list of organisations included in the stakeholder network.