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FEBRUARY 2022

Guest editor: Martina Garau  |  Director

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Two of the most influential HTA agencies in the world review their methods. This year has started with the publication of the new methods guide of the National Institute for Health and Care Excellence (NICE) and February will mark the start of its implementation. On the other side of the globe, Australia is starting its HTA methods review. Are those signs that Health Technology Assessment (HTA) decision makers are embracing change?

Ultimately, HTA decisions should inform funding of the most valuable interventions within health systems and investment decisions on R&D efforts made by industry. Hence, the methods used by HTAs, which are statements of preferred evidence and approaches for conducting such assessments, are crucial.

 

When considering why a review should be triggered, there are supply side factors that matter, such as technological advances (and we have seen many in the last few years, from digital health technologies to gene therapies). Novel regulatory frameworks have been created to accelerate approval of promising interventions, but they haven’t been translated into HTA methods updates, increasing the pressure for methods revisions. Key in triggering changes are also methodological developments, particularly when applying a certain technique or framework for value assessment has proven challenging or inadequate in supporting the system in meeting its goals.

 

OHE has explored and provided solutions on many of these challenges, for example those related to the appropriate evidence and type of economic evaluation to assess digital health technologies, and on the methods to split the value of combination therapies. 

 

When considering how a review can take place, first there is a need for willingness to change practice by the key decision makers including HTA agencies but it is also important to get support from the broader community. An example of when this didn’t take place was in 2014 when, as part of the Value Based Assessment (VBA) proposals, the introduction of proportional shortfall as a measure of severity of illness was suggested but found little endorsement among stakeholders responding to the consultation.

 

Another key enabler is the availability of accepted approaches to incorporate new methods into practice. Related to severity, proportional shortfall was proposed in the early 2000s by a group of Dutch health economists  and since then has been tested and implemented in different contexts. NICE has just introduced an explicit severity modifier based on proportional shortfall and another metric in its new manual. Another example of slow methodological uptake is provided by OHE’s Chris Sampson in his latest editorial.

 

Finally, we need evidence, in particular empirical evidence in support of methods change. In the case of severity that means studies demonstrating that society is willing to prioritise sicker patients which is available but it is not necessarily captured in HTA decision making.

 

We might be observing some signs of change endorsement in HTA systems (I am thinking, for example, about the new “modular” approach that NICE is committed to using in upcoming updates) but it still takes far too long (over 10 years in some cases) to alter, evolve or adapt unsatisfactory methods used to assess the value of innovative treatments. The wind of change should be stronger!

MY TOP READ OF THE MONTH

“Most published CEAs (95%) do not include assumptions about future generic prices for intervention drugs […] The omission of assumptions about genericization means that CEAs may misrepresent the long run opportunity costs for drugs"

Do Cost-Effectiveness Analyses Account for Drug Genericization? A Literature Review and Assessment of Implications? | 12 November, 2021

Generics comprise 90% of US prescriptions. The authors of this paper investigate how genericization (a formal consideration of medicine price declines following generic entry) is captured (or not) in cost effectiveness analysis (CEA). They found that a third of HTA guidelines only 

 mentions genericization and that the vast  majority of CEA publications (95%) do not consider it. The impact on cost-effectiveness should be greater for medicines that patients take over longer time periods, such as multiple sclerosis. Failure to consider genericization could distort results of CEAs by misrepresenting total drug costs and not reflecting real-world conditions.

 

Read

NEW OHE LITERATURE

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NICE and the EQ-5D-5L: Ten Years Trouble

 

Ten years have passed since the publication of the EQ-5D-5L descriptive system and 5 years since a value set for England was first published. In this editorial, OHE Chris Sampson provides an overview of the debacle. He concludes that NICE should revise its reference case regularly and recommend the 5L value set for England.

 

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Dramatic Innovations in the Treatment of Spinal Muscular Atrophy, But Many Unknowns Remain

More evidence on cost, effectiveness, and patient preferences for treatments for spinal muscular atrophy (SMA) has recently been published. In this editorial, OHE Chris Skedgel comments on the challenges to a full understanding of the value of these emerging treatments, including how utility instruments may not be sensitive to gains that patients may value highly.

 

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Learnings from the Assessments of Entrectinib and Larotrectinib: HTA Challenges Associated with Tumour-Agnostic Therapies

A paradigm shift is occurring in cancer care with the introduction of tumour-agnostic therapies, for which the indication is defined by the molecular signature of the tumour rather than by its location. One of the biggest challenges lies in the clinical and economic assessment of these therapies, as well as subsequent decisions regarding reimbursement This report provides an analysis of HTA agency assessments and reimbursement decisions for entrectinib and larotrectinib across 7 countries.

NEWS HIGHLIGHTS

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The Regulation on HTA, a deliverable of the EU Pharmaceutical Strategy, has been adopted

The Regulation, which focuses on clinical aspects of HTA, will entail Joint Clinical Assessments conducted by Member States' HTA bodies. They will also engage in Joint Scientific Consultations, “horizon scanning” exercises, and potentially in further voluntary cooperation. The Regulation will apply from January 2025, but the implementing work starts now.

 

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Over half of nurses had problems sleeping during the first six months of the pandemic

A newly released study has highlighted the scale of impact that the COVID-19 pandemic has had on the mental health of health care professionals. Sleep problems were found to be interwoven with anxiety and depression symptoms with over half of nurses in the study reporting anxiety and almost a quarter reporting being depressed.

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The search is on for next-gen COVID-19 vaccines

The WHO’s technical advisory group on COVID-19 vaccine compositions (TAG-CO-VAC) has encouraged vaccine developers to provide data on new vaccines in its first official statement since inception. The group is using immune response data to determine which variants of concern new vaccines should target in a broader decision-making framework on vaccine composition. Seeking help from the pharmaceutical industry represents a departure from the WHO’s approach to deciding the composition for seasonal flu jabs.

 

UPCOMING EVENTS

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Do we need animal health economics?

10 March  |  Economic analysis has been central to human health and health care decision-making for decades. The same cannot be said for animal health. There is a long-standing interest in the interaction of animal and human health; see our 1969 paper on antibiotics in animal husbandry, for example. However, few have explored the potential for broader application of health economics thinking to animal health.

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 Join us as we explore  the question ‘do we need animal health economics?’

 

Each of our panellists will present their views on this question, exploring a range of health economics topics as they may relate to animals, from market failures to measuring wellbeing. The panel will identify the complexities of answering this question across agriculture, wildlife, and companion animal settings, and acknowledge the challenge of navigating conflicting ethical principles.

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The panellists:

 

Hareth Al-Janabi, Professor of Health Economics, University of Birmingham

Werner Brouwer, Professor of Health Economics, Erasmus University Rotterdam

Stefan Lipman, Assistant Professor, Erasmus University Rotterdam

Louise Proud, PhD student, University of Bristol

Chris Sampson, Principal Economist, Office of Health Economics

 

Register your free ticket

 

 

 

 

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