Early Health Technology Assessment for a COVID-19 Vaccine

As the COVID-19 pandemic continues to unfold, it has become increasingly accepted that day-to-day life will not return to anything close to normality until a vaccine or effective treatment is available and widely accessible.

While there are numerous vaccine candidates in development, it is expected that an effective vaccine will not be available until the first half of 2021 at the earliest. It is also likely that the vaccine will not be produced in high enough volumes to be given to the entire population in need at once. It may take a year, or even two, to vaccinate the eligible global population, all this assuming that the price of the vaccine is not a barrier. As countries, individually and in coalitions, prepare for a vaccine to become available, they should consider conducting early health technology assessment so they are ready for the pricing negotiations and coverage decisions to come.

Priorities for a COVID-19 vaccine

As governments around the globe plan for a vaccine alongside the ongoing R&D efforts, they should consider a number of important questions before implementing a COVID-19 vaccination programme:

• Which population groups should be prioritised for vaccination?
• How many people should the government aim to vaccinate?
• Are there any measures, such as antibody testing before vaccination, that can maximise the impact of available vaccines in the first place?
• What price should the government be prepared to pay for the vaccine?

The answers to these questions will vary depending on the characteristics of the vaccine(s) that becomes available. As we anticipate that multiple vaccine candidates will soon be competing, it is important for governments to be able to make informed purchasing decisions about the vaccine(s) they choose. The vaccine’s value will be determined by its efficacy (in terms of both reduction of COVID-19 infection risk and severity) and safety profile, number of doses required, and cold chain storage requirements of a COVID-19 vaccine. These characteristics will be critical for a large scale rollout, but are all, at this stage, unclear. The World Health Organization’s target product profile for a COVID-19 vaccine can serve as a guide for manufacturers and governments, but it offers a range of acceptable characteristics: a successful vaccine for COVID-19 is hardly a binary state of affairs.

What can governments do to prepare for a vaccine roll out?

Traditional health technology assessment (HTA) assesses the added value of health innovations at launch, when their attributes have been well-established and studied, and the innovation has been given marketing authorisation. Early HTA, combined with mathematical modelling, can help payers and technology sponsors understand the potential added value of innovations higher up in the pipeline or even hypothetical ones. In addition to helping public planners prepare through scenario analyses, early HTA can help shape the development of COVID-19 vaccines by signalling preferable vaccine characteristics (e.g., safety and efficacy profiles, mode of administration, number of vaccine doses, vaccine storage requirements, target populations, vaccine purchasing, and delivery costs) that can maximise the public health impact. Purchasers will be will  pay prices that represent good value for money in their respective settings. This is the crux of the benefit-based Advance Market Commitment (AMC): used by global coalitions such as the recently launched Gavi Covax AMC and the European coalition, and by individual country-led initiatives such as the US Operation Warp Speed, early HTA can ensure ex ante commitments are conditional on product performance. Early HTA can also help to inform clinical trial design, including the selection of appropriate surrogate outcomes and efficient sample sizes, and has been extensively used by regulators together with payers in Europe and elsewhere.

Benefits of early HTA analyses

Conducting early HTA analyses will streamline and accelerate the decision-making process when one (or more) COVID-19 vaccine does become available. A range of hypothetical characteristics and economic and planning scenarios should be explored and could readily feed into the final HTA analyses that will prove crucial when deciding how a licensed vaccine or treatment should be utilised.  As an example, Thailand previously conducted an early HTA economic evaluation for a potential HIV vaccine and published the results here. If countries are able to determine context-specific minimum performance thresholds for a COVID-19 vaccine, early HTA will help to shorten the process of deciding whether a realised vaccine would be suitable for their context. This is important for high-income countries that are already engaged in bilateral deals, and for the Gavi-led coalition, but also for any middle-income emerging markets. In particular, this would benefit countries in Asia (such as Thailand) and in Latin America that may not be part of any such buyers clubs and will have to make an adoption and purchasing decision themselves.

Countries should consider conducting early HTA assessments for rolling out a future COVID-19 vaccine in their own settings to ensure that they are well-prepared for pricing negotiations and coverage decisions. These preparations will also help them be ready for the practicalities of population targeting and operationalising the roll out once a vaccine does become available. Such initiatives can then inform decisions by country coalitions such as the WHO-led ACTA ambition aiming to crowd in multiple countries and pool procurement for vaccines (and treatments). There are early HTA appraisal studies of a COVID-19 vaccine underway in Thailand and Singapore already.

To find out more details about these projects please contact Dr. Yot Teerawattananon ([email protected]) and Dr. Hannah Clapham ([email protected]).