Assessing the value of vaccines: Considerations from the HTA perspective

As the world struggles to gain control of the COVID-19 pandemic, the development and distribution of an effective vaccine has become a globally prioritized initiative. While the initial focus surrounding the COVID-19 vaccine was centered on efficacy, and production logistics, discussions have broadened toward affordability, pricing, and allocation now that several vaccines are available (Figure 1). Determining a fair pricing strategy that incentivizes development while ensuring value and access for patients, however, has remained a difficult process exacerbated by the unique demands of a global health crisis. During initial approvals of the vaccine, pricing and distributions were subject to heavy negotiations between manufacturers, governing bodies, and multilateral entities such as the World Health Organization. Consequently, preliminary vaccination efforts have largely consisted of short-term, pre-purchasing agreements between manufacturers and government entities, allowing vaccines to be obtained at below-market costs. In several cases, manufacturers have pledged to sell vaccine doses on a not-for-profit basis during the pandemic, yet how these prices might change post pandemic is still unclear. 

Figure 1. Building blocks of an effective global vaccination program against COVID-19

 ^{Key: WHO – World Health Organization.}

Defining the value of vaccines
Compared to the value appraisal and pricing approaches for other health technologies and interventions, the value assessment and pricing of vaccines requires unique considerations. For example, traditional economic evaluations used to assess the value of drug therapeutics (eg, incremental cost-utility analysis) often overlook broader societal and individual benefits that are uniquely associated with vaccines, such as herd immunity or decreased severity of disease.

 
Even without formal assessment, the value of the COVID-19 vaccine is objectively high due to the seriousness of the disease and the extending impact the virus has had on the global economy and healthcare systems. Nonetheless, aligning the value and price of a vaccine remains an important endeavor for COVID-19 as well as future vaccine developments overall. Furthermore, given the uncertainty of vaccine pricing in an endemic stage as well as the likelihood for COVID-19 vaccines to require booster immunizations to maintain effectiveness, an informed pricing strategy will be crucial for allocating resources over the coming years. 

Assessing the value and associated costs of vaccines

The pricing of new vaccines under normal circumstances is subject to several factors across markets, including competitions, cost of production, price-demand curves, and incremental value of the vaccine among other factors. Although several vaccine pricing strategies have been proposed or used in the past (Table 1), each approach carries different advantages and limitations that must be weighed carefully by stakeholders. 

Table 1. Pricing approaches for novel vaccines

^{Key: R&D – research and development.}

Cost-effectiveness (CE) analyses remain one of the most widely used assessments to inform the pricing of vaccines for payers and health authorities. A recent CE analysis evaluated the CE of the Moderna COVID-19 vaccine, which was concluded to be cost-effective (up to $150 per dose) in US adults based on the incremental cost per quality-adjusted life-years gained. This study measured benefits to vaccinated individuals, though secondary societal gains (eg, possible reductions in transmission) or societal costs of the pandemic (eg, damage to the economy) were not considered. Despite the pervasiveness of this type of CE analysis for therapeutics, not sufficiently capturing the societal costs of the pandemic and benefits of immunization can lead to underestimating the true value of the vaccine. CE and value assessments in a pandemic thus differ from conventional practices, necessitating the consideration of a wider range of individual and societal factors that extend beyond the healthcare system. 

The role of HTAs in pricing the COVID-19 vaccine

In terms of pricing COVID-19 vaccines, common themes across health technology assessment (HTA) agencies have emphasized the need for cooperation between public and private entities in order to prioritize a pricing strategy that continues to foster novel therapeutic developments at an accessible cost. Given the challenges associated with defining the value of the COVID-19 vaccine, HTA organizations have raised key questions as to which broader effects may be most critical to include when conducting value and CE assessments to inform pricing. Considering the feasibility issues of compiling an exhaustive list of variables worth examining in value and CE assessments, identifying practical constraints as well as variables that are most relevant can still offer a systematic framework for deliberating the cost and value of the vaccine. 

Conclusions 

The COVID-19 pandemic underscores pressures between balancing affordability, access, value, and ethics of healthcare technologies and other services. Policy makers have an obligation to ensure efficient use of resources and aligning price with the value. HTAs and national health services have an important role in evaluating the costs associated with different vaccines (eg, costs per dose and implementation costs), identifying barriers to efficient manufacturing and distribution, assisting with monitoring long-term safety and efficacy, and helping to determine the most ideal and cost-effective vaccination strategy from both societal and healthcare points of view. While debates surrounding the cost and value of the COVID-19 vaccine are unlikely to end anytime soon, ensuring appropriate utilization of resources to balance affordability while supporting innovation will be beneficial for ending the current pandemic and preventing future pandemics in the years to come. 

The article should be referenced as follows: 

Choate A. Assessing the value of vaccines: Considerations from the HTA perspective. HTA Quarterly. Summer 2021. https://www.xcenda.com/insights/htaq-summer-2021-value-vaccines-hta-perspective

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