What is adaptive health technology assessment?

Ideally, all health policy decisions should involve the use of HTA processes and methods which offer quality, context-specific and locally relevant evidence. However, where the ‘gold standard’ of HTA is not immediately possible, countries may seek to expedite or adapt some aspects of the HTA approach.5 The broad concept of aHTAs is not new; it is used in high-income countries such as the UK, Canada and the European Union.6 7 These approaches are largely focused on expedited processes to respond to time constraints, for example, in the case of a new technology or a public health emergency.8 However, there are limited examples from LMICs transferring the same types of approaches, as LMICs are more likely to be constrained not only by time, but also by capacity, resources and data. Hence there is a need for HTA processes, methods and analytics that can be adapted to suit LMIC HTA constraints.

We seek to define aHTA as a blanket approach for HTA methods and processes which are fit-for-purpose and focused on context-specific practicality considerations. Methodologically, aHTA may leverage or adapt available international data, economic evaluations, models and/or decisions from the published literature or established HTA agencies to expedite policy decisions while adequately accounting for concerns of transferability and uncertainty.9 The aHTA process should be pragmatic, though still informed by key HTA principles such as transparency, independence, consultation and contestability.

There is no ‘one-size-fits-all’ approach to aHTA as no two health systems are alike, but generally components of traditional HTA can be modified or adapted pragmatically to suit LMICs’ needs (table 1). Hence, aHTA may benefit LMICs which either have a nascent HTA agency or not one at all, and do not receive HTA submissions from pharmaceutical companies. In circumstances where an LMIC does have an active HTA agency with adequate capacity to appraise evidence, it may be feasible to receive pharmaceutical dossiers as part of the HTA process.

Adaptive health technology assessment methods

There are numerous aHTA methods which vary by scope, approach, complexity and mix of data sources used depending on contexts-specific constraints.10 The loosely categorised examples below demonstrate the breadth of these approaches which we are aware of in LMICs.

Limitations of using adaptive health technology assessments

The primary incentive for using aHTA in LMICs is to serve policy makers who may be short on capacity, resources, time or bandwidth to take decisions for various government processes such as budget negotiations, ministerial and parliamentary meetings, procurement contracting and tariff negotiations.20 In such situations, pursuing an aHTA approach represents a practical and useful option; rather than taking up to 1–2 years for a full HTA process from topic selection to implementation as is perhaps usual under more traditionally applied HTA frameworks, aHTA provides relevant evidence quickly and reduces the domestic analytical burden.

However, aHTA also has its limitations, the most important of which is transferability of international data and information to the local setting, a process which can increase the uncertainty of results. Even for topics which are well studied in other countries, the evidence is often from high- or middle-income countries that have different health systems, healthcare costs, patient characteristics, burdens of disease, value judgements and provider/clinical practice norms than the country under study.21 This is further complicated if the evidence used comes from countries where the HTA recommendations are linked with academic and commercial in confidence data (such as the UK), as well as by the publication bias towards technologies with positive cost-effectiveness results. If not adequately acknowledged in the appraisal process using available approaches for assessing transferability with the right expertise in health economics, reliance on misinterpreted international evidence risks leading to suboptimal decision making.9 22 Furthermore, if evidence for many technologies is quickly reviewed without such expertise, it could result in a disproportionate number of cost-ineffective technologies being covered, putting unnecessary pressure on the sustainability of public finances as it did in Romania using a rapid ‘scorecard approach’.23

In addition to transferability, aHTAs can generally only be conducted on topics for which international data and/or models are available. For topics which are not well-studied globally, de novo collection of local data is required. Depending on the topic and availability of locally relevant data, aHTA may also demand substantial local clinical expertise to understand local health system constraints, clinical pathways and outcomes, all of which are critical to transferring evidence from other jurisdictions.

Furthermore, aHTA may not build the needed wide-ranging capacity—in epidemiological and medical statistics, health economics, HTA processes, evidence appraisal and translation of economic evidence to policy—or create the incentives for building capacity to support HTA institutionalisation.9 If countries rely solely on aHTA as an approach to priority setting despite its limitations, sustainable HTA infrastructure and processes may never be built and reliance on development partners may continue.

Finally, while the HTA process has been undertaken in many LMICs and adapted in various ways, publications which detail HTA modifications, benefits, pitfalls and lessons learnt are limited. Moreover, we are not aware of any publication which assesses an aHTA approach against a more traditional one to empirically understand these benefits and pitfalls.

Benefits of using adaptive health technology assessment as a ‘tool’ in the toolbox

The limitations of aHTA make it clear that while it can offer some relevant and adequately nuanced evidence, which is better than no evidence at all, it is not a replacement for traditional HTA approaches, even those based on more expedited processes but still requiring significant expertise (eg, UK National Institute for Health and Care Excellence (NICE) Single Technology Appraisal). Rather, it is possible that aHTA, if fit-for-purpose, could be a permanent tool in a larger HTA toolbox as it already is in many countries, and support the long-term uptake of HTA. We have found through our work at the international Decision Support Initiative that doing HTA rather than talking about HTA is a useful and impactful means of sensitising key stakeholders on the processes and analytics required for good HTA. Through lived experiences, aHTA can spark demand for future HTAs and uncover key data gaps that need to be addressed for use in HTA.

Furthermore, aHTA saves time by identifying ‘low-hanging fruits,’—well-studied technologies which are known to be cost saving, highly cost-effective or very cost-ineffective internationally—minimising the amount of effort required for review. This can allow resource space to be made available for the conduct of more intensive HTAs dedicated to local priorities and technologies that are not well studied in other countries or those that are well studied but there is greater uncertainty about their marginal benefits and costs. Local capacity building can then be a much greater feature in the conduct of such HTAs.

For the future, aHTA requires developing processes, governance structures and analytics that can be leveraged to support a fully institutionalised HTA model. In multiple countries, aHTA has created the impetus for small HTA ‘core teams’, mini topic selection processes, and appraisal processes which can be directly built on for HTA institutionalisation. Policy-makers are also keen to incorporate local data into the aHTA, including for example, cost, epidemiology and coverage rates, which in turn demands locally relevant, more complex, analysis.24 In the first instance, there are a few initial steps that researchers, policy makers, and donors could take to support the uptake of aHTA:

• For HTA practitioners, write and publish peer-reviewed examples of aHTAs for global knowledge sharing, detailing where HTAs were adaptive, how they were modified and strengths, weaknesses and lessons learnt.

• For researchers, develop, test and validate a set of standardised approaches for conducting aHTAs in LMICs—drawing on lessons learnt from other LMICs’ HTA journeys—articulating strengths, weaknesses and uncertainty of each approach and identifying necessary skill sets for implementation.

• For policy makers, leverage aHTA as one mechanism for evidence-based decision making, identify priority topics for aHTA and those which demand more detailed analysis, build processes and governance structures which include aHTA, or even develop a ‘reference case’ for the conduct of aHTA.

• For clinicians, develop clinical practice guidelines, pathways and health benefit packages that are more cost conscious and informed by aHTA approaches at least initially, which are updated subsequently if evidence from a traditional HTA becomes available.

• For donors, support the uptake of aHTA and long-term HTA institutionalisation through making key investments such as capacity building, model sharing, model databases, and Incremental Cost-Effectiveness Ratio (ICER)databases (eg, Tufts Cost-Effectiveness Analysis Registry), as well as including HTA uptake as a key indicator for sustainability and aid transition.