Discussion Summary

The challenges of defining value

Defining “value” is a huge and complex task, reflective of the cultural and social values of the beholder, and contextual factors such as economic status and population size. How one chooses to define value will determine what is measured, how it is measured and will influence how innovation will be valued and paid for - and by whom. Different stakeholders can hold widely disparate interpretations of value which can be challenging when searching for common ground in a specific context.

The following definitions of value were described:

- General definitions of “value”: The regard something is held to deserve; the material or monetary worth of something; the worth of something compared to the price paid for it “value for money”.

- Definition of “value” in the literature (Porter, NEJM 2010): Value is the health outcomes achieved per dollar spent.

The definition of value needs to evolve

All stakeholders should be included in discussions to re-define and expand the concept of “value” to include, for instance:

- Incorporating social, cultural and scientific aspects in addition to economic considerations;

- Considering that the value of a technology can refer to qualities which are inherent in the technology itself, such as effectiveness, quality, safety, etc., and/or relate to the experience of the patient or aspects of the care setting such as the freedom to choose, accessibility, comfort, wait times, etc.

- Adapting the definition to focus on the essential nature or reuniting principles at the core of the practice of medicine – the patient-physician relationship, to do no harm, care that is of the highest quality, safe, equitable, effective, patient-centred, efficient, etc.

What matters in “value” therefore, what to measure?

Determining which aspects of value are to be measured in technology assessment is dependent on a range of factors including decision maker needs, the perspectives of different stakeholders and the organization of health systems, as well as also broader social and ethical considerations, including cultural standards and beliefs.

Table 1 (see link above in "downloads") presents an overview of the range of stakeholders whose perspectives – along with contextual dimensions – influence the choice of value criteria to be assessed. While this list is not exhaustive, it provides a starting point to conceptualize “value”.

Complex mix of stakeholder perspectives and cultural/social influences in defining value and what to measure

Cultural and societal context play a major role in determining the prioritization and weightings of the value criteria selected for measurement. For instance, the different countries assign different priority to economic assessments such as cost-benefit analysis.

The role of different stakeholders in selecting criteria for measurement also varies. In some systems, for instance, patients are becoming increasingly involved in determining what counts as value particularly with respect to health outcomes and their experience of treatment (e.g., comfort, ease of use, level of invasiveness), how much uncertainty they are willing to tolerate and the minimum difference they expect to see in innovative technologies.

Most HTA agencies have a remit to meet the needs of decision and/or policy makers, and therefore the expansion inclusion of new or different kinds of value criteria in HTA will tend to follow the requirements of decision/policy makers.

Consider choosing criteria for which data/methods already exist, but continue to develop infrastructure and methodology

Some suggested that the selection of what to measure should also take into consideration pragmatic aspects, e.g., those for which adequate methods and data already exist, and where it is possible to generate reliable data to meet specific decision making needs and timelines. However, other value criteria that are deemed to be important should be recognized, with robust methods and data infrastructure developed, where needed.

End of discussion summary on Defining Value. Please provide comments, additional information, references, using the "Add Comment" below.

Discussion Summary

How is value measured/assessed?

Methods to assess value vary across sociocultural contexts with many countries (e.g., USA, UK, Canada) applying economic evaluation as part of the first line of assessment, whereas in others (e.g., Germany) cost-benefit analysis is only undertaken when the health benefit is assessed to be marginal.

There are many methods used to measure the value of health technologies, as summarised below:

Examples of methods and measures:

- QALYs: TTO, SG, VAS or MAUs: EQ-5D, HUI, QWB

- DALYs, HYEs

- WTP (willingness to pay), SPDCEs

- Disease specific: with/without interval properties

- Experienced utility (Patient adjustment to treatment, i.e., patient has accommodated their disease)

- Measures of wellbeing

“Equity” weights: e.g. adjusting for disease severity:

- UK Value-Based Pricing proposes Burden of Illness weights

- Implication is that a QALY is worth more in a disease area where there is high burden (is every QALY we get weighted equally? Patient severity is key starting point)

- Parallels with:

WHO’s Global Burden of Disease Project, based on DALYs

Stolk proposal for weighting by “proportional shortfall”

- Other weights could include: income, age, unmet need, (what income groups would benefit – which age groups?)

Strong focus on economic methods, less on other areas (e.g., social, ethical value, or value/costs accrued elsewhere)

Most of the methods described at the meeting addressed economic and clinical aspects, with limited discussion of other methods, e.g., to assess ethics, social, cultural value, or how to assess the value accrued in other areas within or beyond the health system.

It is important to consider that value is relative (incremental, comparative, differential) and not absolute, and therefor all value criteria (effectiveness, safety, comfort, etc.) are relative measures. Some debate ensured about the selection of the comparator to generate measures of incremental benefit. The standard of care may have low cost but offer high value, or the standard of practice may be a generic drug which may not be an appropriate measure for a new innovation in pharmaceuticals offering a higher cost, but also a higher incremental benefit. Furthermore, the downstream costs associated with new technologies, particularly disruptive technologies, needs to be taken into account to determine an accurate assessment of the value offered by a technology.

Consider different measurement approaches for different types of technology

The measurement of value may require that diagnosis, devices, drugs, outcomes, etc., may require different assessment approaches, and in settings where only disease-specific evidence is available, this may render choices across different disease areas more difficult to make. Data availability is part of the problem as there is little post-market, post-procedural data routinely collected. Precision of measurement is important, e.g., avoiding double counting of consumption and income effects in measures of health gain. Where measurement lacks precision, or where it has been inappropriately generalized, an intervention may appear to offer higher value than what it actually does.

How (or if) to aggregate measurements of value

The complex nature of the practice of medicine is not realistically reducible to a single number, and aggregation of data offer limited utility. Nonetheless, where used appropriately (i.e., where is it not used as a replacement for decision making), aggregation can be a useful tool for the uptake of complex data into decision making both at the system and clinical levels. It was suggested that the methods for aggregation might be expanded beyond quantitative data to include broader value criteria and measurement methods.

Current methods to aggregate measures of value include:

1. QALY : weight it up or down to take account of aspects of value not captured (or fully captured) in the “basic” QALY

2. Convert everything into dollars – threshold and willingness to pay

3. Deliberation – a committee has to judge or make implicit judgments

4. MCDA: a way to weight equity considerations (deliberating in structured way)

End of discussion summary on Measuring/Assessing Value. Please provide comments, additional information, references, using the "Add Comment" below.

Discussion Summary

Health system considerations

The arrangement of the health system can impact how value is paid for/covered. For instance, some stakeholders perceive that performance/outcome-based payment processes are creating wrong incentives and needs to be changed to produce actual benefits. In systems where HTA recommendations are binding, decisions to adopt technologies are separated from the budget considerations, resulting in difficult reallocation or disinvestment decisions having to be made to accommodate the incoming technology (e.g., in the UK where new technologies must be implemented in the NHS within 3 months of the recommendation from NICE).

Budget silos can present barriers since there can be resistance to pay for something when the benefits are not enjoyed by the local budget/department, but rather are received elsewhere in the value chain.

When considering the broad array of possible value criteria (e.g., see Table 1) it may be useful to view them through the eyes of payers to differentiate between value and purchasing value. There may are many aspects of value that are worthwhile, but considering these through the lens of willingness-to-pay and trade-offs may be useful. For instance, an aesthetically pleasing clinical environment may be of value, but it may not warrant spending on a limited budget, particularly if it means trade-offs with higher priority values such as shorter wait times or increased duration of clinician visits.

Considerations for innovation

Where and how health systems choose to cover/pay for value is a powerful driver of technology innovation as industry will tend to develop technologies in these areas. Systems offering Managed Entry/Coverage with Evidence Development (CED) schemes present a further opening for innovation as systems can pay for promising new technologies that do not currently meet the standard for full coverage.

Innovative technologies may tend to cost more than the standard of care and it was suggested that prudence be used where required to determine if/how to pay for new technologies as spending more money may not necessarily mean better health outcomes are achieved.

Differentiating value, cost and price

It is important to distinguish between the cost and price of health technologies. The language in HTA is about “measuring cost” but the price of a technology may be different from the cost. Price is not a fixed entity, i.e., it reflects variability in negotiation, consumer willingness-to-pay, and the economic climate in different markets. Changes in the health services delivery/service setting may also affect the price of technologies. For instance, the rise of personalized medicine and genome diagnosis can increase the targeting of specific treatments to patients, but in so doing, the size of the patient population for a treatment decreases and in order to recuperate development costs, industry may need to raise prices.

Different economies relate cost and value differently and changes in the economic climate (e.g., austerity measures) have, in some cases, altered the pricing dynamics between industry and government. Pricing and value may be more easily addressed in managed entry systems.

Further questions were raised about the relationship between cost and price, i.e., the role or impact of international reference pricing and how industry determines value (price) and where this might be (or is) linked to other values.

Other factors influencing covering/paying for technologies

The role of other stakeholders and service sectors in the coverage/payment of technologies was briefly discussed. For example, what is the role of employers, pension plans, unemployment programs, workers compensation or other employment-based health plans in paying for value? With population aging there are more people coping with chronic diseases later in life. Determining how the needs of an aging workforce will be paid for will be a likely driver in the innovation of health technologies and the coverage/payment arrangements in the future.

End of discussion summary on Covering/Paying for Value. Please provide comments, additional information, references, using the "Add Comment"

Discussion Summary

Definition of innovation

Innovation: Something that is new or different; a more effective or otherwise better product, process, or other technology; addresses the demand (unmet need) of, is accepted or adopted by, or is otherwise beneficial to users/markets; presents a meaningful (e.g., clinically and statistically significant) positive change.

An innovation of value: Achieves desirable/acceptable improvement in outcomes per incremental expenditure

Processes of innovation generally follow the market or where the money is, in other words, where health systems chose to reimburse technologies is where most innovation will arise. Similarly, Coverage with Evidence Development or Managed Entry programs (where available) can foster innovation by providing opportunities for unproven technologies to gain gradual access to health markets as the evidence base of effectiveness, safety, etc. is established.

The perceptions of some that HTA can “speed” or “slow” the process rests in the eye of the beholder, for instance, decision makers or payers who reject certain innovations may be labelled as “anti-innovation” when, in fact, they are very pro-innovation but are looking for a certain type of innovation or one which offers a minimum threshold of increased value compared to the standard of care.

HTA, value and innovation: methods and approaches

HTA can and does foster innovation, for example, by sending explicit, a priori signals to innovators regarding the evidence requirements to demonstrate value. HTA may unintentionally impede (or appear to impede) innovation through a limited range of current methods available to capture certain dimensions of value, or due to low political/decision maker demand for HTAs which assess such attributes.

The basis of HTA is evidence production and assessment, therefore evidence in some form must be generated to assess innovation/value. What evidence is needed, then, to assess innovation and are there HTA methods and toolkits available to measure this?

HTA processes/methods might be adapted in broader areas of value, for instance, areas of unmet medical need, severity of disease, prevalence of condition, latitude for clinical judgment, patient preference, public health impact, population/demographic equity, demographic group, societal impact or highly promising technologies with “upside potential”.

As a final note, there is currently a debate around if innovation has a value over and above the properties offered by the technology itself. For instance, the process of innovation is one which produces incremental innovation, and therefore, it may be of value in itself. The production of a revolutionary or high-impact technology requires that sufficiently robust processes of innovation are ongoing and supported. This was mentioned at the meeting but was not explored in depth.

End of discussion summary on Value and Innovation. Please provide comments, additional information, references, using the "Add Comment" below.

Several ideas were proposed of how the policy forum might structure and frame the February 2013 meeting on HTA and Value.  Suggestions included:

Meeting objectives:

> Look for common ground in one or more of these areas:

      - Establish a minimum agreement of what counts as value. Bridge understanding across different stakeholder views and determine areas of common interest/value.

      - Identify what areas of value are important and determine if there are methods and data available in these areas.

      - Develop a value proposition for application/use 1) across markets; and, 2) across all stakeholders.  Determine if there are commonalities across these two areas.

> Focus on methods only, elucidating the pros and cons of each type of approach or the implications of doing some and not others. NOTE: A word of caution was raised here since it may not be feasible (nor necessarily desirable) for the Forum to delve too deeply into the technical aspects of methods for measuring value.

> Examine the relationship between price, cost and value, and how price is set in different contexts.

> Develop a broad list of value characteristics then determine where these might be grouped together, which are more easily measured than others, and which are more suited to aggregation. 

> Discussion of the trade-offs of different aspects of value (with respect to the criteria looked at, the methods for measurement, and decision making processes).

> Arrive at a consensus statement of a definition of value (i.e., it is relative, not absolute; is incremental)

> Forum could examine if innovation has a value over and above the direct benefits of the technology itself and then issue a position paper in this debate.

> Conduct an analysis of how innovation works in different countries, looking at what are the qualities of successful markets.

Invited guests to consider including:

> One or more completely different perspectives on “value” at the Forum meeting (e.g., a representative from education, judiciary, transport, or other sectors).

> One or more technology developers, to understand the perspective of innovators and how HTA might help them in their work (e.g., providing information on what is/will be valued in order they can produce highly valued innovations).

Meeting structure:

> Break the meeting into subgroups to look in-depth at each of the four areas of HTA and Value.

End of summary of suggestions for the framing/structue of the February Forum meeting. Please provide comments, additional suggestions, etc., using the "Add Comment" below.