HTA Pharmaceuticals

History and Future of the “ISPOR Value Flower”

That is the name of a recent paper in Value in Health from three of pharmacoeconomics field’s leading scholars: Peter Neumann, Lou Garrison and Richard Wilke. The paper begins by comparing the ISPOR value flower against the recommendations from the Second Panel on Cost Effectiveness in Health and Medicine.

  • Intervention types. The ISPOR Value Flower focused almost exclusively on pharmaceuticals whereas the Second Panel considered interventions more generally. Whereas the Value Flower was an ISPOR initiative, the Second Panel was sponsored by the US Public Health Services. I would say, however, that the “value of knowing” within the ISPOR value flower does pertain to the value of diagnostics.
  • Participants: The ISPOR value flower task force was largely comprised of health economists; the Second Panel had a more multi-disciplinary group of experts.
  • View on QALYS. Both groups “Both groups recognized the strengths of conventional cost per quality-adjusted life years (QALYs) as a starting point for discussions about value, but also highlighted that metric’s limitations.”
  • Elements not included in the Second Panel. The paper cites two value elements in the ISPOR value flower that were not in the second panel: the “value of knowing” and “insurance value”. The former is the value individuals place on knowing one’s diagnosis even if this information may not lead to improved health outcomes or changes in treatment; the reduction in uncertainty itself is valuable. The insurance value examines individual willingness to pay for coverage for new interventions in the case that someone does require treatment in the future.
  • Elements not included in the Value Flower. The authors note that “absence of alternative effective therapies” is included in the Second Panel but not explicitly mentioned in the ISPOR Value Flower. The Value Flower does mention “Equity” as an important value element, but does not link that directly to the absence of other effective treatments.
  • Multiple criterion decision analysis (MCDA). This is mentioned explicitly in the Value Flower paper whereas the Second Panel simply aimed to partition value elements into different segments.

The paper notes some cases where health technology assessment (HTA) bodies have made exceptions to standard CEA approaches. These include:

  • Sweden’s Dental and Pharmaceutical Benefits Agency. This HTA has for a number of years “…applied a severity modifier, with the potential to allow a higher threshold for treatments of severe diseases (where severity is based on the expected loss of QALYs if patients are not treated).”
  • Scottish Medicines Consortium (SMC). SMC allows for value modifiers when drugs produce “…substantial changes in life expectancy and QOL and also consideration of factors such as equity, the absence of alternative therapies, and situations in which a drug may provide a bridge to another proven therapy (labeled option value in the value flower).”
  • National Institute for Health and Care Excellence (NICE). In its latest update, NICE now allows for modifiers for “innovation, end-of-life care, magnitude of treatment benefit, curative potential, rarity, age, burden of illness (severity), health inequality, and uncertainty.”
  • Institute of Clinical and Economic Review (ICER). ICER considers various “contextual considerations” and “other benefits and disadvantage” of therapies. These include factors such as disease severity, lack of alternatives, novel mechanism of action, and health disparities. These factors may impact whether their panel votes to consider a treatment high-value but they do not impact their empirical estimate of what should be the value-based price.

What has happened since the ISPOR Value Flower and Second Panel were developed. Some key developments include:

  • Generalized risk-adjusted cost-effectiveness (GRACE). This approach was developed to show that patient risk preferences matter as does the uncertainty around health outcomes. The authors hypothesized that there were diminishing returns to quality of life improvement so that treatments for severe diseases should be valued more highly.
  • COVID-19 pandemic. This clearly was a case where many of the broader value elements because highly relevant (see my paper on this topic, Shafrin et al. (2020).
  • Extended CEA (eCEA) and distributional CEA (DCEA). eCEA projects the distribution of health gains and financial consequences across income quintiles; DCEA allows one to look at societal preferences for reduced inequality of health outcomes and value treatments that reduce inequality more highly than those that do not.

The Neumann et al. (2022) paper also discusses a variety of empirical estimates of the broader value elements. In terms of practical impacts on payers, the paper concludes as follows:

…many HTA bodies and payers have considered certain aspects of the value flower for some time, although mostly in a qualitative manner. Nevertheless, explicit and quantitative adoption of certain petals of the value flower (eg, insurance value, option value, value of hope) or other aspects of societal perspective (eg, caregiver spillovers) has yet to gain traction. In part, the lack of uptake may simply reflect the recency of the STF report and
other research, but it may also reflect other factors: a relative dearth of empirical estimates to support novel elements, the difficulties of changing established practices, the absence of strong incentives for US payers to consider nonhealth effects and externalities,
and an unwillingness of health insurers to consider elements such as option value or scientific spillovers because they rely on yet undiscovered innovation.

The paper is interesting throughout and worth a read.

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