Week 10 - Value Trade Off

Agenda

The “official” Purpose of HTA

  • a multidisciplinary process that summarizes information about media, social, economic, and ethical issues…

  • Aim: To inform the formulation of safe, effective, health policies that are patient-focused, and set to achieve best value

“Ethical Paradox”

→ the intention: Ethics has been a stated, constituent part of HTA since its inception in the 1970s

→ the reality: “despite almost 40 years with repeated intentions, only a few HTA reports include ethical analysis” (Hofmann, 2014)

  • not printed in the actual report

the moral imperative

  • HTA is not just a calculation; it serves as a stewardship mechanism

  • At the hospital level:

    • Imperative: Responsible use of resources for the local community

    • Question: Does this new surgical robot mean cutting nursing hours elsewhere?”

  • At the Provincial level (e.g., BC HTA, INESS, Ontario Health):

    • Imperative: Balancing the health budget and ensuring equitable access

    • Question: “Does funding a $500k/year drug for 20 people mean 2000 people lose physiotherapy?”

  • At the Federal Level (e.g., CADTH):

    • Imperative: National standards, pricing, consistency, fairness

    • Question: “What precedent does this decision set for the entire country?”

  • Every HTA decision has moral consequences

What is normatively at stake?

  • Shifting from a technical problem to an ethical and political one

  • Technical Question (old HTA) vs. normative Question (real HTA)

  • Efficacy → what is the value of the outcome?

    • e.g., 3 months of life in pain vs. one month in high-quality life?

  • Cost effectiveness → What is a fair price, and what is the opportunity cost?

    • What do we give up by funding this?

  • Target Population  → Who gets left behind by this definition?

    • Those not in trial, with co-morbidities, marginalised groups 

  • Measurement → what should we measure?

    • Clinical endpoints, patient hope, family burden, social participation?

  • Innovation → Is this innovation responsible?

    • Addresses real needs or just a market opportunity? Is it sustainable?

Shaping the dilemma: Key tradeoffs

  • All HTA is a balancing act. There is no single right answer, only a justifiable one

  • common dilemmas

    • individuality vs collective

      • Life-saving drug for one vs. public health program for thousands

    • efficiency vs equity

      • maximum

    • innovation vs affordability

      • Rewarding new, uncertain, expensive tech vs. long-term sustainability 

    • Transparency vs. health complexity

      • Simple, public decisions vs. Capturing complex, multi-dimensional value

The political choice

  • Balancing a tradeoff is not a scientific calculation; it is a political choice

  • Evidence informs the decision; it does not make it

  • Values (equity, solidarity, innovation, cost-effectiveness) drive the decision

  • The weight given to each value is a political act

  • Example 4$1M/ year rare disease drug

    • Technical frame: “ ICER is $1.5M/QALY above $50k threshold → recommend ‘no

    • Political frame: “We prioritise system sustainability over Rule of Rescue and vertical equity for this group”

Which value should matter most in a public system?

  • maximising total health

    • Getting the “most bang for the buck” ( highly cost-effective hip replacement)

  • innovation

    • Prioritizing cutting-edge tech (AI, gene therapy)

  • Fairness and Equity

    • Prioritising the sickest of those with no other options 

  • Sustainability

    • Protecting the budget even if it means saying no to beneficial drugs

From Calculation to deliberation 

  • How do we structure messy, value-based decisions?

  • We need models that move beyond simple calculation and embrace deliberation 

  • Calculation:

    • plugging numbers into a formula to get the ‘right’ answer

  • Deliberation: 

    • A structured, transparent, and fair process from making a justifiable choice in the face of value conflicts

Models for valuing tradeoffs
Model 1: Classic HTA

  • Is it worth it?

  • Tool: Cost-Utility Analysis (CUA) 

  • Metric QALY (Quality-Adjusted Life Year)

    • 1 QALY = one year of life in perfect health 

    • 0.5 QALY = 1 year of half at 50% health, or 6 months in perfect health 

  • The ICER (Incremental Cost-effectiveness Ratio): 

    • ICER = (Cost new - Cost old)/(QALY new - QALY old)

      • =$ per QALY Gained 

  • Threshold: decision rule (e.g.) $50,000 per QALY) for judging value

Limits of QALY

  • Utilitarian focus: maximise total QALY, regardless of who gets them 

  • ‘ageism’: Preferentially funds treatments for younger people

  • Disability Bias:

    • Baseline utility for chronic disability may be 0.7; a treatment restoring to 0.7 may be valued as 0 gain

    • Meanwhile, a minor gain in a healthy person (0.9 →1.0) is valued

  • Conclusion: The QALY is a useful tool, but a poor master

Model 2: Accountability for reasonableness (A4R)

  • Core Question: What makes the decision legitimate and fair?

  • Focus: Fair process rather than a single “right” outcome

  • Four conditions for a fair process:

    • Publicity/transparency 

      • Decisions, rationales, and evidence are publicly accessible

    • Relevence

      • Rationales based on reasons and values that stakeholders see as relevant 

    • Appeals/Revision

      • Mechanisms to challenge and revise decisions in light of new evidence

    • Enforcement

      • Assurance that the first three conditions are actually followed

A4R in practice

  • Shifts HTA from a “black box” to a transparent deliberative body 

  • What A4R does:

    • Creates a space for value trade-offs to be discussed

    • Hosts the political and ethical debate in a structured way

  • What A4R does not do:

    • Does not define substantive values 

    • Does not tell you how to weigh competing values

  • Examples:

    • CADTH and INESS publish decisions and rationales, offer reconsideration processes, and include expert and public committees

Model 3: Responsible innovation in Health (RIH)

  • Core Question: Is this innovation responsive to systemic health system challenges?

  • Focus: move assessment upstream; steer innovation, not just screen it

  • Systemic challenges addressed:

    • Equitable access and reduction of inequalities 

    • Workforce shortages and burnout

    • Accountable policy-tradeoffs 

    • Environmental Sustainability 

  • Key Value domains:

    • Population health value

    • health system value

    • Economic value (including frugality) 

    • Environmental value

RIH in Proactive 

  • Shifts HTA from reactive gatekeeper  → Proactive system steward

  • Example: AI Surgical robot

  • Classes HTA question: Is it more effective than a human surgeon?

  • RIH-informed questions:

    • Does it exacerbate workforce shortages by requiring highly specialised staff?

    • Does it worsen inequality by being available only in elite hospitals?

    • What is its environmental footprint (energy-use, e-waste)?

  • RIH forces attention to long-term, system-wide impacts

Model 4: INESSS Multi-Dimensional Framework

  • Question: What is the total value of this technology for society across all relevant dimensions?

  • Focus: Holistic, value-based assessment integrating A4R and RIH principles

  • Five evolving dimensions of value:

    • Population Health Value:

      • Burden reduction, equity, social justice, and patient autonomy 

    • Health System Value

      • Resilience, accessibility, responsiveness, and coordination 

    • Economic Value

      • Affordability, opportunity cost, and long-term sustainability

    • Organizational Value 

      • Governance, transparency, stakeholder participation, and data stewardship

    • Environmental Value

      • Lifecycle footprint, material waste, energy demand, e-waste

INESS model in practice: Rare Disease Example

Scenario: $1M drug for ~10 patients with low-quality evidence

  • Clinical dimension:

    • Acknowledge uncertainty; integrate experiential evidence from patients and caregivers

  • Population dimension:

    • Quantify unmet need; recognize priority status of ultra-rare, severely affected group 

  • Economic dimension: 

    • Recognize extreme opportunity cost and budget impact

  • Sociocultural dimension:

    • incorporate values of hope and solidarity (Rule of Rescue)

  • Environmental dimension:

    • usually downplayed here

Possible recommendation:

  • Yes, but…” (e.g., restricted centers, conditional coverage with evidence development)

Model 5: Multi-Criteria Decision Analysis (MCDA) 

  • Question: How can we quantify values for a transparent choice?

  • Focua: Practical toolbox for multi-dimensional, value-based decisions

  • Typical MCDA process:

  • Step 1: Define criteria

    • Efficacy, equity, cost, innovation, quality of evidence, etc. 

  • Step 2: Assign weights (political choice)

    • Committee debates relative importance (e.g., equity 30%, innovation 10%)

  • Step 3: Score options

    • Rate each technology (e.g., 1-5) on each criterion 

  • Step 4: Calculate

    • Weighted average produces a composite “value score.”

Model comparison

Case studies

Case Study 1: AI in Medical Imaging

  • Technology: AI-driven software tool for a hospital radiology department