Healthcare Economics & Reimbursement

LESSON 03

Healthcare Economics & Reimbursement

Health Economics Fundamentals

A QALY is not an abstraction — it is the unit payers use to decide whether your product deserves to exist in their formulary.

15 min read

Health economics is the discipline that provides payers and health technology assessment bodies with the analytical framework to decide whether a new product or intervention is worth paying for. It is not a soft science of preferences and opinions. It produces quantitative models with specific inputs, specific outputs, and reviewable assumptions. Founders who do not understand how these models work cannot effectively challenge the assumptions payers use against them, and cannot credibly present economic evidence in their favor.

The quality-adjusted life year, or QALY, is the primary unit of health outcome in most economic evaluations conducted outside the United States, and increasingly within it. One QALY represents one year of life lived in perfect health. A year lived in a health state with diminished quality — due to pain, disability, or functional limitation — is worth less than one QALY. The utility weight assigned to any given health state falls between 0 (equivalent to death) and 1 (perfect health). These utility weights are measured through patient surveys and validated instruments, and they are contested. The assumption that a year with moderate chronic pain has a utility of 0.72 is a modeling choice that will determine whether your product clears the cost-effectiveness threshold.

Cost-effectiveness analysis, or CEA, compares the incremental cost of a new intervention against the incremental health benefit it produces relative to the current standard of care. The output is an incremental cost-effectiveness ratio, or ICER — not to be confused with the Institute for Clinical and Economic Review, which uses the same acronym. The ICER is expressed as cost per QALY gained. In the UK, the National Institute for Health and Care Excellence, or NICE, uses a threshold of approximately £20,000 to £30,000 per QALY. In the US, ICER has proposed a threshold range of $100,000 to $150,000 per QALY as a reference point, though no single US payer is legally bound by any threshold.

The perspective of the analysis is one of the most consequential modeling choices and the one most frequently glossed over in submitted economic dossiers. A societal perspective includes all costs and benefits, including those borne by patients, caregivers, and the broader economy through productivity effects. A payer perspective includes only what the payer pays and what the payer saves. A product that looks highly cost-effective from a societal perspective because it dramatically reduces workplace absenteeism may look cost-ineffective from a payer perspective because those productivity gains do not flow back to the payer's budget. Payers evaluate from their own perspective. Build your model accordingly.

Real-world evidence, or RWE, refers to clinical and economic data derived from actual patient care outside controlled trial settings — from electronic health records, insurance claims, patient registries, and wearable or sensor data. RWE has become increasingly important because randomized controlled trials, while the gold standard for clinical evidence, are expensive, take years, and enroll patient populations that may not reflect the real-world patients who will use the product. Payers increasingly require RWE to validate that trial-based efficacy translates to real-world effectiveness. The gap between efficacy (what a product does under ideal conditions) and effectiveness (what it does in routine practice) is where many coverage decisions are lost.

Health technology assessment, or HTA, is the formal process by which health systems and payers evaluate new technologies for coverage and reimbursement decisions. In the UK, NICE conducts HTA. In Germany, the Institute for Quality and Efficiency in Health Care, or IQWiG, conducts it. In the US, there is no single mandatory HTA body — the Inflation Reduction Act of 2022 introduced Medicare drug price negotiation authority, and ICER functions as an independent HTA organization whose reports payers and PBMs increasingly reference in coverage decisions. Understanding how your target market conducts HTA is not optional if you are pricing above commodity levels.

Discount rates in health economic models are not an arcane technical detail. They reflect the assumption that costs and health benefits occurring in the future are worth less than those occurring today — the same logic as net present value in finance. Standard discount rates are typically 3% to 5% per year for both costs and outcomes. A product with most of its benefit realized five or ten years from now — such as a preventive intervention — looks far less cost-effective under discounting than one with immediate benefit. This is one of the structural reasons preventive care consistently struggles to clear cost-effectiveness thresholds despite obvious long-term value.

An ICER built on optimistic utility weights and short time horizons is not a health economic model. It is a sales document that will be dismantled in an HTA submission.

This lesson is coming soon.

TERMS

Term of focus

QALY (Quality-Adjusted Life Year)

A QALY is a unit of health outcome that combines length of life and quality of life into a single metric by multiplying years of survival by a utility weight between 0 and 1. It is the primary outcome measure used in cost-effectiveness analysis for payer and HTA decision-making globally. The utility weights assigned to specific health states are derived from population surveys and are a major source of model sensitivity and contestation.

The ICER is the ratio of the difference in cost between a new intervention and its comparator, divided by the difference in health outcomes, expressed as cost per QALY gained. Payers and HTA bodies compare a product's ICER against their willingness-to-pay threshold to determine whether coverage is justified. A product with an ICER above the threshold is not necessarily rejected, but it faces a significantly higher evidentiary burden to justify coverage.

Real-world evidence is clinical and economic data generated from routine health care delivery rather than controlled experimental settings, drawn from sources such as claims databases, electronic health records, and disease registries. Payers use RWE to assess whether trial-demonstrated efficacy translates into effectiveness in the broader patient population they cover. A strong RWE package can accelerate coverage decisions; a weak or absent one is increasingly a barrier to premium pricing.

HTA is the structured, evidence-based evaluation of a new medical technology's clinical, economic, and ethical implications to inform coverage and reimbursement decisions. It is conducted by bodies such as NICE in the UK and IQWiG in Germany, and referenced by payers and PBMs in the US through organizations like ICER. Submitting a product for HTA review without a complete economic dossier is equivalent to raising a funding round without a financial model.

CEA is a type of economic evaluation that compares a new health intervention to an existing comparator by calculating the cost per unit of health outcome gained, typically expressed as cost per QALY. It requires a defined comparator, a defined time horizon, explicit modeling assumptions, and a clear statement of analytical perspective. CEA is the standard language for communicating economic value to payers and HTA bodies.

A utility weight is the numerical value between 0 and 1 assigned to a specific health state to reflect its quality relative to perfect health, used in QALY calculations. Weights are estimated through validated instruments such as the EQ-5D questionnaire administered to patients or general population samples. Because small differences in utility weights propagate through CEA models to significantly change ICERs, the choice of measurement instrument and study population is a major methodological battleground in HTA submissions.

The discount rate in health economic modeling is the annual percentage by which future costs and health outcomes are reduced to reflect their present value, analogous to a financial discount rate. Standard practice applies a 3% to 5% annual discount rate to both costs and QALYs in long-term models. Products whose primary benefits occur years after initial use — especially preventive interventions — are structurally disadvantaged by discounting, producing ICERs that understate long-term value.

BEFORE YOUR NEXT MEETING

What utility weight are we using for the baseline health state of our target patient population, and where is that weight sourced — from a published EQ-5D study or from a modeling assumption?

Is our cost-effectiveness model built from a payer perspective or a societal perspective, and have we prepared a separate payer-perspective model for submissions to US health plans that will not credit productivity gains?

What is our ICER at current pricing, and at what price does our product fall below the $150,000 per QALY threshold ICER uses as a reference — have we modeled the sensitivity?

What is our plan for generating real-world evidence after launch, and have we designed our product's data capture to support that evidence generation or treated it as a separate future workstream?

Have we identified which HTA bodies are relevant in our target markets and reviewed a recent submission in our therapeutic area to understand what level of evidence they expect?

REALITY CHECK

SOURCES

LESSON 03 OF 04