Estimated reading time: 3 minutes
Why this document exists
A medicine can be approved by regulators and still fail commercially, because the public bodies and insurers who pay for medicines apply their own, separate test. This risk — that an approved medicine does not achieve the expected price, coverage, or patient access — is one of the largest sources of loss in healthcare investing.
Today, this risk is usually assessed by the same teams whose work is being judged. Their forecasts are produced honestly, but they are structurally optimistic: their job is to advance the asset, not to question it. The investor bears the loss if the forecast is wrong, yet the investor rarely holds an independent view of this specific risk at the moment the decision is made.
This document proposes a simple standard. Any healthcare investment that depends on future reimbursement should include an independent market-access check that meets the six criteria below. It does not matter who performs the check. It matters that the check meets the standard.
The six criteria
1. Independent of the parties with a stake in the outcome. The assessment must be produced by someone who does not benefit from the investment proceeding and cannot be instructed — formally or informally — by the company being assessed or the team proposing the deal. An assessment the sponsor can influence is a second draft of the sponsor’s own forecast.
2. The same method, every time. The check must apply one documented method consistently across every medicine it assesses. Only then can two assets be compared, a portfolio be viewed as a whole, and this year’s assessment be read against last year’s. A bespoke opinion, however expert, cannot be compared with anything.
3. Tested against real past decisions. The method must have been checked against actual historical decisions by the bodies that decide whether health systems pay for medicines. It should be possible to ask: when this method said “low risk” in the past, how often was it right? A method that has never been scored against reality is a hypothesis, not a benchmark.
4. Reasoning that can be inspected. Every conclusion must be traceable to stated evidence — trial results, comparator choices, pricing precedents, prior decisions in similar cases. A score without visible reasoning cannot be defended later, and defense is the entire purpose of the check.
5. A track record published openly — including the mistakes. Whoever provides the check should publish how its past assessments compared with actual outcomes, the misses alongside the hits. A provider that only reports its successes has not earned trust; it has avoided the test.
6. Kept current, under documented rules. Evidence changes: new trial data, new competitors, new pricing decisions. The check must be updated when material evidence changes, and the method itself must evolve through a documented, versioned process — not silently, and not on request.
How to use this standard
One line in the investment approval paper is sufficient: “Independent market-access check: [provider], [result], [date], meets the six criteria.” The cost is one sentence. The value appears years later, when the decision is examined and the question is asked: what independent view of this risk did we rely on at the time?
An investment that cannot answer that question was not more boldly made. It was less completely examined.
Prepared by MARA Rating Company AG, Switzerland, as a contribution to investment-practice standards in healthcare. This document describes a standard, not a product; any provider meeting the six criteria satisfies it.