Capability
HTA Pre-Assessment
A product can be approved and still commercially dead. If the assessment body rejects the value case, the marketing authorisation is a licence to sell into a market that will not pay.
Overview
Approval and reimbursement are different tests
Regulatory approval asks whether a product is safe and effective. Health technology assessment asks whether it is worth paying for relative to what is already available. These are separate questions judged by separate bodies against separate evidence.
Assets clear the first test and fail the second regularly. The trial used a comparator the payer does not accept. The endpoint is not the one the assessment body values. The comparison is against a therapy that has since gone generic, collapsing the price the market will support.
Discovered after in-licensing, these findings are expensive and often unfixable. Discovered before, they change the price, the territory list, or the decision itself.
Comparator checked early
The comparator a payer expects frequently differs from the one used in the trial. This single question decides many reimbursement outcomes.
Evidence gaps identified while fixable
Missing evidence found before a licensing decision can be planned into the development program. Found afterwards, it is a sunk problem.
Assessed market by market
Assessment frameworks differ substantially between countries. A case that succeeds in one market can fail in a neighbouring one on the same data.
Feeds the valuation
Reimbursement feasibility is a direct input into what an asset is worth and which territories belong in the deal.
Coverage
What a pre-assessment covers
The screen is deliberately early and directional. It identifies whether a defensible value case exists and what it would require, not a submission-ready dossier.
Comparator landscape
What the assessment body will treat as standard of care in each target market, and whether the available evidence compares against it.
Endpoint acceptability
Whether the endpoints used are the ones payers value, or whether a surrogate will require additional justification.
Evidence gap analysis
What the existing package supports, what is missing, and whether the gap needs new analysis or new studies.
Pricing environment
Reference pricing, existing therapy pricing and the effect of imminent generic or biosimilar entry on the achievable price.
Framework differences
How the assessment process, evidence expectations and decision criteria vary across your target markets.
Budget impact
Eligible population size and the scale of the payer's exposure, which frequently matters more to the decision than cost-effectiveness alone.
In practice
How a pre-assessment runs
A screen is scoped to inform a decision quickly. It is not a substitute for a full HTA submission later.
- 01
Asset & market framing
The indication, positioning and target markets are defined, since the value case only exists relative to a specific market and a specific comparator.
- 02
Comparator & endpoint review
Expected comparators and valued endpoints are established per market and compared against what the asset's evidence actually supports.
- 03
Evidence gap assessment
Gaps are identified and classified by whether they can be closed with existing data, new analysis or new studies.
- 04
Pricing & budget context
The achievable price range and the budget impact are estimated against the current and expected competitive landscape.
- 05
Directional recommendation
The output is a market-by-market view of feasibility, the principal risks, and what would have to be true for the case to succeed.
Questions
Frequently asked
A pre-assessment is a directional screen intended to inform a licensing or territory decision. A full submission is a formal dossier prepared to a specific body's requirements once the asset is approaching approval.
Screen an asset
Share the asset, the indication and the territories under consideration, and we will outline what a pre-assessment would cover.
Related
The other capabilities
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