HEOR.

Evidence.

State 01

The evidence state.

We build and defend the evidence that gets a product reimbursed in Europe. Submission-ready, source-controlled, delivered under your brand.

The evidence state, where value is built and validated.

RJC HEOR, the evidence state

01 / What we deliver

Most of what a market access team needs is not one deliverable, it is a chain: the evidence has to be found, compared, modelled, written up, and then survive a reviewer who is paid to find its weak point. We work anywhere along that chain.

02 / The chain

01 Systematic review support

Protocol, searches, screening and extraction, run to a standard that holds up when a national HTA body repeats it.

02 Indirect treatment comparison

Network meta-analysis where the evidence network allows it, matching-adjusted indirect comparison or simulated treatment comparison where it does not.

03 Health economic modelling

Cost-effectiveness, cost-utility, budget impact and burden-of-disease models, built to be validated rather than admired.

04 HTA dossiers

National submissions and Joint Clinical Assessment support, written to the reviewer’s checklist.

05 Global value dossiers

The reference document your country teams actually reuse, structured so it can be cut apart.

EU HTA moved the clinical review to one assessment. The evidence gap moved with it.

03 / EU HTA and the JCA

Regulation (EU) 2021/2282 replaced the repeated national clinical review with a single Joint Clinical Assessment, phased in from January 2025 for oncology medicines and advanced therapy medicinal products, January 2028 for orphan medicinal products, and January 2030 for everything else. Pricing and reimbursement remain national decisions.

The consequence is that an evidence gap is no longer a one-country problem. The JCA uses a PICO framework, and because standards of care differ across Member States a single assessment can carry many PICO combinations at once, inside a fixed window. That is a capacity problem before it is a science problem, and it is exactly the kind of surge we exist to absorb.

Primary sources: the European Commission HTA pages and the EMA.

Germany is the largest market in Europe and the most procedural.

04 / AMNOG and the G-BA

Under AMNOG, a new active substance triggers a benefit dossier to the Federal Joint Committee, assessed against an appropriate comparator therapy on patient-relevant endpoints, usually with IQWiG involved. The result drives the reimbursement negotiation that follows.

Two things decide the outcome more often than the headline efficacy result: whether the comparator was chosen the way the G-BA would have chosen it, and whether the subpopulation definitions hold. We work on both before the dossier is written, not after it comes back.

Primary sources: the G-BA and IQWiG.

05 / Common questions

What is a global value dossier?

A global value dossier is the internal reference document holding the complete value story: disease burden, unmet need, clinical evidence, economic evidence, and the payer arguments that follow. It is not itself a submission. Country teams adapt it into national HTA submissions, so it is written to be cut apart and reused.

What changes under the EU HTA Regulation?

Regulation (EU) 2021/2282 moves the clinical part of assessment from repeated national reviews to a single Joint Clinical Assessment. It applies to oncology medicines and advanced therapy medicinal products from January 2025, orphan medicinal products from January 2028, and all other medicinal products from January 2030. Pricing and reimbursement stay national.

When do you need an indirect treatment comparison?

When there is no head-to-head trial against the comparator an HTA body will ask about. A network meta-analysis works when the trials share a common comparator. A matching-adjusted indirect comparison is for when they do not and you hold individual patient data for one side.

Need the evidence, not the retainer.

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