Market access, HEOR & payer/HTA

Approval gets you to market, evidence gets you paid

The evidence payers need is rarely the evidence a regulatory package produces, and the gap only becomes visible at reimbursement. This hub helps teams build the access case early, while the trial can still carry the endpoints that pay for the programme.

Start here: the HTA & Payer Field Guide

Evidence expectations market by market: US payers, NICE, G-BA, HAS and the EU Joint Clinical Assessment. If Europe is on your roadmap, start with the JCA section, the timelines surprise people. Free, and yours to keep.

State of Evidence Generation 2026

The annual report on how evidence gets planned, funded and used across drug development.

Brief: Two bars, not one

Your external control arm has to clear the regulator's bar and the payer's. The design moves that do both. Four pages, free.

Watch: the video series

Latest from this hub

One evidence plan for payer, regulator and prescriber: the comparator is the fork where it breaks

One evidence plan for payer, regulator and prescriber: the comparator is the fork where it breaks

Why one integrated evidence plan has to satisfy payer, regulator and prescriber at once, and how the comparator choice is the fork where it usually breaks.

Integrated evidence plans: A key tool for regulatory success

Integrated evidence plans: A key tool for regulatory success

How an integrated evidence plan aligns evidence generation across functions to de-risk the path to regulatory success.

How the IRA will impact Drug Development

How the IRA will impact Drug Development

What the Inflation Reduction Act's pricing and negotiation rules mean for how drug development programmes are designed and prioritised.

The four decisions with an expiry date: why HEOR belongs in the IEP before the protocol locks

The four decisions with an expiry date: why HEOR belongs in the IEP before the protocol locks

The four early decisions that expire once the protocol locks, and why HEOR has to be in the integrated evidence plan from day one.

The second invoice: choosing a pivotal-trial endpoint that clears the regulator and the payer

The second invoice: choosing a pivotal-trial endpoint that clears the regulator and the payer

How to choose a pivotal-trial endpoint that clears both the regulator and the payer, so you avoid a second invoice at reimbursement.

The evidence gap audit: grade your programme before payers and HTA do

The evidence gap audit: grade your programme before payers and HTA do

Five axes to grade your evidence the way an HTA reviewer or payer will, so you find the gaps before they do.

Is access evidence on your plate this year?

We have seen real world evidence unlock reimbursement after an initial payer no. If your access story has gaps, the earlier someone looks at it the cheaper it is to fix. Get in touch and we will tell you where it stands.


Privacy Policy · © 2026. All rights reserved.