Approval gets you to market. Reimbursement decides if it was worth going.
Regulators ask whether a product is safe and effective. Payers ask a harder question: whether it is worth paying for, at your price, instead of what they cover today. That case is built from evidence, and the window to generate it is during development, not after launch. We build the access strategy alongside the regulatory program: the payer evidence plan, the price and its defense, the HTA submissions, and, for devices, the coding, coverage, and payment pathway that turns clearance into revenue.
A cleared product no one will pay for has not launched. We plan for both, from the start.
Clearing the FDA earns you the right to sell. Clearing the payer earns you the ability to. The second gate comes later, is decided by people who rebuild your evidence themselves, and it is the one that determines whether the product has a business.
“Is it safe and effective?”
Answer this and you may place the product on the market. It is necessary, it is hard, and it is only half the journey to a patient.
“Is it worth paying for, at your price, over what we cover today?”
Answer this and the product actually sells. The evidence to win it has to be planned years earlier, while the trials that can still generate it are running.
Approval lets you sell. Coverage is what actually moves the product down this corridor to a patient.
The evidence a payer demands is different from the evidence a regulator accepts, and most of it can only be generated once. We build the access disciplines into the program while the window is still open.
Because every serious payer and HTA body will rebuild your model and rerun your comparisons.
The HTA and payer evidence a launch will need, mapped into the trial program while the studies that can still generate it are open.
A launch price is not one decision; it is the anchor every later negotiation and every reference-pricing market leans on. Set it once, defend it everywhere.
The HTA body is your second regulator. Under the EU HTA Regulation, the Joint Clinical Assessment runs in parallel with the EMA and can demand comparisons your trial never planned.
Economic evidence and the value story that gets retold inside a payer committee you will never enter, built to survive the analysts who will stress-test every assumption.
A cleared device is not a reimbursed device. Three separate systems have to align, and any one of them missing quietly stops the product at the point of use.
Coding, coverage, and payment are three separate decisions, each able to stop the product cold.
Without a code to bill against, the device cannot be reimbursed at all, no matter how good it is.
A coded device with no coverage policy will not be ordered; the payer simply says no.
A covered device paid below the cost to deliver it will not be stocked or used.
Access decisions start years before launch, but most companies hire their access lead months before it. Our senior consultants act as your head of market access, building the evidence and value strategy alongside the regulatory program until you are ready to own it.
A negative HTA recommendation, a restrictive coverage policy, or an AMNOG price below expectations is the start of a negotiation, not the end of one. We diagnose why the case fell short and rebuild the evidence and argument for resubmission.
Access is won by knowing how the other side actually decides. Your leads are senior market access and health economics practitioners, including former payers and HTA reviewers, who have built value cases, negotiated prices, and defended dossiers under the scrutiny of the analysts who rebuild them.
We know how a payer committee actually weighs a value case, because our leads have sat in those rooms.
We plan the payer evidence while the trials can still generate it, not after the window has closed.
Pricing and HTA for medicines, and the coding, coverage, and payment chain for devices, in one team.
A price defended across reference-pricing markets, so a concession in one does not cascade through the rest.
A value case is drawn from the same evidence and the same global plan as the regulatory program. These are the services access most often connects to.
The launch sequence that also drives reference pricing, planned so the two reinforce rather than undercut each other.
Explore Global →The value dossiers and economic narratives a payer reads, written to survive the committee you will never enter.
Explore Writing →The regulatory strategy that generates the evidence the payer case is built on, aligned from the first trial.
Explore FDA →Tell us where the program stands: evidence in hand, markets in scope, and the access questions keeping the plan honest. We'll match you with a senior market access lead and respond within one business day. All inquiries are strictly confidential.
