The Launch Begins Long Before Approval Day

Approval day is the moment everyone celebrates, and it is the wrong milestone to organize a launch around. By the time it arrives, the people who will decide whether patients can actually get the therapy have already made up their minds about it.

Market access is still widely treated as a phase that begins after approval. It does not. Payers form a view of a therapy across pivotal data, publication, congress presentations, guideline signals and competitor positioning, most of which happens years before a commercial team is allowed to make its case. Since 2023, federal law has made it explicit that manufacturers may talk to those decision makers before approval, within defined limits. Most organizations still do not use that window, and the launch pays for it.

Approval day is a milestone, not a starting line

The ritual is understandable. Approval is the culmination of years of work, enormous expense and genuine scientific risk. It deserves the celebration. What it does not deserve is the role it has been given in the commercial calendar, where it functions as the starting gun for a conversation that should already be well underway.

Treating access as a post-approval activity produces a specific and avoidable failure. The commercial team arrives with a well-built case, delivered to an audience that formed its opinion somewhere around the phase 3 readout. The work is not wasted, but it is doing something much harder than it was designed to do. It is asking people to revise a conclusion rather than helping them form one.

What a payer already believes before you ask

By the time a product reaches approval, the people making coverage decisions have usually already answered four questions for themselves. What problem does this therapy solve, and for whom. How does it compare to what they are already paying for. Roughly what will it cost them across a covered population. And how much administrative friction will it take to control utilization.

None of those answers came from the manufacturer. They came from the published literature, from congress presentations, from analyst coverage, from guideline movement and from competitors who were happy to frame the category first. That is not a failure of payer diligence. It is what happens when one party talks for three years and the other stays silent.

The exchange is now explicitly permitted

The reason most organizations stayed quiet was never really strategy. It was legal caution. Pre-approval communication sat in genuinely ambiguous territory for years, and the reasonable instinct in ambiguous territory is to say nothing.

That ambiguity has narrowed considerably. Section 114 of the FDA Modernization Act opened the door to health care economic information in 1997, the FDA finalized guidance on payer communications in 2018, and pre-approval information exchange was codified in the Consolidated Appropriations Act of 2023. The result is a defined lane rather than a gray zone.

Read the left column as a commercial planning document rather than a compliance one. Utilization projections and anticipated timelines are exactly what a formulary committee needs in order to budget, and exactly what it cannot construct on its own. Supplying them early is not promotion. It is removing the guesswork that otherwise gets resolved conservatively, and conservative guesses become restrictive criteria.

What actually gets decided before approval

Three things are effectively settled before the first commercial meeting, and all three are hard to move afterward.

1. The comparator. Whichever product the category is measured against becomes the baseline for every value conversation that follows. That frame is usually set in the literature, not in a negotiation.
2. The budget expectation. A payer that has not been given a utilization projection will build one, and it will build one defensively. That number becomes the anchor.
3. The control posture. Whether a therapy is treated as something to manage tightly or something to enable is a disposition formed well before the first authorization criteria are drafted.

None of those are contract terms. They are prior beliefs, and they are considerably more durable than contract terms.

Evidence a payer can use, not evidence that impressed a regulator

There is a translation problem underneath all of this. The evidence package that satisfies a regulator answers a different question than the one a payer is asking. A regulator asks whether the therapy is safe and effective for a defined population. A payer asks what happens to a covered population and a budget over a plan year.

Those are not the same question and the second one is rarely prepared with the same rigor as the first. Building it early is not an additional burden invented by commercial. It is the thing that decides whether the clinical work translates into patients actually starting therapy.

Where this connects to the patient

Everything above sounds like a payer strategy discussion. It is actually a patient access discussion wearing different vocabulary.

A payer who forms a cautious view of a therapy expresses that caution operationally. It becomes step edits, tighter authorization criteria, narrower initial coverage and longer review cycles. Each of those lands on a specific patient at a specific counter, and each one widens an exit that was already open. The decisions described here are made years earlier and several levels of abstraction away, but they arrive as a delay in somebody’s treatment.

This is the same principle running in reverse. Everything done before approval determines how wide the exits will be after it. What happens to the measurement once the product is in market is a separate problem, and I wrote about that in A Launch Does Not Fail in the Forecast. What a forecast is actually for, once it exists, is a separate question again, and I took that up in The Forecast Is Not the Deliverable.

The alignment this depends on

This is why I keep returning to Patients + Profitability™. Improving patient outcomes and building a commercially sustainable product are not competing objectives that have to be balanced against each other. They are the same objective measured from two ends, and both of them are decided far earlier than the org chart suggests.

The enterprise’s role stays narrow throughout. It develops, manufactures, prices, contracts, distributes and supports. It does not diagnose, prescribe, dispense or treat. What it can do is arrive early enough that the people deciding coverage are working from information rather than from inference.

Companies that treat commercialization as a development-phase discipline do not just launch better. They launch into a market that already understands what the therapy is for, which is the only condition under which a launch ever goes well.

The description of permitted pre-approval communication is a general summary of publicly available material and is not legal or regulatory advice. Any specific communication should be reviewed by qualified counsel and the appropriate internal review committee. The views expressed are my own and are not made on behalf of any current or former employer. All trademarks belong to their respective owners.