If your team has already made a call on pricing, coverage, distribution, or coding, without meaning to, you're not alone. One of the biggest misconceptions in biotech is that market access planning starts shortly before launch. In reality, the decisions that ultimately determine revenue, patient access, margin, and speed to payment are made 12 to 36 months before launch — sometimes earlier.
By the time launch approaches, many of these decisions are expensive, slow, or impossible to unwind.
Book a 25-minute call →None of these wait for a market access hire. Whoever is closest to the decision at the time — finance, regulatory, whoever happens to be in the room — makes the call by default.
What a product can charge is set well before anyone tests willingness to pay. Net price, not list price, is what shows up in the model — and net price is shaped by gross-to-net architecture, rebate strategy, and government pricing exposure that get built years before a commercial team exists.
Coverage doesn't happen automatically on launch day. Utilization management criteria and formulary timing are usually benchmarked against precedent set long before approval. Miss that window, and patients can go without coverage for a full quarter or more.
How a product reaches a patient — specialty pharmacy, buy-and-bill, a hub model — is a margin decision as much as a logistics one. Channel economics get locked into contracts before most companies have anyone dedicated to managing them.
Coding, coverage, and payment are three separate decisions, not one. A product can be approved and covered, and still take months to actually get paid for, if the coding pathway wasn't mapped in advance.
By launch, many of these decisions are expensive, slow, or impossible to unwind. None of it is recoverable later.
It isn't a failure of planning. It's a sequencing problem.
Most companies don't create a dedicated market access role until commercialization feels close. But the decisions above are made long before that point — usually by people whose job is something else entirely, and who are making a reasonable call with the information they have, not a market access call.
Nobody labels a finance model assumption as "the pricing decision" or a benefit-design choice as "the coverage decision." They get made inside other conversations — a budget model, a regulatory strategy meeting, a term sheet — without anyone flagging that they're setting a course that's hard to reverse.
A pricing assumption is cheap to change in a spreadsheet. It is not cheap to change after it's been communicated to investors, built into a payer strategy, or reflected in a term sheet. The cost of a market access decision rises steeply the longer it goes unexamined.
Companies don't need a full-time market access executive 12 to 36 months before launch — the volume of work usually doesn't justify it yet. What they need is someone applying that judgment to the handful of decisions being made right now, before those decisions get made by default.
Want a second opinion on the decisions already being made in your program?
Book a 25-minute call →I spent 25+ years making these decisions in-house, across rare disease, oncology, immunology, hematology, ophthalmology, and medical devices. Now, through Engro & Associates, I bring that same leadership to companies on a fractional or interim basis — sized to how much market access work actually exists at each stage, not to a full-time org chart.
Whether you're building the market access function for the first time, filling an open seat, or want a second opinion on a specific launch, I am glad to talk it through — three ways to reach me:
Bill Engro, Founder & Principal