Most biotech companies build their market access function only once, for the first time, right before launch. This is a guide to what that strategy actually needs to cover, and why the work usually needs to start years earlier than most teams expect.
For companies 12–36 months from launch, building market access for the first time.
Book a 25-minute call →Every market access decision falls into one of three categories. Most careers, and most internal hires, only ever cover one.
Products dispensed through a pharmacy, priced and reimbursed through PBMs, formularies, and pharmacy benefit design.
Products administered in a clinical setting, covered under a patient's medical benefit rather than their pharmacy plan, with its own coverage and coding rules.
How a product physically reaches a patient — specialty pharmacy, buy-and-bill, direct distribution — which shapes margin and patient access regardless of which benefit a product falls under.
These are the questions a strategy has to work through, whether or not anyone is officially in the role yet.
What can this product charge, and does the model account for gross-to-net, not just list price?
What criteria will payers use to cover it, and does the evidence plan actually support that criteria?
How will the product actually reach a patient, and what does that path cost in margin and speed?
Is there an existing code this product can use, or does a new one need to be established before launch?
Answering these questions after a market access team is hired is normal. Answering them before decisions get made elsewhere in the company — in finance, in regulatory, by whoever is closest to the question at the time — is what a strategy is for.
Read why this timing matters more than most companies realize →
Most pre-commercial companies don't need a full-time hire yet. They need the judgment applied at the right moments.
The right starting point for most pre-commercial companies. A fixed-scope review of your pricing assumptions, likely coverage, and evidence gaps, ending in a ranked list of what could go wrong and a ninety-day plan.
For companies ready to build the function properly, without a full-time hire yet. I hold the market access seat: strategy, payer and pricing decisions, vendor oversight, and reporting.
For companies with an open role or a leadership gap heading into launch, until a permanent hire is in place.
More on how fractional and interim leadership actually works →
I spent 25+ years building market access strategy in-house, across rare disease, oncology, immunology, hematology, ophthalmology, and drug-device combination products. Now, through Engro & Associates, I bring that same judgment to pre-commercial companies before the function exists full-time.
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