Everyone in market access says "get payers involved early." After a dozen GI launches, I think that's only half the advice — and the half nobody checks is the one that sinks products. Ask any GI-focused

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biotech what "launch readiness" means and you'll get the same answer: regulatory approval, label negotiation, pricing dossier, done. That's the checklist. It's also, in my experience, precisely why so many rare disease launches undershoot their potential in year one. Approval is a milestone, not a finish line. In small, underdiagnosed GI populations, the harder problem is almost never the science or even the pricing — it's finding the patients and getting the right specialists comfortable enough to act on a diagnosis they may see once a career. I've watched teams spend eighteen months building the perfect access strategy for payers who move fast, then discover the real bottleneck was that community gastroenterologists didn't have a reliable referral pathway to the tertiary centres running trials. The dossier was flawless. The disease-awareness infrastructure didn't exist. The fix isn't complicated, but it is unfashionable: build patient-finding and HCP education workstreams in parallel with the regulatory submission, not after it clears. Treat medical affairs and market access as one motion, not two functions that hand off at approval day. Start piloting referral pathways with academic centres before you even have a label, using the disease science, not the brand. None of this shows up on a typical launch Gantt chart, because it doesn't have a clean regulatory milestone attached to it. But in rare GI disease, where the addressable population might be a few thousand patients across a market, the launch isn't won on pricing negotiations. It's won in the eighteen months before approval, in the unglamorous work of making sure clinicians know what to look for. Approval opens the door. Somebody still has to walk the patients through it. For those who've run rare disease launches — where did your access strategy break first: pricing, prescriber readiness, or patient identification? #MarketAccess #RareDisease #PharmaLaunch