So it's public, ICER will review COMP360 psilocybin for treatment-resistant depression icer.org/news-insights/press…

$CMPS $DFTX $HELP $STIM Some useful details (some new/some not) from the @COMPASSPathway team this past week regarding pricing and commercial launch readiness, particularly at the Deutsche Bank 2026 Healthcare Summit and TD Cowen Neuropsychiatry Summit. 1. Drug Pricing: Compass cited roughly $50–$65k as the annual cost of Spravato and said it expects COMP360’s annual drug pricing to land around that range. Its assumption of three COMP360 doses per year on average implies about $17–$22k per dose. Lori Englebardt, Chief Commercial Officer: "Right now, currently, on average, SPRAVATO is in the range of anywhere from $50,000 to $65,000 annually. We have, based on our discussions with payers, but also given the product profile and the value proposition that we're bringing, you can expect pricing on an annualized basis to be around that. We will be pricing on a per dose basis... We believe that will be somewhere in the two to four range, which means an average of three [annually]. The reason I say two to four is not to be silly, but it is to articulate that there will definitely be patients that probably only need two, and there will be patients that probably need four. The average will be somewhere in the three range." 2. REMS/Label: Compass expects a broad label that could describe two initial doses at least three weeks apart, followed by additional treatment at the clinician’s discretion for a total of roughly 2-4 treatments per year. It also expects a REMS similar to Spravato’s, using much of the same clinic infrastructure, with the only key difference being six hours of monitoring instead of Spravato’s minimum two. Steve Levine, Chief Patient Officer: "We expect a fairly broad label to essentially say for the treatment of treatment-resistant depression. As far as the dosing, we have studied up to four doses in a year in our COMP006 trial. They were up to three in the COMP005 trial. We looked at an initial dose in two different ways. One was a single initial administration in COMP005. That was our placebo-controlled trial. In our three-dose, low-medium-high 006 study, we looked at two initial administrations, three weeks apart. What we have seen from that study with the two initial doses three weeks apart, as well as from the part B data, the blinded part B data from the first study, where that second dose was given a bit later, typically between weeks 10 and 14, is that for many participants, there was a significant additional benefit of having a second dose. Ultimately, we think that that will translate into a label that may talk about initiation of treatment as two doses no sooner than three weeks apart, with additional treatment at clinician discretion or as clinically indicated." 3. Commercial Reach: Compass estimates there are about 8,000 Spravato-certified sites today, growing by roughly 500 per quarter. It says approximately 80% of Spravato volume comes from 20% of sites. They are currently building out a sales team to develop prescribing-site engagement and a referral network, targeting all 8,000 clinics and roughly 2,000-2,500 nearby referring physicians, including psychiatrists and PCPs. Lori Englehardt, Chief Commercial Offider: "These sites are growing at about 500 sites a quarter. So whereas there are about 8,000 now, by the time we launch, if that trajectory continues, there will be quite a few additional clinics that will be prepared to administer multi-hour treatments by the time we launch. This has been pretty remarkable growth. These sites are growing because they are growing in anticipation of additional multi-hour treatments coming to market... We have already started our sales force hiring to make their offers contingent upon approval, to which they will cover all of these 8,000 sites. Most importantly, they will also cover referring physicians. So those physicians that are surrounding outside of these interventional psychiatry treatment centers to make sure that physicians who have treatment-resistant depression patients in their practice understand what the opportunities are for new products coming to market." 4. Reimbursement: Compass expects sites to have existing billing pathways available at launch while the psychedelic service codes remain in Category III. It also plans to seek a dedicated drug code for buy-and-bill after approval and estimates that moving the service codes to Category I could take about 18 months. It is also hiring field reimbursement specialists to help sites navigate billing for the time spent supporting and monitoring patients. Regarding billing at launch, Lori Englebert, Chief Commercial Officer, mentioned, "no site should be disadvantaged versus providing Spravato"; however, they also indicated this could contribute to a slower ramp-up period post-launch. Lori Englehardt, Chief Commercial Officer: "We know the number one reason that physicians won't prescribe, and Steve alluded to it previously, if you don't get reimbursed or it's not easy to get reimbursed, they likely won't prescribe the product. The patient has a bad experience because they're not well prepared, or they don't understand what is happening, or they themselves can't get the product reimbursed, then the sites will likely not prescribe. So we're trying to remove all those barriers, and because of that, it will take some hand-holding along the way to make sure that sites are well-trained, well-educated, and fully prepared, and can hopefully get the reimbursement codes through easily. Due to that, we anticipate the launch to be somewhat slow coming out of the gate, just because this is a new product, and sites are going to want to get a little bit of clinical experience before they start doing additional ramp. We do expect, if we do it well, that that ramp will be quite dramatic, and most likely be a pretty dramatic increase in fast fashion. Go slow to go fast." Reiteration of Timeline: Compass continues to expect completion of its rolling NDA submission in Q4 2026 and a potential launch in H1 2027, subject to FDA approval and federal and state rescheduling. COMP360 received a national priority voucher carrying an FDA target of 30–60 days for review of a submitted application (some skepticism mentioned about whether they can meet this target). Federal law then gives the DEA up to 90 days to reschedule (April EO could shorten this timeframe). Following federal rescheduling would be state rescheduling. Compass estimates that 44–45 states, representing about 93% of the U.S. population, could reschedule within 30 days of federal action. Overall, Compass appears to feel confident in its commercial launch plans and seems to have a good line of sight into regulators and treatment centers. I remain slightly cautious about reimbursement at launch. The existence of billing codes is helpful, but actual coverage, payer rules, payment rates, and clinics’ confidence that they will be paid adequately for a six-hour visit will matter for adoption. Uncertain and confusing billing pathways partly contributed to a slower Spravato roll-out back in 2019. Englebert has described feedback with payers as "overwhelmingly positive," so we shall see, and this will be something to continue to monitor.