Loving the timeline view. Nice work Jack!

If you want to stay in the know about all things policy and regulation, globally and in the US, @PsychStates / @JackGorsline has a great tracker to track it all!

$CMPS $DFTX $HELP $STIM COMP360 will have an ICER review. Why it matters for adoption: The Institute for Clinical and Economic Review (ICER) is an independent nonprofit. It's separate from the FDA and has no say in whether a drug gets approved, but its review can shape what payers think a drug is worth paying for, and that affects how easily patients can access it. Today, ICER published a draft scope for Compass's psilocybin 25 mg (COMP360) in treatment-resistant depression [1]. It will compare COMP360 to Spravato, rTMS, and IV ketamine. The patients are adults with depression who haven't responded to two or more antidepressants in their current episode. What we know about the analysis so far: - A five-year time horizon, because it's still unclear how long the effect lasts. A lifetime analysis only if the evidence supports it - A health care system view (direct medical costs), plus a separate analysis adding patient and caregiver productivity and time spent in treatment - Results as cost per quality-adjusted life year (QALY), along with response, remission, relapse, retreatment, side effects, and costs The model's structure, inputs, and assumptions come in the analysis plan in January. Full Timeline: - Comments open through Nov 10, 2026 - Revised scope on Nov 18 - Analysis plan on Jan 22, 2027 - Draft evidence report on Mar 16, 2027 (comments through Apr 12) - Public meeting of ICER's New England Comparative Effectiveness Public Advisory Council (CEPAC) panel on May 20, 2027 - Final report on Jun 18, 2027 As a reference, ICER reviewed Spravato in 2019 and MDMA in 2024, both in the same year as FDA decisions. For Spravato: FDA came first, then ICER: - FDA advisory committee (Feb 12, 2019) - FDA approval (Mar 5, 2019) - ICER draft evidence report (Mar 21, 2019) - ICER's public meeting (May 23, 2019) - Final report (Jun 20, 2019) FDA's advisory committees voted 14-2 (1 abstain) that benefits outweighed risks, despite only one positive short-term trial, and FDA required strict supervised dosing [2]. One panelist, Walter Dunn, called it a potential "game-changer" but said "the issues of cost and patient accessibility need to be addressed" [2]. Separately, ICER's panel voted 0-17 that the evidence wasn't adequate to show Spravato was better than IV ketamine, and 0-17 versus TMS, ECT, or antipsychotic add-on therapy [3]. ICER put a fair price at $17,700 to $25,200 a year against a $32,400 list price, a 25-52% discount, and rated it low value for money [4]. ICER also issued an affordability alert, warning that at list price only about 16% of eligible patients could be treated before added spending exceeded its national budget limit, well below the roughly half experts expected to be offered it [3][4]. Major commercial plans still cover it, though with step-therapy and prior-authorization rules that vary widely. For MDMA: Timing ran in the opposite order of Spravato. ICER weighed in before the FDA did: - ICER draft evidence report (Mar 2024) - ICER's public meeting (May 30, 2024) - FDA advisory committee (Jun 4, 2024) - ICER final report (Jun 27, 2024) - Lykos announced the FDA rejection (Aug 9, 2024) ICER’s draft rated the evidence for Lykos’ MDMA-assisted therapy for PTSD as insufficient. It pointed to functional unblinding (nearly everyone on MDMA could tell they got it) and to concerns about how the trials were run. ICER's panel voted 14-1 that the evidence wasn't strong enough to show the therapy did more good than harm compared with usual care. With the evidence that uncertain, ICER didn't estimate a fair price [5]. FDA's advisory committee then voted 9-2 that the trial data didn't show MDMA-assisted therapy was effective for PTSD, and 10-1 that its benefits didn't outweigh its risks [6]. In August, Lykos announced that the FDA had declined to approve it and asked for another Phase 3 trial [7]. Looking ahead, ICER's COMP360 review will give an outside read on cost-effectiveness that could shape reimbursement and payer rules. In a 2022 survey of 51 US payers, 79% said ICER's recommendations had at least occasionally influenced their coverage decisions over the prior two years (20% said often) [8][9]. As the figure shows, payers rated ICER the most useful of five value frameworks and often described it as at least somewhat useful for formulary decisions (90%) and pricing negotiations (82%) [8]. As an example, New York Medicaid can use an ICER review to set a target rebate for a drug. A rebate is money the drugmaker pays back to the state Medicaid program after it buys the drug, which works like a discount. If the drugmaker won't agree to that rebate, the state can require prior authorization, making access more restrictive [10]. Because ICER is comparing COMP360 to Spravato, IV ketamine, and rTMS, its verdict can shape how payers weigh it against treatments they already cover. Overall, ICER's review will show how cost-effective COMP360 is compared with treatments already in use, like Spravato, IV ketamine, and rTMS. That matters for access in two ways. 1) The results can shape payer rules like prior authorization, which control who can get the treatment. 2) They can affect reimbursement rates, which drive clinic economics. If reimbursement is too low, prescribers may not prescribe it, and clinics may not set aside as much capacity for it. In my Substack series, Beyond Approval, I will explore this in more detail: beyondapprovalpsychedelics.s…