The decision by the Scottish Medicines Consortium not to recommend automatic reimbursement of Efmody in NHS Scotland complicates Efmody's roll out post-approval.
Compounding this is the recognition that some Clinical Commissioning Groups elsewhere in the UK also rely on the recommendation of SMC. While we would hope that larger endocrinology centres in the UK may come to their own conclusion, based on patient need and the attributes offered by Efmody, this decision will clearly negatively impact Diurnal's near term efforts to effect an expeditious launch of Efmody in the UK. As a result, Diurnal has provided preliminary revenue guidance for the year ended June 2022 to reflect this.
Despite this assessment from SMC, Diurnal remains committed to gaining automatic reimbursement for Efmody in congenital adrenal hyperplasia (CAH) in the UK. While this will require new data confirming Efmody's benefit in patients with CAH, we note that clinical data should be forthcoming from a combination of the head to head study versus Plendaren in patients with adrenal insufficiency (CHAMPAIN), as well as in patients with CAH (CONnECT). We have previously noted that we expect the design of the CHAMPAIN study, where Efmody is compared to Plenadren, to overcome any lingering doubts following the initial failed European Phase 3 study as well as the decision not to confer orphan drug status in Europe. CHAMPAIN is expected to read out at the end of 2022.
We believe that CHAMPAIN will deliver a positive result given that it assesses the ability of Efmody to deliver higher concentrations of hydrocortisone versus Plenadren in the morning after 4 weeks of treatment. Plenadren may deliver a higher concentration of hydrocortisone during the first 4 hours after administration, but this rapidly tails off during the day and completely misses out on the early morning increase and peak on awakening. Unlike Plenadren, Efmody successfully provides physiological peak cortisol levels on awakening. Consequently, we believe that this comparator study with Plenadren is important, with success delivering not only an approval in AI but also orphan drug status in Europe for the first time. Confirmation of orphan drug status in AI would help justify not only the premium pricing over generic hydrocortisone preparations, but would also remove any lingering doubt regarding Efmody's superior profile.
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