Efmody® (modified-release hydrocortisone) receives MHRA approval for adrenal insufficiency in the UK On May 6 2026, Efmody® (modified-release hydrocortisone) received MHRA approval for adrenal insufficiency in the UK. In congenital adrenal hyperplasia (CAH) patients, for whom Efmody® has been approved since 2021, not only has it shown better control of the condition – it has also enabled patients to reduce their dose (mitigating the long-term negative impact of steroid use), as well as reducing stress dosing and adrenal crises so improved overall quality of life. Here we tell you a little more about the newly licensed medication, how it works, the research supporting it, and how it is prescribed. What is Efmody® and how is it taken? Why is modified release a benefit? Supporting Research Where is it licensed and who for? How much does it cost? Can I get it on prescription? What next? What is Efmody® and how is it taken? Efmody® is a 'modified release' form of hydrocortisone, which can be used to treat all types of adrenal insufficiency, including Addison's disease. Modified release means that it is not immediately released into the blood stream when it is swallowed, allowing for it's effects to happen at a point some time after taking the medication. Efmody® comes in a hard capsule, where the coating is pH resistant so that it does not break down and release the hydrocortisone in the stomach. Instead, it is released in the small intestine, peaking approximately 4.5hours post-dose. Dose Efmody® is available in 5mg and 10mg capsules. An 'average' daily dose is 25mg, taken following a 'toothbrush regimen': a larger dose at night and a smaller dose in the morning. Why is 'modified release' a benefit? In a 'normal' cortisol curve in someone with fully functioning adrenal glands (the red line on the two graphs above), cortisol levels rise gradually during the early hours of the morning when you are sleeping and give a 'pre-dawn rise'. When someone with adrenal insufficiency wakes up, they have almost no cortisol in the body at a time when it’s designed to be at its peak. Clinicians think that this is the reason why many people struggle with quality-of-life issues in the early morning, and struggle to get out of bed or feel nauseous until their morning dose has kicked in. Following a dose of standard 'immediate release' hydrocortisone, prescribed for many people with adrenal insufficiency, cortisol levels in the body start to rise after 20-30 minutes, peaking around an hour after taking the medication (Fig.1.). Following taking a bed time dose of Efmody®, the modified release structure means it will be released at a time to more closely match the 'normal' cortisol curve (Fig.2.), addressing the pre-dawn rise of cortisol (shaded blue in Fig.1.), which people with Addison’s and adrenal insufficiency, miss out on as they're still sleeping! Supporting Research In our Winter 2024/5 magazine, we shared an article where Dr Alessandro Prete, one of the clinical advisors to the ADSHG, updated us on the research he led on Efmody. This study, involving 58 UK patients with Addison's disease (primary adrenal insufficiency) has now been published in the Lancet (Jan 2026): Effects of modified release hydrocortisone on restoration of early morning cortisol, quality of life, and fatigue in adrenal insufficiency (The CHAMPAIN study): a randomised, double-blind, double-dummy, cross-over study comparing Chronocort and Plenadren - eClinicalMedicine We summarise the study here, starting with it's hypothesis, that is, what it was setting out to prove or disprove; Hypothesis Restoration of the physiological overnight rise in cortisol has more beneficial effects than daytime cortisol replacement alone in patients with adrenal insufficiency. The study compared the efficacy, safety, and tolerability of Efmody® with Plenadren®, another modified-release hydrocortisone formulation. Included patients were: Male or female, aged over 18 years old On stable glucocorticoid treatment for primary adrenal insufficiency (Addison's disease) for more than 3 months before screening On stable mineralocorticoid treatment (fludrocortisone) as appropriate, for more than 3 months before screening Had an early morning, 'pre-dose' cortisol level of <50 nmol/L Many were recruited by the ADSHG for this study back in 2024 - thank you for your support! Following screening, patients were randomly given either Efmody® or Plenadren® for 4 weeks - Treatment Period 1 and then switched and given the other medication for 4 weeks during Treatment Period 2. It was a 'double-blind study', which is to say that they did not know which medication they were taking in either of the treatment periods. What the study showed The main 'test' of they hypothesis (known as the 'primary endpoint') was to look at 7am cortisol levels in the participants after 4 weeks of treatment, and to compare them for the 2 patient groups taking either Efmody® or Plenadren®. The primary endpoint results were statistically significant and showed that 7am cortisol levels in the patients taking Efmody® were higher than those taking Plenadren®. 'Secondary Endpoints' were other ways they measured how the medications were affecting the participants. For this, they asked participants to complete a variety of standardised questionnaires to measure fatigue, overall health and quality of life. Statistically significant results were noted for the following: MAF Global Fatigue Index (which measures self-reported fatigue in adults which chronic illness: Participants on Efmody® reported less fatigue. PROMIS 7b (which evaluates daily fatigue): Participants on Efmody® reported less fatigue. AddiQoL (which quantifies altered well-being and treatment effects in Addison's disease): Participants on Efmody® reported better quality of life. EQ-5D-5L (which assesses health outcomes on a common scale): Participants on Efmody® reported better health. Where is it licensed now and who for? Expanding on from the existing license for patients with CAH (since Oct 2021), Efmody® was granted MHRA approval for adrenal insufficiency patients in the UK on 6th May. This includes England and the devolved nations. It is licensed only for patients of 12 years and more in both the UK and EU. Please click on the link below for the news release from Immedica Pharma AB, who manufacture Efmody®. Immedica Pharma AB news release It has also been given EMA approval for use with adrenal insufficiency patients in the EU (on 27th March). There is no license for it in the USA. Efmody® has not been developed as a 'first line medication', i.e. it would not be prescribed on diagnosis; the primary glucocorticoid treatment for adrenal insufficiency is immediate release hydrocortisone, as noted in the NICE Guidelines for the Identification and Management of Adrenal Insufficiency (2024). Clinicians are yet to develop the guidance around when to prescribe it, but it is likely to be for patients with complex health needs for whom other steroid replacements such as immediate release hydrocortisone, or prednisolone, have not been successful and who have enduring symptoms that affect quality of life. How much does it Cost? Efmody® costs around £4000/year per patient, for an average dose of 25mg/day. The cost is the same whether it is a private prescription (where the patient pays) or an NHS prescription. In comparison, 25mg of immediate release hydrocortisone costs (very approximately as prices vary from brand to brand, month to month and depend on tablet size) £320 a year/patient. Can I get a prescription for Efmody®? Currently there are 3 ways of getting it prescribed and it will depend on your area (unfortunately and frustratingly, this does mean a postcode lottery!), as it depends on individual Integrated Care Boards (ICBs) and which medications they have on their approved lists. Private Prescription Efmody® is available with a private prescription (from a private prescribing clinician) across all areas of the UK now that it is licensed for patients of 12 years old+, who have any type of adrenal insufficiency. The cost for this would be around £4000/year, plus the cost of an appointment with a private prescribing clinician. Individual Funding Request Prescribers in all areas of the UK are able to make Individual Funding Requests for a licensed medication that is not on their ICB approved medication list, if they feel that it will be of particular clinical benefit to a patient. Decisions on Individual Funding Requests are made by an independent multi-disciplinary panel and only take into account clinical reasoning. It is likely that they would only be approved if the patient has enduring symptoms impacting quality of life after trying primary glucocorticoid treatments such as hydrocortisone and prednisolone. For more information on Individual Funding Requests in England, please see below. The processes are slightly different for each region so please talk to your endocrinologist in the first instance, who can explain more about the specific process in your area. NHS England: Individual Funding Requests Efmody being added to the ICB approved medications list: a formulary application on behalf of a patient This route is applicable only for England and Wales (where Efmody has been approved for use with CAH patients). In Scotland and Northern Ireland, only the previous two options are available to you (private prescription or individual funding requests). There are 40 Integrated Care Boards (ICBs) in England, and each have their own individual approved medication lists. These list medications using a traffic light system of green/amber/red, which indicates a number of factors including how frequently they might be prescribed by hospital clinicians, and in what clinical circumstances. Currently, out of these 40, 23 have approved Efmody® as either an amber or red medication for use with CAH patients. As the license for adrenal insufficiency patients has only just been approved, none of the 40 ICBs yet have Efmody® as an approved medication on their list. It is not clear whether the 23 that already have it on their approved lists already, will automatically approve it for adrenal insufficiency patients, or whether a forumlary application will need to be submitted as if it were a new medication. Applications for new medications to be added to an ICB approved list involve a clinician submitting an application on behalf of their patient. Similar to the Independent Funding Referral, it requires clinical justification of the need for the more expensive drug. What next and what can you do to help? This is all happening against the backdrop of the UK Rare Disease Framework. This is a policy supported by England and the devolved nations which aims to improve access to medications for rare diseases by addressing the unique challenges faced by these conditions. Key points that are included in this framework are: the need for a patient focused regulatory approach streamlining the regulatory process for rare disease treatments supporting collaboration among patients, healthcare professionals and researchers to enhance development and approval of treatments make it quicker and easier to get therapies tested and approved in the UK Whilst further studies in the future will likely bring more understanding of the benefits of Efmody®, for patients in the CHAMPIAN study we share above, it had statistically significant benefits in terms of health and quality of life. Clinical guidelines need to be drawn up still around who is most likely to benefit from Efmody®, but in the meantime, it is important that prescribing hospital clinicians take the step of applying for Efmody® to be added to their ICB approved medicines lists. The trigger for this to happen is for you to talk to your endocrinologist if your low cortisol symptoms are seriously impacting your health and quality of life on your current replacement steroid medication regimen. So, if this describes you, ask your endocrinologist if you can trial Efmody®. Be prepared to tell them about your symptoms, e.g. fatigue, nausea or brain fog, and how it impacts on your life, as they will need this information to justify their application. Are you a member of our charity? Whether you're newly diagnosed or have lived with the condition for years - please join our community and support our cause! You'll receive the latest expert advice, guidance and ADSHG news, whilst being part of our inspiring and supportive community. Join Us Together we will improve the lives of those with Addison's disease and adrenal insufficiency! Say hello! Follow us on X/Twitter, Bluesky, Facebook, Instagram, LinkedIn, Threads, TikTok and YouTube. Manage Cookie Preferences