While it is similar in some respects, Germany\u2019s new compassionate use psilocybin program has some unique features.<\/p>\n
A key feature is that, unlike in some other systems, where regulators like Health Canada are the decision-makers, the German program allows licensed psychiatrists at one of the two sites to decide whether a patient should be included in the program. \u201cThis decision cannot be made by any formal regulatory or governmental authority\u201d, Gr\u00fcnder told us. While psychiatrists may decide on patient participation, Gr\u00fcnder remains the \u2018responsible person\u2019 for the program.<\/p>\n
This means that it will not be necessary to wait for patient-by-patient approval from a regulatory authority, which could represent a significant improvement over other programs, eliminating a key bottleneck in the patient journey and empowering healthcare professionals to make decisions as opposed to bureaucrats.<\/p>\n
What\u2019s more, permission need not be sought for every single dose, Gr\u00fcnder told us. \u201cOur protocol allows us to repeat the treatment in case of non-response to a first dose or to maintain the treatment effect\u201d, he explained.<\/p>\n
In terms of that protocol, Gr\u00fcnder said that it was provided to BfArM and includes \u201cvery strict\u201d rules, \u201cespecially with regard to safety monitoring.\u201d The dosing session, for example, will be \u201cmonitored by two trained health-care professionals, including one physician\u201d, he told us.<\/p>\n
Those rules \u201ccannot be changed\u201d, he emphasised; \u201cthey cannot be relaxed.\u201d<\/p>\n
For now, the program is limited to CIMH and OVID. Gr\u00fcnder told Psychedelic Alpha that there is the option to add more sites, in time, but that starting with two sites allows them to establish procedures. \u201cWe are assuming that there will be lots of interest from other sites\u201d, he said, but they \u201chave to qualify according to criteria that were communicated to the authorities.\u201d<\/p>\n
In terms of patient eligibility, patients with TRD (which means those who have not responded to at least two classical antidepressants that were administered for sufficient duration and at a sufficient dose) must show that participation in a psilocybin trial is not possible.<\/p>\n
While he wouldn\u2019t share specific inclusion and exclusion criteria with us, out of concern that patients might conceal conditions relevant to safety, he said that \u201cin general, those criteria are more flexible than in clinical studies.\u201d<\/p>\n
Aside from site expansion, might the program grow to include other indications? Gr\u00fcnder said that EU regulations stipulate that such programs are only possible in indications \u201cfor which there is sufficient evidence and at least one ongoing Phase 3 trial.\u201d \u201cTherefore, the only other possible indication would be [generalised anxiety disorder], but only with LSD\u201d, he continued.<\/p>\n
In terms of scale, the group does not anticipate more than 50 patients in its first year, due to limited resources. \u201cWe are allowed to treat more\u201d, Gr\u00fcnder clarified.<\/p>\n
Other countries\u2019 pre-approval access programs have faced issues with accessibility due to high costs. But this group believes they will be able to offer psilocybin therapy in a much more affordable manner.<\/p>\n
Gr\u00fcnder says that the drug itself has to be provided to patients for free, under the terms of the program, and that the treatment \u201cwill be part of an overall treatment plan that includes general psychiatric care at both facilities.\u201d<\/p>\n
\u201cIt will therefore be covered by health insurance of the patients\u201d, he added.<\/p>\n
In terms of data collection, the group says that it is very interested in \u2018scientific monitoring\u2019, beyond the \u2018detailed reports\u2019 it is obligated to provide to authorities on the program\u2019s progress. \u201cIn addition to a variety of psychometric scales that will be used to measure outcomes,\u201d Gr\u00fcnder told us, \u201cthere will also be accompanying research that will be site-specific\u201d. That will include imaging studies at CIMH, for example.<\/p>\n
\u201cWe are of course very much interested in sharing these data\u201d, Gr\u00fcnder added.<\/p>\n","protected":false},"excerpt":{"rendered":"While it is similar in some respects, Germany\u2019s new compassionate use psilocybin program has some unique features. A…\n","protected":false},"author":2,"featured_media":307996,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5310],"tags":[2000,299,1824],"class_list":{"0":"post-307995","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-germany","8":"tag-eu","9":"tag-europe","10":"tag-germany"},"share_on_mastodon":{"url":"","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/307995","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=307995"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/307995\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/307996"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=307995"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=307995"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=307995"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}