following a full submission considered under the orphan process:
hydrocortisone modified release (Plenadren®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of adrenal insufficiency in adults.
Compared with three times daily immediate-release hydrocortisone, once daily modified-release hydrocortisone (taken in the morning) demonstrated approximately 20% lower cortisol exposure over 24 hours. A high cortisol concentration peak in the morning and gradual decline during the afternoon with modified-release hydrocortisone partially reflects the physiological profile.
The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
|Drug Name:||hydrocortisone (Plenadren)|
|SMC Drug ID:||848/12|
|Indication:||for the treatment of adrenal insufficiency in adults.|
|Sub Category:||6.3 Corticosteroids|
|Submission Type:||Full submission|
|Date Advice Published:||12 December 2016|
|hydrocortisone (Plenadren)||Non submission||14 January 2013|