following a full submission assessed under the orphan equivalent medicine process:
hydrocortisone modified-release (Efmody®) is not recommended for use within NHSScotland.
Indication under review: treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
In a phase III study, androgen suppression was similar with hydrocortisone modified-release compared with standard of care in adults.
The submitting company did not present 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.
- Medicine name:
- hydrocortisone modified-release hard capsules (Efmody)
- SMC ID:
For treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults
- Pharmaceutical company
- Diurnal Limited
- BNF chapter
- Endocrine system
- Submission type
- Not recommended
- Date advice published
- 07 March 2022