hydrocortisone (Alkindi)

following a full submission:

hydrocortisone (Alkindi®) is accepted for restricted use within NHSScotland.

Indication under review: replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to <18 years old).

SMC restriction: for the first-line treatment of infants and young children with adrenal insufficiency aged from birth to less than six years of age for whom hydrocortisone must otherwise be individually prepared by manipulation such as by compounding (or crushing) or by production of special solutions in order to produce age-appropriate doses, or hydrocortisone given as off-label buccal tablets.

In a single-dose, single-arm, phase III study in children aged <6 years with adrenal insufficiency, Alkindi® significantly increased plasma cortisol levels at 60 minutes compared with baseline.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of Alkindi®. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.