HYDROCORTISONE PHARMIS (hydrocortisone sodium succinate) - Corticosteroid

Opinions on drugs - Posted on May 17 2024

Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement only in medical emergencies: hydrocortisone is indicated in the treatment of shock secondary to adrenal insufficiency or shock unresponsive to conventional therapy in the event of adrenal insufficiency.

Unfavourable opinion for reimbursement in the other clinical situations of the MA: Endocrine disorders (primary or secondary adrenal insufficiency), collagen diseases (systemic lupus erythematosus), dermatological diseases (severe erythema multiforme (Stevens-Johnsonsyndrome)) and allergic states (bronchial asthma, anaphylactic reactions).

No clinical added value compared to proprietary medicinal products based on hydrocortisone 100 mg powder and solvent for solution for injection/infusion.

Clinical Benefit

Substantial

The Committee considers that the clinical benefit of HYDROCORTISONE PHARMIS 100 mg (hydrocortisone sodium succinate) powder and solvent for solution for injection/infusion is substantial in the treatment of shock secondary to adrenal insufficiency or shock unresponsive to conventional therapy in the event of adrenal insufficiency.

Insufficient

In conditions in which a rapid and intense corticosteroid effect is required, such as: endocrine disorders (primary or secondary adrenocortical insufficiency), systemic autoimmune diseases (systemic lupus erythematosus), dermatological diseases (severe erythema multiforme: Stevens-Johnson syndrome) and allergic states (bronchial asthma, anaphylactic reactions), the Committee considers that the clinical benefit of HYDROCORTISONE PHARMIS 100 mg (hydrocortisone sodium succinate) powder and solvent for solution for injection/infusion is insufficient.

Clinical Added Value

no clinical added value

This medicinal product is a euro-generic that provides no clinical added value (CAV V) compared to the medicinal products containing hydrocortisone for injection already listed in acute adrenal insufficiency.