GENOTONORM (somatropin) - Growth disturbance

Opinions on drugs - Posted on May 17 2024

Reason for request

Reassessment

Summary of opinion

Favourable opinion for reimbursement only in “growth disturbance (current height SDS or <-3 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS <0 during the last year) by 4 years of age or later.”

Clinical Benefit

Moderate

The Committee deems that the clinical benefit of GENOTONORM (somatropin) is moderate in the indication of growth disturbance (current height SDS <-3 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD, who failed to show catch-up growth (height velocity (HV) SDS <0 during the last year) by 4 years of age or later.