Evolocumab (new indication: primary hypercholesterolemia, patients from ≥ 10 to < 18 years)

Subject:

• Active Substance: Evolocumab
• Name: Repatha^®
• Therapeutic area: Primary hypercholesterolemia or mixed dislipidemia
• Pharmaceutical company: Amgen GmbH

Time table:

• Start: 01.01.2022
• Final decision by G-BA: 16.06.2022

Final decision:

• Patients with heterozygous familial hypercholesterolemia (HeFH)
  a1) Patients aged 10 to 17 years for whom dietary and medical options for lipid lowering have not been exhausted:No additional benefit proved
  a2) Patients aged 10 to 17 years for whom dietary and medical options for lipid lowering have been exhausted: No additional benefit proved
• Patients with homozygous familial hypercholesterolemia (HoFH)
  b1) Patients aged 10 or 11 years for whom dietary and medical options for lipid lowering have not been exhausted: No additional benefit proved
  b2) Patients aged 10 or 11 years for whom dietary and medical options for lipid lowering have been exhausted: No additional benefit proved