Tuesday, April 16, 2024

G-BA decisions from 21 September 2023

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Here are the decisions made by the G-BA during their meeting on September 21, 2023, regarding the early benefit assessments of various medications:

  1. Nubeqa (darolutamide): It received a new indication for treating metastatic hormone-sensitive prostate cancer when combined with docetaxel and androgen deprivation therapy, and it was found to provide a considerable additional benefit.
  2. Spravato (esketamine): This medication, used for therapy-resistant depression in combination with SSRI or SNRI, was re-assessed after the previous resolution expired. There’s a hint of a considerable additional benefit.
  3. Reblozyl (luspatercept): It gained a new indication for treating β-thalassemia with non-transfusion-dependent anemia. Although it’s an orphan drug, it was determined to provide a minor additional benefit.
  4. Wakix (pitolisant): For narcolepsy treatment in children and adolescents aged 6 to 17 years, with or without cataplexy, this orphan drug showed a hint of not-quantifiable additional benefit.
  5. Dupixent (dupilumab): When used for atopic dermatitis in children aged 6 months up to 5 years, it hinted at a not-quantifiable additional benefit in one of two subgroups.
  6. Dupixent (dupilumab): Its new indication for eosinophilic esophagitis in individuals aged ≥12 years and weighing at least 40 kg did not prove additional benefit.
  7. Trulicity (dulaglutide): This medication’s new indication for diabetes mellitus type 2 in individuals aged ≥10 years did not demonstrate additional benefit.
  8. Lynparza (olaparib): In the case of ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy, additional benefit was not proven after re-assessment.
  9. Rubraca (rucaparib): Following re-assessment, it didn’t prove an additional benefit for ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, maintenance therapy.
  10. Ondexxya (andexanet alfa): The time restriction of the previous resolution, which concerns the reversal of anticoagulation by apixaban or rivaroxaban for life-threatening or uncontrollable bleeding, was extended to August 1, 2024.
  11. Ultomiris (ravulizumab): With a new indication for myasthenia gravis in individuals positive for AChR antibodies, the previous time restriction was removed.

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