Joint assessments

 

Stay informed with our latest assessment reports.


Find our assessment reports regarding the following below:

  • Voxzogo
  • Libmeldy
  • Zynteglo
  • Xtandi
  • Tecentriq


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Voxzogo - September 2023 

Assessed indication: Voxzogo is indicated for the treatment of achondroplasia in patients 2 years of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing. 

 

Libmeldy - February 2022 

Assessed indication: Libmeldy is indicated for the treatment of metachromatic leukodystrophy (MLD) characterized by biallelic mutations in the arylsulfatase A (ARSA) gene leading to a reduction of the ARSA enzymatic activity: 

  • in children with late infantile or early juvenile forms, without clinical manifestations of the disease, 

  • in children with the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline 

The FINOSE assessment report for Libmeldy was used for joint Nordic negotiations between the HTD and the New Expensive Drugs, NED group in Nordic Pharmaceutical Forum. 

 

Zynteglo - June 2020 

Assessed indication: Zynteglo for the treatment of patients 12 years and older with transfusion-dependent β-thalassaemia (TDT) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available 

 

Xtandi - June 2019

Assessment report - Xtandi

Assessed indication: Enzalutamide for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer.

 

Tecentriq - June 2019 

Full indication in combination with bevacizumab, paclitaxel and carboplatin  
Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.  

Assessed subgroups: 

  • Patients with EGFR mutant or ALK-positive NSCLC after failure of appropriate targeted therapies 

  • Patients with liver metastasis