Latest NCPE Advice

Vedolizumab (Entyvio®) in Ulcerative Colitis

Assessment Status Assessment process complete
HTA ID -
Drug Vedolizumab
Brand Entyvio®
Indication For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Assessment Process
Rapid review commissioned 12/09/2014
Rapid review completed 10/10/2014
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 05/03/2015
NCPE assessment completed 13/11/2015
NCPE assessment outcome Reimbursement Not Recommended at the submitted price.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations October 2017.

Vemurafenib (Zelboraf®)

Assessment Status Assessment process complete
HTA ID -
Drug Vemurafenib
Brand Zelboraf®
Indication For the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Assessment Process
Rapid review commissioned 23/12/2011
Rapid review completed 04/01/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 04/05/2012
NCPE assessment outcome Reimbursement not recommended at the submitted price

The NCPE believe that, at the submitted price, vemurafenib (Zelboraf®) is not cost effective for this indication

Technical Summary

September 2014

The HSE has approved reimbursement following confidential price negotiations.

Venetoclax (Venclyxto®) in combination with obinutuzumab (Gazyvaro®). HTA ID: 20046

Assessment Status Assessment process complete
HTA ID 20046
Drug Venetoclax in combination with obinutuzumab
Brand Venclyxto® / Gazyvaro®
Indication For the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
Assessment Process
Rapid review commissioned 07/10/2020
Rapid review completed 22/10/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of venetoclax in combination with obinutuzumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 27/10/2010
Pre-submission consultation with Applicant 30/11/2020
Full submission received from Applicant 05/02/2021
Preliminary review sent to Applicant 31/05/2021
NCPE assessment re-commenced 30/06/2021
Factual accuracy sent to Applicant 27/07/2021
NCPE assessment re-commenced 04/08/2021
NCPE assessment completed 17/08/2021
NCPE assessment outcome The NCPE recommends that venetoclax in combination with obinutuzumab be considered for reimbursement.*

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medicinal Goods) Act 2013.

 

The HSE has approved reimbursement following confidential price negotiations March 2022.

 

Vibegron (Obgemsa®) HTA ID: 24043

Assessment Status Rapid Review Complete
HTA ID 24043
Drug Vibegron
Brand Obgemsa®
Indication Vibegron (Obgemsa®) is indicated for the symptomatic treatment of adult patients with overactive bladder syndrome.
Assessment Process
Rapid review commissioned 11/10/2024
Rapid review completed 26/11/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that vibegron not be considered for reimbursement at the submitted price*.

*This recommendation is considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Voclosporin (Lupkynis®). HTA ID: 23003

Assessment Status NCPE Assessment Process Complete
HTA ID 23003
Drug Voclosporin
Brand Lupkynis®
Indication Voclosporin is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).
Assessment Process
Rapid review commissioned 10/01/2023
Rapid review completed 10/02/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of voclosporin compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 01/03/2023
Pre-submission consultation with Applicant 23/05/2023
Full submission received from Applicant 20/09/2023
Preliminary review sent to Applicant 24/04/2024
NCPE assessment re-commenced 31/05/2024
Follow-up to preliminary review sent to Applicant 02/09/2024
NCPE assessment re-commenced 09/09/2024
Factual accuracy sent to Applicant 25/10/2024
NCPE assessment re-commenced 05/11/2024
NCPE assessment completed 05/12/2024
NCPE assessment outcome The NCPE recommends that voclosporin (Lupkynis®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Vosoritide (Voxzogo®). HTA ID: 22028

Assessment Status NCPE Assessment Process Complete
HTA ID 22028
Drug Vosoritide
Brand Voxzogo®
Indication For the treatment of genetically confirmed achondroplasia in patients aged two years and older whose epiphyses are not closed.
Assessment Process
Rapid review commissioned 09/05/2022
Rapid review completed 01/06/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of vosoritide compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 01/07/2022
Pre-submission consultation with Applicant 26/09/2022
Full submission received from Applicant 21/03/2023
Preliminary review sent to Applicant 24/07/2023
NCPE assessment re-commenced 22/08/2023
Factual accuracy sent to Applicant 13/09/2023
NCPE assessment re-commenced 22/09/2023
NCPE assessment completed 05/10/2023
NCPE assessment outcome Due to the paucity of clinical outcome data, the very high cost and budget impact in addition to the failure to demonstrate cost-effectiveness the NCPE Review Group recommend that vosoritide not be considered for reimbursement*

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regards to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.