Latest NCPE Advice

Tralokinumab (Adtralza®). HTA ID: 21028

Assessment Status Rapid Review Complete
HTA ID 21028
Drug Tralokinumab
Brand Adtralza®
Indication For the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned 29/06/2021
Rapid review completed 29/07/2021
Rapid review outcome A full HTA is not recommended. The NCPE recommends that tralokinumab should not be considered for reimbursement at the submitted price.*

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

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

Tramadol hydrochloride/dexketoprofen (Skudexa®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tramadol hydrochloride/dexketoprofen
Brand Skudexa®
Indication For the symptomatic short-term treatment of moderate to severe acute pain in adult patients whose pain is considered to require a combination of tramadol and dexketoprofen.
Assessment Process
Rapid review commissioned 17/10/2017
Rapid review completed 01/12/2017
Rapid review outcome Reimursement not recommended at the submitted price

Trametinib (Mekinist®)

Assessment Status Assessment process complete
HTA ID -
Drug Trametinib
Brand Mekinist®
Indication For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Assessment Process
Rapid review commissioned 27/11/2015
Rapid review completed 22/12/2015
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full HTA commissioned by the HSE 27/07/2016
NCPE assessment completed 15/03/2017
NCPE assessment outcome Reimbursement Not Recommended at the submitted price.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations; April 2018.

Trastuzumab deruxtecan (Enhertu®). HTA ID: 24028

Assessment Status Rapid Review Complete
HTA ID 24028
Drug Trastuzumab deruxtecan
Brand Enhertu®
Indication As monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
Assessment Process
Rapid review commissioned 17/07/2024
Rapid review completed 21/08/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of trastuzumab deruxtecan compared with the current standard of care.

Trastuzumab deruxtecan (Enhertu®). HTA ID: 25049

Assessment Status Rapid Review Complete
HTA ID 25049
Drug Trastuzumab deruxtecan
Brand Enhertu®
Indication Trastuzumab deruxtecan as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Assessment Process
Rapid review commissioned 06/08/2025
Rapid review completed 03/09/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of trastuzumab deruxtecan compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Further information on this process may be found here.

Further information on the status of this decision may be found here.

Trastuzumab emtansine (Kadcyla®)

Assessment Status Assessment process complete
HTA ID -
Drug Trastuzumab emtansine
Brand Kadcyla®
Indication For the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and taxane, separately or in combination.
Assessment Process
Rapid review commissioned 25/09/2013
Rapid review completed 24/10/2013
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full HTA commissioned by the HSE 05/02/2014
NCPE assessment completed 30/06/2014
NCPE assessment outcome Reimbursement Not Recommended.

The NCPE do not recommend reimbursement of trastuzumab emtansine (Kadcyla®) at the submitted price.

Technical Summary

December 2015

The HSE has approved reimbursement following confidential price negotiations.

Trastuzumab emtansine (Kadcyla®) HTA ID: 20002

Assessment Status Assessment process complete
HTA ID 20002
Drug Trastuzumab emtansine
Brand Kadcyla®
Indication As a single agent, for the adjuvant treatment of adults with HER2-positive, early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
Assessment Process
Rapid review commissioned 20/01/2020
Rapid review completed 27/02/2020
Rapid review outcome A full HTA is recommended to assess the clinical and cost effectiveness of trastuzumab emtansine compared with the current standard of care.
Full HTA commissioned by the HSE 04/03/2020
Pre-submission consultation with Applicant 31/03/2020
Full submission received from Applicant 08/06/2020
Preliminary review sent to Applicant 29/10/2020
NCPE assessment re-commenced 30/11/2020
Factual accuracy sent to Applicant 11/02/2021
NCPE assessment re-commenced 17/02/2021
NCPE assessment completed 12/03/2021
NCPE assessment outcome The NCPE recommends that trastuzumab emtansine (Kadcyla®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.

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

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations December 2021.

Tremelimumab (Imjudo®) in combination with durvalumab (Imfinzi®). HTA ID: 23073

Assessment Status NCPE Assessment Process Complete
HTA ID 23073
Drug Tremelimumab
Brand Imjudo®
Indication Tremelimumab (Imjudo®) in combination with durvalumab (Imfinzi®) is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma.
Assessment Process
Rapid review commissioned 06/12/2023
Rapid review completed 11/01/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tremelimumab in combination with durvalumab compared with the current standard of care.
Full HTA commissioned by the HSE 01/02/2024
Pre-submission consultation with Applicant 26/03/2024
Full submission received from Applicant 16/07/2024
Preliminary review sent to Applicant 20/03/2025
NCPE assessment re-commenced 24/04/2025
Follow-up to preliminary review sent to Applicant 02/05/2025
NCPE assessment re-commenced 08/05/2025
Factual accuracy sent to Applicant 06/06/2025
NCPE assessment re-commenced 13/06/2025
NCPE assessment completed 11/07/2025
NCPE assessment outcome The NCPE recommends that tremelimumab in combination with durvalumab (STRIDE) not 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 Medical Goods) Act 2013.

Trientine Tetrahydrochloride (TETA 4HCL) – Cuprior®

Assessment Status Rapid Review Complete
HTA ID -
Drug Trientine Tetrahydrochloride (TETA 4HCL)
Brand Cuprior®
Indication For the treatment of Wilson’s disease in adults and children ≥ five years intolerant to D-penicillamine therapy.
Assessment Process
Rapid review commissioned 19/08/2019
Rapid review completed 09/10/2019
Rapid review outcome A full HTA is not recommended.The NCPE recommends that trientine tetrahydrochloride (TETA 4HCl) not be considered for reimbursement at the submitted price*.

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

The HSE has approved reimbursement following confidential price negotiations, March 2020.

Trifluridine/tipiracil (Lonsurf®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Trifluridine/tipiracil
Brand Lonsurf®
Indication For the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
Assessment Process
Rapid review commissioned 10/06/2016
Rapid review completed 11/07/2016
Rapid review outcome Full pharmacoeconomic assessment recommended at the submitted price.

Tucatinib (Tukysa®). HTA ID: 22058

Assessment Status NCPE Assessment Process Complete
HTA ID 22058
Drug Tucatinib
Brand Tukysa®
Indication In combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer wo have received at least two prior anti-HER2 treatment regimens.
Assessment Process
Rapid review commissioned 23/08/2022
Rapid review completed 20/09/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tucatinib compared with the current standard of care.
Full HTA commissioned by the HSE 28/09/2022
Pre-submission consultation with Applicant 12/12/2023
Full submission received from Applicant 14/03/2024
Preliminary review sent to Applicant 06/12/2024
NCPE assessment re-commenced 07/03/2025
Follow-up to preliminary review sent to Applicant 10/04/2025
NCPE assessment re-commenced 23/05/2025
Additional follow-up to Preliminary Review sent to Applicant 23/07/2025
NCPE assessment re-commenced 01/08/2025
Factual accuracy sent to Applicant 11/08/2025
NCPE assessment re-commenced 18/08/2025
NCPE assessment completed 25/09/2025
NCPE assessment outcome The NCPE recommends that tucatinib 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

Upadacitinib (Rinvoq®) for giant cell arteritis. HTA ID: 25023

Assessment Status Rapid Review Complete
HTA ID 25023
Drug Upadacitinib
Brand Rinvoq®
Indication Upadacitinib is indicated for the treatment of giant cell arteritis in adult patients.
Assessment Process
Rapid review commissioned 25/03/2025
Rapid review completed 17/04/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of upadacitinib compared with the current standard of care.

Ustekinumab (Stelara®)

Assessment Status Assessment process complete
HTA ID -
Drug Ustekinumab
Brand Stelara®
Indication For the treatment of moderate to severe psoriasis.
Assessment Process
Full submission received from Applicant 01/07/2009
NCPE assessment completed 01/11/2009
NCPE assessment outcome Reimbursement recommended.

Technical Summary

We consider ustekinumab cost effective for the treatment of moderate to severe plaque psoriasis in the Irish healthcare setting.

Vedolizumab (Entyvio®) in Crohn’s Disease

Assessment Status Assessment process complete
HTA ID -
Drug Vedolizumab
Brand Entyvio®
Indication For the treatment of adult patients with moderately to severely active Crohn’s disease 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 01/10/2014
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 02/04/2015
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.

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 HTA commissioned by the HSE 27/10/2020
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 HTA commissioned by the 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.

The HSE has approved reimbursement following confidential price negotiations. October 2025

Vorasidenib (Voranigo®). HTA ID: 25059

Assessment Status Awaiting Full HTA Submission from Applicant
HTA ID 25059
Drug Vorasidenib
Brand Voranigo®
Indication Vorasidenib (Voranigo®) is indicated as monotherapy for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy.
Assessment Process
Rapid review commissioned 01/10/2025
Rapid review completed 23/10/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost-effectiveness of vorasidenib compared with the current standard of care.
Full HTA commissioned by the HSE 29/10/2025
Pre-submission consultation with Applicant 09/12/2025

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 HTA commissioned by the 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.

Zanubrutinib (Brukinsa®) for marginal zone lymphoma. HTA ID: 23072

Assessment Status NCPE Assessment Process Complete
HTA ID 23072
Drug Zanubrutinib
Brand Brukinsa®
Indication Zanubrutinib monotherapy is indicated for adult patients with relapsed/refractory marginal zone lymphoma with at least one prior anti-CD20-based therapy.
Assessment Process
Rapid review commissioned 01/12/2023
Rapid review completed 09/01/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of zanubrutinib compared with the current standard of care.
Full HTA commissioned by the HSE 31/01/2024
Pre-submission consultation with Applicant 12/03/2024
Full submission received from Applicant 20/08/2024
Preliminary review sent to Applicant 23/05/2025
NCPE assessment re-commenced 20/06/2025
Follow-up to preliminary review sent to Applicant 08/07/2025
NCPE assessment re-commenced 10/07/2025
Factual accuracy sent to Applicant 30/07/2025
NCPE assessment re-commenced 08/08/2025
NCPE assessment completed 03/09/2025
NCPE assessment outcome The NCPE recommends that zanubrutinib 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.