Latest NCPE Advice

Tivozanib (Fotivda®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tivozanib
Brand Fotivda®
Indication For the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.
Assessment Process
Rapid review commissioned 09/01/2019
Rapid review completed 24/01/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tivozanib compared with the current standard of care.

The HSE has approved reimbursement following confidential price negotiations August 2019.

Tixagevimab /cilgavimab (Evusheld®). HTA ID: 22015

Assessment Status NCPE Assessment Process Complete
HTA ID 22015
Drug Tixagevimab /cilgavimab
Brand Evusheld®
Indication For the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.
Assessment Process
Rapid review commissioned 09/03/2022
Rapid review completed 11/04/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tixagevimab/cilgavimab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 29/04/2022
Pre-submission consultation with Applicant 29/06/2022
Full submission received from Applicant 16/08/2022
Preliminary review sent to Applicant 28/10/2022
NCPE assessment re-commenced 28/11/2022
Factual accuracy sent to Applicant 12/12/2022
NCPE assessment re-commenced 19/12/2022
NCPE assessment completed 21/12/2022
NCPE assessment outcome The NCPE recommends that tixagevimab/cilgavimab not be considered for reimbursement unless 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

Tixagevimab/cilgavimab (Evusheld®).HTA ID: 22074

Assessment Status Rapid Review Complete
HTA ID 22074
Drug Tixagevimab/cilgavimab
Brand Evusheld®
Indication Is indicated for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID-19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
Assessment Process
Rapid review commissioned 12/12/2022
Rapid review completed 25/01/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tixagevimab/cilgavimab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies*.

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

Tobramycin (TOBI Podhaler®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tobramycin
Brand TOBI Podhaler®
Indication For the suppressive therapy of chronic pulmonary infection due to Ps aeruginosa in adults and children aged 6 years and older with CF.
Assessment Process
Rapid review commissioned 03/11/2010
Rapid review completed 29/11/2010
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Tocilizumab SC (RoActemra®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tocilizumab SC
Brand RoActemra®
Indication For the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.  It is licensed in monotherapy in patients who are intolerant of methotrexate or in cases where methotrexate is inappropriate.
Assessment Process
Rapid review commissioned 28/04/2014
Rapid review completed 16/07/2014
Rapid review outcome Full pharmacoeconomic assessment recommended at the submitted price.

The HSE has approved reimbursement following confidential price negotiation.

Tofacitinib (Xeljanz®) for active polyarticular juvenile idiopathic arthritis. HTA ID: 21034

Assessment Status Rapid Review Complete
HTA ID 21034
Drug Tofacitinib
Brand Xeljanz®
Indication For the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive or negative polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs. Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Assessment Process
Rapid review commissioned 18/08/2021
Rapid review completed 08/09/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tofacitinib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

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

Tofacitinib (Xeljanz®) for ankylosing spondylitis. HTA ID: 22005

Assessment Status Rapid Review Complete
HTA ID 22005
Drug Tofacitinib
Brand Xeljanz®
Indication For the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.
Assessment Process
Rapid review commissioned 07/02/2022
Rapid review completed 08/03/2022
Rapid review outcome A full HTA is not recommended. The NCPE recommends that tofacitinib 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.

Tofacitinib (Xeljanz®) for Ulcerative Colitis

Assessment Status Rapid Review Complete
HTA ID -
Drug Tofacitinib
Brand Xeljanz®
Indication For the treatment of adult patients with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy (i.e. corticosteroids, azathioprine, 6-mercaptopurine) or a biologic agent (i.e. TNF inhibitor).
Assessment Process
Rapid review commissioned 16/07/2018
Rapid review completed 18/09/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tofacitinib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

The HSE has approved reimbursement following confidential price negotiations November 2020.

Tolvaptan (Jinarc®)

Assessment Status Assessment process complete
HTA ID –
Drug Tolvaptan
Brand Jinarc®
Indication To slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1-3 at initiation of treatment with evidence of rapidly progressing disease.
Assessment Process
Rapid review commissioned 04/01/2016
Rapid review completed 12/01/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 27/01/2017
Full pharmacoeconomic assessment re-commissioned by HSE 14/08/2017
Pre-submission consultation with Applicant 18/09/2017
Full submission received from Applicant 06/02/2018
Preliminary review sent to Applicant 03/04/2018
NCPE assessment re-commenced 14/05/2018
Follow-up to preliminary review sent to Applicant 03/07/2018
NCPE assessment re-commenced 23/07/2018
Factual accuracy sent to applicant 27/08/2018
NCPE assessment re-commenced 06/09/2018
NCPE assessment completed 13/09/2018
NCPE assessment outcome The NCPE recommends that tolvaptan not be considered for reimbursement unless 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 Goods) Act 2013.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations; May 2019

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 pharmacoeconomic assessment commissioned by 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: 22050

Assessment Status NCPE Assessment Process Complete
HTA ID 22050
Drug Trastuzumab deruxtecan
Brand Enhertu®
Indication As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
Assessment Process
Rapid review commissioned 11/07/2022
Rapid review completed 27/07/2022
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.
Full pharmacoeconomic assessment commissioned by HSE 31/08/2022
Pre-submission consultation with Applicant 25/10/2022
Full submission received from Applicant 09/03/2023
Preliminary review sent to Applicant 15/09/2023
NCPE assessment re-commenced 13/10/2023
Factual accuracy sent to Applicant 23/11/2023
NCPE assessment re-commenced 30/11/2023
NCPE assessment completed 12/12/2023
NCPE assessment outcome The NCPE recommends that trastuzumab deruxtecan (Enhertu®) be considered for reimbursement if 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.

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 pharmacoeconomic assessment commissioned by 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 pharmacoeconomic assessment commissioned by 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.

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.

Ublituximab (Briumvi®). HTA ID: 24008

Assessment Status Rapid Review Complete
HTA ID 24008
Drug Ublituximab
Brand Briumvi®
Indication For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
Assessment Process
Rapid review commissioned 28/02/2024
Rapid review completed 02/04/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ublituximab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

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®) for Acute Myeloid Leukaemia. HTA ID: 22001

Assessment Status NCPE Assessment Process Complete
HTA ID 22001
Drug Venetoclax
Brand Venclyxto®
Indication In combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
Assessment Process
Rapid review commissioned 05/01/2022
Rapid review completed 01/02/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of venetoclax in combination with a hypomethylating agent compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 23/02/2022
Pre-submission consultation with Applicant 05/07/2022
Full submission received from Applicant 13/10/2022
Preliminary review sent to Applicant 25/04/2023
NCPE assessment re-commenced 25/05/2023
Factual accuracy sent to Applicant 26/07/2023
NCPE assessment re-commenced 03/08/2023
NCPE assessment completed 26/09/2023
NCPE assessment outcome The NCPE recommends that venetoclax 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.

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.

 

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.

Vutrisiran (Amvuttra®). HTA ID: 23035

Assessment Status Rapid Review complete
HTA ID 23035
Drug Vutrisiran
Brand Amvuttra®
Indication Indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy
Assessment Process
Rapid review commissioned 06/07/2023
Rapid review completed 03/08/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that vutrisiran 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.