| 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 |
Latest NCPE Advice
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.
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 HTA commissioned by the HSE | 27/07/2016 |
| NCPE assessment completed | 15/03/2017 |
| NCPE assessment outcome | Reimbursement Not Recommended at the submitted price. |
The HSE has approved reimbursement following confidential price negotiations; April 2018.
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.
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.
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. |
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*. |
*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. |
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. |
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. |
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
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.* |
*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*. |
*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
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* |
*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*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Zilucoplan (Zilbrysq®). HTA ID: 26024
| Assessment Status | Rapid Review Complete |
| HTA ID | 26024 |
| Drug | Zilucoplan |
| Brand | Zilbrysq® |
| Indication | Zilucoplan (Zilbrysq®) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are all anti-acetylcholine receptor (AChR) antibody positive. |
| Assessment Process | |
| Rapid review commissioned | 13/05/2026 |
| Rapid review completed | 27/05/2026 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of zilucoplan compared with the current standard of care. |