Sulthiame (Ospolot®) oral suspension. HTA ID: 25030

Assessment Status Rapid Review Complete
HTA ID 25030
Drug Sulthaime
Brand Ospolot®
Indication Sulthiame (Ospolot®) oral suspension is indicated for the treatment of Self-Limited Epilepsy with Centrotemporal Spikes (SeLECTS) (former Rolandic epilepsy) in children and adolescents aged three years and above who are non-respondent/intolerant to other treatments or without other therapeutic alternatives.
Assessment Process
Rapid review commissioned 11/04/2025
Rapid review completed 27/05/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that sulthiame (Ospolot®) oral suspension 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.

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.

Tadalafil (Adcirca®)

Assessment Status Rapid Review Complete
HTA ID
Drug Tadalafil
Brand Adcirca®
Indication In adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organisation (WHO) Functional Class (FC) II and III, to improve exercise capacity.
Assessment Process
Rapid review commissioned 13/07/2011
Rapid review completed 21/09/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended
May 2014 In accordance with the Health Act (Pricing and Supply of Medical Goods) 2013 (section 18(4)), the HSE has requested the NCPE to re-examine the cost effectiveness of Tadalafil (Adcirca®).
Rapid review commissioned 09/05/2014
Rapid review completed 23/05/2014
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

 

Tafamidis (Vyndaqel®). HTA ID: 20017

Assessment Status Assessment process complete
HTA ID 20017
Drug Tafamidis
Brand Vyndaqel®
Indication For the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.
Assessment Process
Rapid review commissioned 30/03/2020
Rapid review completed 07/04/2020
Rapid review outcome A full HTA is recommended to assess the clinical and cost effectiveness of tafamidis compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 29/04/2020
Pre-submission consultation with Applicant 18/05/2020
Full submission received from Applicant 01/07/2020
Preliminary review sent to Applicant 18/08/2020
NCPE assessment re-commenced 10/09/2020
Factual accuracy sent to Applicant 11/09/2020
NCPE assessment re-commenced 18/09/2020
NCPE assessment completed 25/09/2020
NCPE assessment outcome The NCPE recommends that tafamidis 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

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

Tafamidis meglumine (Vyndaqel®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tafamidis meglumine
Brand Vyndaqel®
Indication For the treatment of transthyretin amyloidosis in adult patients with stage I symptomatic polyneuropathy to delay peripheral neurologic impairment.
Assessment Process
Rapid review commissioned 12/03/2018
Rapid review completed 10/05/2018
Rapid review outcome A full pharmacoeconomic assessment is not recommended until additional efficacy and/or safety data is submitted. On the basis of current evidence, the NCPE recommends that tafamidis not be considered for reimbursement in accordance with the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Tafasitamab (Minjuvi®) in combination with lenalidomide. HTA ID: 22008

Assessment Status Rapid Review Complete
HTA ID 22008
Drug Tafasitamab
Brand Minjuvi®
Indication In combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem-cell transplant (ASCT).
Assessment Process
Rapid review commissioned 14/02/2022
Rapid review completed 15/02/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tafasitamab in combination with lenalidomide compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Tafluprost (Saflutan®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tafluprost
Brand Saflutan®
Indication For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.
Assessment Process
Rapid review commissioned 25/03/2011
Rapid review completed 09/04/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended.

Talazoparib (Talzenna®) HTA ID: 19032

Assessment Status Assessment process complete
HTA ID 19032
Drug Talazoparib
Brand Talzenna®
Indication As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer.
Assessment Process
Rapid review commissioned 19/08/2019
Rapid review completed 03/09/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of talazoparib compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 09/09/2019
Pre-submission consultation with Applicant 02/12/2019
Full submission received from Applicant 06/03/2020
Preliminary review sent to Applicant 24/04/2020
NCPE assessment re-commenced 05/06/2020
Factual accuracy sent to Applicant 14/08/2020
NCPE assessment re-commenced 21/08/2020
NCPE assessment completed 18/09/2020
NCPE assessment outcome The NCPE recommends that talazoparib (Talzenna®) 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

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

Talazoparib (Talzenna®) in combination with enzalutamide for mCRPC. HTA ID: 23074

Assessment Status Rapid Review Complete
HTA ID 23074
Drug Talazoparib
Brand Talzenna®
Indication Talazoparib (Talzenna®) in combination with enzalutamide is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
Assessment Process
Rapid review commissioned 07/12/2023
Rapid review completed 21/12/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that talazoparib in combination with enzalutamide 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.

Talimogene laherparepvec (Imlygic®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Talimogene laherparepvec
Brand Imlygic®
Indication For the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.
Assessment Process
Rapid review commissioned 16/02/2016
Rapid review completed 14/03/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.

Not considered cost-effective due to non-submission of full pharmacoeonomic assessment.

Talquetamab (Talvey®). HTA ID: 23057

Assessment Status NCPE Assessment Process Complete
HTA ID 23057
Drug Talquetamab
Brand Talvey®
Indication Talquetamab is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Assessment Process
Rapid review commissioned 20/09/2023
Rapid review completed 10/11/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of talquetamab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 29/11/2023
Pre-submission consultation with Applicant 23/01/2024
Full submission received from Applicant 02/05/2024
Preliminary review sent to Applicant 12/12/2024
NCPE assessment re-commenced 05/02/2025
Factual accuracy sent to Applicant 10/04/2025
NCPE assessment re-commenced 18/04/2025
NCPE assessment completed 26/05/2025
NCPE assessment outcome The NCPE recommends that talquetamab 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.

Tapentadol (Palexia®)

Assessment Status Assessment process complete
HTA ID -
Drug Tapentadol
Brand Palexia®
Indication For the management of adult patients with severe chronic/acute pain.
Assessment Process
Rapid review commissioned 19/10/2010
Rapid review completed 22/10/2020
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 31/01/2011
NCPE assessment completed 08/04/2011
NCPE assessment outcome Reimbursement Recommended

Tapentadol (Palexia®) may be considered cost-effective but should be reserved for patients who cannot tolerate existing strong oral opioids.

Technical Summary

Tedizolid phosphate (Sivextro®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tedizolid phosphate
Brand Sivextro®
Indication For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults
Assessment Process
Rapid review commissioned 07/05/2015
Rapid review completed 07/07/2015
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Tegafur/Gimeracil/Oteracil (Teysuno®)

Assessment Status Rapid Review Complete
Drug Tegafur/Gimeracil/Oteracil
Brand Teysuno®
Indication For the treatment of advanced gastric cancer.
Assessment Process
Rapid review commissioned 27/02/2012
Rapid review completed 23/03/2012
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Telaprevir (Incivo®)

Assessment Status Assessment process complete
HTA ID -
Drug Telaprevir
Brand Incivo®
Indication As add-on therapy to pegylated interferon and ribavirin for the treatment of patients infected with Hepatitis C Genotype 1.
Assessment Process
Rapid review commissioned 28/10/2011
Rapid review completed 02/11/2011
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 08/11/2011
NCPE assessment completed 19/01/2012
NCPE assessment outcome Reimbursement Recommended

We consider telaprevir (Incivo®) a highly cost-effective therapy when added to peginterferon-ribavirin for the treatment of patients infected with genotype 1 hepatitis C virus in the Irish healthcare setting.

Technical Summary

Telavancin (Vibativ®)

Assessment Status Rapid Review Complete
Drug Telavancin
Brand Vibativ®
Indication For the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumomia, known or suspended to be caused by methicillin-resistant Staphylococcus aureas (MRSA).  Vabitiv® should be used only in situations where it is known or suspected that other alternatives are not suitable.
Assessment Process
Rapid review completed 13/01/2015
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Tenecteplase (Metalyse®): HTA ID 24046

Assessment Status Rapid Review Complete
HTA ID 24046
Drug Tenecteplase
Brand Metalyse®
Indication Tenecteplase (Metalyse®) is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.
Assessment Process
Rapid review commissioned 08/11/2024
Rapid review completed 27/11/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that tenecteplase be considered for reimbursement*.

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

Teriflunomide (Aubagio®)

Assessment Status Assessment process complete
HTA ID -
Drug Teriflunomide
Brand Aubagio®
Indication For the first line treatment of adult patients with relapsing remitting multiple sclerosis (MS).
Assessment Process
Rapid review commissioned 27/08/2013
Rapid review completed 20/09/2013
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 25/11/2013
NCPE assessment completed 19/06/2014
NCPE assessment outcome Reimbursement Not Recommended.

The NCPE does not recommend reimbursement of teriflunomide (Aubagio®) at the current price.

Technical Summary

The HSE has approved reimbursement following price negotiations-September 2014

Tezepelumab (Tezspire®). HTA ID: 23025

Assessment Status NCPE Assessment Process Complete
HTA ID 23025
Drug Tezepelumab
Brand Tezspire®
Indication Tezepelumab (Tezspire®) is indicated as add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma, who are inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Assessment Process
Rapid review commissioned 10/05/2023
Rapid review completed 15/06/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that tezepelumab not be considered for reimbursement at the submitted price*.
Full pharmacoeconomic assessment commissioned by HSE 01/02/2024
Pre-submission consultation with Applicant 05/03/2024
Full submission received from Applicant 04/06/2024
Preliminary review sent to Applicant 13/03/2025
NCPE assessment re-commenced 11/04/2025
Factual accuracy sent to Applicant 11/06/2025
NCPE assessment re-commenced 17/06/2025
NCPE assessment completed 01/07/2025
NCPE assessment outcome The NCPE recommends that tezepelumab (Tezspire®) not be considered for reimbursement as add-on treatment for adults and adolescents 12 years and older with severe asthma with blood eosinophil levels < 300 cells per microlitre, who are inadequately controlled despite high-dose inhaled corticosteroids plus another maintenance treatment (subpopulation of the licensed population)*.

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.

Ticagrelor (Brilique®)

Assessment Status Assessment process complete
HTA ID -
Drug Ticagrelor
Brand Brilique®
Indication For the prevention of atherothrombotic events in adult patients with Acute Coronary Syndrome (ACS) including patients managed medically, and those who are managed with PCI (Percutaneous Coronary Intervention) or CABG (Coronary Artery Bypass Graft).
Assessment Process
Rapid review commissioned 25/11/2010
Rapid review completed 20/01/2011
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 27/07/2011
NCPE assessment completed 10/10/2011
NCPE assessment outcome Reimbursement Recommended

We consider Ticagrelor (Brilique®) a cost effective therapy for the prevention of atherothrombotic events in adult patients with ACS including patients managed medically and those managed with PCI or CABG.

Technical Summary

Ticagrelor (Brilique®) in combination with acetylsalicyclic acid

Assessment Status Rapid Review Complete
HTA ID -
Drug Ticagrelor
Brand Brilique®
Indication Co-administered with acetylsalicylic acid (ASA), for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.
Assessment Process
Rapid review commissioned 29/02/2016
Rapid review completed 04/05/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.

 Not considered cost-effective due to non-submission of full pharmacoeonomic evaluation

Tildrakizumab (Ilumetri®). HTA ID: 19029

Assessment Status Assessment process complete
HTA ID 19029
Drug Tildrakizumab
Brand Ilumetri®
Indication For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned 30/07/2019
Rapid review completed 28/08/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tildrakizumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.
Full pharmacoeconomic assessment commissioned by HSE 19/05/2020
Pre-submission consultation with Applicant 08/02/2021
Full submission received from Applicant 04/05/2021
Preliminary review sent to Applicant 20/07/2021
NCPE assessment re-commenced 23/08/2021
Factual accuracy sent to Applicant 15/10/2021
NCPE assessment re-commenced 03/11/2021
NCPE assessment completed 25/11/2021
NCPE assessment outcome The NCPE recommends that tildrakizumab (Ilumetri®), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy and who have failed treatment with non-biologic therapies and first-line biologic treatment with adalimumab, 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 May 2022.

Tirbanibulin (Klisyri®). HTA ID: 21054

Assessment Status Rapid Review Complete
HTA ID 21054
Drug Tirbanibulin
Brand Klisyri®
Indication For the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.
Assessment Process
Rapid review commissioned 15/11/2021
Rapid review completed 30/11/2021
Rapid review outcome A full HTA is not recommended. The NCPE recommends that tirbanibulin 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.

Tisagenlecleucel (Kymriah®) for DLBCL

Assessment Status Assessment process complete
HTA ID -
Drug Tisagenlecleucel
Brand Kymriah®
Indication For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Assessment Process
Rapid review commissioned 19/08/2018
Rapid review completed 18/10/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tisagenlecleucel compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 22/10/2018
Pre-submission consultation with Applicant 06/11/2018
Full submission received from Applicant 23/01/2019
Preliminary review sent to Applicant 28/05/2019
NCPE assessment re-commenced 26/06/2019
Factual accuracy sent to Applicant 27/08/2019
NCPE assessment re-commenced 04/09/2019
NCPE assessment completed 20/09/2019
NCPE assessment outcome The NCPE recommends that tisagenlecleucel (Kymriah®) 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

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

Tisagenlecleucel (Kymriah®) for pALL

Assessment Status Assessment process complete
HTA ID -
Drug Tisagenlecleucel
Brand Kymriah®
Indication For the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
Assessment Process
Rapid review commissioned 19/09/2018
Rapid review completed 19/10/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tisagenlecleucel compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 22/10/2018
Pre-submission consultation with Applicant 06/11/2018
Full submission received from Applicant 30/01/2019
Preliminary review sent to Applicant 11/04/2019
NCPE assessment re-commenced 10/05/2019
Factual accuracy sent to Applicant 23/07/2019
NCPE assessment re-commenced 01/08/2019
NCPE assessment completed 27/08/2019
NCPE assessment outcome The NCPE recommends that tisagenlecleucel (Kymriah®) 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

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

Tisagenlecleucel (Kymriah®). HTA ID: 22044

Assessment Status NCPE Assessment Process Complete
HTA ID 22044
Drug Tisagenlecleucel
Brand Kymriah®
Indication For the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Assessment Process
Rapid review commissioned 28/06/2022
Rapid review completed 27/07/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tisagenlecleucel compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 31/08/2022
Pre-submission consultation with Applicant 06/12/2022
Full submission received from Applicant 14/07/2023
Preliminary review sent to Applicant 06/02/2024
NCPE assessment re-commenced 08/03/2024
Follow-up to preliminary review sent to Applicant 11/04/2024
NCPE assessment re-commenced 18/04/2024
Factual accuracy sent to Applicant 27/05/2024
NCPE assessment re-commenced 05/06/2024
Follow up to factual accuracy check sent to Applicant 16/07/2024
NCPE assessment re-commenced 23/07/2024
NCPE assessment completed 12/08/2024
NCPE assessment outcome The NCPE recommends that tisagenlecleucel not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

Plain English Summary

Technical 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.

Tislelizumab (Tevimbra®). HTA ID 25033

Assessment Status Rapid Review Complete
HTA ID 25033
Drug Tislelizumab
Brand Tevimbra®
Indication Tislelizumab (Tevimbra®) is indicated in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) whose tumours express programmed death-ligand (PD-L1) with a tumour area positivity (TAP) score ≥ 5%.
Assessment Process
Rapid review commissioned 08/05/2025
Rapid review completed 09/06/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that tislelizumab 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.

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.

Tislelizumab (Tevimbra®). HTA ID: 25014

Assessment Status Rapid Review Complete
HTA ID 25014
Drug Tislelizumab
Brand Tevimbra®
Indication Tislelizumab (Tevimbra®) as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.
Assessment Process
Rapid review commissioned 18/02/2025
Rapid review completed 04/03/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tislelizumab compared with the current standard of care.

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: 23011

Assessment Status NCPE Assessment Process complete
HTA ID 23011
Drug Trastuzumab deruxtecan
Brand Enhertu®
Indication Trastuzumab deruxtecan as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Assessment Process
Rapid review commissioned 20/02/2023
Rapid review completed 16/03/2023
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 30/03/2023
Pre-submission consultation with Applicant 30/05/2023
Full submission received from Applicant 20/09/2023
Preliminary review sent to Applicant 25/03/2024
NCPE assessment re-commenced 26/04/2024
Factual accuracy sent to Applicant 20/08/2024
NCPE assessment re-commenced 28/08/2024
NCPE assessment completed 30/09/2024
NCPE assessment outcome The NCPE recommends that trastuzumab deruxtecan 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 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: 25039

Assessment Status Rapid Review Complete
HTA ID 25039
Drug Trastuzumab Deruxtecan
Brand Enhertu®
Indication Trastuzumab deruxtecan (Enhertu®) is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.
Assessment Process
Rapid review commissioned 13/06/2025
Rapid review completed 14/07/2025
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.

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.

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 pharmacoeconomic assessment commissioned by 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.

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.