| Assessment Status | Rapid Review Complete |
| HTA ID | 25004 |
| Drug | Ruxolitinib |
| Brand | Opzelura® |
| Indication | Ruxolitinib (Opzelura®) is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. |
| Assessment Process | |
| Rapid review commissioned | 09/01/2025 |
| Rapid review completed | 17/02/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ruxolitinib cream for this indication compared with the current standard of care. |
Latest NCPE Advice
Sacituzumab govitecan (Trodelvy®). HTA ID: 23079
| Assessment Status | Rapid Review Complete |
| HTA ID | 23079 |
| Drug | Sacituzumab govitecan |
| Brand | Trodelvy® |
| Indication | Sacituzumab govitecan is indicated for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. |
| Assessment Process | |
| Rapid review commissioned | 21/12/2023 |
| Rapid review completed | 26/01/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sacituzumab govitecan compared with the current standard of care. |
Sacubitril/valsartan (Entresto®)
| Assessment Status | Assessment Process Complete |
| HTA ID | - |
| Drug | Sacubitril/valsartan |
| Brand | Entresto® |
| Indication | For the treatment of symptomatic chronic heart failure with reduced ejection fraction if adult patients. |
| Assessment Process | |
| Rapid review commissioned | 06/11/2015 |
| Rapid review completed | 30/11/2015 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full submission received from Applicant | 07/03/2016 |
| NCPE assessment completed | 08/07/2016 |
| NCPE assessment outcome | Reimbursement Recommended |
The NCPE considers valsartan/sacubitril (Entresto) cost-effective for the current licensed indication and recommends reimbursement.
The HSE has approved reimbursement following confidential price negotiations October 2017.
Selpercatinib (Retsevmo®) for advanced RET fusion-positive non-small cell lung cancer. HTA ID: 25035
| Assessment Status | Rapid Review Complete |
| HTA ID | 25035 |
| Drug | Selpercatinib |
| Brand | Retsevmo® |
| Indication | Selpercatinib is indicated as monotherapy for the treatment of adult patients with advanced RET fusion-positive non-small cell lung cancer not previously treated with a RET inhibitor. |
| Assessment Process | |
| Rapid review commissioned | 22/08/2025 |
| Rapid review completed | 10/10/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that selpercatinib for this indication not be considered for reimbursement at the submitted price. |
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.
Selpercatinib (Retsevmo®) for advanced RET fusion-positive thyroid cancer. HTA ID: 25034b
| Assessment Status | Rapid Review Complete |
| HTA ID | 25034b |
| Drug | Selpercatinib |
| Brand | Retsevmo® |
| Indication | Selpercatinib (Retsevmo®) is indicated in adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate). |
| Assessment Process | |
| Rapid review commissioned | 15/05/2025 |
| Rapid review completed | 01/07/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selpercatinib compared with the current standard of care. |
Selpercatinib (Retsevmo®) for advanced RET-mutant medullary thyroid cancer. HTA ID: 25034a
| Assessment Status | Rapid Review Complete |
| HTA ID | 25034a |
| Drug | Selpercatinib |
| Brand | Retsevmo® |
| Indication | Selpercatinib (Retsevmo®) Is indicated in adults and adolescents 12 years and older with advanced rearranged during transfection (RET)-mutant medullary thyroid cancer. |
| Assessment Process | |
| Rapid review commissioned | 15/05/2025 |
| Rapid review completed | 01/07/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selpercatinib 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.
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 recommendation may be found here.
Selumetinib (Koselugo®). HTA ID: 22032
| Assessment Status | NCPE assessment process complete |
| HTA ID | 22032 |
| Drug | Selumetinib |
| Brand | Koselugo® |
| Indication | For the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above. |
| Assessment Process | |
| Rapid review commissioned | 10/05/2022 |
| Rapid review completed | 25/05/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selumetinib (Koselugo®) compared with the current standard-of-care. |
| Full HTA commissioned by the HSE | 01/07/2022 |
| Pre-submission consultation with Applicant | 20/09/2022 |
| Full submission received from Applicant | 29/01/2024 |
*A full HTA submission was received on 09/01/2023 and withdrawn by the company on 23/06/2023.
Resubmission of HTA
| Assessment Process | NCPE assessment process complete |
| Full submission received from Applicant | 29/01/2024 |
| Preliminary review sent to Applicant | 15/08/2024 |
| NCPE assessment re-commenced | 17/10/2024 |
| Factual accuracy sent to Applicant | 06/11/2024 |
| NCPE assessment re-commenced | 14/11/2024 |
| NCPE assessment completed | 13/12/2024 |
| NCPE assessment outcome | The NCPE recommends that selumetinib (Koselugo®) not 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.
Semaglutide (Ozempic®) 2mg. HTA ID: 25060
| Assessment Status | Rapid Review Complete |
| HTA ID | 25060 |
| Drug | Semaglutide |
| Brand | Ozempic® |
| Indication | Semaglutide (Ozempic®) 2mg is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. |
| Assessment Process | |
| Rapid review commissioned | 06/10/2025 |
| Rapid review completed | 23/10/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that semaglutide (Ozempic®) 2mg solution for injection not be considered for reimbursement at the submitted price*. |
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
Semaglutide 2.4 mg (Wegovy®) in adolescent patients. HTA ID: 25025
| Assessment Status | Rapid Review Complete |
| HTA ID | 25025 |
| Drug | Semaglutide |
| Brand | Wegovy® |
| Indication | Semaglutide 2.4 mg (Wegovy®) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with: ∙ obesity (Body Mass Index (BMI) ≥ 95th percentile as defined on sex and age-specific BMI growth charts) and ∙ body weight above 60 kg^ |
| Assessment Process | |
| Rapid review commissioned | 21/03/2025 |
| Rapid review completed | 01/05/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that semaglutide not be considered for reimbursement at the submitted price*. |
^ The applicant is seeking reimbursement in a subpopulation of the licensed adolescent population, specifically:
- adolescent patients between the ages 12 and 17 years (inclusive) with a body weight above 60kg,
- with a BMI > 99.6th percentile,
- and two or more of the comorbidities as defined by Children’s Health Ireland (CHI) complex obesity referral form criteria.
*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.
Serplulimab (Hetronifly®). HTA ID: 25021
| Assessment Status | Rapid Review Complete |
| HTA ID | 25021 |
| Drug | Serplulimab |
| Brand | Hetronifly® |
| Indication | Serplulimab (Hetronifly®) in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). |
| Assessment Process | |
| Rapid review commissioned | 10/03/2025 |
| Rapid review completed | 15/04/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that serplulimab 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.
Sodium thiosulfate (Pedmarqsi®). HTA ID: 25002
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25002 |
| Drug | Sodium thiosulfate |
| Brand | Pedmarqsi® |
| Indication | Sodium thiosulfate (Pedmarqsi®) is indicated for the prevention of ototoxicity caused by cisplatin chemotherapy in patients one month to < 18 years of age with localised, non-metastatic, solid tumours. |
| Assessment Process | |
| Rapid review commissioned | 08/01/2025 |
| Rapid review completed | 06/02/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sodium thiosulfate (Pedmarqsi®) compared with the current standard of care. |
| Full HTA commissioned by the HSE | 26/03/2025 |
| Pre-submission consultation with Applicant | 16/04/2025 |
| Full submission received from Applicant | 17/06/2025 |
| Preliminary review sent to Applicant | 23/10/2025 |
| NCPE assessment re-commenced | 21/11/2025 |
| Factual accuracy sent to Applicant | 15/12/2025 |
| NCPE assessment re-commenced | 22/12/2025 |
| NCPE assessment completed | 05/01/2026 |
| NCPE assessment outcome | The NCPE recommends that sodium thiosulfate not be considered for reimbursement unless cost effectiveness can be improved*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Somapacitan (Sogroya®). HTA ID: 23060
| Assessment Status | Rapid Review Complete |
| HTA ID | 23060 |
| Drug | Somapacitan |
| Brand | Sogroya® |
| Indication | Somapacitan (Sogroya®) is indicated for the replacement of endogenous growth hormone in children aged three years and above and adolescents with growth failure due to growth hormone deficiency (GHD), and in adults with GHD. |
| Assessment Process | |
| Rapid review commissioned | 25/09/2023 |
| Rapid review completed | 27/11/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that somapacitan 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.
Sparsentan (Filspari®). HTA ID: 24020
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24020 |
| Drug | Sparsentan |
| Brand | Filspari® |
| Indication | For the treatment of adults with primary immunoglobulin A (IgA) nephropathy with a urine protein excretion >1.0 g/day (or urine protein-to-creatine ratio ≥0.75 g/g). |
| Assessment Process | |
| Rapid review commissioned | 30/05/2024 |
| Rapid review completed | 26/06/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sparsentan compared with the current standard of care. |
| Full HTA commissioned by the HSE | 31/07/2024 |
| Pre-submission consultation with Applicant | 01/10/2024 |
| Full submission received from Applicant | 12/12/2024 |
| Preliminary review sent to Applicant | 18/09/2025 |
| NCPE assessment re-commenced | 17/10/2025 |
| Follow-up to preliminary review sent to Applicant | 23/10/2025 |
| NCPE assessment re-commenced | 03/11/2025 |
| Factual accuracy sent to Applicant | 17/11/2025 |
| NCPE assessment re-commenced | 24/11/2025 |
| NCPE assessment completed | 26/11/2025 |
| NCPE assessment outcome | The NCPE recommends that sparsentan 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.
Sufentanil Citrate (Dzuveo®) HTA ID: 23062
| Assessment Status | Rapid Review Complete |
| Drug | Sufentanil Citrate |
| Brand | Dzuveo® |
| Indication | For the management of acute moderate to severe pain in adult patients |
| Assessment Process | |
| Rapid review commissioned | 02/10/2023 |
| Rapid review resubmission required | 04/12/2023 |
| Rapid review completed | 22/12/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that sufentanil citrate 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.
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 HTA commissioned by the 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.
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. |
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 HTA commissioned by the 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.
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 HTA commissioned by the 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*. |
*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. November 2025
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 HTA commissioned by the 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.
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 HTA commissioned by the 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.
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 |
Teprotumumab (Tepezza®). HTA ID: 25057
| Assessment Status | Awaiting full HTA submission from Applicant |
| HTA ID | 25057 |
| Drug | Teprotumumab |
| Brand | Tepezza® |
| Indication | Teprotumumab (Tepezza®) is indicated in adults for the treatment of moderate to severe thyroid eye disease. |
| Assessment Process | |
| Rapid review commissioned | 16/09/2025 |
| Rapid review completed | 15/10/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of teprotumumab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 29/10/2025 |
| Pre-submission consultation with Applicant | 11/12/2025 |
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 HTA commissioned by the 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.
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 HTA commissioned by the 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)*. |
*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 2025
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 HTA commissioned by the 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.
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 HTA commissioned by the 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.
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.
Tirzepatide (Mounjaro®). HTA ID: 24024
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24024 |
| Drug | Tirzepatide |
| Brand | (Mounjaro®) |
| Indication | For chronic weight management, including weight loss and weight maintenance, in adults with an initial body mass index of: ≥30 kg/m2, or ≥27 kg/m2 to <30 kg/m2 in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus). |
| Assessment Process | |
| Rapid review commissioned | 24/06/2024 |
| Rapid review completed | 30/07/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical and cost effectiveness of tirzepatide for this indication compared with the current standard of care. |
| Full HTA commissioned by the HSE | 27/08/2024 |
| Pre-submission consultation with Applicant | 15/10/2024 |
| Full submission received from Applicant | 10/04/2025 |
| Preliminary review sent to Applicant | 20/06/2025 |
| NCPE assessment re-commenced | 21/07/2025 |
| Follow-up to preliminary review sent to Applicant | 01/08/2025 |
| NCPE assessment re-commenced | 08/08/2025 |
| Factual accuracy sent to Applicant | 04/11/2025 |
| NCPE assessment re-commenced | 18/11/2025 |
| NCPE assessment completed | 03/12/2025 |
| NCPE assessment outcome | The NCPE recommends that tirzepatide, as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial BMI of: ≥ 30kg/m2, or ≥ 27kg/m2 to < 30kg/m2 in the presence of at least one WRC 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.
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 HTA commissioned by the 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.
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 HTA commissioned by the 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.
The HSE has approved reimbursement following confidential price negotiations July 2021.
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. |
Tislelizumab (Tevimbra®). HTA ID: 25070
| Assessment Status | Rapid Review Complete |
| HTA ID | 25070 |
| Drug | Tislelizumab |
| Brand | Tevimbra® |
| Indication | Tislelizumab (Tevimbra®) is indicated in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with human epidermal growth factor (HER2)-negative locally advanced unresectable or metastatic gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours express programmed death-ligand 1 (PD-L1) with a tumour area positivity (TAP) score ≥ 5. |
| Assessment Process | |
| Rapid review commissioned | 11/12/2025 |
| Rapid review completed | 18/12/2025 |
| 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.
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 HTA commissioned by the 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.
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.
The HSE has approved reimbursement following confidential price negotiations; May 2019