| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Clindamycin 1% with tretinoin 0.025% |
| Brand | Treclinac® |
| Indication | For the topical treatment of acne vulgaris when comedones, papules and pustules are present in patients 12 years or older. |
| Assessment Process | |
| Rapid review commissioned | 08/04/2014 |
| Rapid review completed | 06/05/2014 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended |
Latest NCPE Advice
Co-enzyme Q10 (CoQun®). HTA ID: 19045
| Assessment Status | Rapid Review complete |
| HTA ID | 19045 |
| Drug | Co-enzyme Q10 |
| Brand | CoQun® eye drops |
| Indication | As a complementary add-on treatment to antihypertensive glaucoma therapy. |
| Assessment Process | |
| Rapid review commissioned | 16/10/2019 |
| Rapid review completed | 13/01/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that CoQ10 eye drops 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.
Cobimetinib (Cotellic®)
| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Cobimetinib |
| Brand | Cotellic® |
| Indication | For use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
| Assessment Process | |
| Rapid review commissioned | 19/04/2016 |
| Rapid review completed | 26/04/2016 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full submission received from Applicant | 18/07/2016 |
| NCPE assessment completed | 05/01/2017 |
| NCPE assessment outcome | Reimbursement Not Recommended at the Submitted Price. |
The NCPE does not consider cobimetinib (Cotellic®) with vemurafenib (Zelboraf®) cost-effective for the treatment of advanced (unresectable or metastatic) melanoma with the BRAF V600 mutation and therefore it is not recommended for reimbursement at the submitted price.
The HSE has approved reimbursement following confidential price negotiations; April 2018.
Colesevelam (Cholestagel®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Colesevelam |
| Brand | Cholestagel® |
| Indication | Hypercholesterolaemia |
| Assessment Process | |
| Rapid review commissioned | 19/10/2010 |
| Rapid review completed | 22/10/2010 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not Recommended. |
Colistimethate sodium (Colobreathe®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Colistimethate sodium |
| Brand | Colobreathe® |
| Indication | For the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. |
| Assessment Process | |
| Rapid review commissioned | 07/06/2013 |
| Rapid review completed | 28/06/2013 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended |
Collagenase Clostridium Histolyticum (Xiapex®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Collagenase Clostridium Histolyticum |
| Brand | Xiapex® |
| Indication | Treatment of Dupuytren’s contracture in adult patients with a palpable cord. |
| Assessment Process | |
| Rapid review commissioned | 20/05/2011 |
| Rapid review completed | 09/06/2011 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not Recommended |
Conestat alfa (Ruconest®). HTA ID: 21017
| Assessment Status | Rapid Review complete |
| HTA ID | 21017 |
| Drug | Conestat alfa |
| Brand | Ruconest® |
| Indication | For the treatment of acute angioedema attacks in adults, adolescents, and children (aged 2 years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. |
| Assessment Process | |
| Rapid review commissioned | 21/04/2021 |
| Rapid review completed | 02/06/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that conestat alfa 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 January 2022.
Corifollitropin alfa (Elonva®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Corifollitropin alfa |
| Brand | Elonva® |
| Indication | Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. |
| Assessment Process | |
| Rapid review commissioned | 22/09/2010 |
| Rapid review completed | 22/10/2010 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not Recommended. |
Crizotinib (Xalkori®)
| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Crizotinib |
| Brand | Xalkori® |
| Indication | Treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) (i.e. in the 2nd / 3rd–line treatment setting) |
| Assessment Process | |
| Rapid review commissioned | 09/01/2013 |
| Rapid review completed | 31/01/2013 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full submission received from Applicant | 24/05/2013 |
| NCPE assessment completed | 27/08/2013 |
| NCPE assessment outcome | Reimbursement not recommended. The NCPE do not consider Crizotinib (Xalkori®) a cost-effective treatment for adult patients with previously treated ALK positive advanced non small cell lung cancer (NSCLC). |
August 2015
The HSE has approved reimbursement following confidential price negotiations.
Crizotinib (Xalkori®) for first line ALK+ NSCLC
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Crizotinib |
| Brand | Xalkori® |
| Indication | For the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
| Assessment Process | |
| Rapid review commissioned | 06/02/2017 |
| Rapid review completed | 24/04/2017 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended. |
Crizotinib (Xalkori®) for ROS1 NSCLC
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Crizotinib |
| Brand | Xalkori® |
| Indication | For the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). |
| Assessment Process | |
| Rapid review commissioned | 06/02/2017 |
| Rapid review completed | 24/04/2017 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended. |
Cysteamine bitartrate delayed-release (Procysbi®)
| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Cysteamine bitartrate delayed-release |
| Brand | Procysbi® |
| Indication | For the treatment of proven nephropathic cystinosis. |
| Assessment Process | |
| Rapid review commissioned | 01/12/2015 |
| Rapid review completed | 15/12/2015 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended at the submitted price |
| Full HTA commissioned by the HSE | 23/12/2015 |
| Pre-submission consultation with Applicant | 22/05/2017 |
| Full submission received from Applicant | 13/07/2017 |
| Preliminary review sent to Applicant | 22/08/2017 |
| NCPE assessment re-commenced | 29/08/2017 |
| Factual accuracy sent to Applicant | 17/10/2017 |
| NCPE assessment re-commenced | 15/11/2017 |
| NCPE assessment completed | 15/11/2017 |
| NCPE assessment outcome | Reimbursement not recommended at the submitted price |
The HSE has approved reimbursement following confidential price negotiations; July 2019
Darolutamide (Nubeqa®). HTA ID: 26033a
| Assessment Status | Rapid Review Complete |
| HTA ID | 26033a |
| Drug | Darolutamide |
| Brand | Nubeqa® |
| Indication | Darolutamide (Nubeqa®) for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). |
| Assessment Process | |
| Rapid review commissioned | 08/07/2026 |
| Rapid review completed | 04/08/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that darolutamide plus ADT 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
Darolutamide (Nubeqa®). HTA ID: 26033b
| Assessment Status | Rapid Review Complete |
| HTA ID | 26033b |
| Drug | Darolutamide |
| Brand | Nubeqa® |
| Indication | Darolutamide (Nubeqa®) for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (ADT). |
| Assessment Process | |
| Rapid review commissioned | 08/07/2026 |
| Rapid review completed | 04/08/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that darolutamide in combination with docetaxel and ADT 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
Datopotamab deruxtecan (Datroway®) for triple-negative breast cancer. HTA ID: 26037
| Assessment Status | Pre-submission consultation scheduled |
| HTA ID | 26037 |
| Drug | Datopotamab deruxtecan |
| Brand | Datroway® |
| Indication | Datopotamab deruxtecan as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. |
| Assessment Process | |
| Rapid review commissioned | 13/07/2026 |
| Rapid review completed | 21/08/2026 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost-effectiveness of datopotamab deruxtecan (Datroway®) compared with the current standard of care. |
| Full HTA commissioned by the HSE | 21/08/2026 |
Decitabine/cedazuridine (Inaqovi®). HTA ID 26007
| Assessment Status | Rapid Review Complete |
| HTA ID | 26007 |
| Drug | Decitabine/cedazuridine |
| Brand | Inaqovi® |
| Indication | Decitabine/cedazuridine (Inaqovi®) is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 19/02/2026 |
| Rapid review appraisal commenced | 18/03/2026 |
| Rapid review completed | 08/04/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that decitabine/cedazuridine (Inaqovi®) not be considered for reimbursement for this indication 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
Depemokimab (Exdensur®) HTA ID: 26041
| Assessment Status | Rapid Review Complete |
| HTA ID | 26041 |
| Drug | Depemokimab |
| Brand | Exdensur® |
| Indication | Depemokimab (Exdensur®) is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by blood eosinophil count in adults and adolescents aged 12 years and older who are inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus another asthma controller. |
| Assessment Process | |
| Rapid review commissioned | 21/08/2026 |
| Rapid review completed | 22/09/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that depemokimab not be considered for reimbursement for this indication 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
Depemokimab (Exdensur®). HTA ID: 26040
| Assessment Status | Rapid Review Complete |
| HTA ID | 26040 |
| Drug | Depemokimab |
| Brand | Exdensur® |
| Indication | Depemokimab (Exdensur®) is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. |
| Assessment Process | |
| Rapid review commissioned | 21/08/2026 |
| Rapid review completed | 09/09/2026 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of depemokimab for this indication compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here
Further information on the status of this decision may be found here
Dostarlimab (Jemperli®). HTA ID: 21045
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21045 |
| Drug | Dostarlimab |
| Brand | Jemperli® |
| Indication | Indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen. |
| Assessment Process | |
| Rapid review commissioned | 26/10/2021 |
| Rapid review completed | 30/11/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of dostarlimab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 22/12/2021 |
| Full submission received from Applicant | 16/06/2022 |
| Preliminary review sent to Applicant | 22/11/2022 |
| NCPE assessment re-commenced | 20/12/2022 |
| Follow-up to preliminary review sent to Applicant | 08/02/2023 |
| NCPE assessment re-commenced | 10/02/2023 |
| Factual accuracy sent to Applicant | 27/02/2023 |
| NCPE assessment re-commenced | 10/03/2023 |
| NCPE assessment completed | 27/03/2023 |
| NCPE assessment outcome | The NCPE recommends that dostarlimab 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.
Dupilumab (Dupixent®) for eosinophilic oesophagitis. HTA ID: 23047
| Assessment Status | Rapid Review Complete |
| HTA ID | 23047 |
| Drug | Dupilumab |
| Brand | Dupixent® |
| Indication | Dupilumab (Dupixent®) is indicated for the treatment of adults and adolescents 12 years and older, weighing at least 40 kg, with eosinophilic oesophagitis (EoE) who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. |
| Assessment Process | |
| Rapid review commissioned | 26/07/2023 |
| Rapid review completed | 07/09/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of dupilumab for this indication compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Dupilumab (Dupixent®) for prurigo nodularis. HTA ID: 23043
| Assessment Status | Rapid Review Complete |
| HTA ID | 23043 |
| Drug | Dupilumab |
| Brand | Dupixent® |
| Indication | Dupilumab (Dupixent®) is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 21/07/2023 |
| Rapid review completed | 24/08/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that dupilumab 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. September 2025
Dupilumab (Dupixent®) for severe asthma (children 6 to 11 years old). HTA ID: 23044
| Assessment Status | Rapid Review Complete |
| HTA ID | 23044 |
| Drug | Dupilumab |
| Brand | Dupixent® |
| Indication | Dupilumab (Dupixent®) is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. |
| Assessment Process | |
| Rapid review commissioned | 24/07/2023 |
| Rapid review completed | 05/09/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that dupilumab 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. December 2025
Durvalumab (Imfinzi®). HTA ID: 25010
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25010 |
| Drug | Durvalumab |
| Brand | Imfinzi® |
| Indication | Durvalumab (Imfinzi®) is indicated as monotherapy for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy. |
| Assessment Process | |
| Rapid review commissioned | 14/02/2025 |
| Rapid review completed | 06/03/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of durvalumab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 27/03/2025 |
| Pre-submission consultation with Applicant | 14/05/2025 |
| Full submission received from Applicant | 10/09/2025 |
| Preliminary review sent to Applicant | 13/02/2026 |
| NCPE assessment re-commenced | 26/02/2026 |
| Factual accuracy sent to Applicant | 24/03/2026 |
| NCPE assessment re-commenced | 30/03/2026 |
| NCPE assessment completed | 02/04/2026 |
| NCPE assessment outcome | The NCPE recommends that durvalumab be considered for reimbursement for this indication if cost-effectiveness can be improved*. |
*Next steps: The NCPE Assessment Report and recommendation and Patient Organisation submission, 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.
Please see the HSE Pricing and Reimbursement Tracker for any updates on the reimbursement status of this drug.
Durvalumab (Imfinzi®). HTA ID: 26012
| Assessment Status | Rapid Review Complete |
| HTA ID | 26012 |
| Drug | Durvalumab |
| Brand | Imfinzi® |
| Indication | Durvalumab (Imfinzi®) is indicated in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable non-small cell lung cancer at high risk of recurrence and no EGFR mutations or ALK. |
| Assessment Process | |
| Rapid review commissioned | 13/03/2026 |
| Rapid review completed | 22/04/2026 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of durvalumab for this indication compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this decision may be found here
Durvalumab (Imfinzi®). HTA ID: 26018
| Assessment Status | Rapid Review Complete |
| HTA ID | 26018 |
| Drug | Durvalumab |
| Brand | Imfinzi® |
| Indication | Durvalumab (Imfinzi®) in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient. |
| Assessment Process | |
| Rapid review commissioned | 10/04/2026 |
| Rapid review completed | 15/05/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that durvalumab 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
Enalapril maleate (Aqumeldi®). HTA ID: 24011
| Assessment Status | Rapid Review complete |
| HTA ID | 24011 |
| Drug | Enalapril maleate |
| Brand | Aqumeldi® |
| Indication | For the treatment of heart failure in children and adolescents from birth to less than 18 years of age. |
| Assessment Process | |
| Rapid review commissioned | 25/03/2024 |
| Rapid review completed | 12/04/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that enalapril maleate mini ODTs 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. October 2025
Eplontersen (Wainzua®) HTA ID: 24047
| Assessment Status | Rapid Review Complete |
| HTA ID | 24047 |
| Drug | Eplontersen |
| Brand | Wainzua® |
| Indication | Eplontersen (Wainzua®) is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy. |
| Assessment Process | |
| Rapid review commissioned | 15/11/2024 |
| Rapid review completed | 19/12/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that eplontersen 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.
Please see the HSE Pricing and Reimbursement Tracker for any updates on the reimbursement status of this drug.
Evinacumab (Evkeeza®). HTA ID: 26034
| Assessment Status | Rapid Review Complete |
| HTA ID | 26034 |
| Drug | Evinacumab |
| Brand | Evkeeza® |
| Indication | Evinacumab (Evkeeza®) as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and paediatric patients aged 6 months and older with homozygous familial hypercholesterolaemia (HoFH). |
| Assessment Process | |
| Rapid review commissioned | 08/07/2026 |
| Rapid review completed | 30/07/2026 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost-effectiveness of evinacumab (Evkeeza®) compared with the current standard of care. |
Evolocumab (Repatha®). HTA ID: 25055
| Assessment Status | Rapid Review Complete |
| HTA ID | 25055 |
| Drug | Evolocumab |
| Brand | Repatha® |
| Indication | Evolocumab is indicated for both primary hypercholesterolaemia and mixed dyslipidaemia and heterozygous familial hypercholesterolaemia. In this submission the Applicant is proposing to reduce the LDL-C thresholds specified in the current managed access protocol. The revised patient population includes: • adults with established atherosclerotic cardiovascular disease (i.e. confirmed diagnosis of myocardial infarction +/- revascularisation procedures, non-haemorrhagic stroke or peripheral arterial disease [i.e. secondary prevention] or in those who have undergone coronary artery bypass graft), with a LDL-C persistently ≥ 3.0 mmol/L and • adults with a confirmed diagnosis of heterozygous familial hypercholesterolaemia with a LDL-C persistently ≥ 2.5 mmol/L. |
| Assessment Process | |
| Rapid review commissioned | 28/08/2025 |
| Rapid review completed | 30/09/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that evolocumab 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
Faricimab (Vabysmo®). HTA ID: 26015
| Assessment Status | Rapid Review Complete |
| HTA ID | 26015 |
| Drug | Faricimab |
| Brand | Vabysmo® |
| Indication | Faricimab (Vabysmo®) is indicated for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion. |
| Assessment Process | |
| Rapid review commissioned | 30/03/2026 |
| Rapid review completed | 07/05/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that faricimab (Vabysmo®) not be considered for reimbursement for this indication 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
Fezolinetant (Veoza™). HTA ID: 24005
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24005 |
| Drug | Fezolinetant |
| Brand | Veoza™ |
| Indication | Fezolinetant is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. |
| Assessment Process | |
| Rapid review commissioned | 09/02/2024 |
| Rapid review completed | 12/03/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of fezolinetant compared with the current standard of care. |
| Full HTA commissioned by the HSE | 08/04/2024 |
| Pre-submission consultation with Applicant | 24/04/2024 |
| Full submission received from Applicant | 20/08/2025 |
| Preliminary review sent to Applicant | 08/12/2025 |
| NCPE assessment re-commenced | 16/01/2026 |
| Factual accuracy sent to Applicant | 27/03/2026 |
| NCPE assessment re-commenced | 07/04/2026 |
| NCPE assessment completed | 17/04/2026 |
| NCPE assessment outcome | The NCPE recommends that fezolinetant be considered for reimbursement if cost effectiveness can be improved relative to existing treatments. HRT is expected to provide more benefits, than fezolinetant, in individuals who can take HRT. Thus, the HSE may wish to implement prescribing guidelines should a decision be made to reimburse fezolinetant. |
Next steps
The NCPE Assessment Report, recommendation and Patient Organisation Submission, 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.
Finerenone (Kerendia®). HTA ID: 22012
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22012 |
| Drug | Finerenone |
| Brand | Kerendia® |
| Indication | For the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. |
| Assessment Process | |
| Rapid review commissioned | 21/02/2022 |
| Rapid review completed | 15/03/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of finerenone compared with the current standard of care. |
| Full HTA commissioned by the HSE | 01/04/2022 |
| Pre-submission consultation with Applicant | 24/05/2022 |
| Full submission received from Applicant | 10/11/2022 |
| Preliminary review sent to Applicant | 24/02/2023 |
| NCPE assessment re-commenced | 29/03/2023 |
| Follow-up to preliminary review sent to Applicant | 08/05/2023 |
| NCPE assessment re-commenced | 18/05/2023 |
| Factual accuracy sent to Applicant | 12/06/2023 |
| NCPE assessment re-commenced | 04/07/2023 |
| NCPE assessment completed | 22/08/2023 |
| NCPE assessment outcome | The NCPE recommends that finerenone (Kerendia®) 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
Finerenone (Kerendia®). HTA ID: 23077
| Assessment Status | Rapid Review Complete |
| HTA ID | 23077 |
| Drug | Finerenone |
| Brand | Kerendia® |
| Indication | Finerenone (Kerendia®) is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes (T2D) in adults. |
| Assessment Process | |
| Rapid review commissioned | 20/12/2023 |
| Rapid review completed | 23/01/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that finerenone 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.
Givinostat (Duvyzat®). HTA ID: 25048
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25048 |
| Drug | Givinostat |
| Brand | Duvyzat® |
| Indication | Givinostat (Duvyzat®) is indicated for the treatment of Duchenne Muscular Dystrophy in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment. |
| Assessment Process | |
| Rapid review commissioned | 05/08/2025 |
| Rapid review completed | 14/08/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of givinostat compared with the current standard of care. |
| Full HTA commissioned by the HSE | 26/08/2025 |
| Pre-submission consultation with Applicant | 30/09/2025 |
| Full submission received from Applicant | 15/01/2026 |
| Preliminary review sent to Applicant | 22/01/2026 |
| NCPE assessment re-commenced | 19/02/2026 |
| Factual accuracy sent to Applicant | 20/02/2026 |
| NCPE assessment re-commenced | 26/02/2026 |
| NCPE assessment completed | 03/03/2026 |
| NCPE assessment outcome | The NCPE recommends that givinostat not be considered for reimbursement unless cost effectiveness can be improved*. |
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.
*This recommendation should be considered while also having regards to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Glofitamab (Columvi®) in combination with gemcitabine and oxaliplatin. HTA ID: 25037
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25037 |
| Drug | Glofitamab |
| Brand | Columvi® |
| Indication | Glofitamab in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT). |
| Assessment Process | |
| Rapid review commissioned | 30/05/2025 |
| Rapid review completed | 02/07/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of glofitamab in combination with gemcitabine and oxaliplatin compared with the current standard of care. |
| Full HTA commissioned by the HSE | 30/07/2025 |
| Pre-submission consultation with Applicant | 24/09/2025 |
| Full submission received from Applicant | 12/12/2025 |
| Preliminary review sent to Applicant | 01/04/2026 |
| NCPE assessment re-commenced | 29/04/2026 |
| Factual accuracy sent to Applicant | 29/06/2026 |
| NCPE assessment re-commenced | 06/07/2026 |
| NCPE assessment completed | 31/07/2026 |
| NCPE assessment outcome | The NCPE recommends that glofitamab (Columvi®) in combination with gemcitabine and oxaliplatin be considered for reimbursement, for the indication under assessment, if costeffectiveness can be improved relative to existing treatments. |
*Next steps: The NCPE Assessment Report and recommendation and Patient Organisation submission, 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.
Please see the HSE Pricing and Reimbursement Tracker for any updates on the reimbursement status of this drug.
Guselkumab (Tremfya®). HTA ID: 25050
| Assessment Status | Rapid Review Complete |
| HTA ID | 25050 |
| Drug | Guselkumab |
| Brand | Tremfya® |
| Indication | Guselkumab (Tremfya®) is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. |
| Assessment Process | |
| Rapid review commissioned | 05/08/2025 |
| Rapid review completed | 11/09/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that guselkumab not be considered for reimbursement for this indication 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
Guselkumab (Tremfya®). HTA ID: 25051
| Assessment Status | Rapid Review Complete |
| HTA ID | 25051 |
| Drug | Guselkumab |
| Brand | Tremfya® |
| Indication | Guselkumab (Tremfya®) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment. |
| Assessment Process | |
| Rapid review commissioned | 05/08/2025 |
| Rapid review completed | 11/09/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that guselkumab not be considered for reimbursement for this indication 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
Ibrutinib (Imbruvica®) for MCL
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Ibrutinib |
| Brand | Imbruvica® |
| Indication | For the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL). |
| Assessment Process | |
| Rapid review commissioned | 07/11/2014 |
| Rapid review completed | 18/12/2014 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full HTA commissioned by the HSE | 10/04/2015 |
| NCPE assessment completed | 06/10/2015 |
| NCPE assessment outcome | Reimbursement not recommended. |
The cost effectiveness of ibrutinib (Imbruvica®) in the treatment of patients with relapsed or refractory MCL has not been demonstrated. Therefore it is not recommended for reimbursement at the submitted price.
The HSE has approved reimbursement following confidential price negotiations.
Ibrutinib (Imbruvica®). HTA ID: 22054
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22054 |
| Drug | Ibrutinib |
| Brand | Imbruvica® |
| Indication | In combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia. |
| Assessment Process | |
| Rapid review commissioned | 27/07/2022 |
| Rapid review completed | 02/09/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ibrutinib in combination with venetoclax compared with the current standard of care. |
| Full HTA commissioned by the HSE | 28/09/2022 |
| Pre-submission consultation with Applicant | 14/11/2022 |
| Full submission received from Applicant | 14/02/2023 |
| Preliminary review sent to Applicant | 01/09/2023 |
| NCPE assessment re-commenced | 02/10/2023 |
| Factual accuracy sent to Applicant | 25/01/2024 |
| NCPE assessment re-commenced | 31/01/2024 |
| NCPE assessment completed | 09/02/2024 |
| NCPE assessment outcome | The NCPE recommends that ibrutinib (given in combination with venetoclax) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia, 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
Icosapent ethyl (Vazkepa®). HTA ID: 23006
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23006 |
| Drug | Icosapent ethyl |
| Brand | Vazkepa® |
| Indication | Icosapent ethyl (Vazkepa®) is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (?150 mg/dL [?1.7 mmol/L] and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. |
| Assessment Process | |
| Rapid review commissioned | 10/02/2023 |
| Rapid review completed | 10/03/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of icosapent ethyl compared with the current standard of care. |
| Full HTA commissioned by the HSE | 28/03/2023 |
| Pre-submission consultation with Applicant | 20/06/2023 |
| Full submission received from Applicant | 01/11/2023 |
| Preliminary review sent to Applicant | 18/09/2024 |
| NCPE assessment re-commenced | 25/10/2024 |
| Follow-up to preliminary review sent to Applicant | 22/01/2025 |
| NCPE assessment re-commenced | 30/01/2025 |
| Factual accuracy sent to Applicant | 04/03/2025 |
| NCPE assessment re-commenced | 12/03/2025 |
| NCPE assessment completed | 20/03/2025 |
| NCPE assessment outcome | The NCPE recommends that icosapent ethyl (Vazkepa®) be considered for reimbursement if cost effectiveness can be improved relative to existing treatments and that a Managed Access Programme is introduced*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Idelalisib (Zydelig®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Idelalisib |
| Brand | Zydelig® |
| Indication | In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. |
| Assessment Process | |
| Rapid review commissioned | 08/12/2014 |
| Rapid review completed | 30/12/2014 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full HTA commissioned by the HSE | 04/06/2015 |
| NCPE assessment completed | 16/02/2016 |
| NCPE assessment outcome | Reimbursement not recommended. |
The HSE has approved reimbursement following confidential price negotiations December 2016.
Imlifidase (Idefirix®). HTA ID: 23041
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23041 |
| Drug | Imlifidase |
| Brand | Idefirix® |
| Indication | For desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of imlifidase should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients. |
| Assessment Process | |
| Rapid review commissioned | 19/07/2023 |
| Rapid review completed | 01/08/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of imlifidase compared with the current standard of care. |
| Full HTA commissioned by the HSE | 30/08/2023 |
| Pre-submission consultation with Applicant | 21/11/2023 |
| Full submission received from Applicant | 22/04/2024 |
| Preliminary review sent to Applicant | 16/09/2024 |
| NCPE assessment re-commenced | 09/10/2024 |
| Factual accuracy sent to Applicant | 21/11/2024 |
| NCPE assessment re-commenced | 28/11/2024 |
| NCPE assessment completed | 28/11/2024 |
| NCPE assessment outcome | The NCPE recommends that imlifidase be considered for reimbursement*. |
*This recommendation should be considered while also having regards to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations; July 2026
Inclisiran (Leqvio®). HTA ID: 20051
| Assessment Status | Assessment process complete |
| HTA ID | 20051 |
| Drug | Inclisiran |
| Brand | Leqvio® |
| Indication | For the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adult patients, as an adjunct to diet (a) in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or (b) alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. |
| Assessment Process | |
| Rapid review commissioned | 23/11/2020 |
| Rapid review completed | 16/12/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of inclisiran compared with the current standard of care. |
| Full HTA commissioned by the HSE | 06/01/2021 |
| Pre-submission consultation with Applicant | 22/02/2021 |
| Full submission received from Applicant | 23/07/2021 |
| Preliminary review sent to Applicant | 19/10/2021 |
| NCPE assessment re-commenced | 16/11/2021 |
| Factual accuracy sent to Applicant | 16/02/2022 |
| NCPE assessment re-commenced | 23/02/2022 |
| NCPE assessment completed | 23/03/2022 |
| NCPE assessment outcome | The NCPE recommends that inclisiran (Leqvio®) 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.
Indacterol/glycopyrronium/mometasone furoate (Enerzair®). HTA ID: 20023
| Assessment Status | Rapid Review Complete |
| HTA ID | 20023 |
| Drug | Indacterol/glycopyrronium/mometasone furoate |
| Brand | Enerzair® |
| Indication | As a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting β2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year. |
| Assessment Process | |
| Rapid review commissioned | 13/05/2020 |
| Rapid review completed | 10/06/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that indacterol/glycopyrronium/mometasone furoate (Enerzair®) 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.
The HSE has approved reimbursement; November 2020
Indacterol/mometasone furoate (Atectura®). HTA ID: 20024
| Assessment Status | Rapid Review Complete |
| HTA ID | 20024 |
| Drug | Indacterol/mometasone furoate |
| Brand | Atectura® |
| Indication | As maintenance treatment of asthma in adults and adolescents 12 years and older not adequately controlled with inhaled corticosteroids and inhaled short acting β2 agonists. |
| Assessment Process | |
| Rapid review commissioned | 13/05/2020 |
| Rapid review completed | 10/06/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Indacterol/mometasone furoate (Atectura®) 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.
Infliximab (Inflectra®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Infliximab |
| Brand | Inflectra® |
| Indication | For the treatment of Rheumatoid Arthritis, Adult Crohn’s disease, Paediatric Crohn’s disease, Ulcerative Colitis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis. |
| Assessment Process | |
| Rapid review commissioned | 10/09/2013 |
| Rapid review completed | 20/09/2013 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Infliximab (Remsima SC®) induction phase of treatment in patients with rheumatoid arthritis. HTA ID: 26017
| Assessment Status | Rapid Review Complete |
| HTA ID | 26017 |
| Drug | Infliximab induction phase of treatment in patients with rheumatoid arthritis |
| Brand | Remsima SC® |
| Indication | Infliximab (Remsima SC®) is indicated in combination with methotrexate, indicated in rheumatoid arthritis (RA) for the reduction of signs and symptoms as well as the improvement in physical function in: • Adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. • Adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs*. Reimbursement is sought for the infliximab 120mg solution for injection in pre-filled pen (PFP) (pack of four pens) for the induction phase of treatment in patients with RA. |
| Assessment Process | |
| Rapid review commissioned | 08/04/2026 |
| Rapid review completed | 24/04/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that infliximab SC (four PFPs per pack for induction treatment for patients with RA) 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
Infliximab (Remsima SC®). HTA ID: 20012
| Assessment Status | Rapid Review Complete |
| HTA ID | 20012 |
| Drug | Infliximab |
| Brand | Remsima SC® |
| Indication | In combination with methotrexate, is indicated in rheumatoid arthritis for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. |
| Assessment Process | |
| Rapid review commissioned | 04/03/2020 |
| Rapid review completed | 24/03/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that infliximab SC 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.
Infliximab (Remsima® SC). HTA ID: 20042
| Assessment Status | Rapid Review Complete |
| HTA ID | 20042 |
| Drug | Infliximab |
| Brand | Remsima® SC |
| Indication | For treatment of adult patients with Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis in line with the adult indications of the IV formulation. |
| Assessment Process | |
| Rapid review commissioned | 23/09/2020 |
| Rapid review completed | 15/10/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Remsima SC 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.
Infliximab (Remsima®) for Crohn’s disease dose escalation. HTA ID: 25022
| Assessment Status | Rapid Review Complete |
| HTA ID | 25022 |
| Drug | Infliximab |
| Brand | Remsima® |
| Indication | Infliximab (Remsima®) is indicated for the treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. It is also indicated for treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). |
| Assessment Process | |
| Rapid review commissioned | 18/03/2025 |
| Rapid review completed | 11/04/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that infliximab (Remsima®), for Crohn’s disease dose escalation, 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.