| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Pegylated Interferon beta-1a |
| Brand | Plegridy® |
| Indication | Treatment of adult patients with relapsing remitting multiple sclerosis |
| Assessment Process | |
| Rapid review commissioned | 25/11/2014 |
| Rapid review completed | 22/12/2014 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Latest NCPE Advice
Pegylated liposomal irinotecan (Onivyde®). HTA ID: 20028
| Assessment Status | Assessment process complete |
| HTA ID | 20028 |
| Drug | Pegylated liposomal irinotecan |
| Brand | Onivyde® |
| Indication | For the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in adult patients who have progressed following gemcitabine based therapy. |
| Assessment Process | |
| Rapid review commissioned | 13/06/2017 |
| Rapid review completed | 13/07/2017 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended.
The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven. |
| Rapid review re-commissioned | 15/06/2020 |
| Rapid review completed | 14/07/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegylated liposomal irinotecan compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 14/07/2020 |
| Pre-submission consultation with Applicant | 07/09/2020 |
| Full submission received from Applicant | 04/03/2021 |
| Preliminary review sent to Applicant | 02/09/2021 |
| NCPE assessment re-commenced | 04/10/2021 |
| Factual accuracy sent to applicant | 20/10/2021 |
| NCPE assessment re-commenced | 29/10/2021 |
| NCPE assessment completed | 12/11/2021 |
| NCPE assessment outcome | The NCPE recommends that peg-IRI + 5FU + LV 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.
Pembrolizumab (Keytruda ®) for Urothelial Carcinoma 1L
| ssessment Status | Rapid Review Complete |
| HTA ID | – |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | For the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 06/12/2017 |
| Rapid review completed | 21/12/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Following an amendment of the product licence by the EMA, a new rapid review was commissioned by the HSE. | |
| Rapid review commissioned | 21/06/2018 |
| Rapid review received | 10/07/2018 |
| Rapid review completed | 27/07/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab 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 – February 2021.
Pembrolizumab (Keytruda®) 1L NSCLC with chemotherapy
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations. |
| Assessment Process | |
| Rapid review commissioned | 14/08/2018 |
| Rapid review completed | 29/08/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 14/09/2018 |
| Pre-submission consultation with Applicant | 22/10/2018 |
| Full submission received from Applicant | 20/12/2018 |
| Preliminary review sent to Applicant | 14/06/2019 |
| NCPE assessment re-commenced | 10/07/2019 |
| Factual accuracy sent to Applicant | 31/07/2019 |
| NCPE assessment re-commenced | 09/08/2019 |
| NCPE assessment completed | 15/08/2019 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab (Keytruda®), prescribed in combination with platinum chemotherapy plus pemetrexed for the first line treatment of non-squamous NSCLC, 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 Medial Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations – February 2021.
Pembrolizumab (Keytruda®) 1L squamous NSCLC with chemotherapy
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | In combination with carboplatin and either paclitaxel or nab-paclitaxel for the treatment of the first-line treatment of metastatic squamous non-small cell lung carcinoma. |
| Assessment Process | |
| Rapid review commissioned | 25/02/2019 |
| Rapid review completed | 25/03/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab in combination with carboplatin and either paclitaxel or nab-P 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 – February 2021.
Pembrolizumab (Keytruda®) for Classical Hodgkin Lymphoma
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | As monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. |
| Assessment Process | |
| Rapid review commissioned | 06/12/2017 |
| Rapid review completed | 21/12/2017 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended at the submitted price. |
The HSE has approved reimbursement following confidential price negotiations – November 2018.
Pembrolizumab (Keytruda®) for colorectal cancer. HTA ID: 21002
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21002 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Is indicated as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults. |
| Assessment Process | |
| Rapid review commissioned | 08/02/2021 |
| Rapid review completed | 03/03/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 24/03/2021 |
| Pre-submission consultation with Applicant | 21/04/2021 |
| Full submission received from Applicant | 21/01/2022 |
| Preliminary review sent to Applicant | 10/06/2022 |
| NCPE assessment re-commenced | 08/07/2022 |
| Factual accuracy sent to Applicant | 07/09/2022 |
| NCPE assessment re-commenced | 19/09/2022 |
| NCPE assessment completed | 13/10/2022 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab 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 April 2023.
Pembrolizumab (Keytruda®) for persistent, recurrent or metastatic cervical cancer. HTA ID: 22041
| Assessment Status | Rapid Review Complete |
| HTA ID | 22041 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Is indicated in combination with chemotherapy with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥1. |
| Assessment Process | |
| Rapid review commissioned | 16/06/2022 |
| Rapid review completed | 06/07/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard-of-care. |
The company has not submitted a HTA dossier to the NCPE, therefore the cost effectiveness of the technology could not be proven.
Pembrolizumab (Keytruda®) for Urothelial Carcinoma 2L
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 06/12/2017 |
| Rapid review completed | 21/12/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full HTA commissioned by the HSE | 04/02/2018 |
| Pre-submission consultation with Applicant | 12/02/2018 |
| Full submission received from Applicant | 03/10/2018 |
| Preliminary review sent to Applicant | 05/12/2018 |
| NCPE assessment re-commenced | 18/01/2019 |
| Factual accuracy sent to Applicant | 06/03/2019 |
| NCPE assessment re-commenced | 20/03/2019 |
| NCPE assessment completed | 25/03/2019 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab (Keytruda®) be considered for reimbursement for this indication 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 – February 2021.
Pembrolizumab (Keytruda®) in combination with lenvatinib (Lenvima®) for endometrial carcinoma. HTA ID: 22006
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22006 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | In combination with lenvatinib (Lenvima®) is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting, and who are not candidates for curative surgery or radiation. |
| Assessment Process | |
| Rapid review commissioned | 07/02/2022 |
| Rapid review completed | 04/03/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab in combination with lenvatinib compared with the current standard of care. |
| Full HTA commissioned by the HSE | 01/04/2022 |
| Pre-submission consultation with Applicant | 09/05/2022 |
| Full submission received from Applicant | 21/02/2023 |
| Preliminary review sent to Applicant | 03/08/2023 |
| NCPE assessment re-commenced | 05/09/2023 |
| Follow-up to preliminary review sent to Applicant | 19/09/2023 |
| NCPE assessment re-commenced | 06/11/2023 |
| Factual accuracy sent to Applicant | 01/12/2023 |
| NCPE assessment re-commenced | 11/12/2023 |
| NCPE assessment completed | 18/12/2023 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab, in combination with lenvatinib, 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.
Pembrolizumab (Keytruda®). HTA ID: 23056
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23056 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Pembrolizumab (Keytruda®) In combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1. |
| Assessment Process | |
| Rapid review commissioned | 07/09/2023 |
| Rapid review completed | 03/10/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 01/11/2023 |
| Pre-submission consultation with Applicant | 05/12/2023 |
| Full submission received from Applicant | 02/05/2024 |
| Preliminary review sent to Applicant | 19/12/2024 |
| NCPE assessment re-commenced | 31/01/2025 |
| Factual accuracy sent to Applicant | 15/04/2025 |
| NCPE assessment re-commenced | 23/04/2025 |
| NCPE assessment completed | 12/05/2025 |
| NCPE assessment outcome | The NCPE recommends that Pembrolizumab (Keytruda®) not be considered for reimbursement, for this indication, 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
Pembrolizumab (Keytruda®). HTA ID: 23070
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23070 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Pembrolizumab (Keytruda®) is indicated in combination with fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced, unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 |
| Assessment Process | |
| Rapid review commissioned | 21/11/2023 |
| Rapid review completed | 18/12/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 09/01/2024 |
| Pre-submission consultation with Applicant | 30/01/2024 |
| Full submission received from Applicant | 01/08/2024 |
| Preliminary review sent to Applicant | 09/05/2025 |
| NCPE assessment re-commenced | 06/06/2025 |
| Follow-up to preliminary review sent to Applicant | 01/07/2025 |
| NCPE assessment re-commenced | 10/07/2025 |
| Additional follow-up to Preliminary Review sent to Applicant | 24/07/2025 |
| NCPE assessment re-commenced | 25/07/2025 |
| Factual accuracy sent to Applicant | 01/08/2025 |
| NCPE assessment re-commenced | 12/08/2025 |
| NCPE assessment completed | 25/08/2025 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab, in combination with fluoropyrimidine and platinum-containing chemotherapy, not be considered for reimbursement, for this indication 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.
Pembrolizumab (Keytruda®). HTA ID: 23078
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23078 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Pembrolizumab (Keytruda®) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy*. |
| Assessment Process | |
| Rapid review commissioned | 20/12/2023 |
| Rapid review completed | 24/01/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab 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 | 02/02/2024 |
| Pre-submission consultation with Applicant | 27/08/2024 |
| Full submission received from Applicant | 27/02/2025 |
| Preliminary review sent to Applicant | 09/10/2025 |
| NCPE assessment re-commenced | 07/11/2025 |
| Factual accuracy sent to Applicant | 28/01/2026 |
| NCPE assessment re-commenced | 06/02/2026 |
| NCPE assessment completed | 19/02/2026 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab (Keytruda®) not be considered for reimbursement, for this indication, unless cost effectiveness can be improved relative to existing treatment.* |
*The Applicant is seeking reimbursement in a subgroup of the eligible population whose tumours express PD-L1 <50%.
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Pembrolizumab (Keytruda®). HTA ID: 24013
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24013 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Pembrolizumab, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung carcinoma (NSCLC) at high risk of recurrence in adults. |
| Assessment Process | |
| Rapid review commissioned | 22/04/2024 |
| Rapid review completed | 16/05/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment of resectable NSCLC, compared with the current standard of care. |
| Full HTA commissioned by the HSE | 29/05/2024 |
| Pre-submission consultation with Applicant | 02/07/2024 |
| Full submission received from Applicant | 22/05/2025 |
| Preliminary review sent to Applicant | 23/10/2025 |
| NCPE assessment re-commenced | 28/11/2025 |
| Factual accuracy sent to Applicant | 30/01/2026 |
| NCPE assessment re-commenced | 10/02/2026 |
| NCPE assessment completed | 10/03/2026 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab, for the indication under assessment, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments* |
*The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the Patient Organisation Submission and the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Pembrolizumab (Keytruda®). HTA ID: 24049
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24049 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Pembrolizumab (Keytruda®) in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 04/12/2024 |
| Rapid review completed | 10/01/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab for this indication compared with the current standard of care. |
| Full HTA commissioned by the HSE | 29/01/2025 |
| Pre-submission consultation with Applicant | 24/02/2025 |
| Full submission received from Applicant | 13/11/2025 |
| Preliminary review sent to Applicant | 30/03/2026 |
| NCPE assessment re-commenced | 30/04/2026 |
| Factual accuracy sent to Applicant | 29/06/2026 |
| NCPE assessment completed | 24/07/2026 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab (Keytruda®) be considered for reimbursement, within its licensed indication in the pMMR subpopulation, if cost-effectiveness can be improved relative to existing treatments*. There is insufficient information available to reliably inform cost-effectiveness in the dMMR subpopulation. |
*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.
Pembrolizumab (Keytruda®). HTA ID: 26026
| Assessment Status | Rapid Review Complete |
| HTA ID | 26026 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Pembrolizumab (Keytruda®) in combination with paclitaxel, with or without bevacizumab, for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens. |
| Assessment Process | |
| Rapid review commissioned | 21/05/2026 |
| Rapid review completed | 19/06/2026 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab 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
Polihexanide (Akantior®). HTA ID: 25045
| Assessment Status | Rapid Review Complete |
| HTA ID | 25045 |
| Drug | Polihexanide |
| Brand | Akantior® |
| Indication | Polihexanide (Akantior®) for the treatment of Acanthamoeba Keratitis in adults and children from 12 years of age. |
| Assessment Process | |
| Rapid review commissioned | 10/07/2025 |
| Rapid review completed | 14/08/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that polihexanide (Akantior®) 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.
Ravulizumab (Ultomiris®). HTA ID: 25012
| Assessment Status | Rapid Review Complete |
| HTA ID | 25012 |
| Drug | Ravulizumab |
| Brand | Ultomiris® |
| Indication | Ravulizumab (Ultomiris®) is indicated as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive. |
| Assessment Process | |
| Rapid review commissioned | 17/02/2025 |
| Rapid review completed | 12/03/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab compared with the current standard of care. |
Relugolix with estradiol and norethisterone acetate (Ryeqo®). HTA ID: 24018
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24018 |
| Drug | Relugolix with estradiol and norethisterone acetate |
| Brand | Ryeqo® |
| Indication | Relugolix with estradiol and norethisterone acetate (Ryeqo®) is Indicated in adult women of reproductive age for symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis. |
| Assessment Process | |
| Rapid review commissioned | 28/05/2024 |
| Rapid review completed | 15/07/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of relugolix combination therapy compared with the current standard of care. |
| Full HTA commissioned by the HSE | 31/07/2024 |
| Pre-submission consultation with Applicant | 18/02/2025 |
| Full submission received from Applicant | 15/07/2025 |
| Preliminary review sent to Applicant | 29/01/2026 |
| NCPE assessment re-commenced | 10/03/2026 |
| Factual accuracy sent to Applicant | 08/04/2026 |
| NCPE assessment re-commenced | 16/04/2026 |
| NCPE assessment completed | 28/04/2026 |
| NCPE assessment outcome | The NCPE recommends that relugolix CT (Ryeqo®) not be considered for reimbursement, for this indication, unless cost-effectiveness can be improved relative to existing treatment |
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.
Retifanlimab (Zynyz®). HTA ID: 26047
| Assessment Status | Rapid Review Complete |
| HTA ID | 26047 |
| Drug | Retifanlimab |
| Brand | Zynyz® |
| Indication | Retifanlimab (Zynyz®) is indicated in combination with carboplatin and paclitaxel for first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal. |
| Assessment Process | |
| Rapid review commissioned | 19/09/2026 |
| Rapid review completed | 15/10/2026 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of retifanlimab (Zynyz®) for this indication compared with the current standard of care. |
Ribociclib (Kisqali®). HTA ID: 24045
| Assessment Status | Rapid Review Complete |
| HTA ID | 24045 |
| Drug | Ribociclib |
| Brand | Kisqali® |
| Indication | Ribociclib in combination with an aromatase inhibitor (AI) is indicated for the adjuvant treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. |
| Assessment Process | |
| Rapid review commissioned | 13/11/2024 |
| Rapid review appraisal commenced | 22/11/2024 |
| Rapid review completed | 19/12/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that ribociclib 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. October 2025
Ripretinib (Qinlock®). HTA ID: 26046
| Assessment Status | Pre-submission consultation scheduled |
| HTA ID | 26046 |
| Drug | Ripretinib |
| Brand | Qinlock® |
| Indication | Ripretinib (Qinlock®) is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. |
| Assessment Process | |
| Rapid review commissioned | 15/09/2026 |
| Rapid review completed | 30/09/2026 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ripretinib compared with the current standard of care. |
| Full HTA commissioned by the HSE | 30/09/2026 |
Risdiplam (Evrysdi®). HTA ID: 25061
| Assessment Status | Rapid Review Complete |
| HTA ID | 25061 |
| Drug | Risdiplam |
| Brand | Evrysdi® |
| Indication | Risdiplam is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. The Applicant is seeking reimbursement in a subpopulation of the licensed population as follows: • infants with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies from birth to two months of age. |
| Assessment Process | |
| Rapid review commissioned | 17/10/2025 |
| Rapid review completed | 24/11/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that risdiplam for the proposed subpopulation 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.
Risdiplam (Evrysdi®). HTA ID: 25062
| Assessment Status | Rapid Review Complete |
| HTA ID | 25062 |
| Drug | Risdiplam |
| Brand | Evrysdi® |
| Indication | Risdiplam is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. The Applicant is seeking reimbursement in a subpopulation of the licensed population as follows: • Patients aged 18 years and older with a clinical diagnosis of SMA Type 2 or Type 3 or with one to four SMN2 copies, who have not previously been treated with a disease modifying therapy. |
| Assessment Process | |
| Rapid review commissioned | 17/10/2025 |
| Rapid review completed | 20/11/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that risdiplam for the proposed subpopulation 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.
Ritlecitinib (Litfulo®) HTA ID: 23071
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23071 |
| Drug | Ritlecitinib |
| Brand | Litfulo® |
| Indication | For the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. |
| Assessment Process | |
| Rapid review commissioned | 27/11/2023 |
| Rapid review appraisal commenced | 11/12/2023 |
| Rapid review completed | 22/12/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ritlecitinib compared with the current standard of care. |
| Full HTA commissioned by the HSE | 31/01/2024 |
| Pre-submission consultation with Applicant | 10/09/2024 |
| Full submission received from Applicant | 11/02/2025 |
| Preliminary review sent to Applicant | 12/08/2025 |
| NCPE assessment re-commenced | 10/09/2025 |
| Factual accuracy sent to Applicant | 24/10/2025 |
| NCPE assessment re-commenced | 03/11/2025 |
| Follow up to factual accuracy check sent to Applicant | 11/11/2025 |
| NCPE assessment re-commenced | 28/11/2025 |
| NCPE assessment completed | 02/12/2025 |
| NCPE assessment outcome | The NCPE recommends that ritlecitinib 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.
Ropeginterferon alfa-2b (Besremi®). HTA ID: 23004
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23004 |
| Drug | Ropeginterferon alfa-2b |
| Brand | Besremi® |
| Indication | Ropeginterferon alfa-2b is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly. |
| Assessment Process | |
| Rapid review commissioned | 20/01/2023 |
| Rapid review completed | 15/03/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ropeginterferon alfa-2b compared with the current standard of care. |
| Full HTA commissioned by the HSE | 29/03/2023 |
| Pre-submission consultation with Applicant | 03/05/2023 |
| Full submission received from Applicant | 20/07/2023 |
| Preliminary review sent to Applicant | 27/11/2023 |
| NCPE assessment re-commenced | 03/01/2024 |
| Factual accuracy sent to Applicant | 26/06/2024 |
| NCPE assessment re-commenced | 15/07/2024 |
| NCPE assessment completed | 15/08/2024 |
| NCPE assessment outcome | The NCPE recommends that ropeginterferon alfa-2b (Besremi®) 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.
Rucaparib (Rubraca®). HTA ID: 25011
| Assessment Status | Rapid Review Complete |
| HTA ID | 25011 |
| Drug | Rucaparib |
| Brand | Rubraca® |
| Indication | Rucaparib (Rubraca®) is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 17/02/2025 |
| Rapid review completed | 24/03/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that rucaparib 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.
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-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.
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.
Serplulimab (Hetronifly®). HTA ID: 26035
| Assessment Status | Rapid Review Complete |
| HTA ID | 26035 |
| Drug | Serplulimab |
| Brand | Hetronifly® |
| Indication | Serplulimab (Hetronifly®) in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with non-squamous NSCLC with no EGFR, ALK or ROS1 positive mutations and who have locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC. |
| Assessment Process | |
| Rapid review commissioned | 10/07/2026 |
| Rapid review completed | 14/08/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that serplulimab 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
Sodium Zirconium Cyclosilicate (Lokelma®). HTA ID: 24039
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24039 |
| Drug | Sodium Zirconium Cyclosilicate |
| Brand | Lokelma® |
| Indication | Sodium Zirconium Cyclosilicate is indicated for the treatment of hyperkalaemia in adult patients. |
| Assessment Process | |
| Rapid review commissioned | 01/10/2024 |
| Rapid review completed | 06/11/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost-effectiveness of SZC for this indication compared with the current standard of care. |
| Full HTA commissioned by the HSE | 27/11/2024 |
| Pre-submission consultation with Applicant | 05/03/2025 |
| Full submission received from Applicant | 04/09/2025 |
| Preliminary review sent to Applicant | 10/03/2026 |
| NCPE assessment re-commenced | 15/04/2026 |
| Follow-up to preliminary review sent to Applicant | 27/04/2026 |
| NCPE assessment re-commenced | 13/05/2026 |
| Factual accuracy sent to Applicant | 23/06/2026 |
| NCPE assessment re-commenced | 01/07/2026 |
| NCPE assessment completed | 21/07/2026 |
| NCPE assessment outcome | The NCPE recommends that SZC, for treatment of HK in patients with S-K levels ≥ 5.5 mmol/L who have advanced CKD (stage 3 to 5) and/or HF and are being treated with RAASi, not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.* The full licensed population is broader than the subpopulation used to inform the cost-effectiveness analysis. |
*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.
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.
Sotatercept (Winrevair ®). HTA ID: 24041
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24041 |
| Drug | Sotatercept |
| Brand | Winrevair ® |
| Indication | Sotatercept, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class II to III, to improve exercise capacity. |
| Assessment Process | |
| Rapid review commissioned | 09/09/2024 |
| Rapid review completed | 24/10/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sotatercept compared with the current standard of care. |
| Full HTA commissioned by the HSE | 29/11/2024 |
| Pre-submission consultation with Applicant | 28/01/2025 |
| Full submission received from Applicant | 15/05/2025 |
| Preliminary review sent to Applicant | 16/12/2025 |
| NCPE assessment re-commenced | 23/01/2026 |
| Factual accuracy sent to Applicant | 11/02/2026 |
| NCPE assessment re-commenced | 18/02/2026 |
| NCPE assessment completed | 03/03/2026 |
| NCPE assessment outcome | The NCPE recommends that sotatercept (when given in combination with other PAH therapies), for this indication, not be considered for reimbursement.* |
*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.
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.
Subcutaneous pembrolizumab (Keytruda®). HTA ID 26004
| Assessment Status | Rapid Review Complete |
| HTA ID | 26004 |
| Drug | Subcutaneous pembrolizumab |
| Brand | Keytruda® |
| Indication | Subcutaneous pembrolizumab (Keytruda®) for all previously approved adult indications where pembrolizumab is authorised for intravenous infusion. |
| Assessment Process | |
| Rapid review commissioned | 05/02/2026 |
| Rapid review completed | 21/04/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that subcutaneous pembrolizumab 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
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 appraisal commenced | 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.