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 pharmacoeconomic assessment commissioned by 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®) as monotherapy for unresectable or metastatic gastric, small intestine, or biliary cancer (2L+).
Assessment Status | Rapid Review Complete |
HTA ID | 23058 |
Drug | Pembrolizumab |
Brand | Keytruda® |
Indication | Pembrolizumab as monotherapy for the treatment of mismatch repair deficient or microsatellite instability-high tumours in adults with unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. |
Assessment Process | |
Rapid review commissioned | 20/09/2023 |
Rapid review completed | 25/10/2023 |
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. |
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 pharmacoeconomic assessment commissioned by 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 neoadjuvant/adjuvant treatment of triple negative breast cancer. HTA ID: 22027
Assessment Status | NCPE Assessment Process Complete |
HTA ID | 22027 |
Drug | Pembrolizumab |
Brand | Keytruda® |
Indication | Is indicated in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. |
Assessment Process | |
Rapid review commissioned | 27/04/2022 |
Rapid review completed | 26/05/2022 |
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. |
Full pharmacoeconomic assessment commissioned by HSE | 01/07/2022 |
Pre-submission consultation with Applicant | 30/08/2022 |
Full submission received from Applicant | 16/03/2023 |
Preliminary review sent to Applicant | 11/09/2023 |
NCPE assessment re-commenced | 09/10/2023 |
Factual accuracy sent to Applicant | 27/11/2023 |
NCPE assessment re-commenced | 04/12/2023 |
NCPE assessment completed | 18/12/2023 |
NCPE assessment outcome | The NCPE recommends that pembrolizumab (Keytruda®) plus chemotherapy, followed by pembrolizumab monotherapy, 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.
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 pharmacoeconomic assessment commissioned by 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 pharmacoeconomic assessment commissioned by 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: 23070
Assessment Status | Rapid Review 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. |
Pembrolizumab (Keytruda®). HTA ID: 23078
Assessment Status | Rapid Review 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. |
*The Applicant is seeking reimbursement in a subgroup of the eligible population whose tumours express PD-L1 <50%.
Polatuzumab vedotin (Polivy®). HTA ID: 22043
Assessment Status | NCPE Assessment Process Complete |
HTA ID | 22043 |
Drug | Polatuzumab vedotin |
Brand | Polivy® |
Indication | In combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). |
Assessment Process | |
Rapid review commissioned | 27/06/2022 |
Rapid review completed | 27/07/2022 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pola-R-CHP compared with the current standard of care. |
Full pharmacoeconomic assessment commissioned by HSE | 31/08/2022 |
Pre-submission consultation with Applicant | 08/11/2022 |
Full submission received from Applicant | 26/01/2023 |
Preliminary review sent to Applicant | 20/07/2023 |
NCPE assessment re-commenced | 18/08/2023 |
Factual accuracy sent to Applicant | 16/11/2023 |
NCPE assessment re-commenced | 23/11/2023 |
NCPE assessment completed | 05/12/2023 |
NCPE assessment outcome | The NCPE recommends that polatuzumab vedotin (Polivy®) 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.
Quizartinib (Vanflyta®). HTA ID: 24006
Assessment Status | Rapid Review Complete |
HTA ID | 24006 |
Drug | Quizartinib |
Brand | Vanflyta® |
Indication | Quizartinib is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia that is FLT3-ITD positive. |
Assessment Process | |
Rapid review commissioned | 09/02/2024 |
Rapid review completed | 11/03/2024 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of quizartinib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Ravulizumab (Ultomiris®). HTA ID: 19054
Assessment Status | Assessment Process Complete |
HTA ID | 19054 |
Drug | Ravulizumab |
Brand | Ultomiris® |
Indication | For the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH): in patients with haemolysis with clinical symptom(s) indicative of high disease activity and in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. |
Assessment Process | |
Rapid review commissioned | 04/12/2019 |
Rapid review completed | 02/03/2020 |
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, on the basis of the proposed price relative to currently available therapies. |
Full pharmacoeconomic assessment commissioned by HSE | 04/03/2020 |
Pre-submission consultation with Applicant | 28/06/2021 |
Full submission received from Applicant | 05/11/2021 |
Preliminary review sent to Applicant | 28/02/2022 |
NCPE assessment re-commenced | 25/03/2022 |
Factual accuracy sent to Applicant | 29/04/2022 |
NCPE assessment re-commenced | 10/05/2022 |
NCPE assessment completed | 30/05/2022 |
NCPE assessment outcome | The NCPE recommends that ravulizumab (Ultomiris®), for the treatment of adult patients with PNH, be considered for reimbursement provided certain conditions are met*. These are that the cost of ravulizumab should not exceed any eculizumab products currently available or anticipated to be available in the near future. A price premium over eculizumab is not justified given that both treatments appear to have similar efficacy. In addition, ravulizumab did not demonstrate an improvement in treatment-related burden compared with eculizumab in clinical trials. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Ravulizumab (Ultomiris®). HTA ID: 20036
Assessment Status | Assessment Process Complete |
HTA ID | 20036 |
Drug | Ravulizumab |
Brand | Ultomiris® |
Indication | Indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve, or have received eculizumab for at least 3 months and have evidence of response to eculizumab. |
Assessment Process | |
Rapid review commissioned | 24/07/2020 |
Rapid review completed | 21/08/2020 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab (Ultomiris®) compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Full pharmacoeconomic assessment commissioned by HSE | 27/08/2020 |
Pre-submission consultation with Applicant | 28/06/2021 |
Full submission received from Applicant | 05/11/2021 |
Preliminary review sent to Applicant | 24/03/2022 |
NCPE assessment re-commenced | 21/04/2022 |
Follow-up to preliminary review sent to Applicant | 29/04/2022 |
NCPE assessment re-commenced | 05/05/2022 |
Additional follow-up to Preliminary Review sent to Applicant | 25/05/2022 |
NCPE assessment re-commenced | 16/06/2022 |
Factual accuracy sent to Applicant | 08/07/2022 |
NCPE assessment re-commenced | 15/07/2022 |
NCPE assessment completed | 28/07/2022 |
NCPE assessment outcome | The NCPE recommends that ravulizumab not be considered for reimbursement unless cost effectiveness can be improved relative to comparator treatments*. This recommendation should consider the imminent introduction of eculizumab biosimilars. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Rezafungin (Rezzayo®). HTA ID: 24007
Assessment Status | Rapid Review Complete |
HTA ID | 24007 |
Drug | Rezafungin |
Brand | Rezzayo® |
Indication | Rezafungin (Rezzayo®) is indicated for the treatment of invasive candidiasis in adults. |
Assessment Process | |
Rapid review commissioned | 22/03/2024 |
Rapid review completed | 26/03/2024 |
Rapid review outcome | A full HTA is not recommended. The NCPE recommends that rezafungin 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.
Rimegepant (Vydura®). HTA ID: 22051
Assessment Status | NCPE Assessment Process Complete |
HTA ID | 22051 |
Drug | Rimegepant |
Brand | Vydura® |
Indication | For the acute treatment of migraine with or without aura in adults; and for the preventive treatment of episodic migraine in adults who have at least four migraine attacks per month. |
Assessment Process | |
Rapid review commissioned | 13/07/2022 |
Rapid review completed | 12/09/2022 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of rimegepant (Vydura®) compared with the current standard of care. |
Full pharmacoeconomic assessment commissioned by HSE | 28/09/2022 |
Pre-submission consultation with Applicant | 10/11/2022 |
Full submission received from Applicant | 07/02/2023 |
Preliminary review sent to Applicant | 27/03/2023 |
NCPE assessment re-commenced | 18/04/2023 |
Factual accuracy sent to Applicant | 03/05/2023 |
NCPE assessment re-commenced | 10/05/2023 |
NCPE assessment completed | 18/05/2023 |
NCPE assessment outcome | The NCPE recommends that rimegepant (Vydura®) 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.
Risankizumab (Skyrizi®) for Crohn’s Disease. HTA ID: 23061
Assessment Status | NCPE Assessment Process Complete |
HTA ID | 23061 |
Drug | Risankizumab |
Brand | Skyrizi® |
Indication | Risankizumab 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 agent. The Applicant is seeking reimbursement in a subgroup of the licensed population, as second-line treatment after failure of the first biologic therapy. |
Assessment Process | |
Rapid review commissioned | 26/09/2023 |
Rapid review completed | 07/11/2023 |
Rapid review outcome | A full HTA is not recommended. The NCPE recommends that risankizumab 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.
Ritlecitinib (Litfulo®) HTA ID: 23071
Assessment Status | Rapid Review 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 resubmission required | 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. |
Sacituzumab govitecan (Trodelvy®). HTA ID: 23079
Assessment Status | Rapid Review Complete |
HTA ID | 23079 |
Drug | Sacituzumab govitecan |
Brand | Trodelvy® |
Indication | Sacituzumab govitecan is indicated for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. |
Assessment Process | |
Rapid review commissioned | 21/12/2023 |
Rapid review completed | 26/01/2024 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sacituzumab govitecan compared with the current standard of care. |
Sacubitril/valsartan (Entresto®)
Assessment Status | Assessment Process Complete |
HTA ID | - |
Drug | Sacubitril/valsartan |
Brand | Entresto® |
Indication | For the treatment of symptomatic chronic heart failure with reduced ejection fraction if adult patients. |
Assessment Process | |
Rapid review commissioned | 06/11/2015 |
Rapid review completed | 30/11/2015 |
Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
Full submission received from Applicant | 07/03/2016 |
NCPE assessment completed | 08/07/2016 |
NCPE assessment outcome | Reimbursement Recommended |
The NCPE considers valsartan/sacubitril (Entresto) cost-effective for the current licensed indication and recommends reimbursement.
The HSE has approved reimbursement following confidential price negotiations October 2017.
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.
Sufentanil Citrate (Dzuveo®) HTA ID: 23062
Assessment Status | Rapid Review Complete |
Drug | Sufentanil Citrate |
Brand | Dzuveo® |
Indication | For the management of acute moderate to severe pain in adult patients |
Assessment Process | |
Rapid review commissioned | 02/10/2023 |
Rapid review resubmission required | 04/12/2023 |
Rapid review completed | 22/12/2023 |
Rapid review outcome | A full HTA is not recommended. The NCPE recommends that sufentanil citrate not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in
the Health (Pricing and Supply of Medical Goods) Act 2013.
Tadalafil (Adcirca®)
Assessment Status | Rapid Review Complete |
HTA ID | – |
Drug | Tadalafil |
Brand | Adcirca® |
Indication | In adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organisation (WHO) Functional Class (FC) II and III, to improve exercise capacity. |
Assessment Process | |
Rapid review commissioned | 13/07/2011 |
Rapid review completed | 21/09/2011 |
Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
May 2014 | In accordance with the Health Act (Pricing and Supply of Medical Goods) 2013 (section 18(4)), the HSE has requested the NCPE to re-examine the cost effectiveness of Tadalafil (Adcirca®). |
Rapid review commissioned | 09/05/2014 |
Rapid review completed | 23/05/2014 |
Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Tafamidis (Vyndaqel®). HTA ID: 20017
Assessment Status | Assessment process complete |
HTA ID | 20017 |
Drug | Tafamidis |
Brand | Vyndaqel® |
Indication | For the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy. |
Assessment Process | |
Rapid review commissioned | 30/03/2020 |
Rapid review completed | 07/04/2020 |
Rapid review outcome | A full HTA is recommended to assess the clinical and cost effectiveness of tafamidis compared with the current standard of care. |
Full pharmacoeconomic assessment commissioned by HSE | 29/04/2020 |
Pre-submission consultation with Applicant | 18/05/2020 |
Full submission received from Applicant | 01/07/2020 |
Preliminary review sent to Applicant | 18/08/2020 |
NCPE assessment re-commenced | 10/09/2020 |
Factual accuracy sent to Applicant | 11/09/2020 |
NCPE assessment re-commenced | 18/09/2020 |
NCPE assessment completed | 25/09/2020 |
NCPE assessment outcome | The NCPE recommends that tafamidis not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations March 2022.
Tafamidis meglumine (Vyndaqel®)
Assessment Status | Rapid Review Complete |
HTA ID | - |
Drug | Tafamidis meglumine |
Brand | Vyndaqel® |
Indication | For the treatment of transthyretin amyloidosis in adult patients with stage I symptomatic polyneuropathy to delay peripheral neurologic impairment. |
Assessment Process | |
Rapid review commissioned | 12/03/2018 |
Rapid review completed | 10/05/2018 |
Rapid review outcome | A full pharmacoeconomic assessment is not recommended until additional efficacy and/or safety data is submitted. On the basis of current evidence, the NCPE recommends that tafamidis not be considered for reimbursement in accordance with the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013. |
Tafasitamab (Minjuvi®) in combination with lenalidomide. HTA ID: 22008
Assessment Status | Rapid Review Complete |
HTA ID | 22008 |
Drug | Tafasitamab |
Brand | Minjuvi® |
Indication | In combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem-cell transplant (ASCT). |
Assessment Process | |
Rapid review commissioned | 14/02/2022 |
Rapid review completed | 15/02/2022 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tafasitamab in combination with lenalidomide compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Tafluprost (Saflutan®)
Assessment Status | Rapid Review Complete |
HTA ID | - |
Drug | Tafluprost |
Brand | Saflutan® |
Indication | For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension. |
Assessment Process | |
Rapid review commissioned | 25/03/2011 |
Rapid review completed | 09/04/2011 |
Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended. |
Talazoparib (Talzenna®) HTA ID: 19032
Assessment Status | Assessment process complete |
HTA ID | 19032 |
Drug | Talazoparib |
Brand | Talzenna® |
Indication | As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. |
Assessment Process | |
Rapid review commissioned | 19/08/2019 |
Rapid review completed | 03/09/2019 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of talazoparib compared with the current standard of care. |
Full pharmacoeconomic assessment commissioned by HSE | 09/09/2019 |
Pre-submission consultation with Applicant | 02/12/2019 |
Full submission received from Applicant | 06/03/2020 |
Preliminary review sent to Applicant | 24/04/2020 |
NCPE assessment re-commenced | 05/06/2020 |
Factual accuracy sent to Applicant | 14/08/2020 |
NCPE assessment re-commenced | 21/08/2020 |
NCPE assessment completed | 18/09/2020 |
NCPE assessment outcome | The NCPE recommends that talazoparib (Talzenna®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
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.
Tapentadol (Palexia®)
Assessment Status | Assessment process complete |
HTA ID | - |
Drug | Tapentadol |
Brand | Palexia® |
Indication | For the management of adult patients with severe chronic/acute pain. |
Assessment Process | |
Rapid review commissioned | 19/10/2010 |
Rapid review completed | 22/10/2020 |
Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
Full pharmacoeconomic assessment commissioned by HSE | 31/01/2011 |
NCPE assessment completed | 08/04/2011 |
NCPE assessment outcome | Reimbursement Recommended |
Tapentadol (Palexia®) may be considered cost-effective but should be reserved for patients who cannot tolerate existing strong oral opioids.
Tebentafusp (Kimmtrak®). HTA ID: 23064
Assessment Status | Rapid Review Complete |
HTA ID | 23064 |
Drug | Tebentafusp |
Brand | Kimmtrak® |
Indication | Tebentafusp is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. |
Assessment Process | |
Rapid review commissioned | 10/10/2023 |
Rapid review completed | 13/11/2023 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tebentafusp compared with the current standard of care. |
Tedizolid phosphate (Sivextro®)
Assessment Status | Rapid Review Complete |
HTA ID | - |
Drug | Tedizolid phosphate |
Brand | Sivextro® |
Indication | For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults |
Assessment Process | |
Rapid review commissioned | 07/05/2015 |
Rapid review completed | 07/07/2015 |
Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Tegafur/Gimeracil/Oteracil (Teysuno®)
Assessment Status | Rapid Review Complete |
Drug | Tegafur/Gimeracil/Oteracil |
Brand | Teysuno® |
Indication | For the treatment of advanced gastric cancer. |
Assessment Process | |
Rapid review commissioned | 27/02/2012 |
Rapid review completed | 23/03/2012 |
Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Telaprevir (Incivo®)
Assessment Status | Assessment process complete |
HTA ID | - |
Drug | Telaprevir |
Brand | Incivo® |
Indication | As add-on therapy to pegylated interferon and ribavirin for the treatment of patients infected with Hepatitis C Genotype 1. |
Assessment Process | |
Rapid review commissioned | 28/10/2011 |
Rapid review completed | 02/11/2011 |
Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
Full pharmacoeconomic assessment commissioned by HSE | 08/11/2011 |
NCPE assessment completed | 19/01/2012 |
NCPE assessment outcome | Reimbursement Recommended |
We consider telaprevir (Incivo®) a highly cost-effective therapy when added to peginterferon-ribavirin for the treatment of patients infected with genotype 1 hepatitis C virus in the Irish healthcare setting.
Telavancin (Vibativ®)
Assessment Status | Rapid Review Complete |
Drug | Telavancin |
Brand | Vibativ® |
Indication | For the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumomia, known or suspended to be caused by methicillin-resistant Staphylococcus aureas (MRSA). Vabitiv® should be used only in situations where it is known or suspected that other alternatives are not suitable. |
Assessment Process | |
Rapid review completed | 13/01/2015 |
Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Tepotinib (Tepmetko®). HTA ID: 22025
Assessment Status | NCPE Assessment Process Complete |
HTA ID | 22025 |
Drug | Tepotinib |
Brand | Tepmetko® |
Indication | For the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. |
Assessment Process | |
Rapid review commissioned | 22/04/2022 |
Rapid review completed | 30/05/2022 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tepotinib compared with the current standard of care. |
Full pharmacoeconomic assessment commissioned by HSE | 01/07/2022 |
Pre-submission consultation with Applicant | 13/09/2022 |
Full submission received from Applicant | 10/01/2023 |
Preliminary review sent to Applicant | 23/05/2023 |
NCPE assessment re-commenced | 22/06/2023 |
Factual accuracy sent to Applicant | 18/10/2023 |
NCPE assessment re-commenced | 03/11/2023 |
NCPE assessment completed | 29/11/2023 |
NCPE assessment outcome | The NCPE recommends that tepotinib 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.
Teriflunomide (Aubagio®)
Assessment Status | Assessment process complete |
HTA ID | - |
Drug | Teriflunomide |
Brand | Aubagio® |
Indication | For the first line treatment of adult patients with relapsing remitting multiple sclerosis (MS). |
Assessment Process | |
Rapid review commissioned | 27/08/2013 |
Rapid review completed | 20/09/2013 |
Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
Full pharmacoeconomic assessment commissioned by HSE | 25/11/2013 |
NCPE assessment completed | 19/06/2014 |
NCPE assessment outcome | Reimbursement Not Recommended. |
The NCPE does not recommend reimbursement of teriflunomide (Aubagio®) at the current price.
The HSE has approved reimbursement following price negotiations-September 2014
Ticagrelor (Brilique®)
Assessment Status | Assessment process complete |
HTA ID | - |
Drug | Ticagrelor |
Brand | Brilique® |
Indication | For the prevention of atherothrombotic events in adult patients with Acute Coronary Syndrome (ACS) including patients managed medically, and those who are managed with PCI (Percutaneous Coronary Intervention) or CABG (Coronary Artery Bypass Graft). |
Assessment Process | |
Rapid review commissioned | 25/11/2010 |
Rapid review completed | 20/01/2011 |
Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
Full pharmacoeconomic assessment commissioned by HSE | 27/07/2011 |
NCPE assessment completed | 10/10/2011 |
NCPE assessment outcome | Reimbursement Recommended |
We consider Ticagrelor (Brilique®) a cost effective therapy for the prevention of atherothrombotic events in adult patients with ACS including patients managed medically and those managed with PCI or CABG.
Ticagrelor (Brilique®) in combination with acetylsalicyclic acid
Assessment Status | Rapid Review Complete |
HTA ID | - |
Drug | Ticagrelor |
Brand | Brilique® |
Indication | Co-administered with acetylsalicylic acid (ASA), for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event. |
Assessment Process | |
Rapid review commissioned | 29/02/2016 |
Rapid review completed | 04/05/2016 |
Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
Not considered cost-effective due to non-submission of full pharmacoeonomic evaluation
Tildrakizumab (Ilumetri®). HTA ID: 19029
Assessment Status | Assessment process complete |
HTA ID | 19029 |
Drug | Tildrakizumab |
Brand | Ilumetri® |
Indication | For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. |
Assessment Process | |
Rapid review commissioned | 30/07/2019 |
Rapid review completed | 28/08/2019 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tildrakizumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Full pharmacoeconomic assessment commissioned by HSE | 19/05/2020 |
Pre-submission consultation with Applicant | 08/02/2021 |
Full submission received from Applicant | 04/05/2021 |
Preliminary review sent to Applicant | 20/07/2021 |
NCPE assessment re-commenced | 23/08/2021 |
Factual accuracy sent to Applicant | 15/10/2021 |
NCPE assessment re-commenced | 03/11/2021 |
NCPE assessment completed | 25/11/2021 |
NCPE assessment outcome | The NCPE recommends that tildrakizumab (Ilumetri®), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy and who have failed treatment with non-biologic therapies and first-line biologic treatment with adalimumab, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations May 2022.
Tirbanibulin (Klisyri®). HTA ID: 21054
Assessment Status | Rapid Review Complete |
HTA ID | 21054 |
Drug | Tirbanibulin |
Brand | Klisyri® |
Indication | For the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults. |
Assessment Process | |
Rapid review commissioned | 15/11/2021 |
Rapid review completed | 30/11/2021 |
Rapid review outcome | A full HTA is not recommended. The NCPE recommends that tirbanibulin not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Tirzepatide (Mounjaro®). HTA ID: 24003
Assessment Status | Rapid Review Complete |
HTA ID | 24003 |
Drug | Tirzepatide |
Brand | Mounjaro® |
Indication | Tirzepatide (Mounjaro®) 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 | 24/01/2024 |
Rapid review completed | 06/02/2024 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tirzepatide compared with the current standard of care. |
Tisagenlecleucel (Kymriah®) for DLBCL
Assessment Status | Assessment process complete |
HTA ID | - |
Drug | Tisagenlecleucel |
Brand | Kymriah® |
Indication | For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. |
Assessment Process | |
Rapid review commissioned | 19/08/2018 |
Rapid review completed | 18/10/2018 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tisagenlecleucel compared with the current standard of care. |
Full pharmacoeconomic assessment commissioned by HSE | 22/10/2018 |
Pre-submission consultation with Applicant | 06/11/2018 |
Full submission received from Applicant | 23/01/2019 |
Preliminary review sent to Applicant | 28/05/2019 |
NCPE assessment re-commenced | 26/06/2019 |
Factual accuracy sent to Applicant | 27/08/2019 |
NCPE assessment re-commenced | 04/09/2019 |
NCPE assessment completed | 20/09/2019 |
NCPE assessment outcome | The NCPE recommends that tisagenlecleucel (Kymriah®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.* |
This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations July 2021.
Tisagenlecleucel (Kymriah®) for pALL
Assessment Status | Assessment process complete |
HTA ID | - |
Drug | Tisagenlecleucel |
Brand | Kymriah® |
Indication | For the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse. |
Assessment Process | |
Rapid review commissioned | 19/09/2018 |
Rapid review completed | 19/10/2018 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tisagenlecleucel compared with the current standard of care. |
Full pharmacoeconomic assessment commissioned by HSE | 22/10/2018 |
Pre-submission consultation with Applicant | 06/11/2018 |
Full submission received from Applicant | 30/01/2019 |
Preliminary review sent to Applicant | 11/04/2019 |
NCPE assessment re-commenced | 10/05/2019 |
Factual accuracy sent to Applicant | 23/07/2019 |
NCPE assessment re-commenced | 01/08/2019 |
NCPE assessment completed | 27/08/2019 |
NCPE assessment outcome | The NCPE recommends that tisagenlecleucel (Kymriah®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.* |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations July 2021.
Tivozanib (Fotivda®)
Assessment Status | Rapid Review Complete |
HTA ID | - |
Drug | Tivozanib |
Brand | Fotivda® |
Indication | For the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. |
Assessment Process | |
Rapid review commissioned | 09/01/2019 |
Rapid review completed | 24/01/2019 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tivozanib compared with the current standard of care. |
The HSE has approved reimbursement following confidential price negotiations August 2019.