| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Oladaterol |
| Brand | Striverdi®, Respimat® |
| Indication | As a maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD). |
| Assessment Process | |
| Rapid review commissioned | 07/04/2014 |
| Rapid review completed | 02/05/2014 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Latest NCPE Advice
Olaparib (Lynparza®) (1L maintenance of BRCA-mutated advanced OVCA)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Olaparib |
| Brand | Lynparza® |
| Indication | For the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) 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 | 30/04/2019 |
| Rapid review completed | 09/05/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of olaparib compared with the current standard of care. |
| Full HTA commissioned by the HSE | 15/05/2019 |
| Pre-submission consultation with Applicant | 15/07/2019 |
| Full submission received from Applicant | 10/10/2019 |
| Preliminary review sent to Applicant | 08/01/2020 |
| NCPE assessment re-commenced | 24/01/2020 |
| Factual accuracy sent to Applicant | 09/03/2020 |
| NCPE assessment re-commenced | 13/03/2020 |
| NCPE assessment completed | 30/03/2020 |
| NCPE assessment outcome | The NCPE recommends that olaparib (Lynparza®) for this indication 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; December 2020
Olaparib (Lynparza®) capsules for BRCA-mutated platinum sensitive relapsed ovarian, fallopian tube, or peritoneal cancer
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Olaparib |
| Brand | Lynparza® |
| Indication | As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 05/01/2015 |
| Rapid review completed | 19/02/2015 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full HTA commissioned by the HSE | 17/08/2015 |
| NCPE assessment completed | 17/12/2015 |
| NCPE assessment outcome | Reimbursement not recommended. |
The HSE has approved reimbursement following confidential price negotiations November 2017.
Olaparib (Lynparza®) for breast cancer
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Olaparib |
| Brand | Lynparza® |
| Indication | For the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. |
| Assessment Process | |
| Rapid review commissioned | 29/03/2019 |
| Rapid review completed | 10/04/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of olaparib 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.
Olaparib (Lynparza®) for mCRPC. HTA ID: 21019
| Assessment Status | Rapid Review Complete |
| HTA ID | 21019 |
| Drug | Olaparib |
| Brand | Lynparza® |
| Indication | As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. |
| Assessment Process | |
| Rapid review commissioned | 11/05/2021 |
| Rapid review completed | 15/06/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that olaparib not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations March 2023.
Olaparib (Lynparza®) for platinum sensitive relapsed ovarian cancer
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Olaparib |
| Brand | Lynparza® |
| Indication | As monotherapy for the maintenance treatment of adult patients with PSR high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 19/09/2018 |
| Rapid review completed | 01/10/2018 |
| Rapid review outcome | The NCPE recommend a full HTA to assess the clinical effectiveness and cost effectiveness of olaparib compared with the current standard of care. |
| Full HTA commissioned by the HSE | 16/10/2018 |
| Pre-submission consultation with Applicant | 26/11/2018 |
| Full submission received from Applicant | 28/06/2019 |
| Preliminary review sent to Applicant | 30/09/2019 |
| NCPE assessment re-commenced | 25/10/2019 |
| Factual accuracy sent to Applicant | 02/12/2019 |
| NCPE assessment re-commenced | 12/12/2019 |
| NCPE assessment completed | 04/02/2020 |
| NCPE assessment outcome | The NCPE recommends that olaparib (Lynparza®), for this indication, 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.
Olaparib (Lynparza®) in combination with abiraterone and prednisone. HTA ID: 23029
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23029 |
| Drug | Olaparib |
| Brand | Lynparza® |
| Indication | Olaparib in combination with abiraterone and prednisone or prednisolone is indicated for the treatment of adult patients with mCRPC in whom chemotherapy in not clinically indicated |
| Assessment Process | |
| Rapid review commissioned | 31/05/2023 |
| Rapid review completed | 13/06/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of olaparib in combination with abiraterone and prednisone or prednisolone compared with the current standard of care. |
| Full HTA commissioned by the HSE | 28/06/2023 |
| Pre-submission consultation with Applicant | 09/08/2023 |
| Full submission received from Applicant | 31/01/2024 |
| Preliminary review sent to Applicant | 21/11/2024 |
| NCPE assessment re-commenced | 19/12/2024 |
| Follow-up to preliminary review sent to Applicant | 13/02/2025 |
| NCPE assessment re-commenced | 11/03/2025 |
| Factual accuracy sent to Applicant | 28/04/2025 |
| NCPE assessment re-commenced | 02/05/2025 |
| NCPE assessment completed | 10/06/2025 |
| NCPE assessment outcome | The NCPE recommends that olaparib (Lynparza®) 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.
Olaparib (Lynparza®) tablets for BRCA-mutated platinum sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Olaparib |
| Brand | Lynparza® |
| Indication | As monotherapy for the maintenance treatment of adult patients with BRCA-mutated platinum sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. This is a sub-group of the entire licensed population. |
| Assessment Process | |
| Rapid review commissioned | 23/07/2019 |
| Rapid review completed | 06/08/2019 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that olaparib 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.
Omalizumab (Xolair®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Omalizumab |
| Brand | Xolair® |
| Indication | As an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment. |
| Assessment Process | |
| Rapid review commissioned | 25/03/2014 |
| Rapid review completed | 25/04/2014 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Omalizumab (Xolair®) for the treatment of severe allergic asthma
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Omalizumab |
| Brand | Xolair® |
| Indication | As an add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1<80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. |
| Assessment Process | |
| Full HTA commissioned by the HSE | 22/08/2014 |
| NCPE assessment completed | 25/06/2015 |
| NCPE assessment outcome | Reimbursement not recommended. |
Following NCPE assessment of the company submission, omalizumab (Xolair ®) is not considered cost-effective for the treatment of severe allergic asthma and therefore is not recommended for reimbursement.
Omaveloxolone (Skyclarys®). HTA ID: 24033
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24033 |
| Drug | Omaveloxolone |
| Brand | Skyclarys® |
| Indication | For the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older |
| Assessment Process | |
| Rapid review commissioned | 02/08/2024 |
| Rapid review completed | 29/08/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of omaveloxolone compared with the current standard of care. |
| Full HTA commissioned by the HSE | 25/09/2024 |
| Pre-submission consultation with Applicant | 04/02/2025 |
| Full submission received from Applicant | 02/07/2025 |
| Preliminary review sent to Applicant | 17/09/2025 |
| NCPE assessment re-commenced | 29/10/2025 |
| Factual accuracy sent to Applicant | 27/11/2025 |
| NCPE assessment re-commenced | 04/12/2025 |
| NCPE assessment completed | 16/12/2025 |
| NCPE assessment outcome | The NCPE recommends that omaveloxolone 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.
Omega-3-acid ethyl esters (Omacor®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Omega-3-acid ethyl esters |
| Brand | Omacor® |
| Indication | As an adjuvant treatment in secondary prevention after myocardial infarction in addition to other standard therapy. Omacor® is also indicated for the treatment of endogenous hypertriglyceridaemia as a supplement to diet, when dietary measures alone are insufficient to produce an adequate response. |
| Assessment Process | |
| Full HTA commissioned by the HSE | 11/02/2013 |
| NCPE assessment completed | 19/04/2013 |
| NCPE assessment outcome | Reimbursement not recommended. |
The NCPE believe that Omacor® is not a cost-effective adjuvant treatment for patients post-myocardial infarction in the Irish Healthcare Setting. The cost effectiveness of Omacor® for treatment of endogenous hypertriglyceridaemia as a supplement to diet has not been demonstrated.
Omeprazole (Appizped®). HTA ID: 25038
| Assessment Status | Rapid Review Complete |
| HTA ID | 25038 |
| Drug | Omeprazole |
| Brand | Appizped® |
| Indication | Omeprazole (Appizped®) is indicated for: Paediatric use (Children over 1 month of age) • Treatment of reflux oesophagitis • Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease; Children over 4 years of age and adolescents • In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori (H. pylori); Adults • Treatment of duodenal ulcers • Prevention of relapse of duodenal ulcers • Treatment of gastric ulcers • Prevention of relapse of gastric ulcers • In combination with appropriate antibiotics, H. pylori eradication in peptic ulcer disease • Treatment of NSAID-associated gastric and duodenal ulcers • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk • Treatment of reflux oesophagitis • Long-term management of patients with healed reflux esophagitis • Treatment of symptomatic gastro-oesophageal reflux disease (GORD) |
| Assessment Process | |
| Rapid review commissioned | 05/06/2025 |
| Rapid review completed | 30/06/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that omeprazole (Appizped®) 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 recommendation may be found here.
Omeprazole (Pedippi®) 2mg/ml powder for oral suspension. HTA ID: 20049
| Assessment Status | Rapid Review Complete |
| HTA ID | 20049 |
| Drug | Omeprazole 2mg/ml powder for oral suspension |
| Brand | Pedippi® |
| Indication | For the management of Gastro-oesphageal reflux disease (GORD) and Peptic Ulcer Disease (PUD) in children and adult patients. Please refer to the SPC for the full range of licensed indications. The Applicant is seeking reimbursement for a subgroup of the licensed population: Children over 1 month of age for the treatment of reflux esophagitis and symptomatic treatment of heartburn and acid regurgitation in gastro oesophageal reflux disease (GORD); Children over 4 years of age and adolescents in combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori (H. pylori). |
| Assessment Process | |
| Rapid review commissioned | 23/11/2020 |
| Rapid review completed | 11/02/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that omeprazole (Pedippi®) not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.
The HSE has approved reimbursement following confidential price negotiations September 2021.
Onasemnogene abeparvovec (Zolgensma®). HTA ID: 20021
This HTA is being undertaken as part of the BENELUXA collaboration. It is a joint assessment between Ireland, Netherlands and Belgium with Austria acting as reviewer. Please see www.beneluxa.org for further information.
| Assessment Status | Assessment process complete |
| HTA ID | 20021 |
| Drug | Onasemnogene abeparvovec |
| Brand | Zolgensma® |
| Indication | For the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene. |
| Assessment Process | |
| Rapid review commissioned | 14/04/2020 |
| Rapid review completed | 13/05/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of onasemnogene abeparvovec (Zolgensma®) compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 27/05/2020 |
| Concept dossier received | 08/06/2020 |
| Response to Applicant | 29/06/2020 |
| Final Complete Dossier accepted | 02/11/2020 |
| First draft report complete** | 07/12/2020 |
| Final Report** | 02/04/2021 |
| NCPE assessment outcome | The NCPE recommends that Onasemnogene abeparvovec (Zolgensma®) 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.
Executive summary Zolgensma Beneluxa (Ireland)Final Version
**The Beneluxa process differs slightly from the process in Ireland where the Drug Committee received only the final report. In the Beneluxa process the respective committees in the Netherlands (WAR) and Belgium (CTG) receive draft versions of the report (2 drafts). Edits, if appropriate are made in this time and the report is finalised after the second round of reviewing.
The HSE has approved reimbursement following confidential price negotiations October 2021.
Opicapone (Ongentys®). HTA ID: 20055
| Assessment Status | Rapid Review Complete |
| HTA ID | 20055 |
| Drug | Opicapone |
| Brand | Ongentys® |
| Indication | As adjunctive therapy to levodopa and DOPA decarboxylase inhibitors (L-DOPA+DDCI) in adults with Parkinson’s disease and end-of-dose motor fluctuations in patients not stabilised on such combinations. |
| Assessment Process | |
| Rapid review commissioned | 14/12/2020 |
| Rapid review completed | 18/01/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends opicapone not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations January 2022.
Opium Tincture (Dropizol®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Opium Tincture |
| Brand | Dropizol® |
| Indication | For severe diarrhoea such as diarrhoea caused by cytostatic medication, radiation or neuroendocrine tumours when use of other anti-diarrhoea treatments have not given sufficient effect. |
| Assessment Process | |
| Rapid review commissioned | 04/03/2019 |
| Rapid review completed | 03/04/2019 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that opium tincture (Dropizol) 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.
Oritavancin (Tenkasi®). HTA ID: 21061
| Assessment Status | Rapid Review Complete |
| HTA ID | 21061 |
| Drug | Oritavancin |
| Brand | Tenkasi® |
| Indication | For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
| Assessment Process | |
| Rapid review commissioned | 07/12/2021 |
| Rapid review completed | 24/01/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of oritavancin 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 June 2022.
Osilodrostat (Isturisa®). HTA ID: 22023
| Assessment Status | Rapid Review Complete |
| HTA ID | 22023 |
| Drug | Osilodrostat |
| Brand | Isturisa® |
| Indication | For the treatment of endogenous Cushing’s syndrome in adults. |
| Assessment Process | |
| Rapid review commissioned | 21/04/2022 |
| Rapid review completed | 17/05/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of osilodrostat compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Osimertinib (Tagrisso®)
| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Osimertinib |
| Brand | Tagrisso® |
| Indication | For the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor [EGFR] T790M mutation positive non-small cell lung cancer [NSCLC]. |
| Assessment Process | |
| Rapid review commissioned | 26/02/2016 |
| Rapid review completed | 22/03/2016 |
| Rapid review outcome | Reimbursement not recommended at this point in time |
| Updated clinical evidence submitted by the Applicant | 21/12/2016 |
| Rapid Review completed | 10/01/2017 |
| Rapid Review outcome | Full pharmacoeconomic assessment recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 30/01/2017 |
| Pre-submission consultation with Applicant | 20/03/2017 |
| Full submission received from Applicant | 02/06/2017 |
| Preliminary review sent to Applicant | 28/07/2017 |
| NCPE assessment re-commenced | 24/11/2017 |
| Factual accuracy sent to Applicant | 21/12/2017 |
| NCPE assessment re-commenced | 16/01/2018 |
| NCPE assessment completed | 16/01/2018 |
| NCPE assessment outcome | An updated submission incorporating new clinical evidence, a new cost-effectiveness model and budget impact model was submitted by the applicant at the end of the NCPE assessment process, during the factual accuracy check of the NCPE’s final report. This submission will be considered following a re-commissioning of the full pharmacoeconomic assessment by the HSE. |
| Full pharmacoeconomic assessment re-commissioned by HSE | 18/01/2018 |
| NCPE assessment commenced | 19/01/2018 |
| Preliminary review sent to Applicant | 23/02/2018 |
| NCPE assessment re-commenced | 06/03/2018 |
| Factual accuracy sent to Applicant | 06/04/2018 |
| NCPE assessment re-commenced | 13/04/2018 |
| NCPE assessment completed | 03/05/2018 |
| NCPE assessment outcome | The NCPE recommends that osimertinib (Tagrisso®) 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 2020.
Osimertinib (Tagrisso®) for the first-line treatment of metastatic NSCLC
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Osimertinib |
| Brand | Tagrisso® |
| Indication | As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. |
| Assessment Process | |
| Rapid review commissioned | 19/07/2018 |
| Rapid review completed | 07/08/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of osimertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations compared with the current standard of care. |
| Full HTA commissioned by the HSE | 28/08/2018 |
| Pre-submission consultation with Applicant | 08/10/2018 |
| Full submission received from Applicant | 21/01/2019 |
| Preliminary review sent to Applicant | 13/05/2019 |
| NCPE assessment re-commenced | 28/05/2019 |
| Factual accuracy sent to Applicant | 19/07/2019 |
| NCPE assessment re-commenced | 30/07/2019 |
| NCPE assessment completed | 06/08/2019 |
| NCPE assessment outcome | The NCPE recommends that osimertinib 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; October 2020
Oxycodone/naloxone (Targin®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Oxycodone/naloxone |
| Brand | Targin® |
| Indication | For severe pain, which can be adequately managed only with opioid analgesics. |
| Assessment Process | |
| Full HTA commissioned by the HSE | 05/05/2010 |
| NCPE assessment completed | 12/07/2010 |
13/07/2010
We do not recommend reimbursement of oxycodone/naloxone (Targin®) under the Community Drugs Schemes at the proposed price.
19/10/2010
Following a price revision oxycodone/naloxone (Targin®) is now reimbursed under the Community Drugs Schemes.
Ozanimod (Zeposia®) for Ulcerative Colitis. HTA ID: 22002
| Assessment Status | Rapid Review Complete |
| HTA ID | 22002 |
| Drug | Ozanimod |
| Brand | Zeposia® |
| Indication | For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. |
| Assessment Process | |
| Rapid review commissioned | 10/01/2022 |
| Rapid review completed | 01/02/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ozanimod 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, December 2022.
Ozanimod (Zeposia®). HTA ID: 20045
| Assessment Status | Rapid Review Complete |
| HTA ID | 20045 |
| Drug | Ozanimod |
| Brand | Zeposia® |
| Indication | For the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. |
| Assessment Process | |
| Rapid review commissioned | 06/10/2020 |
| Rapid review completed | 23/11/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ozanimod 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 August 2021
Ozenoxacin (Dubine®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Ozenoxacin |
| Brand | Dubine® |
| Indication | For the short term treatment of non-bullous impetigo in adults, adolescents, children, and infants aged 6 months and older. |
| Assessment Process | |
| Rapid review commissioned | 12/11/2018 |
| Rapid review completed | 13/12/2018 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that ozenoxacin cream 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.
Palbociclib (Ibrance®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Palbociclib |
| Brand | Ibrance® |
| Indication | For the treatment of women with metastatic hormone receptor-positive, HER2-negative breast cancer. |
| Assessment Process | |
| Rapid review commissioned | 20/09/2016 |
| Rapid review completed | 28/09/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full HTA commissioned by the HSE | 10/10/2016 |
| Pre-submission consultation with Applicant | 11/11/2016 |
| Full submission received from Applicant | 20/12/2016 |
| Preliminary review sent to Applicant | 24/05/2017 |
| NCPE assessment re-commenced | 30/05/2017 |
| Follow-up to preliminary review sent to Applicant | 13/06/2017 |
| NCPE assessment re-commenced | 15/06/2017 |
| Additional follow-up to Preliminary Review sent to Applicant | 16/06/2017 |
| NCPE assessment re-commenced | 21/06/2017 |
| Factual accuracy sent to Applicant | 04/07/2017 |
| NCPE assessment completed | 28/07/2017 |
| NCPE assessment outcome | Reimbursement not recommended. |
The HSE has approved reimbursement following confidential price negotiations; June 2018.
Paliperidone palmitate (Xeplion®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Paliperidone palmitate |
| Brand | Xeplion® |
| Indication | For maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate, and a long acting injectable treatment is needed. |
| Assessment Process | |
| Rapid review commissioned | 23/03/2011 |
| Rapid review completed | 09/04/2011 |
Panobinostat (Farydak®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Panobinostat |
| Brand | Farydak® |
| Indication | In combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. |
| Assessment Process | |
| Rapid review commissioned | 26/01/2016 |
| Rapid review completed | 09/02/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
Not considered cost-effective due to non-submission of full pharmacoeonomic evaluation
Paritaprevir boosted with ritonavir and ombitasvir (Vierkirax®) with or without dasabuvir (Exviera®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Paritaprevir boosted with ritonavir and ombitasvir with or without dasabuvir |
| Brand | (Vierkirax®)/(Exviera®) |
| Indication | Exviera® is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (CHC) in adults. Exviera® must not be administered as monotherapy. Depending on the patient population The recommended co-administered medicinal products for exviera® combination therapy are viekirax® or viekirax® and ribavirin. Viekirax® is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (CHC) in adults viekirax® must not be administered as monotherapy. Depending on the patient population, the recommended co-administered medicinal products for viekirax® are exviera® or exviera® and ribavirin or ribavirin. |
| Assessment Process | |
| Rapid review commissioned | 21/12/2014 |
| Rapid review completed | 13/01/2015 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full HTA commissioned by the HSE | 15/01/2015 |
| NCPE assessment completed | 10/02/2016 |
| NCPE assessment outcome | Reimbursement recommended in certain sub-populations of patients with genotype 1 & 4 |
Pasireotide (Signifor®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Pasireotide |
| Brand | Signifor® |
| Indication | For the treatment of adult patients with Cushing’s Disease for whom surgery is not an option or for whom surgery has failed |
| Assessment Process | |
| Rapid review commissioned | 29/03/2012 |
| Rapid review completed | 10/04/2012 |
| 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.
Patisiran (Onpattro®)
| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Patisiran |
| Brand | Onpattro® |
| Indication | For the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. |
| Assessment Process | |
| Rapid review commissioned | 07/12/2018 |
| Rapid review completed | 03/01/2019 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 09/01/2019 |
| Pre-submission consultation with Applicant | 26/02/2019 |
| Full submission received from Applicant | 28/06/2019 |
| Preliminary review sent to Applicant | 18/10/2019 |
| NCPE assessment re-commenced | 15/11/2019 |
| Follow-up to preliminary review sent to Applicant | 22/11/2019 |
| NCPE assessment re-commenced | 06/12/2019 |
| Factual accuracy sent to applicant | 31/01/2020 |
| NCPE assessment re-commenced | 13/02/2020 |
| Factual Accuracy #2 sent to Applicant | 18/02/2020 |
| NCPE assessment re-commenced | 19/02/2020 |
| NCPE assessment completed | 20/02/2020 |
| NCPE assessment outcome | The NCPE recommends that patisiran (Onpattro®) is not 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 October 2021
Pegaspargase (Oncaspar®) powder for solution for injection/infusion. HTA ID: 20003
| Assessment Status | Rapid Review Complete |
| HTA ID | 20003 |
| Drug | Pegaspargase |
| Brand | Oncaspar® |
| Indication | As a component of antineoplastic combination therapy in acute lymphoblastic leukaemia in paediatric patients from birth to 18 years. |
| Assessment Process | |
| Rapid review commissioned | 05/02/2020 |
| Rapid review completed | 13/03/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that pegaspargase (Oncaspar®) be considered for reimbursement*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.
The HSE has approved reimbursement, March 2020
Pegvaliase (Palynziq®) HTA ID: 21057
For further details of previous submission see: Pegvaliase (Palynziq®) HTA ID: 20001
| Assessment Status | Assessment process complete |
| HTA ID | 21057 |
| Drug | Pegvaliase |
| Brand | Palynziq® |
| Indication | for the treatment of patients with phenylketonuria aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options. |
| Assessment Process | |
| Full submission received from Applicant | 18/11/2021 |
| Preliminary review sent to Applicant | 21/03/2022 |
| NCPE assessment re-commenced | 22/04/2022 |
| Follow-up to preliminary review sent to Applicant | 02/06/2022 |
| NCPE assessment re-commenced | 24/06/2022 |
| Factual accuracy sent to Applicant | 08/08/2022 |
| NCPE assessment re-commenced | 16/08/2022 |
| NCPE assessment completed | 29/09/2022 |
| NCPE assessment outcome | The NCPE recommends that pegvalisae (Palynziq®) 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.
Pegylated Interferon beta-1a (Plegridy®)
| 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 |
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: 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. |