Latest NCPE Advice

Nivolumab (Opdivo®) for muscle invasive urothelial carcinoma. HTA ID: 22046

Assessment Status NCPE Assessment Process Complete
HTA ID 22046
Drug Nivolumab
Brand Opdivo®
Indication Is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥1%, who are at high risk of recurrence after undergoing radical resection of MIUC.
Assessment Process
Rapid review commissioned 01/07/2022
Rapid review completed 08/08/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nivolumab for this indication compared with the current standard of care
Full pharmacoeconomic assessment commissioned by HSE 31/08/2022
Pre-submission consultation with Applicant 29/11/2022
Full submission received from Applicant 21/02/2023
Preliminary review sent to Applicant 02/10/2023
NCPE assessment re-commenced 01/11/2023
Factual accuracy sent to Applicant 21/12/2023
NCPE assessment re-commenced 12/01/2024
NCPE assessment completed 21/02/2024
NCPE assessment outcome The NCPE recommends that nivolumab (Opdivo®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

* This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Nivolumab in combination with ipilimumab (Opdivo® and Yervoy®) malignant pleural mesothelioma. HTA ID: 21018

Assessment Status NCPE Assessment Process Complete
HTA ID 21018
Drug Nivolumab in combination with ipilimumab
Brand Opdivo® plus Yervoy®
Indication Nivolumab in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
Assessment Process
Rapid review commissioned 27/04/2021
Rapid review completed 13/05/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nivolumab in combination with ipilimumab 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 31/05/2021
Pre-submission consultation with Applicant 20/07/2021
Full submission received from Applicant 21/01/2022
Preliminary review sent to Applicant 03/05/2022
NCPE assessment re-commenced 01/06/2022
Factual accuracy sent to Applicant 29/07/2022
NCPE assessment re-commenced 10/08/2022
NCPE assessment completed 07/09/2022
NCPE assessment outcome The NCPE recommends that nivolumab plus ipilimumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

*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.

Nivolumab+relatlimab (Opdualag® ). HTA ID: 24009

Assessment Status Rapid Review Complete
HTA ID 24009
Drug Nivolumab+relatlimab
Brand Opdualag®
Indication Nivolumab+relatlimab (Opdualag® ) is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%.
Assessment Process
Rapid review commissioned 05/03/2024
Rapid review completed 16/04/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nivolumab+relatlimab compared with the current standard of care.

Obeticholic acid (Ocaliva®)

Assessment Status Assessment process complete
HTA ID -
Drug Obeticholic acid
Brand Ocaliva®
Indication For the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Assessment Process
Rapid review commissioned 18/11/2016
Rapid review completed 21/12/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 17/01/2017
Pre-submission consultation with Applicant 27/02/2017
Full submission received from Applicant 02/06/2017
Preliminary review sent to Applicant 31/07/2017
NCPE assessment re-commenced 11/09/2017
Factual accuracy sent to Applicant 09/10/2017
NCPE assessment re-commenced 24/10/2017
NCPE assessment completed 31/10/2017
NCPE assessment outcome Reimbursement not recommended at the submitted price

Technical Summary

The HSE has approved reimbursement following confidential price negotiations – October 2022.

Obinutuzumab (Gazyvaro®) for Follicular Lymphoma

Assessment Status Assessment process complete
HTA ID -
Drug Obinutuzumab
Brand Gazyvaro®
Indication In combination with bendamustine followed by obinutuzumab maintenance for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Assessment Process
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 26/07/2016
NCPE assessment completed 25/01/2017
NCPE assessment outcome Reimbursement not recommended at the submitted price

Technical Summary

The HSE has approved reimbursement following confidential price negotiations October 2017.

Obinutuzumab (Gazyvaro®) for Lymphocytic Leukaemia

Assessment Status Assessment process complete
HTA ID -
Drug Obinutuzumab
Brand Gazyvaro®
Indication In combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia and with comorbidities making them unsuitable for full-dose fludarabine based therapy.
Assessment Process
Rapid review commissioned 08/08/2014
Rapid review completed 11/09/2014
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 30/09/2014
NCPE assessment completed 02/04/2015
NCPE assessment outcome Reimbursement not recommended.

Technical Summary

December 2015

The HSE has approved reimbursement following confidential price negotiations.

Obinutuzumab (Gazyvaro®) for previously untreated advanced follicular lymphoma

Assessment Status Assessment process complete
HTA ID -
Drug Obinutuzumab
Brand Gazyvaro®
Indication In combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma.
Assessment Process
Rapid review commissioned 08/08/2017
Rapid review completed 13/09/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 25/09/2017
Pre-submission consultation with Applicant 10/10/2017
Full submission received from Applicant 21/11/2017
Preliminary review sent to Applicant 26/02/2018
NCPE assessment re-commenced 08/03/2018
Factual accuracy sent to Applicant 27/03/2018
NCPE assessment re-commenced 13/04/2018
NCPE assessment completed 03/05/2018
NCPE assessment outcome The NCPE recommends that obinutuzumab (Gazyvaro®) in combination with chemotherapy followed by obinutuzumab maintenance therapy for this indication should 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.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations; May 2019

Ocrelizumab (Ocrevus®) for PPMS

Assessment Status Assessment process complete
HTA ID -
Drug Ocrelizumab
Brand Ocrevus®
Indication For the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.
Assessment Process
Rapid review commissioned 29/11/2017
Rapid review completed 14/12/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 17/01/2018
Pre-submission consultation with Applicant 20/02/2018
Full submission received from Applicant 27/03/2018
Preliminary review sent to Applicant 08/06/2018
NCPE assessment re-commenced 06/07/2018
Factual accuracy sent to Applicant 30/08/2018
NCPE assessment re-commenced 07/09/2018
NCPE assessment completed 04/10/2018
NCPE assessment outcome The NCPE recommends that ocrelizumab (Ocrevus®) 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.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations; October 2020

Ocrelizumab (Ocrevus®) for RMS

Assessment Status Assessment process complete
HTA ID -
Drug Ocrelizumab
Brand Ocrevus®
Indication For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
Assessment Process
Rapid review commissioned 29/11/2017
Rapid review completed 14/12/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 17/01/2018
Pre-submission consultation with Applicant 20/02/2018
Full submission received from Applicant 16/03/2018
Preliminary review sent to Applicant 25/07/2018
NCPE assessment re-commenced 13/08/2018
Factual accuracy sent to Applicant 13/08/2018
NCPE assessment re-commenced 16/08/2018
NCPE assessment completed 29/08/2018
NCPE assessment outcome The NCPE recommends that ocrelizumab (Ocrevus®) 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.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations for this indication only; October 2019.

Ocriplasmin (Jetrea®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Ocriplasmin
Brand Jetrea®
Indication For the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
Assessment Process
Rapid review commissioned 12/06/2013
Rapid review completed 09/07/2013
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Ofatumumab (Arzerra®) (Previously untreated Chronic Lymphocytic Leukaemia)

Assessment Status Rapid Review Complete
HTA ID -
Drug Ofatumumab
Brand Arzerra®
Indication In combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Assessment Process
Rapid review commissioned 13/10/2014
Rapid review completed 18/12/2014
Rapid review outcome Full Pharmacoeconomic Assessment Recommended at the submitted price.

The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven.

Ofatumumab (Arzerra®) (Refractory CLL)

Assessment Status Rapid Review Complete
HTA ID -
Drug Ofatumumab
Brand Arzerra®
Indication For the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab.
Assessment Process
Rapid review commissioned 01/06/2010
Rapid review completed 22/06/2010
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.

Ofatumumab (Kesimpta®). HTA ID: 21008

Assessment Status Assessment process complete
HTA ID 21008
Drug Ofatumumab
Brand Kesimpta®
Indication For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
Assessment Process
Rapid review commissioned 15/03/2021
Rapid review completed 16/04/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ofatumumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.

The HSE has approved reimbursement following confidential price negotiations January 2022.

Oladaterol (Striverdi®, Respimat®)

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

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 pharmacoeconomic assessment commissioned by 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.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations; December 2020

Olaparib (Lynparza®) adjuvant treatment of early breast cancer. HTA ID: 22065

Assessment Status NCPE Assessment Process Complete
HTA ID 22065
Drug Olaparib
Brand Lynparza®
Indication As monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
Assessment Process
Rapid review commissioned 26/10/2022
Rapid review completed 20/10/2022
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 pharmacoeconomic assessment commissioned by HSE 26/10/2022
Pre-submission consultation with Applicant 13/12/2022
Full submission received from Applicant 27/09/2023
Preliminary review sent to Applicant 09/05/2024
NCPE assessment re-commenced 06/06/2024
Follow-up to preliminary review sent to Applicant 05/07/2024
NCPE assessment re-commenced 11/07/2024
Factual accuracy sent to Applicant 20/08/2024
NCPE assessment re-commenced 27/08/2024
NCPE assessment completed 24/09/2024
NCPE assessment outcome The NCPE recommends that olaparib be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

*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®) 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 pharmacoeconomic assessment commissioned by HSE 17/08/2015
NCPE assessment completed 17/12/2015
NCPE assessment outcome Reimbursement not recommended.

Technical Summary

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 pharmacoeconomic assessment commissioned by 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.

Technical Summary

Plain English Summary

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.

Olaparib (Lynparza®). HTA ID: 24029

Assessment Status Rapid Review Complete
HTA ID 24029
Drug Olaparib
Brand Lynparza®
Indication Olaparib (Lynparza®) is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen
Assessment Process
Rapid review commissioned 17/07/2024
Rapid review completed 13/08/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of olaparib for this indication compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Olipudase alfa (Xenpozyme®). HTA ID: 23014

Assessment Status Rapid Review Complete
HTA ID 23014
Drug Olipudase alfa
Brand Xenpozyme®
Indication As an enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in paediatric and adult patients with type A/B or type B.
Assessment Process
Rapid review commissioned 08/03/2023
Rapid review completed 31/03/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of olipudase alfa compared with the current standard of care.

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 pharmacoeconomic assessment commissioned by 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.

Technical Summary

Omaveloxolone (Skyclarys®). HTA ID: 24033

Assessment Status Rapid Review 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.

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 pharmacoeconomic assessment commissioned by 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.

Technical Summary

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

Plain English Summary

**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.

Technical Summary

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 pharmacoeconomic assessment commissioned by 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.

Technical Summary

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 pharmacoeconomic assessment commissioned by HSE 05/05/2010
NCPE assessment completed 12/07/2010

Technical Summary

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 06/10/2022
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 pharmacoeconomic assessment commissioned by 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.

Technical Summary

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 pharmacoeconomic assessment commissioned by 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

Technical Summary

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.

Pasireotide LAR (Signifor® LAR). HTA ID: 22034

Assessment Status Rapid Review Complete
HTA ID 22034
Drug Pasireotide LAR
Brand Signifor® LAR
Indication For the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Assessment Process
Rapid review commissioned 13/05/2022
Rapid review completed 16/06/2022
Rapid review outcome for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue*.

 *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 – July 2022.

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.

Technical Summary

Plain English Summary

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

 

Pegcetacoplan (Aspaveli®). HTA ID: 21064

Assessment Status NCPE Assessment Process Complete
HTA ID 21064
Drug Pegcetacoplan
Brand Aspaveli®
Indication For the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least three months.
Assessment Process
Rapid review commissioned 13/12/2021
Rapid review completed 26/01/2022
Rapid review outcome Rapid Review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegcetacoplan 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 23/02/2022
Pre-submission consultation with Applicant 17/10/2022
Full submission received from Applicant 26/05/2023
Preliminary review sent to Applicant 05/12/2023
NCPE assessment re-commenced 16/01/2024
Follow-up to preliminary review sent to Applicant 02/02/2024
NCPE assessment re-commenced 09/02/2024
Factual accuracy sent to Applicant 08/03/2024
NCPE assessment re-commenced 19/03/2024
NCPE assessment completed 24/04/2024
NCPE assessment outcome The NCPE recommends that pegcetacoplan not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

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*.

Technical Summary

Plain English Summary

*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