| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Loteprednol |
| Brand | Lotemax 0.5% eye drops suspension |
| Indication | For treatment of post-operative inflammation following ocular surgery. |
| Assessment Process | |
| Rapid review commissioned | 15/11/2011 |
| Rapid review completed | 05/12/2011 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Latest NCPE Advice
Loxapine inhalation powder (Adasuve®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Loxapine inhalation powder |
| Brand | Adasuve® |
| Indication | For the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. |
| Assessment Process | |
| Rapid review commissioned | 21/06/2016 |
| Rapid review completed | 28/07/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
Not considered cost-effective due to non-submission of full pharmacoeonomic evaluation.
Lutetium (177Lu) Oxodotreotide (Lutathera®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Lutetium (177Lu) Oxodotreotide |
| Brand | Lutathera® |
| Indication | For the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor (SSTR) positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults. |
| Assessment Process | |
| Rapid review commissioned | 23/10/2018 |
| Rapid review completed | 16/11/2018 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 21/11/2018 |
| Pre-submission consultation with Applicant | 17/12/2018 |
| Full submission received from Applicant | 23/05/2019 |
| Preliminary review sent to Applicant | 04/10/2019 |
| NCPE assessment re-commenced | 01/11/2019 |
| Follow-up to preliminary review sent to Applicant | 22/11/2019 |
| NCPE assessment re-commenced | 02/12/2019 |
| Factual accuracy sent to Applicant | 10/01/2020 |
| NCPE assessment re-commenced | 20/01/2020 |
| NCPE assessment completed | 07/02/2020 |
| NCPE assessment outcome | The NCPE recommends that lutetium (177Lu) oxodotreotide (Lutathera®) 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.
The HSE has approved reimbursement following confidential price negotiations February 2021.
Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®). HTA ID: 23002
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23002 |
| Drug | Lutetium (177Lu) vipivotide tetraxetan |
| Brand | Pluvicto® |
| Indication | Lutetium (177Lu) vipivotide tetraxetan in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition for the treatment of adult patients with progressive prostate specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 09/01/2023 |
| Rapid review completed | 10/02/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 01/03/2023 |
| Pre-submission consultation with Applicant | 09/05/2023 |
| Full submission received from Applicant | 19/07/2023 |
| Preliminary review sent to Applicant | 06/02/2024 |
| NCPE assessment re-commenced | 05/03/2024 |
| Factual accuracy sent to Applicant | 11/07/2024 |
| NCPE assessment re-commenced | 19/07/2024 |
| NCPE assessment completed | 12/08/2024 |
| NCPE assessment outcome | The NCPE recommends that 177Lu vipivotide tetraxetan (Pluvicto®) 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
Macitentan plus tadalafil (Yuvanci®). HTA ID: 25009
| Assessment Status | Rapid Review Complete |
| HTA ID | 25009 |
| Drug | Macitentan plus tadalafil |
| Brand | Yuvanci® |
| Indication | Macitentan plus tadalafil (Yuvanci®) is indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets. |
| Assessment Process | |
| Rapid review commissioned | 10/02/2025 |
| Rapid review completed | 11/03/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that macitentan plus tadalafil (Yuvanci®) not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this decision may be found here.
Mavacamten (Camzyos®). HTA ID: 23028
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23028 |
| Drug | Mavacamten |
| Brand | Camzyos® |
| Indication | Mavacamten (Camzyos®) is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II–III), obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. |
| Assessment Process | |
| Rapid review commissioned | 19/05/2023 |
| Rapid review completed | 27/06/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of mavacamten compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 26/07/2023 |
| Pre-submission consultation with Applicant | 12/09/2023 |
| Full submission received from Applicant | 20/12/2023 |
| Preliminary review sent to Applicant | 16/07/2024 |
| NCPE assessment re-commenced | 14/08/2024 |
| Factual accuracy sent to Applicant | 12/12/2024 |
| NCPE assessment re-commenced | 19/12/2024 |
| NCPE assessment completed | 20/01/2025 |
| NCPE assessment outcome | The NCPE recommends that mavacamten 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.
Melatonin (Slenyto®). HTA ID: 22048
| Assessment Status | Rapid Review Complete |
| HTA ID | 22048 |
| Drug | Melatonin |
| Brand | Slenyto® |
| Indication | For the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome (SMS), where sleep hygiene measures have been insufficient. |
| Assessment Process | |
| Rapid review commissioned | 05/07/2022 |
| Rapid review completed | 09/08/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of prolonged release melatonin (Slenyto®) compared with the current standard of care. |
Melphalan flufenamide (Pepaxti®). HTA ID: 23067
| Assessment Status | Rapid Review Complete |
| HTA ID | 23067 |
| Drug | Melphalan flufenamide |
| Brand | Pepaxti® |
| Indication | Melphalan flufenamide (Pepaxti®) is indicated in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least three years from transplantation. |
| Assessment Process | |
| Rapid review commissioned | 09/11/2023 |
| Rapid review completed | 15/12/2023 |
| Rapid review outcome | A full HTA is not recommended. On the basis of current evidence, the NCPE recommends that melphalan flufenamide in combination with dexamethasone 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.
Melphalan flufenamide (Pepaxti®). HTA ID: 25028
| Assessment Status | Rapid Review Complete |
| HTA ID | 25028 |
| Drug | Melphalan flufenamide |
| Brand | Pepaxti® |
| Indication | Melphalan flufenamide in combination with dexamethasone, is indicated for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least three years from transplantation. |
| Assessment Process | |
| Rapid review commissioned | 01/04/2025 |
| Rapid review completed | 09/05/2025 |
| Rapid review outcome | A full HTA is not recommended until additional efficacy and/or safety data is submitted. On the basis of current evidence, the NCPE recommends that melflufen+dex 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.
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
Methyl aminolevulinate (Metvix®). HTA ID: 19049
| Assessment Status | Rapid Review Complete |
| HTA ID | 19049 |
| Drug | Methyl aminolevulinate |
| Brand | Metvix® |
| Indication | For the treatment of: thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp, when other therapies are considered less appropriate; superficial and/or nodular basal cell carcinoma unsuitable for other available therapies; and squamous cell carcinoma in situ (Bowen´s disease) when surgical excision is considered less appropriate. |
| Assessment Process | |
| Rapid review commissioned | 06/11/2019 |
| Rapid review completed | 18/12/2019 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that methyl aminolevulinate (Metvix®) 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.
Midostaurin (Rydapt®) for AML
| Assessment Status | Assessment Process Complete |
| HTA ID | - |
| Drug | Midostaurin |
| Brand | Rydapt® |
| Indication | Is indicated in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive. |
| Assessment Process | |
| Rapid review commissioned | 13/08/2018 |
| Rapid review completed | 10/09/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of midostaurin compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 19/09/2018 |
| Pre-submission consultation with Applicant | 15/10/2018 |
| Full submission received from Applicant | 20/12/2018 |
| Preliminary review sent to Applicant | 25/06/2019 |
| NCPE assessment re-commenced | 12/08/2019 |
| Factual accuracy sent to Applicant | 24/10/2019 |
| NCPE assessment re-commenced | 11/11/2019 |
| NCPE assessment completed | 04/12/2019 |
| NCPE assessment outcome | The NCPE recommends midostaurin (Rydapt®) for AML 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 2021
Migalastat (Galafold®)
| Assessment Status | Assessment Process Complete |
| HTA ID | - |
| Drug | Migalastat |
| Brand | Galafold® |
| Indication | For the long term treatment of adult and adolescent patients 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. |
| Assessment Process | |
| Rapid review commissioned | 14/07/2016 |
| Rapid review completed | 18/08/2016 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full submission received from Applicant | 03/01/2017 |
| NCPE assessment completed | 01/06/2017 |
| NCPE assessment outcome | Reimbursement Recommended |
The NCPE recommends reimbursement of Migalastat (Galafold®) subject to the continuing availability of a patient access scheme.
Mirikizumab (Omvoh®). HTA ID: 23040
| Assessment Status | Rapid Review Complete |
| HTA ID | 23040 |
| Drug | Mirikizumab |
| Brand | Omvoh® |
| Indication | Mirikizumab (Omvoh®) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. |
| Assessment Process | |
| Rapid review commissioned | 19/07/2023 |
| Rapid review completed | 24/08/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that mirikizumab 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.
Molnupiravir (Lagevrio®). HTA ID: 21060
| Assessment Status | Rapid Review Complete |
| HTA ID | 21060 |
| Drug | Molnupiravir |
| Brand | Lagevrio® |
| Indication | For the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. |
| Assessment Process | |
| Rapid review commissioned | 30/11/2021 |
| Rapid review completed | 24/12/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of molnupiravir compared with the current standard of care on the basis of the proposed price. |
Mometasone furoate plus olopatadine (Ryaltris®). HTA ID: 21051
| Assessment Status | Rapid Review Complete |
| HTA ID | 21051 |
| Drug | Mometasone furoate plus olopatadine |
| Brand | Ryaltris® |
| Indication | Is indicated for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis in adults and adolescents aged 12 years and older. |
| Assessment Process | |
| Rapid review commissioned | 15/11/2021 |
| Rapid review completed | 22/12/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that mometasone furoate plus olopatadine (Ryaltris®) 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 May 2022.
Mosunetuzumab (Lunsumio®). HTA ID: 23023
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23023 |
| Drug | Mosunetuzumab |
| Brand | Lunsumio® |
| Indication | Mosunetuzumab (Lunsumio®) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies. |
| Assessment Process | |
| Rapid review commissioned | 27/04/2023 |
| Rapid review completed | 25/05/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of mosunetuzumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 31/05/2023 |
| Pre-submission consultation with Applicant | 04/07/2023 |
| Full submission received from Applicant | 22/02/2024 |
| Preliminary review sent to Applicant | 22/10/2024 |
| NCPE assessment re-commenced | 18/11/2024 |
| Follow-up to preliminary review sent to Applicant | 11/12/2024 |
| NCPE assessment re-commenced | 18/12/2024 |
| Factual accuracy sent to Applicant | 20/02/2025 |
| NCPE assessment re-commenced | 25/02/2025 |
| Follow up to factual accuracy check sent to Applicant | 28/02/2025 |
| NCPE assessment re-commenced | 03/03/2025 |
| NCPE assessment completed | 24/03/2025 |
| NCPE assessment outcome | The NCPE recommends that mosunetuzumab 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.
Naloxone (Nyxoid®) intranasal spray. HTA ID: 20019
| Assessment Status | Rapid Review Complete |
| HTA ID | 20019 |
| Drug | Naloxone |
| Brand | Nyxoid® |
| Indication | Intranasal spray is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings. Nyxoid® is indicated in adults and adolescents aged 14 years and over. Nyxoid® is not a substitute for emergency medical care. |
| Assessment Process | |
| Rapid review commissioned | 14/04/2020 |
| Rapid review completed | 12/05/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that naloxone (Nyxoid®) intranasal spray 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 2021.
Naltrexone / bupropion (Mysimba®)
| Assessment Status | Assessment Process Complete |
| HTA ID | - |
| Drug | Naltrexone / bupropion |
| Brand | Mysimba® |
| Indication | Is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥ 18 years) with a BMI of ≥30 kg/m2 (obese) or ≥27 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities. |
| Assessment Process | |
| Rapid review commissioned | 12/03/2017 |
| Rapid review completed | 28/03/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 29/03/2017 |
| Pre-submission consultation with Applicant | 29/05/2017 |
| Full submission received from Applicant | 06/11/2017 |
| Preliminary review sent to Applicant | 05/01/2018 |
| NCPE assessment re-commenced | 01/02/2018 |
| Factual accuracy sent to Applicant | 24/04/2018 |
| NCPE assessment re-commenced | 01/05/2018 |
| NCPE assessment completed | 09/05/2018 |
| NCPE assessment outcome | The NCPE recommends that naltrexone/bupropion (Mysimba ®) should 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.
Neratinib (Nerlynx®). HTA ID: 19057
| Assessment Status | Assessment Process Complete |
| HTA ID | 19057 |
| Drug | Neratinib |
| Brand | Nerlynx® |
| Indication | For the extended adjuvant treatment of adults with early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago. |
| Assessment Process | |
| Rapid review commissioned | 18/12/2019 |
| Rapid review completed | 30/01/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of neratinib compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 05/02/2020 |
| Pre-submission consultation with Applicant | 21/04/2020 |
| Full submission received from Applicant | 04/08/2020 |
| Preliminary review sent to Applicant | 17/12/2020 |
| NCPE assessment re-commenced | 26/01/2021 |
| Factual accuracy sent to Applicant | 16/04/2021 |
| NCPE assessment re-commenced | 22/04/2021 |
| NCPE assessment completed | 12/05/2021 |
| NCPE assessment outcome | The NCPE recommends that neratinib (Nerlynx®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations March 2022.
Nintedanib (Ofev®). HTA ID: 20034
| Assessment Status | Assessment Process Complete |
| HTA ID | 20034 |
| Drug | Nintedanib |
| Brand | Ofev® |
| Indication | For the treatment of other progressive, chronic fibrosing interstitial lung diseases (PF-ILD) in adults. |
| Assessment Process | |
| Rapid review commissioned | 17/07/2020 |
| Rapid review completed | 28/08/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nintedanib compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 01/09/2020 |
| Pre-submission consultation with Applicant | 05/10/2020 |
| Full submission received from Applicant | 10/11/2020 |
| Preliminary review sent to Applicant | 16/03/2021 |
| NCPE assessment re-commenced | 15/04/2021 |
| Follow-up to preliminary review sent to Applicant | 21/04/2021 |
| NCPE assessment re-commenced | 30/04/2021 |
| Factual accuracy sent to Applicant | 28/05/2021 |
| NCPE assessment re-commenced | 04/06/2021 |
| NCPE assessment completed | 24/06/2021 |
| NCPE assessment outcome | The NCPE recommends that nintedanib (Ofev®) 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.
Nivolumab (Opdivo®) for advanced or metastatic gastric, gastro oesophageal junction or oesophageal adenocarcinoma (1L). HTA ID: 21049
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21049 |
| Drug | Nivolumab |
| Brand | Opdivo® |
| Indication | Nivolumab is indicated in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first line treatment of adult patients with HER2 negative advanced or metastatic gastric, gastro oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥5. |
| Assessment Process | |
| Rapid review commissioned | 01/11/2021 |
| Rapid review completed | 29/11/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nivolumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 07/12/2021 |
| Pre-submission consultation with Applicant | 01/02/2022 |
| Full submission received from Applicant | 10/10/2022 |
| Preliminary review sent to Applicant | 27/03/2023 |
| NCPE assessment re-commenced | 03/05/2023 |
| Factual accuracy sent to Applicant | 16/06/2023 |
| NCPE assessment re-commenced | 30/06/2023 |
| NCPE assessment completed | 11/07/2023 |
| NCPE assessment outcome | The NCPE recommends that nivolumab (Opdivo®) in combination with chemotherapy 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.
Nivolumab (Opdivo®) subcutaneous. HTA ID: 25036
| Assessment Status | Rapid Review Complete |
| HTA ID | 25036 |
| Drug | Nivolumab (Opdivo®) |
| Brand | Opdivo® |
| Indication | Nivolumab (Opdivo®) for subcutaneous (SC) use co-formulated with recombinant human hyaluronidase (rHuPH20), is indicated across multiple previously approved adult solid tumours as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy®) combination therapy, or in combination with chemotherapy or cabozantinib. |
| Assessment Process | |
| Rapid review commissioned | 19/05/2025 |
| Rapid review completed | 18/06/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that nivolumab (Opdivo®) SC 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
Nivolumab (Opdivo®) with Ipilimumab (Yervoy®). HTA ID 25003
| Assessment Status | Rapid Review Complete |
| HTA ID | 25003 |
| Drug | Nivolumab with Ipilimumab |
| Brand | Opdivo® with Yervoy® |
| Indication | Nivolumab (Opdivo®) with Ipilimumab (Yervoy®) is indicated for the first-line treatment of adult patients with unresectable or metastatic mismatch repair deficient or microsatellite instability-high colorectal cancer. |
| Assessment Process | |
| Rapid review commissioned | 08/01/2025 |
| Rapid review completed | 14/02/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Nivo+Ipi 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.
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*. |
*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.
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 |
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 |
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. |
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.
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.
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.
The HSE has approved reimbursement following confidential price negotiations for this indication only; October 2019.
Ocrelizumab subcutaneous (Ocrevus SC®). HTA ID: 25015
| Assessment Status | Rapid Review Complete |
| HTA ID | 25015 |
| Drug | Ocrelizumab |
| Brand | Ocrevus SC® |
| Indication | Ocrelizumab SC is indicated • For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. • 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 | 18/02/2025 |
| Rapid review completed | 20/03/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that ocrelizumab SC not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
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.
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.
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 pharmacoeconomic assessment commissioned by 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 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.
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 pharmacoeconomic assessment commissioned by 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.
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.
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.
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.