| 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. |
Latest NCPE Advice
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.
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.
Nirmatrelvir/Ritonavir (Paxlovid®). HTA ID: 22014
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22014 |
| Drug | Nirmatrelvir/Ritonavir |
| Brand | Paxlovid® |
| Indication | Is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19. |
| Assessment Process | |
| Rapid review commissioned | 08/03/2022 |
| Rapid review completed | 15/03/2022 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Nirmatrelvir/Ritonavir (Paxlovid®) not be considered for reimbursement at the submitted price*. |
| Full pharmacoeconomic assessment commissioned by HSE | 05/05/2023 |
| Pre-submission consultation with Applicant | 08/09/2023 |
| Full submission received from Applicant | 01/02/2024 |
| Preliminary review sent to Applicant | 14/02/2024 |
| NCPE assessment re-commenced | 13/03/2024 |
| Factual accuracy sent to Applicant | 30/05/2024 |
| NCPE assessment re-commenced | 07/06/2024 |
| NCPE assessment completed | 20/06/2024 |
| NCPE assessment outcome | The NCPE recommends that Paxlovid be considered for reimbursement if cost-effectiveness can be improved* |
*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®) 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*. |
* 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®) 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.
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®) 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*. |
*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. |
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®) 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 (Pedippi®) 2mg/ml powder for oral suspension. HTA ID: 20049
| Assessment Status | Rapid Review Complete |
| HTA ID | 20049 |
| Drug | Omeprazole 2mg/ml powder for oral suspension |
| Brand | Pedippi® |
| Indication | For the management of Gastro-oesphageal reflux disease (GORD) and Peptic Ulcer Disease (PUD) in children and adult patients. Please refer to the SPC for the full range of licensed indications. The Applicant is seeking reimbursement for a subgroup of the licensed population: Children over 1 month of age for the treatment of reflux esophagitis and symptomatic treatment of heartburn and acid regurgitation in gastro oesophageal reflux disease (GORD); Children over 4 years of age and adolescents in combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori (H. pylori). |
| Assessment Process | |
| Rapid review commissioned | 23/11/2020 |
| Rapid review completed | 11/02/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that omeprazole (Pedippi®) not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.
The HSE has approved reimbursement following confidential price negotiations September 2021.
Onasemnogene abeparvovec (Zolgensma®). HTA ID: 20021
This HTA is being undertaken as part of the BENELUXA collaboration. It is a joint assessment between Ireland, Netherlands and Belgium with Austria acting as reviewer. Please see www.beneluxa.org for further information.
| Assessment Status | Assessment process complete |
| HTA ID | 20021 |
| Drug | Onasemnogene abeparvovec |
| Brand | Zolgensma® |
| Indication | For the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene. |
| Assessment Process | |
| Rapid review commissioned | 14/04/2020 |
| Rapid review completed | 13/05/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of onasemnogene abeparvovec (Zolgensma®) compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 27/05/2020 |
| Concept dossier received | 08/06/2020 |
| Response to Applicant | 29/06/2020 |
| Final Complete Dossier accepted | 02/11/2020 |
| First draft report complete** | 07/12/2020 |
| Final Report** | 02/04/2021 |
| NCPE assessment outcome | The NCPE recommends that Onasemnogene abeparvovec (Zolgensma®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.* |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.
Executive summary Zolgensma Beneluxa (Ireland)Final Version
**The Beneluxa process differs slightly from the process in Ireland where the Drug Committee received only the final report. In the Beneluxa process the respective committees in the Netherlands (WAR) and Belgium (CTG) receive draft versions of the report (2 drafts). Edits, if appropriate are made in this time and the report is finalised after the second round of reviewing.
The HSE has approved reimbursement following confidential price negotiations October 2021.
Opicapone (Ongentys®). HTA ID: 20055
| Assessment Status | Rapid Review Complete |
| HTA ID | 20055 |
| Drug | Opicapone |
| Brand | Ongentys® |
| Indication | As adjunctive therapy to levodopa and DOPA decarboxylase inhibitors (L-DOPA+DDCI) in adults with Parkinson’s disease and end-of-dose motor fluctuations in patients not stabilised on such combinations. |
| Assessment Process | |
| Rapid review commissioned | 14/12/2020 |
| Rapid review completed | 18/01/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends opicapone not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations January 2022.
Opium Tincture (Dropizol®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Opium Tincture |
| Brand | Dropizol® |
| Indication | For severe diarrhoea such as diarrhoea caused by cytostatic medication, radiation or neuroendocrine tumours when use of other anti-diarrhoea treatments have not given sufficient effect. |
| Assessment Process | |
| Rapid review commissioned | 04/03/2019 |
| Rapid review completed | 03/04/2019 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that opium tincture (Dropizol) not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Oritavancin (Tenkasi®). HTA ID: 21061
| Assessment Status | Rapid Review Complete |
| HTA ID | 21061 |
| Drug | Oritavancin |
| Brand | Tenkasi® |
| Indication | For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
| Assessment Process | |
| Rapid review commissioned | 07/12/2021 |
| Rapid review completed | 24/01/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of oritavancin compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
The HSE has approved reimbursement following confidential price negotiations June 2022.
Osilodrostat (Isturisa®). HTA ID: 22023
| Assessment Status | Rapid Review Complete |
| HTA ID | 22023 |
| Drug | Osilodrostat |
| Brand | Isturisa® |
| Indication | For the treatment of endogenous Cushing’s syndrome in adults. |
| Assessment Process | |
| Rapid review commissioned | 21/04/2022 |
| Rapid review completed | 17/05/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of osilodrostat compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Osimertinib (Tagrisso®)
| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Osimertinib |
| Brand | Tagrisso® |
| Indication | For the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor [EGFR] T790M mutation positive non-small cell lung cancer [NSCLC]. |
| Assessment Process | |
| Rapid review commissioned | 26/02/2016 |
| Rapid review completed | 22/03/2016 |
| Rapid review outcome | Reimbursement not recommended at this point in time |
| Updated clinical evidence submitted by the Applicant | 21/12/2016 |
| Rapid Review completed | 10/01/2017 |
| Rapid Review outcome | Full pharmacoeconomic assessment recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 30/01/2017 |
| Pre-submission consultation with Applicant | 20/03/2017 |
| Full submission received from Applicant | 02/06/2017 |
| Preliminary review sent to Applicant | 28/07/2017 |
| NCPE assessment re-commenced | 24/11/2017 |
| Factual accuracy sent to Applicant | 21/12/2017 |
| NCPE assessment re-commenced | 16/01/2018 |
| NCPE assessment completed | 16/01/2018 |
| NCPE assessment outcome | An updated submission incorporating new clinical evidence, a new cost-effectiveness model and budget impact model was submitted by the applicant at the end of the NCPE assessment process, during the factual accuracy check of the NCPE’s final report. This submission will be considered following a re-commissioning of the full pharmacoeconomic assessment by the HSE. |
| Full pharmacoeconomic assessment re-commissioned by HSE | 18/01/2018 |
| NCPE assessment commenced | 19/01/2018 |
| Preliminary review sent to Applicant | 23/02/2018 |
| NCPE assessment re-commenced | 06/03/2018 |
| Factual accuracy sent to Applicant | 06/04/2018 |
| NCPE assessment re-commenced | 13/04/2018 |
| NCPE assessment completed | 03/05/2018 |
| NCPE assessment outcome | The NCPE recommends that osimertinib (Tagrisso®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations; July 2020.
Osimertinib (Tagrisso®) for the first-line treatment of metastatic NSCLC
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Osimertinib |
| Brand | Tagrisso® |
| Indication | As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. |
| Assessment Process | |
| Rapid review commissioned | 19/07/2018 |
| Rapid review completed | 07/08/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of osimertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations compared with the current standard of care. |
| Full 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.
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 |
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. |
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 |
