Latest NCPE Advice

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*.

Technical Summary

Plain English Summary

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

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. *

Technical Summary

Plain English Summary

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

The HSE has approved reimbursement following confidential price negotiations 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

Technical Summary

The NCPE recommends reimbursement of Migalastat (Galafold®) subject to the continuing availability of a patient access scheme.

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*

Technical Summary

Plain English Summary

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

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.

Technical Summary

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

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*.

Technical Summary

Plain English Summary

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

The HSE has approved reimbursement following confidential price negotiations 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*.

Technical Summary

Plain English Summary

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

Nivolumab (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*.

Technical Summary

Plain English Summary

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

Nivolumab (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*.

Technical Summary

Plain English Summary

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

The HSE has approved reimbursement following confidential price negotiations April 2023.

Obeticholic acid (Ocaliva®)

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

Technical Summary

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

Obinutuzumab (Gazyvaro®) for Follicular Lymphoma

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

Technical Summary

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

Obinutuzumab (Gazyvaro®) for Lymphocytic Leukaemia

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

Technical Summary

December 2015

The HSE has approved reimbursement following confidential price negotiations.

Obinutuzumab (Gazyvaro®) for previously untreated advanced follicular lymphoma

Assessment Status Assessment process complete
HTA ID -
Drug Obinutuzumab
Brand Gazyvaro®
Indication In combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma.
Assessment Process
Rapid review commissioned 08/08/2017
Rapid review completed 13/09/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 25/09/2017
Pre-submission consultation with Applicant 10/10/2017
Full submission received from Applicant 21/11/2017
Preliminary review sent to Applicant 26/02/2018
NCPE assessment re-commenced 08/03/2018
Factual accuracy sent to Applicant 27/03/2018
NCPE assessment re-commenced 13/04/2018
NCPE assessment completed 03/05/2018
NCPE assessment outcome The NCPE recommends that obinutuzumab (Gazyvaro®) in combination with chemotherapy followed by obinutuzumab maintenance therapy for this indication should not be considered for reimbursement, unless cost-effectiveness can be improved relative to existing treatments*.

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

Technical Summary

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

Ocrelizumab (Ocrevus®) for PPMS

Assessment Status Assessment process complete
HTA ID -
Drug Ocrelizumab
Brand Ocrevus®
Indication For the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.
Assessment Process
Rapid review commissioned 29/11/2017
Rapid review completed 14/12/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 17/01/2018
Pre-submission consultation with Applicant 20/02/2018
Full submission received from Applicant 27/03/2018
Preliminary review sent to Applicant 08/06/2018
NCPE assessment re-commenced 06/07/2018
Factual accuracy sent to Applicant 30/08/2018
NCPE assessment re-commenced 07/09/2018
NCPE assessment completed 04/10/2018
NCPE assessment outcome The NCPE recommends that ocrelizumab (Ocrevus®) not be considered for reimbursement*.

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

Technical Summary

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

Ocrelizumab (Ocrevus®) for RMS

Assessment Status Assessment process complete
HTA ID -
Drug Ocrelizumab
Brand Ocrevus®
Indication For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
Assessment Process
Rapid review commissioned 29/11/2017
Rapid review completed 14/12/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 17/01/2018
Pre-submission consultation with Applicant 20/02/2018
Full submission received from Applicant 16/03/2018
Preliminary review sent to Applicant 25/07/2018
NCPE assessment re-commenced 13/08/2018
Factual accuracy sent to Applicant 13/08/2018
NCPE assessment re-commenced 16/08/2018
NCPE assessment completed 29/08/2018
NCPE assessment outcome The NCPE recommends that ocrelizumab (Ocrevus®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

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

Technical Summary

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

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.

Technical Summary

Plain English Summary

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.

Technical Summary

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

Olaparib (Lynparza®) for breast cancer

Assessment Status Rapid Review Complete
HTA ID -
Drug Olaparib
Brand Lynparza®
Indication For the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments.
Assessment Process
Rapid review commissioned 29/03/2019
Rapid review completed 10/04/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of olaparib compared with the current standard of care.

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

Olaparib (Lynparza®) for mCRPC. HTA ID: 21019

Assessment Status Rapid Review Complete
HTA ID 21019
Drug Olaparib
Brand Lynparza®
Indication As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
Assessment Process
Rapid review commissioned 11/05/2021
Rapid review completed 15/06/2021
Rapid review outcome A full HTA is not recommended. The NCPE recommends that olaparib not be considered for reimbursement at the submitted price*.

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

The HSE has approved reimbursement following confidential price negotiations March 2023.

Olaparib (Lynparza®) for platinum sensitive relapsed ovarian cancer

Assessment Status Assessment process complete
HTA ID -
Drug Olaparib
Brand Lynparza®
Indication As monotherapy for the maintenance treatment of adult patients with PSR high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Assessment Process
Rapid review commissioned 19/09/2018
Rapid review completed 01/10/2018
Rapid review outcome The NCPE recommend  a full HTA to assess the clinical effectiveness and cost effectiveness of olaparib compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 16/10/2018
Pre-submission consultation with Applicant 26/11/2018
Full submission received from Applicant 28/06/2019
Preliminary review sent to Applicant 30/09/2019
NCPE assessment re-commenced 25/10/2019
Factual accuracy sent to Applicant 02/12/2019
NCPE assessment re-commenced 12/12/2019
NCPE assessment completed 04/02/2020
NCPE assessment outcome The NCPE recommends that olaparib (Lynparza®), for this indication, not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

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

Technical Summary

Plain English Summary

Olaparib (Lynparza®) 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*.

Technical Summary

Plain English Summary

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

Olaparib (Lynparza®) 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.

Olipudase alfa (Xenpozyme®). HTA ID: 23014

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

Omalizumab (Xolair®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Omalizumab
Brand Xolair®
Indication As an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment. 
Assessment Process
Rapid review commissioned 25/03/2014
Rapid review completed 25/04/2014
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Omalizumab (Xolair®) for the treatment of severe allergic asthma

Assessment Status Assessment process complete
HTA ID -
Drug Omalizumab
Brand Xolair®
Indication As an add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1<80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 22/08/2014
NCPE assessment completed 25/06/2015
NCPE assessment outcome Reimbursement not recommended.

Following NCPE assessment of the company submission, omalizumab (Xolair ®) is not considered cost-effective for the treatment of severe allergic asthma and therefore is not recommended for reimbursement.

Technical Summary

Omega-3-acid ethyl esters (Omacor®)

Assessment Status Assessment process complete
HTA ID -
Drug Omega-3-acid ethyl esters
Brand Omacor®
Indication As an adjuvant treatment in secondary prevention after myocardial infarction in addition to other standard therapy.  Omacor® is also indicated for the treatment of endogenous hypertriglyceridaemia as a supplement to diet, when dietary measures alone are insufficient to produce an adequate response.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 11/02/2013
NCPE assessment completed 19/04/2013
NCPE assessment outcome Reimbursement not recommended.

The NCPE believe that Omacor® is not a cost-effective adjuvant treatment for patients post-myocardial infarction in the Irish Healthcare Setting.  The cost effectiveness of Omacor® for treatment of endogenous hypertriglyceridaemia as a supplement to diet has not been demonstrated.

Technical Summary

Omeprazole (Appizped®). HTA ID: 25038

Assessment Status Rapid Review Complete
HTA ID 25038
Drug Omeprazole
Brand Appizped®
Indication Omeprazole (Appizped®) is indicated for: Paediatric use (Children over 1 month of age) • Treatment of reflux oesophagitis • Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease; Children over 4 years of age and adolescents • In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori (H. pylori); Adults • Treatment of duodenal ulcers • Prevention of relapse of duodenal ulcers • Treatment of gastric ulcers • Prevention of relapse of gastric ulcers • In combination with appropriate antibiotics, H. pylori eradication in peptic ulcer disease • Treatment of NSAID-associated gastric and duodenal ulcers • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk • Treatment of reflux oesophagitis • Long-term management of patients with healed reflux esophagitis • Treatment of symptomatic gastro-oesophageal reflux disease (GORD)
Assessment Process
Rapid review commissioned 05/06/2025
Rapid review completed 30/06/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that omeprazole (Appizped®) not be considered for reimbursement at the submitted price.

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

Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Further information on this process may be found here.

Further information on the status of this recommendation may be found here.

 

Omeprazole (Pedippi®) 2mg/ml powder for oral suspension. HTA ID: 20049

Assessment Status Rapid Review Complete
HTA ID 20049
Drug Omeprazole 2mg/ml powder for oral suspension
Brand Pedippi®
Indication For the management of  Gastro-oesphageal reflux disease (GORD) and Peptic Ulcer Disease (PUD) in children and adult patients. Please refer to the SPC for the full range of licensed indications. The Applicant is seeking reimbursement for a subgroup of the licensed population: Children over 1 month of age for the treatment of  reflux esophagitis and symptomatic treatment of heartburn and acid regurgitation in gastro oesophageal reflux disease (GORD); Children over 4 years of age and adolescents in combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori (H. pylori). 
Assessment Process
Rapid review commissioned 23/11/2020
Rapid review completed 11/02/2021
Rapid review outcome A full HTA is not recommended. The NCPE recommends that omeprazole (Pedippi®) not be considered for reimbursement at the submitted price*.

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

The HSE has approved reimbursement following confidential price negotiations September 2021.

Onasemnogene abeparvovec (Zolgensma®). HTA ID: 20021

This HTA is being undertaken as part of the BENELUXA collaboration. It is a joint assessment between Ireland, Netherlands and Belgium with Austria acting as reviewer. Please see www.beneluxa.org for further information.

Assessment Status Assessment process complete
HTA ID 20021
Drug Onasemnogene abeparvovec
Brand Zolgensma®
Indication For the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene.
Assessment Process
Rapid review commissioned 14/04/2020
Rapid review completed 13/05/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of onasemnogene abeparvovec (Zolgensma®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 27/05/2020
Concept dossier received 08/06/2020
Response to Applicant 29/06/2020
Final Complete Dossier accepted 02/11/2020
First draft report complete** 07/12/2020
Final Report** 02/04/2021
NCPE assessment outcome The NCPE recommends that Onasemnogene abeparvovec (Zolgensma®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.*

 

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

Executive summary Zolgensma Beneluxa (Ireland)Final Version

Plain English Summary

**The Beneluxa process differs slightly from the process in Ireland where the Drug Committee received only the final report.  In the Beneluxa process the respective committees in the Netherlands (WAR) and Belgium (CTG) receive draft versions of the report (2 drafts).  Edits, if appropriate are made in this time and the report is finalised after the second round of reviewing.

The HSE has approved reimbursement following confidential price negotiations October 2021.

Opicapone (Ongentys®). HTA ID: 20055

Assessment Status Rapid Review Complete
HTA ID 20055
Drug Opicapone
Brand Ongentys®
Indication As adjunctive therapy to levodopa and DOPA decarboxylase inhibitors (L-DOPA+DDCI) in adults with Parkinson’s disease and end-of-dose motor fluctuations in patients not stabilised on such combinations.
Assessment Process
Rapid review commissioned 14/12/2020
Rapid review completed 18/01/2021
Rapid review outcome A full HTA is not recommended. The NCPE recommends opicapone not be considered for reimbursement at the submitted price*.

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

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

Opium Tincture (Dropizol®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Opium Tincture
Brand Dropizol®
Indication For severe diarrhoea such as diarrhoea caused by cytostatic medication, radiation or neuroendocrine tumours when use of other anti-diarrhoea treatments have not given sufficient effect.
Assessment Process
Rapid review commissioned 04/03/2019
Rapid review completed 03/04/2019
Rapid review outcome A full HTA is not recommended. The NCPE recommends that opium tincture (Dropizol) not be considered for reimbursement at the submitted price*.

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

Oritavancin (Tenkasi®). HTA ID: 21061

Assessment Status Rapid Review Complete
HTA ID 21061
Drug Oritavancin
Brand Tenkasi®
Indication For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Assessment Process
Rapid review commissioned 07/12/2021
Rapid review completed 24/01/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of oritavancin compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

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

Osilodrostat (Isturisa®). HTA ID: 22023

Assessment Status Rapid Review Complete
HTA ID 22023
Drug Osilodrostat
Brand Isturisa®
Indication For the treatment of endogenous Cushing’s syndrome in adults.
Assessment Process
Rapid review commissioned 21/04/2022
Rapid review completed 17/05/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of osilodrostat compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Osimertinib (Tagrisso®)

Assessment Status Assessment process complete
HTA ID –
Drug Osimertinib
Brand Tagrisso®
Indication For the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor [EGFR] T790M mutation positive non-small cell lung cancer [NSCLC].
Assessment Process
Rapid review commissioned 26/02/2016
Rapid review completed 22/03/2016
Rapid review outcome Reimbursement not recommended at this point in time
Updated clinical evidence submitted by the Applicant 21/12/2016
Rapid Review completed 10/01/2017
Rapid Review outcome Full pharmacoeconomic assessment recommended
Full pharmacoeconomic assessment commissioned by HSE 30/01/2017
Pre-submission consultation with Applicant 20/03/2017
Full submission received from Applicant 02/06/2017
Preliminary review sent to Applicant 28/07/2017
NCPE assessment re-commenced 24/11/2017
Factual accuracy sent to Applicant 21/12/2017
NCPE assessment re-commenced 16/01/2018
NCPE assessment completed 16/01/2018
NCPE assessment outcome An updated submission incorporating new clinical evidence, a new cost-effectiveness model and budget impact model was submitted by the applicant at the end of the NCPE assessment process, during the factual accuracy check of the NCPE’s final report. This submission will be considered following a re-commissioning of the full pharmacoeconomic assessment by the HSE.
Full pharmacoeconomic assessment re-commissioned by HSE 18/01/2018
NCPE assessment commenced 19/01/2018
Preliminary review sent to Applicant 23/02/2018
NCPE assessment re-commenced 06/03/2018
Factual accuracy sent to Applicant 06/04/2018
NCPE assessment re-commenced 13/04/2018
NCPE assessment completed 03/05/2018
NCPE assessment outcome The NCPE recommends that osimertinib (Tagrisso®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

 

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

Technical Summary

The HSE has approved reimbursement following confidential price negotiations; July 2020.