Pembrolizumab (Keytruda®) for Urothelial Carcinoma 2L

Assessment Status Assessment process complete
HTA ID -
Drug Pembrolizumab
Brand Keytruda®
Indication As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
Assessment Process
Rapid review commissioned 06/12/2017
Rapid review completed 21/12/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full HTA commissioned by the HSE 04/02/2018
Pre-submission consultation with Applicant 12/02/2018
Full submission received from Applicant 03/10/2018
Preliminary review sent to Applicant 05/12/2018
NCPE assessment re-commenced 18/01/2019
Factual accuracy sent to Applicant 06/03/2019
NCPE assessment re-commenced 20/03/2019
NCPE assessment completed 25/03/2019
NCPE assessment outcome The NCPE recommends that pembrolizumab (Keytruda®) be considered for reimbursement for this indication if cost-effectiveness can be improved relative to existing treatments*.

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

Technical Summary

The HSE has approved reimbursement following confidential price negotiations – February 2021.

Pembrolizumab (Keytruda®) in combination with lenvatinib (Lenvima®) for endometrial carcinoma. HTA ID: 22006

Assessment Status NCPE Assessment Process Complete
HTA ID 22006
Drug Pembrolizumab
Brand Keytruda®
Indication In combination with lenvatinib (Lenvima®) is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting, and who are not candidates for curative surgery or radiation.
Assessment Process
Rapid review commissioned 07/02/2022
Rapid review completed 04/03/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab in combination with lenvatinib compared with the current standard of care.
Full HTA commissioned by the HSE 01/04/2022
Pre-submission consultation with Applicant 09/05/2022
Full submission received from Applicant 21/02/2023
Preliminary review sent to Applicant 03/08/2023
NCPE assessment re-commenced 05/09/2023
Follow-up to preliminary review sent to Applicant 19/09/2023
NCPE assessment re-commenced 06/11/2023
Factual accuracy sent to Applicant 01/12/2023
NCPE assessment re-commenced 11/12/2023
NCPE assessment completed 18/12/2023
NCPE assessment outcome The NCPE recommends that pembrolizumab, in combination with lenvatinib, not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

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.

Pembrolizumab (Keytruda®). HTA ID: 23056

Assessment Status NCPE Assessment Process Complete
HTA ID 23056
Drug Pembrolizumab
Brand Keytruda®
Indication Pembrolizumab (Keytruda®) In combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1.
Assessment Process
Rapid review commissioned 07/09/2023
Rapid review completed 03/10/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care.
Full HTA commissioned by the HSE 01/11/2023
Pre-submission consultation with Applicant 05/12/2023
Full submission received from Applicant 02/05/2024
Preliminary review sent to Applicant 19/12/2024
NCPE assessment re-commenced 31/01/2025
Factual accuracy sent to Applicant 15/04/2025
NCPE assessment re-commenced 23/04/2025
NCPE assessment completed 12/05/2025
NCPE assessment outcome The NCPE recommends that Pembrolizumab (Keytruda®) not be considered for reimbursement, for this indication, unless cost-effectiveness can be improved relative to existing treatments*.

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

Pembrolizumab (Keytruda®). HTA ID: 23070

Assessment Status NCPE Assessment Process Complete
HTA ID 23070
Drug Pembrolizumab
Brand Keytruda®
Indication Pembrolizumab (Keytruda®) is indicated in combination with fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced, unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1
Assessment Process
Rapid review commissioned 21/11/2023
Rapid review completed 18/12/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care.
Full HTA commissioned by the HSE 09/01/2024
Pre-submission consultation with Applicant 30/01/2024
Full submission received from Applicant 01/08/2024
Preliminary review sent to Applicant 09/05/2025
NCPE assessment re-commenced 06/06/2025
Follow-up to preliminary review sent to Applicant 01/07/2025
NCPE assessment re-commenced 10/07/2025
Additional follow-up to Preliminary Review sent to Applicant 24/07/2025
NCPE assessment re-commenced 25/07/2025
Factual accuracy sent to Applicant 01/08/2025
NCPE assessment re-commenced 12/08/2025
NCPE assessment completed 25/08/2025
NCPE assessment outcome The NCPE recommends that pembrolizumab, in combination with fluoropyrimidine and platinum-containing chemotherapy, not be considered for reimbursement, for this indication unless cost effectiveness can be improved relative to existing treatments*.

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.

Pembrolizumab (Keytruda®). HTA ID: 23078

Assessment Status NCPE Assessment Process Complete
HTA ID 23078
Drug Pembrolizumab
Brand Keytruda®
Indication Pembrolizumab (Keytruda®) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy*.
Assessment Process
Rapid review commissioned 20/12/2023
Rapid review completed 24/01/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.
Full HTA commissioned by the HSE 02/02/2024
Pre-submission consultation with Applicant 27/08/2024
Full submission received from Applicant 27/02/2025
Preliminary review sent to Applicant 09/10/2025
NCPE assessment re-commenced 07/11/2025
Factual accuracy sent to Applicant 28/01/2026
NCPE assessment re-commenced 06/02/2026
NCPE assessment completed 19/02/2026
NCPE assessment outcome The NCPE recommends that pembrolizumab (Keytruda®) not be considered for reimbursement, for this indication, unless cost effectiveness can be improved relative to existing treatment.*

Technical Summary

Plain English Summary

*The Applicant is seeking reimbursement in a subgroup of the eligible population whose tumours express PD-L1 <50%.

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

Pembrolizumab (Keytruda®). HTA ID: 24013

Assessment Status NCPE Assessment Process Complete
HTA ID 24013
Drug Pembrolizumab
Brand Keytruda®
Indication Pembrolizumab, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung carcinoma (NSCLC) at high risk of recurrence in adults.
Assessment Process
Rapid review commissioned 22/04/2024
Rapid review completed 16/05/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment of resectable NSCLC, compared with the current standard of care.
Full HTA commissioned by the HSE 29/05/2024
Pre-submission consultation with Applicant 02/07/2024
Full submission received from Applicant 22/05/2025
Preliminary review sent to Applicant 23/10/2025
NCPE assessment re-commenced 28/11/2025
Factual accuracy sent to Applicant 30/01/2026
NCPE assessment re-commenced 10/02/2026
NCPE assessment completed 10/03/2026
NCPE assessment outcome The NCPE recommends that pembrolizumab, for the indication under assessment, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*

Summary

Plain English Summary

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

Pembrolizumab (Keytruda®). HTA ID: 24049

Assessment Status NCPE Assessment Process Complete
HTA ID 24049
Drug Pembrolizumab
Brand Keytruda®
Indication Pembrolizumab (Keytruda®) in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned 04/12/2024
Rapid review completed 10/01/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab for this indication compared with the current standard of care.
Full HTA commissioned by the HSE 29/01/2025
Pre-submission consultation with Applicant 24/02/2025
Full submission received from Applicant 13/11/2025
Preliminary review sent to Applicant 30/03/2026
NCPE assessment re-commenced 30/04/2026
Factual accuracy sent to Applicant 29/06/2026
NCPE assessment completed 24/07/2026
NCPE assessment outcome The NCPE recommends that pembrolizumab (Keytruda®) be considered for reimbursement, within its licensed indication in the pMMR subpopulation, if cost-effectiveness can be improved relative to existing treatments*. There is insufficient information available to reliably inform cost-effectiveness in the dMMR subpopulation.

Summary

Plain English Summary

*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.

Pembrolizumab (Keytruda®). HTA ID: 26026

Assessment Status Rapid Review Complete
HTA ID 26026
Drug Pembrolizumab
Brand Keytruda®
Indication Pembrolizumab (Keytruda®) in combination with paclitaxel, with or without bevacizumab, for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.
Assessment Process
Rapid review commissioned 21/05/2026
Rapid review completed 19/06/2026
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

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

Further information on this process may be found here

Further information on the status of this decision may be found here

 

Polihexanide (Akantior®). HTA ID: 25045

Assessment Status Rapid Review Complete
HTA ID 25045
Drug Polihexanide
Brand Akantior®
Indication Polihexanide (Akantior®) for the treatment of Acanthamoeba Keratitis in adults and children from 12 years of age.
Assessment Process
Rapid review commissioned 10/07/2025
Rapid review completed 14/08/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that polihexanide (Akantior®) not be considered for reimbursement at the submitted price*.

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

 

Further information on this process may be found here.

 

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

Ravulizumab (Ultomiris®). HTA ID: 25012

Assessment Status Rapid Review Complete
HTA ID 25012
Drug Ravulizumab
Brand Ultomiris®
Indication Ravulizumab (Ultomiris®) is indicated as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive.
Assessment Process
Rapid review commissioned 17/02/2025
Rapid review completed 12/03/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab compared with the current standard of care.

Relugolix with estradiol and norethisterone acetate (Ryeqo®). HTA ID: 24018

Assessment Status NCPE Assessment Process Complete
HTA ID 24018
Drug Relugolix with estradiol and norethisterone acetate
Brand Ryeqo®
Indication Relugolix with estradiol and norethisterone acetate (Ryeqo®) is Indicated in adult women of reproductive age for symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.
Assessment Process
Rapid review commissioned 28/05/2024
Rapid review completed 15/07/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of relugolix combination therapy compared with the current standard of care.
Full HTA commissioned by the HSE 31/07/2024
Pre-submission consultation with Applicant 18/02/2025
Full submission received from Applicant 15/07/2025
Preliminary review sent to Applicant 29/01/2026
NCPE assessment re-commenced 10/03/2026
Factual accuracy sent to Applicant 08/04/2026
NCPE assessment re-commenced 16/04/2026
NCPE assessment completed 28/04/2026
NCPE assessment outcome The NCPE recommends that relugolix CT (Ryeqo®) not be considered for reimbursement, for this indication, unless cost-effectiveness can be improved relative to existing treatment

Summary

Plain English Summary

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.

Ribociclib (Kisqali®). HTA ID: 24045

Assessment Status Rapid Review Complete
HTA ID 24045
Drug Ribociclib
Brand Kisqali®
Indication Ribociclib in combination with an aromatase inhibitor (AI) is indicated for the adjuvant treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence.
Assessment Process
Rapid review commissioned 13/11/2024
Rapid review appraisal commenced 22/11/2024
Rapid review completed 19/12/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that ribociclib 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. October 2025

Risdiplam (Evrysdi®). HTA ID: 25061

Assessment Status Rapid Review Complete
HTA ID 25061
Drug Risdiplam
Brand Evrysdi®
Indication Risdiplam is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. The Applicant is seeking reimbursement in a subpopulation of the licensed population as follows: • infants with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies from birth to two months of age.
Assessment Process
Rapid review commissioned 17/10/2025
Rapid review completed 24/11/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that risdiplam for the proposed subpopulation 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.

 

Risdiplam (Evrysdi®). HTA ID: 25062

Assessment Status Rapid Review Complete
HTA ID 25062
Drug Risdiplam
Brand Evrysdi®
Indication Risdiplam is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. The Applicant is seeking reimbursement in a subpopulation of the licensed population as follows: • Patients aged 18 years and older with a clinical diagnosis of SMA Type 2 or Type 3 or with one to four SMN2 copies, who have not previously been treated with a disease modifying therapy.
Assessment Process
Rapid review commissioned 17/10/2025
Rapid review completed 20/11/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that risdiplam for the proposed subpopulation 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.

 

Ritlecitinib (Litfulo®) HTA ID: 23071

Assessment Status NCPE Assessment Process Complete
HTA ID 23071
Drug Ritlecitinib
Brand Litfulo®
Indication For the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.
Assessment Process
Rapid review commissioned 27/11/2023
Rapid review appraisal commenced 11/12/2023
Rapid review completed 22/12/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ritlecitinib compared with the current standard of care.
Full HTA commissioned by the HSE 31/01/2024
Pre-submission consultation with Applicant 10/09/2024
Full submission received from Applicant 11/02/2025
Preliminary review sent to Applicant 12/08/2025
NCPE assessment re-commenced 10/09/2025
Factual accuracy sent to Applicant 24/10/2025
NCPE assessment re-commenced 03/11/2025
Follow up to factual accuracy check sent to Applicant 11/11/2025
NCPE assessment re-commenced 28/11/2025
NCPE assessment completed 02/12/2025
NCPE assessment outcome The NCPE recommends that ritlecitinib 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.

Ropeginterferon alfa-2b (Besremi®). HTA ID: 23004

Assessment Status NCPE Assessment Process Complete
HTA ID 23004
Drug Ropeginterferon alfa-2b
Brand Besremi®
Indication Ropeginterferon alfa-2b is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Assessment Process
Rapid review commissioned 20/01/2023
Rapid review completed 15/03/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ropeginterferon alfa-2b compared with the current standard of care.
Full HTA commissioned by the HSE 29/03/2023
Pre-submission consultation with Applicant 03/05/2023
Full submission received from Applicant 20/07/2023
Preliminary review sent to Applicant 27/11/2023
NCPE assessment re-commenced 03/01/2024
Factual accuracy sent to Applicant 26/06/2024
NCPE assessment re-commenced 15/07/2024
NCPE assessment completed 15/08/2024
NCPE assessment outcome The NCPE recommends that ropeginterferon alfa-2b (Besremi®) 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.

Rozanolixizumab (Rystiggo®). HTA ID: 26023

Assessment Status Rapid Review Complete
HTA ID 26023
Drug Rozanolixizumab
Brand Rystiggo®
Indication Rozanolixizumab (Rystiggo®) is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
Assessment Process
Rapid review commissioned 13/05/2026
Rapid review completed 28/05/2026
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of rozanolixizumab compared with the current standard of care.

Rucaparib (Rubraca®). HTA ID: 25011

Assessment Status Rapid Review Complete
HTA ID 25011
Drug Rucaparib
Brand Rubraca®
Indication Rucaparib (Rubraca®) is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) 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 17/02/2025
Rapid review completed 24/03/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that rucaparib 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.

Sacubitril/valsartan (Entresto®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Sacubitril/valsartan
Brand Entresto®
Indication For the treatment of symptomatic chronic heart failure with reduced ejection fraction if adult patients.
Assessment Process
Rapid review commissioned 06/11/2015
Rapid review completed 30/11/2015
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 07/03/2016
NCPE assessment completed 08/07/2016
NCPE assessment outcome Reimbursement Recommended

The NCPE considers valsartan/sacubitril (Entresto) cost-effective for the current licensed indication and recommends reimbursement.

Technical Summary

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

Selpercatinib (Retsevmo®) for advanced RET fusion-positive non-small cell lung cancer. HTA ID: 25035

Assessment Status Rapid Review Complete
HTA ID 25035
Drug Selpercatinib
Brand Retsevmo®
Indication Selpercatinib is indicated as monotherapy for the treatment of adult patients with advanced RET fusion-positive non-small cell lung cancer not previously treated with a RET inhibitor.
Assessment Process
Rapid review commissioned 22/08/2025
Rapid review completed 10/10/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that selpercatinib for this indication 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.

Selpercatinib (Retsevmo®) for advanced RET fusion-positive thyroid cancer. HTA ID: 25034b

Assessment Status Rapid Review Complete
HTA ID 25034b
Drug Selpercatinib
Brand Retsevmo®
Indication Selpercatinib (Retsevmo®) is indicated in adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Assessment Process
Rapid review commissioned 15/05/2025
Rapid review completed 01/07/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selpercatinib compared with the current standard of care.

Selpercatinib (Retsevmo®) for advanced RET-mutant medullary thyroid cancer. HTA ID: 25034a

Assessment Status Rapid Review Complete
HTA ID 25034a
Drug Selpercatinib
Brand Retsevmo®
Indication Selpercatinib (Retsevmo®) Is indicated in adults and adolescents 12 years and older with advanced rearranged during transfection (RET)-mutant medullary thyroid cancer.
Assessment Process
Rapid review commissioned 15/05/2025
Rapid review completed 01/07/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selpercatinib 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.

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.

Selumetinib (Koselugo®). HTA ID: 22032

Assessment Status NCPE assessment process complete
HTA ID 22032
Drug Selumetinib
Brand Koselugo®
Indication For the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above.
Assessment Process
Rapid review commissioned 10/05/2022
Rapid review completed 25/05/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selumetinib (Koselugo®) compared with the current standard-of-care.
Full HTA commissioned by the HSE 01/07/2022
Pre-submission consultation with Applicant 20/09/2022
Full submission received from Applicant 29/01/2024

*A full HTA submission was received on 09/01/2023 and withdrawn by the company on 23/06/2023.

Resubmission of HTA

Assessment Process NCPE assessment process complete
Full submission received from Applicant 29/01/2024
Preliminary review sent to Applicant 15/08/2024
NCPE assessment re-commenced 17/10/2024
Factual accuracy sent to Applicant 06/11/2024
NCPE assessment re-commenced 14/11/2024
NCPE assessment completed 13/12/2024
NCPE assessment outcome The NCPE recommends that selumetinib (Koselugo®) 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

Plain English Summary

Semaglutide (Ozempic®) 2mg. HTA ID: 25060

Assessment Status Rapid Review Complete
HTA ID 25060
Drug Semaglutide
Brand Ozempic®
Indication Semaglutide (Ozempic®) 2mg is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes.
Assessment Process
Rapid review commissioned 06/10/2025
Rapid review completed 23/10/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that semaglutide (Ozempic®) 2mg solution for injection 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

Semaglutide 2.4 mg (Wegovy®) in adolescent patients. HTA ID: 25025

Assessment Status Rapid Review Complete
HTA ID 25025
Drug Semaglutide
Brand Wegovy®
Indication Semaglutide 2.4 mg (Wegovy®) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with: ∙ obesity (Body Mass Index (BMI) ≥ 95th percentile as defined on sex and age-specific BMI growth charts) and ∙ body weight above 60 kg^
Assessment Process
Rapid review commissioned 21/03/2025
Rapid review completed 01/05/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that semaglutide not be considered for reimbursement at the submitted price*.

^ The applicant is seeking reimbursement in a subpopulation of the licensed adolescent population, specifically:

  • adolescent patients between the ages 12 and 17 years (inclusive) with a body weight above 60kg,
  • with a BMI > 99.6th percentile,
  • and two or more of the comorbidities as defined by Children’s Health Ireland (CHI) complex obesity referral form criteria.

 

*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.

Serplulimab (Hetronifly®). HTA ID: 25021

Assessment Status Rapid Review Complete
HTA ID 25021
Drug Serplulimab
Brand Hetronifly®
Indication Serplulimab (Hetronifly®) in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Assessment Process
Rapid review commissioned 10/03/2025
Rapid review completed 15/04/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that serplulimab 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.

 

 

Serplulimab (Hetronifly®). HTA ID: 26035

Assessment Status Rapid Review Complete
HTA ID 26035
Drug Serplulimab
Brand Hetronifly®
Indication Serplulimab (Hetronifly®) in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with non-squamous NSCLC with no EGFR, ALK or ROS1 positive mutations and who have locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC.
Assessment Process
Rapid review commissioned 10/07/2026
Rapid review completed 14/08/2026
Rapid review outcome A full HTA is not recommended. The NCPE recommends that serplulimab 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

Sodium thiosulfate (Pedmarqsi®). HTA ID: 25002

Assessment Status NCPE Assessment Process Complete
HTA ID 25002
Drug Sodium thiosulfate
Brand Pedmarqsi®
Indication Sodium thiosulfate (Pedmarqsi®) is indicated for the prevention of ototoxicity caused by cisplatin chemotherapy in patients one month to < 18 years of age with localised, non-metastatic, solid tumours.
Assessment Process
Rapid review commissioned 08/01/2025
Rapid review completed 06/02/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sodium thiosulfate (Pedmarqsi®) compared with the current standard of care.
Full HTA commissioned by the HSE 26/03/2025
Pre-submission consultation with Applicant 16/04/2025
Full submission received from Applicant 17/06/2025
Preliminary review sent to Applicant 23/10/2025
NCPE assessment re-commenced 21/11/2025
Factual accuracy sent to Applicant 15/12/2025
NCPE assessment re-commenced 22/12/2025
NCPE assessment completed 05/01/2026
NCPE assessment outcome The NCPE recommends that sodium thiosulfate not be considered for reimbursement unless cost effectiveness can be improved*.

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. 

Sodium Zirconium Cyclosilicate (Lokelma®). HTA ID: 24039

Assessment Status NCPE Assessment Process Complete
HTA ID 24039
Drug Sodium Zirconium Cyclosilicate
Brand Lokelma®
Indication Sodium Zirconium Cyclosilicate is indicated for the treatment of hyperkalaemia in adult patients.
Assessment Process
Rapid review commissioned 01/10/2024
Rapid review completed 06/11/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost-effectiveness of SZC for this indication compared with the current standard of care.
Full HTA commissioned by the HSE 27/11/2024
Pre-submission consultation with Applicant 05/03/2025
Full submission received from Applicant 04/09/2025
Preliminary review sent to Applicant 10/03/2026
NCPE assessment re-commenced 15/04/2026
Follow-up to preliminary review sent to Applicant 27/04/2026
NCPE assessment re-commenced 13/05/2026
Factual accuracy sent to Applicant 23/06/2026
NCPE assessment re-commenced 01/07/2026
NCPE assessment completed 21/07/2026
NCPE assessment outcome The NCPE recommends that SZC, for treatment of HK in patients with S-K levels ≥ 5.5 mmol/L who have advanced CKD (stage 3 to 5) and/or HF and are being treated with RAASi, not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.* The full licensed population is broader than the subpopulation used to inform the cost-effectiveness analysis.

Summary

Plain English Summary

 

*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.

Somapacitan (Sogroya®). HTA ID: 23060

Assessment Status Rapid Review Complete
HTA ID 23060
Drug Somapacitan
Brand Sogroya®
Indication Somapacitan (Sogroya®) is indicated for the replacement of endogenous growth hormone in children aged three years and above and adolescents with growth failure due to growth hormone deficiency (GHD), and in adults with GHD.
Assessment Process
Rapid review commissioned 25/09/2023
Rapid review completed 27/11/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that somapacitan 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.

Sotatercept (Winrevair ®). HTA ID: 24041

Assessment Status NCPE Assessment Process Complete
HTA ID 24041
Drug Sotatercept
Brand Winrevair ®
Indication Sotatercept, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class II to III, to improve exercise capacity.
Assessment Process
Rapid review commissioned 09/09/2024
Rapid review completed 24/10/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sotatercept compared with the current standard of care.
Full HTA commissioned by the HSE 29/11/2024
Pre-submission consultation with Applicant 28/01/2025
Full submission received from Applicant 15/05/2025
Preliminary review sent to Applicant 16/12/2025
NCPE assessment re-commenced 23/01/2026
Factual accuracy sent to Applicant 11/02/2026
NCPE assessment re-commenced 18/02/2026
NCPE assessment completed 03/03/2026
NCPE assessment outcome The NCPE recommends that sotatercept (when given in combination with other PAH therapies), for this indication, 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.

Sparsentan (Filspari®). HTA ID: 24020

Assessment Status NCPE Assessment Process Complete
HTA ID 24020
Drug Sparsentan
Brand Filspari®
Indication For the treatment of adults with primary immunoglobulin A (IgA) nephropathy with a urine protein excretion >1.0 g/day (or urine protein-to-creatine ratio ≥0.75 g/g).
Assessment Process
Rapid review commissioned 30/05/2024
Rapid review completed 26/06/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sparsentan compared with the current standard of care.
Full HTA commissioned by the HSE 31/07/2024
Pre-submission consultation with Applicant 01/10/2024
Full submission received from Applicant 12/12/2024
Preliminary review sent to Applicant 18/09/2025
NCPE assessment re-commenced 17/10/2025
Follow-up to preliminary review sent to Applicant 23/10/2025
NCPE assessment re-commenced 03/11/2025
Factual accuracy sent to Applicant 17/11/2025
NCPE assessment re-commenced 24/11/2025
NCPE assessment completed 26/11/2025
NCPE assessment outcome The NCPE recommends that sparsentan 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.

Subcutaneous pembrolizumab (Keytruda®). HTA ID 26004

Assessment Status Rapid Review Complete
HTA ID 26004
Drug Subcutaneous pembrolizumab
Brand Keytruda®
Indication Subcutaneous pembrolizumab (Keytruda®) for all previously approved adult indications where pembrolizumab is authorised for intravenous infusion.
Assessment Process
Rapid review commissioned 05/02/2026
Rapid review completed 21/04/2026
Rapid review outcome A full HTA is not recommended. The NCPE recommends that subcutaneous pembrolizumab 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

Sufentanil Citrate (Dzuveo®) HTA ID: 23062

Assessment Status Rapid Review Complete
Drug Sufentanil Citrate
Brand Dzuveo®
Indication For the management of acute moderate to severe pain in adult patients
Assessment Process
Rapid review commissioned 02/10/2023
Rapid review appraisal commenced 04/12/2023
Rapid review completed 22/12/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that sufentanil citrate 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.

Sulthiame (Ospolot®) oral suspension. HTA ID: 25030

Assessment Status Rapid Review Complete
HTA ID 25030
Drug Sulthaime
Brand Ospolot®
Indication Sulthiame (Ospolot®) oral suspension is indicated for the treatment of Self-Limited Epilepsy with Centrotemporal Spikes (SeLECTS) (former Rolandic epilepsy) in children and adolescents aged three years and above who are non-respondent/intolerant to other treatments or without other therapeutic alternatives.
Assessment Process
Rapid review commissioned 11/04/2025
Rapid review completed 27/05/2025
Rapid review outcome A full HTA is not recommended. The NCPE recommends that sulthiame (Ospolot®) oral suspension 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.

Tadalafil (Adcirca®)

Assessment Status Rapid Review Complete
HTA ID
Drug Tadalafil
Brand Adcirca®
Indication In adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organisation (WHO) Functional Class (FC) II and III, to improve exercise capacity.
Assessment Process
Rapid review commissioned 13/07/2011
Rapid review completed 21/09/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended
May 2014 In accordance with the Health Act (Pricing and Supply of Medical Goods) 2013 (section 18(4)), the HSE has requested the NCPE to re-examine the cost effectiveness of Tadalafil (Adcirca®).
Rapid review commissioned 09/05/2014
Rapid review completed 23/05/2014
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

 

Tafamidis (Vyndaqel®). HTA ID: 20017

Assessment Status Assessment process complete
HTA ID 20017
Drug Tafamidis
Brand Vyndaqel®
Indication For the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.
Assessment Process
Rapid review commissioned 30/03/2020
Rapid review completed 07/04/2020
Rapid review outcome A full HTA is recommended to assess the clinical and cost effectiveness of tafamidis compared with the current standard of care.
Full HTA commissioned by the HSE 29/04/2020
Pre-submission consultation with Applicant 18/05/2020
Full submission received from Applicant 01/07/2020
Preliminary review sent to Applicant 18/08/2020
NCPE assessment re-commenced 10/09/2020
Factual accuracy sent to Applicant 11/09/2020
NCPE assessment re-commenced 18/09/2020
NCPE assessment completed 25/09/2020
NCPE assessment outcome The NCPE recommends that tafamidis 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 March 2022.

Tafamidis meglumine (Vyndaqel®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tafamidis meglumine
Brand Vyndaqel®
Indication For the treatment of transthyretin amyloidosis in adult patients with stage I symptomatic polyneuropathy to delay peripheral neurologic impairment.
Assessment Process
Rapid review commissioned 12/03/2018
Rapid review completed 10/05/2018
Rapid review outcome A full pharmacoeconomic assessment is not recommended until additional efficacy and/or safety data is submitted. On the basis of current evidence, the NCPE recommends that tafamidis not be considered for reimbursement in accordance with the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Tafluprost (Saflutan®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tafluprost
Brand Saflutan®
Indication For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.
Assessment Process
Rapid review commissioned 25/03/2011
Rapid review completed 09/04/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended.

Talazoparib (Talzenna®) HTA ID: 19032

Assessment Status Assessment process complete
HTA ID 19032
Drug Talazoparib
Brand Talzenna®
Indication As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer.
Assessment Process
Rapid review commissioned 19/08/2019
Rapid review completed 03/09/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of talazoparib compared with the current standard of care.
Full HTA commissioned by the HSE 09/09/2019
Pre-submission consultation with Applicant 02/12/2019
Full submission received from Applicant 06/03/2020
Preliminary review sent to Applicant 24/04/2020
NCPE assessment re-commenced 05/06/2020
Factual accuracy sent to Applicant 14/08/2020
NCPE assessment re-commenced 21/08/2020
NCPE assessment completed 18/09/2020
NCPE assessment outcome The NCPE recommends that talazoparib (Talzenna®) 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 May 2021.

Talazoparib (Talzenna®) in combination with enzalutamide for mCRPC. HTA ID: 23074

Assessment Status Rapid Review Complete
HTA ID 23074
Drug Talazoparib
Brand Talzenna®
Indication Talazoparib (Talzenna®) in combination with enzalutamide is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
Assessment Process
Rapid review commissioned 07/12/2023
Rapid review completed 21/12/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that talazoparib in combination with enzalutamide 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.

Talimogene laherparepvec (Imlygic®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Talimogene laherparepvec
Brand Imlygic®
Indication For the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.
Assessment Process
Rapid review commissioned 16/02/2016
Rapid review completed 14/03/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.

Not considered cost-effective due to non-submission of full pharmacoeonomic assessment.

Talquetamab (Talvey®). HTA ID: 23057

Assessment Status NCPE Assessment Process Complete
HTA ID 23057
Drug Talquetamab
Brand Talvey®
Indication Talquetamab is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Assessment Process
Rapid review commissioned 20/09/2023
Rapid review completed 10/11/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of talquetamab compared with the current standard of care.
Full HTA commissioned by the HSE 29/11/2023
Pre-submission consultation with Applicant 23/01/2024
Full submission received from Applicant 02/05/2024
Preliminary review sent to Applicant 12/12/2024
NCPE assessment re-commenced 05/02/2025
Factual accuracy sent to Applicant 10/04/2025
NCPE assessment re-commenced 18/04/2025
NCPE assessment completed 26/05/2025
NCPE assessment outcome The NCPE recommends that talquetamab 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. November 2025

Tapentadol (Palexia®)

Assessment Status Assessment process complete
HTA ID -
Drug Tapentadol
Brand Palexia®
Indication For the management of adult patients with severe chronic/acute pain.
Assessment Process
Rapid review commissioned 19/10/2010
Rapid review completed 22/10/2020
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full HTA commissioned by the HSE 31/01/2011
NCPE assessment completed 08/04/2011
NCPE assessment outcome Reimbursement Recommended

Tapentadol (Palexia®) may be considered cost-effective but should be reserved for patients who cannot tolerate existing strong oral opioids.

Technical Summary

Tedizolid phosphate (Sivextro®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tedizolid phosphate
Brand Sivextro®
Indication For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults
Assessment Process
Rapid review commissioned 07/05/2015
Rapid review completed 07/07/2015
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Tegafur/Gimeracil/Oteracil (Teysuno®)

Assessment Status Rapid Review Complete
Drug Tegafur/Gimeracil/Oteracil
Brand Teysuno®
Indication For the treatment of advanced gastric cancer.
Assessment Process
Rapid review commissioned 27/02/2012
Rapid review completed 23/03/2012
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Telaprevir (Incivo®)

Assessment Status Assessment process complete
HTA ID -
Drug Telaprevir
Brand Incivo®
Indication As add-on therapy to pegylated interferon and ribavirin for the treatment of patients infected with Hepatitis C Genotype 1.
Assessment Process
Rapid review commissioned 28/10/2011
Rapid review completed 02/11/2011
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full HTA commissioned by the HSE 08/11/2011
NCPE assessment completed 19/01/2012
NCPE assessment outcome Reimbursement Recommended

We consider telaprevir (Incivo®) a highly cost-effective therapy when added to peginterferon-ribavirin for the treatment of patients infected with genotype 1 hepatitis C virus in the Irish healthcare setting.

Technical Summary

Telavancin (Vibativ®)

Assessment Status Rapid Review Complete
Drug Telavancin
Brand Vibativ®
Indication For the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumomia, known or suspended to be caused by methicillin-resistant Staphylococcus aureas (MRSA).  Vabitiv® should be used only in situations where it is known or suspected that other alternatives are not suitable.
Assessment Process
Rapid review completed 13/01/2015
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Teprotumumab (Tepezza®). HTA ID: 25057

Assessment Status Awaiting full HTA submission from Applicant
HTA ID 25057
Drug Teprotumumab
Brand Tepezza®
Indication Teprotumumab (Tepezza®) is indicated in adults for the treatment of moderate to severe thyroid eye disease.
Assessment Process
Rapid review commissioned 16/09/2025
Rapid review completed 15/10/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of teprotumumab compared with the current standard of care.
Full HTA commissioned by the HSE 29/10/2025
Pre-submission consultation with Applicant 11/12/2025

Teriflunomide (Aubagio®)

Assessment Status Assessment process complete
HTA ID -
Drug Teriflunomide
Brand Aubagio®
Indication For the first line treatment of adult patients with relapsing remitting multiple sclerosis (MS).
Assessment Process
Rapid review commissioned 27/08/2013
Rapid review completed 20/09/2013
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full HTA commissioned by the HSE 25/11/2013
NCPE assessment completed 19/06/2014
NCPE assessment outcome Reimbursement Not Recommended.

The NCPE does not recommend reimbursement of teriflunomide (Aubagio®) at the current price.

Technical Summary

The HSE has approved reimbursement following price negotiations-September 2014