Pegvaliase (Palynziq®) HTA ID: 21057

For further details of previous submission see:  Pegvaliase (Palynziq®) HTA ID: 20001

Assessment Status Assessment process complete
HTA ID 21057
Drug Pegvaliase
Brand Palynziq®
Indication for the treatment of patients with phenylketonuria aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
Assessment Process
Full submission received from Applicant 18/11/2021
Preliminary review sent to Applicant 21/03/2022
NCPE assessment re-commenced 22/04/2022
Follow-up to preliminary review sent to Applicant 02/06/2022
NCPE assessment re-commenced 24/06/2022
Factual accuracy sent to Applicant 08/08/2022
NCPE assessment re-commenced 16/08/2022
NCPE assessment completed 29/09/2022
NCPE assessment outcome The NCPE recommends that pegvalisae (Palynziq®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

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

Pegylated Interferon beta-1a (Plegridy®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Pegylated Interferon beta-1a
Brand Plegridy®
Indication Treatment of adult patients with relapsing remitting multiple sclerosis
Assessment Process
Rapid review commissioned 25/11/2014
Rapid review completed 22/12/2014
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Pegylated Liposomal irinotecan (Onivyde). HTA ID: 24030

Assessment Status Rapid Review Complete
HTA ID 24030
Drug Pegylated Liposomal irinotecan
Brand Onivyde®
Indication Liposomal irinotecan in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Assessment Process
Rapid review commissioned 24/07/2024
Rapid review completed 22/08/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegylated liposomal irinotecan compared with the current standard of care.

Pegylated liposomal irinotecan (Onivyde®). HTA ID: 20028

Assessment Status Assessment process complete
HTA ID 20028
Drug Pegylated liposomal irinotecan
Brand Onivyde®
Indication For the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in adult patients who have progressed following gemcitabine based therapy.
Assessment Process
Rapid review commissioned 13/06/2017
Rapid review completed 13/07/2017
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.

Rapid review re-commissioned 15/06/2020
Rapid review completed 14/07/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegylated liposomal irinotecan compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 14/07/2020
Pre-submission consultation with Applicant 07/09/2020
Full submission received from Applicant 04/03/2021
Preliminary review sent to Applicant 02/09/2021
NCPE assessment re-commenced 04/10/2021
Factual accuracy sent to applicant 20/10/2021
NCPE assessment re-commenced 29/10/2021
NCPE assessment completed 12/11/2021
NCPE assessment outcome The NCPE recommends that peg-IRI + 5FU + LV 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

Pembrolizumab (Keytruda ®) for Urothelial Carcinoma 1L

ssessment Status Rapid Review Complete
HTA ID
Drug Pembrolizumab
Brand Keytruda®
Indication For the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
Assessment Process
Rapid review commissioned 06/12/2017
Rapid review completed 21/12/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Following an amendment of the product licence by the EMA, a new rapid review was commissioned by the HSE.
Rapid review commissioned 21/06/2018
Rapid review received 10/07/2018
Rapid review completed 27/07/2018
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

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

Pembrolizumab (Keytruda®) 1L NSCLC with chemotherapy

Assessment Status Assessment process complete
HTA ID -
Drug Pembrolizumab
Brand Keytruda®
Indication In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.
Assessment Process
Rapid review commissioned 14/08/2018
Rapid review completed 29/08/2018
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 pharmacoeconomic assessment commissioned by HSE 14/09/2018
Pre-submission consultation with Applicant 22/10/2018
Full submission received from Applicant 20/12/2018
Preliminary review sent to Applicant 14/06/2019
NCPE assessment re-commenced 10/07/2019
Factual accuracy sent to Applicant 31/07/2019
NCPE assessment re-commenced 09/08/2019
NCPE assessment completed 15/08/2019
NCPE assessment outcome The NCPE recommends that pembrolizumab (Keytruda®), prescribed in combination with platinum chemotherapy plus pemetrexed for the first line treatment of non-squamous NSCLC, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.*

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

Technical Summary

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

Pembrolizumab (Keytruda®) 1L squamous NSCLC with chemotherapy

Assessment Status Rapid Review Complete
HTA ID -
Drug Pembrolizumab
Brand Keytruda®
Indication In combination with carboplatin and either paclitaxel or nab-paclitaxel for the treatment of the first-line treatment of metastatic squamous non-small cell lung carcinoma.
Assessment Process
Rapid review commissioned 25/02/2019
Rapid review completed 25/03/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab in combination with carboplatin and either paclitaxel or nab-P 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 – February 2021.

Pembrolizumab (Keytruda®) adjuvant treatment of stage IIB or IIC melanoma. HTA ID: 22042

Assessment Status NCPE Assessment Process Complete
HTA ID 22042
Drug Pembrolizumab
Brand Keytruda®
Indication Is indicated for the adjuvant treatment of adults and adolescent (≥12 years) with stage IIB or IIC melanoma following complete resection.
Assessment Process
Rapid review commissioned 22/06/2022
Rapid review completed 14/07/2022
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 pharmacoeconomic assessment commissioned by HSE 27/07/2022
Pre-submission consultation with Applicant 15/11/2022
Full submission received from Applicant 27/07/2023
Preliminary review sent to Applicant 21/12/2023
NCPE assessment re-commenced 01/02/2024
Factual accuracy sent to Applicant 28/03/2024
NCPE assessment re-commenced 05/04/2024
NCPE assessment completed 14/05/2024
NCPE assessment outcome The NCPE recommends that pembrolizumab be considered for reimbursement, for this indication, 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.

Pembrolizumab (Keytruda®) as monotherapy for unresectable or metastatic gastric, small intestine, or biliary cancer (2L+).

Assessment Status Rapid Review Complete
HTA ID 23058
Drug Pembrolizumab
Brand Keytruda®
Indication Pembrolizumab as monotherapy for the treatment of mismatch repair deficient or microsatellite instability-high tumours in adults with unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
Assessment Process
Rapid review commissioned 20/09/2023
Rapid review completed 25/10/2023
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.

Pembrolizumab (Keytruda®) for adjuvant treatment of RCC. HTA ID: 22026

Assessment Status NCPE Assessment Process Complete
HTA ID 22026
Drug Pembrolizumab
Brand Keytruda®
Indication Is indicated as monotherapy for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Assessment Process
Rapid review commissioned 22/04/2022
Rapid review completed 01/06/2022
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 pharmacoeconomic assessment commissioned by HSE 01/07/2022
Pre-submission consultation with Applicant 06/09/2022
Full submission received from Applicant 23/03/2023
Preliminary review sent to Applicant 08/12/2023
NCPE assessment re-commenced 18/01/2024
Factual accuracy sent to Applicant 11/04/2024
NCPE assessment re-commenced 18/04/2024
NCPE assessment completed 29/04/2024
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*.

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®) for Classical Hodgkin Lymphoma

Assessment Status Rapid Review Complete
HTA ID -
Drug Pembrolizumab
Brand Keytruda®
Indication As monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
Assessment Process
Rapid review commissioned 06/12/2017
Rapid review completed 21/12/2017
Rapid review outcome Full pharmacoeconomic assessment recommended at the submitted price.

The HSE has approved reimbursement following confidential price negotiations – November 2018.

Pembrolizumab (Keytruda®) for colorectal cancer. HTA ID: 21002

Assessment Status NCPE Assessment Process Complete
HTA ID 21002
Drug Pembrolizumab
Brand Keytruda®
Indication Is indicated as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults.
Assessment Process
Rapid review commissioned 08/02/2021
Rapid review completed 03/03/2021
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 pharmacoeconomic assessment commissioned by HSE 24/03/2021
Pre-submission consultation with Applicant 21/04/2021
Full submission received from Applicant 21/01/2022
Preliminary review sent to Applicant 10/06/2022
NCPE assessment re-commenced 08/07/2022
Factual accuracy sent to Applicant 07/09/2022
NCPE assessment re-commenced 19/09/2022
NCPE assessment completed 13/10/2022
NCPE assessment outcome The NCPE recommends that pembrolizumab 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.

Pembrolizumab (Keytruda®) for persistent, recurrent or metastatic cervical cancer. HTA ID: 22041

Assessment Status Rapid Review Complete
HTA ID 22041
Drug Pembrolizumab
Brand Keytruda®
Indication Is indicated in combination with chemotherapy with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥1.
Assessment Process
Rapid review commissioned 16/06/2022
Rapid review completed 06/07/2022
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.

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

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 pharmacoeconomic assessment commissioned by 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 pharmacoeconomic assessment commissioned by 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.

Pemigatinib (Pemazyre®). HTA ID: 24026

Assessment Status Rapid Review Complete
HTA ID 24026
Drug Pemigatinib
Brand Pemazyre®
Indication Pemigatinib (Pemazyre®) is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Assessment Process
Rapid review commissioned 05/07/2024
Rapid review completed 16/07/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pemigatinib compared with the current standard-of-care, on the basis of the proposed price relative to currently available therapies.

Quizartinib (Vanflyta®). HTA ID: 24006

Assessment Status Rapid Review Complete
HTA ID 24006
Drug Quizartinib
Brand Vanflyta®
Indication Quizartinib is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia that is FLT3-ITD positive.
Assessment Process
Rapid review commissioned 09/02/2024
Rapid review completed 11/03/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of quizartinib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Ravulizumab (Ultomiris®). HTA ID: 19054

Assessment Status Assessment Process Complete
HTA ID 19054
Drug Ravulizumab
Brand Ultomiris®
Indication For the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH): in patients with haemolysis with clinical symptom(s) indicative of high disease activity and in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months.
Assessment Process
Rapid review commissioned 04/12/2019
Rapid review completed 02/03/2020
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, on the basis of the proposed price relative to currently available therapies.
Full pharmacoeconomic assessment commissioned by HSE 04/03/2020
Pre-submission consultation with Applicant 28/06/2021
Full submission received from Applicant 05/11/2021
Preliminary review sent to Applicant 28/02/2022
NCPE assessment re-commenced 25/03/2022
Factual accuracy sent to Applicant 29/04/2022
NCPE assessment re-commenced 10/05/2022
NCPE assessment completed 30/05/2022
NCPE assessment outcome The NCPE recommends that ravulizumab (Ultomiris®), for the treatment of adult patients with PNH, be considered for reimbursement provided certain conditions are met*. These are that the cost of ravulizumab should not exceed any eculizumab products currently available or anticipated to be available in the near future. A price premium over eculizumab is not justified given that both treatments appear to have similar efficacy. In addition, ravulizumab did not demonstrate an improvement in treatment-related burden compared with eculizumab in clinical trials.

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.

Ravulizumab (Ultomiris®). HTA ID: 20036

Assessment Status Assessment Process Complete
HTA ID 20036
Drug Ravulizumab
Brand Ultomiris®
Indication Indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve, or have received eculizumab for at least 3 months and have evidence of response to eculizumab.
Assessment Process
Rapid review commissioned 24/07/2020
Rapid review completed 21/08/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab (Ultomiris®) 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 27/08/2020
Pre-submission consultation with Applicant 28/06/2021
Full submission received from Applicant 05/11/2021
Preliminary review sent to Applicant 24/03/2022
NCPE assessment re-commenced 21/04/2022
Follow-up to preliminary review sent to Applicant 29/04/2022
NCPE assessment re-commenced 05/05/2022
Additional follow-up to Preliminary Review sent to Applicant 25/05/2022
NCPE assessment re-commenced 16/06/2022
Factual accuracy sent to Applicant 08/07/2022
NCPE assessment re-commenced 15/07/2022
NCPE assessment completed 28/07/2022
NCPE assessment outcome The NCPE recommends that ravulizumab not be considered for reimbursement unless cost effectiveness can be improved relative to comparator treatments*. This recommendation should consider the imminent introduction of eculizumab biosimilars.

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.

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

Assessment Status Rapid Review 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.

Rezafungin (Rezzayo®). HTA ID: 24007

Assessment Status Rapid Review Complete
HTA ID 24007
Drug Rezafungin
Brand Rezzayo®
Indication Rezafungin (Rezzayo®) is indicated for the treatment of invasive candidiasis in adults.
Assessment Process
Rapid review commissioned 22/03/2024
Rapid review completed 26/03/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that rezafungin 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.

Rimegepant (Vydura®). HTA ID: 22051

Assessment Status NCPE Assessment Process Complete
HTA ID 22051
Drug Rimegepant
Brand Vydura®
Indication For the acute treatment of migraine with or without aura in adults; and for the preventive treatment of episodic migraine in adults who have at least four migraine attacks per month.
Assessment Process
Rapid review commissioned 13/07/2022
Rapid review completed 12/09/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of rimegepant (Vydura®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 28/09/2022
Pre-submission consultation with Applicant 10/11/2022
Full submission received from Applicant 07/02/2023
Preliminary review sent to Applicant 27/03/2023
NCPE assessment re-commenced 18/04/2023
Factual accuracy sent to Applicant 03/05/2023
NCPE assessment re-commenced 10/05/2023
NCPE assessment completed 18/05/2023
NCPE assessment outcome The NCPE recommends that rimegepant (Vydura®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments and that a managed access programme is introduced*.

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.

Risankizumab (Skyrizi®) HTA ID: 24025

Assessment Status Rapid Review Complete
HTA ID 24025
Drug Risankizumab
Brand Skyrizi®
Indication For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional or biologic therapy. The Applicant is seeking reimbursement in a subgroup of the licensed population, as second-line treatment after failure of the first biologic therapy.
Assessment Process
Rapid review commissioned 02/07/2024
Rapid review completed 06/08/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that risankizumab not be considered for reimbursement at the submitted price.

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 pharmacoeconomic assessment commissioned by 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.

Sacituzumab govitecan (Trodelvy®). HTA ID: 23079

Assessment Status Rapid Review Complete
HTA ID 23079
Drug Sacituzumab govitecan
Brand Trodelvy®
Indication Sacituzumab govitecan is indicated for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.
Assessment Process
Rapid review commissioned 21/12/2023
Rapid review completed 26/01/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sacituzumab govitecan compared with the current standard of care.

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.

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

Assessment Status Rapid Review 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.

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 Rapid Review 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.

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 resubmission required 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.

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 pharmacoeconomic assessment commissioned by 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.

Tafasitamab (Minjuvi®) in combination with lenalidomide. HTA ID: 22008

Assessment Status Rapid Review Complete
HTA ID 22008
Drug Tafasitamab
Brand Minjuvi®
Indication In combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem-cell transplant (ASCT).
Assessment Process
Rapid review commissioned 14/02/2022
Rapid review completed 15/02/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tafasitamab in combination with lenalidomide compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

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 pharmacoeconomic assessment commissioned by 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.

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 pharmacoeconomic assessment commissioned by 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

Tebentafusp (Kimmtrak®). HTA ID: 23064

Assessment Status Rapid Review Complete
HTA ID 23064
Drug Tebentafusp
Brand Kimmtrak®
Indication Tebentafusp is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Assessment Process
Rapid review commissioned 10/10/2023
Rapid review completed 13/11/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tebentafusp compared with the current standard of care.

Teclistamab (Tecvayli®). HTA ID: 22064

Assessment Status NCPE Assessment Process Complete
HTA ID 22064
Drug Teclistamab
Brand Tecvayli®
Indication As monotherapy 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 20/09/2022
Rapid review completed 03/11/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of teclistamab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 29/11/2022
Pre-submission consultation with Applicant 24/01/2023
Full submission received from Applicant 18/05/2023
Preliminary review sent to Applicant 06/02/2024
NCPE assessment re-commenced 07/03/2024
Follow-up to preliminary review sent to Applicant 16/04/2024
NCPE assessment re-commenced 01/05/2024
Additional follow-up to Preliminary Review sent to Applicant 09/05/2024
NCPE assessment re-commenced 10/05/2024
Factual accuracy sent to Applicant 05/06/2024
NCPE assessment re-commenced 12/06/2024
NCPE assessment completed 04/07/2024
NCPE assessment outcome The NCPE recommends that teclistamab 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

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 pharmacoeconomic assessment commissioned by 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

Tenecteplase (Metalyse®): HTA ID 24046

Assessment Status Rapid Review Complete
HTA ID 24046
Drug Tenecteplase
Brand Metalyse®
Indication Tenecteplase (Metalyse®) is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.
Assessment Process
Rapid review commissioned 08/11/2024
Rapid review completed 27/11/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that tenecteplase 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.

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 pharmacoeconomic assessment commissioned by 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

Ticagrelor (Brilique®)

Assessment Status Assessment process complete
HTA ID -
Drug Ticagrelor
Brand Brilique®
Indication For the prevention of atherothrombotic events in adult patients with Acute Coronary Syndrome (ACS) including patients managed medically, and those who are managed with PCI (Percutaneous Coronary Intervention) or CABG (Coronary Artery Bypass Graft).
Assessment Process
Rapid review commissioned 25/11/2010
Rapid review completed 20/01/2011
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 27/07/2011
NCPE assessment completed 10/10/2011
NCPE assessment outcome Reimbursement Recommended

We consider Ticagrelor (Brilique®) a cost effective therapy for the prevention of atherothrombotic events in adult patients with ACS including patients managed medically and those managed with PCI or CABG.

Technical Summary

Ticagrelor (Brilique®) in combination with acetylsalicyclic acid

Assessment Status Rapid Review Complete
HTA ID -
Drug Ticagrelor
Brand Brilique®
Indication Co-administered with acetylsalicylic acid (ASA), for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.
Assessment Process
Rapid review commissioned 29/02/2016
Rapid review completed 04/05/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.

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

Tildrakizumab (Ilumetri®). HTA ID: 19029

Assessment Status Assessment process complete
HTA ID 19029
Drug Tildrakizumab
Brand Ilumetri®
Indication For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned 30/07/2019
Rapid review completed 28/08/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tildrakizumab 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 19/05/2020
Pre-submission consultation with Applicant 08/02/2021
Full submission received from Applicant 04/05/2021
Preliminary review sent to Applicant 20/07/2021
NCPE assessment re-commenced 23/08/2021
Factual accuracy sent to Applicant 15/10/2021
NCPE assessment re-commenced 03/11/2021
NCPE assessment completed 25/11/2021
NCPE assessment outcome The NCPE recommends that tildrakizumab (Ilumetri®), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy and who have failed treatment with non-biologic therapies and first-line biologic treatment with adalimumab, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.

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

Technical Summary

Plain English Summary

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