Latest NCPE Advice | National Centre for Pharmacoeconomics

Abemaciclib (Verzenios®). HTA ID: 22020

Assessment Status	NCPE Assessment Process complete
HTA ID	22020
Drug	Abemaciclib
Brand	Verzenios®
Indication	in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence.
Assessment Process
Rapid review commissioned	11/04/2022
Rapid review completed	06/05/2022
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of abemaciclib compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	26/05/2022
Pre-submission consultation with Applicant	26/07/2022
Full submission received from Applicant	28/03/2023
Preliminary review sent to Applicant	06/04/2023
NCPE assessment re-commenced	10/05/2023
Follow-up to preliminary review sent to Applicant	21/06/2023
NCPE assessment re-commenced	29/06/2023
Factual accuracy sent to Applicant	18/08/2023
NCPE assessment re-commenced	25/08/2023
NCPE assessment completed	19/09/2023
NCPE assessment outcome	The NCPE recommends that abemaciclib (Verzenios®) 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

Andexanet alfa (Ondexxya®). HTA ID: 20014

Assessment Status	NCPE Assessment Process Complete
HTA ID	20014
Drug	Andexanet alfa
Brand	Ondexxya®
Indication	For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Assessment Process
Rapid review commissioned	12/03/2020
Rapid review completed	23/04/2020
Rapid review outcome	A full HTA is required to assess the clinical effectiveness and cost-effectiveness of andexanet alfa compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	29/04/2020
Pre-submission consultation with Applicant	26/01/2021
Full submission received from Applicant	26/10/2021
Preliminary review sent to Applicant	13/12/2021
NCPE assessment re-commenced	31/01/2022
Factual accuracy sent to Applicant	27/04/2022
NCPE assessment re-commenced	04/05/2022
NCPE assessment completed	27/05/2022
NCPE assessment outcome	The NCPE recommends that andexanet alfa (Ondexxya®) 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 April 2023.

Apalutamide (Erleada®). HTA ID: 20010

Assessment Status	NCPE Assessment Process Complete
HTA ID	20010
Drug	Apalutamide
Brand	Erleada®
Indication	For the treatment of metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy.
Assessment Process
Rapid review commissioned	26/02/2020
Rapid review completed	23/03/2020
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of apalutamide for this indication compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	24/03/2020
Pre-submission consultation with Applicant	15/06/2020
Full submission received from Applicant	20/04/2021
Preliminary review sent to Applicant	01/11/2021
NCPE assessment re-commenced	26/11/2021
Factual accuracy sent to Applicant	09/02/2022
NCPE assessment re-commenced	17/02/2022
NCPE assessment completed	03/03/2022
NCPE assessment outcome	The NCPE recommends that apalutamide (Erleada®) in combination with androgen deprivation therapy 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 March 2023.

Atezolizumab (Tecentriq®) for adjuvant treatment of NSCLC. HTA ID: 22036

Assessment Status	NCPE Assessment Process Complete
HTA ID	22036
Drug	Atezolizumab
Brand	Tecentriq®
Indication	As an adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells and who do not have EGFR mutant or ALK-positive NSCLC.
Assessment Process
Rapid review commissioned	18/05/2022
Rapid review completed	02/06/2022
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of atezolizumab compared with the current standard-of-care.
Full pharmacoeconomic assessment commissioned by HSE	01/07/2022
Pre-submission consultation with Applicant	04/10/2022
Full submission received from Applicant	02/12/2022
Preliminary review sent to Applicant	05/05/2023
NCPE assessment re-commenced	02/06/2023
Factual accuracy sent to Applicant	06/07/2023
NCPE assessment re-commenced	12/07/2023
NCPE assessment completed	20/07/2023
NCPE assessment outcome	The NCPE recommends that atezolizumab (Tecentriq ®) should 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.

Atezolizumab (Tecentriq®) for triple-negative breast cancer.

Assessment Status	NCPE Assessment Process Complete
HTA ID	-
Drug	Atezolizumab
Brand	Tecentriq®
Indication	In combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Assessment Process
Rapid review commissioned	03/07/2019
Rapid review completed	19/07/2019
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of atezolizumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	30/07/2019
Pre-submission consultation with Applicant	07/10/2019
Full submission received from Applicant	13/01/2020
Preliminary review sent to Applicant	05/05/2020
NCPE assessment re-commenced	29/05/2020
Factual accuracy sent to Applicant	06/08/2020
NCPE assessment re-commenced	14/08/2020
NCPE assessment completed	01/09/2020
NCPE assessment outcome	The NCPE recommends that atezolizumab (Tecentriq®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

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

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

Atezolizumab (Tecentriq®) in combination with bevacizumab. HTA ID: 20060

Assessment Status	NCPE Assessment Process Complete
HTA ID	20060
Drug	Atezolizumab in combination with bevacizumab
Brand	Tecentriq®
Indication	For the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have not received prior systemic therapy.
Assessment Process
Rapid review commissioned	21/12/2020
Rapid review completed	08/02/2021
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of atezolizumab in combination with bevacizumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	24/02/2021
Pre-submission consultation with Applicant	22/11/2021
Full submission received from Applicant	26/07/2022
Preliminary review sent to Applicant	24/11/2022
NCPE assessment re-commenced	22/12/2022
Factual accuracy sent to Applicant	08/03/2023
NCPE assessment re-commenced	15/03/2023
NCPE assessment completed	08/05/2023
NCPE assessment outcome	The NCPE recommends that atezolizumab (Tecentriq ®) in combination with bevacizumab 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.

Atogepant (Aquipta®) for prophylaxis of episodic migraine. HTA ID: 23059

Assessment Status	Rapid Review Complete
HTA ID	23059
Drug	Atogepant
Brand	Aquipta®
Indication	Atogepant is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month.
Assessment Process
Rapid review commissioned	20/09/2023
Rapid review completed	26/10/2023
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of atogepant on the basis of the proposed price relative to currently available therapies.

Atogepant (Aquipta®). HTA ID: 23039

Assessment Status	Rapid Review Complete
HTA ID	23039
Drug	Atogepant
Brand	Aquipta®
Indication	Prophylaxis of migraine in adults who have at least 4 migraine days per month
Assessment Process
Rapid review commissioned	10/07/2023
Rapid review completed	21/08/2023
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of atogepant for this indication 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.

Avacopan (Tavneos®). HTA ID: 22009

Assessment Status	NCPE Assessment Process Complete
HTA ID	22009
Drug	Avacopan
Brand	Tavneos®
Indication	In combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis or microscopic polyangiitis.
Assessment Process
Rapid review commissioned	14/02/2022
Rapid review completed	08/03/2022
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of avacopan (Tavneos®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	01/04/2022
Pre-submission consultation with Applicant	21/06/2022
Full submission received from Applicant	19/10/2022
Preliminary review sent to Applicant	24/02/2023
NCPE assessment re-commenced	28/04/2023
Factual accuracy sent to Applicant	03/07/2023
NCPE assessment re-commenced	11/07/2023
NCPE assessment completed	20/07/2023
NCPE assessment outcome	The NCPE recommends that avacopan 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.

Avelumab (Bavencio®)

Assessment Status	NCPE Assessment Process Complete
HTA ID	-
Drug	Avelumab
Brand	Bavencio®
Indication	For the treatment of adults with metastatic Merkel Cell Carcinoma.
Assessment Process
Rapid review commissioned	17/10/2017
Rapid review completed	21/11/2017
Rapid review outcome	Full Pharmacoeconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE	22/11/2017
Pre-submission consultation with Applicant	11/12/2017
Full submission received from Applicant	16/03/2018
Preliminary review sent to Applicant	12/07/2018
NCPE assessment re-commenced	10/08/2018
Factual accuracy sent to Applicant	06/09/2018
NCPE assessment re-commenced	20/09/2018
NCPE assessment completed	08/10/2018
NCPE assessment outcome	The NCPE recommends that avelumab (Bavencio®) for the treatment of metastatic Merkel Cell Carcinoma not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.

Technical Summary

The HSE has approved reimbursement “approval is restricted to second line” following confidential price negotiations May 2019.

Avelumab (Bavencio®). HTA ID: 19046

Assessment Status	NCPE Assessment Process Complete
HTA ID	19046
Drug	Avelumab
Brand	Bavencio®
Indication	Avelumab in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma.
Assessment Process
Rapid review commissioned	29/10/2019
Rapid review completed	02/01/2020
Rapid review outcome	Avelumab in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma.
Full pharmacoeconomic assessment commissioned by HSE	07/01/2020
Pre-submission consultation with Applicant	18/02/2020
Full submission received from Applicant	31/07/2020
Preliminary review sent to Applicant	02/02/2021
NCPE assessment re-commenced	09/03/2021
Follow-up to preliminary review sent to Applicant	24/03/2021
NCPE assessment re-commenced	14/04/2021
Factual accuracy sent to Applicant	28/05/2021
NCPE assessment re-commenced	04/06/2021
NCPE assessment completed	23/06/2021
NCPE assessment outcome	The NCPE recommends that avelumab in combination with axitinib 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 Medicinal Goods) Act 2013

Avelumab (Bavencio®). HTA ID: 21001

Assessment Status	NCPE Assessment Process Complete
HTA ID	21001
Drug	Avelumab
Brand	Bavencio®
Indication	As monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed with first line platinum-based induction chemotherapy.
Assessment Process
Rapid review commissioned	25/01/2021
Rapid review completed	03/03/2021
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of avelumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	24/03/2021
Pre-submission consultation with Applicant	20/04/2021
Full submission received from Applicant	10/06/2021
Preliminary review sent to Applicant	28/09/2021
NCPE assessment re-commenced	22/10/2021
Factual accuracy sent to Applicant	29/11/2021
NCPE assessment re-commenced	06/12/2021
NCPE assessment completed	22/12/2021
NCPE assessment outcome	The NCPE recommends that avelumab (Bavencio®), for first-line maintenance treatment of adult patients with bladder cancer who are disease free following platinum-based chemotherapy, not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

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

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

Axicabtagene Ciloleucel (Yescarta®)

Assessment Status	NCPE Assessment Process Complete
HTA ID	-
Drug	Axicabtagene Ciloleucel
Brand	Yescarta®
Indication	For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
Assessment Process
Rapid review commissioned	10/09/2018
Rapid review completed	18/10/2018
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of axi-cel compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	22/10/2018
Pre-submission consultation with Applicant	03/12/2018
Full submission received from Applicant	20/03/2019
Preliminary review sent to Applicant	15/10/2019
NCPE assessment re-commenced	13/11/2019
Follow-up to preliminary review sent to Applicant	13/12/2019
NCPE assessment re-commenced	20/12/2019
Factual accuracy sent to Applicant	04/02/2020
NCPE assessment re-commenced	11/02/2020
NCPE assessment completed	21/02/2020
NCPE assessment outcome	The NCPE recommend that axicabtagene ciloleucel (Yescarta®) 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 April 2022.

Baricitinib (Olumiant®) for atopic dermatitis. HTA ID: 21050

Assessment Status	Rapid Review complete
HTA ID	21050
Drug	Baricitinib
Brand	Olumiant®
Indication	Treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned	09/11/2021
Rapid review completed	16/12/2021
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that baricitinib 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.

Baricitinib (Olumiant®) for moderate to severe atopic dermatitis. HTA ID: 20056

Assessment Status	Rapid Review complete
HTA ID	20056
Drug	Baricitinib
Brand	Olumiant®
Indication	Treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned	14/12/2020
Rapid review completed	28/01/2021
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that baricitinib 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.

Bazedoxifene (Conbriza®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Bazedoxifene
Brand	Conbriza®
Indication	Treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of verterbral fractures has been demonstrated; efficacy on hip fractures has not been established.
Assessment Process
Rapid review commissioned	20/09/2011
Rapid review completed	02/11/2011
Rapid review outcome	Full Pharmacoeconomic Evaluation not Recommended.

Beclometasone /formoterol (Fostair®) for COPD. HTA ID 23037

Assessment Status	Rapid Review Complete
HTA ID	23037
Drug	Beclometasone /formoterol
Brand	Fostair®
Indication	Beclometasone / formoterol (Fostair®) for COPD. HTA ID 23037 Symptomatic treatment of patients with severe chronic obstructive pulmonary disease [COPD] (forced expiratory volume [FEV1] <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Assessment Process
Rapid review commissioned	10/07/2023
Rapid review completed	20/07/2023
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that Fostair® for this indication 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.

Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide (Trimbow®). HTA ID: 23033

Assessment Status	Rapid Review Complete
HTA ID	23033
Drug	Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide
Brand	Trimbow®
Indication	Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide (Trimbow®) is indicated for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disorder (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) or a combination of a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA).
Assessment Process
Rapid review commissioned	21/06/2023
Rapid review completed	19/07/2023
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that Trimbow® for this indication 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.

Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide (Trimbow®). HTA ID: 23034

Assessment Status	Rapid Review Complete
HTA ID	23034
Drug	Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide
Brand	Trimbow®
Indication	Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide (Trimbow®) for the maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a medium or high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year
Assessment Process
Rapid review commissioned	21/06/2023
Rapid review completed	19/07/2023
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that Trimbow® for this indication 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.

Beclometasone/formoterol (Fostair®) for asthma. HTA ID: 23038

Assessment Status	Rapid Review Complete
HTA ID	23038
Drug	Beclometasone/formoterol
Brand	Fostair®
Indication	Beclometasone/formoterol (Fostair®) is indicated for the regular treatment of asthma where use of a combination product (inhaled corticosteroid [ICS] and long-acting beta2-agonist [LABA]) is appropriate: -in patients not adequately controlled with ICS and 'as needed' inhaled rapid-acting beta2-agonist; or -in patients already adequately controlled on both ICS and LABA.
Assessment Process
Rapid review commissioned	10/07/2023
Rapid review completed	20/07/2023
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that Fostair® for this indication 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.

Bedaquiline (Sirturo®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Bedaquiline
Brand	Sirturo®
Indication	For use as part of an appropriate combination regimen for pulmonary MDR‑TB in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Assessment Process
Rapid review commissioned	23/01/2015
Rapid review completed	20/02/2015
Rapid review outcome	Full Pharmacoeconomic Evaluation Not Recommended

Full HTA not required. The NCPE however recommend that if reimbursed that use of bedaquiline be subject to certain conditions.

Belatacept (Nulojix®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Belatacept
Brand	Nulojix®
Indication	In combination with corticosteroids and a mycophenolic acid (MPA), for prophylaxis of graft rejection in adults receiving a renal transplant. It is recommended to add an interleukin (IL)-2 receptor antagonist for induction therapy to this belatacept-based regimen.
Assessment Process
Rapid review commissioned	15/11/2011
Rapid review completed	23/01/2012
Rapid review outcome	Full Pharmacoeconomic Evaluation Recommended

Belimumab (Benlysta®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Belimumab
Brand	Benlysta®
Indication	As add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.
Assessment Process
Rapid review commissioned	11/08/2011
Rapid review completed	31/08/2011
Rapid review outcome	Full Pharmacoeconomic Evaluation Recommended

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

Belimumab (Benlysta®) for lupus nephritis. HTA ID: 23021

Assessment Status	Rapid Review Complete
HTA ID	23021
Drug	Belimumab
Brand	Benlysta®
Indication	Belimumab is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.
Assessment Process
Rapid review commissioned	24/04/2023
Rapid review completed	16/05/2023
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of belimumab 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.

Belimumab (Benlysta®) for systemic lupus erythematosus. HTA ID: 23022

Assessment Status	Rapid Review Complete
HTA ID	23022
Drug	Belimumab
Brand	Benlysta®
Indication	Belimumab is indicated as add-on therapy in patients aged five years and older with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.
Assessment Process
Rapid review commissioned	24/04/2023
Rapid review completed	29/05/2023
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of belimumab 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.

Bempedoic acid (Nilemdo®). HTA ID: 20026a

Assessment Status	NCPE Assessment process complete
HTA ID	20026a
Drug	Bempedoic acid
Brand	Nilemdo®
Indication	In adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet: In combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, OR Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated
Assessment Process
Rapid review commissioned	15/06/2020
Rapid review completed	03/07/2020
Rapid review outcome	A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of bempedoic acid compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	06/07/2020
Pre-submission consultation with Applicant	22/09/2020
Full submission received from Applicant	30/04/2021
Preliminary review sent to Applicant	22/06/2021
NCPE assessment re-commenced	19/07/2021
Factual accuracy sent to Applicant	28/07/2021
NCPE assessment re-commenced	11/11/2021
NCPE assessment completed	16/11/2021
NCPE assessment outcome	The NCPE recommends that bempedoic acid (Nilemdo®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments and that a managed access programme is introduced*.

*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

Bempedoic acid/Ezetimibe (Nustendi®). HTA ID: 20026b

Assessment Status	NCPE Assessment Process Complete
HTA ID	20026b
Drug	Bempedoic acid/Ezetimibe
Brand	Nustendi®
Indication	In adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet (a) in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe (b) alone in patients who are either statin – intolerant or for whom a statin is contraindicated and are unable to reach LDL-C goals with ezetimibe alone and (c) in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without a statin.
Assessment Process
Rapid review commissioned	15/06/2020
Rapid review completed	03/07/2020
Rapid review outcome	A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of of bempedoic acid + ezetimibe (Nustendi®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	06/07/2020
Pre-submission consultation with Applicant	22/09/2020
Full submission received from Applicant	30/04/2021
Preliminary review sent to Applicant	22/06/2021
NCPE assessment re-commenced	19/07/2021
Factual accuracy sent to Applicant	28/07/2021
NCPE assessment re-commenced	11/11/2021
NCPE assessment completed	16/11/2021
NCPE assessment outcome	The NCPE recommends that bempedoic acid + ezetimibe (Nustendi®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments and that a managed access programme is introduced*.

*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

Benralizumab (Fasenra®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Benralizumab
Brand	Fasenra®
Indication	As add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
Assessment Process
Rapid review commissioned	15/01/2018
Rapid review completed	14/02/2018
Rapid review outcome	Full Pharmacoeconomic Evaluation Recommended at the Submitted Price

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

Benralizumab (Fasenra®) Autoinjector. HTA ID: 20018

Assessment Status	Rapid Review complete
HTA ID	20018
Drug	Benralizumab
Brand	Fasenra®
Indication	As an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
Assessment Process
Rapid review commissioned	31/03/2020
Rapid review completed	28/04/2020
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that benralizumab not be considered for reimbursement under high tech drug arrangements 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 2021

Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Bictegravir/emtricitabine/tenofovir alafenamide
Brand	Biktarvy®
Indication	Treatment of adults infected with HIV-1 without any known mutations associated with resistance to the individual components.
Assessment Process
Rapid review commissioned	30/04/2018
Rapid review completed	07/06/2018
Rapid review outcome	Full pharmacoeconomic assessment not recommended. The NCPE recommends that Biktarvy® not be considered for reimbursement at the submitted price in accordance with the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.

The HSE has approved reimbursement following confidential price negotiations December 2018.

Bilastine (Drynol®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Bilastine
Brand	Drynol®
Indication	Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.
Assessment Process
Rapid review commissioned	10/03/2011
Rapid review completed	23/03/2011
Rapid review outcome	Full Pharmacoeconomic Evaluation not Recommended.

Bimekizumab (Bimzelx®) for psoriatic arthritis. HTA ID: 23075

Assessment Status	Rapid Review Complete
HTA ID	23075
Drug	Bimekizumab
Brand	Bimzelx®
Indication	Bimekizumab (Bimzelx®) is indicated alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs
Assessment Process
Rapid review commissioned	11/12/2023
Rapid review completed	21/12/2023
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that bimekizumab 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.

Blinatumomab (Blincyto®) CD19+ BCP-ALL

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Blinatumomab
Brand	Blincyto®
Indication	As monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukaemia (BCP-ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1%.
Assessment Process
Rapid review commissioned	19/08/2019
Rapid review completed	23/09/2019
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that blinatumomab 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 February 2021.

Blinatumomab (Blincyto®) (paediatric ALL)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Blinatumomab
Brand	Blincyto®
Indication	Treatment of paediatric patients aged 1 year and older with Philadelphia chromosome negative B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation
Assessment Process
Rapid review commissioned	15/01/2019
Rapid review completed	30/01/2019
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of blinatumomab 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; May 2019

Blinatumomab (Blincyto®). HTA ID: 21031

Assessment Status	Rapid Review complete
HTA ID	21031
Drug	Blinatumomab
Brand	Blincyto®
Indication	Treatment of paediatric patients (aged 1 year plus) with high-risk first-relapsed Ph- CD19+ B-precursor acute lymphoblastic leukaemia as part of consolidation therapy.
Assessment Process
Rapid review commissioned	05/07/2021
Rapid review completed	03/08/2021
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that blinatumomab 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 May 2022.

Boceprevir (Victrelis®)

Assessment Status	NCPE Assessment Process Complete
HTA ID	-
Drug	Boceprevir
Brand	Victrelis®
Indication	As add-on therapy to pegylated interferon and ribavirin for the treatment of patients infected with Hepatitis C Genotype 1.
Assessment Process
Full submission received from Applicant	19/08/2011
NCPE assessment completed	17/01/2012
NCPE assessment outcome	Reimbursement Recommended

We consider boceprevir 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

Bosentan (Tracleer®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Bosentan
Brand	Tracleer®
Indication	Treatment pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO Functional Class (FC) III and WHO FC II. It is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Assessment Process
Rapid review commissioned	27/06/2014
Rapid review completed	04/07/2014
Rapid review outcome	Full Pharmacoeconomic Evaluation Not Recommended

Bosutinib (Bosulif®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Bosutinib
Brand	Bosulif®
Indication	Treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Assessment Process
Rapid review commissioned	09/08/2013
Rapid review completed	18/09/2013
Rapid review outcome	At the current price a full HTA would be required.

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

Brentuximab vedotin (Adcetris®)

Assessment Status	NCPE Assessment Process Complete
HTA ID	-
Drug	Brentuximab vedotin
Brand	Adcetris®
Indication	Treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma following autologous stem cell transplant or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and is also indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.
Assessment Process
Rapid review commissioned	28/11/2012
Rapid review completed	21/12/2012
Rapid review outcome	Full Pharmacoeconomic Assessment Recommended
Full submission received from Applicant	16/09/2013
NCPE assessment completed	11/04/2014
NCPE assessment outcome	Reimbursement not Recommended

December 2015

The HSE has approved reimbursement following confidential price negotiations.

Technical Summary

Brentuximab vedotin (Adcetris®) for CD30+ cutaneous T-cell lymphoma (CTCL)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Brentuximab vedotin
Brand	Adcetris®
Indication	Treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (license extension).
Assessment Process
Rapid review commissioned	07/02/2018
Rapid review completed	06/03/2018
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.

The HSE has approved reimbursement following confidential price negotiations, December 2022.

Brentuximab vedotin (Adcetris®) for CD30+ Hodgkins lymphoma. HTA ID: 19058

Assessment Status	NCPE Assessment Process Complete
HTA ID	19058
Drug	Brentuximab vedotin
Brand	Adcetris®
Indication	Treatment of adult patients with CD30+ Hodgkin’s lymphoma at increased risk of relapse or progression following autologous stem cell transplant.
Assessment Process
Rapid review commissioned	30/12/2019
Rapid review completed	29/01/2020
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of brentuximab vedotin compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	05/02/2020
Pre-submission consultation with Applicant	19/05/2020
Full submission received from Applicant	11/01/2021
Preliminary review sent to Applicant	12/07/2021
NCPE assessment re-commenced	06/08/2021
Factual accuracy sent to Applicant	24/09/2021
NCPE assessment re-commenced	30/09/2021
NCPE assessment completed	22/10/2021
NCPE assessment outcome	The NCPE recommends that brentuximab vedotin 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 Medicinal Goods) Act 2013.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations, December 2022.

Brentuximab vedotin (Adcetris®). HTA ID: 21010

Assessment Status	Rapid Review complete
HTA ID	21010
Drug	Brentuximab vedotin
Brand	Adcetris®
Indication	In combination with cyclophosphamide [C], doxorubicin [H] and prednisone [P] (CHP) in combination for use in adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).
Assessment Process
Rapid review commissioned	24/03/2021
Rapid review completed	23/04/2021
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of brentuximab vedotin (Adcetris®) compared with the current standard of care, on the basis of the proposed price relative to currently available therapies*.

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

The HSE has approved reimbursement following confidential price negotiations, December 2022.

Brigatinib (Alunbrig®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Brigatinib
Brand	Alunbrig®
Indication	As monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
Assessment Process
Rapid review commissioned	19/11/2018
Rapid review completed	11/12/2018
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of brigatinib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

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

Brigatinib (Alunbrig®). HTA ID: 20031

Assessment Status	Rapid Review complete
HTA ID	20031
Drug	Brigatinib
Brand	Alunbrig®
Indication	As monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK-inhibitor.
Assessment Process
Rapid review commissioned	16/06/2020
Rapid review completed	06/08/2020
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that brigatinib 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 2020

Brimonidine (Mirvaso®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Brimonidine
Brand	Mirvaso®
Indication	Treatment of facial erythema of rosacea in adult patients.
Assessment Process
Rapid review commissioned	09/04/2014
Rapid review completed	06/05/2014
Rapid review outcome	Full Pharmacoeconomic Evaluation Not Recommended

Brivaracetam (Briviact®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Brivaracetam
Brand	Briviact®
Indication	As adjunctive therapy in the treatment of partial-onset seizures (POS) with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy.
Assessment Process
Rapid review commissioned	15/02/2016
Rapid review completed	22/03/2016
Rapid review outcome	Full Pharmacoeconomic Evaluation Recommended at the submitted price.

The HSE has approved reimbursement following confidential price negotiations.

Brodalumab (Kyntheum®)

Assessment Status	Rapid Review complete
HTA ID	-
Drug	Brodalumab
Brand	Kyntheum®
Indication	Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned	25/07/2017
Rapid review completed	29/08/2017
Rapid review outcome	Full pharmacoeconomic assessment recommended at submitted price

The HSE has approved reimbursement following confidential price negotiations January 2018.

Brolucizumab (Beovu®). HTA ID: 20009

Assessment Status	Rapid Review complete
HTA ID	20009
Drug	Brolucizumab
Brand	Beovu®
Indication	Treatment of neovascular (wet) age-related macular degeneration.
Assessment Process
Rapid review commissioned	26/02/2020
Rapid review completed	07/04/2020
Rapid review outcome	A full HTA is recommended to assess the clinical and cost effectiveness of brolucizumab 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.

Bulevirtide (Hepcludex®). HTA ID: 22067

Assessment Status	NCPE Assessment Process Complete
HTA ID	22067
Drug	Bulevirtide
Brand	Hepcludex®
Indication	Chronic hepatitis delta (CHD) infection in plasma (or serum) HDV RNA-positive adult patients with compensated liver disease.
Assessment Process
Rapid review commissioned	06/10/2022
Rapid review completed	10/11/2022
Rapid review outcome	A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of bulevirtide compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE	30/11/2022
Pre-submission consultation with Applicant	10/01/2023
Full submission received from Applicant	06/09/2023
Preliminary review sent to Applicant	06/10/2023
NCPE assessment re-commenced	09/11/2023
Factual accuracy sent to Applicant	19/01/2024
NCPE assessment re-commenced	26/01/2024
NCPE assessment completed	22/02/2024
NCPE assessment outcome	The NCPE recommends that bulevirtide 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.

Buprenorphine and naloxone (Zubsolv®). HTA ID: 22037

Assessment Status	Rapid Review complete
HTA ID	22037
Drug	Buprenorphine/Naloxone
Brand	Zubsolv®
Indication	As substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who agreed to be treated for addiction.
Assessment Process
Rapid review commissioned	26/05/2022
Rapid review completed	21/06/2022
Rapid review outcome	A full HTA is not recommended. The NCPE recommends that Zubsolv® 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.