Latest NCPE Advice

Cytisine (Citidaron®). HTA ID: 23063

Assessment Status Rapid Review Complete
HTA ID 23063
Drug Cytisine
Brand Citidaron®
Indication Cytisine (Citidaron®) is indicated for smoking cessation and reduction of nicotine cravings in smokers who are willing to stop smoking.
Assessment Process
Rapid review commissioned 09/10/2023
Rapid review completed 28/11/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that cytisine 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.

Daratumumab (Darzalex®). HTA ID: 22039

Assessment Status NCPE Assessment Process Complete
HTA ID 22039
Drug Daratumumab
Brand Darzalex®
Indication In combination with lenalidomide (Revlimid®) and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
Assessment Process
Rapid review commissioned 30/05/2022
Rapid review completed 30/06/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of daratumumab in combination with lenalidomide and dexamethasone for this indication compared with the current standard of care
Full pharmacoeconomic assessment commissioned by HSE 27/07/2022
Pre-submission consultation with Applicant 11/10/2022
Full submission received from Applicant 09/01/2023
Preliminary review sent to Applicant 07/06/2023
NCPE assessment re-commenced 05/07/2023
Factual accuracy sent to Applicant 23/08/2023
NCPE assessment re-commenced 31/08/2023
NCPE assessment completed 20/09/2023
NCPE assessment outcome The NCPE recommends daratumumab in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, 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 regards to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Defatted powder of Arachis hypogaea L., semen (peanuts) (Palforzia®). HTA ID: 22019

Assessment Status NCPE Assessment Process Complete
HTA ID 22019
Drug Defatted powder of Arachis hypogaea L., semen (peanuts)
Brand Palforzia®
Indication For the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. Palforzia® may be continued in patients 18 years of age and older. Palforzia® should be used in conjunction with a peanut-avoidant diet.
Assessment Process
Rapid review commissioned 01/04/2022
Rapid review completed 04/05/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of Palforzia® compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 26/05/2022
Pre-submission consultation with Applicant 22/11/2022
Full submission received from Applicant 06/01/2023
Preliminary review sent to Applicant 31/05/2023
NCPE assessment re-commenced 29/06/2023
Factual accuracy sent to Applicant 27/10/2023
NCPE assessment re-commenced 06/11/2023
NCPE assessment completed 29/11/2023
NCPE assessment outcome The NCPE recommends that Palforzia® 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.

Difelikefalin (Kapruvia®). HTA ID: 23001

Assessment Status NCPE Assessment Process Complete
HTA ID 23001
Drug Difelikefalin
Brand Kapruvia®
Indication For the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis.
Assessment Process
Rapid review commissioned 09/01/2023
Rapid review completed 02/02/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of difelikefalin compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 01/03/2023
Pre-submission consultation with Applicant 16/05/2023
Full submission received from Applicant 12/09/2023
Preliminary review sent to Applicant 24/11/2023
NCPE assessment re-commenced 21/12/2023
Factual accuracy sent to Applicant 22/01/2024
NCPE assessment re-commenced 29/01/2024
NCPE assessment completed 06/02/2024
NCPE assessment outcome The NCPE recommends that difelikefalin 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.

Dostarlimab (Jemperli®). HTA ID: 21045

Assessment Status NCPE Assessment Process Complete
HTA ID 21045
Drug Dostarlimab
Brand Jemperli®
Indication Indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
Assessment Process
Rapid review commissioned 26/10/2021
Rapid review completed 30/11/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of dostarlimab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 22/12/2021
Full submission received from Applicant 16/06/2022
Preliminary review sent to Applicant 22/11/2022
NCPE assessment re-commenced 20/12/2022
Follow-up to preliminary review sent to Applicant 08/02/2023
NCPE assessment re-commenced 10/02/2023
Factual accuracy sent to Applicant 27/02/2023
NCPE assessment re-commenced 10/03/2023
NCPE assessment completed 27/03/2023
NCPE assessment outcome The NCPE recommends that dostarlimab 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.

Dupilumab (Dupixent®) for eosinophilic oesophagitis. HTA ID: 23047

Assessment Status Rapid Review Complete
HTA ID 23047
Drug Dupilumab
Brand Dupixent®
Indication Dupilumab (Dupixent®) is indicated for the treatment of adults and adolescents 12 years and older, weighing at least 40 kg, with eosinophilic oesophagitis (EoE) who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.
Assessment Process
Rapid review commissioned 26/07/2023
Rapid review completed 07/09/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of dupilumab for this indication compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Dupilumab (Dupixent®) for prurigo nodularis. HTA ID: 23043

Assessment Status Rapid Review Complete
HTA ID 23043
Drug Dupilumab
Brand Dupixent®
Indication Dupilumab (Dupixent®) is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned 21/07/2023
Rapid review completed 24/08/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that dupilumab 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.

Dupilumab (Dupixent®) for severe asthma (children 6 to 11 years old). HTA ID: 23044

Assessment Status Rapid Review Complete
HTA ID 23044
Drug Dupilumab
Brand Dupixent®
Indication Dupilumab (Dupixent®) is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Assessment Process
Rapid review commissioned 24/07/2023
Rapid review completed 05/09/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that dupilumab 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.

Dupilumab (Dupixent®) for severe atopic dermatitis in children aged 6 months to 6 years old. HTA ID: 23042

Assessment Status Rapid Review Complete
HTA ID 23042
Drug Dupilumab
Brand Dupixent®
Indication Dupilumab is indicated for the treatment of severe atopic dermatitis in children aged 6 months to 6 years old who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned 21/07/2023
Rapid review completed 01/09/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that dupilumab 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.

Dupilumab (Dupixent®) For severe chronic rhinosinusitis with nasal polyposis. HTA ID: 23046

Assessment Status Rapid Review Complete
HTA ID 23046
Drug Dupilumab
Brand Dupixent®
Indication Dupilumab (Dupixent®) is indicated as an add-on therapy with intranasal corticosteroids, for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.
Assessment Process
Rapid review commissioned 25/07/2023
Rapid review completed 05/09/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of dupilumab compared with the current standard of care for this indication, on the basis of the proposed price relative to currently available therapies.

Enalapril maleate (Aqumeldi®). HTA ID: 24011

Assessment Status Rapid Review complete
HTA ID 24011
Drug Enalapril maleate
Brand Aqumeldi®
Indication For the treatment of heart failure in children and adolescents from birth to less than 18 years of age.
Assessment Process
Rapid review commissioned 25/03/2024
Rapid review completed 12/04/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that enalapril maleate mini ODTs 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.

Epcoritamab (Tepkinly®). HTA ID: 24010

Assessment Status Rapid Review Complete
HTA ID 24010
Drug Epcoritamab
Brand Tepkinly®
Indication Epcoritamab (Tepkinly®) is indicated as monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Assessment Process
Rapid review commissioned 11/03/2024
Rapid review completed 15/04/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of epcoritamab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Estriol (Blissel®) 50 micrograms per gram. HTA ID: 22071

Assessment Status Rapid Review Complete
HTA ID 22071
Drug Estriol
Brand Blissel®
Indication Estriol (Blissel®) 50 micrograms per gram is indicated for local treatment of vaginal dryness in post- menopausal women with vaginal atrophy.
Assessment Process
Rapid review commissioned 05/12/2022
Rapid review completed 23/01/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that Blissel® 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.

Finerenone (Kerendia®). HTA ID: 22012

Assessment Status NCPE Assessment Process Complete
HTA ID 22012
Drug Finerenone
Brand Kerendia®
Indication For the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.
Assessment Process
Rapid review commissioned 21/02/2022
Rapid review completed 15/03/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of finerenone compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 01/04/2022
Pre-submission consultation with Applicant 24/05/2022
Full submission received from Applicant 10/11/2022
Preliminary review sent to Applicant 24/02/2023
NCPE assessment re-commenced 29/03/2023
Follow-up to preliminary review sent to Applicant 08/05/2023
NCPE assessment re-commenced 18/05/2023
Factual accuracy sent to Applicant 12/06/2023
NCPE assessment re-commenced 04/07/2023
NCPE assessment completed 22/08/2023
NCPE assessment outcome The NCPE recommends that finerenone (Kerendia®) 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

Finerenone (Kerendia®). HTA ID: 23077

Assessment Status Rapid Review Complete
HTA ID 23077
Drug Finerenone
Brand Kerendia®
Indication Finerenone (Kerendia®) is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes (T2D) in adults.
Assessment Process
Rapid review commissioned 20/12/2023
Rapid review completed 23/01/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that finerenone 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.

Fostemsavir (Rukobia ®). HTA ID: 23018

Assessment Status Rapid Review Complete
HTA ID 23018
Drug Fostemsavir
Brand Rukobia ®
Indication Fostemsavir (Rukobia ®) in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
Assessment Process
Rapid review commissioned 27/03/2023
Rapid review completed 20/04/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of fostemsavir compared with the current standard of care, on the basis of the proposed 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.

Glofitamab (Columvi®). HTA ID: 23055

Assessment Status Rapid Review Complete
HTA ID 23055
Drug Glofitamab
Brand Columvi®
Indication Glofitamab is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
Assessment Process
Rapid review commissioned 30/08/2023
Rapid review completed 03/10/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of glofitamab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

House dust mite allergen extract (Actair®). HTA ID: 23008

Assessment Status Rapid Review Complete
HTA ID 23008
Drug House dust mite allergen extract
Brand Actair®
Indication Dermatophagoides pteronyssinus and Dermatophagoides farinae in equal parts (Actair®) is indicated for the treatment of moderate-to-severe house dust mite (HDM)–induced allergic rhinitis (AR) or rhinoconjunctivitis diagnosed by clinical history and a positive test of HDM sensitisation (skin prick test [SPT] and/or specific immunoglobulin E [IgE]) in adolescents (aged 12-17 years) and adults.
Assessment Process
Rapid review commissioned 10/02/2023
Rapid review completed 24/02/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of HDM allergen extracts compared with the current standard of care.

Ibrutinib (Imbruvica®) for MCL

Assessment Status Assessment process complete
HTA ID -
Drug Ibrutinib
Brand Imbruvica®
Indication For the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL).
Assessment Process
Rapid review commissioned 07/11/2014
Rapid review completed 18/12/2014
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 10/04/2015
NCPE assessment completed 06/10/2015
NCPE assessment outcome Reimbursement not recommended.

The cost effectiveness of ibrutinib (Imbruvica®) in the treatment of patients with relapsed or refractory MCL has not been demonstrated. Therefore it is not recommended for reimbursement at the submitted price.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations.

Ibrutinib (Imbruvica®). HTA ID: 22054

Assessment Status NCPE Assessment Process Complete
HTA ID 22054
Drug Ibrutinib
Brand Imbruvica®
Indication In combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
Assessment Process
Rapid review commissioned 27/07/2022
Rapid review completed 02/09/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ibrutinib in combination with venetoclax compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 28/09/2022
Pre-submission consultation with Applicant 14/11/2022
Full submission received from Applicant 14/02/2023
Preliminary review sent to Applicant 01/09/2023
NCPE assessment re-commenced 02/10/2023
Factual accuracy sent to Applicant 25/01/2024
NCPE assessment re-commenced 31/01/2024
NCPE assessment completed 09/02/2024
NCPE assessment outcome The NCPE recommends that ibrutinib (given in combination with venetoclax) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia, 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

Idelalisib (Zydelig®)

Assessment Status Assessment process complete
HTA ID -
Drug Idelalisib
Brand Zydelig®
Indication In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Assessment Process
Rapid review commissioned 08/12/2014
Rapid review completed 30/12/2014
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 04/06/2015
NCPE assessment completed 16/02/2016
NCPE assessment outcome Reimbursement not recommended.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations December 2016.

Inclisiran (Leqvio®). HTA ID: 20051

Assessment Status Assessment process complete
HTA ID 20051
Drug Inclisiran
Brand Leqvio®
Indication For the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adult patients, as an adjunct to diet (a) in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or (b) 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 23/11/2020
Rapid review completed 16/12/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of inclisiran compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 06/01/2021
Pre-submission consultation with Applicant 22/02/2021
Full submission received from Applicant 23/07/2021
Preliminary review sent to Applicant 19/10/2021
NCPE assessment re-commenced 16/11/2021
Factual accuracy sent to Applicant 16/02/2022
NCPE assessment re-commenced 23/02/2022
NCPE assessment completed 23/03/2022
NCPE assessment outcome The NCPE recommends that inclisiran (Leqvio®) 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

Indacterol/glycopyrronium/mometasone furoate (Enerzair®). HTA ID: 20023

Assessment Status Rapid Review Complete
HTA ID 20023
Drug Indacterol/glycopyrronium/mometasone furoate
Brand Enerzair®
Indication As a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting β2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.
Assessment Process
Rapid review commissioned 13/05/2020
Rapid review completed 10/06/2020
Rapid review outcome A full HTA is not recommended. The NCPE recommends that indacterol/glycopyrronium/mometasone furoate (Enerzair®) be considered for reimbursement*

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

The HSE has approved reimbursement; November 2020

Indacterol/mometasone furoate (Atectura®). HTA ID: 20024

Assessment Status Rapid Review Complete
HTA ID 20024
Drug Indacterol/mometasone furoate
Brand Atectura®
Indication As maintenance treatment of asthma in adults and adolescents 12 years and older not adequately controlled with inhaled corticosteroids and inhaled short acting β2 agonists.
Assessment Process
Rapid review commissioned 13/05/2020
Rapid review completed 10/06/2020
Rapid review outcome A full HTA is not recommended. The NCPE recommends that Indacterol/mometasone furoate (Atectura®) 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.

Infliximab (Inflectra®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Infliximab
Brand Inflectra®
Indication For the treatment of Rheumatoid Arthritis, Adult Crohn’s disease, Paediatric Crohn’s disease, Ulcerative Colitis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis.
Assessment Process
Rapid review commissioned 10/09/2013
Rapid review completed 20/09/2013
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Infliximab (Remsima SC®). HTA ID: 20012

Assessment Status Rapid Review Complete
HTA ID 20012
Drug Infliximab
Brand Remsima SC®
Indication In combination with methotrexate, is indicated in rheumatoid arthritis for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Assessment Process
Rapid review commissioned 04/03/2020
Rapid review completed 24/03/2020
Rapid review outcome A full HTA is not recommended. The NCPE recommends that infliximab SC not be considered for reimbursement at the submitted price*.

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

Infliximab (Remsima® SC). HTA ID: 20042

Assessment Status Rapid Review Complete
HTA ID 20042
Drug Infliximab
Brand Remsima® SC
Indication For treatment of adult patients with Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis in line with the adult indications of the IV formulation.
Assessment Process
Rapid review commissioned 23/09/2020
Rapid review completed 15/10/2020
Rapid review outcome A full HTA is not recommended. The NCPE recommends that Remsima SC not be considered for reimbursement at the submitted price*.

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

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

Ingenol mebutate gel (Picato®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Ingenol mebutate
Brand Picato®
Indication For cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (AK) in adults.
Assessment Process
Rapid review commissioned 12/11/2012
Rapid review completed 30/11/2012
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Inhaled insulin (Exubera®)

Assessment Status Assessment process complete
HTA ID -
Drug Inhaled insulin
Brand Exubera®
Indication Pfizer submitted a report on the clinical and cost effectiveness of inhaled insulin (Exubera®) versus sub-cutaneous insulin in patients with diabetes mellitus in support of their application for reimbursement under the Community Drug Schemes.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 01/04/2006
NCPE assessment completed 01/06/2006

Technical Summary

Inotersen (Tegsedi®). HTA ID: 19034

Assessment Status Assessment process complete
HTA ID 19034
Drug Inotersen
Brand Tegsedi®
Indication For the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin (TTR) amyloidosis (hATTR).
Assessment Process
Rapid review commissioned 26/08/2019
Rapid review completed 07/10/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of inotersen compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 09/10/2019
Pre-submission consultation with Applicant 08/12/2020
Full submission received from Applicant 23/07/2021
Preliminary review sent to Applicant 05/10/2021
NCPE assessment re-commenced 02/11/2021
Factual accuracy sent to Applicant 22/12/2021
NCPE assessment re-commenced 10/01/2022
NCPE assessment completed 11/02/2022
NCPE assessment outcome The NCPE recommends that inotersen 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 – August 2022.

Inotuzumab ozogamicin (Besponsa®)

Assessment Status Assessment process complete
HTA ID -
Drug Inotuzumab ozogamicin
Brand Besponsa®
Indication As monotherapy for the treatment of adults with relapsed or refractory (R/R) CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
Assessment Process
Rapid review commissioned 03/07/2017
Rapid review completed 08/09/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 11/09/2017
Pre-submission consultation with Applicant 02/10/2017
Full submission received from Applicant 08/03/2018
Preliminary review sent to Applicant 13/07/2018
NCPE assessment re-commenced 02/08/2018
Factual accuracy sent to Applicant 31/08/2018
NCPE assessment re-commenced 07/09/2018
NCPE assessment completed 14/09/2018
NCPE assessment outcome The NCPE recommends that inotuzumab should 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

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

Insulin aspart (Fiasp®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Insulin aspart
Brand Fiasp®
Indication For the treatment of diabetes mellitus in adults.
Assessment Process
Rapid review commissioned 17/05/2017
Rapid review completed 14/06/2017
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Insulin aspart (NovoRapid® FlexTouch ®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Insulin aspart
Brand NovoRapid® FlexTouch ®
Indication For the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Assessment Process
Rapid review commissioned 22/07/2014
Rapid review completed 28/08/2014
Rapid review outcome Full pharmacoeconomic assessment recommended at the submitted price.

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

Insulin Degludec (Tresiba®)

Assessment Status Assessment process complete
HTA ID -
Drug Insulin Degludec
Brand Tresiba®
Indication Treatment of diabetes mellitus
Assessment Process
Rapid review commissioned 17/12/2012
Rapid review completed 04/01/2013
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 04/11/2014
NCPE assessment completed 04/05/2015
NCPE assessment outcome Reimbursement Not Recommended at the submitted price.

Technical Summary

December 2015

The HSE has approved reimbursement following confidential price negotiations.

Insulin degludec/liraglutide (IDegLira) (Xultophy®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Insulin degludec/liraglutide (IDegLira)
Brand Xultophy®
Indication For the treatment of adults with type 2 diabetes mellitus (T2DM) to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or in combination with a Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) or basal insulin does not provide adequate glycaemic control.
Assessment Process
Rapid review commissioned 19/09/2016
Rapid review completed 17/10/2016
Rapid review outcome Full pharmacoeconomic assessment recommended at the submitted price.

The HSE has approved reimbursement; July 2019.

Insulin Glargine (Abasaglar®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Insulin Glargine
Brand Abasaglar®
Indication For the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Assessment Process
Rapid review commissioned 04/09/2015
Rapid review completed 12/10/2015
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Insulin Glargine U300 (Toujeo®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Insulin Glargine U300
Brand Toujeo®
Indication for the treatment of diabetes mellitus in adults.
Assessment Process
Rapid review commissioned 14/05/2015
Rapid review completed 02/07/2015
Rapid review outcome Full Pharmacoeconomic Assessment Recommended at the Submitted Price

The HSE has approved reimbursement following confidential price negotiations.

Ipilimumab (Yervoy®)

Assessment Status Assessment process complete
HTA ID -
Drug Ipilimumab
Brand Yervoy®
Indication For the treatment of advanced (unresectable or metastatic) melanoma in adult patients who have received prior therapy.
Assessment Process
Rapid review commissioned 31/05/2011
Rapid review completed 09/06/2011
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 29/07/2011
NCPE assessment completed 02/09/2011
NCPE assessment outcome Reimbursement Not Recommended at the submitted price.

Technical Summary

September 2013

The HSE has approved reimbursement following confidential price negotiations.

Iron (III) isomaltoside 1000 (Diafer®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Iron (III) isomaltoside 1000
Brand Diafer®
Indication For the treatment of iron deficiency in patients with chronic kidney disease on dialysis, when oral iron preparations are ineffective or cannot be used.
Assessment Process
Rapid review commissioned 10/10/2015
Rapid review completed 18/11/2015
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Iron (III) isomaltoside 1000 (Monover®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Iron (III) isomaltoside 1000
Brand Monover®
Indication For the treatment of Iron deficiency anaemia when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.
Assessment Process
Rapid review commissioned 10/10/2015
Rapid review completed 18/11/2015
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Iron isomaltoside 1000 (MonoVer®)

 

 

Assessment Status Rapid Review Complete
HTA ID -
Drug Iron isomaltoside 1000
Brand MonoVer®
Indication For the treatment of iron deficiency anaemia in the following circumstances: When oral iron preparations are ineffective or cannot be used and where there is a clinical need to deliver iron rapidly.
Assessment Process
Rapid review commissioned 10/01/2011
Rapid review completed 02/02/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Isatuximab (Sarclisa®) in combination with carfilzomib and dexamethasone. HTA ID: 23024

Assessment Status Rapid Review Complete
HTA ID 23024
Drug Isatuximab
Brand Sarclisa®
Indication Isatuximab (Sarclisa®) in combination with carfilzomib and dexamethasone, is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Assessment Process
Rapid review commissioned 09/05/2023
Rapid review completed 25/05/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of isatuximab in combination with carfilzomib and dexamethasone compared with the current standard of care.

Isavuconazole (Cresemba®) for the treatment of invasive aspergillosis.

Assessment Status Rapid Review Complete
HTA ID -
Drug Isavuconazole
Brand Cresemba®
Indication For the treatment of invasive aspergillosis
Assessment Process
Rapid review commissioned 11/04/2016
Rapid review completed 11/05/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended at the submitted price

The HSE has approved reimbursement following confidential price negotiations: April 2018.

Isavuconazole (Cresemba®) for the treatment of mucormycosis

Assessment Status Rapid Review Complete
HTA ID -
Drug Isavuconazole
Brand Cresemba®
Indication For the treatment of mucormycosis in adult patients for whom amphotericin B is inappropriate.
Assessment Process
Rapid review commissioned 11/04/2016
Rapid review completed 11/05/2016
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

The HSE has approved reimbursement following confidential price negotiations: April 2018.

Itopride Hydrochloride (Progit®) 23031

Assessment Status Rapid Review Complete
HTA ID 23031
Drug Itopride Hydrochloride
Brand Progit®
Indication Treatment of gastrointestinal symptoms of functional dyspepsia caused by reduced gastrointestinal motility.
Assessment Process
Rapid review commissioned 06/06/2023
Rapid review completed 07/07/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that itopride 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.

IUB™ Ballerine® MIDI 15mm diameter SCU300B. HTA ID: 20027

Assessment Status Rapid Review Complete
HTA ID 20027
Drug IUB™ Ballerine®
Brand IUB™ Ballerine® MIDI 15mm diameter SCU300B
Indication For intrauterine contraception for up to five years.
Assessment Process
Rapid review commissioned 15/06/2020
Rapid review completed 29/07/2020
Rapid review outcome A full HTA is not recommended. The NCPE recommends that IUB™ Ballerine® SCU300B 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.

IUB™ Ballerine® MIDI 15mm diameter SCU300B. HTA ID: 20062

Assessment Status Rapid Review Complete
HTA ID 20062
Drug IUB™ Ballerine®
Brand IUB™ Ballerine® MIDI 15mm diameter SCU300B
Indication For intrauterine contraception for up to five years.
Assessment Process
Rapid review commissioned 21/12/2020
Rapid review completed 17/02/2021
Rapid review outcome Following resubmission of a rapid review, a full HTA is not recommended. The NCPE recommends that IUB™ Ballerine® SCU300B 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. August 2021.

Ivacaftor (Kalydeco®)

Assessment Status Assessment process complete
HTA ID -
Drug Ivacaftor
Brand Kalydeco®
Indication For the treatment of cystic fibrosis in patients age 6 years and older who have the G551D mutation
Assessment Process
Rapid review commissioned 13/08/2012
Rapid review completed 22/08/2012
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 24/10/2012
NCPE assessment completed 21/01/2013
NCPE assessment outcome Reimbursement not recommended at the submitted price

21 January 2013

In view of the very high acquisition cost (€234,804 per patient per annum), the significant budget impact (approximately €28 million per annum) and the inability of the manufacturer to demonstrate cost-effectiveness the NCPE cannot recommend reimbursement of ivacaftor at the submitted price.

Technical Summary

01 February  2013

The NCPE recommendation led to follow-up discussions between the HSE Corporate Pharmaceutical Unit and the company, Vertex Pharmaceuticals. Following these discussions a positive recommendation was made by the HSE Drugs Group, supporting the provision of ivacaftor (Kalydeco®) for Irish CF patients, whilst at the same time significantly reducing the budget impact of the drug.

Ivacaftor (Kalydeco®) for patients with CF 2 years +

Assessment Status Assessment process complete
HTA ID -
Drug Ivacaftor
Brand Kalydeco®
Indication For the treatment of children with CF aged 2 years and older and weighing less than 25 kg who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R.
Assessment Process
Rapid review commissioned 19/11/2015
Rapid review completed 18/12/2015
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 18/03/2016
NCPE assessment completed 12/10/2016
NCPE assessment outcome Reimbursement not recommended at the submitted price

Technical Summary

The HSE has approved reimbursement following confidential price negotiations.

Ivacaftor (Kalydeco®) for the treatment of CF patients with the R117H mutation.

Assessment Status Assessment process complete
HTA ID -
Drug Ivacaftor
Brand Kalydeco®
Indication For the treatment of patients with cystic fibrosis aged 18 years and older who have the R117H mutation in the CFTR gene.
Assessment Process
Rapid review commissioned 14/01/2016
Rapid review completed 10/02/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 15/04/2016
NCPE assessment completed 05/01/2017
NCPE assessment outcome Reimbursement not recommended at the submitted price

Technical Summary

The HSE has approved reimbursement following confidential price negotiations.