| Assessment Status | Rapid Review Complete |
| HTA ID | 24035 |
| Drug | Dupilumab |
| Brand | Dupixent® |
| Indication | Dupilumab is indicated in adults as an add-on maintenance treatment for uncontrolled COPD characterised by raised blood eosinophils on a combination of an ICS, a LABA, and a LAMA, or on a combination of a LABA and a LAMA, if an ICS is not appropriate. |
| Assessment Process | |
| Rapid review commissioned | 06/09/2024 |
| Rapid review completed | 04/10/2024 |
| 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. |
Latest NCPE Advice
Empagliflozin (Jardiance®). HTA ID: 24042
| Assessment Status | Rapid Review Complete |
| HTA ID | 24042 |
| Drug | Empagliflozin |
| Brand | Jardiance® |
| Indication | Empagliflozin is indicated in adults for the treatment of chronic kidney disease. |
| Assessment Process | |
| Rapid review commissioned | 09/10/2024 |
| Rapid review completed | 22/11/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that empagliflozin be considered for reimbursement for this indication*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
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.
Enfortumab vedotin in combination with pembrolizumab (Padcev® in combination with Keytruda®). HTA ID: 24038
| Assessment Status | Rapid Review Complete |
| HTA ID | 24038 |
| Drug | Enfortumab vedotin in combination with pembrolizumab |
| Brand | Padcev®in combination with Keytruda® |
| Indication | Enfortumab vedotin in combination with pembrolizumab is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 23/09/2024 |
| Rapid review completed | 22/10/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
Erdafitinib (Balversa®). HTA ID: 24034
| Assessment Status | Rapid Review Complete |
| HTA ID | 24034 |
| Drug | Erdafitinib |
| Brand | Balversa® |
| Indication | Erdafitinib monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting. |
| Assessment Process | |
| Rapid review commissioned | 20/08/2024 |
| Rapid review completed | 17/09/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that erdafitinib 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.
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.
Fenfluramine (Fintepla®) for Lennox-Gastaut Syndrome . HTA ID: 23051
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23051 |
| Drug | Fenfluramine |
| Brand | Fintepla® |
| Indication | Fenfluramine (Fintepla®) is indicated for patients (two years of age and older) with Lennox-Gastaut Syndrome as an add-on therapy to other anti-epileptic medicines. |
| Assessment Process | |
| Rapid review commissioned | 09/08/2023 |
| Rapid review completed | 14/09/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of fenfluramine for this indication compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 29/09/2023 |
| Pre-submission consultation with Applicant | 07/11/2023 |
| Full submission received from Applicant | 01/08/2024 |
| Preliminary review sent to Applicant | 07/08/2024 |
| NCPE assessment re-commenced | 02/09/2024 |
| Factual accuracy sent to Applicant | 04/09/2024 |
| NCPE assessment re-commenced | 11/09/2024 |
| NCPE assessment completed | 16/09/2024 |
| NCPE assessment outcome | The NCPE recommends that fenfluramine be considered for reimbursement if cost-effectiveness can be improved.* |
*This recommendation should be considered while also having regards 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*. |
* 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.
Fruquintinib (Fruzaqla®). HTA ID: 24031
| Assessment Status | Rapid Review Complete |
| HTA ID | 24031 |
| Drug | Fruquintinib |
| Brand | Fruzaqla® |
| Indication | For the treatment of adult patients with metastatic colorectal cancer who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF agents, and anti EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine tipiracil or regorafenib |
| Assessment Process | |
| Rapid review commissioned | 31/07/2024 |
| Rapid review completed | 16/09/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of fruquintinib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
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.
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*. |
*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. |
The HSE has approved reimbursement following confidential price negotiations December 2016.
Imlifidase (Idefirix®). HTA ID: 23041
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23041 |
| Drug | Imlifidase |
| Brand | Idefirix® |
| Indication | For desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of imlifidase should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients. |
| Assessment Process | |
| Rapid review commissioned | 19/07/2023 |
| Rapid review completed | 01/08/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of imlifidase compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 30/08/2023 |
| Pre-submission consultation with Applicant | 21/11/2023 |
| Full submission received from Applicant | 22/04/2024 |
| Preliminary review sent to Applicant | 16/09/2024 |
| NCPE assessment re-commenced | 09/10/2024 |
| Factual accuracy sent to Applicant | 21/11/2024 |
| NCPE assessment re-commenced | 28/11/2024 |
| NCPE assessment completed | 28/11/2024 |
| NCPE assessment outcome | The NCPE recommends that imlifidase be considered for reimbursement*. |
*This recommendation should be considered while also having regards to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
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.
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 |
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.
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.
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. |
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. |
September 2013
The HSE has approved reimbursement following confidential price negotiations.
Iptacopan (Fabhalta®). HTA ID: 24023
| Assessment Status | Rapid Review Complete |
| HTA ID | 24023 |
| Drug | Iptacopan |
| Brand | Fabhalta® |
| Indication | Iptacopan is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. |
| Assessment Process | |
| Rapid review commissioned | 04/06/2024 |
| Rapid review completed | 16/07/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical and cost effectiveness of iptacopan compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
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.
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 |
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 |
The HSE has approved reimbursement following confidential price negotiations.
Ixazomib (Ninlaro®)
| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Ixazomib |
| Brand | Ninlaro® |
| Indication | In combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
| Assessment Process | |
| Rapid Review Commissioned | 23/11/2016 |
| Rapid review completed | 16/01/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 23/01/2017 |
| Pre-submission consultation with Applicant | 06/02/2017 |
| Full submission received from Applicant | 01/06/2017 |
| Preliminary review sent to Applicant | 04/08/2017 |
| NCPE assessment re-commenced | 31/08/2017 |
| Factual accuracy sent to applicant | 20/11/2017 |
| NCPE assessment re-commenced | 04/12/2017 |
| Applicant factual accuracy check | 07/12/2017 |
| NCPE assessment re-commenced | 12/12/2017 |
| NCPE assesment completed | 18/12/2017 |
| NCPE assessment outcome | Reimbursement not recommended. |
The HSE has approved reimbursement following confidential price negotiations – December 2018.
Ixekizumab (Taltz®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Ixekizumab |
| Brand | Taltz® |
| Indication | For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 28/06/2016 |
| Rapid review completed | 26/07/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended at the submitted price |
September 2016
The HSE has approved reimbursement following confidential price negotiations.
Ixekizumab (Taltz®) for psoriatic arthritis
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Ixekizumab |
| Brand | Taltz® |
| Indication | For the treatment of active PsA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies |
| Assessment Process | |
| Rapid review commissioned | 16/10/2018 |
| Rapid review completed | 19/11/2018 |
| Rapid review outcome | Full pharmacoeconomic assessment is not recommended. The NCPE recommends that ixekizumab 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
