| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | C1inhibitor (human) |
| Brand | Cinryze® |
| Indication | Treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). Routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment |
| Assessment Process | |
| Rapid review commissioned | 22/10/2012 |
| Rapid review completed | 14/11/2012 |
| Rapid review outcome | Full pharmacoeconomic assessment not recommended |
Latest NCPE Advice
Cabotegravir (Vocabria®) in combination with rilpivirine (Rekambys®). HTA ID: 21026
| Assessment Status | Rapid Review complete |
| HTA ID | 21026 |
| Drug | Cabotegravir/Rilpivirine |
| Brand | Vocabria®/Rekambys® |
| Indication | HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. |
| Assessment Process | |
| Rapid review commissioned | 15/06/2021 |
| Rapid review completed | 21/07/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that cabotegravir in combination with rilpivirine 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 2022.
Cabozantinib (Cometriq®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Cabozantinib |
| Brand | Cometriq® |
| Indication | Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. For patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision. |
| Assessment Process | |
| Rapid review commissioned | 10/07/2014 |
| Rapid review completed | 12/08/2014 |
| Rapid review outcome | Full pharmacoeconomic evaluation 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.
Calcifediol monohydrate (Dnord®). HTA ID: 22063
| Assessment Status | Rapid Review complete |
| HTA ID | 22063 |
| Drug | Calcifediol monohydrate |
| Brand | Dnord® |
| Indication | Treatment of vitamin D deficiency (i.e., 25(OH)D levels <25 nmol/L) in adults, for the prevention of vitamin D deficiency in adults with identified risks such as in patients with malabsorption syndrome, chronic kidney disease mineral and bone disorder (CKD-MBD) or other identified risks, and as an adjuvant for the specific treatment of osteoporosis in patients with vitamin D deficiency or at risk of vitamin D deficiency. |
| Assessment Process | |
| Rapid review commissioned | 12/09/2022 |
| Rapid review completed | 13/10/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that calcifediol monohydrate (Dnord®) be considered for reimbursement. |
The HSE has approved reimbursement, December 2022.
Calcipotriol/Betamethasone dipropionate (Enstilar ®)
| Assessment Status | Rapid review complete |
| HTA ID | - |
| Drug | Calcipotriol/Betamethasone dipropionate |
| Brand | Enstilar® |
| Indication | For the topical treatment of psoriasis vulgaris in adults |
| Assessment Process | |
| Rapid review commissioned | 17/05/2016 |
| Rapid review completed | 21/06/2016 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended |
Camellia sinensis, folium (green tea leaf) (Catephen®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Camellia sinensis, folium (green tea leaf) |
| Brand | Catephen® |
| Indication | Cutaneous treatment of external genital and perianal warts (condylomataacuminata) in immunocompetent patients from the age of 18 years. |
| Assessment Process | |
| Rapid review commissioned | 26/05/2015 |
| Rapid review completed | 10/07/2015 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not recommended |
Canagliflozin (Invokana®)
| Assessment Status | NCPE Assessment Process complete |
| HTA ID | - |
| Drug | Canagliflozin |
| Brand | Invokana® |
| Indication | Treatment of type 2 diabetes as monotherapy or add-on combination therapy to other glucose-lowering medicinal products including insulin |
| Assessment Process | |
| Rapid review commissioned | 25/11/2013 |
| Rapid review completed | 02/12/2013 |
| Rapid review outcome | Full HTA Recommended |
| Full submission received from Applicant | 17/12/2014 |
| NCPE assessment completed | 29/08/2014 |
| NCPE assessment outcome | Reimbursement not recommended under the submitted pricing structure. |
The HSE has approved reimbursement following confidential price negotiations; December 2014.
Caplacizumab (Cablivi®). HTA ID: 22013
| Assessment Status | Rapid Review complete |
| HTA ID | 22013 |
| Drug | Caplacizumab |
| Brand | Cablivi® |
| Indication | Treatment of adults and adolescents aged 12 years and older weighing at least 40 kg experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression. |
| Assessment Process | |
| Rapid review commissioned | 07/03/2022 |
| Rapid review completed | 31/03/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of caplacizumab compared with the current standard of care. |
Capsaicin (Qutenza®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Capsaicin |
| Brand | Qutenza® |
| Indication | Peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. |
| Assessment Process | |
| Rapid review commissioned | 15/06/2012 |
| Rapid review completed | 28/06/2012 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven.
Carfilzomib (Kyprolis®) in combination with daratumumab and dexamethasone (CAR+DAR+DEX). HTA ID: 20054
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 20054 |
| Drug | Carfilzomib (in combination with daratumumab and dexamethasone) |
| Brand | Kyprolis® |
| Indication | In combination with daratumumab and dexamethasone (CAR+DAR+DEX) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
| Assessment Process | |
| Rapid review commissioned | 08/12/2020 |
| Rapid review completed | 14/01/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of carfilzomib in combination with daratumumab and dexamethasone compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 27/01/2021 |
| Pre-submission consultation with Applicant | 12/10/2021 |
| Full submission received from Applicant | 17/07/2023 |
| Preliminary review sent to Applicant | 05/03/2024 |
| NCPE assessment re-commenced | 12/04/2024 |
| Factual accuracy sent to Applicant | 07/06/2024 |
| NCPE assessment re-commenced | 17/06/2024 |
| NCPE assessment completed | 03/07/2024 |
| NCPE assessment outcome | The NCPE recommends that carfilzomib (Kyprolis®) in combination with daratumumab and dexamethasone not 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.
Carfilzomib (Kyprolis®) in combination with dexamethasone (CAR+DEX).
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Carfilzomib (in combination with dexamethasone) |
| Brand | Kyprolis® |
| Indication | For the treatment of adult patients with multiple myeloma who have received at least one prior therapy |
| Assessment Process | |
| Rapid review commissioned | 11/02/2019 |
| Rapid review completed | 19/03/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of carfilzomib in combination with dexamethasone 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; October 2020
Carfilzomib (Kyprolis®) in combination with lenalidomide and dexamethasone (CAR+LEN+DEX)
| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Carfilzomib (in combination with lenalidomide and dexamethasone) |
| Brand | Kyprolis® |
| Indication | For the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
| Assessment Process | |
| Rapid review commissioned | 07/12/2015 |
| Rapid review completed | 06/01/2016 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full submission received from Applicant | 24/03/2016 |
| NCPE assessment outcome | Reimbursement Not Recommended |
The HSE has approved reimbursement following confidential price negotiations September 2018
Carglumic acid (Ucedane®). HTA ID: 22035
| Assessment Status | Rapid Review complete |
| HTA ID | 22035 |
| Drug | Carglumic acid |
| Brand | Ucedane® |
| Indication | Treatment of hyperammonaemia due to N-acetyl-glutamate synthase (NAGS) primary deficiency. |
| Assessment Process | |
| Rapid review commissioned | 16/05/2022 |
| Rapid review completed | 21/06/2022 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that carglumic acid (Ucedane®) 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.
Cariprazine (Reagila®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Cariprazine |
| Brand | Reagila® |
| Indication | For the treatment of schizophrenia in adult patients. |
| Assessment Process | |
| Rapid review commissioned | 27/11/2018 |
| Rapid review completed | 19/12/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cariprazine (Reagila®) 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
Casirivimab/imdevimab (Ronapreve®). HTA ID: 21067
| Assessment Status | Rapid Review complete |
| HTA ID | 21067 |
| Drug | Casirivimab/imdevimab |
| Brand | Ronapreve® |
| Indication | For the treatment and prevention of COVID-19. |
| Assessment Process | |
| Rapid review commissioned | 20/12/2021 |
| Rapid review completed | 01/02/2022 |
| Rapid review outcome | On the basis of current evidence, the NCPE recommends that casirivimab/imdevimab not be considered for reimbursement at this time*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Catumaxomab (Removab®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Catumazomab |
| Brand | Removab® |
| Indication | For the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. |
| Assessment Process | |
| Rapid review commissioned | 05/08/2011 |
| Rapid review completed | 06/09/2011 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not Recommended. |
Ceftazidime/avibactam (Zavicefta®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Ceftazidime/avibactam |
| Brand | Zavicefta® |
| Indication | For the treatment of CIAI, cUTI, HAP (including VAP) and gram negative infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. |
| Assessment Process | |
| Rapid review commissioned | 17/05/2017 |
| Rapid review completed | 13/06/2017 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended at the Submitted Price |
The HSE has approved reimbursement following confidential price negotiations November 2017.
Ceftazidime/avibactam (Zavicefta®). HTA ID: 21003
| Assessment Status | Rapid Review complete |
| HTA ID | 21003 |
| Drug | Ceftazidime/avibactam |
| Brand | Zavicefta® |
| Indication | For paediatric patients aged three months and older for the treatment of: Complicated intra-abdominal infection (cIAI); Complicated urinary tract infection (cUTI), including pyelonephritis; Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); Infections due to aerobic Gram-negative organisms in patients with limited treatment options |
| Assessment Process | |
| Rapid review commissioned | 09/02/2021 |
| Rapid review completed | 04/03/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that of ceftazidime-Avibactam (Zavicefta®) 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.
Ceftolozane/tazobactam (Zerbaxa®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Ceftolozane/tazobactam |
| Brand | Zerbaxa® |
| Indication | For the treatment of complicated urinary tract infections (cUTI), acute pyelonephritis and complicated intra-abdominal infections (cIAI) in adults. |
| Assessment Process | |
| Rapid review commissioned | 03/03/2016 |
| Rapid review completed | 26/04/2016 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation recommended at the Submitted Price. |
September 2016
The HSE has approved reimbursement following confidential price negotiations.
Cemiplimab (Libtayo®). HTA ID: 24048
| Assessment Status | Rapid Review Complete |
| HTA ID | 24048 |
| Drug | Cemiplimab |
| Brand | Libtayo® |
| Indication | Cemiplimab (Libtayo®) is indicated as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 02/12/2024 |
| Rapid review completed | 17/01/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cemiplimab for this indication compared with the current standard of care. |
Ceritinib (Zykadia®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Ceritinib |
| Brand | Zykadia® |
| Indication | For the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. |
| Assessment Process | |
| Rapid review commissioned | 29/05/2015 |
| Rapid review completed | 22/07/2015 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended at the submitted price. |
The HSE has approved reimbursement following confidential price negotiations.
Cerliponase alfa (Brineura®)
| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Cerliponase alfa |
| Brand | Brineura® |
| Indication | For the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency. |
| Assessment Process | |
| Rapid review commissioned | 11/10/2017 |
| Rapid review completed | 27/11/2017 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 29/11/2017 |
| Pre-submission consultation with Applicant | 13/03/2018 |
| Full submission received from Applicant | 02/08/2018 |
| Preliminary review sent to Applicant | 30/11/2018 |
| NCPE assessment re-commenced | 25/01/2019 |
| Factual accuracy sent to Applicant | 25/02/2019 |
| NCPE assessment re-commenced | 08/03/2019 |
| NCPE assessment completed | 25/03/2019 |
| NCPE assessment outcome | The NCPE recommends that cerliponase alfa (Brineura®) 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. |
The HSE has approved reimbursement following confidential price negotiations; November 2020.
Certolizumab pegol (Cimzia ®) for moderate to severe plaque psoriasis
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Certolizumab pegol |
| Brand | Cimzia® |
| Indication | For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 14/10/2019 |
| Rapid review completed | 14/11/2019 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that certolizumab pegol 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.
Certolizumab pegol (Cimzia®)
| Assessment Status | NCPE Assessment Process complete |
| HTA ID | - |
| Drug | Certolizumab pegol |
| Brand | Cimzia® |
| Indication | For the treatment of moderate to severe rheumatoid arthritis. |
| Assessment Process | |
| Full submission received from Applicant | 13/03/2010 |
| NCPE assessment completed | 02/09/2010 |
| NCPE assessment outcome | Reimbursement not Recommended. |
The review group did not consider certolizumab cost-effective at the submitted price in September 2010.
The HSE has approved reimbursement following confidential price negotiations.
Cholecalciferol (Egostar®). HTA ID: 22033
| Assessment Status | Rapid Review complete |
| HTA ID | 22033 |
| Drug | Cholecalciferol |
| Brand | Egostar® |
| Indication | Prevention of vitamin D deficiency in adult patients with an identified risk, initial treatment of clinically relevant vitamin D deficiency, and as an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. |
| Assessment Process | |
| Rapid review commissioned | 11/05/2022 |
| Rapid review completed | 23/06/2022 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Egostar® 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, March 2023.
Cholic acid (Orphacol®). HTA ID: 21062
| Assessment Status | Rapid Review complete |
| HTA ID | 21062 |
| Drug | Cholic acid |
| Brand | Orphacol® |
| Indication | For the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency in infants, children and adolescents aged one month to 18 years, and adults. |
| Assessment Process | |
| Rapid review commissioned | 13/12/2021 |
| Rapid review completed | 12/01/2022 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that cholic acid (Orphacol®) 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, December 2022.
Ciclosporin 1mg/ml eye drops (Ikervis®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Ciclosporin |
| Brand | Ikervis® |
| Indication | For the treatment of severe keratitis in adult patients with dry eye disease (DED), which has not improved despite treatment with tear substitutes. |
| Assessment Process | |
| Rapid review commissioned | 07/01/2015 |
| Rapid review completed | 18/01/2016 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended |
Ciltacabtagene autoleucel (Carvykti®). HTA ID: 22021
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22021 |
| Drug | Ciltacabtagene autoleucel |
| Brand | Carvykti® |
| Indication | For the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. |
| Assessment Process | |
| Rapid review commissioned | 11/04/2022 |
| Rapid review completed | 12/05/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cilta-cel (ciltacabtagene autoleucel) compared with the current standard-of-care. |
| Full pharmacoeconomic assessment commissioned by HSE | 27/05/2022 |
| Pre-submission consultation with Applicant | 12/07/2022 |
| Full submission received from Applicant | 30/11/2022 |
| Preliminary review sent to Applicant | 30/05/2023 |
| NCPE assessment re-commenced | 27/06/2023 |
| Factual accuracy sent to Applicant | 04/09/2023 |
| NCPE assessment re-commenced | 12/09/2023 |
| NCPE assessment completed | 27/09/2023 |
| NCPE assessment outcome | The NCPE recommends that cilta-cel 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.
Cladribine (Mavenclad®)
| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Cladribine |
| Brand | Mavenclad® |
| Indication | For the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features |
| Assessment Process | |
| Rapid review outcome | A Full pharmacoeconomic assessment is recommended |
| Preliminary review sent to Applicant | 09/02/2018 |
| NCPE assessment re-commenced | 02/03/2018 |
| Factual accuracy sent to Applicant | 18/06/2018 |
| NCPE assessment re-commenced | 02/07/2018 |
| NCPE assessment completed | 20/07/2018 |
| NCPE assessment outcome | Following NCPE assessment of the company submission, cladribine (Mavenclad®) is considered cost-effective for the treatment of adult patients with highly active relapsing MS as defined by clinical or imaging features and therefore is recommended for reimbursement. |
The HSE has approved reimbursement following confidential price negotiations September 2018.
Clindamycin 1% with tretinoin 0.025% (Treclinac®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Clindamycin 1% with tretinoin 0.025% |
| Brand | Treclinac® |
| Indication | For the topical treatment of acne vulgaris when comedones, papules and pustules are present in patients 12 years or older. |
| Assessment Process | |
| Rapid review commissioned | 08/04/2014 |
| Rapid review completed | 06/05/2014 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended |
Co-enzyme Q10 (CoQun®). HTA ID: 19045
| Assessment Status | Rapid Review complete |
| HTA ID | 19045 |
| Drug | Co-enzyme Q10 |
| Brand | CoQun® eye drops |
| Indication | As a complementary add-on treatment to antihypertensive glaucoma therapy. |
| Assessment Process | |
| Rapid review commissioned | 16/10/2019 |
| Rapid review completed | 13/01/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that CoQ10 eye drops 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.
Cobimetinib (Cotellic®)
| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Cobimetinib |
| Brand | Cotellic® |
| Indication | For use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
| Assessment Process | |
| Rapid review commissioned | 19/04/2016 |
| Rapid review completed | 26/04/2016 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full submission received from Applicant | 18/07/2016 |
| NCPE assessment completed | 05/01/2017 |
| NCPE assessment outcome | Reimbursement Not Recommended at the Submitted Price. |
The NCPE does not consider cobimetinib (Cotellic®) with vemurafenib (Zelboraf®) cost-effective for the treatment of advanced (unresectable or metastatic) melanoma with the BRAF V600 mutation and therefore it is not recommended for reimbursement at the submitted price.
The HSE has approved reimbursement following confidential price negotiations; April 2018.
Colesevelam (Cholestagel®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Colesevelam |
| Brand | Cholestagel® |
| Indication | Hypercholesterolaemia |
| Assessment Process | |
| Rapid review commissioned | 19/10/2010 |
| Rapid review completed | 22/10/2010 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not Recommended. |
Colistimethate sodium (Colobreathe®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Colistimethate sodium |
| Brand | Colobreathe® |
| Indication | For the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. |
| Assessment Process | |
| Rapid review commissioned | 07/06/2013 |
| Rapid review completed | 28/06/2013 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended |
Collagenase Clostridium Histolyticum (Xiapex®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Collagenase Clostridium Histolyticum |
| Brand | Xiapex® |
| Indication | Treatment of Dupuytren’s contracture in adult patients with a palpable cord. |
| Assessment Process | |
| Rapid review commissioned | 20/05/2011 |
| Rapid review completed | 09/06/2011 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not Recommended |
Conestat alfa (Ruconest®). HTA ID: 21017
| Assessment Status | Rapid Review complete |
| HTA ID | 21017 |
| Drug | Conestat alfa |
| Brand | Ruconest® |
| Indication | For the treatment of acute angioedema attacks in adults, adolescents, and children (aged 2 years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. |
| Assessment Process | |
| Rapid review commissioned | 21/04/2021 |
| Rapid review completed | 02/06/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that conestat alfa 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 January 2022.
Corifollitropin alfa (Elonva®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Corifollitropin alfa |
| Brand | Elonva® |
| Indication | Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. |
| Assessment Process | |
| Rapid review commissioned | 22/09/2010 |
| Rapid review completed | 22/10/2010 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not Recommended. |
Crizotinib (Xalkori®)
| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Crizotinib |
| Brand | Xalkori® |
| Indication | Treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) (i.e. in the 2nd / 3rd–line treatment setting) |
| Assessment Process | |
| Rapid review commissioned | 09/01/2013 |
| Rapid review completed | 31/01/2013 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full submission received from Applicant | 24/05/2013 |
| NCPE assessment completed | 27/08/2013 |
| NCPE assessment outcome | Reimbursement not recommended. The NCPE do not consider Crizotinib (Xalkori®) a cost-effective treatment for adult patients with previously treated ALK positive advanced non small cell lung cancer (NSCLC). |
August 2015
The HSE has approved reimbursement following confidential price negotiations.
Crizotinib (Xalkori®) for first line ALK+ NSCLC
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Crizotinib |
| Brand | Xalkori® |
| Indication | For the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
| Assessment Process | |
| Rapid review commissioned | 06/02/2017 |
| Rapid review completed | 24/04/2017 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended. |
Crizotinib (Xalkori®) for ROS1 NSCLC
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Crizotinib |
| Brand | Xalkori® |
| Indication | For the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). |
| Assessment Process | |
| Rapid review commissioned | 06/02/2017 |
| Rapid review completed | 24/04/2017 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended. |
Crovalimab (Piasky®). HTA ID: 24027
| Assessment Status | Rapid Review complete |
| HTA ID | 24027 |
| Drug | Crovalimab |
| Brand | Piasky® |
| Indication | For the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH): (i) In patients with haemolysis with clinical symptom(s) indicative of high disease activity; (ii) In patients who are clinically stable after having been treated with a complement 5 inhibitor for at least the past 6 months |
| Assessment Process | |
| Rapid review commissioned | 11/07/2024 |
| Rapid review completed | 01/08/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that crovalimab 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.
Cysteamine bitartrate delayed-release (Procysbi®)
| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Cysteamine bitartrate delayed-release |
| Brand | Procysbi® |
| Indication | For the treatment of proven nephropathic cystinosis. |
| Assessment Process | |
| Rapid review commissioned | 01/12/2015 |
| Rapid review completed | 15/12/2015 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended at the submitted price |
| Full pharmacoeconomic assessment commissioned by HSE | 23/12/2015 |
| Pre-submission consultation with Applicant | 22/05/2017 |
| Full submission received from Applicant | 13/07/2017 |
| Preliminary review sent to Applicant | 22/08/2017 |
| NCPE assessment re-commenced | 29/08/2017 |
| Factual accuracy sent to Applicant | 17/10/2017 |
| NCPE assessment re-commenced | 15/11/2017 |
| NCPE assessment completed | 15/11/2017 |
| NCPE assessment outcome | Reimbursement not recommended at the submitted price |
The HSE has approved reimbursement following confidential price negotiations; July 2019
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*. |
*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.
Durvalumab (Imfinzi®). HTA ID: 23009
| Assessment Status | NCPE Assessment Process complete |
| HTA ID | 23009 |
| Drug | Durvalumab |
| Brand | Imfinzi® |
| Indication | Durvalumab in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer. |
| Assessment Process | |
| Rapid review commissioned | 20/02/2023 |
| Rapid review completed | 16/03/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of durvalumab used in combination with gemcitabine and cisplatin compared with the current SOC (gemcitabine and cisplatin). |
| Full pharmacoeconomic assessment commissioned by HSE | 29/03/2023 |
| Pre-submission consultation with Applicant | 06/06/2023 |
| Full submission received from Applicant | 04/10/2023 |
| Preliminary review sent to Applicant | 12/08/2024 |
| NCPE assessment re-commenced | 10/09/2024 |
| Factual accuracy sent to Applicant | 26/11/2024 |
| NCPE assessment re-commenced | 29/11/2024 |
| NCPE assessment completed | 19/12/2024 |
| NCPE assessment outcome | The NCPE recommends that durvalumab (Imfinzi®) 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.
Elafibranor (Iqirvo®). HTA ID: 25005
| Assessment Status | Rapid Review Complete |
| HTA ID | 25005 |
| Drug | Elafibranor |
| Brand | Iqirvo® |
| Indication | Elafibranor (Iqirvo®) is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. |
| Assessment Process | |
| Rapid review commissioned | 27/01/2025 |
| Rapid review completed | 13/03/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of elafibranor compared with the current standard of care, on the basis of the proposed price relative to currently available therapies*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this decision may be found here.
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.
