Latest NCPE Advice

Buprenorphine prolonged-release solution for injection (Buvidal®). HTA ID: 22056

Assessment Status Rapid Review complete
HTA ID 22056
Drug Buprenorphine
Brand Buvidal®
Indication Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.
Assessment Process
Rapid review commissioned 09/08/2022
Rapid review completed 23/09/2022
Rapid review outcome A full HTA is not recommended. The NCPE recommends that Buvidal® 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.

Buprenorphine/Naloxone (Suboxone®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Buprenorphine/Naloxone
Brand Suboxone®
Indication Management of opiate addiction
Assessment Process
Full submission received from Applicant 02/01/2014
NCPE assessment completed 22/05/2014
NCPE assessment outcome Reimbursement Not Recommended

Pharmacoeconomic Evaluation completed in November 2007. Suboxone cannot be considered a cost effective option for patients attending HSE clinics or in the community setting in Ireland.

Technical Summary 2007

 

Pharmacoeconomic Reassessment completed in 2014. The NCPE does not consider Suboxone® to be cost-effective compared to methadone for the treatment of opioid dependence.

Technical Summary 2014

Burosumab (Crysvita®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Burosumab
Brand Crysvita®
Indication Treatment of X-linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.
Assessment Process
Rapid review commissioned 22/11/2018
Rapid review completed 21/12/2018
Rapid review outcome A full HTA is recommended
Full pharmacoeconomic assessment commissioned by HSE 08/01/2019
Pre-submission consultation with Applicant 12/02/2019
Full submission received from Applicant 03/07/2019
Preliminary review sent to Applicant 23/10/2019
NCPE assessment re-commenced 19/11/2019
Factual accuracy sent to Applicant 14/02/2020
NCPE assessment re-commenced 06/03/2020
NCPE assessment completed 12/03/2020
NCPE assessment outcome The NCPE recommends that burosumab (Crysvita®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments**

*The NCPE have revised the timeline for burosumab due to new information received after the factual accuracy stage, which necessitated additional revisions to be made to the final appraisal document.

**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 2021.

Technical Summary

Plain English Summary

C1inhibitor (human) (Cinryze®)

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

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 (Cabometyx®) in combination with nivolumab (Opdivo®). HTA ID: 22018

Assessment Status Rapid Review complete
HTA ID 22018
Drug Cabozantinib/Nivolumab
Brand Cabometyx®/Opdivo®
Indication First-line treatment of advanced renal cell carcinoma in adults.
Assessment Process
Rapid review commissioned 28/03/2022
Rapid review completed 11/05/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cabozantinib (Cabometyx®) in combination with nivolumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

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.

Technical Summary

 

Cannabidiol (Epidyolex®). HTA ID: 20004

Assessment Status NCPE Assessment Process complete
HTA ID 20004
Drug Cannabidiol
Brand Epidyolex®
Indication As adjunctive therapy of seizures associated with Dravet Syndrome in conjunction with clobazam, for patients two years of age and older.
Assessment Process
Rapid review commissioned 05/02/2020
Rapid review completed 11/03/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cannabidiol compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 16/03/2020
Pre-submission consultation with Applicant 27/04/2020
Full submission received from Applicant 14/07/2020
Preliminary review sent to Applicant 13/11/2020
NCPE assessment re-commenced 22/12/2020
Factual accuracy sent to Applicant 02/02/2021
NCPE assessment re-commenced 12/02/2021
NCPE assessment completed 08/03/2021
NCPE assessment outcome The NCPE recommends that cannabidiol (Epidyolex®) 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.

The HSE has approved reimbursement following confidential price negotiations December 2021.

Technical Summary

Plain English Summary

Cannabidiol (Epidyolex®). HTA ID: 20005

Assessment Status NCPE Assessment Process complete
HTA ID 20005
Drug Cannabidiol
Brand Epidyolex®
Indication As adjunctive therapy of seizures associated with Lennox-Gastaut Syndrome in conjunction with clobazam, for patients two years of age and older.
Assessment Process
Rapid review commissioned 05/02/2020
Rapid review completed 11/03/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cannabidiol compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 16/03/2020
Pre-submission consultation with Applicant 27/04/2020
Full submission received from Applicant 14/07/2020
Preliminary review sent to Applicant 13/11/2020
NCPE assessment re-commenced 22/12/2020
Factual accuracy sent to Applicant 05/02/2021
NCPE assessment re-commenced 12/02/2021
NCPE assessment completed 08/03/2021
NCPE assessment outcome The NCPE recommends that cannabidiol (Epidyolex®) 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.

The HSE has approved reimbursement following confidential price negotiations December 2021.

Technical Summary

Plain English Summary

Cannabidiol (Epidyolex®). HTA ID: 21024

Assessment Status Rapid Review complete
HTA ID 21024
Drug Cannabidiol
Brand Epidyolex®
Indication As adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.
Assessment Process
Rapid review commissioned 09/06/2021
Rapid review completed 08/07/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cannabidiol (Epidyolex®) 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 December 2021.

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 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

Technical Summary

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.

Cefiderocol (Fetcroja®). HTA ID: 22003

Assessment Status Rapid Review complete
HTA ID 22003
Drug Cefiderocol
Brand Fetcroja®
Indication For the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Assessment Process
Rapid review commissioned 10/01/2022
Rapid review completed 16/02/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cefiderocol compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Ceftaroline (Zinforo®)

Assessment Status Rapid Review complete
HTA ID -
Drug Ceftaroline
Brand Zinforo®
Indication For the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP).
Assessment Process
Rapid review commissioned 08/10/2012
Rapid review completed 12/10/2012
Rapid review outcome Full pharmacoeconomic evaluation not recommended for HCV genotype 3 infection

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: 21007

Assessment Status NCPE Assessment Process Complete
HTA ID 21007
Drug Cemiplimab
Brand Libtayo®
Indication Is indicated as monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.
Assessment Process
Rapid review commissioned 15/03/2021
Rapid review completed 23/03/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cemiplimab (Libtayo®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 31/03/2021
Pre-submission consultation with Applicant 29/11/2021
Full submission received from Applicant 23/01/2023
Preliminary review sent to Applicant 08/06/2023
NCPE assessment re-commenced 26/07/2023
Factual accuracy sent to Applicant 25/09/2023
NCPE assessment re-commenced 03/10/2023
NCPE assessment completed 24/10/2023
NCPE assessment outcome The NCPE recommends that cemiplimab (Libtayo®) 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.

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.

Technical Summary

 

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.

Technical Summary

Chlormethine gel (Ledaga®). HTA ID: 23049

Assessment Status Rapid Review Complete
HTA ID 23049
Drug Chlormethine gel
Brand Ledaga®
Indication Chlormethine gel (Ledaga®) is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.
Assessment Process
Rapid review commissioned 31/07/2023
Rapid review completed 20/09/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that chlormethine gel 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.

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*.

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.

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.

Technical Summary

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.

Technical Summary

 

 

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.

Technical Summary

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.

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

Technical Summary