Latest NCPE Advice

Andexanet alfa (Ondexxya®). HTA ID: 20014

Assessment Status Assessment Process Complete
HTA ID 20014
Drug Andexanet alfa
Brand Ondexxya®
Indication For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.  
Assessment Process
Rapid review commissioned 12/03/2020
Rapid review completed 23/04/2020
Rapid review outcome A full HTA is required to assess the clinical effectiveness and cost-effectiveness of andexanet alfa compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 29/04/2020
Pre-submission consultation with Applicant 26/01/2021
Full submission received from Applicant 26/10/2021
Preliminary review sent to Applicant 13/12/2021
NCPE assessment re-commenced 31/01/2022
Factual accuracy sent to applicant 27/04/2022
NCPE assessment re-commenced 04/05/2022
NCPE assessment completed 27/05/2022
NCPE assessment outcome The NCPE recommends that andexanet alfa (Ondexxya®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

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

Apalutamide (Erleada®). HTA ID: 20010

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

Technical Summary

Plain English Summary

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

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

Asciminib (Scemblix®). HTA ID: 22053

Assessment Status Rapid Review Complete
HTA ID 22053
Drug Asciminib
Brand Scemblix®
Indication For the treatment of Adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase, who have previously been treated with two or more tyrosine kinase inhibitors.
Assessment Process
Rapid review commissioned 26/07/2022
Rapid review completed 24/08/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of asciminib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

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

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

Technical Summary

Plain English Summary

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

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

Atidarsagene (Libmeldy®). HTA ID: 21009

Assessment Status Assessment Process Complete
HTA ID 21009
Drug Atidarsagene autotemcel
Brand Libmeldy®
Indication For the treatment of metachromatic leukodystrophy characterized by biallelic mutations in the ARSA gene leading to a reduction of the ARSA enzymatic activity, in children with late infantile or early juvenile forms without clinical manifestations of the disease, and in children with the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline.
Assessment Process
Rapid review commissioned 22/03/2021
Rapid review completed 12/04/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of OTL-200 compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 29/04/2021
Full submission received from Applicant 17/12/2021
NCPE assessment completed 30/09/2022
NCPE assessment outcome Following the NCPE/Benaluxa assessment the NCPE recommends that atidarsagene autotemcel not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatment*.

NCPE/Benaluxa Joint Technical Summary

Plain English Summary

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

Avelumab (Bavencio®)

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

Technical Summary

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

Avelumab (Bavencio®). HTA ID: 19046

Assessment Status Assessment Process Complete
HTA ID 19046
Drug Avelumab
Brand Bavencio®
Indication Avelumab in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma.
Assessment Process
Rapid review commissioned 29/10/2019
Rapid review completed 02/01/2020
Rapid review outcome Avelumab in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma.
Full pharmacoeconomic assessment commissioned by HSE 07/01/2020
Pre-submission consultation with Applicant 18/02/2020
Full submission received from Applicant 31/07/2020
Preliminary review sent to Applicant 02/02/2021
NCPE assessment re-commenced 09/03/2021
Follow-up to preliminary review sent to Applicant 24/03/2021
NCPE assessment re-commenced 14/04/2021
Factual accuracy sent to applicant 28/05/2021
NCPE assessment re-commenced 04/06/2021
NCPE assessment completed 23/06/2021
NCPE assessment outcome The NCPE recommends that avelumab in combination with axitinib not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.*

Technical Summary

Plain English Summary

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

Avelumab (Bavencio®). HTA ID: 21001

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

Technical Summary

Plain English Summary

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

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

Axicabtagene Ciloleucel (Yescarta®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Axicabtagene Ciloleucel
Brand Yescarta®
Indication For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
Assessment Process
Rapid review commissioned 10/09/2018
Rapid review completed 18/10/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of axi-cel compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 22/10/2018
Pre-submission consultation with Applicant 03/12/2018
Full submission received from Applicant 20/03/2019
Preliminary review sent to Applicant 15/10/2019
NCPE assessment re-commenced 13/11/2019
Follow-up to preliminary review sent to Applicant 13/12/2019
NCPE assessment re-commenced 20/12/2019
Factual accuracy sent to applicant 04/02/2020
NCPE assessment re-commenced 11/02/2020
NCPE assessment completed 21/02/2020
NCPE assessment outcome The NCPE recommend that axicabtagene ciloleucel (Yescarta®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.*

Technical Summary

Plain English Summary

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

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

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

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

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

Baricitinib (Olumiant®) for moderate to severe active rheumatoid arthritis

Assessment Status Rapid Review complete
HTA ID -
Drug Baricitinib
Brand Olumiant®
Indication Treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate.
Assessment Process
Rapid review commissioned 14/06/2017
Rapid review completed 13/07/2017
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended at the Submitted Price

The HSE has approved reimbursement following confidential price negotiations November 2017

 

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

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

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

Bazedoxifene (Conbriza®)

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

Bedaquiline (Sirturo®)

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

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

Belatacept (Nulojix®)

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

Belimumab (Benlysta®)

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

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

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

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

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

Technical Summary

Plain English Summary

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

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

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

Technical Summary

Plain English Summary

Bendamustine (Levact®)

Assessment Status Assessment process complete
HTA ID -
Drug Bendamustine
Brand Levact®
Indication Treatment of Chronic Lymphocytic Leukaemia (CLL)
Assessment Process
Rapid review commissioned 01/03/2011
Rapid review completed 21/03/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 08/03/2012
NCPE assessment completed 20/11/2012
NCPE assessment outcome Reimbursement recommended

The NCPE  recommends reimbursement of bendamustine (Levact®) for patients unable to tolerate fludarabine/cyclophosphamide.

Technical Summary

Benralizumab (Fasenra®)

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

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

Benralizumab (Fasenra®) Autoinjector. HTA ID: 20018

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

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

The HSE has approved reimbursement following confidential price negotiations October 2021

Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®)

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

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

Bilastine (Drynol®)

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

Bimekizumab (Bimzelx®). HTA ID: 21052

Assessment Status Rapid Review complete
HTA ID 21052
Drug Bimekizumab
Brand Bimzelx®
Indication Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Assessment Process
Rapid review commissioned 15/11/2021
Rapid review completed 07/01/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of bimekizumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Blinatumomab (Blincyto®)

Assessment Status Assessment process complete
HTA ID -
Drug Blinatumomab
Brand Blincyto®
Indication Treatment of adults with Philadelphia chromosome negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukaemia.
Assessment Process
Rapid review commissioned 08/12/2015
Rapid review completed 22/12/2015
Rapid review outcome Full Pharmacoeconomic Evaluation Not Recommended.  The NCPE cannot recommend reimbursement of Blinctyo® at this point in time.*
Full pharmacoeconomic assessment commissioned by HSE 11/04/2017
Pre-submission consultation with Applicant 27/06/2017
Full submission received from Applicant 30/08/2017
Preliminary review sent to Applicant 05/12/2017
NCPE assessment re-commenced 08/02/2018
Factual accuracy sent to applicant 16/03/2018
NCPE assessment re-commenced 10/04/2018
NCPE assessment completed 16/04/2018
NCPE assessment outcome The NCPE recommends that blinatumomab 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

Following submission of new evidence, full pharmacoeconomic evaluation was recommended.

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

Technical Summary

Blinatumomab (Blincyto®) CD19+ BCP-ALL

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

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

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

Blinatumomab (Blincyto®) (paediatric ALL)

 

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

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

Blinatumomab (Blincyto®). HTA ID: 21031

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

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

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

Boceprevir (Victrelis®)

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

We consider boceprevir a highly cost-effective therapy when added to peginterferon-ribavirin for the treatment of patients infected with genotype 1 hepatitis C virus in the Irish healthcare setting.

Technical Summary

Bosentan (Tracleer®)

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

Bosutinib (Bosulif®)

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

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

Brentuximab vedotin (Adcetris®)

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

December 2015

The HSE has approved reimbursement following confidential price negotiations.

Technical Summary

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

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

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

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

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

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

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

Technical Summary

Plain English Summary

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

Brentuximab vedotin (Adcetris®). HTA ID: 21010

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

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

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

Brigatinib (Alunbrig®)

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

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

Brigatinib (Alunbrig®). HTA ID: 20031

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

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

The HSE has approved reimbursement following confidential price negotiations; October 2020

Brimonidine (Mirvaso®)

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

Brivaracetam (Briviact®)

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

The HSE has approved reimbursement following confidential price negotiations.

Brodalumab (Kyntheum®)

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

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

Brolucizumab (Beovu®). HTA ID: 20009

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

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

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

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

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

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 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 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

Burosumab (Crysvita®). HTA ID: 23005

Assessment Status Rapid Review Complete
HTA ID 23005
Drug Burosumab
Brand Crysvita®
Indication Burosumab (Crysvita®) is indicated for X-linked hypophosphataemia in adult patients.
Assessment Process
Rapid review commissioned 03/02/2023
Rapid review completed 14/03/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of burosumab compared with the current standard of care.

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

Cabazitaxel (Jevtana®)

Assessment Status Assessment process complete
HTA ID -
Drug Cabazitaxel
Brand Jevtana®
Indication Treatment of patients with hormone-refractory metastatic prostate cancer previously treated with docetaxel-containing treatment regimen.
Assessment Process
Rapid review commissioned 02/06/2011
Rapid review completed 09/06/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended.
Full submission received from Applicant 03/11/2011
NCPE assessment completed 13/03/2012
NCPE assessment outcome Reimbursement not recommended at the submitted price.

The NCPE believe that, at the submitted price, cabazitaxel is not cost-effective for the treatment of patients with mHRPC previously treated with a docetaxel-containing treatment regimen.

The HSE has approved reimbursement following confidential price negotiations; March 2014.

Technical Summary

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®)

Assessment Status Assessment process complete
HTA ID -
Drug Cabozantinib
Brand Cabometyx®
Indication Treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
Assessment Process
Rapid review commissioned 20/03/2017
Rapid review completed 25/04/2017
Rapid review outcome Full pharmacoeconomic assessment recommended
Full pharmacoeconomic assessment commissioned by HSE 02/05/2017
Pre-submission consultation with Applicant 17/07/2017
Full submission received from Applicant 03/11/2017
Preliminary review sent to Applicant 24/01/2018
NCPE assessment re-commenced 27/04/2018
Factual accuracy sent to applicant 06/06/2018
NCPE assessment re-commenced 29/06/2018
NCPE assessment completed 03/07/2018
NCPE assessment outcome The NCPE recommends that cabozantinib (Cabometyx®) for the treatment of advanced or metastatic clear-cell RCC 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 January 2019.

Technical Summary