Helen O’Donnell

Abatacept (Orencia®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Abatacept
Brand Orencia®
Indication In combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
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 02/07/2013
NCPE assessment completed 11/11/2013
NCPE assessment outcome Reimbursement not recommended at the submitted price

Technical Summary

November 2015

The HSE has approved reimbursement following confidential pricing negotiations.

Abiraterone acetate (Zytiga®) for mCRPC post ADT

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Abiratone
Brand Zytiga®
Indication Treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
Assessment Process
Rapid review commissioned 03/01/2013
Rapid review completed 01/02/2013
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 26/09/2013
NCPE assessment completed 07/03/2014
NCPE assessment outcome Reimbursement not recommended at the submitted price

Technical Summary

December 2015

The HSE has approved reimbursement following confidential price negotiations.

 

Aceclofenac (Vitafen®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Aceclofenac
Brand Vitafen®
Indication For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Assessment Process
Rapid review commissioned 24/08/2016
Rapid review completed 24/01/2017
Rapid review outcome Following a resubmission of the rapid review a full pharmacoeconomic evaluation is recommended at the submitted price.

The HSE has approved reimbursement following confidential price negotiations  Nov 2017.

Aclidinium bromide (Eklira Genuair®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Aclidinium bromide
Brand Eklira Genuair®
Indication For treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). (Maintenance bronchodilator)
Assessment Process
Rapid review commissioned 23/10/2012
Rapid review completed 26/10/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Not Recommended

Aflibercept (Eylea®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Aflibercept
Brand Eylea®
Indication For the treatment of neovascular (wet) age-related macular degeneration (AMD).
Assessment Process
Rapid review commissioned 10/12/2012
Rapid review completed 21/12/2012
Rapid review outcome Full Pharmacoeconomic Assessment Recommended

Alectinib (Alecensa®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Alectinib
Brand Alecensa®
Indication For the treatment of patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with crizotinib.
Assessment Process
Rapid review commissioned 03/01/2017
Rapid review completed 27/02/2017
Rapid review outcome Full pharmacoeconomic evaluation recommended at the submitted price.

The HSE has approved reimbursement following confidential price negotiations October 2017.

Amikacin Sulfate (Arikayce® liposomal nebuliser dispersion). HTA ID: 20048

Assessment Status NCPE Assessment Process Complete
HTA ID 20048
Drug Amikacin Sulfate
Brand Arikayce® liposomal nebuliser dispersion
Indication For the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.
Assessment Process
Rapid review commissioned 28/10/2020
Rapid review completed 18/12/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of amikacin sulfate (Arikayce® liposomal nebuliser dispersion (ALND) compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.
Full pharmacoeconomic assessment commissioned by HSE 04/01/2021
Pre-submission consultation with Applicant 06/12/2021
Full submission received from Applicant 01/04/2022
Preliminary review sent to Applicant 30/08/2022
NCPE assessment re-commenced 05/09/2022
Factual accuracy sent to Applicant 08/12/2022
NCPE assessment re-commenced 16/12/2022
NCPE assessment completed 20/12/2022
NCPE assessment outcome The NCPE recommends that inhaled liposomal amikacin, in addition to guideline-based therapy, for the treatment of adult patients with NTM lung infections caused by MAC and who have failed at least six months of guideline-based 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. October 2023

Apixaban (Eliquis®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Apixaban
Brand Eliquis®
Indication For treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Assessment Process
Rapid review commissioned 29/07/2014
Rapid review completed 10/08/2014
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Apixaban (Eliquis®) for NVAF

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Apixaban
Brand Eliquis®
Indication For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Assessment Process
Rapid review commissioned 07/12/2012
Rapid review completed 21/12/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 05/04/2013
NCPE assessment completed 31/05/2013
NCPE assessment outcome Reimbursement Recommended

Technical Summary

Aripiprazole (Abilify Maintena®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Aripiprazole
Brand Abilify Maintena®
Indication For maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole
Assessment Process
Rapid review commissioned 02/07/2014
Rapid review completed 06/08/2014
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Atezolizumab (Tecentriq®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Atezolizumab
Brand Tecentriq®
Indication As monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR activating mutations or ALK‑positive tumour mutations should also have received targeted therapy before receiving atezolizumab.
Assessment Process
Rapid review commissioned 08/08/2017
Rapid review completed 09/10/2017
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE 11/10/2017
Pre-submission consultation with Applicant 28/11/2017
Full submission received from Applicant 08/01/2018
Preliminary review sent to Applicant 29/05/2018
NCPE assessment re-commenced 15/06/2018
Follow-up to preliminary review sent to Applicant 31/07/2018
NCPE assessment re-commenced 21/08/2018
Factual accuracy sent to Applicant 04/09/2018
NCPE assessment re-commenced 19/09/2018
NCPE assessment completed 20/09/2018
NCPE assessment outcome The NCPE recommends that atezolizumab not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.

Technical 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 2019.

 

Atezolizumab (Tecentriq®) HTA ID: 19030

Assessment Status NCPE Assessment Process Complete
HTA ID 19030
Drug Atezolizumab
Brand Tecentriq®
Indication In combination with carboplatin and etoposide is indicated for first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Assessment Process
Rapid review commissioned 19/08/2019
Rapid review completed 16/09/2019
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 18/09/2019
Pre-submission consultation with Applicant 16/12/2019
Full submission received from Applicant 08/05/2020
Preliminary review sent to Applicant 19/06/2020
NCPE assessment re-commenced 17/07/2020
Follow-up to preliminary review sent to Applicant 31/07/2020
NCPE assessment re-commenced 04/08/2020
Factual accuracy sent to Applicant 04/09/2020
NCPE assessment re-commenced 11/09/2020
NCPE assessment completed 24/09/2020
NCPE assessment outcome The NCPE recommends that atezolizumab in combination with carboplatin and etoposide for the first-line treatment of adult patients with ES-SCLC is not considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

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

Technical Summary

Plain English Summary

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

Axitinib (Inlyta®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Axitinib
Brand Inlyta®
Indication For the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine
Assessment Process
Rapid review commissioned 07/11/2012
Rapid review completed 19/11/2012
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.

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.

Brentuximab vedotin (Adcetris®)

Assessment Status NCPE 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

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

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.

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.

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 A full HTA is not recommended. The NCPE recommends that ceftaroline 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.

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

 

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.

COVID-19 Evidence Review Group

COVID-19 Evidence Review Group for Medicines

The COVID-19 Evidence Review Group for Medicines was established to support the HSE in managing the significant amount of information on treatments for COVID-19.  This COVID-19 Evidence Review Group is comprised of evidence synthesis practitioners from across the National Centre for Pharmacoeconomics (NCPE), Medicines Management Programme (MMP) and the National Medicines Information Centre (NMIC). The group respond to queries raised via the Office of the Chief Clinical Officer, National Clinical Programmes and the Department of Health and respond in a timely way with the evidence review supporting the query.

In order to provide timely information to decision makers a rapid evidence review is the chosen methodology.  The Evidence Review Group uses a systematic search strategy that searches for both peer reviewed and non-peer reviewed publications.  The Rapid Evidence Reviews are updated frequently (1-2 weeks) depending on the topic of the review.

Further information and copies of the Rapid Evidence Reviews can be found here.

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

Dabrafenib plus Trametinib (Tafinlar® plus Mekinist®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Dabrafenib
Brand Tafinlar® plus Mekinist®
Indication In combination with trametinib, is indicated for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection.
Assessment Process
Rapid review commissioned 30/01/2019
Rapid review completed 21/03/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of dabrafenib plus trametinib
Full pharmacoeconomic assessment commissioned by HSE 09/04/2019
Pre-submission consultation with Applicant 28/05/2019
Full submission received from Applicant 02/09/2019
Preliminary review sent to Applicant 09/04/2020
NCPE assessment re-commenced 18/05/2020
Factual accuracy sent to Applicant 10/07/2020
NCPE assessment re-commenced 20/07/2020
NCPE assessment completed 19/08/2020
NCPE assessment outcome The NCPE recommend that dabrafenib and trametinib be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 203

Technical Summary

Plain English Summary

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

Dapagliflozin (Forxiga®)

Assessment Status Rapid review complete
HTA ID -
Drug Dapagliflozin
Brand Forxiga®
Indication Indicated in adults aged 18 years and older with Type 2 Diabetes Mellitus to improve glycaemic control as: Monotherapy: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy: In combination with other glucose lowering drugs including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Assessment Process
Rapid review commissioned 10/10/2012
Rapid review completed 22/10/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 01/08/2013
NCPE assessment completed 31/12/2013
NCPE assessment outcome Reimbursement not recommended at this time

Technical Summary

December 2015

The HSE has approved reimbursement following confidential price negotiations.

Daratumumab (Darzalex®) in combination with bortezomib and dexamethasone

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Daratumumab
Brand Darzalex® in combination with bortezomib and dexamethasone
Indication For the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Assessment Process
Rapid review commissioned 09/10/2017
Rapid review completed 27/11/2017
Rapid review outcome A full pharmacoeconomic evaluation is recommended
Full pharmacoeconomic assessment commissioned by HSE 29/11/2017
Pre-submission consultation with Applicant 23/01/2018
Full submission received from Applicant 21/09/2018
Preliminary review sent to Applicant 30/11/2018
NCPE assessment re-commenced 20/12/2018
Factual accuracy sent to Applicant 05/02/2019
NCPE assessment re-commenced 13/02/2019
NCPE assessment completed 15/03/2019
NCPE assessment outcome The NCPE recommends that daratumumab combination (Darzalex®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.*

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

Technical Summary

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

Decitabine (Dacogen®)

Assessment Status Rapid review complete
HTA ID -
Drug Decitabine
Brand Dacogen®
Indication For AML in patients who are >65yrs who are not candidates for standard induction therapy
Assessment Process
Rapid review commissioned 08/11/2012
Rapid review completed 13/12/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended

05/12/2013  Following additional commercial discussions the HSE has approved reimbursement of Decitabine (Dacogen®) in the hospital setting.

Durvalumab (Imfinzi®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Durvalumab
Brand Imfinzi®
Indication For the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC)  in adults whose tumours express PD-L1 ≥1% on tumour cells and whose disease has not progressed following platinum-based chemo-radiation therapy (CRT).
Assessment Process
Rapid review commissioned 29/03/2019
Rapid review completed 29/04/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of durvalumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 01/05/2019
Pre-submission consultation with Applicant 10/06/2019
Full submission received from Applicant 30/08/2019
Preliminary review sent to Applicant 20/12/2019
NCPE assessment re-commenced 30/01/2020
Factual accuracy sent to Applicant 16/04/2020
NCPE assessment re-commenced 24/04/2020
NCPE assessment completed 07/05/2020
NCPE assessment outcome The NCPE recommends that durvalumab be considered for reimbursement if cost effectiveness can be improved relative to existing treatments.*

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

Technical Summary

Plain English Summary

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

Eltrombopag (Revolade®)

Assessment Status Rapid review complete
HTA ID -
Drug Eltrombopag
Brand Revolade®
Indication For adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy
Assessment Process
Rapid review commissioned 10/01/2014
Rapid review completed 13/02/2014
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (Stribild®)

Assessment Status Rapid review complete
HTA ID -
Drug Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (as fumerate)
Brand Stribild®
Indication For the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to the three antiretroviral agents in Stribild®.
Assessment Process
Rapid review commissioned 28/04/2013
Rapid review completed 17/05/2013
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended

06/12/2013 Following commercial discussions with Gilead, the HSE has approved hospital pricing of Stribild®

Ertugliflozin (Steglatro®)

Assessment Status Rapid review complete
HTA ID -
Drug Ertugliflozin
Brand Steglatro®
Indication For the treatment of the treatment 2 diabetes mellitus (T2DM) in individuals 18 years and over to improve glycaemic control.
Assessment Process
Rapid review commissioned 13/03/2018
Rapid review completed 21/05/2018
Rapid review outcome A full pharmacoeconomic assessment is not recommended. The NCPE recommends that ertugliflozin be considered for reimbursement in accordance with the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.

The HSE has approved reimbursement; July 2018

Everolimus (Afinitor®)

Assessment Status Rapid review complete
HTA ID -
Drug Everolimus
Brand Afinitor®
Indication Treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor
Assessment Process
Rapid review commissioned 21/06/2012
Rapid review completed 12/10/2012
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.

Everolimus (Votubia®)

Assessment Status Rapid review complete
HTA ID -
Drug Everolimus
Brand Votubia®
Indication For the treatment of patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery
Assessment Process
Rapid review commissioned 30/09/2011
Rapid review completed 14/10/2011
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.

Ferumoxytol (Rienso®)

Assessment Status Assessment process complete
HTA ID -
Drug Ferumoxytol
Brand Rienso®
Indication For the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD). 
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 12/08/2012
NCPE assessment completed 17/08/2012
NCPE assessment outcome Full pharmacoeconomic evaluation not recommended.

Fidaxomicin (Dificlir®)

Assessment Status Assessment process complete
HTA ID -
Drug Fidaxomicin
Brand Dificlir®
Indication For the treatment of CDI also known as CDAD in adult patients. Rapid Review
Assessment Process
Rapid review commissioned 09/03/2012
Rapid review completed 23/03/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended.
Full pharmacoeconomic assessment commissioned by HSE 05/12/2012
NCPE assessment completed 05/02/2013
NCPE assessment outcome Reimbursement recommended.

Fidaxomicin (Dificlir®) may be considered a cost-effective use of resources. It should be prescribed according to the recommendations outlined in the recently updated National Clostridium difficile Guidelines (due to be completed in February 2013 www.hpsc.ie).

 

Technical Summary

Fluticasone furoate/vilanterol (Relvar™ Ellipta™)

Assessment Status Rapid Review Complete
HTA ID -
Drug Fluticasone furoate/vilanterol
Brand Relvar™ Ellipta™
Indication For both (i) the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta-2-agonist. and (ii) for symptomatic treatment of patients with COPD with a FEV1<70% of predicted normal (post-bronchodilator) in patients with an exacerbation history despite regular bronchodilator therapy.
Assessment Process
Rapid review commissioned 10/12/2013
Rapid review completed 23/12/2013
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Follitropin delta (Rekovelle®)

Assessment Status Assessment process complete
HTA ID -
Drug Follitropin delta
Brand Rekovelle®
Indication For controlled ovarian stimulation (COS) for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Assessment Process
Rapid review commissioned 25/07/2017
Rapid review completed 15/08/2017
Rapid review outcome Full pharmacoeconomic assessment recommended at submitted price.

Reimbursement approved following new price application – February 2019.

Gilteritinib (Xospata®) for Relapsed or Refractory AML. HTA ID: 19043

Assessment Status Assessment process complete
HTA ID 19043
Drug Gilteritinib
Brand Xospata®
Indication For the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with an FLT3 mutation.
Assessment Process
Rapid review commissioned 14/10/2019
Rapid review completed 29/11/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of gliterinib compared with the current standard of care.*
Full pharmacoeconomic assessment commissioned by HSE 02/12/2019
Pre-submission consultation with Applicant 03/02/2020
Full submission received from Applicant 12/06/2020
Preliminary review sent to Applicant 23/10/2020
NCPE assessment re-commenced 23/11/2020
Factual accuracy sent to Applicant 04/02/2021
NCPE assessment re-commenced 11/02/2021
NCPE assessment completed 03/03/2021
NCPE assessment outcome The NCPE recommends that gilteritinib (Xospata®) should not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Plain English Summary

Technical-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.

Glycopyrronium bromide (Seebri Breezhaler®)

Assessment Status Assessment process complete
HTA ID -
Drug Glycopyrronium bromide
Brand Seebri Breezhaler®
Indication As a maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD).
Assessment Process
Rapid review commissioned 12/08/2012
Rapid review completed 17/08/2012
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Ibrutinib (Imbruvica®) for previously untreated CLL

Assessment Status Rapid Review Complete
HTA ID -
Drug Ibrutinib
Brand Imbruvica®
Indication For the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). This indication is an extension to the original licence in the relapsed/refractory setting.
Assessment Process
Rapid review commissioned 02/08/2016
Rapid review completed 24/08/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended

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

Icatibant (Firazyr®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Icatibant
Brand Firazyr®
Indication For symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (type I and II HAE).
Assessment Process
Rapid review commissioned 22/07/2013
Rapid review completed 31/07/2013
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Ingenol mebutate gel (Picato®)

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

Inotersen (Tegsedi®). HTA ID: 19034

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

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

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations – August 2022.

Insulin Degludec (Tresiba®)

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

Technical Summary

December 2015

The HSE has approved reimbursement following confidential price negotiations.

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

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

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

Ivacaftor (Kalydeco®)

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

21 January 2013

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

Technical Summary

01 February  2013

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

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

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

Technical Summary

The HSE has approved reimbursement following confidential price negotiations.

Larotrectinib (Vitrakvi®). HTA ID: 19050

Assessment Status NCPE Assessment Process Complete
HTA ID 19050
Drug Larotrectinib
Brand Vitrakvi®
Indication For patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion.
Assessment Process
Rapid review completed 13/01/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of larotrectinib compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 20/01/2020
Pre-submission consultation with Applicant 20/04/2020
Full submission received from Applicant 11/02/2021
Preliminary review sent to Applicant 16/07/2021
NCPE assessment re-commenced 30/08/2021
Follow-up to preliminary review sent to Applicant 10/09/2021
NCPE assessment re-commenced 15/09/2021
Additional follow-up to Preliminary Review sent to Applicant 05/10/2021
NCPE assessment re-commenced 13/10/2021
Factual accuracy sent to Applicant 22/10/2021
NCPE assessment re-commenced 03/11/2021
NCPE assessment completed 23/11/2021
NCPE assessment outcome The NCPE recommends that larotrectinib (Vitrakvi®) not be recommended for reimbursement, unless cost effectiveness can be improved relative to existing treatments*.

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

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations; May 2023

Levodopa 20mg/ml + carbidopa monohydrate 5mg intestinal gel (Duodopa®)

Assessment Status Assessment process complete
HTA ID -
Drug Levodopa 20mg/ml + carbidopa monohydrate 5mg intestinal gel
Brand Duodopa®
Indication For the treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. A positive test of the clinical response to Duodopa® administered via a temporary nasoduodenal tube is required before a permanent tube is inserted.
Assessment Process
Rapid review commissioned 13/03/2013
Rapid review completed 16/04/2013
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 25/06/2018
Pre-submission consultation with Applicant 05/07/2018
Full submission received from Applicant 10/09/2018
Preliminary review sent to Applicant 05/12/2018
NCPE assessment re-commenced 14/01/2019
Follow-up to preliminary review sent to Applicant 30/01/2019
NCPE assessment re-commenced 15/02/2019
Factual accuracy sent to Applicant 19/03/2019
NCPE assessment re-commenced 02/04/2019
NCPE assessment completed 14/06/2019
NCPE assessment outcome The NCPE recommends that levodopa and carbidopa intestinal gel (Duodopa®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. 

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

Technical Summary

Levonorgestrel intrauterine system LNG-IUS (Jaydess®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Levonorgestrel intrauterine system LNG-IUS
Brand Jaydess®
Indication For contraception for up to three years.
Assessment Process
Rapid review commissioned 07/03/2013
Rapid review completed 25/03/2013
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended