Apixaban (Eliquis®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Apixaban
Brand Eliquis®
Indication For the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.
Assessment Process
Rapid review commissioned 19/10/2021
Rapid review completed 02/11/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 01/02/2012
NCPE assessment completed 19/06/2012
NCPE assessment outcome The NCPE believe that apixaban is cost effective for the prevention of VTE following total hip replacement and total knee replacement.

Apremilast (Otezla®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Apremilast
Brand Otezla®
Indication For moderate to severe chronic plaque psoriasis.
Assessment Process
Rapid review commissioned 24/02/2015
Rapid review completed 03/04/2015
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 28/07/2015
NCPE assessment completed 27/01/2016
NCPE assessment outcome Reimbursement Not Recommended at the Submitted Price.

Technical Summary

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

Apremilast (Otezla®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Apremilast
Brand Otezla®
Indication Alone or in combination with DMARDs, for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
Assessment Process
Rapid review commissioned 24/02/2015
Rapid review completed 03/04/2015
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 01/09/2015
NCPE assessment completed 29/04/2016
NCPE assessment outcome Reimbursement Not Recommended at the Submitted Price.

Technical Summary

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

Colorectal Cancer Screening programme

Health Technology Assessment (HTA) of population-based colorectal cancer screening programme in Ireland

This HTA was prepared by the National Cancer Registry Ireland, the National Centre for Pharmacoeconomics, the School for Health & Related Research, Sheffield University and Dublin City University.  It is available on the HIQA website.

Website Link

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.

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.

Fingolimod (Gilenya®)

Assessment Status Full Assessment Complete
HTA ID -
Drug Fingolimod
Brand Gilenya®
Indication For the treatment of highly active relapsing-remitting multiple sclerosis.
Assessment Process
Rapid review commissioned 03/12/2010
Rapid review completed 03/01/2011
Rapid review outcome Full Pharmaconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE 03/06/2011
NCPE assessment completed 20/09/2011
NCPE assessment outcome Reimbursement not recommended at the submitted price.

22nd September 2011

Following a price revision we now consider Fingolimod (Gilenya®) a cost-effective therapy for the treatment of relapsing-remitting multiple sclerosis patients in the Irish healthcare setting.

 

Technical Summary

Glucosamine sulfate (Dona®)

Assessment Status Assessment process complete
HTA ID -
Drug Glucosamine sulfate
Brand Dona®
Indication For the treatment of oestoarthritis in the Irish Healthcare setting.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 04/05/2009
NCPE assessment completed 01/06/2009
NCPE assessment outcome Reimbursement not recommended.

Idebenone (Raxone®)

Assessment Status Assessment process complete
HTA ID -
Drug Idebenone
Brand Raxone®
Indication For the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).
Assessment Process
Rapid review commissioned 10/02/2016
Rapid review completed 14/04/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 28/06/2017
Pre-submission consultation with Applicant 25/07/2017
Full submission received from Applicant 17/11/2017
Preliminary review sent to Applicant 10/05/2018
NCPE assessment re-commenced 22/06/2018
Factual accuracy sent to Applicant 30/07/2018
NCPE assessment re-commenced 15/08/2018
NCPE assessment completed 28/08/2018
NCPE assessment outcome The NCPE recommends that idebenone 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

Plain English Summary

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

Idelalisib (Zydelig®)

Assessment Status Assessment process complete
HTA ID -
Drug Idelalisib
Brand Zydelig®
Indication In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Assessment Process
Rapid review commissioned 08/12/2014
Rapid review completed 30/12/2014
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 04/06/2015
NCPE assessment completed 16/02/2016
NCPE assessment outcome Reimbursement not recommended.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations December 2016.

Ireland, as part of Beneluxa, extends its collaborative network.

The Beneluxa collaboration has issued a joint statement with the Nordic Pharmaceutical Forum.  The statement reiterates the importance of cost effectiveness in the assessment of value for medicines as well as the challenges with the lack of availability of robust clinical evidence for decision makers in a timely manner. Joint working on these problems is at the heart of this collaboration.

Joint statement Beneluxa and NPF

Lixisenatide (Lyxumia®)

Lixisenatide (Lyxumia®) for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.

Rapid Review

Commenced Completed Outcome
21/03/2013 10/04/2013 Full Pharmacoeconomic Evaluation Recommended

Pharmacoeconomic Evaluation

Commenced Completed Outcome
04/12/2013  07/08/2014 Reimbursement not Recommended

The NCPE does not recommend reimbursement of lixisenatide for patients with type 2 diabetes mellitus at the submitted price.

Summary

Melatonin (Circadin®)

Assessment Status Full HTA Assessment
HTA ID -
Drug Melatonin
Brand Circadin®
Indication Prolonged release melatonin (Circadin®) for the short-term treatment of primary insomnia.
Assessment Process
Full submission received from Applicant 01/08/2008
NCPE assessment completed 21/10/2008
NCPE assessment outcome Reimbursement not recommended.

Technical Summary

We believe that there is currently insufficient evidence to support the reimbursement of this product under the Community Drugs Schemes.

Mepolizumab (Nucala®) 100mg powder for solution for injection

Assessment Status Assessment Process Complete
HTA ID -
Drug Mepolizumab
Brand Nucala®
Indication Is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
Assessment Process
Rapid review commissioned 16/03/2016
Rapid review completed 04/04/2016
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 29/07/2016
NCPE assessment completed 01/03/2017
NCPE assessment outcome Reimbursement Not Recommended at the Submitted Price.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations May 2018

NCPE Head of Strategy appointed as European HTA Coordination group Chair

Dr. Roisin Adams, NCPE elected as Chair of the Health Technology Assessment Coordination Group.On 28 November 2022, the HTA Coordination Group (HTACG) elected its Chair, Dr. Roisin Adams, National Centre for Pharmacoeconomics, Ireland and co-chairs, Niklas Hedberg Dental and Pharmaceuticals Benefits Agency, Sweden and Marco Marchetti, National Agency for Regional Healthcare Services, Italy (1). At this meeting the Coordination Group also recommended the establishment of a single coordinating group with expertise from both pharmaceutical technologies and medical devices for the implementing phase of the Regulation as well as establishment of four subgroups.

Dr. Adams said “It is an honour to be elected to this position by the Member States.  I look forward to contributing towards this new system that will evaluate comparative evidence for new medicines which will ultimately facilitate more efficient decisions which impact  patients.”

The HTA Coordination Group is the main governance body established under the HTA legislation and under which Joint Clinical Assessments and Joint Scientific Consultations for both pharmaceutical technologies and medical devices will be undertaken following established methodological procedures.

The Regulation on HTA entered into force in January 2022 and will fully apply as of January 2025 (2).  Its purpose is to strengthen the quality of HTA in the European Union and ensure efficiency in the evaluation of new medicines and technologies in a consistent way across member states.

The NCPE has greatly developed Strategic European and International Collaboration for Health Technology Assessment over recent years. The Beneluxa Initiative and the International Horizon Scanning Initiative are further examples of Irelands commitment to joint working and collaboration.

Further information:

Dr Roisin Adams is Head of Strategy and External Engagement at the National Centre for Pharmacoeconomics.

Health Technology Assessment is used to evaluate new technologies and medicines and is a key step in supporting decisions about which medicines get reimbursed by state schemes and at what price.

Further sources:

 

Oncotype DX®

Cost-effectiveness of Oncotype DX® to target chemotherapy use in lymph-node-negative, oestrogen-receptor-positive, early-stage breast cancer in Ireland.

Pharmacoeconomic Evaluation

Commenced Completed Outcome
24/05/2011 22/07/2011 Reimbursement not recommended at the submitted price

3rd October 2011

Following a price revision the NCPE now consider Oncotype DX a cost-effective therapy to target chemotherapy use in lymph-node-negative, oestrogen-receptor-positve, early stage breast cancer in Ireland.

Oncotype DX summary

 

July 2013

The HSE has approved reimbursement following confidential price negotiations.

Patient Education Programme

The NCPE are delighted to facilitate  the delivery of the HTA module of the IPPOSI Pilot Patient Education Programme, commencing this Monday 22nd January. This module will provide students with a detailed knowledge of the principals of HTA, and has been adapted by the NCPE to provide particular insight into the practice of HTA in the Irish setting. Delivery of this module is part of the NCPE’s wider initiative to collaborate with patient groups during the HTA process.’

http://www.ipposi.ie/2018/01/17/patient-education-health-technology-assessment/

Pneumococcal Vaccination

Economic evaluation of a universal childhood pneumococcal conjugate vaccination strategy in Ireland

PCV13 is the most cost-effective option if the analysis is based on a serotype distribution reflecting 2011 data.
download document

Rotavirus Vaccine

Cost effectiveness analysis of a universal infant rotavirus vaccination programme in Ireland.

In January 2010, the National Centre for Pharmacoeconomics completed the evaluation of the cost-effectiveness of a universal rotavirus vaccination programme in Ireland, on behalf of the National Immunisation Advisory Committee (NIAC). A summary of the main findings are available in the attached document.

Rotavirus Vaccine summary

Teduglutide (Revestive®)

Assessment Status Assessment process complete
HTA ID -
Drug Teduglutide
Brand Revestive®
Indication For the treatment of patients aged 1 year and above with short bowel syndrome. Patients should be stable following a period of intestinal adaptation.
Assessment Process
Rapid review commissioned 13/03/2017
Rapid review completed 12/04/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 12/04/2017
Pre-submission consultation with Applicant 15/05/2017
Full submission received from Applicant 31/07/2017
Preliminary review sent to Applicant 21/11/2017
NCPE assessment re-commenced 05/12/2017
Factual accuracy sent to Applicant 06/02/2018
NCPE assessment re-commenced 21/02/2018
NCPE assessment completed 16/03/2018
NCPE assessment outcome Reimbursement Not Recommended.

Technical Summary

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

Universal Infant Hepatitis B Vaccination programme

Cost effectiveness analysis of a universal infant hepatitis B vaccination programme in Ireland

 

In October 2006, the National Centre for Pharmacoeconomics conducted an economic evaluation of the cost-effectiveness of a universal hepatitis B vaccination programme, for the Health Protection Surveillance Centre/National Immunisation Advisory Committee. A summary of the main findings are available in the attached document.

 

Universal Infant Hepatitis B Vaccine Programme summary

Upcoming NCPE webinar: Making A Patient Organisation Submission to the NCPE

 

This webinar is open to members of Patient Organisations who would like to find out more about the NCPE Patient Organisation Submission Process.

Joan O’Callaghan and Dr. Laura Mc Cullagh will cover topics including:

  • Why make a Patient Organisation submission?
  • Overview of the Patient Organisation Submission Process
  • Interpreting NCPE recommendations
  • What happens after the NCPE recommendation?
  • Gathering information: Tips and Tools
  • Presenting your findings
  • Useful resources

The webinar will be held on Tuesday 9th April from 12.30pm to 2pm.

The registration form can be found below. Queries can be sent to [email protected].

 

Making a Patient Organisation Submission to the NCPE

Contact Details

Name(Required)
Email(Required)

Update to Full Submission Template

Version 3.0 of the Full HTA Submission Template is available here. This template, to be completed by Applicants, outlines the content and format of the written submission to the NCPE as part of a full HTA. For those companies who have already started to prepare a full HTA submission, the previous version of the template (Version 2.1) will be acceptable until 01 July 2023.

 

Update to the Budget Impact Model Template

Version 1.8 of this template was published on 08 May 2023 and replaces version 1.7.  The new version is available here

For those companies who have already started to prepare a Budget Impact Model, the previous version of the template (Version 1.7) will be acceptable until 01 August 2023.

Updated NCPE Rapid Review Applicant Submission Template

This template, to be completed by Applicants, is intended to provide a summary of information to facilitate the rapid review process.  Version 2.1 of this template was published on 07 April 2022 and replaces version 2.0. Submissions using the old template (version 2.0) will be accepted until 12 May 2022, after which time only submissions using v 2.1 will be accepted. Version 2.1 includes a requirement to submit the NCPE Budget Impact Model Template for all Rapid Review submissions. Further information may be requested from the NCPE if necessary.  Please email [email protected].

RR Submission template v 2.1