Update on Pharmacoeconomics in the Irish Healthcare Setting, 15th & 16th May 2019 in Dublin Castle.
News
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. |
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. |
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.
Covid updates
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.
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.
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. |
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.
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.
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. |
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. |
The HSE has approved reimbursement following confidential price negotiations May 2018
NCPE Head of Strategy appointed as European HTA Coordination group Chair
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:
- https://health.ec.europa.eu/latest-updates/flash-report-member-state-coordination-group-hta-htacg-28-november-2022-2022-11-28_en
- https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en
Notice for Applicants:
Notice for Applicants:
Please refer to updated versions of the Guidelines for Inclusion of Drug Costs v3.1, Applicant submission template v2. and the Budget Impact Model Template v1.5 when making submissions.
Guidelines for Inclusion of Drug Costs in Pharmacoeconomic Evaluations v3.1
Budget Impact Model Template v1.5
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.
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
Press Release HAG EUNETHTA21
Professor Michael Barry, Director of the National Centre for Pharmacoeconomics joins the inaugural Heads of Agency Group
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.
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. |
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.
Update on Pharmacoeconomics in the Irish Healthcare Setting 2020
Given the ongoing Covid-19 outbreak , the NCPE Annual Symposium “Update on Pharmacoeconomics in the Irish Healthcare Setting” is being postponed until later this year.
Further enquiries should be sent to [email protected]
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 Submission Templates
Notice to Applicants: Please refer to updated versions of the RR Submission Template v2.2, Applicant Template v2.1, and the Submission Checklist v1.4 when making submissions. These are available from the Submission Templates section of the website.
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].
