Helen O’Donnell

Mannitol Dry Powder (Bronchitol®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Mannitol Dry Powder
Brand Bronchitol®
Indication Mannitol dry powder for inhalation for the treatment of cystic fibrosis (CF)
Assessment Process
Rapid review commissioned 11/09/2012
Rapid review completed 21/09/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 14/03/2014
NCPE assessment completed 29/08/2014
NCPE assessment outcome Reimbursement not recommended

Technical Summary 2014

Assessment Status Rapid Review Complete
Rapid review received 02/04/2019
Rapid review completed 29/04/2019
Rapid review outcome A full HTA is not recommended. The NCPE recommends that Mannitol Dry Powder (Bronchitol®) 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.

Midostaurin (Rydapt®) for AML

Assessment Status Assessment Process Complete
HTA ID -
Drug Midostaurin
Brand Rydapt®
Indication Is indicated in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive.
Assessment Process
Rapid review commissioned 13/08/2018
Rapid review completed 10/09/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of midostaurin compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 19/09/2018
Pre-submission consultation with Applicant 15/10/2018
Full submission received from Applicant 20/12/2018
Preliminary review sent to Applicant 25/06/2019
NCPE assessment re-commenced 12/08/2019
Factual accuracy sent to Applicant 24/10/2019
NCPE assessment re-commenced 11/11/2019
NCPE assessment completed 04/12/2019
NCPE assessment outcome The NCPE recommends midostaurin (Rydapt®) for AML 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 October 2021

Midostaurin (Rydapt®) for ASM

Assessment Status Suspended
HTA ID -
Drug Midostaurin
Brand Rydapt®
Indication Midostaurin is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL).
Assessment Process
Rapid review commissioned 13/08/2018
Rapid review completed 10/09/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of midostaurin compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 19/09/2018
Pre-submission consultation with Applicant 16/10/2018
NCPE assessment outcome This appraisal has been suspended until further evidence and analyses are included in a re-submission. An update on the appraisal and associated timelines will be provided in due course.

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

Mirabegron (Betmiga®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Mirabegron
Brand Betmiga®
Indication Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
Assessment Process
Rapid review commissioned 19/12/2012
Rapid review completed 12/03/2013
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Nivolumab (Opdivo®) as monotherapy for the adjuvant treatment of adults with melanoma

Assessment Status Assessment Process Complete
HTA ID -
Drug Nivolumab
Brand Opdivo®
Indication As monotherapy for the adjuvant treatment of adults with melanoma  with involvement of lymph nodes or metastatic disease who have undergone complete resection.
Assessment Process
Rapid review commissioned 09/07/2018
Rapid review completed 27/07/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nivolumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 01/08/2018
Pre-submission consultation with Applicant 03/09/2018
Full submission received from Applicant 30/11/2018
Preliminary review sent to Applicant 26/03/2019
NCPE assessment re-commenced 25/04/2019
Factual accuracy sent to Applicant 10/09/2019
NCPE assessment re-commenced 17/09/2019
NCPE assessment completed 13/10/2019
NCPE assessment outcome The NCPE recommends that nivolumab 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 February 2021.

Nusinersin (Spinraza®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Nusinersen
Brand Spinraza®
Indication Is indicated for the treatment of 5q spinal muscular atrophy (SMA)
Assessment Process
Rapid review commissioned 11/07/2017
Rapid review completed 02/08/2017
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE 14/08/2017
Pre-submission consultation with Applicant 12/09/2017
Full submission received from Applicant 31/10/2017
Preliminary review sent to Applicant 28/11/2017
NCPE assessment re-commenced 06/12/2017
Factual accuracy sent to Applicant 08/12/2017
NCPE assessment re-commenced 14/12/2017
NCPE assessment completed 19/12/2017
NCPE assessment outcome Reimbursement Not Recommended at the Submitted Price.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations July 2019.

Olaparib (Lynparza®) tablets for BRCA-mutated platinum sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer

Assessment Status Rapid Review Complete
HTA ID -
Drug Olaparib
Brand Lynparza®
Indication As monotherapy for the maintenance treatment of adult patients with BRCA-mutated platinum sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. This is a sub-group of the entire licensed population.
Assessment Process
Rapid review commissioned 23/07/2019
Rapid review completed 06/08/2019
Rapid review outcome A full HTA is not recommended. The NCPE recommends that olaparib 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.

Omega-3-acid ethyl esters (Omacor®)

Assessment Status Assessment process complete
HTA ID -
Drug Omega-3-acid ethyl esters
Brand Omacor®
Indication As an adjuvant treatment in secondary prevention after myocardial infarction in addition to other standard therapy.  Omacor® is also indicated for the treatment of endogenous hypertriglyceridaemia as a supplement to diet, when dietary measures alone are insufficient to produce an adequate response.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 11/02/2013
NCPE assessment completed 19/04/2013
NCPE assessment outcome Reimbursement not recommended.

The NCPE believe that Omacor® is not a cost-effective adjuvant treatment for patients post-myocardial infarction in the Irish Healthcare Setting.  The cost effectiveness of Omacor® for treatment of endogenous hypertriglyceridaemia as a supplement to diet has not been demonstrated.

Technical Summary

Pembrolizumab (Keytruda®) 1L NSCLC with chemotherapy

Assessment Status Assessment process complete
HTA ID -
Drug Pembrolizumab
Brand Keytruda®
Indication In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.
Assessment Process
Rapid review commissioned 14/08/2018
Rapid review completed 29/08/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 14/09/2018
Pre-submission consultation with Applicant 22/10/2018
Full submission received from Applicant 20/12/2018
Preliminary review sent to Applicant 14/06/2019
NCPE assessment re-commenced 10/07/2019
Factual accuracy sent to Applicant 31/07/2019
NCPE assessment re-commenced 09/08/2019
NCPE assessment completed 15/08/2019
NCPE assessment outcome The NCPE recommends that pembrolizumab (Keytruda®), prescribed in combination with platinum chemotherapy plus pemetrexed for the first line treatment of non-squamous NSCLC, 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 Medial Goods) Act 2013.

Technical Summary

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

Pembrolizumab (Keytruda®) for classical Hodgkin Lymphoma. HTA ID: 21013

Assessment Status Rapid Review Complete
HTA ID 21013
Drug Pembrolizumab
Brand Keytruda®
Indication For the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.
Assessment Process
Rapid review commissioned 29/03/2021
Rapid review completed 14/05/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab 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 February 2022.

Pembrolizumab (Keytruda®) for NSCLC (second line)

Assessment Status Assessment Process Complete
HTA ID -
Drug Pembrolizumab
Brand Keytruda®
Indication Is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received approved therapy for these mutations prior to receiving pembrolizumab.
Assessment Process
Rapid review commissioned 03/08/2016
Rapid review completed 24/08/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 31/08/2016
Pre-submission consultation with Applicant 10/10/2016
Full submission received from Applicant 21/07/2017
Preliminary review sent to Applicant 23/10/2017
NCPE assessment re-commenced 06/03/2018
Factual accuracy sent to Applicant 17/05/2018
NCPE assessment re-commenced 25/05/2018
NCPE assessment completed 28/05/2018
NCPE assessment outcome The NCPE recommends that pembrolizumab (Keytruda) be considered for reimbursement if 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.

Reimbursement application withdrawn (November 2018)

Perampanel (Fycompa®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Perampanel
Brand Fycompa®
Indication For treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
Assessment Process
Rapid review commissioned 12/07/2013
Rapid review completed 26/07/2013
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Pertuzumab (Perjeta®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Pertuzumab
Brand Perjeta®
Indication The proposed licensed indication is for use (in combination with trastuzumab and docetaxel) in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. 
Assessment Process
Rapid review commissioned 14/01/2013
Rapid review completed 31/01/2013
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 02/05/2013
NCPE assessment completed 28/08/2013
NCPE assessment outcome Reimbursement not recommended

Technical Summary

The NCPE believes that pertuzumab in combination with trastuzumab and docetaxel is not a cost-effective treatment for adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy.

 

 

Piperaquine tetraphosphate/dihidroartemisinin (Eurartesim®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Piperaquine tetraphosphate/dihidroartemisinin
Brand Eurartesim®
Indication For uncomplicated malaria caused by the Plasmodium falciparum parasite
Assessment Process
Rapid review commissioned 22/05/2012
Rapid review completed 28/05/2012
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Polatuzumab vedotin (Polivy®). HTA ID: 19052

Assessment Status Assessment Process Complete
HTA ID 19052
Drug Polatuzumab vedotin
Brand Polivy®
Indication In combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant (HSCT).
Assessment Process
Rapid review commissioned 03/12/2019
Rapid review completed 27/01/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of polatuzumab vedotin (Polivy®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 26/02/2020
Pre-submission consultation with Applicant 31/03/2020
Full submission received from Applicant 10/07/2020
Preliminary review sent to Applicant 27/10/2020
NCPE assessment re-commenced 25/11/2020
Factual accuracy sent to Applicant 26/01/2021
NCPE assessment re-commenced 02/02/2021
NCPE assessment completed 16/02/2021
NCPE assessment outcome The NCPE recommends that polatuzumab vedotin (Polivy®) 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 December 2021.

Radium-223 (Xofigo®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Radium-223
Brand Xofigo®
Indication For the treatment of adults with castration resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.  It is for use in the hospital setting.
Assessment Process
Rapid review commissioned 28/11/2013
Rapid review completed 23/12/2013
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 11/04/2014
NCPE assessment completed 12/12/2014
NCPE assessment outcome Reimbursement not Recommended

The NCPE does not recommend reimbursement of radium-223 at the submitted price.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations December 2015.

Recombinant Human Parathyroid Hormone

Assessment Status Rapid Review Complete
HTA ID -
Drug Recombinant Human Parathyroid Hormone
Brand Natpar®
Indication Is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
Assessment Process
Rapid review commissioned 05/03/2018
Rapid review completed 21/05/2018
Rapid review outcome A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of Natpar 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.

Rifaximin (Targaxan®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Rifaximin
Brand Targaxan®
Indication Is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age. 
Assessment Process
Rapid review commissioned 09/07/2013
Rapid review completed 06/08/2013
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Ruxolitinib (Jakavi®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Ruxolitinib
Brand Jakavi®
Indication For the treatment of splenomegaly or disease-related symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
Assessment Process
Rapid review commissioned 01/08/2012
Rapid review completed 10/08/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 20/12/2012
NCPE assessment completed 09/07/2013
NCPE assessment outcome Reimbursement not Recommended

The NCPE do not consider ruxolitinib to be a cost effective treatment of splenomegaly or disease-related symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations July 2015.

Siponimod (Mayzent®). HTA ID: 19053

Assessment Status Assessment Process Complete
HTA ID 19053
Drug Siponimod
Brand Mayzent®
Indication For the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.
Assessment Process
Rapid review commissioned 03/12/2019
Rapid review completed 13/01/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of siponimod compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 27/01/2020
Pre-submission consultation with Applicant 02/03/2020
Full submission received from Applicant 20/05/2020
Preliminary review sent to Applicant 17/09/2020
NCPE assessment re-commenced 15/10/2020
Factual accuracy sent to Applicant 04/01/2021
NCPE assessment re-commenced 08/01/2021
NCPE assessment completed 25/02/2021
NCPE assessment outcome The NCPE recommends that siponimod 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 December 2021.

Sodium phenylbutyrate (Pheburane®)

Assessment Status Rapid review complete
HTA ID -
Drug Sodium phenylbutyrate
Brand Pheburane®
Indication As adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Assessment Process
Rapid review outcome Full Pharmacoeconomic Evaluation Not Recommended

Sofosbuvir/Velpatasvir (Epclusa®)

Assessment Status Rapid review complete
HTA ID -
Drug Sofosbuvir/Velpatasvir
Brand Epclusa®
Indication For the treatment of chronic hepatitis C virus (HCV) infection in adults
Assessment Process
Rapid review commissioned 12/07/2016
Rapid review completed 23/08/2016
Rapid review outcome Full pharmacoeconomic evaluation not recommended for HCV genotype 3 infection

TCD/NCPE Course on Evidence Synthesis

TCD/NCPE Course on Evidence Synthesis – 9th/ 10th September 2013

Trinity College Dublin in collaboration with the NCPE will run a 2 day course on evidence synthesis for health technology assessments (HTAs).  The course will provide an introduction to Bayesian analysis using WinBUGs, as applied to evidence synthesis for health economic evaluations.  The emphasis will be on practical examples of meta-analyses and mixed treatment comparisons. Code and software to carry out the analyses will be provided.  Prior knowledge of WinBUGs will not be necessary. To book a place on this course please contact  [email protected]

Course leaders: Professor Cathal Walsh and Dr. Susanne Schmitz

Cost: €500 for two days

 

R Project Training Course*   1st/2nd July 2013

Link

Tedizolid phosphate (Sivextro®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Tedizolid phosphate
Brand Sivextro®
Indication For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults
Assessment Process
Rapid review commissioned 07/05/2015
Rapid review completed 07/07/2015
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Tegafur/Gimeracil/Oteracil (Teysuno®)

Assessment Status Rapid Review Complete
Drug Tegafur/Gimeracil/Oteracil
Brand Teysuno®
Indication For the treatment of advanced gastric cancer.
Assessment Process
Rapid review commissioned 27/02/2012
Rapid review completed 23/03/2012
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Vacancies

A full-time temporary position for a Research Information Specialist.

All relevant information is available from the St James’s Hospital website. Closing date is 19th December 2019.

Enquiries regarding the position can be made to Dr. Lesley Tilson, Chief I Pharmacist (Tel:01 410 3427. Email: [email protected]) or Prof. Michael Barry, Clinical Director (Tel: 01 416 2191. Email: [email protected]).

 

 

Vedolizumab (Entyvio®). HTA ID: 20029

Assessment Status Rapid review complete
HTA ID 20029
Drug Vedolizumab
Brand Entyvio®
Indication For subcutaneous administration is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or an anti-TNFα.
Assessment Process
Rapid review commissioned 16/06/2020
Rapid review completed 12/08/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of vedolizumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

The HSE has approved reimbursement following confidential price negotiations October 2021

Vedolizumab (Entyvio®). HTA ID: 20030

Assessment Status Rapid review complete
HTA ID 20030
Drug Vedolizumab
Brand Entyvio®
Indication For subcutaneous administration is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or an anti-TNFα.
Assessment Process
Rapid review commissioned 16/06/2020
Rapid review completed 12/08/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of vedolizumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

The HSE has approved reimbursement following confidential price negotiations October 2021