Arekibo

Liraglutide (Victoza®)

Assessment Status Assessment process complete
HTA ID -
Drug Liraglutide
Brand Victoza®
Indication For treatment of adults with type 2 diabetes mellitus.
Assessment Process
Rapid review commissioned 01/09/2009
Rapid review completed 07/10/2009
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended
Full pharmacoeconomic assessment commissioned by HSE 26/10/2016
Pre-submission consultation with Applicant 21/02/2017
Full submission received from Applicant 29/08/2017
Preliminary review sent to Applicant 17/08/2018
NCPE assessment re-commenced 30/10/2018
Factual accuracy sent to Applicant 07/02/2019
NCPE assessment re-commenced 18/02/2019
NCPE assessment completed 07/03/2019
NCPE assessment outcome The NCPE recommends that liraglutide (Victoza®) 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

Lornoxicam (Xefo®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Lornoxicam
Brand Xefo®
Indication For the short-term relief of acute mild to moderate pain and symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis
Assessment Process
Rapid review commissioned 23/06/2011
Rapid review completed 07/07/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Lotemax 0.5% eye drops suspension (Loteprednol)

Assessment Status Rapid Review Complete
HTA ID -
Drug Loteprednol
Brand Lotemax 0.5% eye drops suspension
Indication For treatment of post-operative inflammation following ocular surgery.
Assessment Process
Rapid review commissioned 15/11/2011
Rapid review completed 05/12/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Mapping

A set of methods where one outcome measure (e.g. health related quality of life weights) are statistically predicted from one or more other measures.

Markov Model

A type of quantitative modelling that involves a specified set of mutually exclusive and exhaustive states (e.g. of a given health status), and for which there are transition probabilities of moving from one state to another (including remaining in the same state). Typically, states have a uniform time period, and transition probabilities remain constant over time.

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.

Meta-analyis

Systematic methods that use statistical techniques for combining results from different studies to obtain a quantitative estimate of the overall effect of a particular intervention or variable on a defined outcome. This combination may produce a stronger conclusion than can be provided by any individual study.

Micro-costing

costing approach based on detailed resources used by patient on item by item basis

Mifamurtide (Mepact®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Mifamurtide
Brand Mepact®
Indication For the treatment of osteosarcoma.
Assessment Process
Rapid review commissioned 22/06/2010
Rapid review completed 13/07/2010
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended

A formal PEA is required to demonstrate value for money prior to reimbursement.

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

Natalizumab (Tysabri®)

Assessment Status Full HTA Assessment
HTA ID -
Drug Natalizumab
Brand Tysabri®
Indication For the treatment of relapsing remitting multiple sclerosis that is rapidly evolving and severe or sub-optimally treated.
Assessment Process
NCPE assessment re-commenced 23/01/2007
NCPE assessment completed 03/04/2007
NCPE assessment outcome Reimbursement recommended.

Natalizumab could be considered borderline cost effective in the Irish healthcare setting. In view of the uncertainty surrounding some of the ICERs a follow up review is advised. The following report was prepared by the National Centre for Pharmacoeconomics and submitted on request to the Department of Health and Children.

Technical Summary

Nepafenac (Nevanac®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Nepafenac
Brand Nevanac®
Indication For the prevention and treatment of postoperative pain and inflammation associated with cataract surgery.
Assessment Process
Rapid review commissioned 14/06/2011
Rapid review completed 27/06/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Net benefit

Benefit (in monetary units) minus total cost (in monetary units)

Nilotinib (Tasigna®) CML resistant/intolerant to imatinib

Assessment Status Full HTA Assessment
HTA ID -
Drug Nilotinib CML resistant/intolerant to imatinib
Brand Tasigna®
Indication For the treatment of chronic phase CML.
Assessment Process
Full submission received from Applicant 03/01/2008
NCPE assessment completed 25/02/2008
NCPE assessment outcome Reimbursement not recommended

Technical Summary

The cost-effectiveness of nilotinib compared to dasatinib, in patients resistant to imatinib has not been demonstrated.

Nilotinib (Tasigna®) newly diagnosed CML

Assessment Status Rapid Review Complete
HTA ID -
Drug Nilotinib
Brand Tasigna®
Indication For the newly diagnosed Chronic Phase Philadelpha Chromosone positive CML.
Assessment Process
Rapid review commissioned 06/10/2010
Rapid review completed 22/10/2020
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended

Nomegestrol acetate/estradiol (Zoely®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Nomegestrol acetate/estradiol
Brand Zoely®
Indication Nomegestrol acetate/estradiol (Zoely®) oral contraception
Assessment Process
Rapid review commissioned 08/12/2011
Rapid review completed 03/01/2012
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Odds ratio (OR)

A measure of treatment effect that compares the probability of a type of outcome in the treatment group with the outcome of a control group, i.e. [Pt ÷ (1 – Pt)] [Pc ÷ (1 – Pc)].

Ofatumumab (Arzerra®) (Refractory CLL)

Assessment Status Rapid Review Complete
HTA ID -
Drug Ofatumumab
Brand Arzerra®
Indication For the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab.
Assessment Process
Rapid review commissioned 01/06/2010
Rapid review completed 22/06/2010
Rapid review outcome Full Pharmacoeconomic Assessment Recommended

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

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.

Opportunity Cost

The amount that could be spent on alternative healthcare strategies if the health technology in question was not used

Oxycodone/naloxone (Targin®)

Assessment Status Assessment process complete
HTA ID -
Drug Oxycodone/naloxone
Brand Targin®
Indication For severe pain, which can be adequately managed only with opioid analgesics.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 05/05/2010
NCPE assessment completed 12/07/2010

Technical Summary

13/07/2010
We do not recommend reimbursement of oxycodone/naloxone (Targin®) under the Community Drugs Schemes at the proposed price.

19/10/2010
Following a price revision oxycodone/naloxone (Targin®) is now reimbursed under the Community Drugs Schemes.

Paliperidone palmitate (Xeplion®)

 

 

Assessment Status Rapid Review Complete
HTA ID -
Drug Paliperidone palmitate
Brand Xeplion®
Indication For maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate, and a long acting injectable treatment is needed.
Assessment Process
Rapid review commissioned 23/03/2011
Rapid review completed 09/04/2011

Perspective

Viewpoint from which an economic evaluation is conducted e.g. healthcare payer, society, individual

Pharmacoeconomics

Pharmacoeconomics is the scientific discipline that evaluates the clinical, economic and humanistic aspects of pharmaceutical products to provide health care decision makers, providers and patients with valuable information for optimal outcomes and the allocation of health care resources. Pharmacoeconomics incorporates health economics, clinical evaluations, risk analysis, technology assessment, and health-related quality of life, epidemiology, decision sciences and health services research

Pirfenidone (Esbriet®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Pirfenidone
Brand Esbriet®
Indication For the treatment of mild to moderate idiopathic pulmonary fibrosis.
Assessment Process
Rapid review commissioned 15/12/2011
Rapid review completed 05/01/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 26/11/2012
NCPE assessment completed 20/03/2013
NCPE assessment outcome Reimbursement not Recommended

Technical Summary

The NCPE believe that, at the submitted price, pirfenidone is not cost-effective for the treatment of patients with mild to moderate Idiopathic Pulmonary Fibrosis.

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

Pitavastatin (Livazo®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Pitavastatin
Brand Livazo®
Indication Is indicated for the reduction of elevated TC and LDL-C, in adult patients with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia and combined (mixed) dyslipidaemia, when response to diet and other non-pharmacological measures are inadequate.
Assessment Process
Rapid review commissioned 22/12/2010
Rapid review completed 24/12/2010
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

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

Prasugrel (Efient®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Prasugrel
Brand Efient®
Indication For the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.
Assessment Process
Full submission received from Applicant 31/07/2009
NCPE assessment completed 01/02/2010
NCPE assessment outcome Reimbursement Recommended

Technical Summary

The review group consider that prasugrel, co-administered with aspirin, is cost-effective in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention in the Irish healthcare setting.

Probabilistic sensitivity analysis (PSA)

Type of sensitivity analysis in which probability distributions are specified for parameters (e.g., outcomes, costs, utilities) to capture the uncertainty around the true parameter value.  A Monte Carlo simulation is performed to generate a probability distribution of expected outcomes and costs

Probability distribution

Portrays the relative likelihood that a range of values is the true value of a treatment effect (or other outcome or result). This distribution may follow the form of a particular function, e.g., a normal, chi square, binomial, or Poisson distribution. An estimate of the most likely true value of the treatment effect is the value at the highest point of the distribution. The area under the curve between any two points along the range gives the probability that the true value of the treatment effect lies between those two points. Thus, a probability distribution can be used to determine an interval that has a designated probability (e.g. 95%) of including the true value of the treatment effect.

Productivity costs

The costs associated with lost or impaired ability to work because of morbidity or death.

Prucalopride (Resolor®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Prucalopride
Brand Resolor®
Indication For the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
Assessment Process
Rapid review commissioned 17/01/2011
Rapid review completed 29/03/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Prucalopride (Resolor®) is to be reimbursed under the Community Drugs Schemes subject to conditions.

Quality-adjusted life year (QALY)

A health outcome measure that adjusts years of life subsequent to an intervention by the quality of life during those years

Ranolazine (Ranexa®)

 

 

 

Assessment Status Rapid Review Complete
HTA ID -
Drug Ranolazine
Brand Ranexa®
Indication Cost-effectiveness of Ranolazine (Ranexa®)
Assessment Process
Rapid review completed 19/11/2009

Regadenoson (Rapiscan®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Regadenoson
Brand Rapiscan®
Indication Cost-effectiveness of Regadenoson (Rapiscan®)
Assessment Process
Rapid review commissioned 19/09/2011
Rapid review completed 02/11/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Relative risk (RR)

The ratio of (statistical) risk in the intervention group to the risk in the control group. A RR of one indicates no difference between comparison groups. For undesirable outcomes an RR that is less than one indicates that the intervention was effective in reducing the risk of that outcome.

Retigabine (Trobalt®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Retigabine
Brand Trobalt®
Indication Cost-effectiveness of Retigabine (Trobalt®)
Assessment Process
Rapid review commissioned 01/04/2011
Rapid review completed 06/04/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Rilpivirine (Edurant®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Rilpivirine
Brand Edurant®
Indication In combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
Assessment Process
Rapid review commissioned 14/12/2011
Rapid review completed 06/01/2012
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Rimonabant (Acomplia®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Rimonabant
Brand Acomplia®
Indication For the management of multiple cardiovascular risks in overweight or obese patients in Ireland
Assessment Process
NCPE assessment completed 01/06/2006

In June 2006, Sanofi-Aventis submitted an evaluation of the cost-effectiveness of rimonabant (in addition to diet and exercise) in the management of multiple cardiovascular risks in overweight or obese patients in Ireland, to support its application for reimbursement of rimonabant under the Community Drugs Schemes. The following report was prepared by the National Centre for Pharmacoeconomics and submitted on request to the Department of Health and Children.

Rimonabant (Acomplia) summary

Rivaroxaban (Xarelto®) for the Prevention of Stroke in Atrial Fibrillation

Assessment Status Assessment Process Complete
HTA ID -
Drug Rivaroxaban
Brand Xarelto®
Indication For the prevention of stroke in atrial fibrillation.
Assessment Process
Rapid review commissioned 17/08/2011
Rapid review completed 31/08/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 11/11/2021
NCPE assessment completed 02/04/2012
NCPE assessment outcome Reimbursement not Recommended

The NCPE do not believe that rivaroxaban is cost effective for this indication at the submitted price.

Technical Summary

19/06/2012

Following the NCPE pharmacoeconomic assessment (2/4/2012) the manufacturer reduced the price of rivaroxaban (23/5/2012).  At this revised price we now consider rivaroxaban cost effective for this indication.  A positive recommendation was made on the 19/06/2012.

Rivaroxaban (Xarelto®) for the Primary Prevention of Venous Thromboembolic Events after Total Hip/Knee Replacement

Assessment Status Full HTA Assessment
HTA ID -
Drug Rivaroxaban
Brand Xarelto®
Indication For the Primary Prevention of Venous Thromboembolic Events in Adult Patients who have Undergone Total Hip Replacement or Total Knee Replacement.
Assessment Process
Full submission received from Applicant 01/05/2008
NCPE assessment completed 18/09/2008
NCPE assessment outcome Reimbursement Recommended

A summary of the main findings are included in the attached document.

Technical Summary

Rivaroxaban (Xarelto®) for the Treatment of Deep Vein Thrombosis

Assessment Status Assessment Process Complete
HTA ID -
Drug Rivaroxaban
Brand Xarelto®
Indication For the Treatment of Deep Vein Thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
Assessment Process
Rapid review commissioned 17/08/2011
Rapid review completed 31/08/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 28/11/2011
NCPE assessment completed 24/02/2012
NCPE assessment outcome Cost effective at submitted price

We consider that at the submitted price Rivaroxaban could be considered cost-effective for this indication.

Technical Summary

Roflumilast (Daxas®)

Assessment Status Full HTA Assessment
HTA ID -
Drug Roflumilast
Brand Daxas®
Indication For the maintenance treatment of severe Chronic Obstructive Pulmonary Disease associated with chronic bronchitis in patients with a history of frequent exacerbations.
Assessment Process
Full submission received from Applicant 11/06/2010
NCPE assessment completed 03/11/2010
NCPE assessment outcome Reimbursement not Recommended

We do not recommend reimbursement of Roflumilast (Daxas®) under the Community Drugs Schemes.

Technical Summary

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

Sapropterin (Kuvan®)

Assessment Status Full HTA Assessment
HTA ID -
Drug Sapropterin
Brand Kuvan®
Indication For the treatment of phenylketonuria (PKU).
Assessment Process
NCPE assessment completed 18/06/2009
NCPE assessment outcome Reimbursement not Recommended

Technical Summary 2009

A new application for reimbursement was made to the HSE and a rapid review was commissioned  in July 2015

Assessment Process Assessment Process Complete
Rapid review commissioned 14/07/2015
Rapid review completed 14/08/2015
Rapid review outcome Full pharmacoeconomic assessment recommended
Full pharmacoeconomic assessment commissioned by the HSE 28/06/2016
Pre-submission consultation with Applicant 19/09/2016
Submission received from Applicant 01/02/2017
Preliminary review sent to Applicant 09/05/2017
NCPE assessment re-commenced 25/05/2017
Factual accuracy sent to Applicant 14/08/2017
NCPE assessment re-commenced 29/08/2017
NCPE assessment completed 15/09/2017
NCPE assessment outcome Reimbursement not Recommended

Technical Summary

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

Sensitivity analysis

A means of exploring the robustness of a mathematical model or analysis to determine how and whether changes in uncertain model inputs affect main results and conclusions of analysis.

Statistical significance

A conclusion that an intervention has a true effect, based upon observed differences in outcomes between the treatment and control groups that are sufficiently large so that these differences are unlikely to have occurred due to chance, as determined by a statistical test. Statistical significance indicates the probability that the observed difference was due to chance if the null hypothesis is true; it does not provide information about the magnitude of a treatment effect.

Sublingual Immunotherapy (Grazax®)

Assessment Status Rapid review complete
HTA ID -
Drug Sublingual Immunotherapy
Brand Grazax®
Indication For the Prevention of Seasonal Grass Pollen-Induced Rhinoconjunctivitis.
Assessment Process
Rapid review commissioned 01/09/2007
Rapid review completed 24/09/2007
Rapid review outcome Reimbursement not recommended

The cost-effectiveness of Grazax® remains to be established and this product cannot be recommended as value for money at this point in time.

Technical Summary

Sunitinib (Sutent®)

Assessment Status Assessment process complete
HTA ID -
Drug Sunitinib
Brand Sutent®
Indication As second-line treatment of patients with gastro-intestinal stromal tumours (GIST); As second line treatment for patients with metastatic renal cell carcinoma (mRCC) 
Assessment Process

Technical Summary

 

Systematic review

A form of structure literature review that addresses a question that is formulated to be answered by analysis of evidence, and involves objective means of searching the literature, applying predetermined inclusion and exclusion criteria to this literature, critically appraising the relevant literature, and extraction and synthesis of data from evidence base to formulate findings.