Abiraterone Acetate (Zytiga®) for mCRPC

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Abiraterone Acetate
Brand Zytiga®
Indication Treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior docetaxel-based chemotherapy.
Assessment Process
Rapid review commissioned 21/10/2011
Rapid review completed 02/11/2011
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full submission received from Applicant 12/12/2011
NCPE assessment completed 22/05/2012
NCPE assessment outcome Reimbursement not recommended at the submitted price

Technical Summary

May 2014

The HSE has approved reimbursement following confidential price negotiations.

Absolute risk

The probability of an event or outcome occurring in a defined population over a specified time period

Absolute risk reduction

A measure of treatment effect that compares the decrease in risk in the control group with that of a treatment group i.e. Pc – Pt

Adalimumab (Humira®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Adalimumab
Brand Humira®
Indication In combination with methotrexate for polyarticular juvenile idiopathic arthritis in children and adolescents (4-17yrs) in patients who have had an inadequate response to DMARDs.  Also licensed as monotherapy in cases of intolerance to MTX or when continued therapy with MTX is inappropriate.
Assessment Process
Rapid review commissioned 20/05/2011
Rapid review completed 02/06/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Adenuric (Febuxostat®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Adenuric
Brand Febuxostat®
Indication A xanthine oxidase inhibitor for the treatment of gout.
Assessment Process
Rapid review commissioned 15/11/2009
Rapid review completed 08/12/2009
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Adverse event

An undesirable effect of a health technology

Agomelatine (Valdoxan®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Agomelatine
Brand Valdoxan®
Indication For the treatment of major depressive disorder.
Assessment Process
Full submission received from Applicant 01/04/2009
NCPE assessment completed 03/09/2009
NCPE assessment outcome Reimbursement not recommended

3rd September 2009 – At the current price agomelatine (Valdoxan®) is not considered cost-effective for the treatment of major depressive episodes under the Community Drugs Schemes.

11th December 2009 – Following a revision in price application we now consider agomelatine (Valdoxan®) cost effective under the Community Drugs schemes.  The product will now be added to the list of items reimbursable under the schemes.

Technical Summary

Ambrisentan (Volibris®)

Assessment Status Full HTA Assessment
HTA ID -
Drug Ambrisentan
Brand Volibris®
Indication For the treatment of patients with Functional Class II or III pulmonary arterial hypertension.
Assessment Process
Full submission received from Applicant 24/10/2008
NCPE assessment completed 25/02/2009

A summary of the report that was prepared by the National Centre for Pharmacoeconomics and submitted to the HSE is included in the attached document.

Technical Summary

July 2014

In accordance with the Health Act (Pricing and Supply of Medical Goods) 2013 (section 18(4)), the HSE has requested the NCPE to re-examine the cost effectiveness of ambrisentan (Volibris®).

Assessment Status Rapid Review Complete
Rapid review commissioned 27/05/2014
Rapid review completed 04/07/2014
Rapid Review outcome Full Pharmacoeconomic Evaluation not Recommended.

 

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.

Asenapine (Sycrest®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Asenapine
Brand Sycrest®
Indication For the treatment of moderate to severe manic episodes associated with biopolar 1 disorder in adults.
Assessment Process
Rapid review commissioned 17/08/2011
Rapid review completed 06/09/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Azilsartan (Edarbi®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Azilsartan
Brand Edarbi®
Indication For the treatment of essential hypertension in adults.
Assessment Process
Rapid review commissioned 10/01/2012
Rapid review completed 11/01/2012
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Base Case

Analysis conducted using the set of preferred methods most appropriate for the decision-maker

Bayesian Method

A branch of statistics that uses prior information based on subjective opinion and objective evidence, such as the results of previous research, for estimation and inference

Bazedoxifene (Conbriza®)

Assessment Status Rapid Review complete
HTA ID -
Drug Bazedoxifene
Brand Conbriza®
Indication Treatment of postmenopausal osteoporosis in women at increased risk of fracture.  A significant reduction in the incidence of verterbral fractures has been demonstrated; efficacy on hip fractures has not been established.
Assessment Process
Rapid review commissioned 20/09/2011
Rapid review completed 02/11/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Belatacept (Nulojix®)

Assessment Status Rapid Review complete
HTA ID -
Drug Belatacept
Brand Nulojix®
Indication In combination with corticosteroids and a mycophenolic acid (MPA), for prophylaxis of graft rejection in adults receiving a renal transplant. It is recommended to add an interleukin (IL)-2 receptor antagonist for induction therapy to this belatacept-based regimen.
Assessment Process
Rapid review commissioned 15/11/2011
Rapid review completed 23/01/2012
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended

Belimumab (Benlysta®)

Assessment Status Rapid Review complete
HTA ID -
Drug Belimumab
Brand Benlysta®
Indication As add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.
Assessment Process
Rapid review commissioned 11/08/2011
Rapid review completed 31/08/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended

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

Bendamustine (Levact®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Bendamustine
Brand Levact®
Indication Treatment of Chronic Lymphocytic Leukaemia (CLL)
Assessment Process
Rapid review commissioned 01/03/2011
Rapid review completed 21/03/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 08/03/2012
NCPE assessment completed 20/11/2012
NCPE assessment outcome Reimbursement recommended

The NCPE  recommends reimbursement of bendamustine (Levact®) for patients unable to tolerate fludarabine/cyclophosphamide.

Technical Summary

Bias

Bias is any distorting influence that makes the results of a study an inaccurate reflection of the true situation

Bilastine (Drynol®)

Assessment Status Rapid Review complete
HTA ID -
Drug Bilastine
Brand Drynol®
Indication Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.
Assessment Process
Rapid review commissioned 10/03/2011
Rapid review completed 23/03/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Blinding

When patients, investigators, researchers and/or assessors are kept unaware of the allocation of treatments (investigational agent or control) to participants in a study

Boceprevir (Victrelis®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Boceprevir
Brand Victrelis®
Indication As add-on therapy to pegylated interferon and ribavirin for the treatment of patients infected with Hepatitis C Genotype 1.
Assessment Process
Full submission received from Applicant 19/08/2011
NCPE assessment completed 17/01/2012
NCPE assessment outcome Reimbursement Recommended

We consider boceprevir a highly cost-effective therapy when added to peginterferon-ribavirin for the treatment of patients infected with genotype 1 hepatitis C virus in the Irish healthcare setting.

Technical Summary

Budget Impact Analysis

Estimates the financial consequences of adoption and diffusion of a new health-care intervention within a specific health-care setting or system context given inevitable resource constraints.

Buprenorphine/Naloxone (Suboxone®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Buprenorphine/Naloxone
Brand Suboxone®
Indication Management of opiate addiction
Assessment Process
Full submission received from Applicant 02/01/2014
NCPE assessment completed 22/05/2014
NCPE assessment outcome Reimbursement Not Recommended

Pharmacoeconomic Evaluation completed in November 2007. Suboxone cannot be considered a cost effective option for patients attending HSE clinics or in the community setting in Ireland.

Technical Summary 2007

 

Pharmacoeconomic Reassessment completed in 2014. The NCPE does not consider Suboxone® to be cost-effective compared to methadone for the treatment of opioid dependence.

Technical Summary 2014

Cabazitaxel (Jevtana®)

Assessment Status NCPE Assessment process complete
HTA ID -
Drug Cabazitaxel
Brand Jevtana®
Indication Treatment of patients with hormone-refractory metastatic prostate cancer previously treated with docetaxel-containing treatment regimen.
Assessment Process
Rapid review commissioned 02/06/2011
Rapid review completed 09/06/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended.
Full submission received from Applicant 03/11/2011
NCPE assessment completed 13/03/2012
NCPE assessment outcome Reimbursement not recommended at the submitted price.

The NCPE believe that, at the submitted price, cabazitaxel is not cost-effective for the treatment of patients with mHRPC previously treated with a docetaxel-containing treatment regimen.

The HSE has approved reimbursement following confidential price negotiations; March 2014.

Technical Summary

Catumaxomab (Removab®)

Assessment Status Rapid Review complete
HTA ID -
Drug Catumazomab
Brand Removab®
Indication For the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Assessment Process
Rapid review commissioned 05/08/2011
Rapid review completed 06/09/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Certolizumab pegol (Cimzia®)

Assessment Status NCPE Assessment Process complete
HTA ID -
Drug Certolizumab pegol
Brand Cimzia®
Indication For the treatment of moderate to severe rheumatoid arthritis.
Assessment Process
Full submission received from Applicant 13/03/2010
NCPE assessment completed 02/09/2010
NCPE assessment outcome Reimbursement not Recommended.

The review group did not consider certolizumab cost-effective at the submitted price in September 2010.

The HSE has approved reimbursement following confidential price negotiations.

Technical Summary

Clinical outcome

An outcome of major clinical importance that is defined on the basis of the disease being studied (e.g. fracture in osteoporosis, relapse rates).

Clinical significance

A conclusion that an intervention has an effect that is of practical meaning to patients and health care providers. Effects identified as statistically significant are not always clinically significant, because the effect is small or the outcome is not important.

Clinical trial

A carefully controlled and monitored research study on human subjects or patients evaluating one or more health interventions.  Each trial is designed to answer specific scientific questions.

Colesevelam (Cholestagel®)

Assessment Status Rapid Review complete
HTA ID -
Drug Colesevelam
Brand Cholestagel®
Indication Hypercholesterolaemia
Assessment Process
Rapid review commissioned 19/10/2010
Rapid review completed 22/10/2010
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Collagenase Clostridium Histolyticum (Xiapex®)

Assessment Status Rapid Review complete
HTA ID -
Drug Collagenase Clostridium Histolyticum
Brand Xiapex®
Indication Treatment of Dupuytren’s contracture in adult patients with a palpable cord.
Assessment Process
Rapid review commissioned 20/05/2011
Rapid review completed 09/06/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

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

Comparative effectiveness

The ability of one treatment, relative to another, to demonstrate clinical effectiveness

Comparator

the alternative to which the intervention is compared

Corifollitropin alfa (Elonva®)

Assessment Status Rapid Review complete
HTA ID -
Drug Corifollitropin alfa
Brand Elonva®
Indication Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.
Assessment Process
Rapid review commissioned 22/09/2010
Rapid review completed 22/10/2010
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Cost

the value of opportunity forgone as a result of engaging resources in an activity

Cost benefit analysis (CBA)

An economic evaluation comparing alternative interventions in which costs and outcomes are quantified using the same monetary units

Cost consequences analysis

An economic evaluation in which the components of costs and consequences (health outcomes, adverse effects etc.) are measured and presented in their natural units, without any attempt to aggregate the outputs

Cost minimisation analysis (CMA)

An economic evaluation comparing the costs of different interventions that are assumed to produce equivalent benefits

Cost of illness analysis

A determination of the economic impact of a disease or health condition, including treatment costs.

Cost per QALY

A measure used in cost-utility-analysis, expressed as monetary cost per unit of outcome

Cost utility analysis (CUA)

An economic evaluation in which costs are measured in monetary units and outcomes are measured in terms of their utility e.g. using the quality adjusted life year (QALY).

Cost-effective

A technology is considered cost effective for a specified indication if the incremental benefits of the technology versus its comparator justify its incremental costs and harms; value for money

Cost-effectiveness analysis (CEA)

An economic evaluation in which costs are measured in monetary units and outcomes are measured in nonmonetary units related to health e.g. as life years gained or clinical events avoided

Cost-effectivenss plane

Graph plotting the difference in effect between the technology of interest and the comparator on the horizontal axis, and difference in costs on the vertical access.

Critical appraisal

The process of assessing and interpreting evidence by systematically considering its validity, results and relevance.

Dabigatran etexilate (Pradaxa®) – for the prevention of stroke and systematic embolisom in atrial fibrillation

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Dabigatran
Brand Pradaxa®
Indication For the prevention of stroke and systemic embolism in atrial fibrillation
Assessment Process
Full submission received from Applicant 02/11/2010
NCPE assessment completed 03/06/2011
NCPE assessment outcome Reimbursement not recommended

Technical Summary

03/10/2012

Following the NCPE pharmacoeconomic assessment (August 2011) the manufacturer reduced the price of dabigatran.  At this revised price we now consider dabigatran cost effective for this indication.

Dabigatran Etexilate (Pradaxa®) for the Primary Prevention of Venous Thromboembolic Events after Total Hip/Knee Replacement

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Dabigatran
Brand Pradaxa®
Indication For the Primary Prevention of Venous Thromboembolic Events in Adult Patients who have undergone Total Hip Replacement or Total Knee Surgery.
Assessment Process
Full submission received from Applicant 01/07/2008
NCPE assessment completed 01/09/2008
NCPE assessment outcome Reimbursement recommended