Decision analysis

A systematic approach to decision making under uncertainty.  This involves the modelling of the sequences or pathways of multiple possible strategies (e.g. of diagnosis and treatment for a particular clinical problem) to determine which is optimal

Decision tree

A graphical framework for representing alternatives for use in decision analysis

Degarelix (Firmagon®)

Assessment Status Rapid review complete
HTA ID -
Drug Degarelin
Brand Firmagon®
Indication For the treatment of prostate cancer
Assessment Process
Rapid review completed 15/10/2019
Rapid review outcome Full Pharmacoeconomic Evaluation Not Recommended

Cost-effectiveness of Degarelix (Firmagon®)

Denosumab (Prolia®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Denosumab
Brand Prolia®
Indication For the Prevention of Osteoporotic Fractures in Postmenopausal Women
Assessment Process
Rapid review commissioned 27/05/2010
Rapid review completed 01/07/2010
Rapid review outcome We consider denosumab a cost-effective therapy for the prevention of osteoporotic fractures in postmenopausal women in the Irish healthcare setting

Denosumab (Xgeva®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Denosumab
Brand Xgeva®
Indication For the prevention of skeletal related events in adults with bone metastases from solid tumours in Ireland
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 15/08/2011
NCPE assessment completed 08/12/2011
NCPE assessment outcome Denosumab (Xgeva®) is considered a cost-effective therapy for the prevention of skeletal-related events in adults with bone metastases from solid tumours in the Irish healthcare setting.

Deterministic sensitivity analysis (DSA)

A method of capturing the level of uncertainty in the results of decision analysis which varies variables one at a time (one-way sensitivity analysis) or two or more at a time (multi-way sensitivity analysis).

Dexamethasone Intravitreal Implant (Ozurdex®)

Assessment Status NCPE Assessment Process Complete
HTA ID -
Drug Dexamethasone Intravitreal Implant
Brand Ozurdex®
Indication Treatment of macular oedema following Retinal Vein Occlusion
Assessment Process
Rapid review commissioned 12/11/2010
Rapid review completed 16/12/2010
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE 24/11/2011
NCPE assessment completed 16/03/2012
NCPE assessment outcome Reimbursement not recommended the submitted price, Ozurdex® cannot be considered cost-effective therapy for the treatment of macular oedema following retinal vein occlusion

Technical Summary

July 2013

Following resubmission of pricing information the NCPE conclude that Ozurdex® is a cost effective treatment strategy versus observation (base case) in RVO. The ICER for Ozurdex® versus observation is €25,601/QALY (basecase).   The probability of cost effectiveness at a threshold of €45,000/QALY is 88.97%.

Dexmedetomidine (Dexdor®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Dexmedetomidine
Brand Dexdor®
Indication For the treatment of ICU adult patients requiring light to moderate sedation
Assessment Process
Rapid review commissioned 08/07/2011
Rapid review completed 06/09/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended

Diagnosis Related Group (DRG)

A patient classification scheme that provides a clinically meaningful way of relating the types of patients treated in a hospital to the resources required by the hospital

Dienogest (Visanne®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Dienogest
Brand Visanne®
Indication For the Treatment of Endometriosis
Assessment Process
Rapid review commissioned 17/09/2010
Rapid review completed 04/10/2010
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended

Direct costs

The fixed and variable costs of all resources (goods, services, etc.) consumed in the provision of an intervention as well as any consequences of the intervention such as adverse effects or goods or services induced by the intervention – includes direct medical costs and direct nonmedical costs such as transportation or child care

Direct medical costs

A medical cost that varies directly with the provision of a health care intervention (e.g. physician salaries).

Direct non-medical costs

A non-medical cost associated with provision of medical services (e.g. transportation of a patient to a hospital).

Discount rate

The interest rate used to discount or calculate future costs and benefits so as to arrive at their present values, e.g. 4%

Discounting

the process used in economic analyses to convert future costs or benefits to present values using a discount rate. Discounting costs reflects societal preference for costs to be experienced in the future rather than the present, and for benefits to be realised in the present rather than at a later date

Distribution

A mathematical function describing the variability of a variable.

Dominance

a strategy is dominated if it is less effective and has higher costs than an alternative strategy

Dronedarone (Multaq®)

Assessment Status Rapid review complete
HTA ID -
Drug Dronedarone
Brand Multaq®
Assessment Process
Rapid review commissioned 04/01/2010
Rapid review completed 12/01/2023
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Economic evaluation

The comparison of alternative courses of action in terms of their costs and consequences, to inform and support the decision-making process

Economic model

a framework for bringing together different types of data from a range of sources to describe the patient pathway and the choices and consequences for the interventions under study. Modelling may be used to combine different data sets changing the information collected from a clinical trial into a form that can be used, to extrapolate short-term clinical data to longer term, to link intermediate with final endpoints, to generalise from clinical trial settings to routine practice and to estimate the relative effectiveness of technologies where these have not been directly compared in clinical trials

Eculizumab (Soliris®)

Assessment Status Assessment process complete
HTA ID -
Drug Eculizumab
Brand Soliris®
Indication For the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in the Irish healthcare setting.
Assessment Process
Rapid review commissioned 20/01/2010
Rapid review completed 20/03/2010
Rapid review outcome Reimbursement not recommended
NCPE assessment re-commenced 15/07/2013
NCPE assessment completed 14/10/2013
NCPE assessment outcome Reimbursement not recommended.

Alexion Pharma UK. Ltd have failed to demonstrate the cost-effectiveness of eculizumab  (Soliris®) for the treatment of PNH in the Irish healthcare setting.

Technical Summary 2010

Pharmacoeconomic Reassessment

The NCPE do not believe that eculizumab (Soliris®) is value for money for the treatment of patients with PNH in the Irish Healthcare setting

Technical Summary-2013

 

Effectiveness

The evaluation of benefit or risk, in a standard clinical setting, using outcomes measuring issues of importance to patients.

Efficacy

The evaluation of benefit or risk in a defined population in controlled or ideal circumstances e.g. in a laboratory setting, under research conditions

Eltrombopag (Revolade®)

Assessment Status Assessment process complete
HTA ID -
Drug Eltrombopag
Brand Revolade®
Indication For the treatment of chronic immune thrombocytopenic purpura (ITP)
Assessment Process
Full submission received from Applicant 30/07/2010
NCPE assessment completed 05/11/2010
NCPE assessment outcome The review group do not recommend the reimbursement of eltrombopag under the High Tech Drug scheme

Technical Summary

A new rapid review was commissioned by the HSE in December 2017
Rapid review commissioned 04/12/2017
Rapid review completed 16/04/2018
Rapid Review outcome A full pharmacoeconomic assessment is recommended on the basis of the proposed price, which is not comparable with currently available therapies.

Eribulin (Halaven®)

Assessment Status Assessment process complete
HTA ID -
Drug Eribulin
Brand Halaven®
Indication For the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
Assessment Process
Rapid review commissioned 09/02/2011
Rapid review completed 09/03/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 26/09/2012
NCPE assessment completed 07/12/2012
NCPE assessment outcome Reimbursement Not Recommended at the submitted price.

The NCPE believe that, at the submitted price, eribulin (Halaven®) is not cost effective for the treatment of patients with locally advanced breast cancer or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease.

Technical Summary

December 2014

The HSE has approved reimbursement following confidential price negotiations.

EVPI

Expected value of perfect information: describes the maximum amount a decision maker would be willing to pay in order to obtain perfect information, where perfect information would allow them to make a choice under certainty

Exenatide (Bydureon®)

Assessment Status Rapid review complete
HTA ID -
Drug Exenatide
Brand Bydureon®
Indication For the treatment of type II diabetes mellitus combined with Metformin, Sulphonylurea, Thiazolidinedione, Metform and SU and Metformn and TZD in adults who have not acheived glycaemic control on maximally tolerated doses of these oral therapies.
Assessment Process
Rapid review commissioned 31/05/2011
Rapid review completed 09/06/2011
Rapid review outcome Full Pharmacoeconomic Evaluation Not Recommended

Extended dominance

In the comparison of mutually exclusive programmes, the situation where one option has a higher incremental cost effectiveness ratio than a more effective alternative.

Extrapolation

Refers to the application of results to a wider population. Means to infer, predict, extend or project the results beyond what was recorded, observed or experienced

Fampridine (Fampyra®)

Assessment Status Assessment process complete
HTA ID -
Drug Fampridine
Brand Fampyra®
Indication For the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).
Assessment Process
Rapid review commissioned 01/09/2011
Rapid review completed 26/09/2011
Rapid review outcome Full Pharmaconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE 23/05/2012
NCPE assessment completed 17/08/2012
NCPE assessment outcome Reimbursement not recommended

As the manufacturer is unable to demonstrate the cost-effectiveness of fampridine we are unable to recommend reimbursement

 

Technical Summary

 

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

Gefitinib (Iressa®)

Assessment Status Assessment process complete
HTA ID -
Drug Gefitinib
Brand Iressa®
Indication For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 16/06/2010
NCPE assessment completed 05/11/2020

We do not recommend the reimbursement of gefitinib for first line therapy on the High Tech Drug Scheme.  However, it may be considered for second line therapy.

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.

Golimumab (Simponi®)

Assessment Status Assessment process complete
HTA ID -
Drug Golimumab
Brand (Simponi®)
Indication For the treatment of moderate to severe rheumatoid arthritis.
Assessment Process
Rapid review commissioned 20/11/2009
Rapid review completed 11/05/2010
Rapid review outcome Reimbursement recommended following price review, June 2010.

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

Following a price reduction the review group now consider golimumab to be cost-effective. June 2010.

Technical Summary

Grass pollen allergen extract (Oralair®)

Assessment Status Assessment process complete
HTA ID -
Drug Grass pollen allergen extract
Brand Oralair®
Indication For the treatment of allergic grass pollen rhinitis with or without conjunctivitis in adults, adolescents and children (above the age of 5) with clinically relevant symptoms confirmed by a positive cutaneous test and/or a positive titre of the specific IgE to the grass pollen.
Assessment Process
Rapid review commissioned 26/09/2011
Rapid review completed 03/10/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Health outomes

The results or impact of any type of intervention on health, (e.g. a clinical procedure, health policy or program, etc.).

Health technology assessment (HTA)

The systematic evaluation of properties, effects, and/or impacts of health care technology. It may address the direct, intended consequences of technologies as well as their indirect, unintended consequences. Its main purpose is to inform technology-related policymaking in healthcare. HTA is conducted by interdisciplinary groups using explicit analytical frameworks drawing from a variety of methods.

Heterogeneity

In meta-analysis heterogeneity refers to variability or differences between studies e.g. due to different study designs, different statistical methods, differences in key characteristics of the participants, interventions or outcome measures

Hydroxycarbamide (Siklos®)

Assessment Status Assessment process complete
HTA ID -
Drug Hydroxycarbamide
Brand Siklos®
Indication For use in the prevention of painful, recurrent vaso-occlusive crises, including acute chest syndrome, in adults, adolescents and children over 2 years of age suffering from symptomatic sickle-cell disease.
Assessment Process
Rapid review commissioned 22/08/2011
Rapid review completed 06/09/2011
Rapid review outcome Full Pharmacoeconomic Evaluation not Recommended.

Incremental cost effectiveness ratio (ICER)

The additional cost of an intervention as compared with the comparator, divided by the difference in effect or patient outcome between the interventions, e.g. additional cost per QALY.

Indacaterol (Onbrez®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Indacaterol
Brand Onbrez®
Indication For the treatment of COPD.
Assessment Process
Rapid review completed 15/01/2010
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Indirect costs

The cost of time lost from work (or leisure) and decreased productivity due to disease, disability, or death. In cost accounting, refers to costs that cannot be attributed to a particular activity but can be allocated across different activities; may be “fixed” regardless of activity intensity (e.g., building maintenance) or “variable” where their magnitude varies with activity (e.g., heating and lighting a building)

Inhaled insulin (Exubera®)

Assessment Status Assessment process complete
HTA ID -
Drug Inhaled insulin
Brand Exubera®
Indication Pfizer submitted a report on the clinical and cost effectiveness of inhaled insulin (Exubera®) versus sub-cutaneous insulin in patients with diabetes mellitus in support of their application for reimbursement under the Community Drug Schemes.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 01/04/2006
NCPE assessment completed 01/06/2006

Intangible costs

the cost of pain and suffering resulting from a disease, condition, or intervention

Ipilimumab (Yervoy®)

Assessment Status Assessment process complete
HTA ID -
Drug Ipilimumab
Brand Yervoy®
Indication For the treatment of advanced (unresectable or metastatic) melanoma in adult patients who have received prior therapy.
Assessment Process
Rapid review commissioned 31/05/2011
Rapid review completed 09/06/2011
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 29/07/2011
NCPE assessment completed 02/09/2011
NCPE assessment outcome Reimbursement Not Recommended at the submitted price.

Technical Summary

September 2013

The HSE has approved reimbursement following confidential price negotiations.

Iron isomaltoside 1000 (MonoVer®)

 

 

Assessment Status Rapid Review Complete
HTA ID -
Drug Iron isomaltoside 1000
Brand MonoVer®
Indication For the treatment of iron deficiency anaemia in the following circumstances: When oral iron preparations are ineffective or cannot be used and where there is a clinical need to deliver iron rapidly.
Assessment Process
Rapid review commissioned 10/01/2011
Rapid review completed 02/02/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Lapatinib (Tyverb®)

Assessment Status Assessment process complete
HTA ID -
Drug Lapatinib
Brand Tyverb®
Indication For the treatment of women with previously treated advanced or metastatic HER2 positive breast cancer.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 03/12/2007
NCPE assessment completed 28/01/2008
NCPE assessment outcome Reimbursement recommended.

Lapatinib could be considered cost-effective in Ireland. However in view of the uncertainty surrounding the ICER, we (NCPE) suggest conditional reimbursement under the High Tech Drugs scheme.

Technical Summary

Lidocaine 5% plasters (Versatis®)

Assessment Status Assessment process complete
HTA ID -
Drug Lidocaine 5% plasters
Brand Versatis®
Indication For the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).
Assessment Process
Rapid review commissioned 09/09/2010
Rapid review completed 22/10/2010
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 10/06/2015
NCPE assessment completed 24/09/2015
NCPE assessment outcome Reimbursement Not Recommended

The NCPE concludes that the cost effectiveness of the 5% lidocaine plaster has not been demonstrated.

Technical Summary

Linagliptin (Trajenta®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Linagliptin
Brand Trajenta®
Indication For treatment of type 2 diabetes mellitus to improve glycaemic control in adults, as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment, as combination therapy in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control, in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Assessment Process
Rapid review commissioned 18/08/2011
Rapid review completed 06/09/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended