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)

Intangible costs

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

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.

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

Net benefit

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

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)].

Opportunity Cost

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

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

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.

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

Quizartinib (Vanflyta®). HTA ID: 24006

Assessment Status Rapid Review Complete
HTA ID 24006
Drug Quizartinib
Brand Vanflyta®
Indication Quizartinib is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia that is FLT3-ITD positive.
Assessment Process
Rapid review commissioned 09/02/2024
Rapid review completed 11/03/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of quizartinib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

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.

Relugolix (Orgovyx®). HTA ID: 23017

Assessment Status Rapid Review Complete
HTA ID 23017
Drug Relugolix
Brand Orgovyx®
Indication Indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.
Assessment Process
Rapid review commissioned 14/03/2023
Rapid review completed 31/03/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that relugolix 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.

The HSE has approved reimbursement following confidential price negotiations January 2024.

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.

Sufentanil Citrate (Dzuveo®) HTA ID: 23062

Assessment Status Rapid Review Complete
Drug Sufentanil Citrate
Brand Dzuveo®
Indication For the management of acute moderate to severe pain in adult patients
Assessment Process
Rapid review commissioned 02/10/2023
Rapid review resubmission required 04/12/2023
Rapid review completed 22/12/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that sufentanil citrate 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.

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.

Technology

In pharmacoeconomic evaluation, ‘technology’ is used to mean a drug or other treatment that is being assessed.

Tezepelumab (Tezspire®). HTA ID: 23025

Assessment Status Full HTA submission received from Applicant
HTA ID 23025
Drug Tezepelumab
Brand Tezspire®
Indication Tezepelumab (Tezspire®) is indicated as add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma, who are inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Assessment Process
Rapid review commissioned 10/05/2023
Rapid review completed 15/06/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that tezepelumab not be considered for reimbursement at the submitted price*.
Full pharmacoeconomic assessment commissioned by HSE 01/02/2024
Pre-submission consultation with Applicant 05/03/2024
Full submission received from Applicant 04/06/2024

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Time Horizon

Period of time over which costs and outcomes are measured in economic evaluation.

Transition Probability

The probability that the health of a patient changes from one health state to another health state within a given period

Uncertainty

a state in which the true value of a parameter or the structure of a process is unknown

Utility

A measure of preference for a specific health outcome, obtained by methods that involve uncertainty (e.g., standard gamble approach).  Utilities are usually expressed on a cardinal scale of zero to one (e.g. death typically has a utility value of zero and a full healthy life has a value of one) and are used as health-related quality of life weights to calculate QALYs.

Value-of-information (VOI)

value-of-information techniques assess the expected costs of uncertainty surrounding a decision made on the basis of current information, in order to determine whether further research should be conducted and how this should be designed.

Willingness-to-pay (WTP)

Evaluation method used to determine the maximum amount of money an individual is willing to pay for a particular outcome or benefit (e.g. to receive a health care service).  This method is often used in cost-benefit analysis to quantify outcome in monetary terms.