Accelerated Approval
Accelerated approval is an FDA pathway that approves medicines for serious conditions on a surrogate endpoint, with confirmatory trials to verify benefit.
Explore comprehensive, evidence-informed explanations of key health economics concepts, including their development, application and relationships to other concepts. Published entries are validated through human expert review.
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Accelerated approval is an FDA pathway that approves medicines for serious conditions on a surrogate endpoint, with confirmatory trials to verify benefit.
Access negotiation is the process in which a health technology supplier and a payer agree the price, eligibility and other conditions for patient access.
Acquired treatment resistance is the loss of a cancer treatment's effect after initial response or disease control, as the tumour adapts and progresses.
Addiction treatment economics is the economic evaluation of treatments for substance use disorders, weighing their costs against health and crime outcomes.
ADME studies measure how a drug is absorbed, distributed, metabolised and excreted, informing dose adjustments for organ impairment and drug interactions.
An advanced therapy medicinal product (ATMP) is an EU-regulated gene, cell or tissue-based medicine, often given once, whose lasting value HTA must judge.
AI diagnostic value is the assessment of an AI diagnostic tool's net health and cost effect in a care pathway, judged on outcomes, not accuracy alone.
Alcohol use economics estimates what drinking costs health services and society and tests the value for money of alcohol screening and control policies.
The AMCP dossier is a manufacturer's evidence package, built to AMCP's Format for Formulary Submissions, that US health plans use in formulary decisions.
AMR economic burden is the extra cost antimicrobial resistance imposes on health systems and economies, measured against susceptible or no infection.
Annuity payment is an agreement to pay for a one-off therapy in yearly instalments, not upfront, with later ones sometimes stopping if the therapy fails.
Antibiotic stewardship is a coordinated programme that improves antibiotic prescribing to protect patients, slow resistance and cut avoidable costs.
Antimicrobial economics applies health economics to anti-infectives: resistance as an externality, population value and incentives for new antibiotics.
Antimicrobial resistance (AMR) is the ability of microbes to withstand antimicrobial medicines, making infections harder to treat and costlier to manage.
The Beers Criteria are the American Geriatrics Society's list of medicines best avoided in older adults, also used to evaluate quality of care and cost.
A behaviour change intervention is a coordinated set of behaviour change techniques aiming to change a health behaviour, judged by cost per health gain.
Best supportive care (BSC) is symptom-directed care without anticancer treatment, used as a control arm in oncology trials and as a comparator in HTA.
Bioavailability is the rate and extent to which an active drug reaches the systemic circulation, which sets the dose and drug cost of a target exposure.
Treatment using a medicinal product made from or derived from a biological source, assessed for a specific indication, delivery pathway and patient outcome.
A biomarker is a measured biological characteristic, such as a gene or protein, signalling disease or treatment response; HTA may tie treatment to it.