Biosimilar
A biosimilar is a biological medicine licensed as highly similar to an approved reference biologic, bringing price competition once its exclusivity ends.
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A biosimilar is a biological medicine licensed as highly similar to an approved reference biologic, bringing price competition once its exclusivity ends.
Biosimilar approval is the regulatory licensing of a biosimilar shown to be highly similar to an approved reference biologic, so the two can compete.
Biosimilar substitution is dispensing a biosimilar instead of a prescribed reference biologic without consulting the prescriber, where rules allow.
Breast Cancer Screening is regular mammography of women without symptoms to cut deaths, judged economically against overdiagnosis and cost per QALY.
Cancer Burden is the toll of cancer on a population, counted as new cases, deaths and disability-adjusted life years, and often valued as economic cost.
Cancer Registry is an information system holding data on people with cancer, from tumour stage to treatment and survival, used to model survival in HTA.
Cancer Screening is testing symptom-free people to find cancer or precancer early, judged economically on deaths prevented against cost and overdiagnosis.
CAR-T Therapy is a one-off cancer treatment made from a patient's own T cells, engineered to attack the cancer; its high price rests on lasting remission.
Cardiac Rehabilitation is supervised exercise, education and psychological care after a cardiac event; most economic evaluations find it cost-effective.
Clawback is a payment that medicine manufacturers return to a payer when total public spending on medicines exceeds an agreed cap.
Clinical benefit rate (CBR) is the share of cancer trial patients with a complete or partial response, or stable disease lasting a set minimum time.
A clinical development plan is a sponsor's ordered programme of clinical trials, with decision points, to support marketing approval and often HTA.
Clinical trial design is the protocol plan for a trial's comparator, population, endpoints, follow-up and sample size, setting how far results inform HTA.
A companion diagnostic (CDx) is a test that identifies patients a specific drug is likely to help or harm, so the drug and test are assessed together.
A comparability study is a stepwise comparison showing a biologic is highly similar to its pre-change version or, for a biosimilar, its reference product.
Compassionate use is the supply of an unauthorised medicine, outside a trial, to patients with a serious disease and no satisfactory authorised treatment.
Competition-based pricing sets a medicine's price from the prices of rival treatments for the same condition, not from its own cost or added health value.
Confidential pricing keeps a medicine's negotiated net price secret between manufacturer and payer, while a higher list price stays public.
A confirmatory trial is a controlled trial testing pre-set hypotheses to give firm evidence of efficacy or safety, for licensing or after early approval.
Cost-based pricing sets the price of a medicine from its research and development, manufacturing, regulatory and overhead costs plus a profit margin.