New Medicines Reviews 2013

Reports on the role of SMC & Review of IPTR & ADTC

Glossary of terms and abbreviations

ABPI: see Association of the British Pharmaceutical Industry

ADTC: see Area Drug and Therapeutics Committee

All Wales Medicines Strategy Group (AWMSG): established in 2002 to bring together NHS clinicians, pharmacists, healthcare professionals, academics, health economists, industry representatives and patient advocates to provide advice on strategic medicines management and prescribing to the Minister for Health & Social Services.

All Wales Prescribing Advisory Group (AWPAG): formed in October 2003 to advise AWMSG on strategic developments in primary and secondary care. It assists with monitoring prescribing, advising on prescriber training, and developing prescribing indicators and audits for a national incentive scheme.

Area Drug and Therapeutics Committees (ADTCs): committees within each of the 14 Scottish Health Boards to support the safe and effective user of medicines by prescribers and the local population

Association of the British Pharmaceutical Industry (ABPI): the trade association for more than 70 companies in the UK producing prescription medicines. Its member companies research, develop, manufacture and supply more than 80 per cent of the medicines prescribed through the National Health Service (NHS).

AWMSG: see All Wales Medicines Strategy Group

Citizen's Council: A panel of 30 members of the public, which provides NICE with a public perspective on overarching moral and ethical issues that NICE must take into account when it produces guidance.

CUA: see Cost Utility Analysis

Cost Utility Analysis (CUA): A method of cost-effectiveness analysis that uses the Quality adjusted life year (QALYs) as a measure.

EMEA: see European Medicines Evaluation Agency:

European Medicines Evaluation Agency (EMEA): a decentralized body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

Healthcare Improvement Scotland (HIS): A Scottish Health body which supports healthcare providers in Scotland to deliver high quality, evidence-based, safe, effective and person-centred care; and to scrutinise those services to provide public assurance about the quality and safety of that care.

Health Technology Appraisal/ Assessment (HTA): "a multidisciplinary activity that systematically examines the safety, clinical efficacy and effectiveness, cost, cost-effectiveness, organisational implications, social consequences, legal and ethical considerations of the application of a health technology - usually a drug, medical device or clinical/surgical procedure" (Taylor and Taylor 2009).

HTA: see Health Technology Appraisal/ Assessment

HIS: see Healthcare Improvement Scotland

Horizon-Scanning: the systematic examination of potential future developments (e.g. in treatments) which are at the margins of current thinking and planning.

ICER: see Incremental Cost effectiveness ratio

Incremental Cost effectiveness ratio (ICER): The difference in costs divided by the difference in benefits (Phillips 2005).

Individual Patient Treatment Request (IPTR): A process by which a patient may receive a medicines within its licensed indications when, SMC or NHS HIS has yet to issue advice on the medicine, SMC or NHS HIS has issued "not recommended" advice for the medicine (including medicines not recommended by SMC due to company non-submission) or the request relates to the use of the medicine outwith an SMC restriction (NHS Greater Glasgow and Clyde).

IPTR: see Individual Patient Treatment Request

Medicines Appraisal: The structured evaluation of the properties and effects of a medicine, ideally with consideration of its clinical effectiveness and cost effectiveness when used for the specified indication (see Health Technology Appraisal/Assessment).

National Institute for Health and Clinical Excellence (NICE): established in 1998, it is an independent organization responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

New Drugs Committee (NDC): formed in May 2002 to enable SMC to manage the broadened appraisal process. This group meets month to consider the evidence on new medicines, and to provide preliminary recommendations to SMC on the introduction of these medicines in Scotland.

NICE: see National Institute for Health and Clinical Excellence

Office of Fair Trading (OFT): the UK's consumer and competition authority, which aims to make markets work well for consumers.

Off-label: Use of a medicine outside the terms of its official labelling.

Off-Licence: See off-label

OFT: see Office of Fair Trading

Opportunity cost: the cost of a unit of a resource is the benefit that would be derived from using it in its best alternative use.

Orphan Medicine: One licensed for treating or preventing life-threatening rare diseases affecting fewer than 5 in 10,000 people in the European Union". This equates to around 2, 5000 prevalent cases in Scotland.

PAPIG: see Patient and Public Involvement Group

PASAG: see Patient Access Scheme Assessment Group

Patient Access Scheme (PAS): Methods by which manufacturers of medicines can offer means to enable patients to gain access to high cost medicines.

Patient Access Scheme Assessment Group (PASAG): The group which assesses proposed Patient Access (PAS) Schemes for acceptability in NHS Scotland against standard objective criteria.

Patient and Public Involvement Group (PAPIG): a subgroup of the Scottish Medicines Consortium (SMC) , which makes recommendations to SMC on the development of public involvement opportunities and ensures that the patient/carer perspective is reflected in the deliberations of SMC

Pharmaceutical Price Regulation Scheme (PPRS): A voluntary agreement between the UK Government and the Association of the British Pharmaceutical Industry (ABPI) which allows pharmaceutical companies to set their own prices for branded prescription medicines, but with constraints placed upon overall profit.

PPRS: see Pharmaceutical Price Regulation Scheme

QALY: see Quality adjusted life Year

Quality adjusted life Year (QALY) A measurement that takes into account the extent to which a treatment both prolongs and improves the quality of a patient's life. A QALY is calculated mathematically by multiplying the number of additional years of life achieved by a treatment by a measure of the quality of life. The cost-effectiveness of treatments can be compared by evaluating the cost of the treatment per QALY gained (Cost per QALY).

Scottish Medicines Consortium (SMC): Body formed in 2002 to provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products.

Single Technology Appraisal: A single technology appraisal covers a single technology (e.g. a medicine) for a single indication.

SMC: see Scottish Medicines Consortium

SMC UGF: see User Group Forum (SMC UGF):

Ultra Orphan Medicine: Medicines that are licensed for the treatment of diseases with a UK prevalence of less than 1 in 50,000. This equates to around 100 prevalent cases in Scotland.

User Group Forum (SMC UGF): A subgroup of SMC which identifies and address and resolve issues related to the HTA processes of SMC



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