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Accepted

A decision made by SMC to accept a medicine for routine use by NHS Scotland.

 

Accepted restricted

A decision made by SMC to accept a medicine for routine use with certain restrictions on which groups of patients can be treated with it or who can prescribe it. 

 

Adverse Drug Reaction (ADR)

A reaction to a medicine which is harmful, or potentially harmful, to a patient. If a reaction happens while a patient is taking a medicine, it may have been caused by the medicine, but it may have another cause, such as the disease being treated. For this reason they are sometimes called 'adverse events'. 'ADR' is used for those reactions which are likely to have been caused by the medicine.  

 

Adverse event

See adverse drug reaction.

 

All Wales Medicines Strategy Group (AWMSG)

Provides advice on strategic medicines management and prescribing to the Welsh government. 

 

Antimicrobial

A substance that kills microorganisms ('germs') or slows down their growth or replication. 

 

Antimicrobial stewardship

A plan that promotes the appropriate use of antimicrobials (including antibiotics), improves patient care, reduces microbial resistance and decreases the spread of infections caused by multi drug resistant organisms. 

Misuse and overuse of antimicrobials are part of the world's most pressing public health problems. Infectious organisms can adapt to the antimicrobials designed to kill them, meaning the antimicrobials no longer work. People infected with antimicrobial resistant organisms are more likely to have longer, more expensive hospital stays, and may be more likely to die as a result of an infection. 

 

Applicant company

A pharmaceutical company that submits a medicine it manufactures to SMC for assessment to see if it will be accepted for routine use in NHS Scotland. May also be referred to as the submitting company. 

 

Area Drug and Therapeutics Committees (ADTCs)

Committees responsible for providing advice to the regional NHS boards on the use of medicines to meet the needs of the patients in that health board area. There are 14 regional health boards in Scotland.

Find out more about Scotland's health boards.

 

Association of British Pharmaceutical Industries (ABPI)

Trade association that represents the pharmaceutical industry in the UK.

Find out more about ABPI.

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Bioequivalent

If two medicines are said to be bioequivalent it means that the same amount of active drug in both medicines reaches the site of action in the body.

 

Biologic (biological medicine)

A medicine whose active substance is made by a living thing. Examples include human insulins and monoclonal antibody preparations, eg Humira (adalimumab) which is used to treat rheumatoid arthritis. 

 

Biosimilar

biological medicine that closely resembles and works in a similar way to an existing ('reference') biological medicine, but they are not identical. An example of a biosimilar medicine is Remsima - both it, and the reference medicine Remicade, contain the active biological medicine infliximab. 

 

Biotechnology 

Technology that is based on biology. It uses biological processes in cells to make things that we can use. In medicine, biotechnology companies make biological medicines. 

 

Budget impact

The cost to the NHS of buying the medicine for the number of patients who are likely to use it. The budget impact may sometimes relate only to the cost of the medicine (the medicines budget impact) itself, but it can also sometimes include the costs associated with other things that are needed alongside the medicine, e.g additional blood tests or monitoring visits to a doctor. It also looks at the likely saving associated with the new medicine; for example, one medicine may replace the use of another medicine, which will save money. While SMC presents budget impact information, it should be noted that this information is only to help health service staff plan for the implementation of new treatments: budget impact is not a factor in SMC decision making. 

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CDAD

Clostridium difficile associated disease. 

 

CDI

Clostridium difficile infection. A bacterial infection affecting the digestive system which can cause diarrhoea, high temperature and painful stomach cramps. 

 

Clinical effectiveness

A review of the benefits and risks (e.g side effects) of an intervention (e.g a medicine) used in a standard clinical setting to improve patient care. 

 

Clinical judgement

A decision made by a healthcare professional based on their medical experience.

 

Clinical need

A person’s ability to benefit (or not) from a medicine (or other health intervention).

 

Clinical trial

A clinical trial is a study that compares one treatment with another or with a placebo. Studies often have to be carried out on a large number of patients before the results can be considered reliable. Clinical trials are used to decide whether a new medicine works to treat a disease and whether it is safe. They can also be used to compare a new medicine with a treatment that is already in use. 

 

Comparative effectiveness

The benefits and risks (e.g side effects) of one treatment compared to another at treating a medical condition as demonstrated in a clinical trial setting. 

 

Comparative efficacy

The ability of one treatment compared to another at treating a medical condition as demonstrated in a clinical setting. 

 

Comparative safety

The ability of one treatment, relative to another, to demonstrate safety.

 

Comparator

The medicine / treatment with which the new medicine is being compared. If the comparator medicine is not normally used in Scotland to treat a condition then it is known as an inappropriate comparator and the submission may be rejected, even though the new medicine appears to work. This is because SMC cannot assess what the advantages and disadvantages of the new treatment are compared to existing treatments in Scotland. Pharmaceutical companies may be asked to repeat the submission with an appropriate comparator medicine that is used in Scotland. 

 

Comparator company

A company that has either the same or a similar product available for treatment (see comparator).

 

Contra-indication

A condition or issue in which use of a particular treatment is not recommended for a patient. For example, aspirin is contra-indicated in children as it can cause a rare, fatal syndrome call Reyes disease. 

 

Cost benefit analysis

A type of economic evaluation used to work out the value for money of a treatment. The costs and benefits of alternative treatments are measured using the same monetary units to see whether the benefits exceed the costs. In cost benefit analysis, the benefits of the treatment would be given a monetary value, unlike in other forms of economic evaluation. A treatment would offer good value if the benefits were greater than the cost. 

 

Cost consequence analysis

A type of economic evaluation used to work out the value for money of a treatment. It compares the costs and outcomes of a treatment to those of other options, but does not summarise the outcomes into a single outcome like in other types of economic evaluations. It may take the format of a list of the extra costs and outcomes of the treatment and the decision maker must then weigh up the advantages and disadvantages to judge overall value for money. 

 

Cost effectiveness analysis

A type of economic evaluation used to work out the value for money of a treatment. This analysis compares two or more treatment options to find out which provides more outcomes for a set cost or which has the lowest cost for a given level of outcome. In cost effectiveness analysis all outcomes of treatment are compared in the same natural unit, eg life years saved, headaches avoided, cases of disease detected. 

 

Cost minimisation analysis

A type of economic evaluation used to work out the value for money of a treatment. A cost minimisation analysis is used where a new medicine has identical benefits compared to an existing treatment. As the two treatments give exactly the same benefit, only the costs are compared and the cheapest option will provide the best value for money. 

Cost utility analysis

A type of economic analysis used to work out the value for money of a treatment. In cost utility analysis the benefits of different treatments are assessed in terms of both quality and duration of life and expressed as quality adjusted life years (see Quality adjusted life year (QALY))

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DAD - detailed advice document

The document produced by SMC providing final advice on whether a medicine is accepted for routine use, not recommended for use or accepted for restricted use in NHS Scotland. 

 

DDD

Defined daily dose - the average dose per day for a medicine used for its main indication in adults.

 

Declaration of conflicting interests

A statement of personal and/or professional interests which have the potential to bias an individual when considering a product from a particular company. Examples are share-holding in a pharmaceutical company or working in a department which receives fees from a company.

Find out more about declaration of interests.

 

Double blind study

A study in which neither the patients nor the investigators know which of the treatments being compared are being taken by an individual patient. Studies which are not blinded may bias the results if there is an expectation that one treatment will be better than another.

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EARS-Net

European Surveillance of Antimicrobial Consumption Network 

 

ESAC-Net

European Antimicrobial Consumption Network.

 

Economic evaluation

A type of analysis used to compare the costs and benefits of a new treatment compared to existing treatments to work out if the new treatment provides value for money. There are several types of economic evaluation: cost benefit analysiscost consequence analysiscost effectiveness analysiscost minimisation analysis and cost utility analysis. All use similar ways to measure costs but differ in the way they measure the benefits of a treatment. 

 

Economic model/modelling

Used in economic evaluations to predict the costs and effects of an intervention over periods of time not covered in a clinical trial or other research. Modelling is often needed because the clinical study was only conducted for a short period of time but the medicine may be used for a much longer period. A model is therefore a way of trying to predict the possible costs and outcomes in the future. 

 

Efficacy

The effect a medicine has on the patient e.g. lowering blood pressure. While it is assumed that the effect will be beneficial to the patient, it cannot automatically be assumed that a medicine which has shown efficacy has shown clinical effectiveness.

 

End of life medicine

At SMC we use the following definition for end of life medicines:

"A medicine used to treat a condition at a stage that usually leads to death within three years with currently available treatments."

Like orphan and ultra-orphan medicines, these medicines can be considered using our Patient and Clinician Engagement (PACE) process. This gives patients and healthcare professionals who will use the medicine a stronger voice in our decision making process. 

 

End point

In a clinical study, this is the point at which an outcome is measured, e.g. the effect of a medicine on a patient at an agreed time point. It should be defined before the start of the study and be designed to provide information in order to answer a relevant clinical question about the treatment. A primary end point provides information which helps to answer the main clinical question the study was designed to answer. A secondary end point may provide useful information but is less essential to the main purpose of the study than the primary end point. Secondary end points are more likely to point the way to further research than to answer a research question on their own. 

 

European Medicines Agency (EMA)

See Medicines Healthcare and products Regulatory Agency (MHRA) and European Medicines Agency (EMA).

 

Evidence

Information that supports whether a belief or an idea is true.

 

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Formulary

List of medicines for use in a health board area.

 

Formulations

Material or mixture prepared according to a formula. Medicines are prepared according to a formula which includes the active part of the medicine and a number of other chemicals or substances. These help to make the active drug into a form we can take easily as a medicine. Paracetamol capsules and paracetamol tablets would be examples of two different formulations of paracetamol.

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Generic medicine

A medicine that is produced when the patent on the original (reference) medicine has expired and is labelled with an approved name. It is bioequivalent to the reference medicine and contains the same active ingredient at the same strength, in the same form, and is used to treat the same disease. 

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HAI

Healthcare associated infection.

 

Healthcare Environment Inspectorate (HEI)

The team that carries out safety and cleanliness inspections across NHSScotland hospitals and services.

Find out more about the Healthcare Environment Inspectorate.

 

Healthcare Improvement Scotland (HIS)

The national healthcare improvement organisation for Scotland. SMC is part of HIS.

Find out more about Healthcare Improvement Scotland. 

 

Health Technology Assessment International (HTAi)

Health Technology Assessment International is the global scientific and professional society for all those who produce, use or encounter Health Technology Assessment. Find out more about HTAi.

 

Horizon Scanning

The process of identifying new medicines or new uses of existing medicines that are expected to receive marketing authorisation from the Medicines and Healthcare products Regulatory Authority (MHRA) or the European Medicines Agency (EMA) in the near future and estimating their potential impact on patient care.

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Incidence

The number of patients who have been newly identified with a disease or condition within a given time period, e.g. 100 per 100 000 population per annum is the number presenting with a particular condition within a year.

 

Incremental Cost Effective Ratio (ICER)

The difference in cost between the new medicine and comparator treatment divided by the difference in benefits between the new medicine and comparator treatment. Benefits are generally expressed in QALYs gained.

 

Indication

A medical condition that a medicine is used to treat or prevent.

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Licensed indication

The medical conditions or diseases a medicine can be legally used to treat (ie has a marketing authorisation). See also off label / unlicensed use. 

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Marketing authorisation

Before a medicine can be prescribed or sold in the UK, it must have a marketing authorisation (previously called a product licence) from the Medicines and Healthcare products Regulatory Agency or the European Medicines Agency (EMA) to show that it meets the standards of safety, quality and efficacy in clinical trials.

 

Medicines Healthcare and products Regulatory Agency (MHRA) / European Medicines Agency (EMA)

The Medicines Healthcare and products Regulatory Agency (MHRA) and European  Medicines Agency (EMA) evaluate requests for licences (see licensed indication) for new medicines. Once a licence is granted, companies are free to promote their products to healthcare professionals in the area covered by the licence (United Kingdom or European Union respectively). Licences are based on demonstration by the company of safety, efficacy and quality of the product; efficacy normally being demonstrated in rigorously conducted randomised controlled clinical studies. In approving a medicine, no regard can be paid to its possible cost, nor to whether there is a need for the product at all.

Find out more about MHRA

Find out more about EMA

 

Medicines appraisal

The evaluation of the properties and effects of a medicine, with consideration of its clinical effectiveness and cost effectiveness when used to treat a particular condition. 

 

Modifiers

In assessing the clinical and cost effectiveness of new medicines, SMC needs a strong clinical and economic case to be made and for the medicine to show value for money. However, in some situations SMC may be able to be more flexible in its decision making and be able to consider other factors (modifiers). These may allow SMC to take into account some of the concerns with the health economic case or a higher cost per QALY. These include: orphan medicines, ultra-orphan medicines, evidence that the medicine will give a substantial improvement in quality of life (with or without survival benefit) and a number of others.

Find out more about modifiers

 

Monoclonal antibody

A type of biological medicine that is designed to bind specifically to a particular protein produced by cells in the body. The protein that they bind will be different depending on the disease they are designed to treat. 

 

MRSA

Methicillin resistant staphylococcus aureus - a type of bacteria which is resistant to many standard antibiotic treatments.

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NES

NHS Educational for Scotland.

 

New Drugs Committee (NDC)

Every medicine submitted to SMC is given initial consideration by the New Drugs Committee (NDC), a scientific sub-group who consider the clinical and economic evidence put forward by a company. The members of NDC are mostly healthcare professionals from area drug therapeutic committees (ADTCs). They make an initial recommendation on whether the medicine should be accepted for use in NHSScotland or not. This recommendation is then presented at the SMC meeting. If the medicine is end of life, orphan or ultra-orphan and the NDC have not recommended it, then the medicine can be considered at a PACE meeting. The output of the PACE meeting is taken into consideration at the SMC meeting.

 

New indication

When a medicine's licence is updated to include the treatment of an additional medical condition this is known as a new indication. 

 

New Product Assessment Form (NPAF)

Form to be filled in by a pharmaceutical company submitting a medicine for review by SMC. 

 

NHS Boards

The role of the NHS Boards is to ensure the efficient, effective and accountable governance of the local NHS system. There are 14 NHS Boards in Scotland.

 

NHSScotland

National Health Service in Scotland.

 

NICE

National Institute for Health and Care Excellence. Provides advice to the National Health Service in England on a wide range of topics relevant to health care. 

Find out more about NICE.

 

Non-submission

If a manufacturer does not make a submission for a medicine, SMC will consider the need to issue not recommended advice to NHSScotland. The company has the opportunity, however, to discuss with SMC what might be an acceptable submission timeline before the decision to issue not recommended advice is taken. 

Find out more about non-submissions.

 

Not recommended

A decision taken by SMC to not recommend a medicine for routine use. For  medicines that have not been recommended by SMC, all NHS boards have procedures in place to consider individual requests when a doctor feels the medicine would be right for a particular patient. 

 

NSS

NHS National Services Scotland.

 

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Off label / unlicensed use

When a licensed medicine is used in a way that is different to what it is licensed for. For example, when a licensed medicine is used to treat a condition that it is not licensed to treat, or used at a different dose than it is licensed for (e.g. amitriptyline is licensed for the treatment of depression, however, sometimes it is used to treat a type of pain). When a medicine is used in this way the pharmaceutical company are not legally responsible for its use, including any adverse affects.

 

Office of Fair Trading (OFT)

The UK's consumer and competition authority, which aims to make markets work well for consumers. 

 

Orphan medicine

An orphan medicine is a medicine use to treat a rare medical condition. At SMC we use the following definition:

"A medicine with European Medicines Agency (EMA) designated orphan status (i.e. conditions affecting fewer than 2,500 people in a population of  5 million) or a medicine to treat an equivalent size of population irrespective of whether it has designated orphan status"

SMC recognises that orphan drugs may have a less well developed clinical trials programme and therefore that less information than usual may be available to assess them on. The assessment may include a PACE meeting. 

 

Outcome

The state of a patient's health resulting from them taking a medicine or other treatment.

 

Overarching Medicines Technology Group (OMTG)

Ensures that guidance issued by Healthcare Improvement Scotland is consistent and that opportunities for joint working are identified. 

 

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Patient and Clinician Engagement (PACE)

In May 2014, SMC introduced the Patient and Clincian Engagement (PACE) process for medicines used at the end of life and for very rare (orphan and ultra orphan) conditions. PACE gathers detailed information from patients and healthcare professionals on the added benefits of a medicine, including how it can impact on the quality of a patient's life. This evidence is taken into consideration in SMC decisions. 

 

Patient Access Scheme (PAS)

A Patient Access Scheme (PAS) is a scheme proposed by a pharmaceutical company in order to improve the cost effectiveness of a medicine and enable patients to receive access to cost effective new medicines. A Patient Access Scheme Assessment Group (PASAG) reviews and advises NHSScotland on the feasibility of the proposed schemes. PASAG operates separately from SMC. 

Find out more about Patient Access Schemes (PAS)

 

Patient group

Patient focussed organisations which provide comments from patients and carers to SMC regarding a medicine under review. The comments form part of a submission of evidence. 

 

Pharmaceutical companies

Organisations that develop and make medicines.

 

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 rules placed on overall profit. 

 

Pharmacodynamics

The mechanisms by which a medicine has an effect on the body, i.e. pharmacodynamics is what the medicine does to the body.

 

Pharmacokinetics

What the body does to a medicine, i.e. the way the body handles a drug when it is taken into the body, circulates the bloodstream, reaches the site of action and then leaves the body, e.g. in urine. These will influence the effect of the medicine and how long the effects will last. 

 

Pharmacovigilance

Systems designed to detect and measure adverse drug reactions after a medicine has been marketed, to inform prescribers and patients of possible risks and, in some cases, to raise and answer questions about whether a product should stay on the market. The UK system for reporting of adverse drug reactions is the Yellow Card scheme. See also adverse drug reaction.

 

Phase I, II, II, IV studies

Clinical trials are divided into phases. These are stages through which a medicine must pass before and after it is licensed. Phase I trials are small trials looking to see if the medicine works in humans (generally volunteers), is safe, and to find a safe dose. Phase II trials are biggers studies looking to see if the new treatment works well enough to test in patients in a larger phase III trial, more about the side effects and more about the best does to use. Phase III trials compare the new treatment with a placebo or the currently used treatment. Phase III trials ae the most important in reviewing new medicines. Phase IV studies gather information after the drug is in use and being prescribed for patients. Not all medicines reach phase III trials.

 

Placebo

A dummy medicine that contains no active treatment.

 

Placebo-controlled study

A clinical study in which one group of patients receives a placebo and the other group receive an active treatment. The difference in effect between the active treatment and placebo allows for the comparison of the effect of the treatment on the patient (after allowing for factors such as chance and natural changes in the patient's condition). Placebo controlled studies do not provide evidence on how the treatment compares to other active treatments that are currently used in clinical practice. 

 

Prevalence

The number of patients identified with a disease or condition at any given time in a given population, e.g. UK prevalence in 2004 = 1000 per 100,000 population - this is the proportion of people who suffered from a given disease when surveyed in the UK in 2004. 

 

Product licence

See Marketing authorisation

 

Public Involvement Network (PIN) Advisory Group

The Public Involvement Network (PIN) is made up of patient and carer groups who use their knowledge, experience and direct contacts with patients and carers to ensure the views of patients, carers and members of the public are captured and continuously used to inform SMC processes. 

The PIN Advisory Group helps SMC to continuously improve how we involve patients, carers and members of the public in our work. Membership includes four PIN patient group partners, each of whom has active contact with patients and carers and previous experience of submitting to SMC. 

Find out more about the PIN Advisory Group

 

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Quality adjusted life year (QALY)

The quality life adjusted year (QALY) is a tool used to work out how much benefit a patient might get from a medicine in terms of the increase in the length of their life weighted according to how high the quality of the life is. A QALYof 1 is equivalent to one year of perfect health. 

QALYs are calculated by estimating the years of life a patient might have after taking a treatment and weighting each year with a quality of life score (on a 0 - 1 scale). It is often measured in terms of the person's ability to perform the acitivities of daily life without pain or suffering. The "cost per QALY", which is calculated by dividing the cost of the medicine by the QALYs a patient gains from taking it, can be used to compare a new medicine to an existing treatment. See also cost utility analysis.

Find out more about QALYs

 

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Randomised controlled clinical studies

Studies which demonstrate the efficacy of a treatment by comparing it with another treatment in patients who have been chosen at random to get either the new treatment or the one it is being compared to. 

 

Recombinant DNA technology

Where human genetic material has been inserted into microbial or animal cells, allowing them to make a particular human protein.

 

Reference medicinal product

A product which is approved in the EU by the licensing authority based on a record of quality, safety and efficacy data and against which the new formulationgeneric or biosimilar is compared.
 
 

Routine use

When a medicine is accepted by SMC it may be routinely prescribed by clinicians in NHSScotland for those patients they consider suitable for treatment with it. 

 
 
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Safety

When there are no or few side effects which may bring harm to a patient (see Adverse drug reaction (ADR))

 

Scottish Antimicrobial Prescribing Group (SAPG)

The Scottish Antimicrobial Prescribing Group (SAPG) delivers a national framework for improving the quality of antimicrobial prescribing in Scotland. (See AntimicrobialAntimicrobial stewardship).

Find out more about the Scottish Antimicrobial Prescribing Group

 

ScotMARAP

Scottish Management of Antimicrobial Resistance Action Plan. The plan developed by SAPG to help tackle antimicrobial resistance in Scotland. 

 

SIGN

Scottish Intercollegiate Guidelines Network. Provides evidence-based guidance on the diagnosis and management of specific conditions for the NHS in Scotland.

Find out more about the Scottish Intercollegiate Guidelines Network (SIGN).

 

Single-blind study

As double-blind study, but where only one party is blinded, e.g. in an investigator blinded study, the investigator will not know what treatment patient is taking but the patient will know. 

 

Single technology appraisal

Covers a single technology (e.g. a medicine) for a single indication

 

Scottish Patient Safety Programme (SPSP)

A national plan that aims to improve the safety and reliability of healthcare and reduce harm whenever care is delivered. 

Find out more about the Scottish Patient Safety Programme

 

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Tolerability

The level to which adverse events bring distress to a patient and/or limit daily activity. For a given set of adverse effects, tolerability may be influenced by the characteristics of the patient, such as their ability to tolerate discomfort, and of the disease where the benefits of treatment may make up for any discomfort which it causes.

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Ultra-orphan medicine

A medicine for a very rare condition. At SMC we use the following definition:

"A medicine used to treat a condition with a prevalence of 1 in 50,000 or less (or around 100 people in Scotland)". 

SMC uses a special process for considering these medicines called the ultra-orphan decision making framework. This considers the nature of the condition, impact of the new medicine, value for money, impact beyond direct health benefits and on specialist services and costs to the NHS and Personal Social Services. These medicine can also be considered as part of our PACE process. 

 

User group forum (SMC UGF)

A subgroup of SMC for members of the pharmaceutical industry to consider issues related to SMC's health technology appraisal processes. 

Find out more about the User Group Forum

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