1. Health Technology Assessment (HTA)
1.1. essential process in examining the safety, clinical efficacy and cost of a (new) health technology – usually a drug, medical device or clinical/surgical procedure
1.2. focuses on two questions
1.2.1. Is the technology clinically effective?
1.2.2. Is the technology cost-effective?
2. New Medicines Appraisal
2.1. The Scottish Medicines Consortium (SMC) carries out an evaluation on the clinical and cost effectiveness of all newly licensed medicines and advises health boards on their use. When a new medicine is licensed the manufacturer is asked to submit details on the medicine to the Scottish Medicines Consortium (SMC)
3. End of Life and Rare Conditions
3.1. In situations where the New Drugs Committee (NDC) has reached a 'not recommended' decision for end-of-life medicines and medicines for rare conditions, the pharmaceutical company is able to request that the Scottish Medicines Consortium (SMC) convenes a PACE Meeting and/or submit a new or revised Patient Access Scheme (PAS).
3.1.1. aim of the PACE meeting is to describe the added benefits of the medicine, from both patient and clinician perspectives, that may not be fully captured within the conventional clinical and economic assessment process
3.1.2. The PACE process strengthens patient and clinician engagement in the SMC process giving them a stronger more direct voice in the decision making process
3.1.2.1. Added Value to Patient
3.1.2.2. Added Value to Family/Carers
3.1.2.3. Clinical Issues
3.2. • End of Life Medicine -
3.2.1. A medicine used to treat a condition at a stage that usually leads to death within three years with currently available treatments.
3.3. • Orphan Medicine-
3.3.1. A medicines with European Medicines Agency designated status for 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 orphan status.
3.4. Ultra-Orphan Medicines
3.4.1. extremely rare conditions with a prevalence of 1 in 50,000 or less
4. NHS Quality Strategy
4.1. Safe - There will be no avoidable injury or harm to people from healthcare, and an appropriate, clean and safe environment will be provided for the delivery of healthcare services at all time.
4.2. Person-Centred - Mutually beneficial partnerships between patients, their families and those delivering healthcare services which respect individual needs and values and which demonstrates compassion, continuity, clear communication and shared decision-making
4.3. Effective - The most appropriate treatments, interventions, support and services will be provided at the right time to everyone who will benefit, and wasteful or harmful variation will be eradicated.
5. Area Drug and Therapeutics Committee (ADTC)
5.1. A committee responsible for providing advice to the NHS board on all matters affecting efficacy, safety and value for money in the use of medicines, to help meet the needs of the local population.
5.2. Purpose and Function of ADTCs
5.2.1. To provide professional advice, clinical advice and leadership to the NHS Board, that supports safe, clinically effective, cost effective and patient centred medicines governance, in all care settings.
5.2.2. To advise and support the strategic direction of all aspects of medicines governance and usage in all care settings ensuring inclusion within wider strategic planning carried out by the NHS Board.
5.2.3. To ensure multi-stakeholder engagement and joint working on all medicine related issues within all care settings, including social care settings.
5.2.4. To inform the financial planning and governance of the NHS Board to ensure the effective use of resources, in relation to medicines
5.3. how do ADTCs promote safe, clinical and cost effective use of medicines
5.3.1. 1. Formulary
5.3.2. 2. Scottish Medicines Consortium (SMC)
5.3.2.1. Two key roles:
5.3.2.1.1. • New Medicines Assessment
5.3.2.1.2. • Horizon Scanning
5.3.3. 3. Market Authorisation (licensing)
5.3.3.1. assesses a drug on the basis of:
5.3.3.1.1. Quality • Safety • Efficacy
5.3.3.1.2. But not: - • Relative effectiveness / cost effectiveness
5.3.4. 4. Value for Money and Cost-Effectiveness
5.3.4.1. SMC evaluates every medicine submitted in terms of whether the benefits for patients may be considered an acceptable use of NHS resources
5.3.4.2. SMC use the Cost per QALY as a means to establish whether a new medicine represents value for money.
5.3.4.2.1. This ratio shows how many extra quality adjusted life years the new medicine gives and how much extra it costs compared with the current treatment.