The Scottish Medicines Consortium (SMC) is the national source of advice on the clinical and cost-effectiveness of all new medicines for NHSScotland. Established to ensure that people in Scotland have timely access to beneficial medicines, the SMC evaluates newly licensed medicines and provides guidance on their use within the National Health Service in Scotland.
Core Functions of the SMC
The SMC’s primary responsibilities include:
- Assessment of New Medicines: Evaluating newly licensed medicines to determine their clinical and cost-effectiveness for use in NHSScotland.
- Providing Guidance to NHSScotland: Offering advice to NHS boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines and all new formulations and new indications of established products.
- Public Involvement: Incorporating the views of patient groups and the public to ensure comprehensive decision-making.
Leadership and Key Contacts
As of January 2025, the SMC operates under the umbrella of Healthcare Improvement Scotland, the national healthcare improvement organization for Scotland.
Contact Details for the SMC
Website: https://www.scottishmedicines.org.uk/
Postal Address:
Scottish Medicines Consortium
Healthcare Improvement Scotland
Gyle Square, 1 South Gyle Crescent
Edinburgh, EH12 9EB
United Kingdom
Telephone: +44 (0)131 623 4300
Challenges in Working with the SMC
Engaging with the SMC involves:
- Understanding Submission Processes: Familiarity with the SMC’s procedures for submitting evidence on new medicines is crucial for successful market access.
- Timely and Accurate Submissions: Ensuring that all necessary documentation is complete and submitted promptly to facilitate evaluation processes.
- Demonstrating Value for Money: Providing robust evidence that new treatments offer value for money within the NHSScotland framework.
Effective collaboration with the SMC can lead to efficient market entry and favorable reimbursement outcomes in Scotland.
Opportunities / Solutions with Justin Stindt Consultants
Justin Stindt’s SMC expertise ensures:
- Expert Consultant SMC Submissions: Creating high-quality submissions for new medicine assessments.
- Market Access SMC Strategies: Developing strategies that align with the SMC’s evaluation framework to optimize market access.
- Specialist SMC Processes: Providing insights into the SMC’s procedures to enhance compliance and expedite approvals.
Justin Stindt Consultants specializes in assisting clients to effectively engage with the SMC’s regulatory environment to achieve successful market access in Scotland.
Case Studies
A Pharmaceutical Company’s Success with the SMC
Challenge:
A pharmaceutical company sought our assistance to obtain approval and reimbursement for a novel therapy in Scotland.
Solution:
We guided them in preparing a comprehensive dossier that addressed the SMC’s evaluation criteria.
Outcome:
Our strategic approach led to a positive outcome, enabling the therapy’s inclusion in the NHSScotland formulary.
Need support with SMC market access? Justin Stindt Consultants has the expertise to help you succeed.
Other Key Institutions in Market Access
Global Institutions
- World Health Organization (WHO)
- International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
United States
- Centers for Medicare & Medicaid Services (CMS)
- Academy of Managed Care Pharmacy (AMCP)
- Institute for Clinical and Economic Review (ICER)
France
Germany
- Gemeinsamer Bundesausschuss (G-BA)
- Institute for Quality and Efficiency in Health Care (IQWiG)
- GKV Spitzenverband
United-Kingdom
- National Institute for Health and Care Excellence (NICE)
- Scottish Medicines Consortium (SMC)
- All Wales Medicines Strategy Group (AWMSG)
- National Health Service (NHS)
Italy
Spain
- Spanish Agency of Medicines and Medical Devices (AEMPS)
- Dirección General de Cartera Común de Servicios del Sistema Nacional de Salud y Farmacia (DGCF)
- Interministerial Commission on Medicine Prices (CIPM)