SMC Patient and Clinician Engagement (PACE) process
The SMC PACE process gathers input from patients, carers, and clinicians about new medicines, especially for end-of-life, rare, and very rare conditions. This input is summarized in a consensus statement that helps decision makers understand the real-world impact of a medicine on patients’ lives and is used to inform funding decisions in Scotland.
At a glance
Use when
Use when assessing medicines for rare, ultra-orphan, or end-of-life conditions where patient perspectives on quality of life and treatment value are critical and traditional evidence is limited.
Avoid when
Avoid when robust quantitative patient-reported outcome data are already available and sufficient, or when patient engagement is not feasible due to lack of organized patient groups or clinical expertise.
Inputs
Input includes lived experience from patient group representatives and clinical expertise from treating clinicians, typically gathered during structured engagement meetings focused on specific medicines.
Outputs
A consensus statement summarizing patient and clinician perspectives on the medicine’s impact, including themes such as health benefits, quality of life, treatment choice, and hope for the future, used to inform SMC decision making.
How it works
The PACE process is a structured engagement method used by the Scottish Medicines Consortium (SMC) during early health technology assessment of medicines for end-of-life, orphan, and ultra-orphan indications. It involves facilitated meetings with patient group representatives and clinicians to elicit qualitative evidence on treatment impact. Outputs include a consensus statement highlighting themes such as health benefits, quality of life, treatment choice, and hope for the future. These statements inform SMC committee deliberations and are integrated into decision-making processes alongside clinical and economic evidence.
- HTA domains
- Clinical Effectiveness, Organisational aspects, Patient and Social Aspects
- Assumptions
- It is assumed that patient and clinician input provides meaningful, complementary evidence to clinical and economic data, and that their perspectives reflect broader patient populations and real-world treatment experiences.
- Strengths
- Incorporates patient-centered evidence into HTA; captures outcomes beyond clinical endpoints; enhances legitimacy and transparency of decisions; particularly valuable for rare and end-of-life conditions with limited trial data.
- Limitations
- Findings may not be generalizable due to small sample sizes; potential for selection bias in participant representation; qualitative nature limits quantitative integration into assessment models.
- Also known as
- PACE, Patient and Clinician Engagement process, SMC PACE
Questions this answers
- › What is the patient and clinician perspective on the value of a new medicine?
- › How does a medicine affect patients' quality of life and ability to participate in daily life?
- › What non-clinical benefits (e.g., hope, treatment choice) do patients and clinicians perceive?
- › How important are convenience of administration and treatment burden from the patient perspective?
- › How do patient and clinician views compare with HTA committee members' views on treatment value?
- › What added value does a medicine bring beyond traditional clinical outcomes?
References & sources
Similar by meaning
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