Start with the unmet need
Define who is underserved, what changes in their daily life, and which decision-maker can act on it — before choosing a single endpoint.
The testCan you name the patient group, the gap and the decision in one sentence?
STRATEGIC GUIDELINES
Eight principles
from evidence to access
A practical framework drawn from my published work and 14 years across Pharma and MedTech. Each principle ends with a test your team can apply tomorrow.
WHAT THE DATA SHOWS
Why value is not recognised by default
142/253
Spanish medicine indications not recommended for reimbursement (2019–2022)
Full-text results; the abstract reports 143. Medicines only, descriptive data.Pinilla-Dominguez & Pinilla-Dominguez, Eur J Health Econ 2025 24/253Reimbursement decisions that explicitly mentioned the therapeutic positioning report
Absence of a citation does not prove evidence was ignored.Pinilla-Dominguez & Pinilla-Dominguez, Eur J Health Econ 2025 42/55Value assessment frameworks including societal impact
Systematic review of literature from 2008–2019.Zhang et al., Value in Health 2022 11/57Frameworks that involved patients or the public in their development
Same review; denominator is all 57 frameworks.Zhang et al., Value in Health 2022 49/484NICE appraisals including carer quality of life in cost–utility analysis (2000–2023)
Considered quantitatively in 40 of those 49.Ahmadu et al., PharmacoEconomics–Open 2025 9 June 2026First EU Joint Clinical Assessment report published
JCA informs national processes; it does not set prices or reimbursement.European Commission; Regulation (EU) 2021/2282Design evidence for the decision
Map every evidence piece to a payer, HTA or clinical question. Evidence that answers no decision is cost, not value.
The testDoes each study link to a named criterion in the assessment?
Challenge the category
Classification can decide value before evidence is read. Test whether the comparator and group reflect function, intended use and patient outcome.
The testIs the comparison fair — or merely convenient?
Make wider value credible
Societal, carer and patient value matter only when measured transparently. Use SROI and PROs with clear assumptions, not as advocacy.
The testWould a sceptical assessor accept the method?
Separate EU from national
JCA strengthens shared clinical evidence. Price, budget and reimbursement stay national — plan for both tracks from day one.
The testIs there a country-level access plan beyond the JCA dossier?
Use AI, keep judgement
AI can generalise, screen and accelerate. Context, trade-offs and knowing which question is worth answering remain human work.
The testWho owns the final interpretation?
Anticipate roadblocks
Rigid budgets, legacy classifications and missing comparators are predictable. Name them early and assign an owner and a mitigation.
The testIs every known roadblock on the risk log?
Measure access, not approval
A positive recommendation is a milestone, not the finish line. Track uptake, prescriber reach and patients actually served.
The testHow many patients have real access today?
Figures are reported with their original denominators and limitations. Positions are the author's own, not study results.
LET’S ASK BETTER QUESTIONS