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Clevidence

Name: Clevidence
Address: Avenida Jacques Delors, Edifício Inovação II, 411/421, Porto Salvo, 2740-122, PT
Telephone: +351913852490

Clevidence stands for clear evidence.

Our aim is to deliver evidence-based assessments that can be used with confidence by health decision-makers and other stakeholders in healthcare.

27/08/2026

A dossier is not judged only by the evidence it contains, but by how clearly its reasoning can be followed.

In complex HTA work, some limitations are unavoidable. What matters is whether they are identified early, documented consistently and linked to the decisions made throughout the analysis.

That is why the first working version should be treated as more than a draft. It is the point at which the analytical logic becomes visible, assumptions can be challenged and potential weaknesses can be addressed before they become harder to resolve.

A defensible dossier does not hide uncertainty. It explains it.

At Clevidence, we support teams in developing clear, traceable and scientifically robust dossiers for HTA and JCA processes.

Get in touch to discuss and strengthen your dossier strategy.

24/08/2026

Comparator strategy is not simply a technical choice. It sits at the intersection of clinical relevance, HTA requirements and national reimbursement practice.

A comparator may appear scientifically reasonable but still fail to reflect the decision context in which the evidence will be assessed. That misalignment can affect the interpretation of relative effectiveness, the feasibility of indirect comparisons and, ultimately, the strength of the value case.

The earlier comparator assumptions are tested across priority markets, the more opportunity there is to refine the evidence plan and reduce avoidable risk.

At Clevidence, we help teams assess comparator relevance from an HTA, pricing and reimbursement perspective.

Get in touch to review your comparator strategy.

19/08/2026

We are proud to present you our new series!
Navigating EU Market Access is a new Clevidence series exploring the decisions, evidence needs and strategic priorities that shape access across Europe.

Across this series, we will share practical perspectives from different stages of the EU market access journey, translating complex requirements into clear, actionable considerations for cross-functional teams.

We begin with Phase 0, where early thinking can influence the entire development pathway. At this stage, the objective is not to finalise the evidence package, but to establish a clear foundation: understand the therapeutic landscape, define the unmet need, shape the initial value hypothesis and align the Target Product Profile with future HTA and market access expectations.

Follow the series as we move from Phase 0 to the next stages of EU market access.

11/08/2026

In a JCA, analytical consistency does not happen by accident.

It depends on decisions being made early, documented clearly and carried through every stage of the process. The HTA Statistical Analysis Plan (SAP) provides that structure.

Its value is not limited to statistical planning. It connects PICO expectations, comparator strategy, indirect treatment comparison (ITC) feasibility assessments and the final evidence package into one coherent analytical pathway.

The earlier this pathway is defined, the easier it becomes to explain what was planned, what was feasible and why each analysis was conducted.

At Clevidence, we support teams in developing HTA SAPs that remain clear, traceable and fit for purpose throughout the JCA.

Get in touch to discuss your upcoming submission.

10/08/2026

The revision of SiNATS under discussion.

On 22 July, Clevidence welcomed around 40 professionals with expertise in health technology assessment to Taguspark for a dedicated discussion on the revision of SiNATS.

Following the publication of Decree-Law No. 118/2026, the meeting created an opportunity to examine the main changes introduced by the new framework, exchange perspectives, and identify areas that may still require further clarification or refinement.

The discussion focused on the practical implications for the assessment, financing, and access to medicines in Portugal, as well as the potential consequences for patients’ access to therapeutic innovation.

We would like to thank all participants for contributing their expertise, experience, and perspectives to a constructive and collaborative discussion focused on supporting better-informed healthcare decisions.

28/07/2026

A Joint Scientific Consultation is not a formality.

In the context of JCA preparation, the JSC is one of the few opportunities to test the evidence plan with European HTA bodies before pivotal evidence is complete.

That matters because the most important JCA questions are often shaped long before dossier writing begins: Which population? Which comparator? Which outcomes? Which analyses? Which evidence gaps?

A JSC will not guarantee a favourable JCA outcome. It will not bind HTA bodies. And it will not replace strategic preparation.

But it can help teams identify misalignment early, refine evidence-generation plans, and prepare a more focused JCA dossier.

In short, the JSC is not about certainty. It is about reducing avoidable uncertainty.

Prepare your JSC with Clevidence. With rigour and confidence.

21/07/2026

Let's start with the following statement. A Budget Impact Analysis is a decision-support tool.

For market access teams, the challenge is not simply to estimate financial impact, but to build a transparent and credible rationale for the expected budget impact.

This requires a clear link between the eligible population, the access pathway, market uptake, the treatment mix, and the resource use assumptions behind the model.

And when that logic is visible from the start, teams are better prepared to address questions, explain uncertainty, and reduce unnecessary rounds of clarification.

So the lesson is clear: build budget impact cases that are methodologically robust, locally relevant, and ready for decision-making.

Do not simply calculate the impact. Make the assumptions transparent and the rationale defensible.

Get in touch and strengthen your budget impact strategy 👉 https://clevidence.pt/contact-us/

14/07/2026

A strong HTA submission is not just about presenting evidence. It is about generating and organising evidence that answers the questions defined by the assessment framework, particularly the PICO.

That means understanding the clinical, economic, methodological, and local access questions that may shape the assessment process from the beginning.

When an HTA strategy is built only around the product, the evidence may be technically complete but strategically underprepared. But when the strategy is developed with the decision context in mind, teams are better prepared to justify assumptions, address uncertainty, and communicate value with clarity.

At Clevidence, we help turn evidence into a structured case for health decision-making.
If your team is preparing for an HTA submission, now is the time to take the right strategic action.

Get in touch and let’s prepare your pathway with confidence 👉 https://clevidence.pt/contact-us/

09/07/2026

A successful launch in Portugal depends on more than a strong dossier. It requires early alignment between evidence, economic value, payer expectations, and likely review questions.

By planning each evidence milestone in sequence, teams can reduce uncertainty, avoid last-minute gaps, and respond with greater confidence throughout the HTA process.

At Clevidence, we are specialists in helping market access, medical, and regulatory teams prepare with clarity, rigour, and strategic focus.

Planning a Portugal HTA submission? Get in touch.

03/07/2026

The new SiNATS regime (Decree-Law No. 118/2026 of 17 June) introduces a relevant change for medicines with non-quantifiable added therapeutic value (ATV).

Where a clinical benefit is recognised, but its magnitude cannot be quantified, the demonstration of economic advantage may be subject to more restrictive criteria.

This issue is particularly relevant in oncology. Among medicines funded in Portugal between 2018 and 2025, 64% of medicines with ATV had non-quantifiable ATV.

The strategic implication is clear.

It will become increasingly important to generate evidence capable of demonstrating benefit in outcomes considered critical within the PICO framework guiding the assessment. These should be definitive clinical outcomes, with a direct impact on patients and measurable in terms of quality of life, survival, or other benefits relevant to decision-making.

The stronger the evidence available to quantify added therapeutic value, the greater the ability to support pricing, reimbursement, and access strategies for therapeutic innovation.

In health technology assessment, evidence should not merely demonstrate benefit. It should enable its magnitude to be measured.

Endereço

Avenida Jacques Delors, Edifício Inovação II, 411/421
Porto Salvo
2740-122

Horário de Funcionamento

Segunda-feira	09:00 - 17:30
Terça-feira	09:00 - 17:30
Quarta-feira	09:00 - 17:30
Quinta-feira	09:00 - 17:30
Sexta-feira	09:00 - 17:30

Telefone

+351913852490

Website

http://clevidence.pt/

Notificações

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