Integrated Scientific Advice

Cohesive Evidence Generation for Both Regulators and HTA Bodies

There is an increasing desire from regulators and health technology assessment (HTA) bodies to provide insight to pharmaceutical and biotechnology companies earlier in the drug development process to allow better alignment of evidence needs for both regulatory approval and market access. While early engagement from regulatory agencies is standard practice, scientific advice from HTA bodies is a relatively recent addition and quickly growing in interest. Providing this consultation in parallel can provide invaluable insight to manufacturers in optimizing evidence generation.

Integrated Scientific Advice™ (ISA) is a multi-stakeholder advice process which brings together regulatory advice (either with country-level agencies or the European Medicines Agency [EMA]) and HTA advice (either with individual country-level agencies or multi-country collaborations).

An Integrated Team Ready to Support Your Evidence Generation Plans

Evidera’s ISA offering provides feedback to companies to help optimize their evidence generation plans to develop robust evidence that is relevant to all stakeholders (patients, clinicians, regulators, HTA bodies, and payers) and supports timely patient access. Our integrated team provides evidence-based support combined with tailored project management to ensure timely delivery of a robust HTA package to maximize the efficiency, quality, and impact of ISA engagement.

Our Experience

45+

Integrated regulatory and HTA advice engagements across 10+ companies

45+

Regulatory scientific advice engagements

25+

Indications in ISA engagements (oncology, CV, rare diseases, neurology, etc.)

15+

HTA scientific advice engagements

ISA Has Benefits for Both Access and Pricing

Early formal testing of aspirational value propositions and proposed evidence

De-risking the clinical development program by better understanding the expectations of regulators and payers

Internal alignment of stakeholders to effectively manage multiple evidence requirements

Minimize duplication in evidence generation activities

Reduce time to HTA decision and patient access

Inform price range testing following feedback on the value proposition

Early understanding of evidence requirements for pricing models and managed access

Well Positioned to Support ISA Strategy and Implementation

Integrated Regulatory and HTA Support

Fully integrated submission support including strategic consulting, real-world evidence, health economics, HTA and regulatory consulting

Extensive Regulatory and HTA Scientific Advice Expertise

Deep knowledge of HTA submission requirements, integrated scientific advice, and extensive experience developing submissions for global HTAs

Senior Expertise with Former HTA Committee Members

Senior team members, including veterans of HTA bodies, such as NICE, with experience of attending scientific advice meetings and HTA committee meetings

Prominent Role in Industry Methods Development

Prominent role in industry methods guidelines development (e.g., ISPOR-SMDM modeling and ISPOR MCDA guidelines, and guidelines for database selection in pharmacoepidemiologic research)

Our Approach

When working with clients, we take a comprehensive, collaborative approach that is customized to each client’s unique needs. This approach includes four key phases with core processes in each to support integrated scientific advice, plus optional tasks tailored to meet specific identified goals.

Related Resources

Fact Sheet

Integrated Scientific Advice (ISA)

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