Strategic Services
Strategy Consulting, Global Market Access and Real-World Evidence on a new level.
EEA: Early HTA/Payor Assessment of Evidence Needs in EU-4 plus UK
Latest during the phase II trial stage, companies should assess their strategic HTA/payor evidence needs, which might be very specific regarding European and local national evidence needs. Our unique EEA (“Early Evidence Assessment”) service maps the HTA/payor requirements in the specific indication and identifies evidence gaps. Optionally, we validate our gap assessment in Advisory Boards or individual discussions with external stakeholders such as clinicians, HTA experts, or payors.
Our USP
Unique knowledge regarding evidence needs in all European archetype HTA regions (cost-effectiveness, clinical effectiveness, budget impact)
Own GER HTA database covering all submissions since 2011
Extended network of KOLs and HTA/payor experts across Europe
Unique EVIGATOR software supporting development of Evidence Generation Planning
Related Whitepaper & Publications
Support in early consultation with HTA bodies
Some basic HTA decisions, such as outcomes of interest or the relevant trial comparator(s), can be identified in strategic EEA projects – but final confirmation can only be reached if companies talk to respective HTA bodies. We support these early consultations by preparing the necessary strategy and documents, supporting our clients during these early advice meetings, and summarizing and interpreting the results afterward.
Our USP:
Experienced team who knows processes, regulations, and requirements around the targeted HTA bodies
Extended payor and HTA network that helps to prepare the right early advice strategy
Related Whitepaper & Publications
Development of strategic evidence generation plans
Based on an Early Evidence Assessment, the very next step is to prepare a strategic Evidence Generation Plan that outlines the needed evidence study by study, incorporating aspects such as priorities, timelines, region, and data availability. Our strategic Evidence Generation Plans include all types of necessary evidence – typical topics are:
Summary value story of the agent and derived main evidence generation strategy, local/region-specific components of that strategy
Planned analyses of clinical trial data
Planned systematic/targeted literature reviews
Planned NMA/anchored NMA
Planned HE modeling and BI modeling
Proposed database studies (registry data, claims data, EMR data, linked datasets)
Proposed chart review studies & prospective non-interventional studies
Proposed patient preference studies, including utility/willingness to pay studies
Validation of developed Evidence Generation Plans with external stakeholders – typically HTA experts, payors, and clinicians – but also with an increasing frequency with patients and private caregivers.
Our USP:
Experienced team who developed >50 Evidence Generation Plans in various indications
Own database tool that provides detailed information about available data
Extended payor and HTA network that helps to prepare the right early advice strategy
Unique EVIGATOR software supporting development of Evidence Generation Planning
Related Whitepaper & Publications
Support of JCA submissions, including strategy development
From 2025 onwards, and starting with ATMPs and oncology assets, pharmaceutical companies need to go through European HTA assessment
This has mainly three implications:
JCA dossiers need to be submitted SIGNIFICANTLY earlier than national HTA dossiers – HTA-driven evidence generation needs to be planned and conducted earlier
Specific evidence categories need to be presented on a European level – but later on a national level; both summarizing them on a European level and keeping them up to date for later national submissions is a new challenge
JCA represents another hurdle to getting final reimbursement – the robustness of evidence packages is more than ever crucial to a successful market access story
We offer the development of JCA strategies, the development of JCA Evidence Generation Plans as well as the development of the writing of JCA dossiers
Our USP:
Experienced team with active involvement in European-level HTA activities since the early development of the JCA process.
Experienced cross-functional consultants who understand EVERY type of required evidence
Medical writing team that can support you in developing the dossier
Unique EVIGATOR platform supporting Early JCA PICO Scoping
Related Whitepaper & Publications
Payor/HTA Insights and Advisory Boards in EU-4 and UK
GIPAM offers, based on its European network of payors & HTA experts, various ways to engage with these experts
Individual discussions regarding Evidence Generation Plans, design of specific studies, and national reimbursement topics
Group discussions with experts – also using advanced techniques such as Delphi techniques
Payor/HTA AdBoards
Our USP:
Experienced team which knows European HTA/payor evidence requirements in every detail
HTA database of previous decisions
Network of European HTA experts & payors who can be engaged in our projects on a formal or more informal basis within days
Delphi Panels with Experts
Delphi Panels can be described as a group of survey techniques that try to generate an “expert consensus”, through repeated surveying of participants by providing them with the results of recent surveys.
GIPAM supports Delphi Panels of experts (clinicians, payors, but also patients) by
Designing such Delphi Panels,
Conducting Delphi Panels with appropriate tools,
Analyzing & Reporting Delphi data,
Publishing Delphi results.
Our USP:
Experienced team who knows the methodology as well as strengths & weaknesses of Delphi Panels
Extended payor, HTA, and clinicians` network that can be engaged in these types of studies
Related Whitepaper is coming soon
Ad hoc analyses of clinical trial data targeting German G-BA requirements
In preparation for German G-BA submissions, often ad hoc analyses of trial data providing results outside the CSR are needed:
Subgroup analyses
Network meta-analysis of several trials regarding specific outcomes of interest
Other requested trial analyses
GIPAM offers to conduct these analyses within a concise timeframe – typically within weeks. That also includes ad hoc analysis of other datasets, including hybrid datasets consisting of trial and observational data. We support all common reporting structures and are also happy to publish analysis results.
Our USP:
Experienced team of biostatisticians who are able to do the required data analyses
Lean processes around statistical analyses – guaranteed timelines
Related Whitepaper is coming soon
Surrogate Endpoint & PRO Assessment & Validation
In a substantial number of clinical trials, so-called “surrogate endpoints” are used. Typically, both regulatory bodies and HTA bodies/payors request a rationale for using these endpoints and, in addition to that, a formal endpoint validation. The same applies to Patient Reported Outcomes (PROs), which are only accepted if thoroughly validated.
Based on different endpoint validation methodologies and guidance instruments, GIPAM offers a variety of services to validate surrogate endpoints:
Providing a rationale for choosing specific endpoints using qualitative & quantitative patient & physician surveys (qualitative preference studies, AdBoards, Delphi panels, quantitative preference study based on a Conjoint methodology)
Doing Correlation Analyses (surrogate and target endpoint correlation) in trial & observational datasets
Doing Systematic Literature Reviews in Preparation of Endpoint Validation Studies
Full endpoint validation studies by correlation of treatment effects on surrogate and finale endpoints, according to IQWIG guidance
Full PRO validation according to FDA/EMA guidance
Our USP:
Experienced team who knows all types and levels of surrogate/PRO endpoint validation
Own questionnaires that have been validated in numerous diseases
Advanced analytical skills to perform required validation analyses
Related Whitepaper & Publications
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Guaranteed timelines and budgets
We do not overpromise, and we guarantee promised timelines. If, due to us, we cannot hold the timelines we pay at least 25% of our budgets back – in all our studies, without any other restrictions. In addition, we guarantee budgets and deliverables. Based on the scope we agreed on we deliver the results, whatever it takes.
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Intelligent & strategically meaningful
We do not do studies that do not help our clients strategically, just for the sake of doing the study. If we are unsure about the strategic value of a study, we do a thorough strategic assessment first – before the study starts.
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Publishable
All our studies will be publishable in peer-review journals. Scientific protocols guide our studies – we do not generate evidence and/or recommend evidence generation that is not scientifically sound.
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Advanced methodologies
are part of our DNA: Whether it is an inverse probability weighting in a comparative study or latent class analyses in preference studies: we always apply the most recent and accepted methods in our studies.
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Modern Reporting:
We go one step forward, in each of our studies. Our GIPAM Study Reporting (GSR) provides DAILY updates through our live reporting tools: Clients see interim results seconds after they have been generated, in our primary data collections daily updated statistics about included patients & their characteristics are provided.