A comprehensive and systematic framework to support you
To help our clients engage payers, Certara creates formal and informal communications with health technology assessment (HTA) and payer stakeholders, either nationally or across the EU.
结果如何？ Integrated evaluation of expected value, clear and concise briefing materials, and a strategic approach.
We have developed a comprehensive and systematic framework to prepare for HTA and payer appraisals. Our team of former payer executives has decades of experience with the criteria used in HTA and payer decision-making processes. Additionally, our HTA expert team has an unmatched wealth of experience in Joint Clinical Assessments (JCA) to support our clients with the upcoming Joint European HTA, with some team members having been involved in the EUnetHTA development and pilot phases.
We bring this rich knowledge into each client’s engagement.
EU Level/National Formal Engagement with HTA bodies
Generate the right evidence for future reimbursement through Early Dialogue/ Scientific Advice from HTA bodies
- Specific feedback on clinical and economic development program
- National formal HTA/regulatory advice before start of pivotal trials
- Joint Scientific Consultation (JSC) across EU
Certara’s expert team advises on engaging with HTA/regulatory bodies in early dialogues/scientific advice and joint European activities:
- Strategic guidance on appropriate approach
- Development of submission materials
- Participation in HTA/regulatory discussion meetings
- Strategic implications on advice received
Prepare for Joint European HTA
Certara’s thought leaders in HTA provide guidance and support clients in the context of Joint Clinical Assessments (JCA) and have previously been involved in the EUnetHTA joint assessment process. We develop robust, evidence-informed dossiers on the relative clinical effectiveness and safety, both for new medicines or certain high-risk medical devices according to the EU Regulation on Health Technology Assessment.
Obtain HTA specific services:
- Scoping process
- Submission package
- Data generation
Gain insights from our Expert Panel of current and former payers and key opinion leaders (KOLs) in the US and global markets
Obtain exclusive access to our Certara Expert Panel, which includes vetted decision makers on clinical benefit, price, access and treatment.
- A large network of EU former payers, members of HTA groups, pricing committees, regional/local decision makers
- A leading US proprietary database of decision makers across managed care, PBM, hospital, GPO, IDN/ACO, and other healthcare stakeholders
To assess level of unmet needs, early value proposition, pricing expectations, HTA comparator, and clinical trial design, we:
- Moderate multi-country or single-country Adboards to gain inputs on level of unmet needs and early value proposition
- Leverage the multiple-criteria decision analysis (MCDA) methodology
- Conduct 1 on 1 interviews