Supporting your market access strategy
Catarina Silva, Health Economics Manager
We at Eurotrials understand that the industry must properly demonstrate and communicate value and identify the requirements of relevant stakeholders, as a fundamental part of the market access strategy to enable a successful product launch – health technologies that truly reach and impact patients’ lives.
Innovative and disruptive health technology is the main key driver for increased expenditure in governments and health authorities’ budgets. At the same time, patients’ demand grows alongside the aspiration for continuously improved standard of care. To solve this challenge in a framework of limited resources, third-payers and regulators rely on specific measures and systematic assessments that focus on two dimensions – the clinical and the economic – to achieve efficient resource allocation whilst maintaining equity in access.
Building on Eurotrials’ 20 years of scientific, clinical and operational expertise in the biopharmaceutical area, together with in-house know-how and existing synergies across departments (Real World & Outcomes Research, Biostatistics, Clinical Trials) we can identify and anticipate gaps in the product’s value proposition and offer advice on strategies to generate the right evidence regarding the efficacy/effectiveness, safety and technology implementation in a real-world setting. The latter inputs may prove essential to create robust HTA assessments or Pharmacoeconomic Studies that respond to health authorities’ questions and demands.
For that reason, market access strategy is now, more than ever, linked to the product full lifecycle.
New pharmaceutical products, medical devices and other health technologies fall under the umbrella of Health Technology Assessment and whilst the health value of novel technologies is a fundamental part or biopharmaceutical research & development, it is also essential to capture economic value .
Moreover, medicinal product economic evaluation studies are now a requirement in most markets after MA has been granted, to enable reimbursement by third-payers. The paradigm is constantly evolving and real world data is assuming a preponderant role to HTA bodies. Several world experience inputs such as outcomes research, ex-post MA observational studies, comparative effectiveness, patients and product registries and patient reported outcomes serve to inform robust technology (re)assessments.
Our team of health economists, statisticians, regulatory affairs and pharmacovigilance professionals can focus on any particular project phase to help you create the optimal strategy for economic evaluation and prepare the necessary regulatory documents to support price and reimbursement procedures:
- Pharmacoeconomic Studies
- Pharmacoterapheutic Reports
- Price and Reimbursement Dossiers