Marketing a drug in France, what are the responsibilities of an exploitant?
Home > Our Services >
Market Access Services
In order to gain market access in pharma and remain competitive, pharmaceutical and medical technology manufacturers must be able to demonstrate clinical and economic evidence to providers, healthcare decision-makers and payers.
In the past, market access for a drug depended almost exclusively on efficacy and safety. These factors are still critical, but today, clinical differentiation and its effects on cost effectiveness is gaining importance. Today, more than ever, pharmaceutical companies must demonstrate how a new drug improves patient outcomes, reduces the burden of the healthcare system as a whole and is worth its price. To satisfy these criteria, pharmaceutical manufacturers have gradually expanded their business “beyond the pill” to build an evidence based strategy and therefore a stronger value story for payers.
For payers and market access stakeholders, the drug value proposition encompasses the optimal combination of disease need, clinical efficacy and economic impact that achieves market access at an optimal price, by validating and communicating the need for treatment and the value of utilizing the drug in question. To do so, market access activities have expanded beyond pricing and reimbursement, and include other elements in the drug development continuum such as:
- Regulatory
- Supply Chain and channels
- Training and education
- Stakeholders and key opinion leader (“KOL”) management
- Financing/Investors
We can help you navigate the increasingly complicated legislative environment. Each stakeholder has their own particular interest in a product, and we can help you communicate the value of your product to stakeholders.
- Understand payer landscape, research and plan development
- Analyze comparative cost of alternative therapies
- Identify outcomes after interventions
- Model development from Early-Phase clinical studies to highly complex modeling depending on the needs and phase in development
- Develop pricing, reimbursement and contracting strategy
- Plan and execute Delphi panels and payer/HCP/patient interviews
- Develop payer and patient value story
- Calculate persistence, adherence, and compliance with therapy
- Conduct RWE (Real World Evidence) studies e.g. registry studies, chart reviews to collect data on the burden of disease, standard of care and for follow up after market entry to close current gaps
- Develop and submit reimbursement dossiers including HTA communication
- Training in health economics, from basic to advanced level
What our clients say
I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.
Lorraine Henry
Compliance Lead, Qualified Person, Amneal Ireland Limited
Compliance Lead, Qualified Person, Amneal Ireland Limited
Hard working and there when you need them
Europe based large biotech
Regulatory Manager
Regulatory Manager