An effective market access strategy rests on two complementary pillars: anticipating the clinical value of your product and the price it can command at an early stage (pricing corridor and price-volume sensitivity); and subsequently securing effective funding through the healthcare systems in which it will be used (market access pathways, coding, and reimbursement in community or hospital settings).
Market Access Strategy for Healthcare Products
Pricing and Volume Strategy
Before submitting any dossier to the health authorities, market research helps anticipate pricing opportunities for your healthcare product.
This generally involves identifying the most appropriate comparators, positioning the product within routine clinical practice, and assessing the expected level of added clinical value (ASMR or ASA in France), based on clinical trial data.
Forecast sales volumes (target population or population likely to receive treatment) are also key determinants of price and should be assessed alongside pricing assumptions, including through price sensitivity analysis.
An in-depth analysis of comparable products also helps assess economic potential using publicly available data, including prices, reimbursement tariffs and statutory health insurance data.
Market research focused on these parameters leads to the definition of a realistic pricing corridor, which will form the basis for subsequent price negotiations.
Market Access, Coding and Reimbursement Strategy
There are often several possible market access pathways. In France, these may involve inclusion on the list of medicines approved for hospital use (known as “agrément collectivités”) and reimbursement through hospital tariffs (GHM), or inclusion on supplementary reimbursement lists (LPPR, UCD, etc.).
Some products included on the outpatient reimbursement list (known as “agrément assurés sociaux”) may also be supplied through hospitals or associated with a medical procedure performed during a consultation, and may therefore require several reimbursement mechanisms.
Alternatively, targeting a special funding mechanism (RIHN for in vitro diagnostics (IVDs), the innovation funding scheme for medical devices, or early access schemes for medicines) can enable faster market access. However, these pathways involve significant requirements and constraints that must be carefully assessed.
Anticipating the appropriate market access pathway and coding strategy helps accelerate patient access and identify the key steps and resources needed to secure funding.
Why Should Pricing and Reimbursement Be Analysed Together?
The pricing strategy establishes the clinical value that can be substantiated and the target price for a healthcare product, while the market access and reimbursement strategy determines the costs associated with bringing that product to market.
Addressing these two dimensions in a coordinated manner, from the clinical development stage onwards, helps anticipate barriers that could restrict prescribing, funding and, ultimately, patient access.
Frequently Asked Questions
Should market research be conducted before or after the pivotal clinical trial?
Ideally, beforehand. The clinical positioning established by the trial (inclusion criteria, line of treatment, choice of control arm, etc.) directly influences potential reimbursement opportunities. Conversely, funding constraints may guide the selection of the most relevant clinical comparators. Clinical trial design should therefore be validated with market access requirements and opportunities in mind.
What determines the final price of a healthcare product in France?
In most cases, the price results from economic negotiations between the manufacturer and the government committee responsible for setting prices (CEPS). These negotiations are governed by regulatory provisions, particularly the incremental clinical value (ASMR or ASA) recognised by the HAS. Working with a consultancy that supports the integrated development of clinical and economic value is therefore a key success factor and can save valuable time in achieving market access in France.
How do European prices influence pricing in France?
Their impact is significant. Although French pricing rules generally take European prices into account primarily for therapeutic innovations, these prices must be included in the pricing dossier and may therefore be used during negotiations. We consequently recommend incorporating prices from other European countries, including the United Kingdom, when assessing the pricing corridor.
Can I start my European market access roadmap with France?
This decision should be assessed on a case-by-case basis. However, assessments issued by the HAS are highly regarded by health technology assessment bodies across Europe, and the pricing opportunities available in France can also help facilitate price negotiations in many other countries.