As we have previously highlighted in our “what is market access?” article, “Market Access” is a broad term that is used to describe activities and processes that pharmaceutical and biotech companies undertake to secure a reimbursed price. The reimbursed price should reflect the product’s value for the broadest possible patient population, within the shortest feasible time-frame, for the highest chance of commercial success.
Achieving such ambitions is no easy feat. In fact, it often requires a team of dedicated market access and pricing professionals to achieve an optimal outcome. While organisational structure can vary from company to company, this educational blog will explore what a global market access team (GMA) does strategically and operationally across the lifetime of a product.
The Global Strategic Perspective
Some multinational pharmaceutical companies will be overseen by a “global” market access function. Typically, the responsibility of the global market access team is to provide the overall access strategy and pricing philosophy for products in the company portfolio.
Alongside the strategic vision, there are a number of operational functions that a GMA and pricing function will perform from early development to post-marketing.
A GMA team could be highly involved in researching potential indications of interest to understand the level of opportunity. By analysing the comparators that make up the standard of care, as well as the patient and economic burden of the disease, the GMA team can identify how the company’s product can be used within the treatment pathway, and what value it would bring to patients and clinicians. In addition, understanding the existing payer unmet needs within the disease area can provide a strong steer in identifying indications of high commercial interest for the company to explore.
Understanding the disease area in a high level of detail allows the GMA team to begin developing the early value narrative for a product. This is essentially a “story” for the product, which highlights a product’s potential clinical and economic value to clinicians and payers. By building this value story early, the clinical and economic benefit can be identified and demonstrated to clinicians and payers through the clinical development program.
A good GMA team will be finely tuned to the demands and needs of payers across the world. For example, in the early stages of product development, the GMA team will work closely with the health economics and outcomes research (HEOR) team to ensure that the known requirements of national payers are met in the evidence generation plan (e.g. inclusion of quality of life endpoints), therefore improving the probability of reimbursement success across the world.
Let’s take an example that we come across regularly in our work, which demonstrates the impact of lack of market access input. Often we are presented with evidence for a product in a chronic disease with 12 weeks of evidence that, on the surface, looks like it has brought real clinical benefit to the patient.
However, talk to a German payer and they will say the level of clinical benefit is unquantifiable. Why? Because their minimum expected duration for a chronic disease trial is 24 weeks. The missing input of an early market access voice has meant that the German launch plan has been jeopardised, and the European launch plan has been endangered.
Depending on the level of independence of the affiliates, GMA teams may also be heavily involved in national or regional pricing and reimbursement processes. This could include co-ordinating health technology assessment (HTA) submissions, which requires significant amounts of clinical and economic evidence to complete successfully. Additionally, the GMA team could also take an active role in pricing negotiations, or at least ensuring the company pricing philosophy is implemented via price governance (e.g. optimising revenue, or focusing on net sales).
Due to the growing use of international reference pricing (IRP), it is more important than ever to have effective communication between regions to ensure cohesion. A global pricing function can guide pricing decisions that ensures a price change of Drug U in country V does not dramatically impact the price of Drug U in countries X,Y and Z.