Successful market access strategies can be crystallised down to five core pillars that will maximise the potential for patient access success.
1. Corporate ownership of market access as a business asset: Market access strategy is an integral component of the marketing mix; companies that gain funding and patient access engender this philosophy within their organisation from test-tube to launch and beyond. It means creating a corporate vision and belief that market access is the business of everyone in the company; research, regulatory, medical and marketing.
For example, when determining phase III trial design, companies need to engender a corporate philosophy that places as much emphasis on payer endpoints and patient experience, as it does on clinical primary endpoints. When evaluating a new treatment for COPD, payers don’t care about FEV1 – they do care about its ability to reduce emergency admissions and length of stay.
2. Goal congruence: Ensure that market access success for each specific product and country is clearly defined and owned at the outset of the market access journey.
Create a corporate vision of market access and communicate it early ensuring each country is tracking its steps to delivering the vision in an integrated and joined-up way.
The UK is often the first country to embark on its market access strategy, often in a vacuum of clinical insights on the molecule. Exposure to UK payer thinking can be invaluable to other countries; but how often is payer insight shared across countries in respect of informing the viability of market access end-game?
3. Right tactics at the right time: Rigorous local market environment analysis carried out two to three years before launch will determine the key market access issues and shape the right tactics for each country. For example, payers are keen to establish the costs for a whole treatment pathway, determine where the new treatment will fit in that pathway and the impact it will have on service costs, as well as drug acquisition costs.
For this to happen clinicians need to have reach consensus about the pathway, at the time that payers are horizon scanning the new drug. Absence of consensus on the treatment pathway among clinicians months before launch, or even worse at launch, will allow payers to drive a coach and horses through funding requests – if clinicians aren’t clear about where the new treatment fits and why, then they cannot expect it to be funded.
Consensus takes time and this time needs to be built into the pre-launch market access activity.
4. Value=P3 – Prescribers, payers and patients: Historically good product launches establish prescriber value at phase III. However, so often phase III trials focus only on clinical endpoints, driven by regulatory focus. This means that there is often an absence of payer outcomes such as reductions in hospital admissions, reductions in length of stay, impact of the treatment on the overall pathway. Payers are keen to see patient-reported outcome measures in the clinical evidence and to balance the difference in how the patient feels about the treatment compared to standard of care. Yet, so often this information is omitted from trial designs, which focus on disease-oriented outcomes exclusively.
Thinks POOs (patient oriented outcomes) as well as DOOs (disease oriented outcomes).
5. Pre-Launch and beyond – market access strategy should deliver a smooth transition between pre- and post-launch commercial requirements. A good market access strategy should deliver patient access from launch. However, market access does not just end at launch, and strategy and tactics need to reflect the need for smooth transition between those responsible for access pre- and post-launch, ensuring for example that that emerging evidence is communicated to payers as well as prescribers.
The Author
Angela McFarlane is Managing Director, HGS Europe Limited
She can be contacted at: angela@hgseurope.co.uk