Ground-breaking science alone will no longer be enough, and having the right capabilities at the right time, along with a robust access plan will be crucial, especially for high-priced, high-budget-impact treatments. The larger the price tag, the more creative the plan required. Access plans must be developed earlier, designed better, and executed more skillfully. Payer value must be created earlier in drug development, then communicated at launch and continuously across the product life cycle.

Payers across Europe are increasingly looking to companies to negotiate managed entry agreements, particularly for high-priced drugs at the cutting edge of medicine. These deals may take many forms but can be broadly divided into financial agreements (discounts, rebates, free stock) or outcomes-based agreements (payment conditional on meeting clinical targets). Manufacturers generally insist on strict confidentiality on the terms of these deals as a key condition of reaching agreement.

Marketing authorisation is the key milestone in a drug’s lifecycle: without it, the product cannot be commercialised. Understandably, companies focus enormous effort on securing regulatory approval. Access, by comparison, is not consistently integrated as a key outcome. Indeed, it is often an afterthought, particularly for companies that lack commercialisation experience. Yet, these companies have the greatest need for understanding and meeting payer requirements.