Risk-sharing agreement

What is a risk-sharing agreement?

A risk-sharing agreement is a contractual arrangement in which a pharmaceutical company and a payer share financial or clinical risk according to a product’s real-world performance. If predefined clinical, economic or utilisation outcomes are not met, the company may provide a discount, rebate, refund or another agreed concession.

Agreements may be financial, outcomes-based or combine both approaches. A financial arrangement might respond to expenditure, treatment duration or patient volume, while an outcomes-based arrangement links payment to measures such as response, disease progression, hospital use or total cost of care.

Why does a risk-sharing agreement matter in market access?

Risk-sharing agreements can support market access when a payer accepts that a treatment has potential value but remains uncertain about its effectiveness in routine care, eligible population, duration of benefit or budget impact. Sharing that uncertainty may make reimbursement possible while limiting the payer’s exposure if expectations are not met.

For manufacturers, the agreement can demonstrate confidence in the value proposition and create a route to adoption for high-cost or innovative treatments. It also creates operational obligations: poor patient identification, incomplete data or an impractical settlement process can reduce access rather than support it.

How is a risk-sharing agreement designed and run?

The parties first define the uncertainty they are trying to manage. They then agree the eligible population, treatment start and stop rules, relevant outcomes, measurement period, data source and financial consequence. The contract should specify how baseline status, switches, discontinuations, deaths and missing data will be handled, rather than leaving these decisions until settlement.

Implementation requires a workable process for identifying patients, recording outcomes, validating data, calculating payments and resolving disputes. The measures should be clinically meaningful, observable in routine practice and attributable to the treatment as far as possible. Reporting frequency, data protection, audit rights, review points and exit arrangements also need to be clear before the scheme begins.

What evidence and data are needed for a risk-sharing agreement?

The evidence package should explain the expected treatment effect, economic value and source of uncertainty. Findings from health technology assessment, trials, economic models and local utilisation data may inform the proposed thresholds and financial exposure.

Once the agreement is active, data may come from claims, electronic health records, registries, pharmacy systems or purpose-built collection. An evidence generation programme can support longer-term learning, but the data required to settle the contract should remain proportionate. A theoretically precise endpoint is of little use if providers cannot collect it consistently or the payer cannot verify it.

Who owns a risk-sharing agreement?

Ownership is usually cross-functional. Market access and pricing and reimbursement teams commonly lead payer negotiation, with input from medical affairs, HEOR, finance, legal, compliance, data privacy, supply and local operations. Healthcare providers or data partners may also have defined responsibilities.

Clear governance matters because the team negotiating the agreement may not be the team operating it. Named owners are needed for data quality, performance review, financial settlement, contract changes and communication with participating centres.

How does a risk-sharing agreement differ from a standard discount or evidence study?

A standard discount changes the net price without making the amount payable depend on agreed real-world performance. A risk-sharing agreement makes at least part of the commercial consequence conditional on clinical, economic, utilisation or budget outcomes.

It is also not simply an observational study. Evidence collection may be part of the arrangement, but the defining feature is the contractual sharing of risk. The agreement therefore sits between conventional reimbursement, financial schemes and real-world evidence generation, combining elements of each when uncertainty affects an access decision.