Table 2 Definitions and examples of the three types of Market Access Agreements

Contract type

• Discount-based contract

• Permanent risk-shifting agreement (outcomes guarantee/insurance) applied on a per-patient basis

• Provisional agreement until new, clearly specified evidence develops from a cohort of patients

Collection and analysis of patient health outcomes data by the payer

• None

• Per patient

• Cohort of patients

Timeframe of the MAA

• Permanent/not linked to final decision-making

• Permanent/not linked to final decision-making based on new robust evidence

• Temporary/provisional until new evidence allows making a final decision

Underlying concept (payer perspective)

• Reducing pharmaceutical expenditure

• Avoiding inefficient expenditure on treating patients who do not respond to a drug and who cannot be identified ex ante (by permanently linking the payment to drug's performance in individual patients)

• Reducing uncertainty about drug's real-life effectiveness (by linking a final HTA, reimbursement and/or pricing decision to drug's performance in a cohort of patients, during a defined test period)

Examples

• Flat price per patient (regardless of the number of doses administered)

• Cost Sharing

• Rebate

• Discount

• Payment for performance

• Pay-back for non performance

• Temporary coverage on a condition that new evidence reduces uncertainty about a pre-specified health outcome:

- Real-life effectiveness

- Higher efficacy in a pre-specified subpopulation of patients

- Long-term effect

- Improved patient's adherence

- Reduction of use of health care resources (e.g. hospitalization)