OBJECTIVES: Stratified treatment, informed by a companion diagnostic (CDx) has the potential to significantly increase care efficacy. To ensure CDx and therapy can be accessed simultaneously by patients, a new pricing and reimbursement (P&R) mechanism is needed, requiring payers, diagnostic and pharmaceutical companies to cooperate and acknowledge each other’s needs. This study aims to understand the market access challenges these stakeholders face and recommends a potential strategy to align P&R of CDx. METHODS: A targeted literature review was conducted to define the P&R landscape for CDx. Interviews with 12 international stakeholders (3 Pharma, 4 Diagnostic, 5 Payers) provided insight on their concerns regarding P&R processes for CDx; how the landscape is expected to change; and what are considered main priorities to ensure that all three stakeholder needs are addressed, and access to appropriate care is enabled. The proposed P&R strategy was tested and validated with these stakeholders. RESULTS: Currently diagnostics are appraised in a separated pathway from pharmaceuticals in many markets and priced on a ‘cost-plus’-basis. However, CDx manufacturers are increasingly seeking value-based pricing due to the added value CDx provides through targeted treatment to the right patients. Whilst this appeals to payers, they voiced concerns that additional costs from extensive testing volumes might exceed the costs saved. Acknowledging that CDx supports better clinical targeting and, thus, can improve cost-effectiveness (CE), pharma wants to minimise the CDx cost to ensure a favourable CEA in the HTA appraisal. CONCLUSIONS: A joint P&R process would incorporate priorities and needs of all three stakeholders: Payers can assess the full value and price for the testing/treatment combination; the value of CDx can be realised based on its ability to select responsive patients. Additionally, pharma and diagnostic companies can negotiate fair revenue distribution and coordinated launch that will ensure appropriate, and timely care for patients.