OBJECTIVES : Value-Based Pricing (VBP) is employed to define the pricing of a technology related to its Therapeutic Value (TV). VBP global experience is limited and mainly from developed countries. In 2018 Colombia issued a VBP framework, containing six TV categories relative to the technology and comparator efficacy/effectiveness and safety; I: Substantially greater; II: Greater than; III: Favorable but not as I/II; IV: Same as; V: Unfavourable; IV: Unclassifiable. However, implementation was postponed until 2021. We aim to synthesize hurdles for implementation based on available evidence and validate those with local stakeholders.

METHODS : We conducted a scoping peer-reviewed and grey literature search within the last decade. Two reviewers selected the relevant evidence and synthetized hurdles for VBP implementation. Case studies were created for comparison. Interviews with local stakeholders (Policymakers, HTA experts, Patient advocates, and Trade associations) were conducted to gather insights.

RESULTS : We selected 44 publications including 12 countries. Case studies from three countries using similar TV categories (Canada, France and Germany) were created as reference. VBP has been implemented to reward innovations, improve payer’s affordability, ensure patient access, and sustain health systems. Differences in the TV definition, due to the elements of value selected and use (e.g. indication, population) were the principal hurdles identified for implementation. Our interviews confirmed stakeholder’s perception that the VBP framework narrow focus on efficacy/effectiveness and safety, may underestimate the value of new technologies, limiting its adoption. In addition, concerns exist with methodological challenges to assess breakthrough innovations approved using early data sets.

CONCLUSIONS : In Developed countries, broader approaches for VBP have not been exempt from challenges (e.g. Gene therapies), while since the COVID-19 pandemic, other elements of value (e.g. “fear of contagion” or “insurance value”) are gaining relevance. Stakeholders consider that Colombia's limited value set might underestimate the TV of technologies limiting patient access to life-saving technologies.