Value-based strategies are designed to highlight how products fit in the disease state value continuum, showcase products compared to other products, and identify key differentiators using real-world evidence, according to a new presentation at AMCP Nexus 2019. These strategies emphasize the overall disease state costs rather than the costs of medications.
Product value, according to the presenters, should be an integral part of product development and pipeline management throughout the product lifecycle. The presenters called for the incorporation of clinical value through the use of clinical studies, noting that required trials in development enhance product value assessment.
The researchers described the life cycle of value strategies to involve the evaluation of the landscape and pipeline, identification of gaps to build value, preparation for launch, and post-launch discovery. They add that product value should be strongly emphasized in the development phase.
Pre-launch work can aid in defining gaps in disease state. The use of real-world data evaluation of disease state results in the definition of potential place in therapy, assessment of competitor landscape and pipeline, and helps determine where trials should be focused, according to the presenters. Post-launch gap identification also leverages real-world evidence to determine areas where more research is needed, and also to compare real-world evidence to clinical trial outcomes.
The presenters described the launch preparation phase to include the following steps:
- Building knowledge of payers’ needs and values
- Assess what potential restrictions in the disease area or drug class
- Prepare accepted budget impact and cost-effectiveness thresholds
- Analyze and evaluate the expected market uptake and challenges
- Physician behavior and potential prescriber inertia
- Develop contracting strategy and risk-sharing agreements (VBC)
They went on to note that the payer should want to look at the evidence to build and evaluate the value story and review their utilization, trends, and disease history. If the payer has medical information, they look at the total disease cost of care and accepted budget impact and cost-effectiveness thresholds. Expected market uptake and challenges should also be considered. The payer should also develop restricted criteria for clinical reasons.
According to their presentation, they felt that risk-sharing agreements can replace traditional contracting or wrap with a traditional contract as well, and added that some products may not be assessed in pre-launch. Post-marketing studies, real-world studies/registries, policies impacting coverage, additional evidence needs, and price reforms potentially impacting the disease area were suggested as possible solutions.
Curry, D, Rivera, S, et al. Managing Value-Based Services & Their Life Cycles. Presented at: AMCP Nexus 2019; October 29 – Nov 1; National Harbor, MD.