What is Project IDEATE?

How best can you design an outcomes based agreement (OBA)? What are the key factors to consider? Project IDEATE is a “cross-disciplinary collaboration between National Health Service (NHS) Wales, industry and academia” with the aim to develop and refine OBA models. This initiative is described in Burton et al. (2024).

What were the key factors IDEATE considered for an OBA?

Feasibility: Identify parameters to determine suitability of a medicine for an OBA. Relevant factors include: (i) uncertainties at the point of HTA and impact on reimbursement, (ii) commercial viability of the agreement and (iii) feasibility and cost of implementation Patient population: Define inclusion/exclusion criteria, patient baselines, and better understand expected health outcomes by exploratory sub-group(s) analysis. Both a treatment and control cohort must be identified.Outcomes: Identify feasible, measurable patient-centered outcomes that describe value for the the target patient population of interest; determine which outcomes would be included in the OBA. Outcome should be determined based on existing literature, clinical experts, and feasibility. Outcomes should be agreed upon jointly by all parties, but also must be able to be measured within a viable timeframe for a commercial contract.Data: Identify a compliant process for accessing the data; identify and link appropriate datasets.Contract design, modelling and implementation: Analyze different OBA scenarios (combinations of outcomes) and different contract parameters to assess impact on proportion of contract payment due and the volatility of payments; consider challenges of operationalizing OBA contracts and modelling their output. Contract parameters include: (i) patient population (inclusion criteria, segment or sub-groups included), (ii) outcome measurement level (population or patient level), (iii) years modelled (time range), (iv) contract duration (number of years) (v) outcomes weighting (percentage of total possible contract payment) (vi) benchmarks and targets (lower and upper limits of outcome performance, relating to payment trigger) (vii) caps (presence/absence of a ceiling on payment) (viii). performance measurement and payment model (linear or threshold model).

IDEATE noted that one of the key challenges of implementing OBA is data availability:

Whilst IDEATE found that OBAs can produce reasonable results based on currently available data, the project also highlighted that some of the data needed to assess the most important outcomes (as identified by clinicians) were not routinely collected in clinical practice, were spread across disparate data sources, were not easily extractable (i.e. in free-text format), or there was a high degree of data missingness

Most people believe that binary outcomes are the easiest to measure for OBA, but they do have drawbacks.

Despite a tendency to believe that single binary outcomes will minimise this burden, IDEATE demonstrates that binary outcomes can lead to significant financial risk for both parties entering an OBA due to high volatility. Determining statistical significance within a volatile outcome, particularly when the sample size is small and the time duration short, is very difficult

Binary outcomes also may increase OBA risk for both parties:

When using a threshold payment model instead of a linear payment model, the volatility increases considerably and impacts total contract payment. Linear payment models are a better solution if both parties want more predictable cashflows. However, threshold payments, even if riskier financially, are appropriate when an OBA incorporates a single binary outcome alone, e.g. 1-year survival.

OBA can result in significant delays in payment due to data collection lags.

Though a 3-year time horizon (2018–2020) for the IDEATE contract was assumed, some outcomes could only be achieved in certain years, e.g. “1-year survival” was only realised in year 2 and payment was only possible in years 2 and 3. Payments for “days disrupted by care” and “intolerance to treatment” are spread across all 3 years.

You can read the full article here. OBAs have a lot of promise, but also there are significant logistical, data and design hurdles to overcome