Along with other advocacy, education and health care organizations, the Institute for Patient Access wrote to the Institute for Clinical and Economic Review this week offering 12 suggestions on how to improve its value framework. The letter responded to ICER’s request for feedback as it prepares to update its framework for 2017.
“Far from an end unto itself,” the letter explains, “a calculation such as ICER’s value-based price benchmark goes on to inform crucial health plan features such as formulary design, cost-sharing ratios and the use of utilization management tools such as prior authorization and step therapy. These factors often determine whether a patient can access the treatment prescribed by his or her physician, and whether a physician can direct patient care as needed.”
IfPA’s recommendations address two areas for which ICER requested feedback: 1) Integration of patient and clinician perspectives on the value of interventions, and 2) Incremental cost-effectiveness ratios and thresholds.
- Formally and transparently involve patients and clinician stakeholders throughout the valuation process.
- Incorporate patient reported outcomes in the comparative assessment of clinical effectiveness.
Patients should participate in identifying which outcomes are to be used to evaluate the effectiveness of a new treatment compared with existing treatment options.
- Consider benefits and disadvantages other than the clinical effectiveness and adverse effects of new treatments.
Patient and community groups should be asked about intervention-related benefits and disadvantages that may be less directly related to the clinical effectiveness of the intervention. Issues to be considered include route of treatment administration (i.e., oral, subcutaneous injection, infusion, etc.); aspects of the treatment that may reduce or improve adherence; other treatment-administration related characteristics.
- Explicitly incorporate contextual factors into the valuation process.
Contextual considerations may include legal, ethical, and other aspects that influence the priority of an illness or treatment. For example, for a particular disease, are alternative treatments available, or is there an under-served need for interventions for the targeted condition? Are there ethical considerations related to the intervention?
- Clearly describe the methods used for achieving consensus on care value.
- Use multi-criteria decision analysis more formally to assess care value.
ICER evaluates the care value of products using four types of criteria: the strength of the evidence, the efficiency, the existence of other benefits and “contextual” factors such as ethical or legal aspects. This process constitutes an informal multi-criteria decision analysis, but following a more formal MCDA process would offer some benefits, chief among them the increased rigor involved.
- Replace the general efficiency threshold with therapeutic-area specific ones.
Using a single threshold imposes the idea that all products must abide by the same efficiency requirement, regardless of the severity of the illness, the unmet need or ICER’s own rating of value. Instead of a general efficiency threshold, ICER should switch to therapeutic area-specific thresholds.
- Derive specific thresholds by constructing efficiency frontiers in each area.
Area-specific thresholds can be easily obtained by considering the best efficiency at particular levels of benefit.
- Increase transparency by making models available to reviewers.
- Report expected budget impact but don’t use it to derive acceptable price.
A major breakthrough should not be held to the same standard as a product that provides little advantage. Moreover, an overall budget impact threshold is an unsound idea in the context of a health care system like the American one, which does not have anything like a global budget.
- Involve patients and clinicians in deliberations regarding the budget impact (“health system value”).
- Provide formal methodological guidelines or citations to existing ones for every aspect.
It is extremely important that every step of the process be conducted following solid methodological guidelines. Where there are gaps in the guidelines, or in places where ICER wishes to introduce its own approach, this needs to be carefully documented.