Drug developer Amgen is questioning the assessment of its multiple myeloma treatments at the hands of the Institute for Clinical and Economic Review.
With value discussions reverberating all around in healthcare, pharmaceutical companies are demanding a fair voice. Drug developer Amgen is questioning the assessment of its multiple myeloma treatments at the hands of the Institute for Clinical and Economic Review or ICER, according to STAT.
With multiple, equally effective, and expensive treatments available for a single indication, payers have started demanding evidence to support inclusion of these drugs on formularies. Multiple myeloma, for instance has 10 treatments available, 3 of which were FDA approved just last year. And these drugs are expensive, ranging from $8000 to $14,000. ICER is working on a report that will provide value-based pricing benchmarks for payers to evaluate health and economic outcomes of multiple treatment regimens for relapsed or refractory multiple myeloma.
ICER plans to evaluate the following regimens in comparison with the standard of care for this population Ilenalidomide or bortezomib in combination with dexamethasone):
The outcomes that will be analyzed include overall survival, progression-free survival, time to progression, overall response rate, duration of response, symptoms control, health-related quality of life, and adverse events. ICER plans to develop a simulation model that will predict the lifetime cost-effectiveness of the various regimens relative to the standard of care as well as potential budgetary impact of each regimen over a 5-year period.
In response to this evaluation by ICER, Amgen issued a statement that says, “Given the stakes for patients, Amgen believes that all economic reviews on the value of medicines should aim to achieve the highest level of transparency, strive for very broad stakeholder engagement, and place scientific rigor and patient interests at the center of the analysis.” Pointing out that quality-adjusted life years and budgetary impacts should not be the primary objectives of evaluating value, the statements goes on to say, “Amgen believes that thorough and balanced assessments should rely on direct data from rigorous comparative trials when available rather than using opaque methods to combine multiple, disparate trials to arrive at different estimates of efficacy.”