Boston, Mass., June 16, 2017 – The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of two anabolic agents for treatment of osteoporosis in postmenopausal women who are at high risk for fracture: abaloparatide (Tymlos™, Radius Health, Inc.) and teriparatide (Forteo®, Eli Lilly and Co.). The report also includes a summary of trial results of a third anabolic agent, romosozumab (Amgen, Inc. and UCB, Inc.), which is currently under review by the Food and Drug Administration (FDA).
This Evidence Report will be the subject of an upcoming public meeting of the California Technology Assessment Forum (CTAF) on June 30, 2017.
“Abaloparatide and teriparatide are important treatment options for patients for whom other therapies have not been effective. Our report suggests that the evidence is inadequate to distinguish among the available options, and that estimated price after rebates remains too high for both drugs to align well with the added benefit they bring to patients,” noted David Rind, MD, MSc., ICER’s Chief Medical Officer. “These findings will be debated at our public meeting on this topic, where we will also engage stakeholders in addressing how best to apply the available evidence to pricing and coverage to ensure that patients can receive appropriate care.”
A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report reflects changes made based on comments received from patient groups, clinicians, the manufacturers of the drugs, and other stakeholders.
ICER’s draft report included detailed clinical and economic analyses of romosozumab, initially expected to receive FDA approval in 2017. In May, Amgen and UCB announced topline results from the ARCH trial of romosozumab, which included a new safety signal related toserious cardiovascular adverse events. The companies no longer expect FDA approval of romosozumab in 2017 while the ARCH trial data are evaluated. As a result of this delay, ICER has removed romosozumab from the analyses, and CTAF will not consider any voting questions that include romosozumab at the June 30th meeting.
ICER’s report assessed evidence for each of the three anabolic therapies for use by postmenopausal women who have osteoporosis and are at high risk for fractures; however, evidence ratings were assigned only to abaloparatide and teriparatide.
ICER’s analyses concluded that, when compared to no therapy, the evidence on both therapies provides moderate certainty of a small or substantial net health benefit. Data were judged insufficient, however, to distinguish benefit between the two agents. Evidence comparing abaloparatide and teriparatide to zoledronic acid was promising but ultimately inconclusive.
In the economic evaluations, ICER used data from SSR Health to estimate average discounts and rebates from the wholesale acquisition cost for teriparatide, estimating a net price of about $1,900 per pen, a 38% discount from wholesale acquisition cost. Since data were not available for the newly-approved abaloparatide, ICER used the average branded prescription drug discount of 27% to calculate a net price of approximately $1,200 per pen. Treatment with abaloparatide requires approximately 12 pens per year, while teriparatide treatment requires 13 pens. Cost-effectiveness calculations accounted for cost offsets related to reduced fractures, and incorporated benefits to patients (measured in quality-adjusted life-years, or QALYs) resulting from small reductions in fractures compared to zoledronic acid.
The commonly accepted threshold for cost-effectiveness is $50,000-$150,000/QALY; both drugs far exceeded this mark, with ICER’s calculations resulting in cost-effectiveness ratios of approximately $942,000 for teriparatide and $334,000 for abaloparatide compared to zoledronic acid. Further analyses, including those in which the fracture risk was assumed to be even higher than in the base case analyses, resulted in slightly more favorable ratios, but they remained well above accepted thresholds.
ICER calculated value-based price benchmarks for each of the two drugs to determine the prices at which the cost of the drugs would align with the added benefit to patients. Teriparatide’s value-based price benchmark was calculated to be approximately $330-$420 per pen, and abaloparatide’s benchmark was calculated to be approximately $520-$665 per pen. At current list prices, the drugs would need to be discounted 86%-89% and 59%-68% from wholesale acquisition cost, respectively, to align with the additional benefit they provide to patients.
The Evidence Report, as well as the accompanying voting questions, all public comments received on the draft report, and ICER’s written response to comments, are available on the ICER website.
The Evidence Report will be the subject of the June 30th public meeting of CTAF, during which the independent council will vote on key questions raised in the report, and a policy roundtable of experts will discuss recommendations to apply the evidence to policy and practice. During the meeting, a limited amount of time will be available for pre-registered stakeholders to provide a brief oral comment on the report and its findings. Requests to make an oral comment were accepted during the public comment period on the Draft Evidence Report.