Only one-fourth of the 6 million women with endometriosis could be treated with a new GnRH antagonist and still meet the Institute for Clinical and Economic Review’s budget threshold, according to a report released by the organization. The new drug has shown promise in clinical trials to lessen the pain associated with endometriosis, which can cause painful menstrual periods and even infertility.
ICER reports that the drug’s price seems to fit within its value-based price range, $50,000-$150,000 per quality-adjusted life year. It’s hard to say, though, because the drug has not yet been approved or assigned a list price by its manufacturer. ICER created a placeholder price tag for its calculations.
ICER also grades the drug an “I” for “inconclusive.” The benefits look promising, ICER’s economists note, but long-term data is lacking. Understandably so, since the drug is still in clinical trials. Then ICER’s economists top their lukewarm assessment with a prediction that the drug’s benefit is probably “overstated to some extent.”
The report’s missteps are familiar ones. As described in “The ICER Myth,” the organization regularly attempts to valuate new drugs with incomplete information, relying upon best judgment and assumptions to fill gaps in data.
Meanwhile, the tentative analysis hardly encourages health plans to provide robust coverage for the drug. That could be a blow for patients, who already face a range of obstacles.
Historically, women often misinterpret their endometriosis symptoms. It’s not unusual for them to have a decade-long gap before diagnosis. Even then they are met with few treatment options for the disease, which has no cure. Moderate-to-severe cases might require surgery; persistent symptoms may require repeated surgeries. Some women are prescribed low-dose oral contraceptives or may take pain medication to manage their symptoms. This may include the use of prescription opioids, which can introduce risks of their own.
None of these approaches is ideal. Thus, the prospect of a middle-ground treatment – something more targeted than birth control but less invasive than surgery – holds promise for patients. Effective treatment could also benefit society. Endometriosis is responsible for reduced productivity and missed days of work and school.
The GnRH antagonist under review is an oral medication that addresses endometriosis symptoms by suppressing estrogen production. Patients, health care providers and advocates have the chance to weigh in on treatment’s value to patients during ICER’s public comment period, which extends until May 31.