The Institute for Clinical and Economic Review (ICER) released an updated evidence report questioning the clinical benefits and value of elagolix (ABT-620), an investigational therapy being developed by AbbVie and Neurocrine Biosciences for endometriosis and uterine fibroids.
A draft version of this report was made available on May 4 for a period of four weeks, allowing public commentary. The updated report reflects the changes made based on relevant comments from patient groups, doctors, drug-makers, and other stakeholders.
Key findings from this report indicated that, compared with no treatment, the clinical effectiveness of elagolix was promising but not conclusive.
According to the report, while the treatment candidate has been shown to reduce pain for women with endometriosis — especially women with menstrual-related pain — there is not enough evidence to exclude the possibility of elagolix-related side effects.
There is also insufficient evidence to compare elagolix’s net health benefit with current treatments such as GnRH agonists, hormonal treatments, and aromatase inhibitors.
”Elagolix shows promise in reducing the pain women with endometriosis experience, but more research is needed to determine the drug’s long-term effectiveness and safety profile, particularly in comparison to alternative agents,” Dan Ollendorf, PhD, ICER’s chief scientific officer, said in a press release.
To determine an estimate for cost-effectiveness, analysts set $7,000 per year as an expected price for the therapy based on predictions. Using this price, they found that elagolix fell within the commonly accepted thresholds for cost-effectiveness of $50,000 – $150,000, compared with no treatment.
The therapy was found to be cost-effective in both the short term (six months) and the long term, the latter of which takes into account factors such as pain recurrence, surgeries, and treatment-related cardiovascular and fracture risks.
However, since the actual price of elagolix is not yet known, it cannot yet be compared to the cost-effectiveness of oral contraceptives, GnRH agonists, or aromatase inhibitors.
Analysts have determined that elagolix should be priced between $8,800 and $12,800 per year for the cost to match the perceived added benefit that elagolix provides to patients.
Because the patient population for endometriosis is large, despite the promising cost-effectiveness findings, only around 26% of women with endometriosis-related pain could actually be treated before spending crossed ICER’s potential budget impact threshold, which is set at $915 million per year.
“While elagolix may be cost-effective in the long-term if priced in line with analyst expectations, the treatment will potentially challenge short-term budgets given the large number of women affected by endometriosis. During our meeting on July 12th, stakeholders will convene to discuss strategies to ensure appropriate patient access while managing system-wide affordability,” Ollendorf said.
This report will be discussed at an upcoming meeting of the New England Comparative Effectiveness Public Advisory Council in Burlington, Vermont, on July 12. Those interested in attending online via webcast or in person can register here.
The U.S. Food and Drug Administration is currently reviewing elagolix, with a decision on its approval expected in mid-2018. If approved, elagolix will become the first oral therapy for the management of endometriosis-associated pain in more than a decade.