- AbbVie's experimental endometriosis drug elagolix could put pressure on healthcare budgets even if priced within commonly used cost-effectiveness thresholds, suggests a new draft report from the Institute for Clinical and Economic Review (ICER), a watchdog group on drug costs.
- The draft evidence review looked at the budgetary impact of elagolix in dysmenorrhea (painful periods) and non-menstrual pelvic pain, both related to endometriosis. The review, which used a placeholder price of $7,000 for the still under-review drug, will remain open for public comment until May 31.
- For dysmenorrhea, using elagolix over non-specific care would add about $5,100 in costs per patient; for non-menstrual pelvic pain, the drug would add around $4,600. Across the healthcare system, these costs would exceed "the ICER annual budget impact threshold of $915 million at all prices of elagolix when treating either symptom." However, the true budget impact won't be clear until a price is assigned.
ICER's draft report is preliminary and, since elagolix hasn't yet been approved, uses an assumed price to estimate the drug's cost-effectiveness and budget impact.
Based on a price of $7,000 per year, ICER estimated that "only one-quarter of the eligible population could be treated annually with elagolix before reaching an annual budget impact threshold linked to overall U.S. economic growth."
ICER assessment of the drug was that it is promising but inconclusive. Despite evidence for improved pain symptoms with elagolix, the possibility of net harm cannot be ruled out at this time, said the watchdog.
Endometriosis is a debilitating disorder, affecting up to one in ten women of reproductive age in the U.S. Symptoms include painful periods, pelvic pain, pain during intercourse and infertility. The cost burden of endometriosis in the U.S. per patient per year includes estimated health care costs of over $10,000, and lost work productivity of over $15,000.
There are few existing treatment options for endometriosis, and none are curative or offer long-term relief. There are a handful of potential therapeutics currently coming through the pipeline. If approved, elagolix could be one of the first oral gonadotropin-releasing hormone receptor antagonists to reach the market, with some forecasts pegging 2022 sales of more than $1 billion for the drug.
A decision from the Food and Drug Administration on approval of elagolix was scheduled for April 2018 but has been extended by three months for the FDA to review additional information from liver function tests.
Elsewhere in the industry, Myovant Sciences is developing relugolix, another small molecule GnRH antagonist, in Phase 3 trials in endometriosis in the U.S. The SPIRIT 1 and SPIRIT 2 trials will test the drug's efficacy and safety, with and without low-dose hormonal add-back therapy. Both Myovant and Takeda Pharmaceutical are carrying out Phase 3 trials in uterine fibroids in the U.S. and Japan respectively.
Correction: In a previous version of this article, we mischaracterized ICER's assessment of elagolix.