Not only does the company have to deal with the U.S. Food and Drug Administration’s three month PDUFA delay for elagolix, but now the watchdog organization, The Institute for Clinical and Economic Review (ICER), has released some disconcerting news over pricing.
AbbVie has a second concern with its endometriosis-associated pain treatment elagolix.
Not only does the company have to deal with the U.S. Food and Drug Administration’s three month PDUFA delay for elagolix, but now the watchdog organization, The Institute for Clinical and Economic Review (ICER), has released some disconcerting news over pricing. ICER released a preliminary report this week that suggested elagolix could add additional pressure to healthcare budgets when the experimental medication is used to treat dysmenorrhea, or menstrual pain, related to endometriosis.
Elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, is an orally administered, short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Data from two Phase III studies used to support AbbVie’s NDA for elagolix showed that the medication significantly reduced the three types of endometriosis-associated pain – daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.
ICER said the costs associated with endometriosis can run approximately $10,000 per patient per year in the United States. As the FDA nears its decision for elagolix, ICER took a look at the efficacy of the treatment as well as the potential costs to individuals and the overall healthcare system. ICER said in its report that based on the treatment of dysmenorrhea, as well as non-menstrual pelvic pain, related to endometriosis, the average potential budgetary impact when using the placeholder price of $7,000, is an “additional per-patient cost of approximately $5,100 annually.” When it came to the treatment of nonmenstrual pelvic pain, ICER said the average potential budgetary impact is an additional $4,600 per-patient cost.
“The total budget impact exceeded the ICER annual budget impact threshold of $915 million at all prices of elagolix when treating either symptom. At its placeholder price, only one-quarter of the eligible population could be treated annually with elagolix before reaching an annual budget impact threshold linked to overall US economic growth,” ICER said in its report.
When breaking down the two treatment options, ICER said elagolix could be used to treat 26 percent of patients who have non-menstrual pelvic pain before hitting the $915 million threshold when the estimated $7,000 price is used. When it comes to treating dysmenorrhea, ICER said about 23 percent of eligible patients could be treated before hitting the threshold.
At this time all of ICER’s report is merely speculation until the FDA provides a ruling on the future of elagolix. The wait has been pushed back until the fall of this year following the FDA’s April announcement it was pushing the PDUFA date back. The FDA said it requires more time to review additional information regarding the results of liver function tests that were submitted along with the New Drug Application (NDA).
If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade. Endometriosis occurs when tissue similar to that normally found in the uterus begins to grow outside of the uterus, leading to long-term pelvic pain (during or between periods), pain with intercourse and other painful symptoms. Analysts predict that elagolix could generate more than $1 billion in annual revenue by 2022.
AbbVie isn’t the only company working on a treatment for endometriosis. Vivek Ramaswamy’s Myovant is also developing a therapy. The company has a Phase III program for relugolix for endometriosis-associated pain. Like elagolix, relugolix is also a small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist.
