Interventions of Interest:

  •  elagolix (ORILISSA®, AbbVie) 

Endometriosis is a chronic gynecological condition with symptoms that include painful menstrual periods, nonmenstrual pelvic pain, and pain during intercourse, as well as infertility. Endometriosis affects between four and ten million women of reproductive age in the US.

Because elagolix’s price aligns with clinical benefit only when compared to no other treatment, insurers may first encourage patients to try oral contraceptives and leuprorelin acetate before progressing to a new treatment that has an unknown long-term safety profile.

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Final Documents

Below you will find the final documents from the assessment review process:

ICER’s Chief Scientific Officer Dan Ollendorf, PhD stated:

“While elagolix appears to offer short-term clinical benefits in terms of reduced pain and improved quality of life for women living with endometriosis, evidence is not yet sufficient to rule out the possibility that this therapy may pose long-term safety risks for patients. Until more is understood about the long-term effects, it would be reasonable for payers to consider prior authorization criteria to ensure prudent use of the therapy, such as requirements for previous treatment with other options, specialist prescribing, and clinician attestation of clinical improvements while using the therapy.”