Endometriosis

Coverage

Pharmacy Benefit Commercial Health Exchange Medicare Under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions. About 40% of the lives under Medi- care Part D formularies are not covered for at least one of the drugs. Unrestricted Restricted Not Covered Not Listed

Medical Benefit Commercial Health Exchange Medicare Under the medical benefit, about 55% of the lives under commercial policies are covered with utilization management restrictions. Meanwhile, almost 71% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions. Covered Restricted Not Covered Unknown

Key Players

MMITNETWORK.COM | [email protected] DATA CURRENT AS OF Q2 2020 Reality Check: Endometriosis

Trends

Myovant Announces Positive Results In April 2020, Myovant Sciences reported positive results in its Phase III studies of once-daily relugolix combination therapy for pain associated with endometriosis. The company said the combination therapy was well-tolerated with minimal bone mineral density loss over 24 weeks.

Via BioSpace

Not Listed Nanotechnology May Be Used in Treatment In April 2020, researchers said that they have developed an accurate, nanotechnology-based treatment to mitigate the pain and fertility issues associated with endometriosis. The process uses photo-responsive, dye-filled nanoparticles to locate and remove the lesions associated with the disorder.

Via Oregon State University

ObsEva SA Initiated Phase III Trial of Linzagolix ObsEva SA announced in May 2019 that the company had initiated Unknown the Phase III development program of linzagolix, a novel, orally ad- ministered gonadotropin-releasing hormone receptor antagonist, to treat women with endometriosis-associated pain.

Via ObsEva

MMITNETWORK.COM | [email protected] DATA CURRENT AS OF Q2 2020 Reality Check: Endometriosis

Key Findings Characteristics Indication Market Events Drive Changes

Most recently, AbbVie Inc.’s Orilissa (elagolix) was approved by the Endometriosis FDA on July 24, 2018. This is the first oral gonadotropin-releasing hormone (GnRH) antagonist in the class.

Competitive Market Landscape Step-Therapy (ST) Policies Minimal contracting is seen for this indication. With Lupaneta Pack A review of ST policies for payer- (leuprolide acetate for depot suspension and norethindrone ac- controlled formularies: etate tablets), Lupron Depot (leuprolide acetate for depot suspension) and the approval of Orilissa, AbbVie continues to have a No ST (82%) strong presence in the endometriosis market. This market will face ST challenges through health care reforms and budgetary restrictions (18%) but will benefit from increasing awareness of women’s disease and with the launch of new products. Single Step (56%) Multistep Coverage Implications (44%)

Drugs for this indication are generally covered and usually fall under both the pharmacy and medical benefits, with the exception Prior-Authorization (PA) of Pfizer Inc.’s Synarel (nafarelin acetate) and Orilissa, which are Policies pharmacy only. Drugs for this indication are considered specialty A review of PA policies for payer- drugs. When prior authorization is defined, a diagnosis is required. controlled formularies: Step restriction is rarely seen, but if it exists, it is through a generic No PA (danazol, NSAIDs or contraceptives). GnRH products are known to (41%) cause loss of bone mass; therefore, bone density measurements PA may be required. (59%)

Appropriate (92%) Restrictive (8%)

DATA CURRENT AS OF Q1 2020 MMITNETWORK.COM | [email protected] DATA CURRENT AS OF Q2 2020