Reality Check: Coverage

Pharmacy Benefit Commercial Health Exchange Medicare Under the pharmacy benefit, about 46% of the lives under commercial formularies are covered with utilization management restrictions. Around 46% of the lives under Medicare formularies are not covered for at least one of the drugs. Unrestricted Restricted Not Covered Not Listed

Medical Benefit Commercial Health Exchange Medicare With Orilissa and Synarel not covered under the medical benefit, about 58% of the lives under commercial policies have access to the with utilization management re- strictions. Meanwhile, about 74% of the Medicare benefi- ciaries are covered without Covered Restricted Not Covered Unknown restrictions in place.

Key Players

MMITNETWORK.COM | [email protected] DATA CURRENT AS OF Q2 2019 Reality Check: Endometriosis Reality Check: Endometriosis Trends

ObsEva SA Initiated Phase III Trial of Linzagolix ObsEva SA announced in May 2019 that they initiated the Phase III development program of linzagolix, a novel, orally administered go- nadotropin-releasing hormone receptor antagonist, to treat women with endometriosis-associated pain.

Via ObsEva

Not Listed rTMS Therapy May Reduce Pelvic Pain A recent study suggested that repetitive transcranial magnetic stimulation (rTMS) may be an effective way to reduce pain and improve quality of life in women with chronic pelvic pain due to endometriosis. The pilot trial, which enrolled a total of 12 women, showed that rTMS is well-tolerated in patients and a majority of them reported at least minimal improvement on the Patient Global Impression of Change measure after five rTMS sessions.

Via Journal of Clinical Medicine FDA Approved Orilissa

Unknown In July 2018, AbbVie Inc. announced that the FDA approved Orilissa () under priority review for patients with moderate to severe endometriosis pain. This is the first and only oral -releasing hormone antagonist specifically developed for this condition, according to the company.

Via AbbVie

MMITNETWORK.COM | [email protected] MMITNETWORK.COM | [email protected] Reality Check: Endometriosis

Key Findings Characteristics Indications Market Events Drive Changes Most recently, AbbVie Inc.’s Orilissa was approved by the FDA on July Endometriosis 24, 2018. This is the first oral gonadotropin-releasing hormone (GnRH) antagonist in the class.

Contracting Landscape Step-Therapy (ST) Policies Minimal contracting is seen for this indication. With Elagolix and the A review of ST policies for payer- approval of Orilissa, AbbVie continues to have a strong presence in the controlled formularies: endometriosis market. No ST Payer Coverage (81%) ST Drugs for this indication are generally covered and usually covered (19%) under both the pharmacy and medical benefits, with the exception of Single Step Pfizer Inc.’s Synarel and Orilissa, which are pharmacy only. Drugs for (35%) this indication are considered specialty drugs. When prior authorization Multi Step is defined, a diagnosis is required. Step restriction is rarely seen, but if (65%) it exists, it is through a generic (, NSAIDs or contraceptives). This market will face challenges through health care reforms and budgetary restrictions, but will benefit from increasing awareness of Prior-Authorization (PA) Policies women’s disease and with the launch of new products. GnRH products are known to cause loss of bone mass; therefore, bone density A review of PA policies for payer- measurements may be required. controlled formularies:

No PA (48%) PA (52%)

Appropriate (87%) Restrictive (13%) MMITNETWORK.COM | [email protected] DATA CURRENT AS OF Q2 2019