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The FDA last week approved Incyte’s Pemazyre for the treatment of elapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement, a rare and aggressive form of blood cancer, in adult patients. The selective fibroblast growth factor receptor (FGFR) inhibitor was first approved in April 2020 to treat cholangiocarcinoma, a rare bile duct cancer. For this indication, it holds covered or better status for 89% of lives under the pharmacy benefit. Evaluate Pharma projects Pemazyre will be Incyte’s no. 4 bestselling drug in 2028, bringing in $197 million in total global sales. Evaluate reported global Pemazyre sales of $69 million for 2021.

California’s Department of Health Care Services last week announced the state’s intention to award Medicaid contracts to three MCOs; Molina Healthcare, Elevance Health’s Anthem Blue Cross Partnership Plan and Centene Corp.’s Health Net. All three are incumbents to the Medi-Cal program, and currently serve a combined 2.96 million lives. This is California’s first statewide managed Medicaid procurement, and the new contracts, which will require the MCOs to follow new quality and transparency requirements, will run for five years. California runs a variety of managed care initiatives throughout the state, and its programs currently serve 12,328,266 Medicaid lives.

The FDA last week approved Johnson & Johnson’s Imbruvica for the treatment of chronic graft-versus-host disease (cGVHD) in pediatric patients following the failure of at least one prior treatment. This is the first pediatric nod for the kinase inhibitor. Imbruvica became the first FDA-approved cGVHD therapy in August 2017. For that indication, it holds covered or better status for virtually all (99%) of insured lives under the pharmacy benefit. 16.5% of insured lives have preferred access to Imbruvica, growing to 42.9% with utilization management restrictions applied.

Elevance Health’s Empire BlueCross BlueShield last week unveiled new partnerships with four virtual behavioral health providers; Alma, Headway, NOCD and Ophelia. The four providers will be in-network across all of Empire’s lines of business. Elevance is currently the largest insurer in New York, with 4,215,983 members. 10.8% of its members are enrolled in commercial risk-based plans.

The FDA on Aug. 19 approved Axsome Therapeutics’ Auvelity for the treatment of major depressive disorder in adult patients. The N-methyl D-asparate (NMDA) receptor antagonist has potential to be groundbreaking — Auvelity can begin to take effect within a week, compared to up to eight weeks in traditional antidepressants. Evaluate Pharma estimates the drug will bring in $831 million in revenue by 2026. Auvelity is not the first NMDA receptor agonist in the depression market basket, however. Johnson & Johnson’s Spravato, a nasal spray, was approved in August 2020, though it is not a first-line therapy. For the treatment of major depressive disorder, Spravato currently holds covered or better status for 62% of lives under the pharmacy benefit, though just 3% of lives have preferred access to the drug.

Blue Cross and Blue Shield of Vermont has filed a lawsuit against Teva Pharmaceuticals, alleging the drugmaker uses unethical marketing tactics and anticompetitive practices to keep prices for its multiple sclerosis drug, Copaxone, “excessively” high and block any generic competition. The suit highlights Copaxone’s 1997 price of $769, compared to more than $5,800 by 2017. About 80% of all insured lives in the U.S. have covered or better access to Copaxone under the pharmacy benefit. Among BCBS Vermont’s formularies, 91% of members have preferred access to Copaxone with utilization management restrictions applied.

With its latest FDA nod, AstraZeneca and Daiichi Sankyo's Enhertu is now the first available drug that specifically targets HER2-mutant non-small cell lung cancer (NSCLC). It will be available to adult patients who have previously received another systemic therapy. Enhertu was first approved to treat HER2-positive metastatic breast cancer in October 2019, an indication for which it currently holds covered or better status for 62% of all insured lives under the pharmacy benefit. 78% of lives have covered or better access to Enhertu under the medical benefit.

The FDA last week approved Samsung Bioepis Co., Ltd. and Organon & Co.’s high-concentration, citrate-free Humira biosimilar, Hadlima, across seven of Humira’s indications. The injectable was previously approved in its low-concentration formulation. Hadlima, like all other approved Humira biosimilars, cannot launch earlier than July 1, 2023. Under the pharmacy benefit, Humira holds covered or better status for 98% of all insured lives. About 13% of lives have preferred access to Humira, growing to 64% with utilization management restrictions applied.

UnitedHealth Group has acquired a small, Houston-based Medicare Advantage organization affiliated with Kelsey-Seybold Clinic, according to an Aug. 16 report from the Star Tribune. The firm, KS Plan Administrators, currently serves 41,536 MA members in its KelseyCare Advantage plans. United, meanwhile, is the largest MA insurer in Texas, with 1,057,563 members. Financial terms of the deal were not disclosed.

The FDA last week granted regular approval to Novartis Pharmaceuticals Corp.’s Tabrecta for the treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have the mesenchymal-epithelial transition (MET) gene, a rare mutation found in about 4% of patients. The kinase inhibitor received accelerated approval in May 2020, based on positive clinical trial data. For the treatment of NSCLC, Tabrecta currently holds covered or better status for 93% of all insured lives under the pharmacy benefit. About 25% of insured lives have preferred access to Tabrecta.