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The FDA on June 13 approved Ipsen’s Bylvay (odevixibat) for the treatment of cholestatic pruritus due to Alagille syndrome, a rare genetic disorder that can cause liver damage, in patients 12 months of age and older. Ipsen bought the ileal bile acid transport inhibitor (IBATi) when it acquired Albireo Pharma, a biotech focused on rare diseases, for $925 million earlier this year. The once-daily therapy was first approved in 2021 for the treatment of cholestatic pruritus from progressive familial intrahepatic cholestasis, another pediatric liver disorder. It currently holds covered or better status for 75% of all insured lives under the pharmacy benefit, largely with utilization management restrictions applied.

CareSource on June 7 said it is partnering with three Kansas-based nonprofits in a bid to serve the state’s revamped Medicaid managed care program, KanCare 3.0. Kansas’ current Medicaid contracts are slated to expire at the end of 2024, and the state is seeking input from providers and other Medicaid stakeholders about the new program. KanCare is currently served by three MCOs, UnitedHealthcare, Aetna and Centene Corp.’s Sunflower Health Plan, with United leading the pack at 180,584 members. Overall, the state enrolls 500,873 people in managed care plans.

Oklahoma on June 8 said it has selected three insurers — Aetna, Centene Corp. and Humana Inc. — to serve its new Medicaid managed care program. The state’s upcoming Medicaid transformation will move away from the fee-for-service model and incorporate a provider-led, value-based care model. The new program is slated to launch in April 2024. The state currently serves 1,349,218 Medicaid beneficiaries.

The FDA on June 6 approved a new indication for Merck’s Prevymis (letermovir). It can now be used to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The oral antiviral was first approved in 2017 to prevent CMV in CMV-seropositive recipients of allogenic hematopoietic stem cell transplants. As a preventive agent against CMV, Prevymis currently holds covered or better status for 82% of all insured lives under the pharmacy benefit. About 19% of lives have preferred access to Prevymis.

The FDA on June 1 approved AstraZeneca and MSD’s Lynparza (olaparib) for the treatment of deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) in adult patients, in combination with Johnson & Johnson’s Zytiga and a corticosteroid. The new indication covers about 10% of mCRPC patients. Lynparza, a PARP inhibitor, was first approved in December 2014 for the treatment of advanced ovarian cancer. For this indication, it holds preferred status for 14.6% of all insured lives under the pharmacy benefit, growing to 47% with utilization management restrictions applied.

Venture-backed insurance startup Friday Health Plans “will begin to wind down its business activities throughout the country, working in close conjunction with state regulators,” the Colorado Division of Insurance (DOI) said on June 1. The insurtech has been placed into receivership by two states, Georgia and Texas, in recent weeks. “While Friday Health Plan of Colorado has maintained the capital required by Colorado law, the problems in other states and with the parent company are now impacting the company here,” Colorado Insurance Commissioner Michael Conway said in a statement. The Affordable Care Act exchange-focused insurer enrolled 398,260 members in seven states as of the latest update to AIS’s Directory of Health Plans.

Kaiser Permanente said it will commit up to $10 million to Denver Health, a Colorado-based health system. Its Denver Health Medical Center serves as the Denver area’s “safety-net hospital,” and provides care to more than one-third of the Denver population, according to a May 30 press release. Kaiser’s funding, which includes an upfront $5 million grant, will “assist Denver Health with vital health care services for the community, including continued access to primary and specialty care for people who do not have the means to pay.” Denver Health’s insurance arm, Denver Health Medical Plan, currently serves 133,790 lives, with 84.7% enrolled in Medicaid managed care.

The FDA on May 26 approved Lexicon Pharmaceuticals’ Inpefa (sotagliflozin) to reduce the risk of heart failure in select patient populations, including adults with Type 2 diabetes and chronic kidney disease. The once-daily pill will be the first SGLT1/SGLT2 inhibitor in the market basket, and is expected to launch by the end of June. Among the most advantaged therapies for chronic heart failure are AstraZeneca’s Farxiga, which is placed on the preferred tier for 49.6% of all insured lives under the pharmacy benefit, and Boehringer Ingelheim and Eli Lilly’s Jardiance, which is preferred for 65.11% of lives.

The FDA last week approved Celltrion Healthcare’s high-concentration Humira biosimilar, Yuflyma, for eight of Humira’s indications. The company expects to launch the drug, which will be available as both a pre-filled syringe and autoinjector, in July, alongside several other Humira copies from other drugmakers. Celltrion is also seeking interchangeability status from the FDA, and anticipates a decision in the fourth quarter of 2024. The first Humira biosimilar, Amgen’s Amjevita, launched Jan. 31. For the treatment of rheumatoid arthritis, the Amjevita autoinjector currently holds covered or better status for 67% of all insured lives under the pharmacy benefit.

Minnesota’s state legislature last week passed legislation that will establish public option health insurance in the state by 2027, joining Colorado, Washington and Nevada in similar efforts. Next year, the state will conduct an actuarial analysis on the initiative, which would serve as an expansion of MinnesotaCare, a state health plan for people living below 200% of the federal poverty line. Payer groups such as AHIP and Minnesota-based health systems have rallied against the proposal. The three largest payers in Minnesota are Blue Cross and Blue Shield of Minnesota (2,166,301 members), the provider-sponsored insurer HealthPartners (903,759 members) and nonprofit insurer Medica (663,434 members).