News Briefs

Amneal Pharmaceuticals, Inc. launched Fylnetra (pegfilgrastim-pbbk), the company said May 16. The granulocyte colony-stimulating factor is the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) to launch in the U.S. The FDA approved the drug on May 26, 2022, to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Its J-code is Q5130. It is the third biosimilar that Amneal has launched in the U.S.

Amgen settled a patent infringement lawsuit (No. 22-cv-1549) with Janssen Biotech Inc., a division of Johnson & Johnson, over a proposed biosimilar of Stelara (ustekinumab), Amgen revealed May 23. Stelara, a human interleukin-12 and -23 antagonist, is indicated for adults with moderate-to-severe plaque psoriasis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis, as well as people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 with active psoriatic arthritis. The FDA first approved it on Sept. 25, 2009. Amgen said the settlement will allow its biosimilar to launch “no later than” Jan. 1, 2025.

In a case closely watched by the health insurance industry, US ex rel. Schutte v. SuperValu, Inc., the Supreme Court on June 1 reversed an appeals court decision that would have hobbled the government’s use of the False Claims Act (FCA) to pursue fraud cases. The SuperValu case — which was consolidated with another whistleblower case, U.S. ex rel. Proctor v. Safeway, Inc. — concerned whether the two pharmacy/grocery chains knowingly filched the U.S. government by “usual and customary” prices for prescription drugs that failed to account for various discount programs. The Seventh Circuit Court of Appeals previously ruled that the companies aren’t liable under the FCA because they could prove they made an “objectively reasonable” interpretation of an ambiguous statute, regardless of whether they intended to commit fraud. But in a unanimous Supreme Court opinion, Justice Clarence Thomas wrote that FCA liability instead should hinge on “what the defendant thought when submitting the false claim — not what the defendant may have thought after submitting it.” In an amicus brief submitted in April, AHIP and the American Hospital Association warned that a ruling in favor of the government’s position in the cases would “create a Wild West of ramifications for any well-intentioned and legitimate hospital or insurance provider that seeks to serve Americans in partnership with the government.”

AHIP President and CEO Matt Eyles will leave his position on Oct. 2, the health insurer trade group said on May 24. Eyles has helmed AHIP for nearly five years, and the organization said his resignation is a “personal decision.” During his tenure, Eyles brought both Aetna and Humana back into the fold, as those two insurers left AHIP before he became president and CEO. He also presided over a branding overhaul, in which the group known as America’s Health Insurance Plans opted to go by its acronym alone “to recognize the industry’s role extends well beyond health insurance coverage to providing solutions that are ‘Guiding Greater Health.’” The executive committee of AHIP’s board of directors will start a national search for Eyles’ replacement.

Eisai Co., Ltd. and Biogen Inc.’s Leqembi (lecanemab) could raise Medicare Part B spending by $8.9 billion or more annually if it receives full approval from the FDA KFF found. And a report by researchers from the RAND Corp. found that Leqembi could increase spending by $2 billion to $5 billion. KFF’s projection was based on an annual list price of $26,500 and uptake among 5% of Alzheimer’s patients. The RAND report included estimates of ancillary costs, such as MRI scans. The FDA granted accelerated approval to the anti-amyloid monoclonal antibody treatment in January, and its decision on full approval is expected soon.

CVS Health Corp is shutting down its clinical trials division, which launched in 2021, and will conclude operations in 2024. The division has worked with more than 30 drugmakers on 50 Phase I, II and IV studies involving 33,000 participants, according to Modern Healthcare.

The national uninsured rate in 2022 was 8.4%, down from 9.2% in 2021 and 9.7% in 2020, according to the Centers for Disease Control and Prevention’s National Health Interview Survey. In a May 18 research note, Citi analyst Jason Cassorla noted that the lower uninsured rate is “not surprising” given efforts to make the Affordable Care Act marketplaces more affordable and accessible, such as elongated special enrollment periods and enhanced premium subsidies. Another likely factor is the Medicaid continuous enrollment requirement that was in place until April 1, 2023, due to the COVID-19 public health emergency. Since Medicaid eligibility redeterminations have now resumed, “we would expect upward pressure on the uninsured rate” going forward, Cassorla wrote, but he added that a “partial offset” would come from newly Medicaid-ineligible individuals signing up for ACA marketplace coverage.

Major pharmaceutical companies are gearing up to file legal challenges to the Medicare price negotiation provisions in the Inflation Reduction Act, Reuters reported. Industry sources who spoke with the news outlet said drugmakers plan to argue that a ban against discussing the price negotiation process violates their First Amendment rights, and that the $1 million per day fine for violations runs afoul of the Eighth Amendment’s protections from excessive fines. Sources also indicated that lawsuits could challenge the legality of initial guidance CMS issued in March regarding the Medicare price negotiation program, as it did not go through a formal process with proposed and final rules. Five of the world’s top drugmakers sent CMS letters raising legal concerns about the Medicare price negotiation program, but they have not yet been made public; CMS said it plans to publish the letters in July when it finalizes its guidance and regulations implementing the program.

Celltrion Healthcare Co. launched Vegzelma (bevacizumab-adcd), the company said on April 17. The FDA approved the injectable last September for multiple types of cancer, including colorectal and non-small cell lung cancer. It is the fourth FDA-approved biosimilar of Avastin (bevacizumab) from Genentech USA, Inc., a member of the Roche Group, to launch in the U.S. While the company has partnered with other companies in marketing biosimilars in the U.S., its Celltrion USA unit is taking full responsibility for this launch.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11-1 that AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) should be limited to people whose tumors have a BRCA mutation. The FDA accepted a supplemental New Drug Application for a broader approval in mCRPC for the poly (ADP-ribose) polymerase (PARP) inhibitor last August. The class of drugs — which also includes GDK’s Zejula (niraparib) and Rubraca (rucaparib), whose rights Clovis Oncology, Inc. recently sold to pharma& Schweiz GmbH a few months after it filed for Chapter 11 bankruptcy — have been under some scrutiny after they withdrew some of their indications.

Based on estimates from the Congressional Budget Office, a new KFF analysis predicts that House Republicans’ Medicaid work requirements proposal would leave 1.7 million enrollees ineligible for Medicaid. The analysis noted that states could continue to cover enrollees who run afoul of work requirements, but they would have to cover 100% of their costs without federal help. If states did go that route, they could collectively face $10.3 billion worth of new costs in 2024. Republicans included Medicaid work requirements provisions in debt-ceiling legislation that passed the House on April 26, although the measure is not expected to clear the Democrat-controlled Senate.

CMS on April 27 proposed new regulations that would “establish tangible, consistent access standards” in Medicaid as well as create “a consistent way to transparently review and assess Medicaid payment rates across states.” The new policies are included in two notices of proposed rulemaking — the Ensuring Access to Medicaid Services NPRM and the Managed Care Access, Finance, and Quality NPRM. Of note for the managed care industry, the proposed regulations would create national maximum standards for certain appointment wait times for Medicaid or Children’s Health Insurance Program (CHIP) managed care enrollees, CMS said. They would also create stronger state monitoring and reporting requirements related to access and network adequacy for Medicaid or CHIP managed care plans, and require states to conduct “independent secret shopper surveys” of Medicaid or CHIP managed care plans to verify compliance with appointment wait time standards and to identify where provider directories are inaccurate. Among other provisions, the NPRMs would additionally require states to conduct annual enrollee experience surveys for each Medicaid managed care plan, and establish a framework for states to implement a Medicaid or CHIP quality rating system, which CMS calls a “one-stop-shop” for enrollees to compare Medicaid or CHIP managed care plans based on quality of care, access to providers, covered benefits and drugs, cost, and other plan performance indicators.

Oklahoma lawmakers accused CVS Health Corp.’s Caremark PBM of “intentionally lying” in its denials of 90-day prescription fills for some patients, according to The Oklahoman. The Oklahoma City newspaper reported that Caremark had routinely denied Oklahoma residents 90-day prescription fills and cited a state law as the reason, claiming that such fills were illegal under the statute. State Rep. Jon Echols, a Republican, said that such a justification was a lie: “Anyone that says that is not misinformed. They don’t misunderstand. They are intentionally lying to you. And we’re not going to stand for it.” Oklahoma’s insurance commissioner, Republican Glen Mulready, earlier this month filed an administrative action against Caremark that, per a press release from Mulready’s office, “targets the practice of ‘steering patients’ to CVS pharmacies and prescription mail-order services and seeks to censure, suspend, place on probation or revoke the Pharmacy Benefit Manager (PBM) license of CVS/Caremark. In addition, the… Department will seek restitution and/or levy fines for each alleged violation.”