News Briefs

News Briefs: Amylyx Is Withdrawing ALS Drug Relyvrio in U.S., Canada

Amylyx Pharmaceuticals, Inc. said on April 4 that it was voluntarily discontinuing the marketing authorization for Relyvrio (sodium phenylbutyrate and taurursodiol) in the U.S. and in Canada, where it is known as Albrioza. As part of a restructuring, the company also is laying off about 70% of its workforce. The FDA approved the agent for the treatment of amyotrophic lateral sclerosis (ALS) on Sept. 29, 2022, based on data from a Phase II trial involving 137 people. But on March 8, the company revealed that its Phase III PHOENIX trial did not meet the prespecified primary or secondary endpoints. Prior to the drug’s approval, the FDA’s Peripheral and Central Nervous System Drugs Advisory committee found that the study did not provide substantial evidence that the therapy was effective, but during a second meeting in September reversed course in favor of approval. At the time of Relyvrio’s approval, Amylyx co-founder and co-CEO Justin Klee declared that “if the PHOENIX trial is not successful, we will do what's right for patients, which includes taking the drug voluntarily off the market.” The company will not allow any new prescriptions for the drug, but it will transition current patients who wish to remain on treatment with Relyvrio to a free drug program. Amylyx will present topline data from the PHOENIX trial at the American Academy of Neurology Annual Meeting in Denver on April 16.

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News Briefs: Biden Administration Finalizes Rules Limiting ‘Junk Insurance’ Plans

HHS and the Labor and the Treasury departments on March 28 released final rules pertaining to short-term, limited-duration (STLDI) health plans. Those plans will be limited to last no more than four months, compared to up to three years under the previous rules. The rules will also require issuers of STLDIs “to include a clear, easy-to-understand consumer notice on marketing, application, enrollment, and reenrollment materials, so that consumers can make informed coverage purchasing decisions.” The departments called STLDI plans “junk insurance” and noted they are not subject to consumer protections enacted in the Affordable Care Act, including guaranteeing coverage for people with preexisting conditions.

Jamie Raskin (D-Md.), the ranking member of the House Oversight and Accountability Committee, sent a letter on March 25 to UnitedHealth Group CEO Andrew Witty requesting information about the ongoing cyberattack on Change Healthcare, a UnitedHealth subsidiary. Raskin inquired about details such as what data may have been exposed and what policies UnitedHealth has in place to prevent an attack, and he asked Witty to respond to the 12 questions in writing by April 8. Meanwhile, Reuters reported that UnitedHealth said on March 22 that it would start processing its medical claims backlog of more than $14 billion.

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News Briefs: ACA Plan Signups Totaled 21M During 2024 Open Enrollment

More than 21 million people selected or were automatically reenrolled in health plans during the most recent Affordable Care Act open enrollment period (OEP). That’s according to one of four reports issued by HHS on March 22 marking the 10-year anniversary of the ACA. HHS also said that 5.1 million more people signed up for coverage during the 2024 OEP compared to the 2023 OEP, representing a 31% increase. Another report found that over 45 million people now have coverage thanks to the creation of the ACA marketplaces and Medicaid expansion -- “the highest total on record.”

The Oregon Health Authority (OHA) on March 14 began a review of UnitedHealth Group’s proposed acquisition of Amedisys Inc., a home health provider. Amedisys disclosed the OHA’s review in a March 19 Securities and Exchange Commission filing. UnitedHealth made a $3.26 billion unsolicited offer for Amedisys last June, shortly after Amedisys had agreed to merge with Option Care Health, Inc., a home infusion provider. Amedisys’s shareholders approved the UnitedHealth deal in September, but the transaction is subject to regulatory approval. In a preliminary analysis published this month, the OHA wrote “this transaction has the potential to reduce competition in Oregon’s market for home health and hospice services and other health care markets in the state.”

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News Briefs: Medicaid MCO Pay Raise Set to Rise in Some States

At least seven states plan to raise capitated payment rates to their contracted Medicaid managed care plans in fiscal year 2025, Modern Healthcare reported. Craig Kennedy, president and CEO of Medicaid Health Plans of America, told the publication that the rates are likely going up “because utilization is increasing post-pandemic.” The article noted that Arizona has proposed a 3% rate increase, California's draft budget includes a 3.8% hike and Missouri is considering a 2.5% raise for managed care plans. But New York plans to reduce insurer compensation by eliminating a quality bonus program and a 1% pay increase that expires this fiscal year.

Doctors are raising the alarm about how health insurers are making it harder for patients to receive coverage for at-home ventilators, the Associated Press reported. The noninvasive ventilators help patients breathe by forcing air into the lungs, often through a mask, and they cost around $1,200 per month. Chuck Coolidge, chief strategy officer for the respiratory supply company VieMed, told the AP that insurance rejections — including both initial approvals and reauthorizations — have increased for patients with Lou Gehrig’s disease and chronic obstructive pulmonary disease. And one neurologist told the news outlet that UnitedHealthcare Medicare Advantage plans now deny nearly all initial requests for the ventilators.

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News Briefs: Wegovy Gains Another Indication

The FDA on March 8 granted Novo Nordisk A/S’s Wegovy (semaglutide) yet another indication — for cardiovascular risk reduction — that could further boost staggering GLP-1 sales. Wegovy is now approved to reduce risk of “major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke” in adults who are either overweight or obese and have established cardiovascular disease, per a Novo press release. FDA official John Sharretts, M.D., described Wegovy as the first weight loss medication “to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight.” As the FDA noted in a press release, approximately 70% of U.S. adults are obese or overweight. The new indication was approved after a priority review.

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News Briefs: Coherus Launches Udenyca Onbody

Coherus BioSciences, Inc. launched its Udenyca Onbody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), the company said Feb. 21. Approved Dec. 22, the OBI is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in people with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Udenyca was first approved Nov. 2, 2018, and the leukocyte growth factor is one of six biosimilars of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency has greenlighted. A health care provider must fill the OBI with the co-packaged syringe and apply it to the patient’s abdomen or back of the arm. About 27 hours after it is applied to the skin, the OBI will deliver a 6 mg/0.6 mL dose of Udenyca over about five minutes.

Catalyst Pharmaceuticals, Inc.’s Agamree (vamorolone) is now available in the U.S., the company said March 13. The FDA approved the first-in-class corticosteroid on Oct. 26 for the treatment of Duchenne muscular dystrophy in people at least 2 years old. The company is offering the comprehensive support program Catalyst Pathways Patient Assistance Program for Agamree for eligible patients. Drugs.com lists the price of 40 mg/mL oral suspension as more than $10,013.

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News Briefs: Cyberattack Targets UnitedHealth’s Change Healthcare

Change Healthcare, which UnitedHealth Group acquired in October 2022, has been targeted by a cyberattack. UnitedHealth said in a regulatory filing that on Feb. 21 it discovered “a suspected nation-state associated cyber security threat actor” had gained access to some of Change Healthcare’s information technology systems, and the firm reacted by isolating the affected systems. According to the latest update on a website dedicated to information about the incident, as of Feb. 23 “the disruption is expected to last at least through the day.” All other systems across UnitedHealth Group’s enterprise are operational, and the company said in the filing that it’s working with security experts and law enforcement to address the incident. “The cyberattack against UnitedHealth Group, one of the largest U.S. commercial prescription processors, is credit negative for the company, as financial and reputational impacts may ensue,” Moody’s Investors Service Vice President and Senior Credit Officer Dean Ungar said in a statement emailed to reporters about the incident.

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News Briefs: FTC, HHS Seek Public Comment on Drug Shortages

The Federal Trade Commission (FTC) and HHS issued a request for information (RFI) on Feb. 14 regarding the role of health care group purchasing organizations (GPOs) and drug wholesalers in widespread generic drug shortages. The agencies are seeking public input about market concentration and contracting practices in those two industries and their involvement in the generic drug market. The agencies noted in a press release that they want information about “how both entities may influence the pricing and availability of pharmaceutical drugs.” Last year, the FTC announced an investigation into rebate-aggregating GPOs tied to major PBMs.

A federal judge on Feb. 12 dismissed a lawsuit brought by the trade group Pharmaceutical Research and Manufacturers of America (PhRMA) challenging the Medicare drug price negotiation program. PhRMA sought to overturn the section of the Inflation Reduction Act creating the program, which allows the federal government to negotiate the price of select high-cost medications. Individual drugmakers such as Merck & Co., Bristol Myers Squibb Co., Johnson & Johnson and AstraZeneca PLC all have similar suits underway. CMS on Feb. 1 sent initial price offers to the manufacturers of the first 10 medications that were selected for the Medicare drug price negotiation program, which goes into effect in 2026.

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News Briefs: AHIP CEO Calls for ‘Stability’ in MA Market

In a post published on the insurer trade group’s website, AHIP CEO and President Mike Tuffin advocated for a better-funded Medicare Advantage program. The post occurred about two weeks after CMS released the 2025 Notice of Medicare Advantage and Part D payment changes, which the agency estimated would result in a -0.16% revenue change without an increase in risk scores. Tuffin wrote that “it is essential that funding keep pace to ensure stability and prevent erosion in the benefits and affordability seniors count on in Medicare Advantage.” He cited an ATI Advisory report from March 2023 that found MA enrollees save an average of $2,400 annually compared with fee-for-service Medicare members, as well as a January AHIP report that found the MA population “is both more diverse and lower income than enrollees in fee-for-service Medicare.”

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News Briefs: At Least 16.4M People Have Been Disenrolled From Medicaid

As of Feb. 1, at least 16.4 million Medicaid enrollees had been disenrolled from coverage since last April, representing about one-third of people who had applied to have their coverage renewed, according to KFF. KFF said the number of people disenrolled is likely higher “due to varying lags for when states report data.” Of the people who had been disenrolled, 71% were terminated for procedural reasons, meaning they did not complete the renewal process in time. The disenrollment rates ranged from 13% in Maine to 61% in Texas. Overall, states and Washington, D.C., have reported renewal outcomes for 52% of people enrolled in Medicaid, while the remaining 48% of people were awaiting decisions as of Feb. 1.

Dirk McMahon, UnitedHealth Group’s president and chief operating officer, plans on retiring, effective April 1. McMahon joined UnitedHealth in 2003 and has been president and COO since February 2021. UnitedHealth has not named a replacement for McMahon, whose previous roles at the company included CEO of UnitedHealthcare and president and COO of Optum.

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