The COVID-19 public health emergency (PHE) will end on May 11, the Biden administration said. Emergency authorities flowing from the PHE have required insurers to make certain COVID-19 testing and treatment available to plan members at no additional cost; expanded access to telehealth in Medicare, Medicaid and CHIP; increased funding to states for Medicaid; and barred states from disenrolling Medicaid members. In December, Congress authorized states to begin disenrolling Medicaid members starting in April, with enhanced funding declining and zeroing out on a set schedule starting then. The Biden administration’s announcement comes as Republicans, newly in control of the House of Representatives, have introduced bills that would end the PHE much sooner. The May 11 end date “align[s] with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the PHE,” according to a White House statement.
During the open enrollment period that ended on Jan. 15 in most states, 16,306,448 people selected an Affordable Care Act marketplace plan, the Biden administration said on Jan. 25. That total represents a 13% increase compared to the same time last year, and accounts for plan selections through Jan. 15 on the 33 states using HealthCare.gov and through Jan. 14 or 15 on the 18 state-based marketplaces. While record-breaking for the exchanges, the signup total for 2023 is not final, as open enrollment continued through Jan. 23 for Massachusetts Health Connector and through Jan. 31 for DC Health Link, Covered California, Get Covered New Jersey, New York State of Health and Health Source Rhode Island. Still, the Biden administration hailed the new enrollment figures, with CMS Administrator Chiquita Brooks-LaSure stating: “On the tenth anniversary of the ACA Marketplaces, the numbers speak for themselves: more people signed up for plans this year than ever before, and the uninsured rate is at an all-time low.”
The FDA declined to grant accelerated approval for Alzheimer’s disease treatment donanemab and requested additional data from its manufacturer, Eli Lilly & Co. said on Jan. 19. The move comes on the heels of the FDA’s decision to bestow accelerated approval on another Alzheimer’s treatment called Leqembi (lecanemab) from Biogen and Eisai — although a National Coverage Determination issued for Biogen’s Aduhelm (aducanumab) significantly limits who can access any drug in that class that receives accelerated approval. In its response letter to Lilly, the FDA cited “the limited number of patients with at least 12 months of drug exposure data provided in the submission” for accelerated approval as its justification for denying the application, and the agency asked Lilly to provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Lilly said it expects to unveil results from its Phase III confirmatory trial in the second quarter of this year, and that “will form the basis of donanemab's application for traditional approval shortly thereafter.”
Medicare Advantage now enrolls more than 30.6 million individuals, including more than 25 million in individual MA plans, according to the latest monthly enrollment data from CMS. Industry trade group AHIP called the information “cause to celebrate,” noting that “just 10 years ago, the program had 13 million enrollees.” Enrollment in the private Medicare plans is likely to rise more in the short term, however, as the 30.6 million figure reflects only those signups accepted through Dec. 2, 2022, and thus does not capture the full outcome of the Annual Election Period that ran from Oct. 15 through Dec. 7, Citi analyst Jason Cassorla pointed out in a Jan. 17 research note.
The percentage of Americans who said they or a family member put off medical treatment due to cost rose to 38% in 2022, representing a 12-percentage-point increase compared to 2021. That’s according to a new Gallup poll, which noted that the percentage of Americans reporting deferring care due to cost was at its highest level since Gallup began its survey in 2001. That finding comes after inflation reached the highest point in 40 years in 2022, and in the wake of “two consecutive 26% readings during the COVID-19 pandemic that were the lowest since 2004.” Gallup also added that “lower-income adults, younger adults and women in the U.S. have consistently been more likely than their counterparts to say they or a family member have delayed care for a serious medical condition.”
UnitedHealth Group kicked off the managed care sector’s latest round of financial results on Jan. 13 by reporting fourth-quarter and full-year 2022 adjusted earnings per share (EPS) of $5.34 and $22.19, respectively. The company’s adjusted EPS for the prior quarter beat the Wall Street consensus estimate of $5.17, and its medical loss ratio of 82.8% was just a hair higher (worse) than the consensus projection of 82.7%. The firm also reported that its full-year revenues of $324.2 billion grew 13% compared to 2021, “with double-digit growth at both Optum and UnitedHealthcare.”
Nearly 15.9 million people have signed up for Affordable Care Act exchange coverage since the start of open enrollment on Nov. 1, CMS reported on Jan. 11. “This record-breaking enrollment represents a 13% increase over last year, including over 3 million people new to the Marketplaces,” the agency said in a press release. As in prior enrollment snapshots, the 15.9 million enrollment figure includes signup data from both the federal and state-based marketplaces. In the 33 states using the HealthCare.gov platform, there were 11.9 million plan selections through Jan. 7, 2023, while the 18 state-based exchanges reported 4 million plan selections through Dec. 31, 2022. Americans in most states have until Jan. 15 to sign up for marketplace coverage for 2023, unless they qualify for a special enrollment period.
Summit County, Ohio, recently filed a lawsuit accusing Cigna Corp.’s Express Scripts and UnitedHealth Group’s Optum Rx PBMs of enabling the opioid addiction epidemic. The lawsuit calls out the “public nuisance” caused by the PBMs “facilitating the use of opioids by favoring, and failing to restrict” the use of opioids in their formularies while “collaborating with opioid manufacturers to deceptively and dangerously promote and fail to disclose the risk of opioids.” The suit also accuses the PBMs of “failures to maintain effective controls to prevent diversion in their own dispensing of opioids and to monitor their own claims data to prevent suspicious or inappropriate prescriptions.” The lawsuit does not seek to form a class of other local governments, but it represents perhaps the first attempt by a local government to seek damages from PBMs for epidemic levels of opioid addiction. Federal lawsuits have resulted in opioid epidemic damages paid to state and local governments, but the defendants in those suits have been manufacturers, such as Purdue Pharma L.P., and pharmacies, such as Walgreens Boots Alliance Inc. and CVS Health Corp. In settlements, CVS agreed to pay $5 billion to states over 10 years, and Walgreens agreed to pay $5.7 billion to states over 15 years. Purdue (and the Sackler family, which controls the company) agreed to pay $6 billion to states as part of its settlement.
The FDA has requested that Oncopeptides AB withdraw the U.S. marketing authorization for Pepaxto (melphalan flufenamide), the company revealed on Dec. 7. “We respect FDA´s accelerated approval regulations,” said CEO Jakob Lindberg in a statement. The FDA initially gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. But then on Oct. 22, 2021, the company requested voluntary withdrawal of the peptide-drug conjugate’s New Drug Application (NDA). That was followed early in 2022 by Oncopeptides’ rescinding the letter requesting the NDA’s withdrawal based on “further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials.” On Sept. 22, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) held a meeting to assess the drug’s risk/benefit profile; it voted 14-2 that the drug is not favorable for adults with relapsed or refractory multiple myeloma. Oncopeptides is commercializing the therapy in Europe, where it is known as Pepaxti, following its full approval on Aug. 18, 2022.
A group of Blue Cross and Blue Shield affiliates has founded the Synergie Medication Collective, a medication contracting organization focused on improving affordability of clinically administered drugs that are covered under patients’ medical benefit. The goal of the organization is to establish “a more efficient contracting model” for things like multimillion-dollar gene therapies and infusible cancer drugs while “utilizing a transparent business model in collaboration with industry stakeholders.” The independent entity will go to market “in January of 2023,” according to a Jan. 5 press release, and is owned by the Blue Cross Blue Shield Association (BCBSA), Elevance Health, Blues-affiliate-owned Evio Pharmacy Solutions and Prime Therapeutics, and nine regional Blues plans. Pharmaceutical industry veteran Jarrod Henshaw will serve as Synergie’s CEO, and BCBSA President and CEO Kim Keck will be the organization’s initial board chair.
AbbVie Inc. is leaving several lobbying organizations, including the Pharmaceutical Research and Manufacturers of America (PhRMA), widely regarded as the most powerful drug industry trade group, according to Politico. PhRMA has had a tough year. In August, the trade group faced its most notable political failure in a generation when Democrats passed Medicare drug price negotiation as part of the Inflation Reduction Act. In the months since, PhRMA has launched an internal review of that episode and has dismissed several of its most prominent executives.
Amgen Inc. plans to acquire Horizon Therapeutics plc. for $27.8 billion, or $116.50 per share, according to regulatory filings; the deal is the largest health care merger of the year, per the Wall Street Journal. Horizon develops specialty drugs for autoimmune and inflammatory diseases. The firm’s best-seller is Tepezza (teprotumumab-trbw), a treatment for thyroid eye disease. If, as expected, Tepezza earns approval in the European Union and Japan, Horizon projects $4 billion in global annual revenue from the drug.
U.S. health care spending grew 2.7% to reach $4.3 trillion in 2021, representing a slowdown in growth compared to the 10.3% increase recorded in 2020. That’s according to the 2021 National Health Expenditures Report from CMS’s Office of the Actuary, which attributed the spending-growth slowdown to a 3.5% year-over-year decline in health care expenditures from federal government that jumped in 2020 amid the COVID-19 response. The decline in government spending “more than offset” the impact of greater insurance coverage and higher health care utilization seen in 2021. The report also noted that private health insurance spending increased by 5.8% in 2021 to reach $1.2 trillion.