FDA

The Senate Committee on Commerce, Science and Transportation on March 22 advanced the Pharmacy Benefit Manager Transparency Act, sending the PBM-regulating legislation to the full Senate. The bill would ban spread pricing, the process in which PBMs charge payers more for a prescription drug than what they reimburse the pharmacy and pocket the difference. It would also “prohibit PBMs from arbitrarily, unfairly, or deceptively clawing back payments made to pharmacies, or arbitrarily, unfairly, or deceptively increasing fees or lowering reimbursements to offset reimbursement changes in federally-funded health plans.” And it would require PBMs to file an annual report with the Federal Trade Commission (FTC) that discloses a variety of information, such as “the aggregate total amount of fees the PBM charged to pharmacies and the total amount of reimbursements the PBM clawed back from pharmacies.” To enforce those new mandates, the bill would authorize the FTC and state attorneys general to seek civil penalties from PBM companies for each violation, plus an additional penalty of up to $1 million.

The FDA is expected to approve several biosimilar medications in the next few years, potentially leading to billions of dollars in savings for payers and patients, according to a recent report from Cardinal Health. However, Bruce Feinberg, D.O., Cardinal Health’s chief medical officer, tells AIS Health that the promise of biosimilars to decrease medication and overall health care costs remains uncertain. He adds that the price differential between biologic drugs and their biosimilars has not reached anywhere near the levels seen between small-molecule medications and their generics.

Feinberg says that “in most of the biosimilars to date, none of the manufacturers have been quite willing to initiate that race to the bottom on price,” in large part due the high costs of producing biosimilars and funding research and development of them. Whereas the introduction of a generic can reduce prices by 90%, Feinberg says “we’re not seeing those kinds of changes [with biosimilars],” claiming the range is usually from 10% to 30% with an average of 15%.

The FDA recently gave an additional approval to BeiGene, Ltd.’s Brukinsa (zanubrutinib), which is already approved for three other rare types of non-Hodgkin lymphoma. Respondents to a Zitter Insights survey said that while its availability will result in a lower level of unmet need in the treatment of chronic lymphocytic leukemia (CLL), there is still moderate or high unmet need for the condition.

On Jan. 19, the FDA expanded the label of Brukinsa to include the treatment of adults with CLL or small lymphocytic lymphoma (SLL). CLL and SLL are the same disease, a type of non-Hodgkin lymphoma, except CLL cancer cells are mostly in the blood and bone marrow, while in SLL, the cells are mainly in the lymph nodes.

Two Alzheimer’s disease drugs developed by Biogen Inc. — Aduhelm (aducanumab) and Leqembi (lecanemab-irmb), which are both meant to attack the buildup of amyloid plaque in the brain — have been met with skepticism by providers and payers. A new report by Tufts University researchers found that few commercial carriers cover Aduhelm, while the Institute for Clinical and Economic Review (ICER) concluded that Leqembi’s high price exceeds its expected clinical value — and one expert says that neither finding is surprising, given the controversies surrounding both drugs.

The FDA on March 6 said that Leqembi, which Biogen developed in a joint venture with Eisai Co., Ltd., will have a full approval decision by July 6. In February, the agency granted Leqembi priority review; the drug gained an accelerated approval designation in January. Aduhelm, meanwhile, garnered accelerated approval in June 2021, despite broad controversy. Aduhelm's accelerated approval was broadly denounced by practitioners, and the HHS Office of Inspector General is investigating improper contacts between FDA staff and Biogen.

The FDA accepted its first application for a biosimilar denosumab, Sandoz disclosed on Feb. 6. The Amgen Inc. reference drug is available as both Prolia and Xgeva. According to AmerisourceBergen’s Feb. 6 U.S. Biosimilar Report, nine companies have denosumab biosimilars in clinicals trials, with five of those in Phase III trials. Prolia and Xgeva are approved for multiple conditions, including for the treatment of postmenopausal women with osteoporosis at high risk for fracture and for the prevention of skeletal-related events in people with multiple myeloma and in people with bone metastases from solid tumors. Sandoz’s application is for all of the drugs’ indications. Prolia’s list price is $1,564.31 per injection every six months, and the per-dose price for Xgeva — which is dosed every four weeks — is $2,877.36.

Elevance Health said on Feb. 15 that it had closed its acquisition of BioPlus, a specialty pharmacy subsidiary of CarepathRx, a portfolio company of Nautic Partners. BioPlus will operate as part of CarelonRx, Elevance’s PBM within Carelon, its health care services brand. Elevance said Nov. 9 that it had entered into an agreement to purchase the company. It did not disclose financial terms of the deal. The firm also said that it “plans to expand BioPlus’ service models across more complex disease treatment areas so the combined company can continue to provide timely access to medications, deliver leading support services for both providers and patients, and ensure individuals receive distinctive clinical expertise and service.

At the American College of Cardiology’s annual meeting in New Orleans, Esperion Therapeutics, Inc., presented data from a highly anticipated clinical trial that shows its cholesterol-lowering drug Nexletol (bempedoic acid) can reduce the risk for heart attack, stroke and other serious cardiac events. Company executives say the results position bempedoic acid as the logical next step for patients who can’t or won’t tolerate statins. Yet some pharmacy benefits experts say it may be a while before the therapy makes a major dent in the market.

“If any impact is seen, it may be slow as the results of the studies were recently released over the weekend,” Mesfin Tegenu, chairman and CEO of RxParadigm, Inc., tells AIS Health, a division of MMIT. “In theory, there would be an increase in uptake for patients with an established atherosclerotic vascular disease and in those at high risk for vascular disease who are unable or unwilling to take statins,” he adds. “However, coverage may continue to be slow until the data is fully analyzed.”

Feb. 3: The FDA expanded the patient population for Takeda’s Takhzyro (lanadelumab-flyo) to include the prevention of hereditary angioedema attacks in people at least 2 years old. The agency initially approved the plasma kallikrein inhibitor on Aug. 3, 2018. Dosing of the subcutaneous injectable in people at least 12 years old is 300 mg every two weeks. In people at least 6 and less than 12, dosing is 150 mg every two weeks, and for people 2 years old and younger than 6, dosing is 150 mg every four weeks. Drugs.com lists the price of one single-dose 300 mg/2 mL subcutaneous solution as more than $26,165.

Feb. 8: The FDA granted another indication to Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept) for the treatment of retinopathy of prematurity in preterm infants. The agency first approved the drug on Nov. 18, 2011. Dosing of the vascular endothelial growth factor (VEGF) inhibitor for the newest indication is 0.4 mg via intravitreal injection; treatment may be given bilaterally on the same day. Injections may be repeated with an interval of at least 10 days. Drugs.com lists the price of a 40 mg/ml intravitreal solution as more than $1,957.

Covis Pharma Group said on March 7 that it will voluntarily stop selling Makena (hydroxyprogesterone caproate), a drug that aims to reduce preterm births and that has become a flashpoint in the debate over the FDA’s accelerated approval pathway. Makena was granted accelerated approval in 2011, but subsequent clinical trials failed to demonstrate its effectiveness, leading FDA advisers last fall to recommend withdrawing the drug from the market. “While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Covis Chief Innovation Officer Raghav Chari, Ph.D., said in a statement. The move comes ahead of an anticipated final decision on Makena’s status by FDA Commissioner Robert Califf and Chief Scientist Namandjé Bumpus.

A Missouri federal judge barred former Cigna Group executive Amy Bricker from moving to CVS Health Corp., finding that Bricker’s planned move would violate her noncompete agreement with Cigna, where she led the Express Scripts PBM. Cigna sued to block Bricker from leaving the company, arguing that Bricker’s knowledge of trade secrets and the firm’s “most highly sensitive information” would aid CVS in direct competition with Cigna. Bricker countered that her new CVS role was not meant to encompass pharmacy benefits and would not have involved any work with CVS’s Caremark PBM division. Earlier this year, the Biden administration announced an effort to ban noncompete clauses in employment agreements.

The number of independent pharmacists remained relatively flat in 2023, according to a survey by the Pharmaceutical Care Management Association (PCMA), a PBM trade group, with 23,353 independent pharmacies in operation across the U.S. The number of independent pharmacies increased by 99 between January 2022 and January 2023, a 0.4% uptick that nearly matches the 0.5% five-year trend, the survey found. Over the past 10 years, the number of independent pharmacies has grown by 7.5%.

The FDA on Feb. 2 granted approval for a self-administered version of Amgen Inc. and AstraZeneca plc’s Tezspire (tezepelumab-ekko), a biologic used as a preventive maintenance therapy for severe asthma. Pharmacy experts tell AIS Health, a division of MMIT, that the drug’s high price tag and high clinical thresholds mean that adoption is unlikely to spike in the short term.

The new version of Tezspire, a human monoclonal antibody, can be self-administered by patients through a pre-filled pen. Doses last four weeks. Tezspire is “the only biologic approved for severe asthma with no phenotype (e.g., eosinophilic or allergic) or biomarker limitation within its approved label,” per an Amgen press release. It was first approved in December 2021, But previously, the drug had to be administered by a practitioner.