Radar on Drug Benefits

Eli Lilly & Co. has announced plans to run a head-to-head clinical trial of its Alzheimer’s drug, donanemab, against Aduhelm (aducanumab), the controversial Biogen Inc. Alzheimer’s drug. Meanwhile, Aduhelm has continued to have what one expert calls “the worst drug launch ever,” after state Medicaid leaders told CMS they want no part of paying for the drug.

In its third-quarter results, Biogen reported in a Securities and Exchange Commission filing that Aduhelm revenues totaled $300,000, citing the fact that many clinicians don’t want to prescribe the drug. Meanwhile, Eli Lilly & Co.’s donanemab is under an accelerated approval process. That process will include a Phase III study comparing donanemab directly to Aduhelm, according to Daniel Skovronsky, M.D., Ph.D., a Lilly senior vice president and its chief scientific and medical officer.

✦ During Centene Corp.’s Oct. 26 conference call to discuss third-quarter 2021 financial results, executives said the insurer will issue a request for proposals (RFP) in 2022 for PBM services. The move — which comes as Centene has been settling a spate of lawsuits filed by states over its PBM practices — is “going to be a huge opportunity for an external PBM,” Chief Financial Officer Drew Asher said during the company’s call with analysts. In addition to using its own internal PBM, Envolve Pharmacy Solutions, and a cloud-based platform that it has invested in, RxAdvance, Centene has a contract with CVS Health Corp.’s Caremark that expires at the end of 2023. The goal of putting out an RFP is to stay “sharp relative to our external partners” and to glean the “greatest economic benefit where we are leveraging an external partner” for a core capability, said Sarah London, vice chairman of Centene’s board of directors.

✦ A new AHIP analysis, which examined financial filings from the 10 largest pharmaceutical companies by revenue in 2020, found that seven spent more on selling and marketing expenses than research and development (R&D). The insurer trade group especially highlighted AbbVie, Bayer and Johnson & Johnson as spending amounts on sales and marketing that dwarfed their spending on R&D. “Big Pharma’s practices clearly show that their growth strategy is based on selling a greater volume of drugs to patients — not on creating groundbreaking new therapies and delivering more value to patients,” AHIP concluded. “We do not have to choose between innovation and the affordability of prescription drugs.”

✦ A pharmacy trade group made a formal request to the Dept. of Justice, asking that the government block UnitedHealth Group’s proposed acquisition of Change Healthcare Inc. “This deal would give UHG a trove of intelligence on its smaller competitors, including thousands of independent pharmacies and their patients. We believe it would use that intelligence to steer patients away from local pharmacies and send them to their own mail-order business,” said National Community Pharmacists Association CEO B. Douglas Hoey, Pharm.D., in a press release. In March, Change Healthcare and UnitedHealth received a request for additional information about their proposed tie-up from the DOJ, signaling that the department would be closely scrutinizing the deal. The American Hospital Association has also asked the DOJ to block the deal. During UnitedHealth’s conference call on Oct. 14 to discuss third-quarter 2021 earnings, President and Chief Operating Officer Dirk McMahon said the firm now expects the transaction to close “in the first part of 2022.”

✦ A mutagenic substance has been detected in three blood pressure medications, prompting the Canadian government to recall the drugs on Sept. 16. Ten firms were included in the recall, including Sanofi Inc. A chemical compound called azido impurities was detected in the recalled drugs and also led to recalls of some batches of similar drugs in the United Kingdom, European Union and South Korea, Bloomberg reported. Health Canada advised patients to continue taking the drugs they already possessed unless their doctor specifically told them to stop doing so. Meanwhile, an FDA inspector has found that at least one large manufacturer in India has a flawed process for controlling the impurities, according to documents reviewed by Bloomberg.