Radar on Drug Benefits

Emerging cell and gene therapy oncology treatments are well suited to value-based payment arrangements, but new contracting models must be able to contend with a complex regulatory and financial environment, experts say.

A new generation of oncology treatments that can cure specific cancers offer a potential breakthrough. Patients who would have had to struggle through chemotherapy and still faced long odds now have the chance to make a significant recovery with one or two rounds of treatment. However, these treatments are extraordinarily expensive — some can cost tens of thousands of dollars for a single course of treatment.

Walmart Inc. — which like Amazon has been diving deeper and deeper into health care — recently made one of its biggest moves yet in that space by partnering with Novo Nordisk to launch private-label insulin at a steeply discounted cash price. While the new offering still may be too expensive for some and likely won’t solve the overarching insulin-affordability problem, some observers say it’s indicative of how well-poised certain companies are to disrupt the health care industry’s least consumer-friendly practices.

“Insulin is, from a business point of view, attractive to competitors like Walmart — they see a product that has a very big audience that is grossly overpriced, where that audience is stressed and dissatisfied because they don’t believe they’re getting the value that they should be getting,” says Michael Abrams, a principal and co-founder at health care consulting firm Numerof & Associates.

State governments have begun to pursue aggressive policies to make PBMs more transparent, accountable to plan sponsors and less expensive to contract with — efforts that are bolstered by Rutledge v. Pharmaceutical Care Management Association (PCMA), a lawsuit decided by the Supreme Court at the end of 2020 in which the justices held that states were not in violation of the Employee Retirement Income Security Act of 1974 (ERISA) in attempting to regulate the rates at which PBMs reimburse pharmacies.

According to the National Academy for State Health Policy (NASHP), a think tank and policy advocacy group, so far this year 42 states have considered 108 bills relating to PBM regulation. That wave of legislation is in part driven by Rutledge, which, as a March Milliman Inc. report put it, “creates a clear pathway for states to impose minimum thresholds on pharmacy…prices affecting reimbursement levels paid by plan sponsors,” which “means PBMs could be forced to pay pharmacies a minimum price for drugs.”

EmployersRX, a coalition of organizations representing health care purchasers that aims to bring down drug costs, has joined the growing number of groups expressing concern about the cost of a recently approved novel Alzheimer’s disease drug. “The approval of Aducanumab despite its questionable effectiveness, and its unjustifiable price, demonstrate the profound need for substantial reforms to how the United States approves and prices prescription drugs,” wrote the group in a letter to congressional leaders dated June 21. The FDA approved Biogen, Inc.’s Aducanumab (aducanumab-avwa) earlier this month even though an independent advisory council advised against it, sparking outcry over concerns about its efficacy as well as its annual wholesale acquisition cost of $56,000.

✦ In other Aducanumab-related news, The Wall Street Journal reported on June 22 that the FDA’s approval of the drug came despite objections from the agency’s drug statistics office, which argued that clinical trial data fell short of the proof typically required to put a new product on the market. The article, which cites “newly released internal memos,” reveals that the FDA ultimately decided to approve the drug in part because Alzheimer’s patients have “a serious, progressive, ultimately fatal disease and are desperate for treatments,” in the words of Peter Stein, director of the FDA’s office of new drugs.

New starts of antidepressants declined by 7.5%, anxiolytics by 5.6%, and antipsychotics by 2.6% compared with forecast levels during the first five months of the COVID-19 pandemic, according to a new study published in Health Affairs. For all medications, declines in new starts were particularly dramatic during the initial stay-at-home order period from March to May 2020. Though there was a significant rebound in new prescription starts after mid-May, the numbers remained below 2019 levels. There were substantial drops in new starts for patients younger than 18, across all medication classes, with a 34.6% decline in antidepressants, 27.3% in anxiolytics and 22.2% in antipsychotics compared with the expected levels.