Radar on Drug Benefits

With the costs of treating cancer patients rising ever higher, payers and providers are increasingly turning to third-party pathways — or treatment protocols designed to provide the optimal therapy regimens — to improve outcomes and reduce excess costs. But not all pathways are created equal, and it’s crucial for oncology drug manufacturers to understand their nuances if they want to ensure their therapies are able to reach the most patients.

Those are the main takeaways from a recent “Meet the Expert” webinar from MMIT, AIS Health’s parent company. “It’s really key to get optimal placement of a brand on a pathway to ensure that patients can have access to these lifesaving therapies,” said Yana Faykina, senior consultant, advisory services at MMIT.

The House in March passed a bill that caps the out-of-pocket cost of insulin at $35 per month for Medicare Part D beneficiaries and for certain privately insured enrollees. A recent Kaiser Family Foundation analysis found that total out-of-pocket spending by Part D enrollees on insulin quadrupled between 2007 and 2019, reaching nearly $1 billion. If a $35 copay cap had been in place in 2019, Part D enrollees without low-income subsidies would have saved $14 per insulin prescription on average. Meanwhile, another study found that over one in four individual and small group enrollees paid more than an average of $35 per month out of pocket for insulin products in 2018. With a $35 cap, median monthly savings could reach $27 in the individual market and $19 in the small and large group markets.

Alvaro Bedoya’s confirmation as a commissioner of the Federal Trade Commission gave new hope to organizations urging the FTC to investigate PBMs. The Senate confirmed Bedoya, a Biden administration nominee, on May 11. Prior to Bedoya’s confirmation, an effort to investigate PBMs stalled when the agency’s existing four commissioners deadlocked along party lines in a Feb. 17 meeting over whether to start such a probe. Instead, the commission on Feb. 24 issued a public request for information (RFI) regarding “the ways that practices by large, vertically integrated Pharmacy Benefit Managers’ (PBMs) are affecting drug affordability and access.”

Meanwhile, Sens. Chuck Grassley (R-Iowa) and Maria Cantwell (D-Wash.) on May 24 introduced legislation that they said would empower the FTC “to increase drug pricing transparency and hold pharmacy benefit managers (PBMs) accountable for unfair and deceptive practices that drive up the costs of prescription drugs at the expense of consumers.” According to the two legislators, the Pharmacy Benefit Manager Transparency Act “would ban deceptive unfair pricing schemes; prohibit arbitrary claw backs of payments made to pharmacies; and require PBMs to report to the FTC how much money they make through spread pricing and pharmacy fees.”

With a raft of biosimilars coming to market starting in 2023, major PBMs are touting the pharmacy infrastructure and services that they say will position them to help customers take advantage of cost-saving opportunities in the coming years.

Speaking during recent conference calls to discuss first-quarter 2022 financial results, they also reported healthy client retention levels as PBMs move through the large-employer selling season.

“Our team is quite excited about and well positioned for the accelerating biosimilar trend that we see in front of us for the coming years,” Cigna CEO David Cordani said during a May 6 conference call to discuss first-quarter 2022 financial results, per a transcript from The Motley Fool.

Centene Corp. has agreed to sell two of its pharmacy businesses, Magellan Rx and PANTHERx Rare, in separate transactions as part of the insurer’s decision last year to exit the PBM industry.

Prime Therapeutics, a PBM jointly owned by 19 Blue Cross and Blue Shield affiliates, is acquiring Magellan Rx for about $1.35 billion in a deal that’s expected to close in the fourth quarter, while a joint venture of the Vistria Group, General Atlantic and Nautic Partners is buying PANTHERx Rare for $1.45 billion in a deal that’s expected to be completed in the next two to four months.

New research published in JAMA Health Forum found that rebate revenue for PBMs grew between 2015 and 2019 — but that growing rebate revenue was not passed on to patients.

The research letter’s authors measured both prerebate and postrebate drug costs taken from medical loss ratio (MLR) filings made by plans to CMS. The research sample includes commercial insurance filings from small group, individual and large group health plans across “approximately 2,200 unique health plans” covering 70 million lives.

Starting next year, biosimilars are expected to generate significant pharmacy cost savings for patients and payers, led by multiple biosimilars of AbbVie Inc.’s blockbuster immunosuppressive drug Humira (adalimumab). With as many as eight Humira competitors expected to launch in 2023, most payers report they will evaluate the biosimilars as they come to market over the course of the year, rather than waiting until all are available before making coverage decisions. And half of payers may adjust Humira contracting in 2022, prior to the biosimilars’ launches.

That’s according to findings from Zitter Insights, which like AIS Health is a division of MMIT. Steve Callahan, a senior manager of market research at MMIT, described Zitter’s market research findings on the Humira biosimilars during an April 5 webinar.

The use of medication abortion — which involves two drugs, mifepristone and misoprostol — has grown significantly since its approval and now accounts for 54% of all pregnancy terminations before nine weeks of gestation in the U.S. If the Supreme Court overturns Roe v. Wade, medication abortion usage is likely to increase as patients in states that ban the procedure are likely to attempt to obtain courses of medication abortion from states that allow it. Only 18 states and the District of Columbia allow both advanced practice clinicians and medical doctors to dispense abortion pills. Six states have passed laws banning any use of telehealth for medication abortion, according to a recent Kaiser Family Foundation analysis. Insurance coverage for both surgical and medical abortion is heavily regulated across the nation. A 2019 study from the Government Accountability Office found that 14 states’ Medicaid programs do not cover mifepristone even in the cases of rape, incest and life endangerment.

UnitedHealthcare will restrict access to Aduhelm (aducanumab) across all of its books of business, arguing that “Aduhelm is unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy,” according to company documents obtained by Stat News. The decision from the insurance branch of UnitedHealth Group, the largest private carrier in the country, follows a controversial move by CMS to restrict access to the drug mainly to patients who are participating in clinical trials. In a National Coverage Determination, CMS said the Medicare program will cover Biogen Inc.’s Aduhelm only for patients enrolled in randomized, controlled clinical trials conducted either through the FDA or the National Institutes of Health. For Medicare patients to be prescribed Aduhelm, they also must have a clinical diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild dementia with a confirmed presence of plaque on the brain.

As scrutiny on PBMs continues, various stakeholders are turning to the legal system to challenge the business practices of major firms.

Centene Corp. has been the target of the most litigation, having now reached settlements with nine state attorneys general over allegations that its PBM subsidiary Envolve overcharged those states’ Medicaid programs for prescription drugs, according to a filing with the Securities and Exchange Commission. The company has set aside $1.25 billion to fund those settlements and potential future lawsuits, and it is in the process of restructuring its PBM holdings.