PBMs/Pharmacy Benefit Managers

PBMs often place biosimilar medications on preferred formulary tiers soon after the drugs hit the market, a change from a few years ago, when payers were more hesitant to cover biosimilars, according to a recent Cardinal Health report. However, one of the report’s authors tells AIS Health that PBMs in some cases have kept the reference biologic product on their preferred tier as well, leading to slower adoption of biosimilars.

For instance, Fran Gregory, Pharm.D., Cardinal Health’s vice president of emerging therapies, notes that CVS Health Corp.'s Caremark, The Cigna Group's Express Scripts and UnitedHealth Group's Optum Rx all added Humira (adalimumab) biosimilars to their national preferred formularies when they launched last year. Gregory says those PBMs were “very strategic” about which of the nine Humira biosimilars to place in a preferred tier, analyzing the wholesale acquisition costs (WACs) and concentrations of the products and tailoring them “based on the lines of business they’re serving.” But the payers all put the same tier as the biosimilars, which Gregory says “is where the challenge lies” with adoption.

Specialty pharmacies and oncology practices dispensing costly specialty medications have long complained that Medicare Part D direct and indirect remuneration (DIR) fees are not appropriate for these drugs. Efforts to do away with these retroactive fees were finally successful, but revamped reimbursement has brought a new problem — underwater reimbursement — claims the Community Oncology Alliance (COA).

DIR includes rebates and price concessions that occur after the point of sale. According to CMS, total DIR “has been growing significantly in recent years.…In 2020, pharmacy price concessions accounted for about 4.8 percent of total Part D gross drug costs ($9.5 billion), up from 0.01 percent ($8.9 million) in 2010.”

When President Joe Biden signed a $460 billion government funding bill on March 9, that legislation was missing something that numerous legislators and other stakeholders have long been pushing for: PBM reform.

Depending on whom you ask, the omission either represents a temporary setback or a sign that it will be a long time before any federal legislation passes that successfully alters major PBMs’ much-criticized business practices.

“There’s still incredible bipartisan, widespread support for action on these issues,” says Joe Shields, managing director of Transparency-Rx, a coalition of smaller PBMs pushing for reform measures targeting their industry-dominant rivals. “We expect there will be action on these issues; that action could be in a matter of weeks, at least from what I’m hearing of some cadence coming out of Capitol Hill.”

As demand for GLP-1s has grown, so has the desire of plan sponsors and other payers to avoid covering the costly drugs as "lifestyle" products — instead, they want to allow only patients who will derive clear medical benefits from GLP-1s to use them. To address that desire, vertically integrated payer-PBMs, among other vendors, have launched buy-up services for commercial plan sponsors that promise to curb demand for GLP-1s by making other weight loss care more available to patients.

Experts say it’s not clear whether those programs will make a difference for patients — or be worth the money for payers.

A lawsuit filed by an employee against Johnson & Johnson could signal that significant changes in the legal obligations of commercial plan sponsors and PBMs around drug pricing are coming, experts say. The suit alleges that J&J violated its fiduciary obligations as a health plan sponsor under the Employee Retirement Income Security Act (ERISA) of 1974 by overpaying the plan’s PBM for employees’ medications.

If it’s successful, the suit could expose plans, plan sponsors and PBMs to significant, ongoing legal risk, experts say. However, they add that the opacity and complexity of drug pricing dynamics mean that the suit’s success is far from certain.

Part of a long-running lawsuit filed by Elevance Health, Inc. against The Cigna Group, over what Elevance considers inappropriate contract practices by Cigna's Express Scripts PBM, entered mediation mandated by the Second Circuit Court of Appeals, according to court documents and Elevance’s latest 10-K filing with the Securities and Exchange Commission (SEC). Elevance was seeking to recover $14.8 billion in damages and is now appealing a district court judge’s dismissal of its remaining claim.

David Kaufman, an attorney at Laurus Law Group LLC, says that the mediation mandated by the Second Circuit is unlikely to do much to satisfy Elevance.

A lawsuit filed by an employee against Johnson & Johnson could signal that significant changes in the legal obligations of commercial plan sponsors and PBMs around drug pricing are coming, experts say. The suit alleges that J&J violated its fiduciary obligations as a health plan sponsor under the Employee Retirement Income Security Act (ERISA) of 1974 by overpaying the plan’s PBM for employees’ medications.

If it’s successful, the suit could expose plans, plan sponsors and PBMs to significant, ongoing legal risk, experts say. However, they add that the opacity and complexity of drug pricing dynamics mean that the suit’s success is far from certain.

An ongoing lawsuit over the use of copay accumulators is drawing to a close following the defendants’ and plaintiffs’ motions to dismiss their appeals. The ball is now in the federal government’s and state insurance commissioners’ courts to enforce a district court judge’s ruling, which states that manufacturer assistance must be counted toward patients’ out-of-pocket responsibility unless a brand-name drug has a medically appropriate generic equivalent.

Health plans and PBMs several years ago began implementing copay accumulators — and then a new iteration known as copay maximizers that declare certain drugs non-essential health benefits to avoid covering them per the Affordable Care Act (ACA) — to counter manufacturer copay assistance programs. Before these tools, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators and maximizers, patients can still use that assistance, but it does not help reduce their out-of-pocket costs.

UnitedHealth Group’s Optum division recently launched a new direct-to-consumer telehealth prescribing venture as part of its Optum Perks vertical, joining a crowded field of DTC prescribing and dispensing. Experts say that the Optum Perks debut is proof that DTC prescribing around “lifestyle drugs” will likely continue to grow rapidly, but they say that there are clear downsides around utilization management and care coordination — particularly where glucagon-like peptide-1 (GLP-1) agonists are concerned.

Optum Perks’ rollout follows closely on the heels of Eli Lilly & Co.’s Lilly Direct launch, which also saw a health care giant steer into DTC prescribing waters. Lilly and industry watchers say that Lilly Direct is mainly intended to dispense its tirzepatide GLP-1 drugs, known by the brand names Mounjaro and Zepbound. Patients may or may not be able to obtain GLP-1s from Optum Perks; UnitedHealth’s press release doesn’t have a comprehensive list of drugs offered under the service, although it says that “low-cost care and prescription treatments for hundreds of conditions ranging from acne to a cough to high blood pressure” are available.

During the recent fourth-quarter earnings calls held by their diversified parent companies, the Big Three PBMs — The Cigna Group’s Express Scripts, UnitedHealth Group’s Optum Rx and CVS Health Corp.’s Caremark — factored prominently into discussions of the firms’ financial results and future growth strategies.

When CVS Health reported its quarterly and full-year results on Feb. 7, CEO Karen Lynch wasted little time before describing what she called CVS’s “innovative models and offerings that create more transparency and choice for consumers and clients.”