Radar on Drug Benefits

With the launch of a new website, Eli Lilly and Co. recently became the first pharmaceutical company to offer weight loss medications though a telehealth provider. The platform — LillyDirect — comes less than two months after Lilly’s weight loss drug Zepbound (tirzepatide) gained FDA approval and joined fellow glucagon-like peptide 1 (GLP-1) agonists from Novo Nordisk A/S, Wegovy (semaglutide) and Saxenda (liraglutide), in the burgeoning obesity drug market.

The weight loss medication market is currently dominated by Wegovy, a once-weekly injectable drug. The FDA initially approved semaglutide for Type 2 diabetes under the brand name Ozempic, but the agency expanded the indications to include weight management three years ago. Pharmacy formularies that cover more than half of commercial-plan enrollees categorize Wegovy as “preferred” or “preferred with utilization management restrictions,” — such as prior authorization and/or step therapy — according to MMIT Analytics. (MMIT is the parent company of AIS Health.)

CVS Health Corp.’s PBM, CVS Caremark, said recently that it will remove AbbVie’s immunosuppressive drug Humira (adalimumab) from its major national commercial template formularies. The move comes on the heels of a year in which 14 near-identical copies of the world’s best-selling drug entered the U.S. market after years of delays, leading major PBMs to generally put selections of several biosimilars on the same coverage tiers as their reference product.

Yet while Wall Street analysts heralded CVS’s decision as an indication that it’s become a trailblazer in the biosimilar space, one prominent PBM critic remains skeptical of the company’s motivations — especially since CVS is working with Humira’s manufacturer on a new cobranded version of the drug.

Walgreens Boots Alliance Inc. agreed to pay Humana Inc. $360 million to settle allegations that Walgreens’ retail pharmacies overcharged for prescription drugs. Walgreens said in a Jan. 4 U.S. Securities and Exchange Commission filing that it had paid $150 million of the settlement amount last month. In May 2023, Walgreens filed a lawsuit asking a judge to overturn a $642 million arbitration judgement awarded to Humana two months earlier. Walgreens has faced other lawsuits in recent years alleging the company overcharged for medications. For instance, Walgreens in 2019 paid the federal government and states a $269.2 million settlement related to allegations that it improperly billed Medicare, Medicaid and other health care programs for insulin pens. And in 2022, three Blue Cross and Blue Shield affiliates sued Walgreens over generic medication pricing.

Eli Lilly & Co. will sell its glucagon-like peptide-1 (GLP-1) weight loss drugs directly to consumers through a telehealth service called LillyDirect, the drugmaker revealed on Jan. 4. Pharmacy benefit experts say that the move is sure to improve market access for Lilly’s weight loss drugs, but they also say that the impact of the new service on PBMs is likely to be minimal.

LillyDirect will contract with “independent healthcare providers,” per a press release, to prescribe the GLP-1 tirzepatide, known by the brand names Mounjaro () and Zepbound. Weight loss-focused telehealth provider Form Health Inc. will be one of those partners, NBC News reported. LillyDirect will also provide “tailored support” from unnamed providers. The service will also feature free “direct home delivery…through third-party pharmacy dispensing services.”

In a move decried by the major PBM trade group but hailed by employer plan sponsors and a pro-reform coalition of smaller PBMs, the U.S. House of Representatives on Dec. 11 passed legislation that would usher in a host of new transparency requirements for what has become a heavily criticized industry.

The Lower Costs, More Transparency Act (H.R. 5378) passed on a 320-71 vote, but an uncertain fate awaits the measure in the Senate. The bill was initially due to be voted on in September but was tabled amid concerns over lawmakers’ support and the House’s focus at the time on passing a stopgap government spending package.

About 81% of people covered by 35 insurers and PBMs representing 117.8 million lives were enrolled in plans with copay accumulators as of September 2023, compared with 89% in 2022, according to data collected by AIS Health’s parent company, MMIT. About 71% of people were enrolled in plans with copay maximizers, down from 76% in 2022. However, on average, payers anticipated a 30% increase in the number of plan sponsors opting into such programs next year and a 14% increase in member enrollment in plans with copay accumulators and maximizers.

Copay accumulators prevent any monetary assistance that pharmaceutical companies offer commercially insured patients from counting toward their deductible or out-of-pocket maximum. Copay maximizers distribute the total amount of a manufacturer’s copay-offset funds over 12 months, making that amount the new monthly copayment on any given drug over the course of a year.

In the latest version of its annual Unsupported Price Increases (UPI) report, the Institute for Clinical and Economic Review (ICER) found that eight high-expenditure drugs with substantial, unjustified net price increases in 2022 cost insurers and patients nearly $1.3 billion.

“After some reduction in net price increases last year, we're again seeing many increases in net prices for drugs with large budget impacts,” ICER Chief Medical Officer David Rind, M.D., tells AIS Health, a division of MMIT. However, Rind says that recent legislative changes could make a difference in future years.

CVS Health Corp.’s Caremark is the latest big PBM to offer clients new pricing models that the company claims will increase transparency and reduce overhead. Experts say that the new offerings are not as transparent as CVS claims they are, and constitute a response to various pressures including likely federal PBM reforms, scrutiny from plan sponsors and disruptive business trends like the growth of Mark Cuban Cost Plus Drug Co.

Most experts expect that the new CVS offerings, called CostVantage and TrueCost, will only make a marginal difference — if any — in either drug costs or price transparency. Industry observers point to similar product rollouts by the other two of the Big Three PBMs, UnitedHealth Group’s Optum Rx and The Cigna Group’s Express Scripts, neither of which seemed to dampen the firms' PBM earnings. Express Scripts’ ClearCareRx and Optum Rx’s Cost Clarity launched in April and May, respectively. Express Scripts also rolled out a new “cost-plus pharmacy pricing” option, called ClearNetwork, in November.

Rite Aid Corp. has delayed the auction of its PBM, Elixir Rx Solutions, as part of its Chapter 11 bankruptcy filing. According to a court filing, the auction was moved from Nov. 20 to Dec. 21 following a Nov. 21 hearing held by the District of New Jersey U.S. Bankruptcy Court. Rite Aid filed for bankruptcy on Oct. 15, at which time MedImpact Healthcare Systems presented a $575 million “stalking horse” offer for the company’s PBM — meaning an initial bid on a bankrupt company's assets from an interested buyer that aims to avoid low bids in a court auction. Under the newly revised schedule, competitive bids for Elixir must be received by Dec. 18 ahead of the Dec. 21 auction — which is the same date as the auction being held for Rite Aid’s retail stores.

The recent approvals of the first two gene therapies for sickle cell disease represent potential major breakthroughs for patients who have faced significant burdens associated with the condition. However, there are still questions about how and whether payers will cover the high-cost treatments and how many patients will be open to taking the new treatments.

The FDA on Dec. 8 approved Casgevy (exagamglogene autotemcel) from CRISPR Therapeutics and Vertex Pharmaceuticals Inc. and Lyfgenia (lovotibeglogene autotemcel) from bluebird, Inc. for patients who are 12 or older and have recurrent vaso-occlusive events (VOEs), the term for severe pain and organ damage. The agency noted about 100,000 people in the U.S. have sickle cell disease and that VOEs “can lead to life-threatening disabilities and/or early death.”