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News Briefs: Wegovy Gains Another Indication

The FDA on March 8 granted Novo Nordisk A/S’s Wegovy (semaglutide) yet another indication — for cardiovascular risk reduction — that could further boost staggering GLP-1 sales. Wegovy is now approved to reduce risk of “major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke” in adults who are either overweight or obese and have established cardiovascular disease, per a Novo press release. FDA official John Sharretts, M.D., described Wegovy as the first weight loss medication “to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight.” As the FDA noted in a press release, approximately 70% of U.S. adults are obese or overweight. The new indication was approved after a priority review.

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PBMs Place Biosimilars on Preferred Tiers, yet Adoption Varies by Product

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.

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Alternative Payment Policies May Help Medicare Part B Reap Greater Savings From Biosimilars

The growing use of biosimilars has reduced spending in the Medicare Part B program, but there are opportunities to further reduce costs — through greater use of more affordable biosimilars and through the implementation of different payment policies, according to a study published by the HHS Office of Inspector General (OIG).

The OIG analyzed the average sales prices, utilization and costs of 21 biosimilar drugs and their reference biologic products in the Medicare Part B program between 2015 and 2021. The agency found that overall use rate of biosimilars in Part B jumped from 18% in 2015 to 62% in 2021. While the adoption of biosimilars has lowered both the prices of biologics and biosimilars, Part B spending could have been reduced by $179 million in 2021 if the five biosimilars that cost less than their reference products — epoetin alfa, infliximab, bevacizumab, rituximab and trastuzumab — had been used at the same rate as the most widely used biosimilar, filgrastim.

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Can PBMs Keep Their Lofty GLP-1 Cost Control Promises?

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.

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Incorporating Pharmacy Spending in Value-Based Payment Models Remains Challenging

Payers face challenges incorporating drug spending into value-based payment models, making it difficult to reduce overall health care costs, according to panelists who participated in a session at the virtual Value-Based Payment Summit on Jan. 31. The speakers were encouraged with the increased attention being paid to expensive medications and difficulties in ensuring people take their prescriptions. However, they stressed that more needs to be done to educate providers and ensure pharmacy spending is in check.

Frank W. McStay, II, assistant research director at the Duke University Margolis Institute for Health Policy and the session’s moderator, noted the federal government and states have recently proposed and implemented policies to reduce drug costs and increase access to medications. For instance, the Biden administration on Jan. 30 announced that it planned to increase access to sickle cell treatments via the Cell and Gene Therapy (CGT) Access Model that CMS introduced last year.

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Direct-to-Consumer Prescribing Could Have Downsides

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.

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News Briefs: Tyson Drops CVS Caremark for Startup PBM

Tyson Foods, Inc. dropped CVS Health Corp.’s Caremark PBM in favor of Rightway, a fee-based PBM partnered with Mark Cuban Cost Plus Drug Co. Rightway promises to save employers 15% on their pharmacy benefit costs. Tyson’s head of benefits, Renu Chhabra, told CNBC that concerning jumps in specialty drug spending were a key reason behind the move. CVS withheld data that Chhabra hoped to use to manage costs, she said. “We were going anywhere between 12% to 14% increases for pharmacy — and on a $200 million spend that’s quite a bit,” said Chhabra. “I wanted to look at Humira, and I wanted to see what the acquisition cost was…it was very difficult to get to those numbers. Part of this was to really get a partner who can help us organize the information, make sure we understand how to manage specialty, and really looking at how to get the best net cost.”

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CVS Removes Humira From Formulary — But the Fine Print Is Key

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.

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Commercial Payers Wrestle With Managing Weight Loss Drug Coverage

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.)

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Obesity Meds, Gene Therapies, NASH Drug Make Payers’ Cost Concern List

For years, payers have been concerned about the rising prices of prescription medications and how to cover newly approved drugs. Pharmaceutical experts tell AIS Health, a division of MMIT, that PBMs and plans will continue to be challenged in 2024 with similar issues, particularly when it comes to gene therapies, obesity medications and other expensive products.

Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth, notes that more than half of pharmacy benefit spending is on specialty medications even though only a small percentage of members use those drugs.

He says dealing with high-cost specialty products “is a focus for most payers” and adds there is a “large target on specialty drugs.”

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© 2024 MMIT