Radar on Drug Benefits

Bristol Myers Squibb on March 18 completed its $14 billion acquisition of Karuna Therapeutics, Inc., whose lead drug, KarXT (xanomeline-trospium), is expected to gain FDA approval for treating schizophrenia later this year. That deal and results from clinical trials suggest KarXT could gain significant market share in a crowded schizophrenia medication marketplace.

However, two drug pricing experts tell AIS Health that it remains to be seen how payers will cover KarXT, especially if it’s priced significantly higher than its generic competitors, as it is expected to be. KarXT, an oral medication, has an FDA Prescription Drug User Fee Act data of Sept. 24, meaning the FDA will make an approval decision by then.

In newly released guidance, CMS told Medicare Part D plans that they’re allowed to cover weight-loss drugs if they’ve been approved for another medical use — a description fitting Novo Nordisk’s Wegovy (semaglutide) after it recently received an FDA nod for preventing major heart problems.

So far, CVS Health Corp., Elevance Health, Inc. and Kaiser Permanente have said their Part D plans will cover Wegovy for its newest approved use: reducing the risk of heart attacks and strokes in people who have cardiovascular disease and who meet body-weight criteria, the Wall Street Journal reported on March 28.

For other insurers that sell Part D plans, the decision about whether to cover Wegovy represents an additional challenge to grapple with, as they’re also facing significant regulatory changes.

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.

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.

For health plans, managing prescription drug coverage has become a highly complex task for myriad reasons, including never-ending regulatory changes and ever-rising prices. And that task is made even more difficult by the fact that an increasing number of drugs are coming to market with limited evidence that they are effective, panelists said during a March 13 session of the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Baltimore.

“One of the challenges for insurers going forward will be the increasing need to manage uncertainty,” said Daniel Ollendorf, Ph.D., chief scientific officer at the Institute for Clinical and Economic Review (ICER). Many drug launch prices, he said, “are being driven by approvals that happen on an accelerated basis with very limited evidence.”

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.

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.

Like its competitors, Humana Inc.’s evolution from a pure-play health insurer to a highly diversified health care firm came with a rebranding. To that end, Humana Pharmacy — the company’s mail-order and retail pharmacy brand — in 2022 became CenterWell Pharmacy, nestled under the company’s CenterWell health services subsidiary. Now, that division not only has a new name, but also a new app.

The app — which is available to CenterWell Pharmacy members covered by Humana’s Medicare Advantage and Part D plans — represents a “total redesign,” with increased personalization capabilities and a streamlined approach to prescription management, the firm said in a Feb. 20 press release.

In a new draft guidance document, CMS lays out a litany of tasks Medicare Part D plans must complete to help enrollees take advantage of an Inflation Reduction Act (IRA) provision that allows people to pay off their prescription drug copays over time.

The memo is the second draft guidance document released by CMS regarding the Medicare Prescription Payment Plan, or “copay smoothing” — a program that the managed care sector appears to be growing uneasy about.

“Part D smoothing is coming; it’s coming like a typhoon,” said Nikki Hungate, an industry consultant speaking at the 7th Annual Medicare Advantage Leadership Innovations conference, held Jan. 30-31 in Scottsdale, Arizona.