Radar on Drug Benefits

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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PBMs Tout Client Wins, Rx Pricing Models on 4Q Earnings Calls

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.”

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News Briefs: U.S. Pays 278% More for Drugs than Other Countries

U.S. patients paid an estimated 278% more for prescription drugs than patients in other high-income countries did for the same drugs in 2022, according to a RAND Corp. study. U.S. gross prices for brand-name originator drugs were 422% higher than drugs in the comparison countries, RAND found; after rebates were applied, brand-name drugs still cost more than three times the amount paid in other countries. Unbranded generics were the only category that were not “substantially higher” in price than drugs in other countries. As RAND pointed out, unbranded generics account for 90% of U.S. drug volume but just 8% of total drug spending at manufacturer gross prices.

A Johnson & Johnson employee sued the firm over allegations that the medical manufacturing giant overpaid for prescription drugs dispensed by the firm’s employee health plan — which she alleges is a violation of J&J’s fiduciary duty under the Employee Retirement Income Security Act of 1974 (ERISA). The suit is part of what some legal experts have predicted will be a “” of litigation against plan sponsors that may have paid more than they should have for certain health care services and products, potentially including prescription drugs or pharmacy benefits. The plaintiff in the suit is Ann Lewandowski, a health care policy and advocacy director at J&J, STAT reported.

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Blue Shield of California’s PBM Overhaul Could Still See Boost From Transparency Legislation

Blue Shield of California’s plan to replace its traditional pharmacy benefit arrangement with what it hopes will be a more transparent assemblage of services won’t go into full effect until 2025, but it has already generated a lot of hope and criticism across the healthcare landscape. The insurer, though, is aiming to inspire as much at it aiming to succeed on its own.

“It’s going to take more than just one plan, or one employer group or one manufacturer. It’s going to take all of us to look at our business model and think about how it can be simpler, more sustainable, more affordable, with higher quality care,” Alison Lum, Blue Shield of California’s VP-Pharmacy Services, said in an interview with the Pink Sheet on 6 February.

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‘D’ Is for Dynamic: CMS Proposals Could Shake Up Medicare Drug Benefits

In two recent proposals, CMS outlines numerous changes to technical aspects of the Medicare Part D program — many of which are related to provisions in the Inflation Reduction Act (IRA) that restructured the Part D benefit phases. Sources tell AIS Health, a division of MMIT, that the proposals could have both positive and negative effects on Part D plan sponsors and beneficiaries and will likely attract a bevy of industry feedback.

The documents in question are the 2025 Advance Notice of payment changes for Medicare Advantage and Part D plans and the Draft 2025 Part D Redesign Program Instructions. While the Advance Notice is unveiled around the same time every year, the draft Part D redesign instructions are being issued to help implement provisions of the IRA that make major changes to the structure of the Part D benefit.

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As More Biosimilars Hit the Market, Uptake Remains Low but Improving

Although 2023 was a banner year for biosimilars hitting the U.S. market, uptake of these near-copies of biologic drugs remains low. Manufacturers of biologics also commonly file lawsuits or take other measures to extend their patents and have successfully delayed the introduction of FDA-approved biosimilars. Pharmaceutical industry experts tell AIS Health, a division of MMIT, that the slow adoption of biosimilars has an impact on payers that would prefer patients receive lower-cost biosimilars rather than expensive biologics.

In fact, a recent study offers evidence that private insurers are increasingly embracing biosimilars. Uptake of biosimilar medications was higher in Medicare Advantage plans than in traditional, fee-for-service Medicare from May 2015 through September 2022, according to a recent study published in JAMA Health Forum. However, biosimilars had less than a 50% market share in six of the seven product classes the authors examined, suggesting providers and patients often still opt for biologics.

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On Roe v. Wade Anniversary, Here’s a Closer Look at U.S. Abortion Access

The Biden administration announced new measures to protect reproductive health care accessibility on the 51st anniversary of the Roe v. Wade ruling, which found that the U.S. Constitution protects the right to have an abortion. HHS, alongside the Labor and Treasury departments, released new guidance that instructs health insurers on how to comply with the Affordable Care Act’s requirements to cover contraception at no cost. For hospitals and provider associations, HHS and CMS launched new efforts to increase awareness about access to emergency medical care — including abortion services — required under the Emergency Medical Treatment and Labor Act.

A year and a half after the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization — which reversed Roe v. Wade — access to abortion is uneven across the nation. As of January 2024, 14 states have made abortion illegal. Among the states without bans, the majority have at least one restriction on the books, such as limiting abortion access to just those who are early in pregnancy and imposing mandatory waiting periods. Arizona, North Carolina and Wisconsin, for example, currently have six abortion-limiting regulations in place, according to a KFF analysis.

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More States Eye Drug Affordability Boards, PBM Regulations

PBM and drug pricing regulation will continue to be hot topics at the state level after several years of busy lawmaking, experts predict, even as PBM reforms are diluted and stalled in Congress. They predict that more states than ever will continue to embrace or pursue policies like drug affordability review boards.

“I do think the momentum is still strong, because states have the ability to do a lot more,” Kate Sikora, managing director at Avalere Health, tells AIS Health, a division of MMIT. “Federal bills typically get a little bit watered down by the time they actually pass. So some of these state laws are a little bit heartier — a little bit more robust — in terms of what they attempt to do.”

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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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New Guidance Puts Finer Point on Birth Control Coverage Rules

On Jan. 22, the 51st anniversary of the now-overturned Roe v. Wade Supreme Court ruling, the Biden administration seized the opportunity to reaffirm its support for reproductive rights — a stance it appears to be increasingly emphasizing as the 2024 presidential election draws near. As part of that effort, three federal agencies issued new guidance to help health plans and issuers avoid running afoul of the Affordable Care Act’s contraception coverage mandate.

Health policy experts who spoke to AIS Health, a division of MMIT, say that the guidance could be a helpful tool for compliance-focused insurers, as it outlines the narrow set of circumstances in which a health plan doesn’t have to fully cover certain types of birth control.

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