Instant Insights The Prescription Drug Problem & PBM Reform

The agency has stepped up its campaign against drugmakers' improper listing of patents in the FDA's Orange Book, which it contends are ploys intended to delay generic competition, by disputing junk patent listings for 300 drugs.

Discussed below are some of the most common contractual provisions that plan fiduciaries and benefits advisors must know to avoid and/or expose a self-serving PBM.

More than five dozen lawsuits have been filed against the makers of weight loss drugs.

Pharmacy benefit manager Optum Rx plans to launch Clear Trend Guarantee in 2025 to allow employers and health insurers to more easily manage their drug spending, while creating more predictability for patients around costs.

An Illinois jury sided with drugmakers GlaxoSmithKline and Boehringer Ingelheim in the first trial over Zantac, which the FDA recalled in 2020 over claims the over-the-counter heartburn medication caused cancer.

Patients are being harmed by Express Scripts and other pharmacy benefit managers that prevent them from using their preferred pharmacies, resulting in decreased availability of medications and higher drug prices, say protestors.

"Teva stifled would-be generic competitors to QVAR because the drug laws do not allow for generic substitution of a given drug-device combination unless the generic is approved for that specific drug-device combination," the complaint alleged.

At a Senate Judiciary Committee hearing, Senators accused drugmakers of gaming the system by filing 100+ patents for any given drug, while trade group PhRMA said the system advances "the development of new medicines."

Ozempic, Trulicity and Mounjaro were first approved to treat diabetes, however, in the last three years, the FDA has approved rebranded versions of Mounjaro and Ozempic for weight loss, leading demand – and prices – to skyrocket.

As the drugmaker moves into Phase III studies for survodutide, its new GLP-1 obesity drug, Walgreens will use its community pharmacies as clinical trial sites, aiming to improve access and address equitable health representation.

As lawmakers scrutinize the nation's pharmacy benefit managers, the California insurer expects to save $500 million in annual drug costs by replacing most of CVS Health's PBM services by January 2025.

Five of the suits were filed by Esperion Therapeutics, which seeks to stop competitors from selling generic versions of the company's cholesterol drug Nexletol.

The proposal would help boost competition and reduce prices for American families by allowing the federal government to step in when private actors.

While the public may view these drugs as a silver bullet solution, there is also a cloud of potential misinformation regarding who should use them, possible side effects, and other long-term risks and successes.

Drugs with higher manufacturing complexity, such as sterile injectables, are more vulnerable to shortages.

Twenty-six of the 28 physicians included in the study received payments from pharmaceutical companies for a variety of reasons, most often noted as food and beverages, speaking or consulting fees.

In a major victory today for the Biden administration, the high court has upheld broad access to mifepristone, the widely used abortion pill, overturning an appeals court ruling that barred mail-order prescriptions.

Of those that currently offer coverage only for diabetes, 19% are considering offering the drugs for weight loss as well.

The Affordable Prescriptions for Patients Act would keep manufacturers from tweaking products to maintain patent protection.

This decision leaves the door open for other plaintiffs who may bring a similar challenge against the FDA and mifepristone in the future.

While shortages of the popular weight loss drugs persist, Hims & Hers, a San Francisco-based telehealth company, will offer access to a compounded form of the GLP-1 weight-loss drugs, starting at $199 a month.

The Federal Trade Commission launched its inquiry of the 6 largest PBMs in June 2022, after Sen. Chuck Grassley (R-Iowa) had pressed the commission for years to review their role in determining prices for prescriptions like insulin.

A state law requires carriers to cover all FDA-approved contraceptives without cost-sharing or restrictions.

Reporters have accused PBMs of steering patients toward more expensive drugs and extracting hidden fees.

According to a new study, from January 2022 to January 2023, an average price increase of $590 occurred for more than 4,200 drugs.

The government plans to bill the drugmakers for the rebates by late 2025, as part of the new Inflation Reduction Act requirement.

The Treat and Reduce Obesity Act provides coverage for patients who had an insurance plan that covered the new weight loss drugs, like Wegovy and Ozempic, before they entered Medicare.

Lisa Gomez, EBSA's chief, testified at a House hearing that the Labor Department has the statutory authority to stop that.

A state board picked those products and two others for reviews that could lead to "upper payment limits."

For brand-name drugs, the average margin gap may be more than $65 per 30-day prescription.

One commissioner voted against release, saying the report lacks "economic rigor expected of Commission reports."

According to the report, new clients realized an average of 11% reduction in costs compared to the previous year, with a different PBM.

The state AGs sent a letter to Senate and House leaders, highlighting the urgent need for federal action to mandate that pharmacy benefit managers increase transparency into their practices by sharing pricing with health plans.

"We believed in our case, and that is why we committed so many resources to litigating it. And in the end, you know, I believe that we got a very excellent result," said Sherrie R. Savett of Berger Montague, who represented the plaintiff.

Democratic Attorney General Charity Clark said CVS Health's Caremark, Cigna Group's Express Scripts and several of their affiliates pushed patients toward more-expensive drugs even when less-expensive alternatives were available.

One provision would keep PBMs from steering enrollees toward their mail-order pharmacies.

The PBM industry is currently experiencing a confluence of technological, regulatory, and marketplace changes that will impact PBMs that operate with opaque business practices and antiquated technology.

Rep. Nick Langworthy asked about duty of care at a committee hearing featuring three top PBM executives.

Viking Therapeutics' dual-action contender could add to pharmacy benefits cost pressure.

But a rating agency expects the new weight loss drugs to reduce spending on bariatric surgery.

But the new GLP-1 agonist obesity and diabetes fighters took up more rungs on Milliman's list of top cash eaters.

The Wells Fargo plan paid almost $10,000 for a generic pill for multiple sclerosis that Wegmans pharmacies sold for $648, according to the complaint, driving up premiums and out-of-pocket costs.

Overall, executives say, sales look stable, and ICHRAs look interesting.

Cost Plus Drugs CEO Mark Cuban was invited to the White House, along with other business and government leaders, to discuss PBM reform, while a trade group for pharmacy benefit managers said they were not invited.

Cost Plus Drug Co., which sells drugs at a discounted rate, has reached an agreement with Community Health Systems, based in Franklin, Tenn., to purchase certain hard-to-source pharmaceuticals, such as epinephrine.

Sen. Bernie Sanders, chair of the Senate Health, Education, Labor and Pensions Committee, has demanded to know why Americans pay "$1,349 a month for [weight loss] prescription drugs that cost less than $5 to manufacture."

The Pfizer settlements come as GSK, a previous Zantac manufacturer, defends itself in an ongoing trial, while Sanofi, which recalled the drug in 2019 over cancer claims, agreed to pay more than $100 million to resolve its Zantac cases.