Drug Pricing

Court Decision on Accumulator Rule Could Encourage State Bans

Under a May 17 court decision striking down a CMS final rule slated to take effect in 2023, pharmaceutical manufacturers will not have to ensure that financial assistance provided to patients goes only to patients and not to payers under their copay accumulator and maximizer programs. However, the renewed attention to these programs could spur more states to take action of their own against them, industry experts tell AIS Health.

The Accumulator Rule (CMS-2482-F), published Dec. 31, 2020, could have resulted in patients facing increased out-of-pocket drug costs and pharma companies being held responsible for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

Third-Party Care Pathways Gain Steam as Cancer Costs Rise

With the costs of treating cancer patients rising ever higher, payers and providers are increasingly turning to third-party pathways — or treatment protocols designed to provide the optimal therapy regimens — to improve outcomes and reduce excess costs. But not all pathways are created equal, and it’s crucial for oncology drug manufacturers to understand their nuances if they want to ensure their therapies are able to reach the most patients.

Those are the main takeaways from a recent “Meet the Expert” webinar from MMIT, AIS Health’s parent company. “It’s really key to get optimal placement of a brand on a pathway to ensure that patients can have access to these lifesaving therapies,” said Yana Faykina, senior consultant, advisory services at MMIT.

$35 Monthly Insulin Cap Could Save Part D Enrollees 29% Per Prescription

The House in March passed a bill that caps the out-of-pocket cost of insulin at $35 per month for Medicare Part D beneficiaries and for certain privately insured enrollees. A recent Kaiser Family Foundation analysis found that total out-of-pocket spending by Part D enrollees on insulin quadrupled between 2007 and 2019, reaching nearly $1 billion. If a $35 copay cap had been in place in 2019, Part D enrollees without low-income subsidies would have saved $14 per insulin prescription on average. Meanwhile, another study found that over one in four individual and small group enrollees paid more than an average of $35 per month out of pocket for insulin products in 2018. With a $35 cap, median monthly savings could reach $27 in the individual market and $19 in the small and large group markets.

Study: With High Prices, Rebate Revenue Is Growing for PBMs

New research published in JAMA Health Forum found that rebate revenue for PBMs grew between 2015 and 2019 — but that growing rebate revenue was not passed on to patients.

The research letter’s authors measured both prerebate and postrebate drug costs taken from medical loss ratio (MLR) filings made by plans to CMS. The research sample includes commercial insurance filings from small group, individual and large group health plans across “approximately 2,200 unique health plans” covering 70 million lives.

Do Pharma/PBM Contracts Play Role in Drugmakers’ Revenue Leakage?

Pharma manufacturers depend on contracts with PBMs — and, increasingly, their group purchasing organizations (GPOs) — to ensure favorable formulary positioning with PBMs’ health plan and employer clients. But as those contracts have grown more complex and less transparent, drugmakers may be at risk of losing significant amounts of money, according to some industry experts.

Revenue leakage — unintended revenue loss because of process inefficiencies — can be a huge financial drain on pharma manufacturers. It also may potentially result in compliance risks with the Anti-Kickback Statute and its discount safe harbor protections, “so it always has to be clearly defined as to what the rebate or any monies between pharma and the PBM being exchanged; there has to be a reason,” explains Stephanie Seadler, vice president of Trade Relations at EmsanaRx.

Novartis’ Pluvicto Brings New Mechanism of Action to mCRPC Options

A new prostate cancer drug is sparking interest among payers and oncologists alike, according to a survey by Zitter Insights. While the product offers a new mechanism of action for the indication, the manufacturer recently halted production of the therapy temporarily in two of its three global sites “out of an abundance of caution” due to “potential quality issues” that could pose a glitch in initial uptake of the therapy.

On March 23, the FDA approved Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in people who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The product from Novartis unit Advanced Accelerator Applications USA, Inc. is the first FDA-approved targeted radioligand therapy for eligible people with mCRPC that combines a targeting compound with a therapeutic radioisotope.

Study Finds PBC Drug’s Real-World, Trial Side Effects Are Similar

A recent study of a new drug to treat primary biliary cholangitis (PBC) found that common symptoms experienced by real-world patients were similar to those experienced by people in clinical trials for the agent.

PBC is a chronic disease that causes the liver’s small bile ducts to be destroyed, resulting in permanent liver damage and putting people at risk for liver failure and death. There is no cure for PBC, and the goal of treatment is to slow progression of the condition and manage its symptoms, which most commonly are itching, also known as pruritis, and fatigue.

Major PBMs Look Ahead to 2023 for Biosimilars Boom

With a raft of biosimilars coming to market starting in 2023, major PBMs are touting the pharmacy infrastructure and services that they say will position them to help customers take advantage of cost-saving opportunities in the coming years.

Speaking during recent conference calls to discuss first-quarter 2022 financial results, they also reported healthy client retention levels as PBMs move through the large-employer selling season.

“Our team is quite excited about and well positioned for the accelerating biosimilar trend that we see in front of us for the coming years,” Cigna CEO David Cordani said during a May 6 conference call to discuss first-quarter 2022 financial results, per a transcript from The Motley Fool.

Study: With High Prices, Rebate Revenue Is Growing for PBMs

New research published in JAMA Health Forum found that rebate revenue for PBMs grew between 2015 and 2019 — but that growing rebate revenue was not passed on to patients.

The research letter’s authors measured both prerebate and postrebate drug costs taken from medical loss ratio (MLR) filings made by plans to CMS. The research sample includes commercial insurance filings from small group, individual and large group health plans across “approximately 2,200 unique health plans” covering 70 million lives.

Most Payers Will Review Humira Biosimilars as They Come

Starting next year, biosimilars are expected to generate significant pharmacy cost savings for patients and payers, led by multiple biosimilars of AbbVie Inc.’s blockbuster immunosuppressive drug Humira (adalimumab). With as many as eight Humira competitors expected to launch in 2023, most payers report they will evaluate the biosimilars as they come to market over the course of the year, rather than waiting until all are available before making coverage decisions. And half of payers may adjust Humira contracting in 2022, prior to the biosimilars’ launches.

That’s according to findings from Zitter Insights, which like AIS Health is a division of MMIT. Steve Callahan, a senior manager of market research at MMIT, described Zitter’s market research findings on the Humira biosimilars during an April 5 webinar.