PBMs/Pharmacy Benefit Managers

Judge Strikes Down CMS’s So-Called ‘Accumulator Rule’

A U.S. district court judge has struck down a CMS rule that would have narrowed the exclusions from Medicaid best price for manufacturer-provided patient-assistance programs. The rule, which was set to go into effect on Jan. 1, would have required drugmakers to determine exactly where their patient assistance is going. If 100% of it was not reaching the patient — particularly via copayment accumulators and maximizers when payers are taking this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — that assistance would need to have been included in Medicaid best price and average manufacturer price (AMP) calculations for prescription drugs. This decision, as well as a recent pharma lawsuit against a maximizer company, may spur more pushback against these copay programs, one industry expert tells AIS Health, a division of MMIT.

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News Briefs: Biogen and Samsung Bioepis Launch Byooviz

Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz (ranibizumab-nuna), and the medication will be commercially available “through major distributors across the U.S.” on July 1. The drug is the first FDA-approved ophthalmology biosimilar and references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.

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FTC to Investigate PBM Business Practices, Consolidation

The Federal Trade Commission (FTC) said on Tuesday that it will investigate the business practices and consolidation of PBMs, following months of pressure from health care stakeholders. The FTC’s investigation, which is just the latest escalation in a nationwide regulatory push to clamp down on PBMs’ most controversial methods, was praised by plan sponsors and pharmaceutical groups.

The FTC’s leadership, a panel of five commissioners, voted unanimously to launch the investigation under section 6(b) of the Federal Trade Commission Act of 1914. The commissioners are a mix of two Democrats and two Republicans, with the fifth seat filled by the party that holds the White House. The unanimous vote is a reversal for the two Republican panelists appointed by former President Donald Trump. The Republican commissioners voted against a similar inquiry in February, deadlocking with the two Democratic commissioners — the swing seat on the panel was unfilled at the time. That fifth commissioner, Democrat Alvaro Martin Bedoya, was confirmed by the Senate in May on a party-line vote.

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Looking to 2023, Employers Focus Benefit Changes on Specialty

Now that many large employers have finalized employee health benefits for 2023, some clear trends are emerging, pharmacy benefit consultants tell AIS Health. Among them: many plan sponsors have traditional drug benefits on auto-pilot but are hyper-focused on high-cost specialty drugs.

For non-specialty drugs, the cost trend is pretty flat, says Paul Burns, a pharmacy practice leader at the HR consulting firm Buck. “There’s been some increases over the pandemic, but it’s not wildly spiking — and that’s where 98% of the utilization is.”

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Payers Worry About High Costs, Low Evidence for Gene Therapies

So far, the FDA has approved eight cell and gene therapies, but the agency is expected to approve several more medications in those classes in the next few years. That has caused concern for payers because such medications have high costs and limited clinical evidence, according to speakers who participated in an Avalere Health webinar on May 25.

As such, the federal government, PBMs, health insurers and other payers are testing innovative ways to reimburse hospitals, providers and pharmaceutical companies for administering cell and gene therapies.

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News Briefs: Launch Prices Grew Dramatically in Recent Years

Between 2008 and 2021, drug launch prices increased by 20% per year, according to new research published in JAMA. In 2020 and 2021, prices rose 11% each year, even after adjusting for manufacturer discounts. In addition, nearly half of all drugs launched in the last two years initially cost at least $150,000 per year. “Rising brand-name drug prices often translate to payers restricting access, raising premiums, or imposing unaffordable out-of-pocket costs for patients,” the study’s authors observed.

An opinion article published in the New England Journal of Medicine argued that the 340B drug program creates “perverse incentives” for preexposure prophylaxis (PrEP) medications that prevent HIV infection by encouraging safety-net clinics to prescribe the most expensive PrEP treatments. The article observes that “insurers reimburse 340B clinics for medications at an amount close to their list price; the difference between the list price and the discounted 340B price results in revenue — known as the ‘340B spread’ — that clinics can allocate toward other health services. The higher the drug’s price, the bigger the spread….The high cost of PrEP medications has made 340B central to the ability of some safety-net clinics…to provide HIV-prevention and other services....Brand-name oral medications for PrEP, Descovy and Truvada… produc[e] a spread of as much as $1,600 per patient per month. That revenue can fund...important services provided by 340B clinics.” That results in “costs to the health care system that far exceed the clinical benefits.”

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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.

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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.

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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.

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Centene Plans to Sell Magellan Rx, PANTHERx Rare for $2.8 Billion

Centene Corp. has agreed to sell two of its pharmacy businesses, Magellan Rx and PANTHERx Rare, in separate transactions as part of the insurer’s decision last year to exit the PBM industry.

Prime Therapeutics, a PBM jointly owned by 19 Blue Cross and Blue Shield affiliates, is acquiring Magellan Rx for about $1.35 billion in a deal that’s expected to close in the fourth quarter, while a joint venture of the Vistria Group, General Atlantic and Nautic Partners is buying PANTHERx Rare for $1.45 billion in a deal that’s expected to be completed in the next two to four months.

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