Spotlight on Market Access

Two congressional committees advanced notable PBM legislation, moving one step closer toward comprehensive changes to PBMs’ dominant business model.

The Senate Finance Committee, with a near-unanimous bipartisan majority, advanced a major Medicare- and Medicaid-focused PBM reform bill on July 26. D.C. insiders tell AIS Health, a division of MMIT, that the committee’s move bodes well for notable commercial market PBM reforms. So does the fact that senators of both parties are emphatically in favor of it, despite reluctance by some Republican members of the House of Representatives to make aggressive changes to PBM regulations.

A new study from the Employee Benefit Research Institute highlights the high — and growing — markups that hospital outpatient departments assign to biologic drugs, while also examining the variation in how HOPDs and physician offices (POs) treat innovator biologics compared to their biosimilars.

The study analyzed medical and pharmacy claims data from Merative MarketScan Commercial Database — which covers nearly 25 million people with private health insurance — from 2013 to 2020, and it focused on seven innovator biologics and their biosimilars that had been launched as of 2020.

With the Inflation Reduction Act (IRA) implemented in a relatively short time frame, many uncertainties remain, including the type of information CMS will deem most useful in drug price negotiations and how the law will impact biosimilars. During a June 20 webinar on navigating the IRA, Mark McClellan, M.D., Ph.D., the Robert J. Margolis Professor of Business, Medicine, and Policy, and founding director of the Duke-Margolis Center for Health Policy at Duke University, addressed some of those issues and how he expects them to play out. McClellan, who served as FDA commissioner from 2002 through 2004 and CMS administrator from 2004 through 2006, also offered advice on what he thinks pharma manufacturers should do as the first steps of price negotiation loom.

The event was presented by Innopiphany and moderated by Lisa Kennedy, Ph.D., managing principal at the life sciences consulting company.

The FDA recently converted accelerated approval to full for Amgen Inc.’s Blincyto (blinatumomab) for certain patients with acute lymphoblastic leukemia (ALL). While the drug is one of many others approved for the condition, respondents to a Zitter Insights survey said there is still unmet need in treating the disease.

On June 21, 2023, the FDA granted full approval to Blincyto for the treatment of adults and pediatric patients with CD19-positive B-cell precursor ALL — which is also known as acute lymphocytic leukemia — in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. The agency first approved the CD19-directed CD3 T-cell engager on Dec. 3, 2014; the accelerated approval for MRD-positive B-cell ALL was granted on March 29, 2018.

For the past couple of years, payers have been focusing more attention on health inequities related to race, income and other factors by hiring staff and investing money in programs to improve access to care and lower costs. More recently, they have adopted similar strategies to address inequities in the pharmacy side of their businesses, according to health plan executives who spoke at a conference last month at the University of Pittsburgh.

The push among payers is known as “pharmacoequity,” a term popularized by Utibe Essien, M.D., an internal medicine physician and assistant professor at UCLA. Essien, who moderated the panel with the payer executives, defines pharmacoequity as “equity in access to pharmacotherapies or ensuring that all patients, regardless of race and ethnicity, socioeconomic status, or availability of resources, have access to the highest quality of pharmacotherapy required to manage their health conditions.”

Following the launch of Amgen Inc.’s Amjevita (adalimumab-atto), a slew of other FDA-approved Humira (adalimumab) biosimilars entered the U.S. market in July under settlement agreements with Humira originator AbbVie Inc. Major PBMs quickly announced that they would add more biosimilars to their formularies to compete with Humira.

At the end of June, UnitedHealth Group’s Optum Rx said it will place Boehringer Ingelheim's Cyltezo (adalimumab-adbm) and Sandoz's Hyrimoz (adalimumab-adaz) on its formulary at parity with Humira starting July 1. The Cigna Group’s Express Scripts then said it would add three biosimilars — Cyltezo, Hyrimoz and adalimumab-adaz (the unbranded equivalent of Hyrimoz) — to its list of preferred drugs.

As plan sponsors continue to grapple with the high costs of specialty drugs, they have undertaken various strategies to deal with them. The use of copayment accumulators, copay maximizers and alternative funding companies has been a fairly recent trend, noted longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. But as that use continues to increase, multiple questions exist around the practices and what the future holds for them.

Fein explained that he chose the focus of the June 23 webinar, titled PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding, because the entities are a hot industry topic currently. “And I think this is a topic of great relevance to manufacturers, to PBMs, to plan sponsors, to patients, to pharmacies, to everyone in the channel. And it’s one that I found is not well understood,” he stated.

Centene Corp. is the fourth-largest health insurer in the U.S., serving more than 21 million lives nationwide. The insurer ranks No. 1 in national managed Medicaid enrollment, holding contracts with 28 states. The insurer also dominates the Affordable Care Act (ACA) exchanges, leading the market with more than 3 million members in 27 states. The company is undergoing a multiyear value-creation program designed to control future administrative costs and focus on its core business — health insurance. In 2022, Centene sold two of its pharmacy businesses, Magellan Rx and PANTHERx Rare, in deals totaling $2.8 billion. The company in June 2023 divested Apixio, its artificial intelligence value-based care platform, to New Mountain Capital.

Alex Oshmyansky, M.D., the CEO of Mark Cuban Cost Plus Drug Co. (MCCPDC), the online cash pharmacy funded by the eponymous billionaire investor, said the company has become a licensed drug wholesaler nationwide and has plans to roll out quasi-PBM business lines including a retail pharmacy network. Oshmyansky discussed these new ventures — and addressed criticism by health care experts that his firm can’t lower specialty pharma costs — during a June 13 keynote at the 2023 AHIP Conference in Portland, Oregon.

“I think it was always our ambition” to work with retail pharmacies, Oshmyansky said. “I think there’s a variety of products where it just doesn’t necessarily make sense for them to be mail-order products,” citing “cold supply chain” and “acute care medications” as examples.

CMS on June 9 revealed a list of 43 Medicare Part B drugs that will be sanctioned for having their prices increase faster than the rate of inflation, as part of the Inflation Reduction Act (IRA). The number of drugs affected is almost double the number that made CMS’s initial list, which the agency made public in March. Starting in July, beneficiaries who normally pay 20% coinsurance under Part B for the 43 drugs will see their cost sharing decline based on an inflation-adjusted price. The federal government will invoice manufacturers for 2023 and 2024 Part B inflation rebates no later than fall 2025, and those funds will be deposited into the Medicare Trust Fund.

Seven of Amgen, Inc.’s medications made the list, including its blockbuster bone cancer treatment Prolia, cancer medications Kyprolis, Vectibix and Blincyto, and Nplate for immune thrombocytopenia.