Morning Briefing
Summaries of health policy coverage from major news organizations
Doctor Survey Suggests Faltering US Drug Supply Chain
CIDRAP: Physician Survey Reveals Cracks In The US Drug Supply Chain
Seven of 10 US physicians say that the COVID-19 pandemic has heightened drug supply chain problems, limiting their ability to provide quality patient care, according to a new US Pharmacopeia (USP) survey. "Physicians on the front lines observed the impact first-hand, navigating shortages in medicines, personal protective equipment and other supplies, on top of the demands of providing care to an unprecedented volume of patients," USP, an independent global scientific organization, said in the survey report. (Van Beusekom, 2/16)
In related news about the costs of prescription drugs —
Modern Healthcare: Certain Specialty Pharmacy Drugs Double In Price At Hospitals, Study Finds
Hospitals, on average, charge double the price for the same drugs sold by specialty pharmacies, according to research from America's Health Insurance Plans. Upon analyzing the 10 drugs that amounted to the highest Medicare Part B spend from 2018-2020—and were purchased, stored and administered in a healthcare setting—an AHIP study published Wednesday found that drug treatments given in hospitals were marked up an average of $7,000, when compared to those purchased through specialty pharmacies. As these drugs typically do not have biosimilars or generics that provide cost competition, specialty pharmacies are responding to a crucial market need to lower drug prices, said Sergio Santiviago, vice president of drug policy at AHIP. (Devereaux, 2/16)
Stat: AstraZeneca Wins One Round In An Escalating Battle Over The 340B Program
In the latest twist in a closely watched legal battle, a U.S. judge ruled Wednesday that a federal agency incorrectly threatened AstraZeneca (AZN) with penalties for curtailing discounts to a controversial prescription drug discount program that serves mostly low-income patients. At issue is the 340B program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% — but could be much higher — on all outpatient drugs to hospitals and clinics that serve low-income populations. There are approximately 12,400 so-called covered entities, including 2,500 hospitals, participating in the program, a number that has grown substantially in recent years. (Silverman, 2/16)
Stat: A Federal Appeals Court Once Again Casts Doubt On 'Skinny Labels'
A U.S. appeals court upheld a ruling that throws into question the ability of generic companies to “carve out” uses for their medicines and supply Americans with lower-cost alternatives to pricey brand-name drugs. And the generic maker on the losing end of this legal battle, Teva Pharmaceuticals (TEVA), now plans to ask the U.S. Supreme Court to overturn the decision. At issue is skinny labeling, which is when a generic company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement. (Silverman, 2/16)
Axios: PBMs Won't Adopt Humira Biosimilars Quickly
The companies that purchase drugs for employers and government programs don't anticipate switching quickly to cheaper copycats of the popular immunology drug Humira. Humira, one of the world's most-used drugs that registered $20.7 billion in global sales in 2021, fended off competition for years for this very reason — to keep its U.S. market share high for as long as possible. Pharmaceutical analysts at Bernstein interviewed eight executives who work at large pharmacy benefit managers about how they will handle Humira in 2023. (Herman, 2/17)
In updates on the opioid crisis —
Stat: Lawmakers Ask Justice Dept. To Explore Criminal Charges Against Sacklers
Several lawmakers have asked the U.S. Department of Justice to explore whether criminal charges should be brought against members of the Sackler family who control Purdue Pharma, which has been blamed for helping to trigger the widespread opioid crisis in the U.S. The lawmakers noted that, in late 2020, Purdue pleaded guilty to three felonies related to the sale and marketing of the OxyContin painkiller as part of an $8.3 billion settlement that also resolved civil charges against the company. At the time, federal authorities indicated criminal charges against individuals had not been ruled out and an investigation remained ongoing. But criminal charges were never filed. (Silverman, 2/16)
The Texas Tribune: Texas Gets $1.17 Billion In Opioid Case Settlement
Texas and some of its largest counties will receive $1.17 billion in opioid relief money as part of a nationwide settlement from three large pharmaceutical distribution companies, Texas Attorney General Ken Paxton announced on Wednesday. The money comes from a $26 billion settlement signed by 52 American states and territories that Texas joined in July. Paxton has pushed for cities and counties to join the settlement with three pharmaceutical companies — McKesson Corp., Cardinal Health and AmerisourceBergen — that have been accused of exacerbating the opioid crisis by overlooking the number of opioid pills that pharmacies ordered in the past two decades. (Zhang, 2/16)
