AstraZeneca Advances Legal Challenge, While New Report Shows How They Kept Blockbuster Drug Prices High for Years
On Monday, AstraZeneca revived one of its multiple lawsuits against Medicare negotiation, this time asking the Fourth Circuit to reverse a Maryland district court dismissal earlier this year. The legal challenge comes as new analysis from AARP’s Public Policy Institute examines AstraZeneca’s layered efforts to delay generic competition, offering a striking look at how drugmakers work to preserve pricing power throughout a drug’s lifecycle. To delay competition on its blockbuster inhaler Symbicort — which has generated more than $55 billion in lifetime global sales — the company accumulated more than 90 patents around the drug and shifted marketing to the newer, more expensive Breztri Aerosphere as Symbicort faced loss of exclusivity — a strategy known as product hopping. Taken together, the developments illustrate the multi-pronged strategy used by drugmakers to fight any constraints on their pricing power: using patent and product strategies to delay competition, while challenging Medicare’s new authority to negotiate prices in court. — [AstraZeneca, Law360, AARP]
PhRMA Files Lawsuit Against the Already Gutted GLOBE Model
PhRMA filed a lawsuit this week challenging the Trump administration’s GLOBE model, asking a D.C. federal court to declare the program unconstitutional. The challenge comes after the administration already substantially weakened GLOBE by allowing drugmakers with voluntary MFN agreements to receive waivers from the mandatory model, alongside additional drug category exemptions. GLOBE is now projected to save only 4% of what CMS originally projected, yet even still, PhRMA is seeking to invalidate what remains. That should be a warning for CMS as it develops GUARD, the corresponding model for Medicare Part D; exempting drugmakers from mandatory pricing policies in exchange for voluntary agreements does not guarantee industry acceptance of the underlying reforms. CMS should not repeat the same mistake by allowing voluntary agreements to hollow out another mandatory model. — [POLITICO, STAT News, Endpoints News, Medical Daily, Pharma Commerce]
Health Care Costs Remain at the Center of Americans’ Affordability Concerns
New KFF polling this week finds that health care costs remain one of voters’ top affordability concerns, exceeding worries about housing, food, utilities, and on par with concerns over gas and transportation costs. Eighty-two percent of voters polled say healthcare costs are extremely or very important for candidates to discuss, while 60% are worried about their ability to afford healthcare for themselves and their families — including insurance, office visits, and prescription drugs. Additionally, a new POLITICO poll also found that 34% of voters say health care costs are the main reason driving their vote this midterm, only second to 45% who listed broader concerns about “affordability and the economy.” These findings continue a pattern KFF has been tracking: policymakers looking to address Americans’ cost-of-living concerns must not overlook lowering prescription drug prices as an important piece of any broader affordability agenda. — [KFF, POLITICO]
ICYMI: Last week, tariffs on imported patented drugs and their ingredients expanded beyond the 17 large drugmakers who received letters from the Trump administration in July. But the policy’s impact will vary significantly: all 17 of those large drugmakers have since secured a 0% tariff through January 2029 under MFN pricing and U.S. manufacturing agreements, while other manufacturers could face rates as high as 100% depending on their products, manufacturing plans, and country of origin. — [Managed Healthcare Executive]