The pharma industry cheered when the Trump administration introduced a proposal putting drug pricing rebates in the crosshairs. But like so many other drug pricing ideas over the years, the measure didn’t go anywhere.
Now, the administration is switching gears to importation. HHS on Wednesday presented a plan for bringing in cheaper drugs from Canada, an approach the industry staunchly opposes. It marks a major shift from previous policies on imports, but the plan itself might not do much to lower prices—or hurt pharma, according to one industry watcher.
The plan would allow imports through two pathways. The first would let states, wholesalers or pharmacists launch pilot projects to import drugs from Canada that are approved in the U.S. and “manufactured consistent with the FDA approval.”
Under the second, the FDA could allow manufacturers to import drugs under new national drug codes, potentially allowing for lower prices than those stipulated by existing contracts. The drugs would have to be identical to their U.S. counterparts and have appropriate labeling. HHS says the pathway could work for insulins, rheumatoid arthritis drugs, cardiovascular meds and more.
While the news may have sent concerns around the halls at top drugmakers, one analyst quickly responded that he isn’t worried. In a note to clients titled “SNOOZE?”, Evercore ISI’s Umer Raffat dug into the plan’s details and outlined some shortfalls—or positives from a pharma industry perspective.
Digging into the first pathway, Raffat pointed out that many of pharma's most costly products—biologics such as AbbVie's Humira; IV drugs, a category that would include many pricey cancer treatments; and inhaled products, such as respiratory therapies from GlaxoSmithKline and AstraZeneca, are all excluded. So are meds that require Risk Evaluation and Mitigation Strategies at the FDA—a group that comprises many expensive and newer drugs, such as multiple sclerosis treatments.
On the second pathway, Raffat wrote that “manufacturers can ask FDA to import versions of drugs intended for foreign countries,” but they wouldn't have any incentive to ask. A branded drugmaker wouldn't want to import its own product at a cheaper price. The idea could lower prices in some cases, but Raffat doesn’t see it as a big deal for the industry.
In all, it’s not “quite that bombshell importation proposal” feared by Wall Street or pharma, Raffat wrote.
But that's not to say the plan isn't a big shift for drug regulators in the U.S. The FDA is on board, which itself is a reversal of a long-held agency stance. Four former FDA commissioners in 2017 wrote to Congress saying the idea “represents a complex and risky approach” that won’t “achieve the aim” to lower prices. Instead, it’ll likely “harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products,” the former commissioners wrote.
More recently, as Florida pushed its own importation proposal, another former commish, Scott Gottlieb, detailed similar concerns.
It remains to be seen where the current proposal will go, but its introduction follows another high-profile administration priority that since collapsed: tackling drug rebates that drive list prices up and don’t benefit patients. Pharma companies supported that idea, but a Congressional Budget Office review found it would boost federal spending by about $177 billion over 10 years. This month, the administration canned the proposal.
Meanwhile, the Senate Finance Committee recently unveiled its own drug pricing bill that aims to lower patients’ share of drug costs in Medicare Part B and D and forces new rebates on branded drugmakers that raise prices more than the rate of inflation.
As next year’s elections near, drug pricing conversation likely won’t die down in Washington. Market watchers are unsure if any proposals will become reality, but the hardball talk from both Republicans and Democrats doesn't bode well, Wells Fargo analyst David Maris said in a Wednesday note.
Discussing the pharma potshots after Tuesday night's Democratic debate, Maris said that "this follows our thesis that overall, things are getting tougher, not easier for the industry as both Trump and Biden want to make pricing tougher."
As for today's importation plan? "Perfect example," Maris said.