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A money-back drugs guarantee? Bad deal

President Trump likes to boast that he mastered the “art of the deal.’’

But one option his administration is considering to encourage lower drug prices, which surfaced in a recent draft executive order, may not be much of a deal for consumers.

The concept has a clunky name — value-based pricing — but it’s fairly simple. One increasingly popular version works like this: A drug maker refunds some money to an insurer if its medicine fails to improve patient health or prevent a costly incident, such as a heart attack.

Seems like a good idea, yes?

Not so fast. There is good reason to be skeptical that prices will drop under this system.

Why? In some cases, it may take years to figure out whether a medication is effective for a given patient. And when a drug maker does give a refund, for the most part that money is unlikely to end up in the hands of consumers.

“It’s not going to lower prices substantially, certainly not in the short term and probably not in the long term,’’ said Dr. Walid Gellad, an associate professor of medicine and codirector of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “It’s an easy way out of addressing the real complexities.’’

Over the last year or so, several drug makers, including Merck, Eli Lilly, Novartis, and Amgen, have struck deals with insurers that promise refunds if patient outcomes aren’t satisfactory. The companies like these deals because they can lock in business for key medicines and, of course, negotiate the metrics that affect refunds.

So the pharmaceutical industry portrays them as win-win paradigm shifts.

“Paying for value moves us in the right direction, as opposed to paying for the volume’’ of drugs that are purchased, said Mike Ciarametaro, vice president of research at the National Pharmaceutical Council, a think tank supported by drug makers. “And it shifts risk to the manufacturers.’’

Insurers seem to find them appealing, too. A recent survey by the consulting firm Avalere Health noted that 70 percent of health plans view outcome-based contracts favorably, and 24 percent already have one such deal in place.

Not surprisingly, much of their interest centered on fields where there are several competing medicines.

For instance, Dr. Michael Sherman, chief medical officer at Harvard Pilgrim Health Care, has inked deals with several companies, but he suggested that one, in particular, illustrates their potential.

In what he described as a first-of-its-kind arrangement, the insurer will receive a full rebate if patients who take a pricey cholesterol-lowering injectable drug sold by Amgen have a heart attack or stroke. And some of that money will be distributed directly to patients to reimburse them for out-of-pocket costs.

“Heads you win, tails you don’t lose, if it proves ineffective,’’ he said.

Well, maybe.

“I want prices set lower at the outset,’’ said David Mitchell, who runs Patients for Affordable Drugs, a nonprofit advocacy group. “Refunds don’t lower the price of the drug. Besides, telling me I’ll get a money-back guarantee doesn’t do much good if I have a heart attack and end up dead.’’

For such reasons, these deals may turn out to be a smoke screen for big drug makers, which want the Trump administration to believe the notion will somehow address high pricing.

As the companies see it, though, they are certainly preferable to being forced into other arrangements, such as negotiating prices with Medicare, which would hurt profits more significantly than doling out some refunds to insurers.

“This has been the drug industry’s preferred solution to the question of drug costs,’’ Sanford Bernstein analyst Ronny Gal wrote in a recent investor note. “While the argument, in principle, is logical — drugs should be priced to the value they provide — it turns every debate on drug costs into a convoluted economic calculation. And the drug industry has so far run circles around payers in developing economic models for the value of drugs they provide.’’

“To the extent value-based pricing is adopted as the main way to address drug costs,’’ he explained, “the industry will likely be in the clear on the drug issue for roughly a decade.’’

David Lassen, chief clinical officer at Prime Therapeutics, a pharmacy benefits manager, isn’t so sure.

He argued that “the future is all about getting value for improving outcomes.’’

But he conceded that Prime has to pick and choose its deals, because developing the infrastructure to track patients and outcomes is “very costly,’’ he explained. “We’re on a journey, and there are still barriers to overcome.’’

One barrier: In some cases, it can take a few years to verify that a patient has benefited from a given drug, by which time the patient may no longer be covered by the same insurer who paid for the medication in the first place.

Another point to consider: Even if a patient takes the medication as instructed, there are lifestyle choices — such as smoking or eating poorly — that affect health and may make adverse events like heart attacks more likely. So how deeply do insurers probe into personal lives to determine whether a drug is working?

Money-back guarantees sound good, but they’re likely to be a superficial approach to high drug prices. But maybe that’s the art of the deal, after all.

Ed Silverman can be reached at ed.silverman@statnews.com. Follow him on Twitter @Pharmalot. Follow Stat on Twitter @statnews.