Deal of the Year Nominee: Over-Protecting Therapeutic Classes in Medicare

Ah, awards season. Why should film critics have all the fun? And voting! It's not just for presidential elections. This year your IN VIVO Blog team is nominating a handful of alliances, acquisitions, financings, regulatory negotiations and legislative compromises in our First Annual DOTY competition. And then you, dear readers, will vote (early and often, we hope) for the winner. Imaginary federal and international biopharmaceutical statutes prohibit us from awarding a monetary prize. But our winners, when they die, on their deathbeds, they will receive total consciousness. So they've got that going for them, which is nice.

When the Medicare outpatient prescription drug benefit began just three years ago (seems longer, doesn’t it?), the story was all about the glitches encountered by beneficiaries, pharmacists, governments (state and federal), and insurers as they all tried to learn together, in real time, how to make stand-alone prescription drug insurance work.

For Forest Labs, though, there was a much bigger glitch. It happened when the Centers for Medicare & Medicaid Services told plans in 2005 that they must cover essentially all drugs in a handful of big therapeutic categories: the now famous six protected classes—antidepressants, antipsychotics, anti-epileptics, anti-neoplastics, immunosuppressants and HIV therapies. The Medicare agency concluded (after hearing loud and clear from patient organizations relying on those medicines) that the need to protect access among vulnerable benficiaries trumped the plans’ need to be able to exclude medicines in an effort to extract deeper discounts for manufacturers.

That was good news, of course, for companies with products in those classes. Except for Forest. Because the Medicare agency made one prominent exception: there was no need for plans to cover Forest’s antidepressant brand Lexapro (escitalopram), the agency said, so long as they covered Forest’s closely related (and off patent) Celexa (citalopram).

In essence, the federal government told plans that Lexapro is equivalent to Celexa, and so plans could meet the agency’s goal—ensuring patients have access to all options in the six critical classes—without having to cover Forest’s biggest product.

That decision took Forest by surprise, to put it mildly. Forest was ultimately able to get the language addressing Lexapro removed from CMS’ policy, and it also managed to get Lexapro on most plan formularies—but at the cost of deeper discounts than it anticipated.

That history explains why a seemingly insignificant clause slipped into a hard-fought compromise on Medicare funding in 2008 may turn out to be the biggest deal of the year.

When Congress “codified” the CMS policy over the summer, it sounded like no big deal. It sounded like a simple matter of elevating the six protected classes from an ad-hoc principle established by administrative fiat to a formal, statutory requirement. No change from the status quo, right?

Well, then people actually read the provision of the law “codifying” the policy. It did no such thing.

Instead of adopting CMS’ language stipulating the classes, Congress instead gave CMS the authority to define any classes as protected. And it also made it much more onerous for CMS to create exceptions to those protections within classes. Call it the Forest clause.

That is a very big deal indeed.

There is nothing to stop the next CMS Administrator from expanding the list to include, say, Alzheimer’s therapies as protected classes. Plenty of people wonder why—if the goal is to protect vulnerable patient populations—AD therapies weren’t on the list in the first place. And then, why not antidiabetics? Surely we shouldn’t disrupt treatment in that class, when the consequences of uncontrolled illness can be so severe and costly. Or rheumatoid arthritis, where decisions by Part D plans have a direct affect on Part D spending. You see where this is headed, right?

Sure, there is no reason to think that the people who created the six protected classes in the first place would expand the list just because Congress says they can. After all, they invented the list and easily could have decided to add more at any time.

But those people won’t be calling the shots anymore, not after January 20. The next CMS Administrator could, with the stroke of a pen, add to the list of protected classes--and be cheered for it by the Democratic leadership of Congress.

No wonder managed care plans are concerned. They weren’t happy about CMS’ policy in the first place, since it basically takes away their leverage to negotiate better prices on some pretty big line items. But they really aren’t happy about the potential for that list to expand, potentially ad infinitum.

And, while manufacturers may feel differently, they better not gloat.

That's because Medicare Part D is itself the product of one of the more unlikely deals of all time. It came about in large part because pharmaceutical manufacturers and their long-time political adversaries, the managed care sector, were able to join forces in support of a never-before-tried concept: stand-alone prescription drug insurance.

That deal helped generate enough support in Congress—just barely—to push the Part D program through in 2003.

And, as the managed care industry is busily reminding Big Pharma, that program will only work if plans are able to do what politicians historically cannot: deny access to medicines if they need to in order to contain costs. The alternative? A program that allows broader access to medicines—but with more direct government intervention in prices.

So when the new Congress turns to price intervention proposals in 2009, remember the deal struck in 2008—a seemingly noncontroversial item slipped into a hard fought compromise bill. If that small deal helps break up the coalition that made Part D possible, that would be a very big deal indeed.