Dirigo or die (continued)

Why Maine? Citing an old Norwegian proverb, Brautigam says, "You dig where you stand. I don’t know why other people aren’t as aggressive. MaineRx is what really started" the groundswell of states taking the lead on prescription-drug and health-care issues, he says, in an attempt to provide an "innovative solution to a problem that was growing in importance. The leadership of the Legislature, and the Governor, said the states can be laboratories of democracy; let’s give this a try. It was a market-based solution, using the power of the state as a purchaser rather than a regulatory authority, so it had a broad appeal."

Except to the pharmaceutical industry, which didn’t give up its efforts against MaineRx until last Friday, when a Rhode Island judge threw out an industry suit against the state. In this latest lawsuit, PhRMA, the industry’s trade group, had sued the state for including a provision for the use of prior authorization — a procedure necessitating state approval before a particular drug can be prescribed — in negotiations with drug manufacturers. Maine has never actually resorted to prior authorization in MaineRx negotiations, although according to Brautigam the state has used the procedure in its Medicaid program "as a way of reducing consumption of drugs that aren’t cost-effective."

Drug manufacturers don’t like prior authorization because the added bureaucratic hassle decreases sales, and while MaineRx allows for prior authorization as a sort of nuclear option in negotiations with drug manufacturers, Brautigam says that the state has no real intention of using prior authorization in MaineRx. The judge, William E. Smith of Rhode Island, recognized this, suggesting that PhRMA "may reassert its challenge" if the state ever does resort to prior authorization in MaineRx negotiations — but for now, MaineRx is free to go about its business of leveraging the collective purchasing power of the state to get better deals for Maine consumers.

What’s next? The NLARx voted to institute less expensive associate memberships at last Friday’s meeting, and also passed two resolutions: one calling for price negotiation in Medicare and the other opposing the conversion of Medicaid into a block-grant program. The Medicare resolution also sought to call attention to the possible hardships of people being moved from Medicaid to a lesser Medicare drug-benefit package.

It’s not every day that state legislators get together and take positions on federal programs, but, as Brautigam notes, the states’ — particularly Maine’s and Vermont’s — activism has already had an effect on the national level. "Maybe in some ways we helped to push toward a Medicare drug benefit," he says. The prescription-drug debate is beginning to be driven by "states doing things on their own at a time when the federal government wasn’t doing much."

Treat agrees. "The only action that’s really going to happen is at the state level, and it’s the state-level stuff that’s forcing things to happen nationally."

This was much in evidence at NLARx’s meeting last Friday, where national groups including the Consumers Union (famous for Consumer Reports magazine), the Prescription Access Litigation Project, the Georgetown University Law Center, and the Interfaith Center on Corporate Responsibility — not to mention drug lobbyists, PhRMA representatives, and various consultants and other interested parties — gave presentations on topics ranging from shareholder resolutions to free-trade agreements to patent law. In Treat’s view, this is one of the most important aspects of NLARx’s recent work. National groups, she says, want to get involved with state legislators, "but they don’t really know how because they’re not set up with chapters all over the country," and conversely, state groups don’t command the financial resources and Washington connections that national groups have. Partnerships can be beneficial in both directions.

"The idea is to provide an opportunity for states to share ideas with each other," Brautigam says, and "also to shine a spotlight on these issues at a level beyond the state houses, to draw attention to some of the issues we’re facing in the states and the lack of action by the federal government."

There was so much on last Friday’s agenda, Brautigam says, that attendees got a "view from 30,000 feet for most of those issues. In future meetings we’re going to focus more in depth on one or two things that are of concern," including the NLARx-sponsored nonprofit PBM — called USA Scripts and run by NLARx co-founder Peter Shumlin — and the Consumers Union project to create a public "Best Buy"-style database analyzing the relative efficacy of similar drugs that might vary widely in price.

The packed agenda, Treat says, was part of a broader plan. "My idea was, let’s expose legislators to everything that’s out there," she says. Then legislators can go home and start carrying bills, and in the NLARx’s next meeting a couple of months from now, "we can really get into the nitty-gritty."

Both are excited about the Consumers Union "Best Buy" initiative. Since the FDA will approve any drug that’s better than a placebo, much drug-industry innovation concentrates on minute variations on existing successful drugs, backed by hugely expensive advertising campaigns and bundles of swag given to doctors. The Consumers Union project will highlight cheaper but therapeutically equivalent drugs. "A lot of doctors will just give you the gold standard because they’re not sensitive to the overall cost of the drugs," Brautigam says. "This is a step in the direction of a little more information for both patients and providers."

Also next up is the continuation of the legal fight over PBMs, in which Maine — and Brautigam — will continue to play a critical role. The case over Maine’s law was argued on September 10, and a decision from the magistrate is expected soon. "In all likelihood, one side of the other will appeal it," Brautigam says, "so that’ll go kind of the same route as MaineRx."

All the way to the Supreme Court?

Not likely, Brautigam says; the Supreme Court only hears a hundred or so cases per year. But you can tell another Supreme Court appearance wouldn’t break his heart. "There are some big issues there, issues of first impression where other courts haven’t addressed anything quite like it."

Big Pharma, it seems, hasn’t heard the last of Maine.

Alex Irvine can be reached at airvine@phx.com