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Lobbying mounts to get Florida approval of two costly schizophrenia drugs

When the public pays the bill, who decides whether a pricey new drug is worth the cost?

For Florida's Medicaid patients, those recommendations come from a panel of doctors and pharmacists who review medications to determine if they should be on the state's preferred drug list.

But a meeting today of the group has sparked warnings that if two expensive new treatments for schizophrenia are rejected, it could be devastating for the mentally ill.

Who's behind the warning? Janssen, maker of one of the new drugs under consideration. Janssen's Invega Sustenna is a monthly injection for schizophrenics that costs up to $2,000 per shot.

Lauren Tate, the New York City publicist running the campaign on behalf of Janssen, insisted that the drugmaker's involvement was irrelevant. But the lobbying effort provides a glimpse at the difficulty of controlling medical costs.

In Florida, Medicaid's pharmaceutical and therapeutics committee meets four times a year to review products' cost and efficacy compared with other medications in the same class. The goal: provide Medicaid patients access to drugs they need without busting the budget.

Anti-psychotics are of particular concern because they are among the most expensive drugs prescribed for chronic conditions. And though most anti-psychotics are approved for only the 2 percent of the population with schizophrenia and bipolar disorder, they are widely prescribed by doctors to treat conditions ranging from insomnia to ADHD.

The Medicaid committee will review both Janssen's Invega Sustenna and Saphris, a new dissolvable tablet for schizophrenia and bipolar disorder from Merck. Currently, the preferred drug list includes nearly all branded and generic anti-psychotics. Most injectable anti-psychotics, however, require prior approval so the state can monitor their usage.

Dr. Daniel Carlat, a psychiatrist and professor at Tufts University School of Medicine in Boston, said Invega Sustenna seems designed to replace a similar twice-monthly injectable from Janssen. That drug is losing patent protection, so a cheaper generic version will be out soon.

"And once it gets cheaper, I'd be hard pressed to put a patient on the more expensive drug," he said.

Carlat, a well-known critic of drug marketing, also said he hasn't seen any strong arguments for prescribing Merck's Saphris. "Maybe it has a place for those rare patients who have swallowing problems."

But Dr. John Bailey, a Tallahassee psychiatrist who is past president of the Florida Psychiatric Society, said mentally ill patients and their physicians should have easy access to all approved treatments. Though he has not prescribed either new drug, he said Janssen's monthly injection could be especially useful for severely ill patients who neglect to take daily medications.

"It's an expensive acquisition cost, but if the patient is noncompliant, that expense is just shifted to the ER or hospital when the patient ends up there," Bailey said. "Overall, the taxpayer still sees those costs."

Medicaid's pharmaceutical and therapeutics committee is scheduled to meet at 9 a.m. today at the Tampa airport Marriott. Public comment is limited to individuals who have preregistered.

Lobbying mounts to get Florida approval of two costly schizophrenia drugs 01/11/10 [Last modified: Tuesday, January 12, 2010 9:38pm]
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