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The Fight for Lyrica
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JEFFERSON CITY - There is only one FDA approved drug for the treatment of Fibromyalgia, a condition that causes chronic pain.

Patients and their health insurance companies disagree about Lyrica's effectiveness. One of those companies is the health insurance provider for the largest employer in mid-Missouri.

For nine million Fibromyalgia sufferers in America, pain is a way of life, and they think Lyrica could make all the difference. But several insurance companies wont pay for it; even though Lyrica is the only drug approved by the Food and Drug Administration to treat Fibromyalgia.

"I could get dressed in the morning; I could get out and go to my doctors visits. I could do a little bit of house work. I don't have that consuming pain where you just can't function," said Robin Skinner, Fibromyalgia patient.

Fibromyalgia causes widespread muscle and joint pain. Along with the pain comes lack of sleep, fatigue and headaches.

"This has been the one medication that has been shown to change their lives, give them back their lives, give them the ability the way you and I and everybody else can live at this point," said Dr. Osvaldo Acosta.

The FDA approved Lyrica last June. But, the health insurance provider for the largest employer in mid-Missouri challenges the drugs effectiveness. Coventry Health Care requires its members to try and get no benefits from a list of other drugs first before the company will pay for Lyrica - a practice known as step therapy.

In a written statement, Coventry said it then covers Lyrica. Coventry's statement also acknowledges Lyrica as the first and only FDA approved treatment for Fibromyalgia, but challenges the drug's use as the first prescription a doctor writes.

The statement says, "The granting of FDA approval, however, does not change its place in the spectrum of available therapy, nor does it necessarily move the drug to a first line recommendation."

The statement goes on to cast doubt on studies on the effectiveness of Lyrica-chemical name Pregabalin. "This study did not address the efficacy of Pregabalin in comparison to any other treatment standards."

KOMU shared this statement with Dr. Acosta, who's lived with Fibromyalgia for nineteen years.

"What they've failed to show is that any other drug that's out there is not effective as Lyrica," said Dr. Acosta.

"I want to know if it's going to work for me. Just because it didn't work for other people that they tried it on, doesn't mean it isn't going to work for me," said Skinner.

In an attempt to strengthen its case for requiring step-therapy, Coventry claims the FDA said the drug causes suicidal tendencies. "In addition, as of Jan. 31, 2008, Pregabalin labeling must include a black box warning based on the FDA's conclusion that patients taking Pregabalin historically have had approximately twice the risk of suicidal behavior or ideation as compared to patients taking placebo."

The FDA said no such warning exists. But KOMU did find this type of warning on two categories of drugs that Coventry requires members to take and fail before the company will cover Lyrica. KOMU contacted to ask about the suicide claim. The company didn't return our phone call. But after we provided Coventry's statement about Lyrica to the drug's maker, Pfizer, the company issued a strongly worded letter to Coventry demanding the insurance company retract what it calls a "false and dangerous allegation."

After receiving Pfizer's letter, Coventry did reissued its statement, changing its argument. Regardless of this fight over the drug's effectiveness, Skinner said Lyrica gave her back her life and that's reason enough to fill her prescription.

"If I have a sprained wrist, I don't have to go through step therapy for the pain of my wrist why step therapy for Fibromyalgia?" asked Skinner.

United Health Care gave KOMU a statement saying the company does not use step therapy. Instead, the company uses a three-tier system that separates drugs based on cost.

Mercy Health refused to comment on it's step therapy policy. The company said, "Thanks for your interest in Mercy Health plans. We are not able to participate at this time."

Reported by: D'Anthony White
Posted by: Kathryn Lucchesi

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