Off-patent Rx leads fibromyalgia category

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As the number of FDA-approved fibromyalgia therapies has grown, so has patient hope for relief from the ailment. However, the condition is still not well understood by the medical community overall, hampering uptake of branded drugs approved for the disorder. A new report suggests that better training for internists, who are on the front lines of diagnosis and treatment, could help.

The problem starts in the exam room. Among primary care physicians (PCPs) who see at least 10 fibromyalgia patients per month, only 4% are comfortable diagnosing it after one visit, compared to over 40% of rheumatologists, according to a survey from Decision Resources which focused on the emerging category. “This underscores the importance of the PCP or internist being able to diagnose and treat fibromyalgia,” analyst Andrea Buurma told MM&M.

Indeed, the survey showed that, when diagnosing fibromyalgia, three-quarters of surveyed PCPs do so without specialist involvement. And because patients in the care of PCPs take longer to receive their diagnosis, they likely must wait longer for drug treatment.

Confusion in the doctor's office has had real implications for marketers. In the more than two years since Pfizer's Lyrica was approved for fibromyalgia— despite the millions spent on marketing by Pfizer and Eli Lilly, whose Cymbalta antidepressant gained approval for fibromyalgia last year—physicians are slightly more likely to prescribe generics than branded drugs for patients with this condition. (Forest/Cypress Bioscience's Savella came on the market in April.)

Surveyed physicians report slightly greater first-line use of off-patent agents amitriptyline and cyclobenzaprine, which have a long history of off-label use.

There is some good news for marketers. Some of the 75 PCPs and 75 rheumatologists surveyed project that their first-line use of generics will decrease in the next two years, presumably as these physicians turn more frequently to drugs with regulatory approval in early lines of treatment.

Still, more education could help boost brand share. On whom should marketers target their educational efforts? According to Decision Resources, a focused effort on reducing the number of visits that an internist needs to diagnose fibromyalgia could accelerate prescriptions for first-line treatments. This is one area where the numbers are in pharma's favor. Though rheumatologists could benefit from more education—45% of them need to see a patient two times before feeling comfortable with a diagnosis—focusing detail efforts on the nation's 4,600 practicing rheumatologists poses a more daunting task than adding another product to the bag of the PCP sales force.

Internists may provide an easier target—and one that could drive more prescriptions. Said Buurma: “they can be patients' first line of contact.”

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