Sunday, February 26, 2012

Qnexa for Obesity: Should It Ever Be Prescribed Without Concurrent Lifestyle Counseling? The Role of Disease and Population Health Management

Physician waiting room chair
for Qnexa candidates?
It's that time of year again. A political as well as cinematic blur of uninspiring candidates are being manipulated by an opaque, unaccountable and moneyed white male nomenklatura that foists "winners" on an unsuspecting public. The Oscars, the primary election year.... what's the difference?

So the Disease Management Care Blog distracted itself by turning its bloggy eye to newsmaker "Qnexa." This is a combination of two well known appetite suppressant drugs, phentermine and topiramate, that was just reviewed by an FDA expert panel. Their 20-2 vote in favor of approval makes it likely the Qnexa will be released to the market for the treatment of obesity sometime after a final Agency review in April.  Investors in Vivus like what it means for the company's prospects.

Population health management service providers should also like the prospects.

That's because Qnexa hasn't been tested as a stand-alone drug and, based on the published evidence, there is no evidence that it works without concurrent lifestyle counseling: 

The CONQUER Trial: "...assessed the efficacy and safety of two doses of phentermine plus topiramate controlled-release combination as an adjunct to diet and lifestyle modification for weight loss and metabolic risk reduction in individuals who were overweight and obese, with two or more risk factors."

The EQUIP Trial: "All patients were provided with standardized lifestyle counseling."

The SEQUEL Study: "All subjects participated in a lifestyle-modification program."

As the DMCB understands it, the FDA expert panel has recommended that Qnexa's release be tied to careful monitoring for an approximate 5% absolute risk of heart valve abnormalities. The DMCB believes they got it half right.

Access to Qnexa, based on the evidence, should also be explicitly tied to concurrent lifestyle counseling.  Assuming physicians are still unable to incorporate this into their usual clinic work flows, that leaves pharmacy benefit managers (who have supported patients with diabetes), patient centered medical homes and, last but not least, disease and population health management vendors.

Image from Wikipedia

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