Monday, July 28, 2008

Chantix vs. Nicotine Patch for Tobacco Cessation & What About Disease Management?

The Disease Management Care Blog was struck by Wall Street Journal Health Blog’s (WSJHB) coverage of another varenicline (Chantix) peer review publication. Reported in Thorax, study participants were randomly assigned to Chantix or to a nicotine patch. While early abstinence rates favored Chantix, the one year quit rates (26% vs. 20%) failed to achieve statistical difference (p=.056). Unsurprisingly, it wasn’t Pfizer that alerted the WSJHB but GlaxoSmithKline. It makes the competing nicotine patch.

WSJHB writes the borderline p value suggests that Chantix was ‘a little bit’ more effective. As in, um, the results were a little bit statistically significant. Sorry guys, the interpretation is that the Chantix vs. patch rates did not achieve the conventionally accepted threshold that distinguishes random chance from a real effect.

This is bad news for Chantix’s manufacturer, Pfizer. Looks like the Mayo Clinic won’t need to change its on line information all that much. Many managed care organizations provide access to nicotine patches via vouchers or discount programs. Since the patch arguably works as well as Chantix, these patch promotion programs will continue and Chantix will continue to be subject to preauthorization that is often dependent on trying the patch 1st.

The DMCB took some additional time to review some other publications on Chantix here, here and here. What was striking about these studies was that Chantix’s success was always accompanied by multiple follow-up 10 minute tobacco cessation office visits. The DMCB interprets this as showing that Chantix’s quit rates are intertwined with a significant degree of ongoing counseling. In fact, we really don’t know how well Chantix works without counseling. What’s more, tobacco cessation guidelines echo the necessity of prescribing tobacco cessation medications in conjunction with close follow-up:

'There is a strong dose-response relationship between the intensity of tobacco dependence counseling and its effectiveness. Treatments involving person-to-person contact (ie, via individual, group, or proactive telephone counseling) are consistently effective, and their effectiveness increases with treatment intensity (eg, the number of minutes of contact). If the patient agrees to attempt cessation, the clinician should then assist in making a quit attempt and should arrange for follow-up contacts to prevent a relapse. The treatment of tobacco dependence, like the treatment of other chronic diseases, requires the use of multiple modalities. '

This is echoed in the Chantix web site and the package insert. Yet, despite the evidence, it’s unlikely that the market or insurance regulators will tolerate making access to Chantix contingent on the availability or use of counseling.

Other options include:

Paying the physicians: In contrast to other preventive care services, tobacco counseling is already covered by many insurers, including Medicare. The problem is that physicians are not taking advantage of it. Maybe it’s not enough money. Alternatives include linking the payment to presence of a Patient Centered Medicial home, pay for performance, a global fee for an episode of care or compensation referring Chantix users to another entity (hint, there's one in each state) that can provide the counseling.

Deploy disease management: Note that the counseling doesn’t necessarily have to be personally provided by a physician or in person. This is an opportunity for the Pharmacy Benefit Managers to provide the service or to partner with a disease management organization that can provide the counseling. Given the scalability and expertise of existing disease management programs, the DMCB suspects this is a more available and cost-effective option.

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