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NCCN Says Comparative Effectiveness in Oncology Won't Clash With Personalized Rx

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By Turna Ray

The National Comprehensive Cancer Network's system for conducting comparative effectiveness assessments for cancer treatments will not be at odds with the principles of personalized medicine, according to a draft white paper.

"The NCCN [Comparative Therapeutic Index] process will not be in conflict with 'personalized medicine' as it pertains to the care of cancer patients," the NCCN said in the draft paper, titled "The NCCN Comparative Therapeutic Index as a Paradigm for Near-Term Comparative Effectiveness Analyses of Existing Data in Oncology."

The draft paper will be available for public comment through Nov. 23. After considering public comments, the group will issue the final version of the paper at the NCCN Oncology Summit on Dec. 7.

NCCN's comment on the convergence of personalized medicine and comparative effectiveness comes at a time when there is concern that the current research infrastructure pits the two disciplines as disparate concepts.

Recently, NIH Director Francis Collins expressed concern that comparative effectiveness research and personalized medicine could be on a "collision course," if such research did not evaluate the clinical and cost effectiveness of treatments in genomically targeted subpopulations [see PGx Repoter 10-28-2009].

"Based on available data, the NCCN guidelines already identify and in some cases, segregate patient groups based on genetics, biomarkers, or other criteria to direct treatment based on these considerations," the NCCN's draft paper states.

In the draft paper, NCCN's Oncology Comparative Effectiveness Work Group has developed a systematic process for evaluating the differential effectiveness of oncology treatments using the so-called, "Comparative Therapeutic Index."

The NCCN describes its CTI system as "a clinical evaluative method that communicates the ratio of the effectiveness of a proposed treatment versus its potential toxicity."

"If necessary, the CTI would be applied to the various options within a specific patient population, not across different patient populations," the NCCN states.

The NCCN CTI model integrates available scientific data and the expert judgment of oncologists. The group plans to implement CTI gradually at first, but the comparative effectiveness method will eventually be adopted in the promulgation of all NCCN guidelines.

CTI also considers "resource utilization" or cost in its comparative effectiveness assessment.

However, at a conference on personalized medicine this week in San Francisco hosted by Burrill & Co., NCCN CEO William McGivney asserted that there is no treatment, personalized or otherwise, that saves the healthcare system money, other than possibly vaccines.

As an example, McGivney said that the fact that the oncologic Erbitux is now indicated for a genomically-defined subpopulation in colorectal cancer, may make the healthcare system more efficient but it won't necessarily save money.

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Certainly, many colorectal cancer patients who do not receive Erbitux as a result of KRAS mutations, avoid paying $80,000 for the typical 18-week treatment that they won't benefit from. Alternatively, many of those patients end up receiving Avastin, which can cost up to $100,000 annually.

The NCCN is a non-profit alliance of 21 leading cancer centers throughout the world, and its Clinical Practice Guidelines in Oncology set the standard of care in oncology in academic and community settings. Payors also pay close attention to the NCCN's guidelines when making coverage decisions.

"Given the NCCN Guidelines' stature and credibility in the cancer community, the NCCN Work Group believes they serve as an ideal channel to disseminate comparative effectiveness results for adoption into practice," the NCCN said in a statement.

The NCCN's Oncology Comparative Effectiveness Work Group comprised representatives from the patient community, clinicians, managed care organizations, the pharmaceutical and biotech industries, as well as health policy makers.

NCCN notes however, that even with comparative effectiveness evaluations, "the final selection of a specific treatment [should be made] based on patient-specific parameters."

"The final selection of the specific treatment is the responsibility of the individual physician based on patient-specific parameters elucidated during the course of the physician-patient relationship," the NCCN states in the draft paper.

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