The NCCN Guidelines and Drug/Biologics Compendium have justifiably earned the Preferred position as the most influential resources in establishing the recommendations that serve as the basis for coverage policies by payers/MCOs. This preferred position has been critically important to patients, clinicians, provider institutions, and innovator biopharma companies. A major reason why the NCCN has assumed the mantle of authority has been the simple, direct, and elegant evaluative process and recommendations that have characterized the NCCN for years.
NCCN has recently released its Categories of Preference as a newly added feature of the NCCN Guidelines. The Categories of Preference will serve as a counterpart to the Categories of Evidence and Consensus and to the Evidence Blocks. It is herein acknowledged that the Categories of Preference have just been released and will likely evolve over time. For now and as written, the Categories of Preference likely will be a concern to patients seeking access to therapies based upon their individual characteristics, to providers making prescribing decisions, and to biopharma companies investing hundreds of millions of dollars or more to meet the needs of patients through innovation.
Briefly some concerns are described below:
Overall, the release of the Categories of Preference is not a positive for the patient, provider or biopharma communities;
The appearance and components of the Categories of Preference duplicate and seem to seek to atone for the failure of the Evidence Blocks to achieve utilization and influence across Stakeholders.
The definition of the category of “other recommended intervention” includes four negative components. As such, NCCN has turned negative with a formal negative recommendation category. Much like negative recommendations from the other four non-NCCN Compendia, one negative recommendation can trump positive recommendations from the other 4 Compendia. This one Category (“other recommended intervention”) may be used by payers to support denials or restrictive UM.
The aforementioned point cannot be taken lightly. NCCN Institutional memory should recall that originally the Category 2B was defined as “lower level evidence and non-uniform consensus”. This “non-uniform consensus” phrase resulted in CMS being silent on NCCN 2B recommendations and some plans like Anthem indicating that that payer would not cover NCCN Category 2B recommendations. Thus, negative definitions such as that under “other recommended intervention” can be and have been used by payers to deny.
The issue of how the stated institutional preference would help determine the Category of Preference is confusing. What happens if four institutions have one preference, 5 another preference, 6 yet another etc.?
The adjectives “preferred” and “optimal” are both used (interchangeably?) in the document including for the goal of “Provide guidance to users of the Guidelines on which recommendation(s) is considered optimal”. “Optimal” and “preferred” do not have the same meaning.
The NCCN answer about “how will NCCN know what each therapy will cost” is a tribute to circumlocution. The question is just not answered and this is a major issue.
The statement that a reason to develop the Categories of Preference is that “restrictive pathways are being developed in response to payer demands” seems to represent a tilt to the payer side; will the tilt be accentuated in the near future. This is concerning given the NCCN Guidelines traditionally have been the bastion of support for patients and providers.
The FAQ piece has inconsistencies and this seems to proceed from wanting to have it both ways.
The “Useful in Certain Circumstances” categories duplicates what is already in the Guidelines as the algorithms already drive to use of agents in specific subpopulations.
The interpretation of the Categories of Consensus, Evidence, and Preference along with the Evidence Blocks may lead to Babelian inconsistencies across the Guidelines and Compendium.
by Bill McGivney, PhD, President, McGivney Global Advisors
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