• A publicly traded American pharmaceutical company received FDA approval for a small molecule inhibitor for the treatment of a hematologic malignancy after treatment with other similar inhibitors

• At a recent scientific conference, updated study data was presented showing significant response rates and overall survival with the agent as frontline therapy

• McGA identified the potential opportunity for the company to significantly expand market access beyond the FDA indication to frontline therapy

• The McGA team conducted an in-depth analysis on the relevant NCCN Guideline and clinical data to develop an NCCN positioning strategy 

• McGA drafted an evidence-based request for NCCN submission before the annual NCCN Panel meeting

• The request was submitted to NCCN in time for Panel consideration at the annual Panel meeting

• As suggested in the request, the NCCN Panel recommended the therapy as frontline in the NCCN Guideline and NCCN Compendium, listed as the first option in front of other agents

• Outcome propels the therapy into the frontline setting, greatly expanding its potential revenue

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• An Australian pharmaceutical company received FDA approval for a novel organ-specific therapy for the treatment of an advanced solid tumor

• Special training is required for proper administration, leading to perceived procedural and logistical complexity

• NCCN Panel assigned a category 3 rating, the lowest rating in the NCCN Guidelines, based on lack of consensus

• As a category 3 rating is not covered under health policies of many payers in the US including Medicare, , the company needed a dedicated special claims team to work with clinicians on obtaining reimbursement for the therapy

• McGA developed an NCCN positioning strategy tailored to the uniqueness of the therapy:

  • Provided evidence-based rationale highlighting organ-specific response and benefit that is consistent with the mechanism of action

  • Acknowledged and addressed NCCN Panel concerns on special training requirements

• The rationale was submitted to NCCN in time for Panel consideration at the annual Panel meeting

• NCCN Panel upgraded the therapy from category 3 to category 2A in the NCCN Guideline and NCCN Compendium

• This represents a major 2-step upgrade as NCCN has 4 categories (1, 2A, 2B, and 3)

• As category 2A recommendations are covered by all major payers, this outcome alleviates the company from the continuous burden of coverage and reimbursement dispute reconciliation

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