© McGivney Global Advisors 2019

Case Studies

Expanding an Oncology Product's Market Share

Opportunity

  • 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

Strategy

  • 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

Consulting Results

  • 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

Client Impact

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Improving Clinical Guideline Rating for Insurance Coverage

Opportunity

  • 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

Strategy

  • 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

Consulting Results

  • 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

Client Impact

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Detailed State-level Analysis of High-Impact Legislation for BioPharma

Opportunity

  • Existing laws and pending legislation can be ranked by comparison to model legislation or other metrics developed collaboratively.  This detailed analysis can inform strategic stakeholder education and engagement and can be augmented by white paper development and training support.

Strategy

  • McGA conducted a legislative landscape review focusing on how states are regulating a specific issue
    (e.g., step therapy)

  • The McGA team addressed the following relevant factors

    • What is the scope of the law (eg, what insurance types does it apply to)?

    • Does the law clearly state definitions, purpose, and limitations?

    • What does the law specifically mandate?

Consulting Results

  • A detailed report of the results of the legislative landscape was presented to the client

  • Existing laws and/or pending legislation were coded and cataloged, so the client had a clear picture of the issues involved

  • McGA evaluated the strength of the law and developed a better understanding to inform strategic stakeholder education and engagement

Client Impact

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  • Strategic advocacy insights related to specific client products were provided to the client

  • Issues potentially limiting product utilization and prescribing by clinicians were identified, giving the client the opportunity to prospectively manage and apply mitigation strategies for shift in utilization