Breakthrough Therapy Designation is Likely to Sway Oncologists’ Confidence in An Agent and Encourage Prescribing

July 14, 2014

Surveyed Payers Formulary Placement of Novel Agents is Likely to be Influenced by Breakthrough Therapy Designation, According to Findings from Decision Resources Group

BURLINGTON, Mass., July 14, 2014 /PRNewswire/ — Decision Resources Group finds that breakthrough therapy designation is likely to positively influence perceptions of emerging drugs for both oncologists and payers. Results of a survey of 100 oncologists (50 medical oncologists and 50 hematological oncologists) and 30 medical directors and pharmacy directors of managed care organizations (MCOs), reveals that despite lower familiarity with the regulatory designation than oncologists, the majority of payers say this designation will likely influence their formulary decisions, including tiering of other therapies in the same indication. Breakthrough therapy designation also confers positive connotations to a therapy in the eyes of oncologists, who frequently associate it with FDA confidence in an agent as well as strong efficacy data – a key influential factor in prescribing habits.


Other key findings from the U.S. Physician & Payer Forum report entitled Getting to Market Quicker: U.S. Physician and Payer Perceptions of Breakthrough Designation for Malignant Melanoma, Breast Cancer, Non-Small-Cell Lung Cancer, Chronic Lymphocytic Leukemia, and Multiple Myeloma:

    --  Influence on oncologist prescribing: Surveyed oncologists associate
        several factors including strong efficacy data with breakthrough therapy
        designation and are more likely to prescribe a therapy based on limited
        clinical data if it has breakthrough therapy designation than an agent
        that has not been awarded this status.
    --  Payer reception of currently approved breakthrough therapies: Janssen
        Biotech/Pharmacyclics' Imbruvica and Roche/Genentech's Gazyva were the
        first breakthrough therapy drugs to be approved, both for chronic
        lymphocytic leukemia. Both agents enjoy wide-spread coverage according
        to surveyed payers, and surveyed oncologists indicate that off-label
        coverage may be available of these agents in select populations.
    --  Perception of emerging breakthrough therapies: Payers and oncologists do
        not view all breakthrough therapy drugs equally; survey data suggests
        varying opinion of which agents most deserve this designation. Factors
        including trial population, choice of combination or comparator (when
        applicable) and treatment setting are strong influences on these key
        stakeholders perception of these agents.

Comments from Decision Resources Group Principal Business Insights Analyst Amy Duval, M.Res.:

    --  "The majority of surveyed oncologists would like emerging drugs to
        qualify for breakthrough therapy designation having demonstrated a
        clinically meaningful benefit over a standard of care. This means to
        reap the positive associations gained with breakthrough therapy
        designation, the early clinical development of promising emerging
        therapies should be carefully designed."
    --  "Influences including robust efficacy data and cost are likely to remain
        key factors for surveyed payers formulary decisions; while breakthrough
        therapy designation may influence payer formulary placement, this status
        is unlikely to compensate for any weaknesses in these standard
        benchmarks for novel therapies."

About Decision Resources Group

Decision Resources Group offers best-in-class, high-value information and insights on critical issues within the healthcare industry. Clients rely on this analysis and data to make informed decisions. Find out more at www.DecisionResourcesGroup.com.

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For more information, contact:

Decision Resources Group

Christopher Comfort



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SOURCE Decision Resources Group

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