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Breakthrough Therapy Designation is Likely to Sway Oncologists' Confidence in An Agent and Encourage Prescribing
Date:7/14/2014

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.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact:

Decision Resources Group
Christopher Comfort
781-993-2597
ccomfort@dresourcesgroup.com

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