BIOTECH 2011 NJ/PA/DE Case Studies
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BIOTECH 2011 NJ/PA/DE Case Studies






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    BIOTECH 2011 NJ/PA/DE Case Studies BIOTECH 2011 NJ/PA/DE Case Studies Presentation Transcript

    • Company with no US commercialization experience created strategic partnerships to manufacturer, distribute and market a lab-based diagnostic. Case Study: EU Diagnostic Company (Co. A)
        • Co. A wanted to target usage by PCP’s without approaching the AMA to alter UTI diagnostic guidelines
        • Co. A wanted higher reimbursement than CMS would clearly pay
        • Co. A’s product was not clinically differentiated from UTI diagnostics and would not receive approval for a new HCPCS code or higher reimbursement rates
      Co. A invested in a product that had no commercial value in the US due to reimbursement and payment issues and scrapped the project. “ Look Before You Leap” - Consider the commercial reimbursement landscape before investing! Results & Lessons Learned
    • Company with some US commercialization experience launched a lyo-formulated SQ injectable biologic for a chronic disease into a very crowded market. Case Study: Mid-size Biotech (Co. B)
        • Co. B had label restricting administration by a HCP in a market where most competitors were self-administered
        • This caused payers to cover the product under the medical benefit in most cases.
        • Prescriber adoption was poor due to the hassles with reimbursement when alternatives were easily accessible with fewer access hurdles.
      Co. B could have considered a pro-active risk management program to mitigate concern with patient education and altered the label pre-approval. “ Consider The Label” – nuances in the label can have drastic repercussions on the future reimbursement scenario! Results & Lessons Learned
    • Well respected medical device manufacturer had challenges with spinal surgeon utilization of artificial disc replacement due to negative US coverage policies (CMS NCD) and technology assessments (BCBS TEC) Case Study: Medical Device Firm (Co. C)
        • Due to high number of initial PA denials, spine surgeons opted for spinal fusion or other interventions
        • In spite of negative coverage policies, Co C possessed many positive case reviews, positive economic models, 15 years of European PRL and a positive NICE TA
        • Co C launched an appeals support program that collected QoL information from the patient and submitted a personalized appeal package with supporting case studies and NICE TA to the payer on behalf of the surgeon and patient
      Co. C saw increased utilization of product due to lower administrative burden on the spine surgeon’s office. Additionally, patients who may have been denied the procedure obtained approval and were treated. Results & Lessons Learned