BIOTECH 2011 NJ/PA/DE Case Studies

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BIOTECH 2011 NJ/PA/DE Case Studies

  1. 1. 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) <ul><ul><li>Co. A wanted to target usage by PCP’s without approaching the AMA to alter UTI diagnostic guidelines </li></ul></ul><ul><ul><li>Co. A wanted higher reimbursement than CMS would clearly pay </li></ul></ul><ul><ul><li>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 </li></ul></ul>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
  2. 2. 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) <ul><ul><li>Co. B had label restricting administration by a HCP in a market where most competitors were self-administered </li></ul></ul><ul><ul><li>This caused payers to cover the product under the medical benefit in most cases. </li></ul></ul><ul><ul><li>Prescriber adoption was poor due to the hassles with reimbursement when alternatives were easily accessible with fewer access hurdles. </li></ul></ul>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
  3. 3. 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) <ul><ul><li>Due to high number of initial PA denials, spine surgeons opted for spinal fusion or other interventions </li></ul></ul><ul><ul><li>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 </li></ul></ul><ul><ul><li>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 </li></ul></ul>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

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