CADTH_2014_D2_Subsequent_Entry_Biologics_Payer_Consideration__Steve Long
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CADTH_2014_D2_Subsequent_Entry_Biologics_Payer_Consideration__Steve Long



Health Technology Assessment of Biosimilars (SEBS): a Canadian Perspective

Health Technology Assessment of Biosimilars (SEBS): a Canadian Perspective



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CADTH_2014_D2_Subsequent_Entry_Biologics_Payer_Consideration__Steve Long CADTH_2014_D2_Subsequent_Entry_Biologics_Payer_Consideration__Steve Long Presentation Transcript

  • SEB Payer Consideration Steve Long, BSc(Pharm), MBA Calgary, AB
  • Overview • Drug Plan Mandate • Criteria for Listing • Challenge of SEB’s • Commentary for discussion
  • Drug Plan Mandates Ontario Public Drug Programs 1. Improving patient access to drugs 2. Ensuring better value for money 3. Promoting the appropriate use of medications 4. Investing in innovative health system research 5. Strengthening transparency and accountability in the public drug system
  • Drug Plan Mandates The purpose of the Alberta Pharmaceutical Strategy is to make drug coverage more accessible, affordable, efficient and therapeutically effective by improving the management, funding and purchasing processes for prescription drugs paid for fully or partially by the Government of Alberta. These processes take place in a complex commercial environment with multiple payers, customers, business interests and advocacy groups. The Alberta Pharmaceutical Strategy will bring greater clarity and consistency to the operation of government sponsored drug benefit programs and improve the efficiency and effectiveness of program governance and management.
  • Criteria for Listing The product must: a) possess therapeutic advantage over other presently accepted therapies or treatments of the disease entity for which the product is indicated, or b) be more cost-effective than presently accepted therapy
  • Assessment of therapeutic advantage: • clinical efficacy; • risk/benefit ratio; • toxicity; • compliance; • clinical outcomes; • Health Canada warnings and advisories; • population health issues; or • any other factor which affects the therapeutic value of the product.
  • Examples • Infliximab – Quantifiable difference in glycosylation pattern – Extrapolation to PA and PP but not CD and IBD – Infusion clinics • Insulin glargine – Smaller biologic – Past experiences with insulin – Administration devices and programs
  • Commentary Patients – Devastating diseases prior to biologics no effective treatments Prescribers – Specialty, criteria based – Naming and product confusion Pharmacy – Preferred provider systems Payers and Producers – Price point – Delivery, adherence and on-going monitoring