iBIO Spring Policy Forum

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  1. 1. SPRING POLICY FORUM
  2. 2. About iBio Champions the life sciences in Illinois and the Midwest MISSION To make Illinois and the surrounding Midwest one of the worlds top life sciences centers A great place to do business A great place to grow new business involving advanced technology WORK PLAN Promote sound public policy at the local, state, and federal levels Improve Illinois and the Midwests ability to create, attract, and retain businesses Through the iBIO Institute, orchestrate industry involvement to help solve Americas math and science education crisis
  3. 3. Thank you
  4. 4. BIO Principles for Substitution of Biosimilars for Innovator Biologic Products 4 Substitution should occur only when the FDA has designated a biologic product as interchangeable The prescribing physician should be able to prevent substitution, i.e. DAW The patient should, at a minimum, be notified of the substitution The prescribing physician should be notified of the substitution A record of the substitution must be kept by the pharmacy for a set period of time Substitution should occur only when the FDA has designated a biologic product as interchangeable Substitution should occur only when the FDA has designated a biologic product as interchangeable The prescribing physician should be able to prevent substitution, i.e. DAW The prescribing physician should be able to prevent substitution, i.e. DAW The patient should, at a minimum, be notified of the substitution The patient should, at a minimum, be notified of the substitution The pharmacist should communicate to the prescribing physician when a substitution is made The pharmacist should communicate to the prescribing physician when a substitution is made A record of the substitution must be kept by the pharmacy and the physician for a set period of time A record of the substitution must be kept by the pharmacy and the physician for a set period of time
  5. 5. The Arthritis Foundation and Interchangeable Biologic Products Michele Guadalupe VP of Advocacy and Public Policy Heartland Region
  6. 6. Our Strategic Pillars: Advocacy and Access Our Strategic Pillars Advocacy and Access Strong federal advocacy in Washington DC Increasing state level focus and leadership in nontraditional arenas where barriers are occurring Access to care as the centerpiece urgent, impactful, relevant, and often outside the regulatory realm Leverages and amplifies voices of 90,000+ e- advocates AF can and should be THE leader the champion for the issues that matter most
  7. 7. Why We Care About Biologics
  8. 8. Our Position on Biosimilars In any instance of an interchangeable biologic product substitution for a biologic medicine, prescriber communication is essential.
  9. 9. We Support a Prescriber Communication Requirement Because: Interchangeable biologic products, like biologics, will be used to treat complex, rare, or chronic medical conditions. The prescriber must know of an interchangeable biologic product substitution in order to appropriately assess the patients experience and further treatment options. Interchangeable biologic products will require a difficult or unusual process of delivery to the patient in preparation for infusion or injection. Handling, storage, inventory or distribution of the drug is not typically available at retail pharmacies. Interchangeable biologic products will require significantly enhanced patient education, management or support, beyond those required for traditional dispensing at a community or retail pharmacy, before and/or after administration of the drug. Interchangeable biologic products are complex medications derived from living sources not simple generics produced through chemical processes. Prescribers and pharmacists must work collaboratively to ensure the protection of the patient!
  10. 10. Where Have We Been
  11. 11. States with Enacted Biosimilar Legislation Green = Enacted Purple = Vetoed Red = Enacted with Sunset None in Alaska or Hawaii
  12. 12. Where Are We Going
  13. 13. Blue = Introduced Green = Enacted None in Alaska Hawaii is Workgroup State Biosimilar Legislation/Regulation 2015 32 Bills in 21 States
  14. 14. The Pathway Just Became Urgent
  15. 15. Michele Guadalupe VP of Advocacy & Public Policy Arthritis Foundation, Heartland Region (312) 880-4736 mguadalupe@arthritis.org Thank You!