July 31, 2014 Mark Johnston Executive Director Idaho Board of Pharmacy 1199 W Shoreline Lane, Suite 303 Boise, ID 83702-9103 Submitted electronically to: [email protected] RE: Biosimilars modifications to be discussed at August Board meeting Dear Mr. Johnston: The Coalition of State Rheumatology Organizations (CSRO) is a national organization composed of 26 state and regional professional rheumatology societies formed in order to advocate for excellence in rheumatologic care and to ensure access to the highest quality care for patients with rheumatologic and musculoskeletal disease. Rheumatologists are entrusted with the safe care of patients with rheumatoid arthritis and other autoimmune diseases that require the careful choice of safe and effective pharmaceutical and biological therapies. Rheumatologists are keenly aware of the dramatic long term, life changing clinical improvements that biological agents have on some of the most crippling and disabling conditions that affect Americans. These biologic response modifying agents are available for the treatment of rheumatoid arthritis and other autoimmune diseases and have a significant impact on improving our patients’ quality of life, preventing disability, decreasing morbidity and lowering mortality. As the Idaho State Board of Pharmacy considers modifications to its rules related to biosimilars, CSRO wishes to convey some concerns. The proposed new rules would add the following definitions: Biological Product. A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), that is applicable to the prevention, treatment, or cure of a disease or condition of human beings. Biosimilar. A biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. Most importantly, the proposed language would add the following: Interchangeable. A biological product that may be substituted for the reference product without the intervention of the health care provider who prescribed the referenced product. Coalition of State Rheumatology Organizations July 31, 2014 Page 2 Biosimilars. Upon the determination by the United States Food and Drug Administration that the biosimilar product is interchangeable with the prescribed biological product. CSRO has serious concerns with this language, which would allow for automatic substitution of a biosimilar upon a finding of interchangeability by the Food and Drug Administration (FDA). In testimony before the FDA, Dr. Gregory Schimizzi, past president of CSRO, noted that there is not sufficient scientific understanding of biosimilars at this time to allow for an interchangeable biological product. As such, Dr. Schimizzi urged FDA to foreclose the interchangeability option until the science advances in this area because anything short of barring interchangeability would be detrimental to patient safety and would erode physician confidence in prescribing these medications. Assuming that FDA does proceed with finding interchangeability for certain biosimilars, however, the current automatic substitution process used for generic medications in many states is inappropriate for biosimilars. As Dr. Schimizzi explained in his testimony, “The physician should always be involved in decisions regarding selection of the biological product a patient receives. Automatic retail substitution of biotech medicines is not appropriate. Currently, all State laws allow the pharmacist to substitute a less expensive generic product for the brand name product, and the determination of the ability to substitute such products is based on the nonproprietary name. In some states, like Pennsylvania, unless the prescriber signs or initials “brand necessary” or “brand medically necessary,” the pharmacist is required by law to provide the generic form, unless the patient demands a brand name drug.” This approach is simply not workable for biosimilars, which are inherently far more complex products than generic drugs. No two patients are the same; in fact, sometimes two individuals who seem to have identical medical conditions “on paper” may respond differently to the same biologic from the same manufacturer. Automatic substitution of the biosimilar for the reference product is not a decision that can be made by those who do not have personal knowledge of the patient’s full medical history, such as pharmacists or health plans. CSRO recognizes that follow-on biologic products are a natural evolution of biotechnology and we welcome the introduction of these medications. However, we must insist that physicians know what medicine their patients receive and that the prescribing physician is notified in a timely manner whenever a patient’s biologic medicine is substituted. Any substitution policy must include the ability of the physician to note that a script be filled as written and must provide adequate notification to ensure accurate medical records in the event of adverse events. Sincerely, Michael Schweitz, M.D. President, Coalition of State Rheumatology Organizations
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