SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS  4:14:22 PM CHAIR SPOHNHOLZ announced that the final order of business would be SENATE BILL NO. 32, "An Act relating to biological products; relating to the practice of pharmacy; relating to the Board of Pharmacy; and providing for an effective date." 4:15:12 PM SENATOR SHELLEY HUGHES, Alaska State Legislature, paraphrased from the Sponsor Statement [Included in members' packets], which read: Senate Bill 32 allows for Alaskans to have access to safe, new, and effective treatment options called interchangeable biological products. Under current state law, pharmacists are allowed to substitute a generic product for drugs that are identical to their proprietary product but cannot do the same with interchangeable biological products. Under SB 32, pharmacists will be able to dispense an FDA approved interchangeable product as a substitute for the proprietary biological product. Due to the complexity and nature of biological products, an exact replication of these drugs is impossible, so a new category of interchangeable products was created by the FDA. This category of drug allows for pharmaceutical companies to create safe and affordable substitutes for drugs that help treat conditions including cancer, multiple sclerosis, severe rheumatoid arthritis, heart disease, and other immune system, neurological and hematologic disorders. In addition to the clear benefits to patients, the lower costs and competition should also bring measurable costs savings to Alaska's Medicaid program and budget. The Center for Medicare and Medicaid Services recommends that state Medicaid programs "view the launch of biosimilar biological products as a unique opportunity to achieve measurable cost savings and greater beneficiary access to expensive therapeutic treatments for chronic conditions." SB 32 allows pharmacists to dispense interchangeable biological products if they communicate this with the prescribing doctor. This bill only allows a pharmacist to substitute an interchangeable product if it is approved by the FDA, and it allows for doctors to require the pharmacist to only dispense the proprietary product if they feel it is a more effective option. Patient consent will also be required before any substitution is made for an interchangeable over the proprietary product. It is important for Alaska to address this issue now as more interchangeable products become available to patients. Senate Bill 32 will allow for new and effective options at a lower cost, without jeopardizing patient safety, and will allow for measurable Medicaid and budget savings for the State. Please join in supporting access to an affordable medication option for Alaskans. SENATOR HUGHES reported that 31 states had already adjusted statutes to allow for these bio-similars when they became available, and that competition should make these much more affordable than the original. She read: "state Medicaid programs should view the launch of bio-similar biologic products as a unique opportunity to achieve measurable cost savings and greater beneficiary access to expansive therapeutic treatments for chronic conditions." She reiterated that there were the original biologic products, the bio-similar products, and now the interchangeable product. The proposed bill would clarify this in statute to allow for a pharmacist to substitute, with patient consent and notification to the prescriber. She pointed out that this proposed bill offered equal control to both pharmacists and physicians. 4:22:07 PM REPRESENTATIVE KITO asked about the character of the biologics. He said that the generic drug replacement for a name brand drug had the exact same chemical make-up. He offered his understanding that patents did not allow biologics to use the same process or procedure, even though they were aiming for the same result. He asked if there were recognitions for how these act or react to different people. He asked if these were the same drug or different, or similar enough to be considered similar to a generic. SENATOR HUGHES said that the cells, as they were derived from living organisms, would never be identical. Even with the same process, these would be "incredibly similar but not identical." She noted that this was part of the thorough FDA testing for this new category. She declared that the drugs would have to reach a level of no clinical difference in results to the original or the interchangeable drugs. 4:24:19 PM REPRESENTATIVE SULLIVAN-LEONARD asked about the aspect of the bio-chemical use for pharmaceuticals, and whether this included blood born pathogens or blood products. 4:25:03 PM THOMAS FELIX, M.D., AMGEN, explained that the definition for biologics in federal statute was very broad, and included vaccines and blood products and components. He said it was important to realize that blood components were not currently being considered for bio-similar development. He noted that the focus was for products created in a living cell that either mimicked something already existing in our body such as insulin, or something that targeted a pathway of disease that would interfere with a cell cycle for growth related to a tumor cell or a growth around a tumor. REPRESENTATIVE SULLIVAN-LEONARD asked if stem cells would be interspersed in this biological system. DR. FELIX, in response, said that stem cells were biologics in terms of concepts, but bio-similars would not be stem cell therapies. He explained that stem cells were what was administered to a patient as therapy, whereas biologics and bio- similars were derived from cells, which were not embryonic or human cells, to make it produce a protein which was then isolated, purified from the cell, and injected into the patient as a therapy. 4:27:25 PM CHAIR SPOHNHOLZ asked if all insulin were derived from the same original set of cells, and therefore not a bio-similar or biologic interchangeable. DR. FELIX pointed out that insulins were covered by a separate legal and regulatory pathway, the Federal Food, Drug, and Cosmetic Act. By 2020, these insulins would be rolled into the legal and regulatory pathway for approval of biologics, the Public Health Service Act. He shared that the history for making insulins had evolved over time, as it used to be collected from animals, whereas now a cell was programmed to produce the insulin more closely to a human insulin. He shared that there was a spectrum of complexity of other types of biologics which were more complex than insulin. He pointed out that a standard biologic technology called a monoclonal antibody was used, which could target a pathway of disease or a healthy pathway. 4:29:56 PM CHAIR SPOHNHOLZ asked if insulin had been traditionally held under an older regulatory model and, in 2020, this would be rolled into the more modern laws which related to biologics. DR. FELIX expressed his agreement and said that insulins and other older biologics which had been approved a long time ago and were much simpler would be transitioned, with a very strict scientific standard for inclusion based on the number of amino acids each contained. CHAIR SPOHNHOLZ reflected on the definition of biologic interchangeables, which were designed to have the same therapeutic outcome, even though they were not exactly 100 percent replicable. She asked if this was related to proprietary law or if it was a biological limitation. DR. FELIX explained that when a bio similar was developed, there was not a recipe book for the process to manufacture the original, hence the need to reverse engineer from an original reference products vial or injection device. He shared that keeping an understanding of the intellectual property landscape in mind would include, in the development, an approach for a slight structural variation whether or not it had clinical significance that was important. He pointed out that, once approved, these would be highly similar to an existing product. He emphasized that this was very different than the way generics were approved, as they typically did not require clinical trials. He said that it would require clinical trials for a bio similar or for an interchangeable biologic product. CHAIR SPOHNHOLZ mused that there was both a cellular reason for difference as well as for avoidance of conflict for intellectual property. 4:34:20 PM AIMEE BUSHNELL, Staff, Senator Shelley Hughes, Alaska State Legislature, paraphrased from the Sectional Analysis [Included in members' packets], which read: Sec. 1 AS 08.80.030 Adds a new subsection requiring the Board of Pharmacy to have a link on the board's website to the United States Food and Drug Administration's (FDA) list of approved interchangeable biological products. Sec. 2 AS 08.80.294 Amends this section by requiring a pharmacist to include on the label of a biological product container the proprietary or proper name of the biological product. This section also includes language to differentiate between drugs that are and are not biological products to ensure that statutes regarding equivalent generic drugs are not substantively changed. Sec. 3 AS 08.80.294 Adds a new subsection to define the term "proper name" being the name that reflects scientific characteristics of a biological product. This new subsection also defines "proprietary name" which is the trademarked and registered name of the product. Sec. 4 AS 08.80.295 Adds language to differentiate between equivalent drug products and interchangeable biological products. Sec. 5 AS 08.80.295 Adds new subsections to provide guidelines as to how pharmacists or their designee will need to communicate with a prescribing doctor when dispensing a biological or interchangeable biological product if an interchangeable product is available. Under subsection (c), a pharmacist must communicate to the prescribing doctor the name and manufacturer of the biological product provided to the patient. This communication must happen within three days after dispensing the product by an entry through an interoperable electronic medical records system, an electronic prescribing technology, a pharmacy benefit management system, or a pharmacy record. If an entry under this subsection is not possible, the pharmacist may communicate by e-mail, telephone, fax, or by any other prevailing means. Under subsection (d) provides an exception to the communication requirement under (c) if the dispensed biological product is a refill of the prescription and is the same biological product. Subsection (e) provides that communication provided under (c)(1) of this section is providing notice to the prescribing doctor. Under subsection (f), a pharmacist is required to maintain a record for two years after a biological product is dispensed. Finally subsection (g) defines "designee" as an agent or employee of a pharmacist who has been authorized to communicate information under subsection (c). Sec. 6 AS 08.80.480(34) Changes language, and gives option to change the term "drug" and "equivalent drug" to "biological product" and "interchangeable biological product". Sec. 7 AS 08.80.480 Adds new subsection (37) to define term "biological product". Adds new subsection (36) to define term "interchangeable biological product" as a biological product as determined by the United States Food and Drug Administration. Under subsection (A) provides that it meets the standard for interchangeability under US code (Regulation of biological products, Safety standards for determining interchangeability). Under subsection (B) provides that it is therapeutically equivalent in the most recent edition of the United States Food and Drug Administration evaluations. Sec. 8 AS 08.80.480 Amends this section by adding transition regulations if necessary to implement changes made by this Act. Having changes take place in accordance with AS 44.62 (Administrative Procedure Act) but not before the effective date of this Act. Sec. 9 AS 08.80.480 Adds language that section 8 of this Act takes effect July 1, 2017. Sec. 10 AS 08.80.480 Adds language that this Act will take effect January 1, 2018, except for a provided in section 9. MS. BUSHNELL stated that there were also several letters of support, including from the Alaska State Hospital and Nursing Home Association (ASHNHA) and from the Alaska State Medical Association (ASMA). She pointed out that ASMA had first written a letter of neutrality and, subsequently, had written a letter of support for the proposed bill. 4:36:21 PM CHAIR SPOHNHOLZ announced that SB 32 would be held over.