SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS  3:12:06 PM CHAIR SPOHNHOLZ announced that the next 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." 3:12:35 PM AIMEE BUSHNELL, Staff, Senator Shelley Hughes, Alaska State Legislature, briefly recapped the main points of the proposed bill, which included: only bio-similars approved by the U.S. Food and Drug Administration (FDA) as interchangeables could be substituted for the original prescription; within three days of dispensation of the product to the patient, a notification must be sent to the original prescriber; and, the prescriber can write "dispense as written" on the prescription, if this is the only product the prescriber wants for the patient. SENATOR SHELLEY HUGHES, Alaska State Legislature, reiterated that access to these medications was important to many Alaskans, and that the proposed bill described the arrangement and notifications between the doctor and the pharmacist. 3:15:13 PM CHAIR SPOHNHOLZ opened public testimony on SB 32. 3:15:22 PM ROBERT THOMS stated that he was also known as Cajun Bob and that he was a Vietnam combat veteran and a recipient of the Silver Star medal, as well as six Purple Hearts. He declared that he had chronic pain for more than 45 years, and that he had been diagnosed with severe rheumatoid arthritis. He reported that his original medication was not a biologic, which "after three years, it almost killed me." He said that he was then prescribed a biologic, Humera, which allowed him to enjoy a functional life after being bed ridden. He noted that, although he was not yet 100 percent, this had allowed him to do chores and projects with his wife. He declared that, although this biologic "was a miracle," he did not know if it would always work. He emphasized that it was necessary to approve this proposed legislation immediately, as he wanted to have immediately available any approved substitute, should this current biologic cease to work. 3:18:25 PM CINDY CASERTA shared that she was also a chronic pain sufferer, and that she spoke as an ambassador for the U.S. Pain Foundation in support of the proposed bill. She referenced a Stanford study of 6200 rheumatoid arthritis patients on biologics, pointing out that 33 percent of these patients stopped taking a biologic within two years because of a loss of effectiveness. She surmised that bio-similars could be the answer for Alaskans. 3:20:10 PM BECKY HULTBERG, President/CEO, Alaska State Hospital and Nursing Home Association (ASHNHA), reported that the Alaska State Hospital and Nursing Home Association had consulted with hospital-based pharmacists and physicians to ensure that the proposed bill would supply the necessary guidance to ensure safe and effective treatments for patients, while providing the potential to lower pharmaceutical costs. She reported that, following this consultation, ASHNHA decided to support the proposed bill. She declared that critical components of the bill included its specific communication requirements and timelines for pharmacists associated with dispensing bio-similar medication. She stated that the proposed bill would meet the needs of pharmacists in a variety of settings, and that the proposed bill strikes the right balance for notification and communication. She reported that bio-similars and interchangeable biological products offered affordability as they would provide competition to biologic drugs, similar to the way generic drugs did for brand name drugs. She offered her belief that proposed SB 32 would protect patients and would benefit the state. 3:21:43 PM PHIL SCHNEIDER, Alliance for Safe Biologic Medicines, paraphrased from a letter of support [included in members' packets], which read as follows [original punctuation provided]: As the chairman and advisory board chair of the Alliance for Safe Biologic Medicines (ASBM), we are writing to urge you to support Senate Bill 32 (SB 32) regarding the pharmacy substitution of biosimilar medical products. ASBM is an organization of patients, physicians, pharmacists, manufacturers of both innovative and biosimilar medicines, researchers and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. As a retired pediatric rheumatologist and a former president of the American Society of Health-system Pharmacists, we are keenly aware of the benefits of biologics in treating serious conditions like cancer, rheumatoid arthritis, diabetes, and MS. "Copies" of these medicines, called "biosimilars" have the potential to provide these therapies at reduced cost. Yet unlike generic versions of chemical drugs biosimilars are not exact duplicates of their reference products. Indeed, the complexity of biologics and their proprietary manufacturing processes mean that these "copies" can only ever be similar, never the same. Even the smallest structural difference between a biologic and its attempted copy can have a significant impact on a patient, including reduced efficacy or unwanted immune responses. We believe that when interchangeable biosimilar products are substituted, communication between patients, pharmacists, and health care providers is essential to patient care. We fully support and are concerned that patient safety will be compromised if this legislation is not enacted. Since 2012, ASBM has conducted surveys of physicians in eleven countries, to gather their perspectives on biosimilars. The results of these surveys have since been shared with policymakers in the U.S., Canada, Europe, and the World Health Organization in Geneva, Switzerland. Our survey of 376 U.S. physicians found that 80% of those surveyed called communication in the event of a biosimilar substitution "very important" or "critical". Further, 82% of U.S. physicians called the authority to block a substitution by indicating "do not substitute" or "dispense as written" on a prescription "very important" or "critical". These results are consistent with those of physicians around the world, including those surveyed in Canada and Europe, where biosimilars are currently in clinical use. All ASBM surveys are available on our website at www.safebiologics.org/surveys. It is our view that SB 32 appropriately reflects the importance of pharmacist-physician communication and keeping treatment decisions the purview of the physician and patient, without posing undue or onerous burdens upon the pharmacist: It provides that only "interchangeable" biosimilars (those determined by the FDA to produce the same effects in a patient as the reference product without additional risks) may ever be substituted. It allows a physician to prevent a substitution they consider inappropriate for their patient by writing on the prescription "dispense as written". It provides that the pharmacist receive the patient's consent in order to make a substitution. The Alliance for Safe Biologic Medicines - PO Box 3691 Arlington, VA 22203 www.safebiologics.org - (703) 971-1700 Finally, SB 32 requires that the pharmacist communicate to the physician within a reasonable time frame (3 days) which biologic the patient actually received whether that prescribed by the physician, or a substituted biosimilar- so that an accurate patient record can be kept by all parties. SB 32 will extend these valuable protections to Alaska's patients while increasing their access to biologic therapies. For these reasons, lawmakers in 26 states and Puerto Rico have passed similar bills in the past few years. 3:24:49 PM CHAIR SPOHNHOLZ asked about the substantial differences for side effects and efficacy for interchangeables. She asked whether it was safe for pharmacists to recommend changes at the pharmacy point of sale, rather than from the prescriber. MR. SCHNEIDER explained that biologics were medicines produced by living cells and that bio-similars were biologics, similar for the therapeutic effect and safety profile, but with minor differences which needed to be considered. He clarified that these were not considered to be interchangeable. He said that the third category was interchangeable bio-similar, which had been categorized by the FDA, based on studies which involved switching patients back and forth between the reference product to the bio-similar, and then back again. These studies had to demonstrate that the interchangeable bio-similar had no differences for both its effectiveness and its safety. He stated that the proposed bill only related to interchangeable bio-similars as considered by the FDA based on the switching studies. He added that the FDA stated that a pharmacist could switch those medicines. The purpose of the state laws was to ensure communication with the prescriber, even though that happened after the fact. 3:28:09 PM KERRY McCLELLAND, Colon Cancer Alliance, stating that he was advocating for all cancer patients, shared his history with cancer and various treatments. He declared that it was important to pass the proposed bill so that Alaskans would not have to travel out of state. 3:30:11 PM MARK GUIMOND, Director, Legislative Affairs, Arthritis Foundation, stated that the Foundation fully supported proposed SB 32. He pointed out that arthritis was a lifelong chronic disease, which could be debilitating. He stated that biologics offered a benefit, as they changed lives to a good quality of life. He pointed out that these were complex medications because they were live cells and were also very expensive. These represented .01 percent of prescriptions filled at pharmacies. He expressed hope that bio-similiars would have the same effect on the market as generic drugs. He suggested that it was best to pass this legislation immediately. He declared that the communication aspect of the proposed bill was essential, as it created a complete medical record for the patients. He declared support for the proposed bill. 3:33:24 PM THOMAS FELIX, MD, Amgen, stated support for the proposed bill, and he discussed one of the five provisions, key to the bill, which was a departure from existing generic substitution law in Alaska. He pointed to the requirement for a pharmacist to communicate with a physician following the substitution of an interchangeable bio-similar. He said that this ensured that members of the health care team were talking with each other, as this created transparency and accessibility to needed information. He allowed that some had advocated for no communication as it was too burdensome. He stated that there had been work with both pharmacists and stakeholders to make sure their perspectives were represented in the proposed bill to make it less burdensome. He said that communication prior to the substitution went against the spirit of the designation of interchangeability. He shared that the federal law which allowed the bio-similar pathway, the description for interchangeability was for the pharmacist to exercise their discretion for substitution without the consent of the prescriber. He relayed that it was important to understand that this facilitated drug safety surveillance, which was required for all biologics, and that bio-similars were also included. He reminded the committee that there were currently four approved bio-similars in the United States, of which two had not yet been distributed. He pointed out that, as two were self- administered, this legislation provided clear terms of use to both the health care team and the patient. He directed attention to a recent draft guidance for interchangeability, which was intended to provide clarity to the community for what was required to receive an interchangeability designation. He added that, as the FDA was very busy developing bio-similars which were trying to mimic 23 reference products coming off patent, there was a need to ensure that the health care community and patients had a clear understanding for use of these products, both when they were interchangeable and when they should not be substituted. He reminded that the FDA had set an appropriate scientific bar for approval of these products and that, once approved, they would be highly similar to an existing reference product and the differences in efficacy and safety should not be a concern. When an interchangeable was approved, it signaled that there was not a concern for its use when switching with the original product. Patients suffering from grievous illness will be comforted by knowing that the appropriate measures that comport with new technologies were being passed. 3:41:11 PM CRYSTAL KOENEMAN shared her personal story for the use of a biologic, Humera. She reported that, although this allowed her to play with her young child and function on a day to day basis, these were "scary. They change your chemical make-up and you are no longer the same." She reported that she had recently developed three lesions on her brain, which appeared similar to multiple sclerosis. She was then unable to take biologics for a few months, and now she relied on a name brand. She expressed her concern that with bio-similars, insurance companies would no longer cover name brands. She expressed her understanding that others could not afford the cost and that some bio-similars would work for some when the name brand did not. She expressed support for the proposed bill as it allowed for choice, but she expressed concern for her ability to choose to be taken away as an unintended consequence. She reported that she was not able to take any other biologic that would in any way affect her nervous system. She asked that the committee be cautious. 3:47:10 PM CHAIR SPOHNHOLZ closed public testimony. 3:47:20 PM CHAIR SPOHNHOLZ moved to adopt Amendment 1, labeled 30- LS0188\J.3, Wallace/Bruce, 4/13/17, which read: Page 4, following line 10: Insert a new bill section to read:  "* Sec. 8. AS 21.42 is amended by adding a new section to read: Sec. 21.42.435. Coverage for biological products. (a) A health care insurer that offers, issues for delivery, delivers, or renews in this state a health care insurance plan that provides coverage for biological products shall provide coverage for a biological product or interchangeable biological product without requiring prior authorization if the biological product or interchangeable biological product is to be dispensed as prescribed. (b) In this section, "biological product" and "interchangeable biological product" have the meanings given AS 08.80.480." Renumber the following bill sections accordingly. Page 4, line 17: Delete "Section 8" Insert "Section 9" Page 4, line 18: Delete "sec. 9" Insert "sec. 10" CHAIR SPOHNHOLZ objected for discussion. CHAIR SPOHNHOLZ explained that a "tsunami" of as many as 41 biologic interchangeables was coming and working through the FDA process. She noted how important biologics were for those who took them, as well as the transformative nature they could have for individuals. She shared the story of a biologic that cost $2000 each day. She explained that her proposed amendment would require that health insurance plans provide coverage for biological products, both interchangeables and biologicals, without prior authorization if the product was to be dispensed as prescribed. She said that this would require coverage of a medication prescribed by a doctor and not necessarily the cheapest one, as a small difference in a product could have a big impact on the health and well-being of an individual. She wanted to ensure that people with serious health care issues in the state be able to have health care coverage by the insurance providers, and that cost not be the only consideration. 3:50:09 PM REPRESENTATIVE KITO reflected on the history of the change to generic drugs from name brand drugs, noting that, as there were some changes, some individuals reacted adversely. He encouraged that the insurance companies be sensitive to provide medications as needed for the patient as identified by the medical team. 3:51:26 PM CHAIR SPOHNHOLZ withdrew proposed Amendment 1. 3:51:40 PM REPRESENTATIVE EASTMAN expressed his support of the proposed bill. 3:51:45 PM REPRESENTATIVE EDGMON moved to report SB 32 out of committee with individual recommendations and the accompanying fiscal notes. There being no objection, SB 32 was moved from the House Health and Social Services Standing Committee. 3:52:03 PM