SILVER STATE SCRIPTS BOARD MEETING MINUTES Date and Time of Meeting: Thursday, June 25, 2020 at 1:00 PM Name of Organization: The State of Nevada, Department of Health and Human Services (DHHS), Division of Health Care Financing and Policy (DHCFP) Public comment is limited to five minutes per individual, organization, or agency, but may be extended at the discretion of the Chairperson. Attendees Board Members (Present) Board Members (Absent) Mark Decerbo, Pharm.D., Chair Aditi Singh, MD Joseph Adashek, MD Evelyn Chu, Pharm.D. Mark Crumby, Pharm.D. Michael Hautekeet, RPh Sapandeep Khurana, MD Brian Passalacqua, MD Kate Ward, Pharm.D. DHCFP: Holly Long, Social Services Program Specialist III Gabriel Lither, DAG Ellen Flowers, Program Officer I Antonio Gudino-Vargas, Social Services Program Specialist II Tammy Moffitt, Social Services Chief III DuAne Young, Deputy Administrator DXC: Jovanna Leid, Pharm.D. OputmRx: Carl Jeffery, Pharm.D. Kevin Whittington, RPh Daniel Medina Public: Maria Agapoval David Large, Biohaven Pharmaceuticals Karen Beattie, Carson City Community Counseling Jimmy Lau Center Jennifer Lauper Jeanette Belz, J. K Belz and Associates Chelsea Leroue, Biohaven Pharmaceuticals Kenneth Berry, Alkermes Lori McDermott, Supernus Josh Bishop Melisa McEwen, OAPI Lorraine Bonaldi, Renovations Mental Health Hector Mobine Jeana Colabianchi, Sunovion Dan Musgrove, Strategies 360 Dana Conell Valerie Ng, Indivior Christa Cooper Joanne Nguyen David Cram, Takeda Gary Okano, BMS Ashley Cruz, Carrara Nevada Carmen Oliver, Biohaven Pharmaceuticals Leslie Dixon, Nevada Psychiatric Association Valerie Padovani Ben Droese, Amgen Hiten Patadia, Otsuka Pharmaceuticals Mark Duerre Deborah Profant Michelle Duke, Genentech Warner Quon, Ascendis Dawn Dynak Leon Ravin, DPBH Georgette Dzwilewski, INDIVIOR Robin Reedy, NAMI David Freilich Carol Ricciotti Jenna Gianninoto, AbbVie Lovell Robinson, ABBVIE Sharron Glass, Alimera Sciences Nicole Robling Suzann Gordon Amy Rodenburg Shannon Groppenbacher, JJHCS William Rowe, Intra-Cellular Therapies, Inc. Deron Grothe, Teva Erin Shaal Penny Higashi, Boehringer Ingelheim Alice Swett Lee Hochner, Amneal Pharmaceuticals Trent Taylor, Johnson & Johnson Anthony Hoovler Ashlie Temple, Albertsons/Safeway Pharmacies Greg Horikoshi, Novo Nordisk Stephanie Yamamoto Steve Isaki, Lundbeck Kelvin Yamashita Chi Kohlhoff, Viela Bio Michael Zarob, Alkermes William Lai, Xeris Pharmaceuticals David Zimmerman 1:00 PM – 2:00 PM – Closed Executive Session Attendance: Sapandeep Khurana Mark Crumby Evelyn Chu Kate Ward Holly Long, DHCFP Brian Passalacqua Gabriel Lither, DHCFP Mark Decerbo Jovanna Leid, DXC Michael Hautekeet Kevin Whittington, OptumRx Joseph Adashek Carl Jeffery, OptumRx 2:00 PM – 5:00 PM – Public Meeting (Open Session) AGENDA 1. Call to Order and Roll Call Meeting called to order at 2:00 PM. Mark Decerbo, Chair: Good afternoon. I would like to call the meeting to order for the Silver State Script Board. We do have seven of the nine members in attendance, so we do have a quorum. We will start with a roll call. Evelyn Chu Mark Crumby Mark Decerbo, Chair Mike Hautekeet Sapandeep Khurana Kate Ward Joseph Adashek 2. Public Comment on Any Matter on the Agenda Mark Decerbo, Chair: We will start with general public comments. I would ask that if you are here to provide testimony on a specific agent, please hold your public comment until your therapeutic class is presented. Robin Reedy: This is Robin Reedy. I have a general comment and a comment for later in the meeting. Mark Decerbo, Chair: Ok, before I turn it over to you, I just want to remind everyone that we have three minutes for public comment. We will have a timer on the screen so you can see how much time you have left. Robin Reedy: I am the Executive Director for NAMI Nevada. Distinguished members of the board, on behalf of NAMI, Nevada, the state chapter of the National Alliance on Mental Illness. I would like to offer our views on the impact of your decisions on our members, families and all those that live with a mental health condition. The current healthcare crisis and our corresponding economic crisis has only exacerbated the effect that you have. As a matter of principle, NAMI is in support of open access to all safe and effective medications for mental health conditions as prescribed by qualified health care professionals. We support excluding anti-psychotic medication from any non-clinically based restrictive formulary measures. Access to meds is crucial. Without the right medications at the right time, they may struggle, have worsening conditions and experience dramatic negative consequences. Effectiveness and side effects vary for every person being put on one med may map the brain and another med that may have worked well before will not work now. Various levels of severity, different levels of effectiveness and the flexibility needed in drug policy and access to all drugs, shows improvement in treatment and outcomes. NAMI believes that the decision to prescribe medication to patients with a mental health condition should be based on the clinical judgment of the treatment providers. Research has shown that prior authorizations, denials for psychiatric populations, results or outcomes, which include increased utilization of ER, higher incarceration and higher usage of mental health inpatient hospitalizations. Thank you. 3. Administrative a. For Possible Action: Review and Approve Meeting Minutes from March 26, 2020. Page 3 of 18 Mark Decerbo, Chair: Thank you. Do we have any other general public comment? I am not seeing any other comment or comments in the chat box. We will move to review and approval of the meeting minutes from our last meeting. Do we have additions, edits, clarification or deletions from the minutes? Hearing none, by unanimous consent, the minutes will stand as approved. Next we will have an update by the DHCFP. b. Status Update by the DHCFP Holly Long: Thank you Dr. Decerbo, this is Holly Long, I am the supervising Social Services Program Specialist for Pharmacy Services at the DHCFP. I just have a couple of quick announcements. The DHCFP recently received approval from CMS for the Disaster Relief SPA submitted to address COVID-19 response efforts. This relief State Plan Amendment provides Nevada Medicaid approval to make specific changes related to the National Emergency declared due to COVID-19 outbreak. And the DHCFP has also created a COVID Billing Guide, which is posted with other provider billing guides on the DHHS Medicaid provider site. There is a general COVID Billing Guide. And in addition to that, there is one specific to COVID Community-Based Testing. This concludes the DHCFP updates, thank you. Mark Decerbo, Chair: Thank you. We will start our presentations today. Some housekeeping first. We will be unmuting lines for public comments, so please mute your line if you are not speaking. Public comment is limited to three minutes. Optum will be displaying their recommendation for preferred and non-preferred, so please take a look at that prior to your testimony. I will turn it over to Carl. Holly Long: This is Holly. Not only will Carl and Kevin be presenting the information, we will be posting the letters and emails that were provided to the State prior to the meeting to the DHCFP public notices site. These were also shared with the board prior to the meeting today. 4. Proposed New Drug Classes a. For Possible Action: Discussion and possible adoption of hormones and hormone modifiers, anti- hypoglycemic agents Carl Jeffery: Good afternoon, thank you for joining us today. Our first class is the Hormones and Hormone Modifiers, anti-hypoglycemic agents. This is a new class of medications and as you can see here, we have our proposed list shown with the glucagon emergency kit recommended as preferred and Baqsimi and Gvoke recommended as non-preferred. We have some written testimony; I am showing that now. The letter is from the manufacturer of Gvoke and there is a lot of information in here. This was sent to the board and will be posted publicly after the meeting. Do we have other comment for this class? Mark Decerbo, Chair: Do we have any public comment? William Lai: My name is William Lai with Xeris Pharmaceuticals. I’m here on behalf of the company to represent Gvoke, a liquid stable glucagon that received FDA approval in September 2019. I am here to present some clinical data, and some thought as to why this should be included on the preferred drug list. Over 30 million adults and children in the US have diabetes, and approximately 7.4 million Americans are treated with insulin annually. In 2014, approximately 14.2 million emergency department visits for ages 18 years and older for hypoglycemia. Currently the standard of care is the glucagon emergency kit. These kits are a multistep process to prepare and administer, usually eight to 11 steps. Handling difficulties as well as inaccuracies in administering these doses have been recorded in the literature. Approximately only one-third of these patients and their families are able to successfully administer the full dosage. If left untreated, severe hypoglycemia can worsen to conditions such as seizures or coma or death. The American Diabetes Associates standard of care states glucagon should be prescribed for all individuals at an increased risk of level two hypoglycemia, that is defined as blood glucose levels of less than 54 milligrams per deciliter. In September 2019, the FDA approved the first and only premixed, prefilled Page 4 of 18 and pre-measured liquid glucagon in both the prefilled syringe as well as the auto injector. The auto injector is very similar to an EpiPen with the two-step process. You open the cap and then inject perpendicular to the skin. It is approved for adults and pediatric patients aged two and above. It can be stored at room temperature and has a shelf-life of approximately 40 months. In terms of clinical data, this has been evaluated in two adult trials and a pediatric trial.