AMCP eLearning Days

• Provided by Pharmacy Times Continuing Education™. 
• Supported by GlaxoSmithKline. 
• Continuing education credit available for pharmacists. 
• Contact hours: 1 

Cancer of the endometrium is the most common gynecologic malignancy in the United States and accounts for 6% of all cancers in women (Board 2019). Approximately 66,570 new cases and more than 12,940 deaths were estimated in the United States in 2021 from uterine cancer. (Siegel, 2021) The majority of cases are diagnosed at an early stage and are amenable to treatment with surgery alone. Five-year overall survival (OS) in patients without metastatic disease ranges from 74% to 91%. (Morice, 2016) An improved understanding of the molecular underpinnings of endometrial cancer has led to the development of novel treatment modalities that may help improve survival and quality of life. Additions to the therapeutic armamentarium include immunotherapies and targeted therapies, with novel mechanisms of action and the potential for delayed-onset adverse effects. There is a clear need for educational activities that provide relevant perspectives on emerging data and best practices for the use of novel therapies in endometrial cancer. Managed care professionals play a key role in ensuring optimal patient outcomes through usage of appropriate biomarker-guided treatment selection for recurrent, metastatic, and high-risk endometrial cancer. Through this activity, managed care professionals will become well-versed on the evolving treatment paradigm for endometrial cancer, including relevant efficacy and safety data that support the use of these agents, guideline recommendations, available biomarker assays, and strategies to implement cost-effective treatment that optimize healthcare resource usage and patient outcomes. This 1-hour educational activity will feature 2 faculty, a clinical oncology expert and a managed care professional, as they discuss the recent and emerging advances in the care of patients with endometrial cancer and best practices in applying the clinical data to managed care considerations.  

Learning Objectives 

• Demonstrate understanding of the epidemiology of endometrial cancer and the role of biomarkers in guiding treatment with novel therapies. 

• Determine the guideline-recommended role of molecularly targeted and immune-based therapies in the management of endometrial cancer. 

• Evaluate the evidence regarding cost of care and cost-effectiveness of novel immunotherapy in the treatment of endometrial cancer. 

Program Manager 

Kylie Ferrentino 
Pharmacy Times Continuing Education™  
View Email Address 

Pre-approval information exchange (PIE) allows manufacturers to communicate certain information about investigational therapies and new indications with payers and health plans to facilitate timely formulary reviews, coverage, and reimbursement decisions for these products. The information that can be shared in PIE communications includes results from clinical trials, endpoints and populations studied, product pricing information, and the anticipated timeline for Food and Drug Administration (FDA) action. The dissemination of appropriate clinical and economic information is critical to expedite coverage decisions and ultimately provide faster patient access to innovative therapies.

There remains some confusion about PIE despite great interest from manufacturers and payers alike. For instance, while the FDA issued guidance in 2018 that clarified that manufacturers can engage in PIE, there remains confusion about whether PIE communications can be done proactively or only upon receipt of an unsolicited request from a payer or health plan. AMCP’s Policy and Government Relations team will dive into outstanding issues discouraging PIE communications under current sub-regulatory guidance and examine current legislative proposals to promote PIE. Attendees will learn about AMCP’s support for a legislative safe harbor for proactive PIE communications and how they can become involved in advocacy efforts supporting this legislation.

Learning Objectives 

At the completion of this activity, participants should be able to: 

• Identify which audiences are allowed to receive PIE communications from manufacturers. 
• Outline two issues with current sub-regulatory guidance that unintentionally discourage PIE communications. 
• Identify the guidance that motivated the development the PIE guidance. 

Target Audience 

This knowledge-based activity has been designed to meet the educational needs of pharmacists in managed care settings. 

Faculty  

Adam Colborn, JD 
Director, Government Relations  
AMCP 
Alexandria, Virginia 

Jennifer L. Mathieu, MA 
Vice President, Policy & Government Relations 
AMCP 
Alexandria, Virginia 

Moderator: 

Kristie Yadro, PharmD
Director, Medical Value and Access Strategy
Astellas Pharma US, Inc.
Newtown, Pennsylvania 

Agenda  

12–12:05pm — Welcome and Introductions 

• Kristie Yadro, PharmD

12:05–12:50pm — Come (Learn) PIE With Me 

• Adam Colborn, JD  
• Jennifer L. Mathieu, MA 

12:50–1pm — Audience Q&A 

• Kristie Yadro, PharmD

Continuing Education Credit — Pharmacists 

The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 

As an ACPE-accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of CPE activities. It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias. 

Earning CPE Credit 

To earn continuing pharmacy education (CPE) credit for this program, you must attend the entire session and participate in the pre- and post-test questions. Once completed, go to http://amcplearn.org to claim CPE credit. In the enrollment code redemption area, enter the enrollment code provided during the session. Complete the program evaluation and enter your NABP ID, birth month and birthday. All CPE credit for this webinar activity must be completed no later than 5:00pm ET on Monday, June 6, 2022. No exceptions can be made after this date. 

• ACPE UAN #: 0233-0000-22-024-L03-P  
• Credit: 1.0 contact hours (0.1 CEU) 
• Activity Type: Knowledge-based 
• Activity Fee: There is no fee to participate in this activity for members and there is $50 fee for non-members. 

System Technical Requirements/Viewing Requirements: 

• For all activities you should have a basic comfort level using a computer and navigating web sites. 
• The live webinar is delivered through GoToWebinar. View minimum technical and system requirements for GoToWebinar. Space is limited to the first 1000 participants that join the webinar. 
• The handout will be delivered via Acrobat PDF. 
• CPE credit will be claimed through AMCP Learn. View the minimum technical and system requirements for AMCP Learn. 

Press 

For individuals from the media/press who are interested in attending, please email media@amcp.org.   

Innovation in oncology is occurring at a swift pace, with ever-expanding options and promise of improved outcomes. Many oncolytic agents recently approved by the Food and Drug Administration or pending approval in coming months are considered to be breakthrough therapies, offer extended indications, or are formulations changing the place of care. Managing the increasing number of high-cost agents, determining value and outcomes, and minimizing toxicities pose challenges when developing utilization policies for these valuable advances in treatment. 

During this session, faculty will highlight recently approved oncology indications or novel mechanisms of action, discuss the place in therapy for these newly approved agents, and focus on managed care considerations related to payment models, access to care, and oncology care pathways. This session will also explore emerging therapies in the oncology pipeline. 

Learning Objectives 

At the completion of this activity, participants should be able to: 

• Identify recently approved high impact oncology agents with novel indications for use or targeted mechanisms of action.  
• Discuss the potential place in therapy of oncology agents likely to be approved in the next six months. 
• Review the financial and operational impact of newly approved therapies on patients, care providers, and health plans 
• Distinguish formulary considerations for newly approved and emerging oncology treatments. 

Target Audience 

This knowledge-based activity has been designed to meet the educational needs of pharmacists in managed care settings. 

Faculty  

Timothy Mok, PharmD, BCPS, BCOP 
Hematology Oncology Pharmacy Research Analyst  
Kaiser Permanente 
Livermore, California 

Philip Schwieterman, PharmD, MHA 
Pharmacist 
University of Kentucky Healthcare 
Lexington, Kentucky 

Moderator: 

Jonny Clark, PharmD 
Consultant
Blue Fin Group
Saint Petersburg, Florida 

Agenda

3–3:05pm — Welcome and Introductions 

• Jonny Clark, PharmD 

3:05–3:50pm — Managed Care Perspectives for the Rapidly Evolving Oncology Landscape 

• Timothy Mok, PharmD, BCPS, BCOP 
• Philip Schwieterman, PharmD, MHA 

3:50–4pm — Audience Q&A 

• Jonny Clark, PharmD    

Continuing Education Credit — Pharmacists 

The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 

As an ACPE-accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of CPE activities. It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias. 

Earning CPE Credit 

To earn continuing pharmacy education (CPE) credit for this program, you must attend the entire session and participate in the pre- and post-test questions. Once completed, go to http://amcplearn.org to claim CPE credit. In the enrollment code redemption area, enter the enrollment code provided during the session. Complete the program evaluation and enter your NABP ID, birth month and birthday. All CPE credit for this webinar activity must be completed no later than 5:00pm ET on Monday, June 6, 2022. No exceptions can be made after this date. 

• ACPE UAN #: 0233-0000-22-025-L01-P 
• Credit: 1.0 contact hours (0.1 CEU) 
• Activity Type: Knowledge-based 
• Activity Fee: There is no fee to participate in this activity for members and there is $50 fee for non-members. 

System Technical Requirements/Viewing Requirements: 

• For all activities you should have a basic comfort level using a computer and navigating web sites. 
• The live webinar is delivered through GoToWebinar. View minimum technical and system requirements for GoToWebinar. Space is limited to the first 1000 participants that join the webinar. 
• The handout will be delivered via Acrobat PDF. 
• CPE credit will be claimed through AMCP Learn. View the minimum technical and system requirements for AMCP Learn. 

Press 

For individuals from the media/press who are interested in attending, please email media@amcp.org.   

• Provided by Pharmacy Times Continuing Education™.
• Supported by GlaxoSmithKline. 
• Continuing education credit available for pharmacists. 
• Contact hours: 1 

Program Description 

Multiple myeloma (MM), characterized by malignant plasma cell expansion in the bone marrow, is the second most common hematologic malignancy in the United States and accounts for 1% of all cancers and 10% of all hematologic malignancies, with an estimated 32,370 new cases and an estimated 12,830 deaths in 2020. [Shah 2020; Cho 2018; American Cancer Society 2018] Despite clinical advances, MM is not currently considered curable, and progression to relapsed/refractory MM (RRMM) has become an expected part of the disease course and is associated with poorer outcomes. [Shah 2020] This highlights a gap in care and the need for other, novel treatment options to improve care, provide durable responses, a potential cure, and optimize patient outcomes. One such novel approach to MM treatment is targeting B-cell maturation antigen (BCMA). BCMA is overexpressed and activated in MM. As a result, it has emerged as a potential therapeutic target for MM to improve the treatment landscape. Three various modalities for targeting BCMA include bispecific antibody construct therapies, antibody-drug conjugates (ADCs), and chimeric antigen receptor (CAR)-modified T-cell therapy. [Shah 2020] Maintaining knowledge of evolving treatment options as part of an interdisciplinary team can be difficult. The purpose of this activity is to educate managed care pharmacists working in oncology on clinically relevant data in the literature regarding the novel approach to the treatment of MM using BCMA to improve patient outcomes. This 1-hour educational activity will feature 2 faculty, a clinical oncology expert and a managed care professional, as they discuss the recent and emerging advances in BCMA-targeted treatments in MM and best practices in applying the clinical data to managed care considerations. 

Learning Objectives 

• Illustrate the mechanism of BCMA as a therapeutic target for multiple myeloma (MM) to better understand the use of these targeted therapies in treatment algorithms. 
• Evaluate the place in therapy for BCMA-targeted therapies in MM and the patient populations who may be candidates for treatment.  
• Analyze strategies for evaluating and developing clinical eligibility criteria for the cost-effective use of BCMA-targeted therapies in the treatment of MM. 

Program Manager 

Kylie Ferrentino 
Pharmacy Times Continuing Education™  
View Email Address 

The growing, evolving specialty pipeline presents an opportunity for payers to assess how they anticipate and prepare for potential financial impacts brought on by new-to-market specialty drugs. This session will provide an overview of data points and best practices available to payers, as well as how to leverage these tools to build valuable cost impact analyses and achieve cost-effective health outcomes.  

Faculty will review the specialty pipeline’s overall potential financial ramifications and opportunities that exist to analyze and anticipate post-approval impact. The faculty will also illustrate this process through two real-world case studies of researching and calculating cost impacts in U.S.-wide patient populations, and how those models can be incorporated into plan forecasts.  

Learning Objectives 

At the completion of this activity, participants should be able to: 

• Identify the potential impact of the specialty pipeline and the importance of preparedness for new-to-market drugs.  
• Describe the important data points that make up comprehensive cost impact models.  
• Explain how to develop a game plan for building out valuable cost impact models.  
• Summarize how cost models can generate an overall forecast for a health plan.  

Target Audience 

This knowledge-based activity has been designed to meet the educational needs of pharmacists in managed care settings. 

Faculty  

Katie Lockhart, MA 
Manager, Forecasting and Pharmacoeconomics  
Magellan Rx Management 
Scottsdale, Arizona 

Brian K. MacDonald, PharmD 
Director, Specialty Clinical Strategy 
Magellan Rx Management 
Middletown, Rhode Island 

Moderator: 

Brittany V. Henry, PharmD, MBA
Assistant Director, Educational Programs
AMCP
Alexandria, Virginia

Agenda 

12–12:05pm — Welcome and Introductions 

• Brittany V. Henry, PharmD, MBA

12:05–12:50pm — Dollars and Sense: Leveraging Data and Minimizing Noise to Estimate Cost Impact in the Specialty Pipeline 

• Katie Lockhart, MA  
• Brian K. MacDonald, PharmD 

12:50–1pm — Audience Q&A 

• Brittany V. Henry, PharmD, MBA 

Continuing Education Credit — Pharmacists 

The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 

As an ACPE-accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of CPE activities. It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias. 

Earning CPE Credit 

To earn continuing pharmacy education (CPE) credit for this program, you must attend the entire session and participate in the pre- and post-test questions. Once completed, go to http://amcplearn.org to claim CPE credit. In the enrollment code redemption area, enter the enrollment code provided during the session. Complete the program evaluation and enter your NABP ID, birth month and birthday. All CPE credit for this webinar activity must be completed no later than 5:00pm ET on Monday, June 6, 2022. No exceptions can be made after this date. 

• ACPE UAN #: 0233-0000-22-027-L01-P 
• Credit: 1.0 contact hours (0.1 CEU) 
• Activity Type: Knowledge-based 
• Activity Fee: There is no fee to participate in this activity for members and there is $50 fee for non-members. 

System Technical Requirements/Viewing Requirements: 

• For all activities you should have a basic comfort level using a computer and navigating web sites. 
• The live webinar is delivered through GoToWebinar. View minimum technical and system requirements for GoToWebinar. Space is limited to the first 1000 participants that join the webinar. 
• The handout will be delivered via Acrobat PDF. 
• CPE credit will be claimed through AMCP Learn. View the minimum technical and system requirements for AMCP Learn. 

Press 

For individuals from the media/press who are interested in attending, please email media@amcp.org.   

Advancements in treating chronic kidney disease (CKD) are being driven by an increased understanding of disease mechanisms and the use of precision medicine approaches to target the underlying causes. It is anticipated that several new treatment options will be approved by the Food and Drug Administration in the next five years. While the new agents may represent scientific advancements, the cost of these treatments will also require assessment of budget impact and appropriate managed care strategies to ensure safe and appropriate use in patients.  

Faculty will provide an overview of current CKD management and a summary of treatment advances likely to be available in the near future. This session will also demonstrate the importance of addressing health disparities in CKD, addressing patient quality of life, and understanding the financial impact of novel therapies.  

Learning Objectives 

At the completion of this activity, participants should be able to: 

• Discuss the recent treatment and emerging pipeline advancements targeting the underlying causes of chronic kidney disease. 
• Describe key health disparities that can impact access to chronic kidney disease care. 
• Discuss the burden of chronic kidney disease on patients and the impact on quality of life. 
• Describe the financial impact of treating chronic kidney disease in the US. 

Target Audience 

This knowledge-based activity has been designed to meet the educational needs of pharmacists in managed care settings.  

Faculty  

Megan Chynoweth, PharmD, APh, CDCES, BCACP  
Ambulatory Care Pharmacist 
Kaiser Permanente  
Ventura, California 

Emmanuel Mensah, MD, MBA 
Attending Physician / Firm Chief 
Beth Israel Deaconess Medical Center / Harvard Medical School 
Brookline, Massachusetts 

Moderator

YuQian Liu, PharmD, RPh
Director, Specialty Clinical Solutions
Magellan Rx Management
North Kingstown, Rhode Island 

Agenda

3–3:05pm — Welcome and Introductions 

• YuQian Liu, PharmD, RPh

3:05–3:50pm — Chronic Kidney Disease: Impact of Next Generation Therapeutics 

• Megan Chynoweth, PharmD, APh, CDCES, BCACP  
• Emmanuel Mensah, MD, MBA  

3:50–4pm — Audience Q&A 

• YuQian Liu, PharmD, RPh

Statement of Commercial Support 

This activity is supported by an independent educational grant from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company. 

Continuing Education Credit — Pharmacists 

The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 

As an ACPE-accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of CPE activities. It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias. 

Earning CPE Credit 

To earn continuing pharmacy education (CPE) credit for this program, you must attend the entire session and participate in the pre- and post-test questions. Once completed, go to http://amcplearn.org to claim CPE credit. In the enrollment code redemption area, enter the enrollment code provided during the session. Complete the program evaluation and enter your NABP ID, birth month and birthday. All CPE credit for this webinar activity must be completed no later than 5:00pm ET on Monday, June 6, 2022. No exceptions can be made after this date. 

• ACPE UAN #: 0233-0000-22-026-L01-P 
• Credit: 1.0 contact hours (0.1 CEU) 
• Activity Type: Knowledge-based 
• Activity Fee: There is no fee to participate in this activity for members and non-members. 

System Technical Requirements/Viewing Requirements: 

• For all activities you should have a basic comfort level using a computer and navigating web sites. 
• The live webinar is delivered through GoToWebinar. View minimum technical and system requirements for GoToWebinar. Space is limited to the first 1000 participants that join the webinar. 
• The handout will be delivered via Acrobat PDF. 
• CPE credit will be claimed through AMCP Learn. View the minimum technical and system requirements for AMCP Learn. 

Press 

For individuals from the media/press who are interested in attending, please email media@amcp.org.   

• Provided by Pharmacy Times Continuing Education™. 
• Supported by Bristol Myers Squibb. 
• Continuing education credit available for pharmacists. 
• Contact hours: 1

Program Description 

Myelofibrosis (MF) is a rare blood cancer with a high rate of mortality within several years of diagnosis. Between 16,000 and 18,500 Americans have been diagnosed with myelofibrosis; about 1 of every 100,000 people is expected to be diagnosed with MF annually, with the median age of diagnosis from 60 to 67 years. [Celgene] Studies have shown that stemming disease progression can extend life significantly. Recent advances in therapeutic approaches using gene therapy offer hope to patients with a diagnosis of MF. With currently 2 Janus-associated kinase (JAK) inhibitor drugs on the market, and with several others in the pipeline, the JAK inhibitors are changing the therapeutic landscape. Each JAK inhibitor has a slightly different mechanism of action and gene targets, making it critical to distinguish among them for individual patients. Managed care pharmacists need to understand the pathogenesis of myelofibrosis, including its primary and secondary manifestations, as well as its clinical signs and symptoms that provide valuable information about disease progression and treatment selection. Through this educational program, managed care professionals will be educated about current and emerging JAK inhibitors in the treatment and management of myelofibrosis. Continuing professional education will improve knowledge of MF and the application of that knowledge to encourage appropriate management of this disease and appropriate use of newly approved therapies. This 1-hour educational activity will feature 2 faculty, a clinical expert and a managed care professional, as they discuss the recent and emerging advances in the care of patients with myelofibrosis and best practices in applying the clinical data to managed care considerations.  

Learning Objectives 

• Review the etiology, pathophysiology, and prognostic scoring system of myelofibrosis.  
• Analyze the treatments for myelofibrosis along with the clinical data for JAK inhibitors and pipeline targeted therapies.  
• Interpret the quality of life and financial toxicity for patients with myelofibrosis and the resources available to assist this population. 

Program Manager 

Kylie Ferrentino 
Pharmacy Times Continuing Education™  
View Email Address 

• Provided by Pharmacy Times Continuing Education™ 
• Supported by Bristol Myers Squibb 
• Continuing education credit available for pharmacists 
• Contact hours: 1 

Program Description 

Multiple sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that affects more than 400,000 people in the United States and over 2.3 million people worldwide. [Rae-Grant 2018] The incidence of MS has increased significantly over the past decade, and women are disproportionately affected. [Zurawski 2018] MS is a chronic disease characterized by plaque or lesion formation, which damages cells, causing symptoms such as vision loss, double vision, limb weakness, and ataxia. It also causes demyelination in the CNS. [Apostolopoulos 2020] The treatment of MS presents many challenges. Unfortunately, there are no medications that can fully prevent or reverse symptoms. [Rae-Grant 2018] Therapy for MS that not only stops or reverses progression but also has minimal adverse effects is greatly needed. Immunotherapy has improved vastly, and more options will become available as research progresses. Biomarkers are another area in MS research that may have promising results in the future. [Solomon 2017] The identified gaps indicate a need to educate pharmacists on current and emerging strategies for the treatment and care management of MS. Continuing professional education will improve the competency of MS and its clinical burden and will enhance clinical decision making. Application of knowledge will facilitate the implementation of care strategies that support guideline-directed therapy and promote positive outcomes for quality of life and cost of care. This 1-hour educational activity will feature 2 faculty, a clinical expert and a managed care professional. The program will feature a unique Patient Perspective that will be delivered as a video interview. 

Learning Objectives 

• Discuss the clinical presentation, classification, and diagnostic challenges of multiple sclerosis (MS).  
• Assess the latest data on the efficacy and safety of new and emerging therapies for MS.  
• Examine the role of managed care professionals in the management of MS. 

Program Manager 

Kylie Ferrentino 
Pharmacy Times Continuing Education™  
kferrentino@pharmacytimes.com 

This session is supported by Amgen Inc.  

Collaborations allow stakeholders to pilot programs, solutions, and initiatives in a collaborative manner to deliver the highest value care. This collaboration focused on improving patient outcomes and adherence to guideline-based care. This session will review the findings and lessons learned from Amgen, Optum Life Sciences, and a health plan network ACO collaborating to improve the blood cholesterol outcomes in atherosclerotic cardiovascular disease (ASCVD) patients by providing guideline-based treatment.  

The reinforcement of and adherence to guideline-based care for any healthcare entity is important because guidelines, by definition, offer recommendations and thresholds for who, how and when to treat patients. Cardiovascular disease is a leading public health issue in the United States. Risk of incurring a cardiovascular event decreases when patients meet guideline-based lipid-management goals. Guidelines from the American College of Cardiology/ American Heart Association (ACC/AHA) have been updated in recent years to indicate the benefit of lipid management. However, subsequent care has been inconsistent across the healthcare system.  

The faculty will share how the collaboration used a team-based approach across patient, provider, and payer stakeholders, reinforced by consistent communication and reference to guidelines, to improve blood cholesterol outcomes in a pilot with an accountable care organization.  

Learning Objectives 

At the completion of this activity, participants should be able to: 

• Understand the impact of CVD in the US and barriers to addressing ASCVD 
• Highlight a novel collaboration to utilize a team-based approach with patient communication to improve blood cholesterol outcomes 
• Discuss the importance of following guideline-based treatment in cardiovascular disease to improve quality of care and appropriate use of treatments 
• Understand how payers and providers can use data to incorporate guideline-based care recommendations with patients and into daily practice processes  

Faculty  

Bethany Kalich, PharmD 
Medical Director, Cardiovascular Medical Affairs 
Amgen  
San Antonio, Texas 

Brian K. Solow, MD 
Chief Medical Officer 
Optum Life Sciences  
Irvine, California  

Moderator: 

Annie Schuster, PharmD, FAMCP
Clinical Programs, Sr Director
CIGNA Health Corporation
Franklin, Tennessee   

Agenda 

12–12:05pm — Welcome and Introductions  

• Annie Schuster, PharmD, FAMCP   

12:05–12:50pm — Lessons Learned: A Collaboration to Support Cardiovascular Disease Guidelines-based Adherence  

• Bethany Kalich, PharmD   
• Brian K. Solow, MD  

12:50–1pm — Audience Q&A  

• Annie Schuster, PharmD, FAMCP 

System Technical Requirements/Viewing Requirements 

• For all activities you should have a basic comfort level using a computer and navigating web sites. 
• The live webinar is delivered through GoToWebinar. View minimum technical and system requirements for GoToWebinar. Space is limited to the first 1000 participants that join the webinar. 
• The handout will be delivered via Acrobat PDF. 
• CPE credit will be claimed through AMCP Learn. View the minimum technical and system requirements for AMCP Learn. 

Press 

For individuals from the media/press who are interested in attending, please email media@amcp.org.   

The digital therapeutics market is rapidly growing, with thousands of digital therapeutics products now available. With this rise brings the need for health plans to develop formulary strategies and coverage determinations for these products, and importantly the ability to distinguish prescription digital therapeutics (PDTs) and non-prescription therapeutics.  

The FDA review and authorization process for PDTs is similar in some respects to the approval process for prescription drugs, yet there are evidentiary and technology assessment differences due to the different statutory and regulatory standards for medical devices (including PDTs) and drugs. Understanding the extent of clinical trial design, data collection, and post-marketing surveillance can assist in the evaluation of digital therapeutics, particularly FDA-cleared or authorized PDTs compared to unapproved products (including wellness apps and other digital health products). 

Since the first FDA-authorized digital therapeutic in 2017, at least nine prescription digital therapeutic products have gained FDA authorization or clearance for a variety of clinical indications. Payers now have FDA review and authorization information when making formulary decisions and need to understand how best to use this data and accompanying evidence for inclusion in coverage decisions. 

Don’t miss your opportunity to learn more about the regulatory review and authorization pathways, outcomes evidence, and formulary considerations for PDTs! 

Learning Objectives 

• At the completion of this activity, participants should be able to:
• Differentiate prescription digital therapeutics (PDTs) from non-prescription therapeutics in terms of definition and key characteristics.
• List at least 3 of the FDA-approved prescription digital therapeutics products and their indication for use.
• Describe the Food and Drug Administration premarket pathways for prescription digital therapeutics.
• Describe the efficacy and safety evidence from clinical trial data necessary for FDA prescription digital therapeutics. 
• Discuss managed care approaches to evaluate prescription digital therapeutics for coverage decisions.  

Target Audience 

This knowledge-based activity has been designed to meet the educational needs of pharmacists in managed care settings. 

 
Faculty  

Pat Gleason, PharmD 
Assistant Vice President 
Prime Therapeutics  
Eagan, Minnesota 

Andy Molnar 
CEO 
Digital Therapeutics Alliance 
Arlington, Virginia 

Allyson B. Mullen, JD  
Director 
Hyman, Phelps & McNamara P.C.  
Washington, District of Columbia 

 
Moderator: 

Drake J. Reiter, PharmD, RPh
Executive Fellow in Healthcare Association Leadership
AMCP
Alexandria, Virginia  

Agenda 

3—3:05pm — Welcome and Introductions 

• Drake J. Reiter, PharmD, RPh 

3:05—4:05pm — Prescription Digital Therapeutics: Regulatory Approval Pathway and Outcomes Evidence 

• Patrick Gleason, PharmD 
• Andy Molnar, 
• Allyson B. Mullen, JD 

4:05—4:15pm —Audience Q&A 

• Drake J. Reiter, PharmD, RPh 

Statement of Commercial Support 

This activity is supported by an independent educational grant from Pear Therapeutics, Inc. 

Continuing Education Credit – Pharmacists 

The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 
  

As an ACPE-accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of CPE activities. It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias. 

 
Earning CPE Credit 

To earn continuing pharmacy education (CPE) credit for this program, you must attend the entire session and participate in the pre- and post-test questions. Once completed, go to http://amcplearn.org to claim CPE credit. In the enrollment code redemption area, enter the enrollment code provided during the session. Complete the program evaluation and enter your NABP ID, birth month and birthday. All CPE credit for this webinar activity must be completed no later than 5:00pm ET on Monday, June 6, 2022. No exceptions can be made after this date. 

• ACPE UAN #: 0233-0000-22-028-L01-P 
• Credit: 1.25 contact hours (0.1 CEU) 
• Activity Type: Knowledge-based 
• Activity Fee: There is no fee to participate in this activity for members and for non-members. 

 
System Technical Requirements/Viewing Requirements 

• For all activities you should have a basic comfort level using a computer and navigating web sites. 
• The live webinar is delivered through GoToWebinar. View minimum technical and system requirements for GoToWebinar. Space is limited to the first 1000 participants that join the webinar. 
• The handout will be delivered via Acrobat PDF. 
• CPE credit will be claimed through AMCP Learn. View the minimum technical and system requirements for AMCP Learn. 

 
Press 

For individuals from the media/press who are interested in attending, please email View Email Address.   

• This activity is provided by Medtelligence and is supported by an independent educational grant from Amarin Pharma, Inc. 
• Continuing education credit available for Pharmacy and managed care healthcare professionals. 
• Contact hours: 1 

This 1.0-hour eLearning Days Virtual Satellite Symposium will feature two nationally recognized leaders in lipid research and practice, sharing the latest evidence and clinical practice pearls to managed care pharmacists.  

Learning Objectives 

• Discuss biologic effects of OM-3s and their mechanisms of action, designating IPE as different  
• Engage with physicians to interpret and relate the recent major clinical trials on OM-3s and their clinical implications to patients  
• Have greater competence on discussion of the use of icosapent ethyl, and define the shortfalls of dietary supplements for ASCVD management 

Program Manager 

Kathleen Wickman 
Medtelligence, Inc.  
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