Welcome. AMCP Partnership Forum. Designing Benefits and Payment Models for Innovative High Investment Medications

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AMCP Partnership Forum Designing Benefits and Payment Models for Innovative High Investment Medications Welcome Bri Palowitch, PharmD, BCGP Manager, Pharmacy Affairs Academy of Managed Care Pharmacy Disclaimer Organizations may not re use material presented at this AMCP webinar for commercial purposes without the written consent of the presenter, the person or organization holding copyright to the material (if applicable), and AMCP. Commercial purposes include but are not limited to symposia, educational programs, and other forms of presentation, whether developed or offered by for profit or not for profit entities, and that involve funding from for profit firms or a registration fee that is other than nominal. In addition, organizations may not widely redistribute or re use this webinar material without the written consent of the presenter, the person or organization holding copyright to the material (if applicable), and AMCP. This includes large quantity redistribution of the material or storage of the material on electronic systems for other than personal use. 1

Agenda 1 2 3 AMCP Partnership Forums Designing Benefits and Payment Models for Innovative High Investment Medications Forum Findings and Recommendations 4 Q&A 5 Closing 2018 Partnership Forums 3 AMCP Partnership Forums Collaboration for Optimization The live, hands on AMCP Partnership Forums bring key decision makers in managed care, integrated care, the pharmaceutical industry, and others together to discuss and collaborate on tactics and strategies to drive efficiencies and outcomes in integrated care and managed care. 2

Partnership Forums Proactive, collaborative approach to solving important issues and challenges Provide a voice to all stakeholders Gain consensus on tactics to address a key challenge or opportunity, as well as how to remove barriers to improve patient care and optimize expenses Represent opportunities for payers, manufacturers, and other stakeholders to work together on common goals and interests Have high visibility among industry stakeholders and policy makers Bring individuals and organizations with different priorities together to find common ground and actionable results 2018 AMCP Partnership Forums 5 Past Forum Results The Pharmaceutical Information Exchange Act (PIE Act) Patient Reported Outcomes The Missing Link to Defining Value developed much needed definitions and parameters on using this important metric to determine value in care Value Based Contracting Forum Resulted in a consensus definition that will help advance this important model AMCP s Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Is the only organization actively engaged in post marketing surveillance of biologics and their corresponding biosimilars. 3

LEADING CHANGE On health care issues that are important to you Live and hands on, AMCP Partnership Forums, bring together key decision makers in managed care, integrated care, the pharmaceutical industry, and others to drive efficiencies and outcomes in managed care. 2018 Partnership Forums Managing Total Cost of Care Through Medical and Pharmacy Integration Building the Foundation for Patient Reported Outcomes: Infrastructure and Methodologies Integrated Delivery Networks Role in Value Based Agreements for Pharmacy and Medical Benefits 2018 Partnership Forums 8 4

Our Faculty Susan Trieu, PharmD Director, Enterprise Specialty Clinical Solutions MedImpact Healthcare Systems, Inc. Jane Barlow, MD, MPH, MBA Chief Clinical Officer Real Endpoints Stephen George, PharmD, MS Senior Consultant Milliman 5

Why Focus on High Investment Medications? They offer breakthrough treatments that can greatly improve outcomes for patients with serious health conditions Many are associated with significant costs that create barriers to patient access and affordability These treatments have higher short term costs but are anticipated to deliver substantial benefits 2018 AMCP Partnership Forums 11 Forum Goals 1. Gain insights on how managed care views high investment medications for chronic versus curative diseases. 2. Develop new solutions for benefit designs and overall value assessment for high investment medications. 3. Identify non traditional contracting methods and reimbursement models. 4. Identify any legal or regulatory barriers 2018 AMCP Partnership Forums 12 6

Forum Participants 25+ participants from health plans, integrated delivery systems, pharmacy benefit managers, employers, data and analytics experts, biopharmaceutical companies and government agencies AbbVie Accredo Alnylam Pharmaceuticals Amgen Analysis Group, Inc Applied Policy AstraZeneca Cambia Health Solutions Celgene Employers Health Coalition Express Scripts Fairview Pharmacy Services Food and Drug Administration Gilead Sciences Global Healthy Living Foundation Harvard Pilgrim Health Plan InterContinental Hotels Group Johns Hopkins University School of Medicine Kaiser Permanente Washington MassHealth / University of Massachusetts Medical School Medicaid Health Plans of America (MHPA) MedImpact Healthcare Systems, Inc Milliman National Pharmaceutical Council National Comprehensive Cancer Network (NCCN) Pharmaceutical Research and Manufacturers of America (PhRMA) Santa Clara Family Health Plan Takeda Pharmaceuticals, USA UnitedHealth Group University of Colorado Anschutz Medical Campus Xcenda 2018 AMCP Partnership Forums 13 Some Challenges and Considerations for High Investment Medications 7

Comparison of Costs over Time for Innovative and Traditional Therapy Years From First Treatment (1 20 years) Large one time treatment cost replaces continuous treatment under current standard of care Comparison of Costs over Time for Innovative and Traditional Therapy Years From First Treatment (1 20 years) 8

Models for Five Hypothetical Therapies for Different Conditions Challenges for Innovative Benefit Designs Needs of various stakeholders Fragmented payer landscape Market constraints Evolving standards of care Strategies for aligning innovative payment models with benefit lifecycles Budget cycle timelines Legal and regulatory barriers Need for long term, real world data for assessing outcomes 2018 AMCP Partnership Forums 18 9

Marketplace Factors Payer challenges assessing risk over time and integrating new financing models with existing benefits Application of new models to different types of benefits, including medical benefits, pharmacy benefits, and highdeductible plans The impact of rebates on pricing structures must be considered when implementing new payment and coverage models Innovative contract models are distinct from rebates Cost savings to payers associated with rebates must be considered when designing new models 2018 AMCP Partnership Forums 19 Patient Selection Identifying appropriate patients is essential to ensure resources are used wisely Selection criteria should be designed with input from clinicians and relevant therapeutic guidelines Real world evidence, FDA labeling, and compendia could also be used to refine criteria To minimize coverage denials, providers should understand which patients are appropriate candidates and what information is required for submission Reasons for denials should be clear and someone with clinical expertise should be available to explain them to providers 2018 AMCP Partnership Forums 20 10

Patient Engagement Particular important for chronic or complicated regimens to encourage adherence and persistence for high investment treatments and any ancillary services Patients need clarity, transparency, and predictability of costs and coverage Accurate, comprehensive cost information is crucial, and ideally should occur at the point of service or time of decision making. Patient health literacy gaps must be addressed to support patient understanding of clinical goals and financial obligations Care coordination and coaching can assist patients with understanding plan designs and cost barriers 2018 AMCP Partnership Forums 21 Defining Value for High Investment Medications Value assessments should be comprehensive Consider factors including survival, quality of life, effectiveness, safety, the patient s perspective, and comprehensive medical and prescription costs Ideally, the value of the standard of care has already been identified so that comparisons can be made Innovative contract models, such as coverage with evidence generation, could capture real world evidence of value Developing the infrastructure to capture and assess real world data may require additional investment 2018 AMCP Partnership Forums 22 11

Addressing Legal and Regulatory Barriers 2018 AMCP Partnership Forums 23 Payer Perspective & Potential Payment Models 12

National Survey of Payer Perspectives 21 national and regional managed care organizations Representing 123 million commercial, Medicare Advantage, and Managed Medicaid covered lives Financial risks and impacts of high investment medications are important concerns for payers Interested in alternative payment models, given the right circumstances Payers expect to use both traditional and alternative payment models to address high investment medications Ciarametaro M, Long G, Johnson M, et al. Health Affairs Blog. June 28, 2018. 2018 AMCP Partnership Forums 25 Payer Survey Key Findings Regarding Gene Therapy Ciarametaro M, Long G, Johnson M, et al. Health Affairs Blog. June 28, 2018. 26 13

Selected Payment Strategies Forum participants selected four payment strategies for detailed discussion: Annuity payments Reinsurance markets Performancebased payments Milestone based contracts 2018 AMCP Partnership Forums 27 Annuity Payments Annuities allow payers to make installment payments over an extended period Viable financing model for short term high investment curative or durable therapies Patient annuity payments considered financially impractical for most patients Not inherently tied to outcomes, but could potentially be linked Annuity payments do not address the price of treatment unless they are combined with other contracting strategies Might be most suited to treatments where a large initial treatment population is expected A relatively short re payment time frame (e.g., 3 to 4 years) may be preferred to manage risks associated with patients who switch plans or die during the course of the annuity 2018 AMCP Partnership Forums 28 14

Reinsurance Markets Reinsurance markets pool risk payers are insured by a third party to protect against high cost claims Generally most useful for smaller payers and self insured employers who have a need to share risks Larger plans are more able to predict the size of their risk pool and factor costs into plan premiums Reinsurance markets are a short term solution to address financial risk for smaller entities Long term, reinsurance premiums are likely to rise as more high investment medications enter the market 2018 AMCP Partnership Forums 29 Performance based Payments Most appropriate for treatments with clinical uncertainty Payments are based on the achievement of pre determined outcomes Outcomes must be clinically appropriate, relevant, and measurable Patient population must be clearly defined When used for chronic therapies, contracts should include appropriate care coordination and interventions over time An infrastructure for capturing and analyzing real world evidence regarding performance is needed Several legal and regulatory barriers (e.g., Medicaid Best Price) 2018 AMCP Partnership Forums 30 15

Milestone based Contracts Similar to performance based contracts Similar issues regarding regulation, needs for well defined and measurable milestones, and the need for access to real world data Key difference is that payment is based on achievement of specific events such as initial therapy administration and therapeutic response, rather than being based on outcomes over time 2018 AMCP Partnership Forums 31 Strategies for Moving Forward While consensus was not reached by all Forum participants, broadly, implementation of innovative payment models requires that stakeholders Address legal and regulatory challenges Implement strategies that improve transparency Support access to real world evidence Strengthen industry partnerships 2018 AMCP Partnership Forums 32 16

AMCP Roles and Opportunities Convener of key resources and stakeholders to advance strategies for better managing high investment medications Clearinghouse to collect and disseminate the designs and results of alternative payment model experiments Facilitator for stakeholder collaborations Conduit for communication and education about factors including legal and regulatory issues and benefit design AMCP Foundation could support pilots for innovative contracting strategies AMCP s dossier system could be leveraged to create a centralized source of PIE and to facilitate value assessments for high investment medications Partnerships with other organizations to maintain a sustainable and innovative healthcare system 2018 AMCP Partnership Forums 33 Key Points High investment medications must be economically justified within sustainable pricing models to maintain the long term viability of the insurance market A new paradigm that addresses concerns about how to pay for these medicines is needed to ensure patients have access to these innovations Several innovative models have been proposed, each with their own benefits, challenges, and potential roles in the payment landscape Aspects of various models could potentially be combined with each other as well as other models that were not specifically addressed at the forum 2018 AMCP Partnership Forums 34 17

Reminder: How to Ask Questions During the Webinar 2018 AMCP Partnership Forums 35 Thank You! 2018 AMCP Partnership Forums 36 18

Upcoming Webinars www.amcp.org/calendar 19