Optimising Medicines, Improving Lives
The Academy of Managed Care Pharmacy (AMCP) is a leading professional association in the United States dedicated to improving patient access to affordable medicine. The AMCP Managed Care & Specialty Pharmacy Annual Meeting is held each spring for managed care professionals who manage health benefits of more than 270 million Americans. The annual meeting brings together all the voices and visions of managed care pharmacy, healthcare, and breakthrough drug therapies. Members of the Academy seek to optimize medicine by focusing on value-based care strategies while promoting cost-effectiveness of treatment.
The annual meeting provides a fertile ground for market access solutions dialogue and for recruitment of additional advisors for ICON’s already robust research panel, AccessLine. More than 4000 managed care professionals, including pharmacy directors at national and regional managed care organisations (MCOs), clinical pharmacists serving on P&T committees, health economics and outcomes research (HEOR) specialists, medical science liaisons, student pharmacists, and more attended the 2019 meeting. Moreover, the meeting’s Expo featured 120 exhibitors from industry stakeholders, such as biopharmaceutical manufacturers, CROs, consultants, and vendors.
Some of the key topics and trends observed during the 2019 annual meeting included the legislative initiative to allow for the early exchange of product information between manufacturers and health plans prior to obtaining FDA approval, the shifting trend toward incorporating cost-effectiveness analysis as part of the therapy value assessment, and best practices on value-based contracting.
The Pharmaceutical Information Exchange (PIE) Act
One of the key initiatives of AMCP this year is to gather bipartisan support for the passage of H.R.2026—The Pharmaceutical Information Exchange (PIE) Act, which failed to pass in 2017. The bill aims to improve patient access to emerging therapies by clarifying the legal framework that would allow for the sharing of clinical and health economic information for therapies that are not yet approved by the FDA.
While recent FDA guidelines aim to clarify the scope and communications of healthcare economics information (HCEI) for investigational therapies, the guidelines are nonbinding and do not establish legally enforceable responsibilities.
Some health plans have noted that the restriction on HCEI exchange causes delays in critical planning, budgeting, and forecasting associated with health benefit design. If the bill passes, manufacturers may provide clinical and economic information 12 to 18 months before FDA approval, thereby facilitating timely access to emerging therapies.
Value-based Care Management and Contracting
Besides legislative and regulatory matters, topics on value-based care management and contracting were popular among attendees. The recent influx of high-cost therapies with uncertain long-term benefits has prompted health coverage decision-makers to explore consensus framework for value assessment and innovative funding mechanisms to cope with budget constraint. Additionally, there is a concerted effort by various organisations to place a higher emphasis on the cost-effectiveness of treatment as part of the formulary coverage decision.
The Institute for Clinical and Economic Review (ICER) was prominently featured in all the talks surrounding value assessment. Premera Blue Cross, a regional MCO in the Northwest (Washington and Alaska), has incorporated ICER reports in their P&T review workflow. Premera shared key learnings and best practices on using ICER reports to address the marketplace challenges the organisation faced. While it is unclear how many MCOs have incorporated ICER assessments as part of their formulary review, the shifting trend toward cost-effectiveness may spur the use of ICER reports on a broader basis.
In terms of value-based contracting, interest remains high despite challenges in defining and measuring the appropriate outcomes in certain disease areas. James Kenney, an ex-payer at Harvard Pilgrim, discussed best practices in designing and data processing for an outcome-based contract. While some manufacturers may be reluctant to enter into a risk-sharing agreement due to a lack of objective outcomes measurement, Kenney argued that payers would be willing to consider proxy measures, such as prescription fill rate, medication adherence, etc, as short-term metrics while waiting for additional data to be generated. Additionally, manufacturers could structure the contract such that it could be used as an offensive or defensive strategy in the marketplace. An offensive strategy requires a demonstration of value in order to improve uptake and grow market share. A defensive strategy, on the other hand, entails a preferential placement on the formulary (or preferred status) to protect current position and maintain market share. Regardless of the type of contract, the ease of data collection and processing has been highlighted as one of the key drivers for success.
In closing, the meeting was a prominent venue to highlight to the market the end-to-end strategy and execution capabilities of ICON’s Access, Commercialisation and Communications (ACC) team. We connected with many biopharmaceutical clients and stakeholders, and it was encouraging to see how ICON’s integrated solutions are indeed well-positioned to help address our clients’ needs in the ever-changing US healthcare marketplace, as observed over the course of the meeting.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
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Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Blended solutions insights
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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