Tricia Seitzer
Leaders from payer organisations and the pharma industry were abuzz with visions of the future at the recent co-located Evidence Europe Congress and World Pharma Pricing and Market Access Congress.
The conversation was framed with an acknowledgement that healthcare systems across the globe face a number of key challenges, including growing deficits, elderly populations, longer life spans and rising healthcare costs. Central to the discussion were the need for solutions that ensure patient have access to truly innovative treatments, while simultaneously meeting tight budget constraints.
It is clear that across the industry, intelligent data, meaning data that can be leveraged to make more informed decisions, and early planning for payer evidence generation, are integral to the solution. There is a plethora of data available currently, but intelligent integrated data needs to be designed to make a difference; this can come in diverse forms- many of which were explored in the conferences.
Innovation in Real World Data collection
For Real World Data (RWD) collection, there was much talk of innovative methods to gather patient information and efficacy outcomes and decrease siloed data. ICON shared how wearables and shareables such as Fitbits and Higi stations (in the US) can be incorporated into trials to lower costs and to improve the ease of gathering real world data.
Other devices such as ingestible sensors, which give real time information on compliance as well as medication effectiveness, and patient-reported outcomes websites such as patientslikeme were also discussed as potential data collection methods. Additionally, a representative from the NHS of Scotland spoke about how industry could learn a thing or two from their intelligent design of data collection services, which is linked across primary care, hospital records and prescribing/dispensers for all patients.
Consider commercialisation early on
With the need to reduce budget impact, but with more crowded pipelines than ever before, payers at the conferences reminded the industry that they will need to make decisions on which therapies they will fund. Payers and pharmaceutical manufacturers alike highlighted the importance of forethought around determining if there is an unmet need in intended indications prior to development. Additionally, industry will need to ensure that trials are designed with payer value in mind.
This means considering the evidence needs of all key decision-makers including patients, with each market’s HTA approach and decision-making criteria in mind. Conference discussions served as a reminder to the industry that hurdles to favourable pricing and market access are only set to increase, emphasising the importance of planning for reimbursement and commercialisation from early in the development lifecycle and taking a cross-functional approach to trial design and evidence generation.
Cross-functional cooperation is the key to success
The conversations at the conference reaffirmed there are no simple answers to solve these complex issues, but one thing is certain: a comprehensive evidence strategy approach that integrates trial design and the use of real world evidence, and addresses key stakeholder perspectives will be increasingly important to ensure commercial success. Only cross-functional and cross-stakeholder cooperation will ensure that patients will benefit from innovative life changing treatments.
Real World Data insights
ICON's real world data (RWD) continues to drive healthcare and research discussions and decisions. Stay up to date with the latest information that regulators, payers and providers demand.
In this section
-
Digital Disruption
-
Clinical strategies to optimise SaMD for treating mental health
-
Digital Disruption whitepaper
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
AI at ICON
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Clinical strategies to optimise SaMD for treating mental health
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel