The traditional healthcare delivery model is changing
Payment models and federal reforms are increasingly focused on the real world impact of treatments and devices. Regulatory bodies are looking to real world evidence to close the gap between how a product performed in clinical trials and how a product performs in the clinical setting on a broader patient population.
Get insights on the key contracting issues you should be considering today to optimise the commercial success of your products
As industry shifts from a fee-for-service healthcare delivery model to one with a greater focus on the value a treatment brings to patient health and system outcomes, drug and medical device developers are taking a more integrated approach in developing their product’s regulatory and reimbursement strategies.
By considering health technology assessment, value frameworks and market access and reimbursement challenges earlier, often as early as Phase I, developers are producing more optimized evidence generation plans, and looking carefully at how each piece of evidence impacts not only product authorization, but earlier and broader market access, and greater product adoption by health care systems, providers, and patients.
ICON is leading the way to support pharma, biotech and medical device clients through its dedicated Commercialisation and Outcomes experts, who apply state-of-the-art technology, advanced methodologies and deep expertise to identify, generate, synthesise and communicate meaningful evidence of their treatments’ value.
Download our white paper, Real World Evidence Generation: The Value of Cross-Sectional Studies and Medical Chart Reviews to learn how this hybrid approach to study design can be advantageous for generating real world evidence. Get insights on the issues you need to consider to ensure that your study is planned to produce robust scientific data that can be extrapolated beyond the study population.
As healthcare systems shift towards value based health care payment models, device developers will need to adopt a strategic approach to maintain premium pricing on the market and to bring new high-value products to market. To be successful, device developers will need an understanding of how incentives are structured and how they influence varying stakeholder interests and behaviours. In addition, they have to identify stakeholder needs early and create strategies for developing evidence to make a compelling value based case for target stakeholder groups.
Read our white paper to learn more about our model for mapping stakeholder value that can help drive profitable device development programmes in increasingly value driven markets.
ICON and ICHOM unveiled the world’s first global patient outcomes benchmarking platform, enabling the collection, storage, aggregation, analysis and visualisation of health outcomes data, at the 2017 ICHOM annual conference.
Through its relationship with ICON, ICHOM is creating a secure central platform where outcomes data is compiled from participating provider organisations around the world. This will enable provider organisations to compare the health outcomes of their patients to those of their peers.
Late phase research is undergoing rapid transformation due to the impact of healthcare digitalisation and the greater availability of and access to Real World Data (RWD). With the right technology infrastructure and support, sponsors can more completely leverage RWE across the enterprise for maximum value.
In December 2016, the Centers for Medicare & Medicaid Services (CMS) expanded the Bundled Payments for Care Improvement (BPCI) Initiative to include cardiovascular and hip fracture services, taking a major step in the march towards value-based care in the US.
How can medical device manufacturers sustain growth and successfully navigate this new model? Download our white paper, Thriving in Value-Based Healthcare: A Guide for Cardiovascular Device Manufacturers
Gain insights to best practices for developing a comprehensive health economic and epidemiologic evidence strategy and evidence generation plan that is targeted to meet the needs of regulators and payers.
The demand from regulators and payers for health economic models is increasing, as these key decision makers struggle to manage budget constraints and provide access to new therapies.
The following briefing is drawn from our webinar ‘Using Early Economic Models in Developing Your Evidence Strategy,’ and explains the nature and value of these models and presents guidelines for their development.