Value Based Healthcare
The traditional healthcare delivery model is changing
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.
ICON is leading the way to support pharma, biotech and medical device clients through its dedicated commercial positioning 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.
Strategies for commercialising oncology treatments for young adults
In this whitepaper we delve into the dynamic landscape of oncology treatments tailored specifically for young adults. As cancer incidence among young individuals surges globally, it's imperative to explore innovative strategies that address their unique needs and challenges.
CMS Price Negotiation for Part D drugs
The announced Centers for Medicare & Medicaid Services price negotiations for Medicare Part D drugs introduces a fundamental change for the process of drug pricing related to Medicare. The implications for the new initiative go far beyond the 10 drugs that CMS will select as their first program participants. The action is expected to significantly impact same-class drugs’ pricing and profitability as well.
- Brief: CMS Part D Price Negotiations: Is your drug on the list?
- Blog: Identifying the drugs likely to be on the CMS list in advance
- Blog: Highlights from the revised Medicare Drug Price Negotiation Program guidance
- Webinar: Medicare Part D Price Negotiation panel discussion
- CMS.gov Medicare Drug Price Negotiation initial guidance release
- CMS.gov Medicare Drug Price Negotiation revised guidance
Survey results
How to engage healthcare decision-makers
A drug’s ability to reach the market is essential; however, pharmaceutical manufacturers have struggled to meet the increased pressure to demonstrate the value of their drugs. Data surrounding the success and efficiency of a drug are rarely sufficient to convince stakeholders that the drug is worth the investment. An effective engagement strategy for healthcare decision-makers is necessary to improve payer satisfaction and retention.
Evidence Synthesis
A solution to sparse evidence, heterogeneous studies, and disconnected networks
In this whitepaper we explain the concepts behind the various advanced statistical methods of evidence synthesis used to address non-standard data such as informative priors, subgroup analyses, meta-regression, and matching-adjusted indirect comparisons.
Accelerated early clinical manufacturing
Speed up timelines and reduce costs
The acceleration of early drug development requires Good Manufacturing Practice (GMP) of Investigational Medicinal Product (IMP).
Ensuring scientific rigor in external control arms
Methodologies to support HTA decision making
Randomized controlled trials are the gold standard for determining the efficacy of a new therapy or evaluating its comparative effectiveness against the standard of care. Yet there are situations, such as in rare or orphan diseases, with breakthrough therapies, or in areas of high unmet medical need, when RCTs are either unfeasible or unethical.
Medical communications in early phase product development
A step-by-step guide to creating market success
Scientific communication during the initial phases of product development establishes interest within the scientific and medical community, and encourages involvement from patients, investors, and the media in later stages of product development.
The affordability hurdle for gene therapies
Until now US payers have absorbed and managed the cost of ultra-expensive therapies, but how long can they continue to do so? Read our whitepaper to understand the payer perspective on advanced therapy medicinal products.
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Closing the evidence gap: Digital health technologies and drug reimbursement
As digital health technologies (DHTs) or "wearables" continue to advance, there are key considerations for drug sponsors to consider to ensure that the data generated by DHTs are acceptable to payers.
Making sense of the biosimilars market
Discover the key regulatory and development concerns for sponsors, including the factors that affect biosimilar uptake in the United States and Europe and recommendations to address these issues.
Generate RWE using cross sectional studies and medical chart reviews
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.
Value Based Healthcare email updates
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ICON selected by the International Consortium for Health Outcomes Measurement to help advance value-based healthcare
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.
Enhancing medical device development returns under value based healthcare
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.
Precision medicine: The future for medical device manufacturers
The precision medicine strategies discussed in this paper present a range of opportunities for new drugs and devices targeted to specific patient populations. These technologies work synergistically together, creating greater value during development and in the clinic. The future will continue to bring rapid convergence of the pharmaceutical and device industries, driven together by the patient, payer, and regulatory forces that are currently shaping the precision medicine market. As we look forward, the future patient may even create a new relationship with device manufacturers as a partner in personalising his or her own healthcare and clinical trial experiences.
Harnessing technology to maximise real world evidence value
Thriving in value-based healthcare: A guide for cardiovascular device manufacturers
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
Optimise your regulatory & HTA submissions with a comprehensive health economic & epidemiologic evidence strategy
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.
Using early economic models in developing your evidence strategy
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.
Value Based Healthcare Email Updates
If you would like to receive our Value Based Healthcare development email updates, including the latest on commercialisation & outcomes, pricing & market access, real world evidence, as well as regulatory updates, click here to go to our preference centre.
Using economic models to guide early development decisions
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.