Health technology assessment
Insights and updates for more productive and successful HTA submissions
As healthcare treatments and interventions evolve, Health Technology Assessment bodies are continually adjusting their evidence requirements and negotiation frameworks. Our health economic, market access and regulatory teams can guide clients to understand the latest updates and prepare for successful access.
Ensuring scientific rigor in external control arms
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.
The impact of COVID-19 on HTA / reimbursement requirements
How will the changes brought about by the pandemic impact your existing pipeline of products? Will you need to adjust your existing HEOR evidence planning and timetables? Are there steps you can take to ensure that patients and providers will still have timely access to your pipeline of products?
Seeking parallel consultation from regulators and HTAs in Europe
Understanding and meeting the evidence requirements of regulators and HTA bodies can be complex. Early engagement can help. Read the whitepaper for key factors to ensure that parallel consultation meetings are well prepared, productive and informative.
Health technology assessment blogs and media contributions
Media article: Health technology assessments - understanding the global landscape and considerations for drug development
Manpreet Sidhu and Ben Cieply share insights on how HTAs inform decisions for market access and reimbursement of new pharmacotherapies.
Blog: Informal deal between council and European Parliament
In June 2021, representatives of the European Parliament and the Council of European Union reached an agreement to boost cooperation amongst EU member States on HTA.
Blog: New procedures for drug prices negotiations and reimbursement in Italy
In March 2021 the Italian Medicines Agency adopted new guidelines for drug pricing and reimbursement decisions.
Blog: Looking back and looking ahead: trends in HEOR
In-person research became impossible due to the pandemic, and forced us to re-examine how patient's voices were being captured. In 2021 we continue to build on what we learned.
Blog: Briefing: the UK NICE methods of health technology assessment
In a statement on February 2021, the UK’s National Institute for Health and Care Excellence (NICE) launched a public consultation on proposals for changes to the processes it uses to develop its guidance on medicines, medical devices, diagnostics and digital health technologies.
Blog: What is the value of real world evidence in oncology in HTA appraisals?
ICON Pricing and Market Access experts conducted an analysis to assess the value of RWE in recent HTA appraisals.
Using external control arm studies in HTA submissions
Learn about the challenges and opportunities when using external control arm trials in submissions to HTA agencies.
The developing HTA landscape in APAC
Join us for insights and key lessons learned when engaging with the developing HTA processes in China and Japan.
HTA and market access implications for gene therapies
Because gene therapies are high cost, a key challenge for manufacturers is to demonstrate value to payers in a HTA setting. Register to learn more.
Survival analysis in HTA submissions: a primer
Join us to review survival analysis in HTA Submissions and its use in economic evaluations. Learn about current guidelines, challenges and recent developments.
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.