Insights and updates for more productive and successful HTA submissions
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.Read the whitepaper
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?Read the whitepaper
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.Read the whitepaper
Manpreet Sidhu and Ben Cieply share insights on how HTAs inform decisions for market access and reimbursement of new pharmacotherapies.
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.
In March 2021 the Italian Medicines Agency adopted new guidelines for drug pricing and reimbursement decisions.
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.
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.
ICON Pricing and Market Access experts conducted an analysis to assess the value of RWE in recent HTA appraisals.
Learn about the challenges and opportunities when using external control arm trials in submissions to HTA agencies.
Join us for insights and key lessons learned when engaging with the developing HTA processes in China and Japan.
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.
Join us to review survival analysis in HTA Submissions and its use in economic evaluations. Learn about current guidelines, challenges and recent developments.
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.