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.
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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
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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.
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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.
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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.
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Media article: Proving long-term value in advanced therapies: Digital technologies can measure durability of effect
McCarthy and Bob Swann discuss how robust assessments based on digital data are a means of reducing the uncertainty that HTA bodies and payers face in making decisions around advanced therapy medicinal products.
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Media article: Minimising the risk of mistakes in HTA
An article in Pharmexec examining mistakes made in relation to Health Technology Assessments (HTA) and strategies to help reduce risks of future mistakes. ICON’s (ICER’s impact on payer decision making) whitepaper was referenced in the article.
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Media article: The path to successful HTA submissions
For companies launching their products globally, gaining market access and reimbursement through HTA reviews is extremely challenging due to these nuances. Manpreet Sidhu discusses the factors that are key to success in achieving favourable HTA reviews around the world in this Pharmafocus article.
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Media article: ICER's Growing Impact On Drug Pricing And Reimbursement
Read Forbes' original article referencing the ICON whitepaper ‘The Role of ICER as an Independent HTA Organisation’, exploring how ICER may have a greater impact on payer decision-making than expected and can be viewed as a ‘decision resource’ for budgetary and formulary policy decision making.
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Blog: Health Technology Assessment: 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.
Webinars
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.