The Benefit-Risk Assessment of New Treatments: The Health Technology Assessment (HTA) Process

September 22, 2022

September 22, 2022 | 5:00-6:00 PM CEST | 11:00 AM – 12:00 PM EDT

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Health Technology Assessment HTA

ABSTRACT

The increasing cost of new treatments, notably of cancer medications, is prompting policymakers to ask if newer therapies are worth their cost. Most European nations use health technology assessment (HTA) to determine the value of new drugs, decide whether insurance should reimburse them, and determine payment.

In France, The Transparency Commission (TC) evaluates each drug’s added benefit in relation to the relevant comparator. The Health Care Products Pricing Committee uses the TC added benefit ranking to determine the maximum price the national health insurance (NHI) will pay.

In order to accelerate the access to promising drugs to patients with serious and deadly illness, “accelerated approval” processes, mostly based on surrogate measures, or even based on non-comparative evidence, have become popular. As the quality of the demonstration is an important determinant of the added benefit of a new drug, drugs included in these accelerated processes have sometimes been negatively assessed by the CT despite having received a market authorization. Typical examples are drugs assessed within Basket trials, that are based on the hypothesis that the presence of selected molecular features determines a patient’s t response to an anticancer targeted treatment. Most often conducted within the phase II setting, basket designs are mostly used to identify preliminary efficacy signals. In certain circumstances, however, evidence acquired from a basket trial has served as the basis for regulatory approval.

During this webinar, we will:

  • Firstly, describe the standard and ideal HTA process for a new drug, with a focus on the French process.
  • The position of the CT for the assessment of Basket Trial will be explained
  • Finally, the moving position of HTA organizations for the early or accelerated assessment of promising drugs will be detailed, with a personal position of the speaker.
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SPEAKERS

Julien Péron, MD – PhD., Associate Professor in Medical Oncology, Lyon University Hospital

Julien Péron holds a PhD in biostatistics from the Lyon 1 University (France). He also holds a MD in medical oncology from the same university. He is Associate Professor in Medical Oncology at the Lyon University Hospital. He is also a Member of the Transparency Committee of the French Health Authority (Haute Autorité de Santé).

Marc Buyse, ScD, Chief Scientific Officer and Founder, IDDI

Marc holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA). He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, two biostatistical service organizations based in the US and Europe. He is interested in clinical trial design, meta-analysis, validation of biomarkers and surrogate endpoints, statistical methods in oncology, statistical detection of errors and fraud, statistical monitoring of clinical trials, and medical data sharing.

Presentation Webinar: The Benefit-Risk Assessment of New Treatments: The Health Technology Assessment (HTA) Process

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