HTA in Question

HTA in Question is a series of events led by Consilium Scientific to explore the current role, pros and cons of the Health Technology Assessment (HTA) processes and methodologies.

Four events will be moderated by Dr. Leeza Osipenko (Consilium Scientific, CEO) and will take place between October 21, 2021 and April 21, 2022 featuring a permanent panel of experts

Prof Carole Longson, CBE - former Head of Centre for Health Technology Evaluation at NICE
Eric Low, OBE - former CEO of Myeloma UK, now CEO of Eric Low Consulting
Dr. Dan Ollendorf - former CSO of ICER, now at Tufts Center for the Evaluation of Value and Risk in Health.
Dr. Wija Oortwijn - Senior Scientific Researcher - Radboud University Medical Centre, President of HTAi

More details about the events:

Each event will explore a different theme relevant to HTA and featuring guest discussants. Each panellist will discuss their perspective on pros and cons of the current HTA purpose and process and propose solutions / potential policy changes. This is an interactive event where attendees will be invited to ask questions, contribute to discussions, and help shape
policy solutions.

The objective is to produce a position paper summarising the current issues with HTA and propose an agenda for the future to make the processes best serve the public, patients, policy makers, payers, product developers, academia and regulators.

All events will be recorded and made available on the Consilium Channel.

Event 1: October 21, 2021 5pm BST  Video | Slides

Evidence Generation: Quality of data for decision-making

Guest Experts: Dr. Frank Hulstaert (KCE, Belgium)

                          Prof Ian Tannock


Problem Statement:

Health technology assessment (HTA) has always faced an issue with comparators: global randomised controlled trials (RCTs) are often run against comparators which do not represent standard of care in the jurisdiction conducting an evaluation. For the same reason, populations in the trial might not be generalisable. Indirect treatment comparisons are routinely used by many HTA agencies, which increases uncertainty for decision-makers. In addition, while the methods for conducting indirect comparisons have evolved significantly in the past 10 years, important differences in trial design, measurement, and timing between contemporaneously-approved medicines often make such comparisons problematic or even impossible. Many HTA methodological frameworks rely on modelling of long-term outcomes not available from the trials and the less and poorer evidence base we have at the start, the more uncertainty we are facing with extrapolation.

Over the past 10 years the innovation agenda, pressures from investors, patient groups, policy incentives to accelerate access to new medicines have influenced clinical trial design. Speed of drug development has become a key metric of success. The regulators benchmark their performance on the number of medicines approved as it is not within their remit to consider the value that these medicines bring to patients and society.

In oncology and rare disease settings in particular, we are seeing an increased number of approvals based on single arm Phase II trials and unvalidated surrogate endpoints. A requirement from the FDA of 2 identical Phase III trials is no longer the norm. In general, trial duration and trial sizes are shrinking resulting in fewer data points and less robust evidence for reimbursement decisions. Despite an increase in the collection of quality-of-life data in clinical trials over the past decades, we are still far from this being a routine practice.

The issues highlighted above are increasing in volume and impact. There seem to be no signs of improvement on the quality of evidence requirements, pushing health systems to resolve uncertainty through price discounts, managed access agreements and the use of real-world evidence.

The first HTA in Question event will discuss the above problems and explore how these issues can be tackled.

We look forward to your participation, reflections, and questions during the session!

Event 2: December 2, 2021 5pm BST
Regulation and HTA

Event 3: February 10, 2022 5pm BST
Evaluation Process and Methods

Event 4: April 21, 2022 5pm BST
Translation into Practice