During the DIA Europe meeting 15-19 of March, NDA consultants conducted a session on value communication for new products or therapies. Chairing the session was Steffen Thirstrup from NDA Advisory Board, accompanied by Carole Longson, Association of the British Pharmaceutical Industry (ABPI) and Neelu Agrawal, Principal at PharmApprove.

Steffen opened the session by providing background on the environment in which value communication is taking place. Ultimately, the sponsor is not fighting a battle; the sponsor is seeking to reach consensus on the best outcome for the new technology.  However, this is occurring in a changing environment. First, we are moving away from the classical description of a disease as something anatomical or histological and instead categorizing diseases according to common biomarkers.  The result is smaller, more targeted patient populations and surrogate endpoints, which makes clinical trials and data interpretation challenging.  Second, there is an emphasis on real-world data, refined into real-world evidence, to demonstrate the value of health technologies. And finally, there is an increasing demand for accelerated approval pathways to shorten time to market access. 

During the session, Steffen, Carol and Neelu discussed the importance of adapting the regulatory data package and argument for approval to a payer audience. 

Lost in translation.

Carol explained the differences between the regulatory evaluation of a drug and health technology assessment. HTA bodies evaluate the technology within the framework of currently available options in a real-world setting, whereas regulatory approval is based on the ideal conditions of clinical trials and how a product or drug performs under those exact circumstance.  Since HTA decisions are based on real life, the assessment can become more ambiguous given the uncertainty and diversity that exist in reality.

The health technology assessment is very context specific, country specific, and even region specific. Within the same region, hospitals may deliver standard care differently.  As a result, it can be challenging for HTA bodies to establish what is routine use and how that will change. The regulatory dossier must be interpreted from a real-world perspective and the HTA bodies may not necessarily come to the same conclusions as the regulatory bodies. The sponsor must be very clear about the value proposition and cannot assume the HTA will automatically extract the data needed to support the value proposition.  

For the HTA, it is not about the disease or the condition, but rather effectiveness and resources.  How does the medicine impact people with the condition and how does that translate into efficient delivery of healthcare?  For example, it is not about improvement on an endpoint such as change in blood pressure, but how the technology impacts quality of life. Health economics often use quality-adjusted life years (QALY) as a generic measure of disease burden, including both the quality and the quantity of life lived.  The problem must be addressed as a whole:  how is this new technology providing a solution to quality or quantity of life?  The sponsor needs to drill down on the benefits – not just to the individual patient but to the healthcare system and society as whole.

As the health technology assessment occurs earlier for Early Access, value claims must be reconciled with incremental pricing.  If these are not aligned, the discussion with an HTA body or a payer will be a difficult and there may be a need to move into the complex world of striking a deal.  However, if a sponsor considers the HTA perspective early in drug development, tangible evidence of benefit can be obtained.  It is too late to start considering HTA at the end of phase three clinical trials.  There is simply not enough time at that point.

The value of being a persuasive negotiator

Neelu discussed the importance of being a persuasive negotiator and best practices for preparation and communication.  Poor negotiation can delay access, impair patient lives, and reduce company profit.  Sponsors must not assume that the data are so compelling that they speak for themselves.

Intensive preparation is needed to develop the messaging strategy. First, ASSESS the value dossier and define the strategy.  Second, ALIGN the team. Third, APPLY and test the strategy with an expert mock panel to evaluate the data, critique the messages, and rigorously prepare for questions.  And then ACT on the advice given to refine the strategy and messaging. 

Follow the Golden Rules: 

1) keep the audience in mind – bridge from the HTA body’s concerns

2) keep it clear – ask how something can be said more simply

3) keep it brief – think about how something can be said more concisely

What is said is important – but so is how it is said.  This includes “speaking” with body and voice – watch posture and demeanor and use vocal cues to emphasize key points.

Take time to deliver excellence on value communication.  There is simply too much at stake.

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