Time is life (Guest blog)
03.10.19
The key issue that keeps me awake at night is how we, at Janssen, can best collaborate with payers to accelerate patient access to groundbreaking treatments. And how we can do so while maintaining a sustainable life sciences industry and addressing payers’ concerns around affordability.
As we move into an exciting new era of innovation in cancer care, it may initially appear difficult to reconcile these tensions, and yet all parties share a common goal and obligation – to improve the outcomes for patients suffering with cancer in a timely manner. We know we must work together to find win-win solutions because time is life, and there is nothing more important than that.
As we move into an exciting new era of innovation in cancer care, it may initially appear difficult to reconcile these tensions, and yet all parties share a common goal and obligation – to improve the outcomes for patients suffering with cancer in a timely manner. We know we must work together to find win-win solutions because time is life, and there is nothing more important than that.
For cancer treatments offering the potential for sustained, long term response, or maybe even a cure, the formal methods of Health Technology Assessment (HTA) and current funding mechanisms are challenging. HTA agencies require information on patients’ overall survival to inform their decisions, which can take years to generate with the new generation of cancer medicines, because patients are living much longer than previously expected. And where current solutions to de-risk reimbursement decisions rely on overall survival data, they do not adequately recognise the value of innovation. It is imperative that all stakeholders work together to find a way forward that’s in the best interests of our patients.
With novel treatments like cell and gene therapies, we see a new dynamic: costs are incurred upfront – often in the form of a one-off infusion – but health and cost saving benefits are accrued over many years, by achieving durable, long term remissions. The payer may not recoup their return on investment for some time and we will need to monitor long term outcomes to prove this. And yet the science gives us real hope that, for many patients, this return is there.
Addressing the key issue requires some creative thinking and a solution-focused approach – how can Janssen make innovation available to patients, while considering the affordability concerns of payers? It may sound difficult, and it will require a different mindset as we move towards a “new normal”, but we have some ideas and potential solutions we think could work.
The first relates to uncertainty. This next generation of cancer medicines are becoming so effective, it is impossible to measure overall survival within the timeframe of a clinical trial. This means intermediate or surrogate endpoints must play a central role in value assessment processes to bridge the gap. We need to work together to identify and validate appropriate surrogate endpoints. However, this will take years to fulfil so, in the meantime, flexibility is needed. This is where real-world evidence plays a pivotal role and we should take full advantage of it.
The second idea relates to risk. We need to get comfortable with making timely decisions with incomplete information and understand that managing risk is business as usual rather than the exception to the rule. Financial risk should not be loaded in any one direction, which is why innovative payment models and outcomes-based risk-sharing approaches must become more widely accepted. The key is to start these discussions early – before new treatments become approved by the European Medicines Agency and European Commission – and to involve all stakeholders, including payers, advocacy organisations and physicians, so all options can be considered, and access solutions can be co-created.
The third potential solution involves separating the clinical value assessment from affordability and access discussions. When HTA agencies evaluate new therapies, the appraisal of clinical benefit needs to be distinct and separate from price negotiations. Once the value of the treatment has been established, it is then up to the manufacturer and the payers to agree on how the financial aspects can be dealt with. There are many ways this can be addressed through managed entry and outcomes-based agreements, or longer-term payment models, all depending on the local context.
From a societal perspective, the new wave of personalised medicines and cell and gene therapies offer real hope to patients with cancer. Our unwavering focus must be to deliver these innovative treatments to the people who need them most, and that means moving swiftly and doing things differently. Right now.
