Overview is needed to bundle forces for reimbursement of personalised medicine

By 24th April 2018News

Overview is needed to bundle forces for reimbursement of personalised medicine

New technology is becoming available at an increasing rate. In healthcare for example, biotech companies and startups are making breakthroughs in diagnostics and drugs that bring ever closer the promise of personalised medicine and treatment for cancer patients. However, reimbursement for these technologies and treatments is lagging. Why? Partially because HTA (health technology assessment) methods don’t have the right framework or the agility to cope with the different metrics used for validation.

“When a drug is very effective for a smaller patient population, it can have a bigger impact if the right patients can be targeted,” a participant said at Wednesday’s Ideas From Europe (IFE) policy perspective meeting on reimbursement for personalised medicine; a prelude to the Ideas from Europe event in the Knights’ Hall in The Hague. “And we can.” But lack of approval means lack of reimbursement. It is here that the adaption of technology that can save lives and healthcare costs is stalling. That was the first conclusion at the roundtable in The Hague.

Change the methodology

What do you do when new technology can prevent disease, cure more patients through personalised medicine, but the assessment methods are too rigid for the much needed approval? You change the methodology, so it can validate diagnostics and drugs that bring personalised medicine and treatment to the forefront of patient care. A simple answer to a simple question. If only the how to change or adapt (HTA) methods and bodies was as easy. But that is the next step to take. And answers to the how are there.

To get to the how, IFE started a Value Track for innovation in healthcare: how to get reimbursement for personalised care? To this end, a wide range of biotech companies and entrepreneurs from all over the EU (Netherlands, Italy, Germany, UK and Hungary) joined forces with experts from the healthcare industry, with a focus on treatment of cancer.

The common denominator in how to change, adapt or replace current methods and their underlining processes and supporting systems is the knowledge to do this, which is available. What is lacking is a good overview, a way to see where and when to combine available insights, experience with HTA approval routes and resources. Don’t re-invent the wheel.

Much needed first step

The IFE policy perspective meeting was a much needed first step. The fact that all participants share much of the same experience and frustration, met with the same hurdles in getting new technology or treatments approved for reimbursement, created a common sense of urgency: we can save more lives, prevent or limit diseases and help limit healthcare costs.

Now we must find the tools to get the right scientific validation for a different, more tailor made approach to fighting cancer: HTA methods can adapt a more agile framework for these more versatile diagnostics and drugs, apply the right pressure at the needed levels of policy makers and enforcers and using the voices that in the end matter the most; those of caretakers and patients.

No certainty is needed

Because in the end, it’s the caretakers that want to cure patients. It’s the patients that want to become healthy again. A big problem with current HTA methods is that they want complete certainty that something works or have as little side effects as possible. But it should be up to the people that can profit the most from new diagnostics and drugs, to decide if the risk is worth the try.

Nobody at the meeting blamed the methods or the bodies – such as the EMA – that use them. The methods have worked for decades. And a system, once in place, will not adapt or change easily. But change, it must. Even the policy makers know and mostly want this. The same goes for HTA bodies, like those in the Netherlands, that are looking for a better suited methodology for personalise medicine. They all see the urgency for a more diverse and agile set of HTA tools.

Common cause is there

So: there is enough data to prove that new diagnostics like biomarkers work. The same goes for drugs that through e.g. the use of biomarkers can be targeted towards people that will benefit the most from them – and not used for people where these drugs don’t work. There is a common sense of urgency at all levels and in all segment of the healthcare industry, from tech companies to policy enforcers. There is a willingness to use the tools for personalised medicine. There are ideas on how to change and speed up scientific validation and HTA methods.

There is, in short, a common cause.

What is missing and what Wednesday’s policy perspective meeting was a first step towards to, is the how to change. One answer is to bundle everything: data, experience, resources, leverage, and existing initiatives for newer HTA methods. But to do that, you must know what to bundle. And you must do it not just on a national but multinational level.

Overview is needed

So an overview is needed, a helicopter vision:

  • To end fragmentation
  • To bundle everything from validation data to knowledge
  • To build up a network of people from tech companies to caretakers and patients, from insurance companies to policy makers, that want to facilitate the needed change.
  • To speak a common language: this is what we want, this is what we need to get there.
  • To apply pressure when and where it is needed, at the right level.
  • To give caretakers and patients the right information – to shout it out if necessary – to help apply this pressure.

 

In the center of it all is the patient, both recipient of personalised medicine and the strongest voice of them all.

Some conclusions, tips and advices

1. Combine knowledge to prove more quickly that new diagnostics and drugs work
There is a discrepancy between what the meeting-participants and HTA bodies see as enough evidence for approval. New pre scientific studies are needed to remedy this. Real life data gathered in countries or across countries for speedy post approval studies. There is a need to use each others data, also across countries. To have IT-systems that get data together.

2. Share knowledge of how the system works in order to change it
There are different aspects of bringing new innovation into healthcare. Who is involved, are all of those talking to each other. We need a platform to facilitate that. Maybe initiatives are already available, but we not know to all stakeholders. Create an overview of them and bring them together. As long as we don’t have an overview of initiatives to change scientific validation for personalised medicine, of HTA methods that encompass a more agile assessment and of all HTA- and other bodies involved in these methods and processes, we will remain fragmented.

3. Apply the right kind of pressure at the right level, through the right voice: ours but even more that of the patient.
There is patient pressure and there is technology pressure. We have to apply certain level of pressure on stakeholders, such as governments. This is possible. Should not shy away from it. We all have networks to bring this tot he right level. To do this, we need lots of data. We have that. We need to combine it to move forward quicker with diagnostics and drug assessment.
We need more agility to adopt quicker. We need our combined power to do this. Build a precision medicine ecosystem where we can use the right pressure instruments.