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Interview — Carolin Miltenburger, HEOR & Market Access Strategist

Carolin Miltenburger is a psychologist, a health economist, and an experienced market access strategist who has seen and participated in the development of the field since its inception.

We spoke to the former senior director at Medtronic about changes in the market access landscape and the important differences between healthcare systems around the world.

You’ve just returned from ISPOR - how was the event this year?

Very interesting. I was there at the first event 17 years ago, when it was just 150 people in Cologne, and today it’s 5,000. I think there is no similar event, and ISPOR has become the place to go to see what’s new.

What’s the most interesting aspect?

For me personally it’s to see the next generation. The whole field was dominated for a long time, by the ‘pioneers’ in the 90’s. And then of course the issue panels - what issues are being debated and what are the trends. This year it was education and preparing the next wave of health economics.

Health economics today is very different from what it was 17 years ago. Then, when you said ‘global’, what you meant was ‘the U.S. and Europe’, and today, it means a wide range of healthcare systems that have to some extent learned from the U.S. and Europe, but in other cases have developed totally new ways to deliver care and to fund healthcare.

Another difference is that it’s much less driven by national organizations today. The real decision-making happens somewhere else.

Are these decisions made more locally?

Well, there was a paper recently on HTA decisions. It looks like, when it comes to reviewing data and scientific information, there is general agreement on whether there is strong data, or whether there are any gaps, but when it comes to the question ‘do we want to buy this, for this price?’, then you are more at the level of willingness to pay, of healthcare priorities in a country, and then the decision-making is much less consistent.

You must have seen a lot of changes in market access over the years - can you say a bit about your experiences in this area?

When I started my career in the mid-nineties in health economics, the term ‘market access’ didn’t exist. I’m a psychologist, I’ve studied health economics and I’ve worked in clinical development, study management and methods development.

The company I was working for back then, Schering, set up a group to monitor and co-ordinate activities around what was then called ‘the fourth hurdle’. Over time, the scope and objective developed much more into becoming proactive during earlier development phases. Today, you would clearly start before phase 2. In those days, anything before phase 3 would be considered early.

Over time, what the whole field has learned is that a positive HTA guidance does not mean a technology will be used more. Advocacy and policy are important - how do you work with committees and individuals which influence clinical practice guidelines?

You may have strong data, but if your product doesn’t make it into a formulary or a guideline then it might be paid but nobody knows that it can or should be used. Today, when we talk about market access it also includes elements of advocacy and raising awareness.

It’s interesting that today, several countries in Asia, particularly China, learn from HTA bodies like NICE in the UK - how they engage with stakeholders, the types of data that they would accept, so Europe has influenced what’s happening in other parts of the world, including the U.S.

Would you say this customer engagement environment is becoming more fragmented and dynamic?

Yes. In the old days, the main stakeholder for a company was a national decision maker. That could be an organization which decides on inclusion in the basket of services, like the GBA (Joint Federal Committee) in Germany, or NICE in the UK.

But this is only part of the game, because over the last five years, more and more risk has been moved from the insurance companies, or the national payer, to the providers.

Clinical Commissioning Groups in the UK are one example. ‘Accountable care’ in the U.S., links reimbursement to quality and efficiency metrics, which means that the financial risk shifts from the payer to the provider. So if you do a surgery, and a month later the problem recurs, there will be no additional payment for the intervention. Diagnosis related groups in hospital follow the same principle. The hospital has to manage the costs of delivering quality care. And, quality means more today.

This withdrawal on the part of national payers from some risks has led healthcare providers, hospitals, and physician groups to try to figure out how to avoid making a loss. This means looking at the overall impact of technologies, as well as other aspects related to being a successful business such as attracting more staff and more patients.

So today, companies have to speak not just with the national payer but with a very large number of local payers and providers. And they decide not just every three or four years about whether the technology makes sense, they want to see this on a quarterly basis.

All of these issues increase interest then in health economics.

Yes, and this is where value communication comes in. One of the key lessons almost 20 years ago now in the U.S., from the American Academy of Managed Care Pharmacy, was the understanding that all the health economics information would end up going to pharmacists, because they’re the ones on the committees deciding which drugs will be included in guidelines and be paid for.

Pharmacists don’t generally have a background in health economics and so the AMCP developed a standardized template for presenting this kind of information to the committees. This made it much easier for the pharmacists to consume the information, and the concept was very successful - it helped decision makers to manage complex information and arguments despite not having an in-depth background in the subject.

Value communication today is even more important, and it’s very dynamic, it needs to be updated frequently.

Is this the attraction of in-house app development - the ability to update value communication tools easily?

I think that what companies are seeing is that the traditional model of KAMs and MSLs is no longer working, and they need new tools for that purpose. It’s important that the tool is consistent - you need clear brand communication across the board, with tools that are easy to update.

All of this is fairly new. In the old days we would submit 200-page dossiers and sales reps would sit there and try to avoid the whole conversation around health economics because they felt uncomfortable with the material. Or, a dedicated sales force with a health economics background would sit there and torture the decision makers with models that took an hour to explain.

I think today we’re talking about market access because we understand there are more things we need to do than just present health economics information. And second, we have a very broad range of different stakeholders today, and we need to understand the KPIs by which they are driven - they are not all driven just by a desire to save money. We need to communicate the value of products around these KPIs.

Does that tie in with the idea of customer-centricity?

It all starts with understanding their needs. What do they want to achieve? It is not that hospital only want to save money. Some might want to become a center of excellence, and would be willing to invest, because they have a goal not just to be financially successful, but also to become the most important center for a certain technology in the region.

In this case, what as a company can you do to help them? If you have a conversation simply on price, on rebates, on new product features, then you may miss the point. It’s about understanding the customer in a broader sense in order to demonstrate value.

I recall from our case study with Medtronic that you used BaseCase to communicate the value of MIS technology.

Yes. Just looking at this particular example, it could be that the technology is more expensive, but it will help the hospital to accomplish broader goals - to become more proficient and successful and known for a particular kind of surgery.

We entered into a collaboration to collect data, and the outcome was clearly that the learning curve is a very important part of saving costs. So the question then becomes - what can we then do to help the customer through the learning curve?

I think companies should move away from the traditional transactional model of selling a product, towards selling a solution and also working with the customer on the solution.

And is that something that the platform helped you to do?

I think what helps is having a flexible tool that can use the data from the customer to create a scenario that is relevant to them. So you can ask questions like ‘how many surgeons do you have?’, ‘how long does it take for this kind of surgery?’ and so on, and adapt the meeting to the situation of the customer.

This helps build trust and credibility, and it can motivate the customer to take another step, to agree to train some of their doctors with the new technology and collect the data again, to see if there is any improvement.

In the past, you would take the data back, calculate the scenario in the company and make a new appointment to meet again. This is inconvenient and it’s not very motivating, particularly if you consider that there are perhaps 30 companies trying to meet that person.

So you could actually use the tool to demonstrate to them how they can change their practices to improve outcomes.

Yes, and with a bespoke scenario. The idea is to use their own data so they can see what it would mean for them. That of course wasn’t possible in the past, because this kind of digital technology wasn’t available. So there are a lot of benefits today from being able to work with better and faster technology.

A typical situation would be that, you have the data, there’s an unmet need, there is a patient segment which could really benefit from a new technology, but there is an issue with the cost. They would have to replace something that they use already and demonstrate that it would be a better investment of their money.

When this is what you want to communicate, then the value communication apps from BaseCase are very good because they are able to visualize this information in a very simple way, and the tools are very flexible to use information from the customer.

This kind of meeting can be difficult for the KAM, as they may not have had any training in this area. The whole storyboard and the language needs to be much more focused and concise, so that the field force will feel comfortable starting a conversation on this topic.

In my experience, we would provide the field team with training, but the traditional conversation would often still be transactional in nature. It may be that the rep has known the customer for a long time, and this kind of meeting is what they’re used to, offering discounts and rebates, things like this.

To change this, we need to look more broadly at the customer relationship. How can we help the customer to be successful and how do we enter into a conversation around added value. Tools that can facilitate this conversation and ease of use and flexibility are critical.

I know that you have a lot of experience in both the U.S. and European markets. I’m interested to hear your perspective on the differences there, in terms of market access.

Well, they are very different. If you look at drugs for example, most launches happen first in the U.S. and then in Europe. The willingness to pay is much higher in the U.S., and there has been the feeling in the past that through their high prices, the U.S. has been subsidizing Europe, which is not willing to pay as much.

The reason for this is that the U.S. is very different from Europe. The U.S. is a commercial system whereas most of the European countries have a tax-funded system, or we pay premiums into a statutory system, where you have to get insurance, like in Germany. Or you have a mix of the two models.

In the U.S. you have a national payer and a national decision-maker as well, which is CMS, the Center for Medicaid and Medicare Services, but they are only for the elderly or the poor. This is a segment of the market that has special rules due to their lower income.

If you’re not in this group, the only way to get healthcare is through a health plan, and these are fully commercial organizations which are often very big, such as Kaiser Permanente or Blue Cross Blue Shield, they sometimes serve an entire industry, and they negotiate with manufacturers over price, coding, coverage and payment. So, it’s a commercial system driven by profit.

Now, there’s more mobility in the job market, and when you change employers you may seek membership in a new health plan. This means that the insurance companies don’t have people for very long. So if you argue, ‘treat the patient like this, because there will be less complications in five years and you will save money’, they are not interested - the patient will be somewhere else. It’s a more short-term perspective.

What about with the Affordable Care Act coming in now, will that change the situation significantly?

Well, the priority was to increase coverage, and at the time of its passing there were about 40 million uninsured. Still, the U.S. over the past five years is rapidly approaching the point where it’s spending 20% of its GDP on healthcare - that’s not sustainable.

My personal view is that we’ll see a lot more of the measures that we are used to in Europe, in the U.S., like cost containment for instance. If the patient comes back with the same problem months after the surgery, the hospital has to pay for it.

The aim is to reward healthcare providers who deliver better quality. Over time, the U.S. will learn from Europe, how they can control the price of technologies and control access. And I think Europe will learn from the U.S. in terms of out of pocket payments for a range of services. The systems may have to focus on what is essential.

As this concept of accountable care expands in the U.S., will that create more of a role for value communication - to demonstrate outcomes information holistically?

Yes, I think it clearly has two roles. One is for stakeholders managing formularies for a health plan. For any given indication, there will be a group of products which are generic and fairly cheap, and these will be available with a low co-pay. Then there will be more innovative products, with a different safety profile maybe, on the second tier, with a higher co-pay. Finally, if you want something that’s launched just this year, or last year, there’s a much higher co-pay.

To decide which treatment goes on which tier is a dynamic process, because it’s influenced by rebates, by new data, and I think BaseCase tools can help decision makers to organize the information and simulate what the right product for them is.

The other role it has is to monitor outcomes. If you are more responsible for outcomes then you are more encouraged to monitor them closely, and look for deviations. I think there could also be a role for more bedside tools, so doctors can use the app directly with patients to collect data.

Have you used the BaseCase platform yourself? What has your role been with the technology?

I was one of the company’s earliest clients, and I was convinced that this was a great approach for our product portfolio, where differentiation was a major challenge. We wanted to show that services beyond the product, such as training and supply chain overall made our offering more cost-effective.

I was looking for ways to do this and I found BaseCase. We organized best practice meetings so that country affiliates became aware of the technology, and then presented several solutions to the global senior leadership.

I think there is also a huge potential for these tools if they’re used for advisory boards. I led several advisory boards where half were health economists and half were clinicians, and typically, one group didn’t understand the science of the other group. What is often done, is to send 100s of pages of PowerPoint slides as a briefing document, you meet, and you have a steep learning curve and maybe a culture clash for the first two hours.

What I thought was, can we share an app before the meeting so that both sides can view the other’s material? This would really help support collaboration between different stakeholders and promote access to the information.

There are clearly opportunities for the software to go beyond tools for the field force. They can help in a much broader sense in the customer relationship. The platform can act as the facilitator.