Pharma Perspective: IBD

Expert Profile

Section 1: Current IBD Landscape

1.1. How would you describe the current IBD commercial landscape?

I see a quite a big difference between different regions. We can talk about higher income countries like the best on European countries and other markets that we can call lower income countries or Central Eastern European countries. The reason behind the geographical differences is that I can see that until a drug gets reimbursement in the system, very different timeframes are applied in the different regions. In Germany for example, the drug could be reimbursed right after the marketing authorization decision. Either, especially in Hungary, this usually takes two or three years until we achieve reimbursement. Usually this is not the full label or not the full reimbursement or regular reimbursement, but really often this is only a partial reimbursement only for a defined a small patient population or something like that.

Of course, there are a few big companies who are on this field. So, there was the TNF-alpha companies. However, infliximab and adalimumab are already off-patent pharmaceuticals. So, there are a really strong biosimilar competition and currently I can see two main participants on this field next to the biosimilars, which is STELARA and ENTYVIO.

There are a few other promising active substances which is coming to the market. However, as I can see right now in the upcoming let’s say one or two years, but in Hungary two or three years. I think this is valid for the Central, Eastern European countries. So, these innovative drugs still have two or three years before the other competitors be, enter into the market. So, this is the basic overview on the competitors and the different companies.

1.2. How are payers reacting to pricing competition in IBD therapy?

From the access perspective or from the payers perspective I see that the COVID situation has a quite big impact, in my opinion, on the upcoming few years. I think the payers will put more and more emphasis on the pricing competition, not only between the biosimilars. So not only between TNF-alphas or between infliximab brand and adalimumab brand, but I think they will introduce so-called jumbo tenders or something similar to that. So, a big price competition between all the accessible product, that could be even ENTYVIO or STELARA in a price competition together with the TNF-alphas because we have some real-world evidence or evaluation made by the public sector, where they define that. So, they came to a result that meant no significant differences could be explored between these different active substances and the payer can use this results as an argument for the jumbo tenders.

1.3. What are the main bottlenecks and geographic differences in IBD drug commercialization?

Usually the Western European countries, a company can get access for a new drug without any access restriction and in earlier lines. However, in the Central and the Eastern European countries, we can see that often if a company can get reimbursement for a product, then compared to the Western European countries this reimbursement is only for later lines. Not in the first line but second or even in third line compared to the TNF-alphas, for example.

It happens really often that a company gets reimbursement for a product and EFPIA which is the Association for Innovative Pharma Manufacturers, has an indicator which shows the time spent until a drug gets reimbursement. However, this indicator has, I think, many problematic points in the methodology because they say that a drug gets reimbursement and the first patient can get the therapy, and in a situation where a drug is included into the positive drug list or reimbursement list. However, in Hungary, and this is the situation in other Central Eastern European countries. When a drug is included into the positive list, that doesn’t mean anything. For example, in Hungary, after a drug is included into the positive list, we need to go through a public tender procedure which can take up to one year.

So that means that the EFPIA indicator shows that we have already reimbursement, however the real situation that we will have the reimbursement in a few months or in a year. So, I see that there are really strong differences between the regions and right now, we are talking only about the biologics in the IBD field. However, in case if you look some orphan indications, then the situation is even worse.

1.4. What has been the impact of COVID-19 on IBD therapy commercialization?

So right now, we cannot see a clear picture about the effect of COVID-19, and I can say that the impact is not only volleying for the IBD field, but for the whole economy and the whole pharmaceutical spending. So, what we can see right now in Hungary and in the region, that the inclusion of new medicines was frozen in the last year. No new medicines came into the regular reimbursement system. However, the companies are trying to negotiate about individual reimbursement and price-volume agreements for a defined, a small patient population and so on, but the regular inclusion of the new medicines is totally frozen right now. We are just trying to figure out when a next inclusion will happen in the system. Currently, we expect that no inclusion will be happen in a year timeframe.

So that means that we have the chance only to negotiate with the payer on a case-by-case approval for every single patient and about price-volume agreement, but we or the newcomers won’t have a chance to get into the regular reimbursement system. To be honest, I think we cannot see the impact of COVID-19 right now. Everyone thinks that we are coming out of the pandemic. However, as I can see in the region, that we are somewhere in the middle of this disaster. So, we will see what we will happen, but I’m not optimistic from the market access point of view. I also have some responsibilities in public affairs. In Hungary, so many other countries have this initiative that we are trying to reach out to the Ministry of Health and there’s the relevant authorities with a solution or with a recommendation or suggestion to provide home treatment for chronic patients.

All the hospitals are under big pressure and in case if a government would provide the home treatment opportunity for the patients, that that would mean that the patients don’t need to go to the hospital. Many times, these patients have comorbidities and so on, so they have more risk to go into the hospital when they go into the hospital. The public sector is not really flexible from this perspective, as I can see. So, all the governments are focusing on the main crisis or on the crisis what could be or what can be visible in the media. However, this is the segment, the chronic patients, and especially the IBD segment is not that figured where they need to put more emphasis during this pandemic.

Section 2: Future of IBD Therapy

2.1. How will the IBD commercial landscape change in the future?

So as the governments would like to have or generate savings in the system, I think all companies must put more emphasis on value-based contracting and achieving reimbursement based on the value of the product. I think where these kind of managed entry agreements will be more and more important in the upcoming years. Where the payer can ensure that they will or they need to pay only for those patients, that the treatment has some real benefit, or which could be proved by real world evidence data. I think these kinds of managed entry agreements will be a common solution for all the new pharmaceuticals, regardless of the therapeutic area.

2.2. What new therapies could be seen for future IBD treatment?

I think there is a lot of innovation which tries to affect the route of administration of the different active substances. So not only the subcutaneous and IV, but other route of administrations are coming, without needle and so on. I think that could be a new segment in the IBD field as well. I heard some information on value-added medicines which means that those active substances which are already off-patent substances could have different route of administration as well. So, some innovation can have them on those field there where the off-patent pharmaceuticals are on the dominant therapies.

I know that there are a few promising substances, are coming into the market in a few years. Within a one or two-year timeframe, so that will change the treatment landscape and the treatment algorithms in Western European countries in the upcoming one or two years for sure and the Central and the Eastern European, or in general the lower income countries, will catch up a few years later.

Right now, the landscape is dominantly IV and subcutaneous. I’m not aware or I don’t know whether other or new oral therapies are coming into the market. However, in case if they will appear on the market within this timeframe, so within a few years, then I think they won’t be able to penetrate that fast that they expected a few years ago. In Hungary and in the Central, Eastern European countries, the payer during the health technology assessment, so during the evaluation procedures the authorities don’t make a big difference based on the route of administration. So, in case if a product has an IV and a subcutaneous form, they won’t pay more for the subcutaneous version.

I expect that in case if an oral therapy is coming to the market, they would like to get a big price premium for the new brand or for the new route of administration because this is significantly more convenient for the patient. Where however I think those countries, which have a big economic crisis or a closed the budget for, as pharmaceutical spending, they won’t pay significantly more for oral treatment. I’m not aware of any active substances which is oral treatments, but that doesn’t mean that they are not coming.

2.3. What niche IBD indications require new types of IBD treatments?

From the market access perspective, I cannot see any unmet need in the therapeutic or in the indications of, for example, the TNF-alphas. I think a medical person could evaluate this perspective, but I would say that from the payer perspective, the more participants or the more brands or companies on a field, the bigger competition that they can organize between the products. So, I think in case if the newcomers want or don’t want to have a premium price and they are happy to go into the price competition. Then of course they can easily come to the market, but I cannot see any unmet need.

To be honest from the lower income country perspective, the first two or three lines could be manageable with off-patent pharmaceuticals. So, if I would be the payer, I would give access only in later lines. So, third-plus lines for the new therapeutic or new brands or new active substances. From the economic perspective or health economic perspective, these off-patent pharmaceuticals can easily treat more patients from the same budget. In case if we use the off-patent pharmaceutical, because there is a bigger price competition between the brands.

This is a big difference between the Western and the Eastern part of Europe, that the patient have many times a restricted access in the lower income countries. Everyone is talking about cost saving and cost saving potential of the off-patent pharmaceuticals. However, in the lower income countries I think there is an investment perspective, not a cost containment perspective of the off-patent pharmaceuticals. So, in case if the government and the payers would realize this, then I think they would reimburse in the first two or three lines only. The off-patent pharmaceuticals and the expensive new, innovative originator products could be reimbursed only in third-plus lines.