>> In your conclusion, Professor May, you stated that we should consider how the market could be regulated "reasonably" in the future. However, the term "reasonable" is not always a top priority for regulatory partners.
May: Precisely for this reason, it's important to establish a connection between the individual market segments, but also between the individual perspectives of the players. Only on this basis can one arrive at a coherent system that serves the perspectives of society, the health insurance companies, and the manufacturers. Because if the latter aren't given reasonable incentives to invest in this market, the savings effects, both possible and desired, while maintaining consistent quality, cannot be realized. In this context, however, rationality also means thinking and designing for the somewhat longer term.

The overall perspective you're demanding...
May: I know this is difficult, because such holistic approaches have often failed. Nevertheless, we must continually demand the understanding that we must finally create a coherent system for promoting the use of biosimilars. Without this understanding, we will also not be able to answer the question of the right instruments, such as a biosimilar quota.

Wasem: Quotas are the ideal starting point! We just heard from Professor Lüftner at the symposium that there is a certain skepticism among the medical profession regarding the question of whether biosimilars are truly good enough to be interchangeable. If a quota were introduced, doctors would be forced to engage with the issue and consider the pros and cons. Initial experiences in some KVs show that this works quite well. They start with a somewhat lower quota, and if the target is met without problems, the quota is increased. Of course, one can argue, from a regulatory policy perspective, whether quotas are an ideal instrument, but given the real concerns and fears of treating physicians, I consider quotas to be a viable starting point.

May: I agree 100 percent. However, I warn against the idea that a quota could also unfairly discriminate against the originator. To cite the counterexample to the quota: discount agreements would lead us into a price war that is as brutal as it is bottomless. That's why I believe we need a coherent overall concept capable of protecting the still fragile biosimilar plant and, if possible, helping it flourish.

Wasem: Before that, we must, of course, discuss whether the legislature should explicitly permit interchangeability by pharmacists. Another example is fixed amounts, quotas, and even open-house contracts: all of them, in effect, assume interchangeability.
Factually yes, but not necessarily legal.
Wasem: Exactly. That's why policymakers must take an honest stance here. Because if there are instruments used in reality that implicitly assume interchangeability, it is right and necessary for policymakers to make biosimilar or biooriginal products interchangeable.

May: The problem is that the G-BA doesn't really want to see this connection. From the Federal Committee's perspective, fixed prices have nothing to do with substitutability. But if you consider that we're not talking about price differences of a cent or a few euros, but rather extremely costly therapies, then a potential co-payment for patients would be in the four-figure range. In effect, this limits the choice, so I can underline your point, Mr. Wasem. In case of doubt, you would have an even stronger argument here than in the generics market, because the fixed price essentially implies interchangeability.

If interchangeability were to be stipulated by the legislature, wouldn't Section 12 of the German Social Code (SGB V) automatically apply, which requires that provisions be prescribed in a sufficient, appropriate and economical manner?
Wasem: Sure. If interchangeability exists, the "aut simile" principle automatically applies to doctors and pharmacies. In a world of list prices, the latter must then hand over the medication with the lowest price.

Does this also apply to the hospital pharmacy?
Wasem: This area needs to be examined in more detail. It depends on whether we're talking about the inpatient dispensing of biosimilar products or dispensing them for outpatient hospital pharmacies. But either way, it's true: If policymakers grant "aut simile" for biosimilar products, this automatically triggers the "aut simile" obligation for pharmacists based on list prices. And I think that makes perfect sense.

Ultimately, the question is: Can a biosimilar be substituted for an original drug or not? If Prof. Lüftner at the Charité can treat around 90 percent of her newly admitted oncology patients – who will certainly not be the easiest cases – with biosimilars, it would be reasonable to assume that the pharmacy pharmacist has been able to do so for a long time.
Wasem: However, one occasionally hears from health insurance circles that the demand for "aut simile" could conflict with the professional self-confidence of doctors, which is why – at least that is the fear I perceive – they could refuse to prescribe biosimilar products as a reaction of defiance.

They don't do that with generics either, where more than 90 percent are now exchanged.
Wasem: But only under the extreme pressure of the performance audit. As you already said, Section 12 of the German Social Code (SGB V) is looming!

Caution: In specific indications, such as antidepressants or thyroid medications, replacement should not be so rapid. However, we are talking about oncology and life-threatening diseases, where even more caution is needed.
Wasem: The study situation, if one may say so on this occasion, as to whether „aut idem“ actually has patient-relevant outcomes and whether compliance is impaired, is not very good.

May: I would have assessed that a little differently. There are good arguments that "aut idem" can certainly cause problems. You quickly see that when you talk to practitioners—doctors or pharmacists. You don't really need a large-scale study for that.

Wasem: Talking to practitioners about patients is a completely different kind of evidence than that generated in studies that actually assess patient-relevant outcomes. Yet I'm missing precisely these studies that would show that "aut idem" actually leads to compliance problems.

However, this won't be a major issue in the biosimilar market. Because, as Professor May demonstrated in his presentation, there are ultimately only one or two products on the market per indication. For this reason alone, there won't be a random switch, neither between biosimilars nor from the original to the biosimilar, and perhaps even back again. Intolerances, side effects, and bioavailability aside.
Wasem: With oncology preparations, the patient doesn't see exactly what's in their infusion bag anyway. Nevertheless, the issue of compliance shouldn't be dismissed. However, we finally need to move beyond qualitative summaries and conduct truly good studies to be able to definitively determine whether or not there is a problem. Substitution can be problematic in some indications, while in others it's only a perceived problem. We just don't know.

We've now discussed two instruments: the quota and "aut simile"/"aut idem." It's still far from a coherent system. What would legislators and self-governing partners need to do to give biosimilars the status they deserve?
Wasem: If we were to allow "aut simile," we would already have taken a big step. Quotas are already permitted, as are open-house contracts as further elements in a possible, but not yet existing, regulatory system. To arrive at a coherent system, we would have to analyze, above all, the issue of hospitals, both at the interface with prescriptions by private practitioners and the different treatment of outpatient and inpatient dispensing in hospitals. This is precisely where our current regulatory system is inconsistent.
In what way?
Wasem: Well, because it generally makes more sense for a hospital pharmacist to prescribe the original drug rather than the biosimilar product. The reason for this is that health insurance companies only look at the discount in euros, not the starting price. This simply means that it makes more sense for the hospital to use the original drug, while from a societal perspective and also from the health insurance companies' perspective, the biosimilar would save money. At this point, we really have a regulatory consistency problem.

May: It's obvious that this kind of thing can no longer be tolerated. Just as one can no longer defend the system of non-transparent remuneration and pricing of parenteral preparations, especially in oncology. I don't understand why substances used in parenteral preparations aren't regulated by the AMPreisV (Medicinal Products Price Regulation) just like conventional finished medicinal products. The remuneration of the pharmacists who prepare the preparations should, in turn, be based on an appropriate flat rate.

Wasem: The initial situation is clear: The legislature simply didn't dare to evaluate the pharmacist's work performance. Therefore, they once again made things easy for themselves and let self-administration regulate the pharmacist's work performance, which is probably sensible. However, the legislature also wanted to trigger discounts that would somehow also reach the health insurance fund. However, considering the overall assessment of the instruments, this probably didn't quite work out. Personally, I would therefore advocate either that the legislature clearly regulate the pharmacist's work performance in the Pharmacy Price Ordinance, or that the Pharmacy Price Ordinance specifically stipulates that self-administration should decide the pharmacist's overall work performance.

Is this a regulatory task for politicians?
May: Yes.

Wasem: Absolutely.

In your lecture, Professor May, you spoke about Germany's international responsibility as Europe's largest pharmaceutical market. Can we really expect the solidarity-based statutory health insurance system to use insured members' contributions to nurture the biosimilar seedling in order to co-finance it both here and in Europe?
May: Spontaneously, I would say: Local government is the wrong contact for this. A social and therefore political decision is needed here.

Wasem: The health insurance companies would rightly object to having to pay more for medicines than absolutely necessary. Regardless of their role in Europe.

Which they aren't even allowed to do.
Wasem: But only because it is not included in the SGB V.

May: However, the necessary framework conditions could be created elsewhere.
This would require a bet on the future that biosimilar funding would actually result in savings in five, ten or even fifteen years.
Wasem: That's precisely the point: This wouldn't be a bet on the future of the European healthcare system, but rather on the German healthcare system in particular. But because Germany, with its dynamic perspective, is the most important core market in Europe for biosimilars, German society and politics must realize that we play a very special role on our continent. That's a certain degree of egoism, just taken one dimension further, so to speak.

Europe as a quasi-positive free-rider effect.
Wasem: You could put it that way.
May: In any case, first of all, we need to force self-governance and the health insurance side to think more long-term.

Which the latter – this time according to the Federal Insurance Office (BVA) – is not allowed to do at all.
Wasem: In many areas, there are things that extend far beyond the normal annual time horizon. The framework we're talking about needs to be changed at a higher level. Once this has been done, the BVA will also have a clear framework for action.

Professors, thank you for the interview. <

The interview was conducted by MVF editor-in-chief Peter Stegmaier.