ARGUMENTS AGAINST AUTOMATIC SUBSTITUTION

From summer 2022 onwards, biosimilars are supposed to be treated like generics. Accordingly, it will no longer be the attending physician who decides on which biopharmaceutical from which manufacturer is suitable for the patient – but instead the discount agreement between

the patient’s health insurance provider and a pharmaceutical manufacturer. This change had grave consequences when it was made concerning generic pharmaceuticals. But what does it mean for biosimilars? Peter Stenico, chairman of the AG Pro Biosimilars, sheds more light on this in the following interview.

Interview with Peter Stenico, Chairman of the AG Pro Biosimilars

The decision made in favour of automatic substitution will come into effect in 2022 – what exactly does that mean?

Stenico: It means that biosimilars will be exchanged following the same pattern as is the case with generics. This is what the new law for more safety in the supply of pharmaceuticals in Germany (GSAV) intends. Biosimilars are successor products of biopharmaceuticals that are genetically engineered.

To date, it was doctors who regulated whether a patient receives the original preparation or a biosimilar, as well as which specific manufacturer’s preparation is most suitable to the patient’s needs. In the future, this is supposed to only play a secondary role, because the pharmacist is meant to hand out only the preparation for which a discount agreement between the patient’s health insurance provider and a specific manufacturer exists to the patient.

Biosimilars will enter the health care system’s pharmaceuticals supply even faster. Why is this problematic?

Stenico: What’s problematic is that – just like with generics – health insurances will be able to enter into exclusive contracts (so-called discount agreements) with individual manufacturers. At first glance, this is cheaper for them since their choice is determined mostly by the cheapest price offer. However, at the same time it harbours more risks: If only one manufacturer is responsible for the supply of all the patients insured by that health insurance, the reliability and security of supply is continuously fragile.

In a market that has very few manufacturers already and in which supply chains are more complex and extensive than is the case with generics, this can have massive consequences.

What consequences could automatic substitution entail?

Stenico: We can see these when it comes to generics. Heavy price pressure has endangered the stability of our pharmaceuticals supply, especially with generic pharmaceuticals, for years. The amount of shortages is increasing and the worldwide COVID crisis has shown us: Due to these massive cost pressures, many important pharmaceuticals are now produced in Asia. Europe’s dependency is increasing – and not least because of the striking narrowing of the market down to very few manufacturers.

Politicians and policymakers have identified the problem. They are discussing measures aimed to turn back this development and restore security of supply. However, in doing this they are not realising that elsewhere – namely, concerning the highly sensible group of biologicals – they have initiated a change which could result in similar problems.

Which benefits do lawmakers expect to reap from this measure?

Stenico: What the state expects to gain from this measure is plausible: saving even more money! The problem, however, is: Biosimilars are not generics. They are made up of highly complex molecules which are manufactured in time-consuming and cost-intensive processes. Furthermore, they are predominantly used to treat patient groups with severe diseases like rheumatism, cancer or chronic-inflammatory bowel diseases like Crohn’s diseases, enabling patients to live a healthier and active life.

If the cost pressures are increased further due to the substitution at pharmacy level, this will occur in an already sensible market which requires a stable general framework for the companies’ high investments. Also, enabling exclusive discount agreements is completely unnecessary because the system which is bound to be fundamentally disrupted here is a system which currently functions very well. The benefits for the health care system and the patients are enormous!

Peter Steinico

Chairman

If politicians and lawmakers are taking the lessons learned from generics in the past seriously, they should rethink their regulations on substitution with biosimilars

What exactly is at risk here?

Stenico: The success of biosimilars which have many positive effects in various places and which the health care system benefits from massively all things considered!

Already biosimilars are resulting in massive savings and a noticeable relief for the health care system. At the same time, they make it possible for more and more patients to gain access to the treatment they need – for example for patients with rheumatism.

Nowadays, their access to a life-changing pharmacotherapy with biologicals is noticeably much faster: Where doctors used to be rather cautious in prescribing biologicals – presumably due to the high costs – they are now much more likely to. Prior to the first biosimilars entering the market, patients with rheumatism in Bavaria, for example, were treated with a chemical basis therapy for more than seven years before receiving a biological. Today, they only wait around four months on average before they start receiving a biological.

All this and at lower costs! This is how the biosimilars of the rheumatism APIs adalimumab and etanercept resulted in savings of around 500 million euros in the year 2020 alone. In the same year, the number of daily defined doses of both APIs increased by 29 per cent. The real costs for the German Statutory Health Insurance decreased by 11 per cent.

Are you apprehensive of reaching similar conditions as with generics?

Stenico: We actually see a higher degree of supply security when it comes to biosimilars. Ever since the first biosimilar entered the market there has not been a single biosimilar supply shortfall.

On the one hand, the strength of Europe as a production location and industry hub is responsible. 56 per cent of daily defined doses of biosimilars for the German market originate from Europe, and even more investments into European biosimilar production are being made. On the other hand, biosimilars benefit from globally diversified production. If you look at biosimilar production sites worldwide, you will see a healthy distribution across the globe.

If you take a look at what happened to generics after discount agreements and subsequent cost pressures came into being, we see a strong dependency on Asia. We absolutely must not go the same way with biosimilars. Especially since the supply chains of biosimilars are even more complex and thus more susceptible to faults or disruptions than those of generics – the danger of shortages or supply shortfalls is far greater.

Peter Stenico

Chairman

When it comes to generics, we clearly see a strong dependency on Asia. We absolutely must not go the same way with biosimilars. Especially since the supply chains of biosimilars are even more complex and thus more susceptible to faults or disruptions – the danger of shortages is far greater.


Which conclusions do you draw from this?

Stenico: If politicians and lawmakers are taking lessons learned from generics seriously, then they rethink their regulations on substitution with biosimilars. This view is also supported by the doctors. As recently as end of January 2021, the Commission of the German Medical Association (AkdÄ) published a revised guideline for the use of biosimilars articulating their concerns: When it comes to biologicals, medical consultations are indispensable. They are essential for the trust of the patient and thus the success of these serious pharmacotherapies.

Not least because of the nocebo effects that could potentially occur because a patient doesn’t believe in the efficacy of a biosimilar, it should be the attending physician’s responsibility to determine and prescribe the preparation. Especially since the application of biopharmaceuticals often requires additional explanations and varies depending on the manufacturer.

And how can more savings be achieved instead?

Stenico: Apart from the savings that a functioning competitive biosimilars market automatically results in, the health care system already has a few good instruments for cost reduction at its disposal. A majority of biosimilars currently available are already part of a discount agreement. Furthermore, the fixed pricing mechanism leads to grave reductions in costs.

Above all, it must be about further spreading awareness of the benefits of biosimilars among doctors and patients. Because knowledge and transparency are the foundations of trust. And that is exactly the way that will lead to an increase in the use of biosimilars and thus to an increase in savings for the health care system.

The pandemic has shown us where massive price pressures can lead. We must go different ways when it comes to biosimilars. Ways that don’t just pursue short term goals, but rather bear the long-term consequences in mind. Measures that don’t makes us discuss how to reverse ensuing developments any time soon.

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