A political mistake with serious consequences?
Why automatic substitution is unnecessary
No benefits, high risks: greater savings with biosimilars can only be achieved at the expense of supply security.
No benefits, high risks: greater savings with biosimilars can only be achieved at the expense of supply security.
According to the law, biotechnologically manufactured medicines should be interchangeable in pharmacies. Until now, doctors have decided whether a patient receives the original product or the equivalent but cheaper biosimilar. Automatic substitution changes this. Why is that?
The biosimilar system works: it ensures maximum supply security and, at the same time, generates massive savings. The competition it creates leads to lower prices. Biosimilars are becoming available more and more quickly and almost all of them are subject to discount agreements.
Automatic substitution undermines this balance. In order to achieve even greater savings, supply security is being put at risk. The example of generic drugs should actually serve as a warning.
chairman
Wherever biosimilars enter the market, the costs for the active ingredients in question fall. This is not only because biosimilars are cheaper than the original preparation. They also cause the manufacturer of the original to lower its price.
Since 2015, biosimilars have generated total savings of €9.5 billion.
The best example is the former blockbuster Humira® (active ingredient: adalimumab). In December 2023, a daily therapeutic dose will cost more than half as much (44 per cent to be precise) as it did before the patent expired.
At first, the pace at which biosimilars penetrated the market was still modest. But with every biosimilar that comes onto the market, the pace is accelerating. Biosimilars now account for around two-thirds of prescriptions in their indications.
Looking at the years of market launch, the dynamics become clear: while biosimilars with the active ingredient infliximab (introduced in 2015) had a market share of just 22 per cent after one year, biosimilars with the active ingredient adalimumab (introduced in 2018) achieved 53 per cent in the same period.
The reason: over the years, doctors have had good experiences with biosimilars and have prescribed them more frequently.
Discount agreements are not only used for generic drugs. They have long since been extended to include biosimilars.
They are an efficient tool for reducing costs when used sensibly and cautiously. With this type of agreement, manufacturers grant health insurance companies discounts on their prices and in return receive guaranteed market shares.
As a result, 90 per cent of biosimilar packages sold are currently covered by discount agreements.
By introducing automatic substitution, policymakers are enabling health insurance companies to conclude exclusive discount agreements with manufacturers. This leads to even higher discounts and market shares, but is also risky.
This is because, in the case of exclusive discount agreements, only one manufacturer is responsible for supplying all insured persons and not several, as is currently the case.
Discount agreements already exist for biosimilars. The exclusive discount agreements planned with automatic substitution jeopardise a functioning system with healthy competition.
Automatic substitution makes exclusive discount agreements possible. This massively increases cost pressure, because only the cheapest manufacturer is then awarded the contract by the health insurance companies. The others leave. It makes supply uncertain and weakens Europe’s position as a biosimilar location.
Biosimilars stand for maximum security of supply, as their production facilities are highly diversified. They are spread across the globe and have a particularly strong presence in Europe. In the past, when temporary supply bottlenecks occurred, other biosimilar manufacturers were able to step in and secure supply.
The European market share of biosimilars required in Germany (in daily therapy doses) is currently 56 per cent.
For several years now, however, large production facilities have also been emerging in Asia and are increasingly taking over the production of biosimilars required in this country.
One thing is certain: the diversity of production sites guarantees resilient supply chains and a reliable supply for patients.
Automatic substitution is expected to bring even greater savings. It enables health insurance companies to conclude exclusive discount agreements with manufacturers.
The development of generic drugs shows that exclusive discount agreements are dangerous for security of supply. Here, enormous cost pressure has led to production being relocated to China and India. Global supply chains have emerged that have become increasingly efficient and at the same time increasingly susceptible to disruption.
The consequence of automatic substitution for generic drugs is repeated supply bottlenecks, which have sometimes already led to supply shortages.
The price for the low prices of generic drugs is paid primarily by patients, who receive important medicines late or not at all.
Automatic substitution of biologics would lead down the same wrong path.
chairman
If doctors no longer decide which medication a patient receives, the safety of treatment is at risk. That is why doctors, pharmacists and patient representatives alike are opposed to automatic substitution.
The medical profession sees the potential nocebo effect as a major problem. This can occur when patients are not convinced of the effectiveness of a drug. The nocebo effect poses a major threat to the success of therapies.
Institutions such as the German Medical Association’s Drug Commission (AkdÄ) see this problem as particularly acute when doctors are no longer able to advise patients on the drugs they prescribe.
Only when a drug is understood by the patient can it be administered successfully, said its former chairman, Prof. Dr. Wolf-Dieter Ludwig, at an event organised by the AG Pro Biosimilars in February 2022, speaking out strongly against automatic substitution: ‘The substitution requires medical advice.
And when a patient hears that they are receiving a cheaper drug for economic reasons — without their doctor having explained to them beforehand that this is possible without any problems — they become sceptical and may reject this drug. And then there can be nocebo effects. We have seen this often enough in studies.’
Former Chairman of the German Medical Association's Drug Commission
Patients also strongly reject automatic substitution. They too see the therapy as being jeopardised by possible nocebo effects or discontinuation of treatment.
If patients were simply given a different drug without being informed because it was cheaper, mistakes could be made in its administration, criticised Dr Martin Danner, chairman of the patient association BAG-Selbsthilfe, at the same event:
‘Automatic substitution jeopardises the success of therapies – simply because the system wants to save money.’
For many, the reason why biopharmaceuticals cannot be treated in the same way as generic medicines is that they differ significantly from them.
Biosimilars are more complex medicines whose use (e.g. with a pen) requires more preparation. From the perspective of pharmacists, for example, this means that there is a greater need for advice.
Dr Kerstin Kemmritz, President of the Berlin Chamber of Pharmacists, therefore emphasised the difference between the two types of drugs in February 2022: while generic drugs can be easily substituted at the pharmacy level, this is not so easy with biosimilars.
‘With biologics, we are dealing with special forms of medication that need to be explained and practised,’ said Kemmritz.