Biosimilars: European Payer Insights (2019)

As the European biosimilars market surges, what do payers see as the next steps?

The approval in 2018 of biosimilar versions of adalimumab (Abbvie's Humira) and trastuzumab (Roche's Herceptin) is a major boost to the European biosimilar sector. Payers are excited by the potential saving and are actively exploring strategies, such as pharmacy-level substitution, to drive wider use. However, challenges remain in key areas such as indication extrapolation, physician education, patient switching and pricing. What strategies are payers using to drive biosimilar update? What do they want from biosimilar developers? How can originator companies respond to defend their brands?

In Biosimilars: European Payer Insights (2019) we conducted in-depth interviews with experienced payers from Germany, France, UK and Spain to reveal their insights on current trends and future developments. Their observations provide business critical knowledge for industry executives at a time when the biosimilars sector, at last, looks like delivering on its promise.

Payers tackle key questions

• What have been the most significant developments in the European biosimilars market in the last 12 months?
• What's the best way to educate key stakeholders about biosimilars and which stakeholders should be targeted?
• What mechanisms are in place to determine pricing of biosimilars for both ambulatory and hospital care medicines?
• Is biosimilar reimbursement granted to the indication for which a clinical trial has been conducted only, or all indications?
• In what circumstances is pharmacy-level substitution of branded biologics for a biosimilar of the same molecule acceptable?
• Will financial gain-sharing agreements be the model to drive greater use of biosimilars?

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What our experts say…

"I think people are generally more positive and understanding that biosimilars do have a role in practise. We're finding there's a lot less barriers for uptake. Just over 12 months ago we had a new commission and guidance policy take place in England, which stipulated the expected uptake of the best value biologic of the originator to be a biosimilar. Within that, the indicative states that 98% of new patients should be on the best value biologic. Further, 90% of existing patients should be switched to a biosimilar within a year. So I think that's created an expectation from a commissioning point of view. In addition, we've had some large programmes that have started using biosimilars and not seen any problems clinically or safety wise. That expectation and experience has created the environment for a much better uptake."
UK Payer

"I think biosimilar companies must meet with stakeholders, it must be personal. If you convince the patient organisation that it is useful to use biosimilars so that all patients can get the drug longer, then this also will influence the stakeholders and the insurances. They need to make contracts with some insurances to get their drug promoted. The insurance sends letters to the doctors that they should use this drug and not the other drugs."
German payer

"Switching patients to biosimilars is one of the main barriers in the market for biosimilars. In general, specialist doctors agree with the idea of beginning the treatment with a biosimilar, but a lot of them are not agreeing with the idea of switch from original to biosimilar, or from one biosimilar to another one. They say that if the patient is stabilised, they don't want to change the status of the patient and have problems. We know perfectly that sometimes this is true."
Spanish payer

"I think pharmacy level substitution is okay because the studies show that they have the same effect. But practically, this wouldn't work as we see this as a big problem even with the normal drugs. Every day, we have one or two patients who complain and want their original tablet which has been changed by the pharmacy. If you do it for biosimilars, which have a much more side effects, I don't think this would work. I think this will not happen in the future because this would say that the pharmacist takes care of what the substitution does to the patient. For generic drugs, this might be okay but not for biologicals."
German payer

What to expect

• A detailed report revealing European payer attitudes to, and ambitions for, the biosimilars sector at a time of change.
• An examination of 22 key issues which originator and biosimilar drug developers need to understand and respond to.
• 32 targeted questions put to industry experts.
• Their perceptive responses that provided 43 insights supported by 224 directly quoted comments.

Expert payer contributors

This report harnesses the critical insights experienced European payers. Their identities have been kept anonymous to ensure free and frank expression of views.

• UK payer has been a chief pharmacist at one of the NHS Trusts for over 10 years with prior experience working as a senior operational and clinical pharmacy lead in a number of Trusts in London.
• UK payer has been a Clinical Director of Pharmacy for 15 years of an NHS Foundation Trust renowned for being clinically focussed and for the work that has been undertaken in improving patient safety.
• German payer is the head of Drug Reimbursement and advisor to the board of the Kassenärztliche Vereinigung Hessen. His work focuses on the areas of drug therapy, quality assurance and new forms of care.
• French payer is a former Transparency Committee member and medicines Co-ordinator at a leading French Hospital. He holds several positions in regulatory bodies, such as the French Medicines Agency where he is leading the market approval committee or the French Public Health Agency.
• French payer is a leading health economist and was formerly a research director at National Institute of Health and Medical Research (INSERM) for over 10 years. He has been directly involved in the teaching, research and implementation of economic valuation methods in France and internationally.
• Spanish payer is a leader in a Spanish Biosimilars organisation and has previously held senior roles at PharmaMar Pharmaceuticals and Sanofi Aventis. She was also the former Director of Institutional Relations and Deputy Director General of the Secretariat at the National Health System in the Ministry of Health.
• German payer is a full member of the Drug Commission of the German Medical Association (AkdÄ) and member of the Foundation Council of the German Kidney Foundation with 33 years of experience.

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