Influence of biosimilar introduction on access to TNFi

Without a policy to reinvest savings in treating more patients, biosimilars may not improve access.

Tumour necrosis factor inhibitors (shortened to TNFi) are a group of biologic medicines that are prescribed for rheumatic diseases such as rheumatoid arthritis. TNFi include adalimumab, etanercept, and infliximab. These drugs have been available now for a long time. Studies show TNFi are effective and safe, but they are not always accessible to everyone who might benefit from using one. This is especially true in low- and middle-income countries, where high prices for drugs can limit their use.

Biosimilars are copies of existing medicines. Biosimilars are highly similar to another biologic medicine already approved (called the reference or originator medicine). To be approved as a biosimilar, these copy medicines have to prove they are highly similar to the originator in terms of structure, activity, efficacy, and safety. Several biosimilars have been approved for people with rheumatic diseases. These medicines are often cheaper than the originators because the manufacturer has not had to invest as much money in their development.

Background on biologic treatment in Poland
In Poland, there are rules from the Ministry of Health about who can get funding to be treated with a biologic. If people are eligible, then they can enter a dedicated drug programme, which means that their treating hospital gets the medicine costs covered by the National Health System. Each hospital has the right to provide patients with a specific product – which means they can switch from a biosimilar to the originator if they think a patient is suffering from intolerance or lower effectiveness. Doctors have to tell people if their drug is switched, and they must provide additional information about equivalence between a biosimilar and its originator. Access to biosimilars has changed drug pricing in Poland, which means some of the originators are now cheaper than they used to be.

What did the authors hope to find?
The authors wanted to see if the prices for adalimumab, etanercept, and infliximab dropped after the introduction of biosimilars. They also hoped to see whether access to treatment with adalimumab, etanercept, and infliximab increased with the introduction of biosimilars.

Who was studied?
This study looked at people treated with adalimumab, etanercept, or infliximab in Poland. This included 12,687 treated patients. People were being treated for dermatologic, gastroenterological, or rheumatic diseases.

How was the study conducted?
The authors collected information on drug prices, the annual drug budget in Poland, and the number of people treated. They used this information to work out estimated and real-life savings for the public healthcare system, as well as average treatment costs for each drug. They also calculated people’s access to treatment by looking directly at how many people received a TNFi, and in an indirect way by looking at how much drug was used annually per 1,000 people. An additional analysis looked only at people with rheumatic diseases.

What were the main findings?
The main finding was that the prices of drugs containing adalimumab, etanercept, or infliximab dropped when biosimilars became available. Real-life savings in 2019–2021 relative to the drug budget in 2018 (adalimumab, infliximab) or 2016 (etanercept) were calculated as €133 million in Poland. The overall decrease in mean annual costs was between 75% and 89%.

However, the authors found that there was only a slight increase in the number of people who received affordable TNFi. This means the healthcare system redirected the savings rather than treating more people with adalimumab, etanercept, or infliximab. But if all budget savings from biosimilars were spent on additional courses of these TNFi, it would be possible to treat almost 45,000 people with rheumatic diseases in 2021 compared to less than 10,000.

This study demonstrates that biosimilar-related reduction in prices mainly led to reduced spending within Polish rheumatology. The findings illustrate the extent of real-life, patient-level benefits in a low- and middle-income country, and demonstrates how a budgetary policy with restrictive prescription can limit biologic accessibility.

Are these findings new?
Yes. This is the first complex, retrospective, nation-level analysis of its kind. It covers all available TNFi biosimilars and provides an exact analysis of public savings associated with their introduction – and the scale of reinvestment of these savings in the treatment of new patients with TNFi at lower prices.

What are the limitations?
It is possible that the analysis could be limited by inconsistencies in data published by the National Health System in Poland. However, the authors tried to account for this by using two different approaches in their calculations.

What do the authors plan on doing with this information?
The authors are planning more studies to look at access and availability and costs. The lack of reinvestment of savings in the treatment of people with less expensive TNFi may mean that the healthcare system has allocated these funds to other needs, but it may also mean that the savings have been used on more expensive innovative therapies for the same indications. The authors say that they have done a new analysis, showing how access to all innovative therapies has changed in the biosimilar era in Poland, also taking into account the costs of therapy and budget analysis. This work will be published separately.

What does this mean for me?
If you receive a TNFi, there may now be cheaper biosimilar drugs available. If you don’t receive a TNFI, but are eligible for one, these biosimilars could increase your chances of access. But that depends on where you live, and the healthcare system policies around reinvesting any savings.

If you have any concerns about your disease or its treatment, you should speak to your doctor.

Date prepared: January 2024
Summary based on research article published on: August 2023
From: Summary from Stajszczyk M, et al. Budget impact analysis and treatment availability with biosimilar TNF inhibitors in rheumatic diseases in Poland: real-world evidence using a nationwide database. Ann Rheum Dis 2023;82:1171–1180. doi:10.1136/ard-2022-223696

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