Understanding biological medicines, their biosimilars and the PBS

A biosimilar medicine is a highly similar version of an original or ‘reference’ brand of biological medicine. Biosimilars have been tested to show they are as safe and effective as the original brand and play an important role in supporting PBS sustainability.

Understanding biological medicines, their biosimilars and the PBS

Biologics, biosimilars and PBS sustainability

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Biologics have a significant and positive impact on the treatment of many severe acute and chronic diseases. After the patents on the original (reference) biologics expire, competing manufacturers are able to develop biosimilars, which are highly similar versions of a specific reference biologic (sometimes called the ‘originator’ biologic). Once this happens, market competition usually drives prices down

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Podcast: Demystifying biologics, their biosimilars and the PBS

This podcast aims to demystify some of the processes involved in the listing of medicines on the Pharmaceutical Benefits Scheme (PBS). Professor Debra Rowett (Discipline Leader of Pharmacy, University of SA) hosts a conversation with Professor Andrew Wilson (Chair of the PBAC) and Dr Paul Kubler (Consultant Rheumatologist, Royal Brisbane Hospital), covering topics including PBS sustainability, cost-efficacy considerations, and the impact of biosimilars on the PBS listing of biological medicines.

 

Understanding biosimilars: For your patients

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Find answers to consumers’ common questions about biosimilars

Understanding biosimilars

 

Avoiding the nocebo effect: talking to your patients about biosimilars

  • Patient perception is an important factor in influencing outcomes associated with the use of biosimilars. A patient’s mindset can influence their symptoms and sense of well-being. If they have a poor perception of biosimilars, they are at an increased risk of experiencing the nocebo effect.
  • The nocebo effect is when negative expectations of a treatment lead to negative outcomes, unrelated to the physiological action of the treatment.1,2
  • It can arise from language barriers, online media as an information source, interactions with healthcare professionals, the setting in which a patient receives information, and other factors outside the control of healthcare professionals.
  • Positive attitudes shown by health professionals and patient education are important factors that mitigate the risk of the nocebo effect.

The Nocebo Effect:

Conversations with consumers around biosimilar medicines

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I plan to change you to a biosimilar medicine which is similar to your current medicine but cheaper for the government.
The new treatment must not work as well or be as safe because it doesn’t cost much.
I’d like to talk to you about changing to a biosimilar, which is as effective and safe as your current medicine, but more affordable for the health care system.
The new treatment works as well as and is as safe as my current medicine and will save the health system money. I’d like to find out more about it.
I see the doctor has prescribed you a biosimilar. Some patients don’t do as well after changing to a biosimilar as they did on their original therapy.
I’m afraid my symptoms will come back after I change, or that the new medicine will have bad side effects.
Research shows that most patients do not have any problems changing to a biosimilar. I’d like to tell you more about it and discuss any concerns you may have.
These medicines have been well researched and my doctor and nurse believe this change will not cause any problems. I’d like to talk to them about it more.
I see your doctor has changed you to a biosimilar. These products are new and I don’t know a lot about them yet. They may cause more adverse effects.
My doctor wants to change me to a new medication that they don’t understand very well yet and it might have more side-effects. I’d rather not change treatment.
I see your doctor has changed you to a biosimilar. In clinical studies and in practice, these medicines have been shown to be equally safe and effective. These medicines are thoroughly tested and there is no difference in the effects on your immune system. Let me give you more information.
My doctor and pharmacist believe this medicine will have the same health benefits for me and is just as safe. I’d like to learn more.

Adapted from: Colloca L, Panaccione R and Murphy TK (2019) The Clinical Implications of Nocebo Effects for Biosimilar Therapy. Front. Pharmacol. 10:1372. doi: 10.3389/fphar.2019.01372

 

Questions commonly asked about biosimilar medicines 5,6

 

To combat a potential nocebo effect, health professionals can:

  • Acknowledge the nocebo effect
  • Encourage patients to seek more information on biosimilars
  • Encourage patients to speak to their prescriber, nurse or pharmacist about their biosimilar options, ensuring open communication between them and all their health professionals.
  • Keep a neutral or positive outlook3
  • Address the misconception that a perceived ‘lower price’ of biosimilars connotes lower quality than the reference product.4