IPU

Missed opportunity on Biosimilars to cost State hundreds of millions

  • €370 million in potential savings already lost since 2017
  • New HPRA Biosimilars Guide misses opportunity to include provision allowing pharmacists to substitute biological medicines for biosimilars
  • Substitution already working well with generic medicines – €1.145 billion in savings since 2013

 17 August 2020: Pharmacists have called on the Minister for Health Stephen Donnelly TD to change legislation to allow them substitute expensive biological medicines for more cost-effective biosimilars. Eoghan Hanly, Vice-President of the Irish Pharmacy Union said allowing pharmacists to substitute biological medicines for biosimilars “is the fastest and most effective way to ensure a rapid and meaningful increase in the use of biosimilars, which could save the Irish State hundreds of millions of euro”.

Commenting on the recently updated Guide to Biosimilars for Healthcare Professionals from the Health Products Regulatory Authority (HPRA), Mr Hanly called it a “massive own goal for the health service that we are not availing of hundreds of millions in potential savings”.

Mr Hanly said, “The finances of the health service have never been in great shape and the ongoing pandemic will only make that worse. Analysis done for the IPU three years ago identified clear savings of hundreds of millions of euro but we are not able to use that money to support people in our health service today, because that opportunity was wasted. Will we be back here again saying the same thing in another three years?”

In 2017 the Department of Health held a public consultation on a National Biosimilar Medicines Policy, and IPU proposals showed €370 million in potential savings were possible if action was taken. Nearly three years later, there has been no action and those savings have not been made.

Mr Hanly continued, “There are no clinically meaningful differences between a biosimilar and reference biological medicine and increased use of biosimilars would result in significant savings. Despite this, uptake has been extremely low in Ireland, with biosimilars representing less than 10% of the market share, which is far below the EU average.

In 2013 pharmacists began facilitating Government policy on the use of generic medication. Consequently, the use of generic medicines in Ireland increased from 17% to over 40%, generating a total of €1.145 billion in savings for the State. As the experience of generic substitution demonstrated, allowing community pharmacists to substitute is the fastest and most effective way to ensure a rapid and meaningful increase in the usage of biosimilars.

“An amendment to the Health (Pricing and Supply of Medical Goods) Act 2013 would allow pharmacists to substitute a biological reference product with a biosimilar, and the IPU is now calling on Minister Stephen Donnelly to legislate for this. Every week that the Government fails to implement this proposal is costing roughly €2 million in potential savings foregone”, concluded Mr Hanly.

 

ENDS

 

NOTES FOR EDITORS:

 

Are biosimilars as effective?

The European Medicines Agency (EMA) has acknowledged that there are no clinically meaningful differences between a biosimilar and the reference biological medicine and has stated that the evidence acquired over 10 years of clinical experience shows that biosimilars approved through the EMA can be used as safely and effectively in all their approved indications as other biological medicines. Consequently, there should be no concerns about the safety or efficacy of biosimilars and their increased use should be encouraged.

See European Medicines Agency, Biosimilars in the EU: Information Guide for Healthcare Professionals, 2017 at http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf).

 

What are the potential savings from biosimilars?

Applied Strategic, a UK consultancy firm with expertise in biosimilar markets, conducted an assessment of the savings opportunity presented by biosimilars in the Irish health system. Using published PCRS data, they concluded that, in the absence of specific steps being taken to improve biosimilar uptake, spending on biologics can be expected to reach €900 million in 2020. Even though biosimilars can provide more cost effective treatment, thus broadening patient access to treatment for a given budget, uptake has been historically low in Ireland, with biosimilars representing less than 10% market share, which is significantly lower than the EU average.

€62 billion worth of biological medicines are expected to go off patent by 2020 globally, providing significant savings possibilities, and there is already a potential three year saving of €370 million for the Irish health system – none of which will be realised if biosimilar usage in Ireland is not brought to European norms.

 

What legislation governs substituting medicines?

The Health (Pricing and Supply of Medical Goods) Act 2013 lays out the rules and regulations for generic substitution of medicinal products, identified as interchangeable by the Health Products Regulatory Authority (HPRA). Pharmacists have demonstrated that they have the competence and capability to implement this legislation, resulting in a significant increase in the usage of generic medicines in Ireland, from 11% by volume pre-2013 to over 40%, generating a total of €1.145 billion in savings for the State. An amendment to this primary legislation is required to facilitate substitution by a pharmacist from a biological reference product to a biosimilar.

How will it work?

The HPRA does not recommend that patients switch back and forth between a biosimilar and a biological reference medicine. In the IPU’s proposal, a pharmacist, on receiving the initial high tech prescription for a patient, will make the decision to dispense and supply a biosimilar or the biological reference medicine. A note of this will be made in the patient’s medication record (PMR) and, because the patient nominates a single specific pharmacy for their high tech medicine, subsequent supplies will be for the same product and no further switching will occur.