Pharmacists call on Health Minister to change biosimilar policy
- Potential savings of €800 million if Government allows pharmacists substitute biological medicines for biosimilars
- €60 million in potential savings lost to date
- Substitution already working well with generic medicines – usage increased from 11% to 53% with co-operation of pharmacists
IPU, Sunday 29 April 2018: Pharmacists have called on the Minister for Health Simon Harris T.D. to change legislation to allow them substitute expensive biological medicines for more cost-effective biosimilars. Representing over 2,000 Irish community pharmacists, the Irish Pharmacy Union (IPU) members at their AGM today passed a motion on biosimilars that could potentially save the Exchequer up to €800 million over 5 years.
IPU Secretary General Darragh O’Loughlin says 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”.
“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% market share, which is far below the EU average.
“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 Simon Harris to legislate for this.”
There is no incentive for industry to market biosimilars in Ireland unless they can be assured of a meaningful market share. Because prescribers tend to prescribe the more expensive biological reference product rather than the biosimilar, sales of biosimilars remain very low. €62 billion worth of biological medicines are expected to go off patent by 2020 globally, providing significant savings possibilities.
Mr. O’Loughlin continued:
“In the absence of specific steps being taken to improve biologic uptake, HSE spending on biologics is expected to reach €900 million by 2020. If this amendment is made, there are potential savings of €370 million over the next 3 years, and up to €800 million over 5 years.”
In 2017 the Department of Health held a public consultation on a National Biosimilar Medicines Policy, and the IPU made these proposals in our submission in September 2017. Mr O’ Loughlin pointed out that if the Government had heeded IPU advice at that time and had allowed pharmacists to substitute biological medicines for biosimilars approximately €60 million would have been saved to date: “Every week that the Government fails to implement this proposal is costing roughly €2 million in potential savings”.
In 2013 pharmacists began facilitating Government policy on the use of generic medication. Consequently, the use of generic medicines in Ireland increased fivefold, saving the State over €667 million by the end of 2017. 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.
“The time to act on this is now, and we’re calling on Minister Harris to amend the Health (Pricing and Supply of Medical Goods) Act 2013 and allow pharmacists to substitute biological medicines with biosimilars”, concluded Mr O’Loughlin.
Further information: Jim Curran, IPU Director of Communications & Strategy, 086 264 0469 Siobhán Kane, IPU Press and Communications Manager, 087 7751510 Graham Union, MKC Communications, 086 7790744
Notes for Editors on next page
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. Applied Strategic’s assessment of the Irish biologics and biosimilar market identified a potential saving of €370 million over the next 3 years, and up to €800 million over 5 years, with optimum biosimilar entry and penetration.
€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. See Medicines for Ireland Policy Manifesto 2017 at https://www.medicinesforireland.ie/wp-content/uploads/2017/07/Medicines-for-Ireland-Manifesto.pdf)
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 53% by 2016.
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.