In a submission made to the National Biosimilar Medicines Policy consultation process, the Irish Pharmaceutical Healthcare Association (IPHA) highlighted the importance of adopting a patient-centric policy on prescribing biologic and biosimilar medicines. In line with common practice across Europe, IPHA believes physicians should remain the decision-makers on prescribing and switching of biologic and biosimilar medicines. Pharmacy-led substitution of these medicines is neither needed not appropriate. The current legislation in the Health (Pricing and Supply of Medicines) Act, 2013 reflects this position and should be retained.
IPHA represents 44 research-based pharmaceutical companies, many of which supply both (originator) biologic medicines and also biosimilar medicines for serious diseases such as cancer, rheumatoid arthritis, Crohn’s disease and multiple sclerosis.
IPHA Chief Executive Oliver O’Connor said:
“IPHA’s fundamental position is that Ireland should have effective policies that bring innovative medicines to patients as fast as in comparable EU countries. Currently we are last among Western European countries on the adoption of new medicines. This must be fixed. Adopting innovation on a continuous basis is key for best outcomes for patients. This is the context for debate about biologic and biosimilar medicines.
“Continuing development of biologic medicines, including biosimilar medicines, creates increased choice for patients and clinicians, increased commercial competition and enhanced value. IPHA supports competitive pricing in post-patent markets to help create headroom to invest in new medicines. Currently, competition between originator biologics and biosimilars is generating a more competitive environment which in turn leads to lower costs.”
In relation to off-patent biologic medicines, the IPHA Agreement made with the State last year provides for a 30% cut when a competitor product becomes available. According to the National Biosimilar Medicines Policy Consultation Paper: “this cost reduction strikes a balance between reducing the cost paid by the HSE and encouraging biosimilars into the market.”
This provision has resulted in cost reductions and savings to the State already. Ireland has at least one biosimilar available for each of the approved biologic molecules which are off-patent in Ireland and commonly available in Europe.
IPHA estimates that savings of over €100m will be provided in this way over 2016-20.
In line with current Health Products Regulatory Authority and other guidelines, IPHA reaffirms that the decision to switch a patient from a biologic originator medicine to a biosimilar should be made by the prescribing physician in consultation with the patient. Due to the nature of biologic medicines, it is not appropriate that that decision be changed at pharmacy-level.
“Currently physicians may prescribe biologics and biosimilars to patients, and they may change a patient’s treatment from a biologic or biosimilar. There is no barrier in current legislation to this. IPHA supports such decision-making by physicians,” said Oliver O’Connor, CEO IPHA.
“What is currently prohibited in law, and reflected in HPRA guidance, is substitution by a pharmacist – this would mean that a patient could be provided a different medicine to that prescribed without either physician or patient input. Ireland is aligned with the majority of countries in the EU in deeming biologic medicines not suitable for automatic or pharmacy- substitution and IPHA supports this position.
“Therefore, IPHA advocates that no change be made to this aspect of current legislation.”
Finally, reiterating its support for competitive pricing in post-patent markets, IPHA opposes the introduction of market-share quotas for biosimilar products. O’Connor said,
“In addition to being unnecessary to achieve best value for the State, quotas for particular products of particular manufacturers should not be a factor in any way in the prescribing decision of a clinician. Prescribing decisions should be made for the clinical needs of the individual patient, taking account of any clinical guidelines that may be in place. Market share quotas are in appropriate for clinical decision-making.”
Contact Philip Hannon on 087 2870891