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In line with common practice across Europe, the Irish Pharmaceutical Healthcare Association (IPHA) have maintained that physicians should be the decision makers when it comes to prescribing and the switching of biologic and biosimilar medicines.

In their submission to the National Biosimilar Medicines Policy consultation process, the IPHA highlighted the importance of adopting a patient-centric policy on prescribing biologic and biosimilar medicines.

The association asserted that pharmacy-led substitution of these medicines is neither needed not appropriate, as is reflected currently in the Health (Pricing and Supply of Medicines) Act, 2013.

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”.

Mr O’Connor emphasised the value of increased commercial competition through the continued development of biologic medicines, including biosimilar medicines, as it improves choice for patients and clinicians.

Currently, competitive pricing in post-patent markets helps to create headroom to invest in new medicines and generates a competitive environment between originator biologics and biosimilars, which leads to lower costs.

Mr O’Connor continued: ‘In relation to off-patent biologic medicines, the IPHA Agreement made with the State last year provides for a 30 per cent 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.

“The IPHA estimated that savings of over €100m will be provided in this way over 2016-20”, he added.

The association reaffirmed that the decision to switch a patient from a biologic originator medicine to a biosimilar should be left to the prescribing physician in consultation with the patient, claiming that it is not appropriate that that decision be changed at pharmacy-level.

The CEO criticised: “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”.

The IPHA has advocated that no change be made to this aspect of current legislation.

Mr O’Connor concluded by stating that prescribing decisions should be made for the clinical needs of the individual patient, and not influenced by market share quotas, which are “inappropriate for clinical decision-making”.

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.