Biologics

IPHA strongly believes that the choice of biologic treatment for an individual patient should be made by their physician in consultation with the patient themselves.  The law already provides for this in that physicians are free to choose which product to prescribe for the patient at any time, be that an originator biologic or a biosimilar, but it is prohibited for this choice to be changed without the knowledge of the physician, thus pharmacy substitution is prohibited.  Section 5 (7) (d) of the Health (Pricing and Supply of Medical Goods) Act, 2013 excludes biologic medicines from being considered interchangeable; similar exclusion provisions are common across Europe as there is insufficient evidence to support interchangeability at this time.  As a result IPHA is strongly opposed to any change in the current legislation and believes it is unnecessary as physicians are already permitted to choose to prescribe any product for a patient which they deem clinically appropriate.  Similarly any change to the legislation which would allow pharmacy substitution would mean that it would be impossible to preclude multiple switches between products and the HPRA and the EMA are both opposed to patients being “switched back and forth”.  IPHA however fully endorses the provision of more education about biologics and biosimilars for physicians which would ensure that they have all of the requisite information to make an informed decision and so feel empowered to prescribe appropriately for each individual patient. 

IPHA would like to reiterate that it is fully supportive of competition in the biologics market as a means of delivering value to be re-invested in innovative products.  This is a relatively new dynamic as some of the biologic molecules reach their patent expiration, thus it is important to make well informed and evidence-based policy decisions grounded in real information.  For example it has been claimed that Ireland doesn’t have the full range of EMA approved biosimilars available, however this is not relevant as Ireland has at least one biosimilar available for each of the approved molecules which are commonly available in Europe, which is sufficient to create competition. 

Biosimilars do indeed have a positive impact on competition and cost reduction, but it is important to ensure that this impact is measured appropriately.  For example, a measure of biosimilar uptake would not reveal the full extent of savings delivered for a particular molecule, since savings do accrue from the reduced cost of the originator biologic.  The cost per treatment day is a more holistic and specific measure which gives an accurate measure of the extent of the cost reduction across all patients.  Any other measures to monitor competition or other aspects such as prescribing activity need to be developed in a way that is appropriate for the Irish healthcare system and which don’t inadvertently distort the market or have a negative impact on patients.

IPHA was cognisant of the changing market dynamic and so biologic medicines were included as a discreet element of the 2016 Agreement for the first time as it was acknowledged that biosimilars were becoming more readily available and since they are not like generics there was a need to make specific provisions for them.  Clause eight of the Agreement refers specifically to biologic medicines and provides for a mandatory reduction in cost of 30% net to the originator biologic as soon as a biosimilar becomes available; this is conservatively estimated to generate €100 million in savings over the lifetime of the Agreement.  In addition the nature of the provision ensures an immediate and risk-free saving to the State with minimal administrative burden and also applies to the treatment of all patients, not just those starting treatment de novo.  Framework agreements between the industry and the State  are common across Europe, their purpose is to outline a mechanism to reduce costs on the one hand while also outlining how new medicines will be made available, with the underlying principle that the savings made help the State to fund the newer innovative medicines.  IPHA looks forward to the publication of the National Biosimilar Medicines Policy which together with the Framework

Agreement will ensure that there is value optimisation in the biologics market creating scope for investment in better innovative products for Irish patients.

IPHA Biologics Position Paper PDF