The introduction of biological therapy has transformed the management of many gastrointestinal (GI) illnesses.
Inflammatory bowel disease (IBD) is characterised by inflammation of the GI tract and has long been a big burden on patients and the health system. Treatment of IBD was traditionally limited to surgery and corticosteroids, but the development of biologicals has revolutionised treatment.
Biologicals are specific to their target and therefore have fewer adverse effects. Biological therapy has also contributed to a reduced need for surgery, earlier and enhanced response to treatment, fewer hospitalisations, and sometimes complete mucosal and histologic healing. Adalimumab, infliximab, and ustekinumab are examples of biologicals medicines effective in treating GI illnesses. Increased risk of infection, increased risk of malignancy, immunogenicity and cost are all drawbacks associated with biological therapy.
The use of biosimilars is an opportunity to reduce costs of this treatment option in GI healthcare.
Interchangeability involves the possibility of exchanging one medicine for another medicine that is expected to have the same clinical effect. In order to pass the approval process, biosimilars must demonstrate that they have no clinically meaningful differences with the reference medicine. After this, biosimilars can be used interchangeably with the reference medicine. However, a biological is not allowed to be substituted for a biosimilar by a pharmacist without prescriber input.
Biosimilars are a huge opportunity for cost reduction in GI health. They tend to be much less expensive than the reference medicine due to lower expenditure on research and development. Consequently, this can lead to price competition among biologic drugs and a further opportunity for savings.
Medicines for Ireland (MFI) is an Irish pharmaceutical trade association and has produced a report outlining the potential for up to €1 billion of savings from 2020 to 2025 by switching to generic and biosimilar medications. These cost reductions can result in money being invested in other areas of the health system, increasing patient access to biological treatments, and could be reinvested in innovative products.
Effect on costs
Biosimilars have an important impact on competition and reduction of costs. When the patent of a biological expires and a biosimilar is on the market, there is a mandatory reduction in the cost of 30 per cent net to the reference medicine. This applies to both new and existing patients. This method alone has been conservatively estimated to save €100 million in a four-year period.
This provides an immediate saving, without the need for patients to switch to a biosimilar. It is important to consider that this is appropriately measured when looking at savings in the healthcare system with which biosimilars have made a contribution.
A look at the uptake of biosimilars would not reveal the full savings of this measure as it does not consider the savings made from the reduced cost of the reference medicine. The cost per treatment day provides a more accurate measure of cost savings.
Arguments exist that Ireland does not provide the full range of biosimilars approved by the European Medicines Agency, but it has at least one biosimilar for each off-patent biological medication used in GI disease. This significantly creates competition and makes huge savings in this market.
There is currently no scope for pharmacists to substitute biologicals and biosimilars. There is an argument that allowing pharmacists to substitute biologicals and biosimilars would allow even greater savings to be made.
Immunogenicity may be a theoretical concern when a patient is undergoing multiple switches between biologicals and different biosimilars. Studies have shown that switching from a reference biological to a biosimilar is not associated with any big efficacy, safety or immunogenicity issues.
However, the Irish Pharmaceutical Healthcare Association is opposed to a change in the legislation that would allow pharmacy substitution. The organisation believes that physicians are allowed to prescribe whatever medical product they consider to be clinically appropriate. IPHA endorses the provision of more education about biologicals and biosimilars to allow correct clinical decisions to be made, while also being good value.
Ireland has made excellent progress in cost-effective measures in relation to biosimilars for GI conditions in recent years. The Medicines Management Programme of the Health Service Executive has identified the particular brand that it regards as the best-value biological for each drug, which is an important consideration to follow.
Biosimilars can play a role in reducing the economic burden on the healthcare system and increasing patient access to biological treatments. Pharmacy substitution of biosimilars for the reference medicine is a potential way for further cost savings. Further discussions and education are required from all stakeholders in examining opportunities for further cost-saving measures.
References on request
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