NOTE: By submitting this form and registering with us, you are providing us with permission to store your personal data and the record of your registration. In addition, registration with Irish Pharmacist includes granting consent for the delivery of that additional professional content and targeted ads, and the cookies required to deliver same. View our Privacy Policy and Cookie Notice for further details.

You can opt out at anytime by visiting our cookie policy page. In line with the provisions of the GDPR, the provision of your personal data is a requirement necessary to enter into a contract. We must advise you at the point of collecting your personal data that it is a required field, and the consequences of not providing the personal data is that we cannot provide this service to you.


ADVERTISMENT

ADVERTISMENT

Economic considerations:The value of biosimilars in gastrointestinal healthcare

By Irish Pharmacist - 01st Apr 2024

Biosimilars are a huge opportunity for cost reduction in GI health, writes Damien O’Brien

 The introduction of biological therapy has transformed the management of many gastrointestinal (GI) illnesses. Inflammatory Bowel Disease (IBD), encompassing Crohn’s disease and ulcerative colitis, 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 under the supervision of a physician. 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. Biosimilars tend to be much less expensive than the reference medicine due to lower expenditure in research and development. In consequence, this can lead to price competition among biologic drugs and 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 in the health system. These savings can increase patient access to biological treatments and 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 from 2021 to 2025. 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 doesn’t have the full number of European Medicines Agency approved biosimilars, 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 his 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. It 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

ADVERTISMENT

Latest

ADVERTISMENT

ADVERTISMENT

ADVERTISMENT

Latest Issue

Irish Pharmacist June 2024

Irish Pharmacist June 2024. Volume 25 | Issue 6 | June 2024. Read the latest issue of Irish Pharmacist here…

Read

OTC Update Spring 2024

Spring 2024 | Issue 1 | Volume 18. Read the latest issue of OTC Update here.

Read

ADVERTISMENT

ADVERTISMENT

ADVERTISMENT

ADVERTISMENT