Ireland Seeks to Overhaul Biosimilar Drugs Policy

Ireland’s Minister for Health has published a consultation paper on overhauling the nation’s approach to biosimilar medicines. The paper indicates that the Irish government is developing a National Biosimilar Medicines Policy “to promote the rational use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”

The consultation paper highlights the fact that only 11 biosimilars are currently reimbursable by the state’s healthcare system, while over €200 million (approximately $235 million) is spent each year on biologic drugs that already have approved biosimilars or that will have available biosimilars by 2018.

Currently, Ireland’s Health Products Regulatory Authority supports physician-led switching of biologics and biosimilars, but stresses that any change in prescribing should be made in consultation with the patient. However, the health authority discourages repeated switches and prohibits automatic substitution with biosimilars at the pharmacy level. Looking forward, the paper indicates that Ireland should consider the following policies and how they have affected biosimilar uptake in the European Union (EU) in order to inform its own approach to the drugs:

Prescribing

• Prescribing biosimilars to new patients, as is broadly permitted in the EU
• Switching patients to biosimilars under clinical monitoring, as is allowable in most EU member states, though clinicians typically make final decisions about switching
• Biosimilar substitution, which is not generally permitted in EU member states
• The establishment of national guidelines for biosimilars
• The enactment of prescription quotas

Education

• Establishment of educational programs for providers, as are used in the United Kingdom (UK) and Germany, where forums and discussions take place among peers to allow information sharing
• Support programs, such as the UK’s Adoption and Impact Program, which offers clinicians additional information concerning biosimilars to use in their practices
• Patient information programs, such as Denmark’s initiative to provide booklets and videos to patients
• Additional patient support to ensure that patients whose therapy is being switched are receiving appropriate monitoring

Incentives and Disincentives

• Gain-sharing agreements, such as the UK’s agreement in which savings from switching patients to biosimilars was used to fund additional staff needs
• Patient copayments, as are used in Spain, to require patients to pay 100% of the cost of non-preferred treatments

Tendering and Pricing

• Implementation of tendering to promote price reductions, such as Norway’s national-level program that achieved up to 72% reductions in price for some biosimilars
• Use of non-exclusive or multi-winner tenders that can allow both reference drugs and biosimilars to be prescribed
• Setting internal or external reference pricing guidelines (setting prices based upon the cost of similar products in the same country, or setting prices based upon the average cost of such products in multiple countries, respectively)

Preventing Inappropriate Business Practices

• Eliminating direct-to-consumer advertising for medicines
• Increasing transparency in clinical trials
• Limiting drug company interaction with educational institutions or physicians

Publication of the consultation paper follows a Department of Public Expenditure report, published in May, that urged the Irish government to make substantial changes to its policies in order to rein in drug spending. The paper explained that the Irish government spends €2 billion per year (approximately $2.36 billion), or 15% of its total healthcare expenditure, on drugs. That number is only expected to grow as new, high-cost drugs continue to dominate the healthcare marketplace; the paper cited an estimated 3% annual growth in drug spending until 2020.

The report also noted that Ireland has one of the lowest biosimilar adoption levels in Europe, across both EU- and non-EU states. With only a 15% uptake for biosimilar granulocyte colony-stimulating factor, Ireland was second only to Belgium in terms of the smallest market share for biosimilars.

The Irish Department of Health is holding a public comment period on the consultation paper through September 22, 2017.