18-6-2010 | Report on Proposed Model for Generic Substitution published by Government

18 June 2010
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'18-6-2010 | Report on Proposed Model for Generic Substitution published by Government' image

As regular visitors to epilepsy.ie will be aware, the Government is in the process of introducing a system of generic substitution which would allow pharmacists to dispense a different, cheaper version of a medicine when a specific brand has been prescribed. This system has been deemed necessary in order to reduce the ever increasing costs of delivering health care in Ireland.

As we have pointed out before, substituting a branded drug with a cheaper generic equivalent is not an issue in most conditions or disease areas. However, the evidence shows that substituting epilepsy medications can lead to the re-emergence of seizures. Click here for more information on this.

For this reason, Brainwave has been lobbying for many years to have epilepsy medications excluded from any system of generic substitution introduced in Ireland. In March, the Minister's working group on reference pricing and generic substitution confirmed to Brainwave in a meeting that epilepsy medications would indeed be excluded.

On June 17th, The Minister published the working group's report on implementing generic substitution. The report sets out a proposed model and identifies the legislative and administrative changes required.

Under the proposed model set out in the report, pharmacists would be permitted to substitute medicines which have been designated as interchangeable. Decisions about the interchangeability of medicines would be evidence-based and take into account best practice elsewhere. It is envisaged that an expert group would provide guidance on this matter.

The report also recommends the introduction of a reference price for each group of interchangeable medicines. Patients would not face any additional costs for products priced at or below the reference price. If a patient would like to receive a particular brand that costs more than the reference price then the patient can pay the additional cost of that product. In reference pricing systems, provision is generally made for prescribers to prohibit substitution for clinical reasons. In these instances patients do not face any additional costs if the prescribed product costs more than the reference price.

Imapct on Epilepsy

From an epilepsy point of view, the report is clear that ONLY interchangeable medications can be substituted. It goes on to say that medicines will not be regarded as interchangeable "where there is a difference in bioavailability between brands of the same medicines, particularly if the medicine has a narrow therapeutic index. Products in this group include the following antiepileptic medicines (e.g. Carbamazepine, Gabapentin, Lamotrigine, Phenytoin, Sodium Valproate)"

Work will now begin on drafting legislation to introduce the new system.

You can download the report from the Department of Health website at http://www.dohc.ie/publications/reference_pricing.html

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