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Managing Treatment and Access to Products post Brexit

Many of our members have expressed concerns about how access to the treatments they require will be maintained following the UK’s departure from the EU.

The Haemophilia Society has discussed the current situation and the mitigation plans in place with NHS England procurement managers, commissioners and clinician representatives. Specifically, we have expressed that it is vital that plans are in place to minimise the impact of a ‘no-deal’ Brexit on the availability of bleeding disorder treatments.

We have been informed that the risks of any disruption to supply are reduced by the fact that all blood products in the UK are procured through a series of tender exercises which specify that, in line with the terms and conditions of the subsequent framework agreements, all supplier must hold a minimum of 12 weeks stock in the UK. NHS England receive monthly stock reports from all companies supplying the NHS framework agreements in order to ensure compliance. All companies are also working towards an additional six weeks of product being kept in the UK in line with DHSC requirements. We are assured that there is adequate stock to allow for most disruptions in supply to not impact on the availability of those products to patients. Almost all products, including plasma derived products, have long shelf lives of up to a year but products with shorter shelf lives such as imported blood components are most likely to be disrupted.

“Blood products” covered by these framework agreements cover most IV treatments for bleeding disorders including recombinant products as well as Emicizumab. However, some products, notably tranexamic acid, DDAVP (Desmopressin) and certain blood components such as platelets, are not covered by these framework agreements and are procured differently.

Many products used in the UK have alternative brands of an equivalent product (e.g recombinant FVIII). If a situation arose where there was insufficient stock of a specific product (i.e. brand) then your clinical team may need to supply you with an alternative product of the same therapeutic effect, for example a different brand of clotting factor of the same type.

Some products do not have direct alternatives but there may be other types of treatments that can be used for that condition. In the unlikely situation of a type of treatment for your bleeding disorder not being available you will, in consultation with your centre, agree what other treatments you can use. If particular treatments become unavailable on a larger scale the NHS will work with The Haemophilia Society and clinician representatives to agree what changes to treatment standards are required.

NHS England manage the tender exercises for most products for the whole of the UK so this information will apply similarly across England, Scotland, Wales and Northern Ireland although there will be differences between centres in different parts of the UK in how they procure some products.

Information for the public and patients will be hosted on the nhs.uk website as it becomes available and regular updates will be published.

We have discussed access to treatments for HIV and viral Hepatitis with other patient groups.

A statement on access to HIV medication from the BHIVA explains that stocks of HIV medication have similarly been increased by 6 weeks and that people with HIV should continue to ensure they have a buffer supply of medication to last one month beyond their next clinic appointment. If you have any concerns you can contact the Terrence Higgins Trust using their THT Direct service on 0808 802 1221 for support, advice and information.

We have been advised that access to treatments for Hepatitis C should also not be impacted but if anyone has any difficulties accessing treatment they can contact The Hepatitis C Trust on their helpline 020 7089 6221.

If you have questions about anything in this statement, please do call us on 020 7939 0780.

Jefferson Courtney

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