EU rules Avastin can be reimbursed for off-label use

30-Nov-2018 - Last updated on 30-Nov-2018 at 14:15 GMT

(Image: Getty/Utah778)

Related tags marketing authorization Eu Ema Uk italy Injection

The European Court of Justice has determined that Roche’s Avastin may be reimbursed for ARMD – despite Novartis and Bayer’s challenge.

In 2014, the Italian Medicines Agency (AIFA) placed Avastin (bevacizumab) on the list of products to be reimbursed by the National Health Service of Italy, for the treatment of age-related macular degeneration (ARMD).

Roche Italia holds marketing authorization for Avastin for the treatment of certain cancers, yet the drug is often prescribed off-label for the treatment of ARMD.

The treatment’s marketing authorization does not cover the use of the product for this condition.

Avastin works by attacking the blood vessels that feed oxygen to tumors, which also works in the application of ARMD, which is caused by the abnormal growth of blood vessels in the back of the eye. In 2012, the US National Institute of Health found that Avastin was as effective as Lucentis (ranibizumab) in the treatment of ARMD.

Patients that receive Avastin must also be given information on the existence of alternative therapies. These therapies include Lucentis which is authorized for the treatment of ARMD. Lucentis, which is more expensive than Avastin, is marketed by Novartis in the EU (Genentech holds the US rights) and reimbursed by the AIFA. Bayer’s Eylea (aflibercept) is also approved for the treatment of ARMD.

Rulings and reimbursements

European Union (EU) law does not prohibit the use of off-label prescriptions nor the repackaging of medicines for that purpose. It does require that the products comply with conditions, including the requirement of holding marketing and manufacturing authorizations of the product.

The court concluded that the management of health services are subject to the discretion of member states regarding the pricing and reimbursement of medicinal products. However, the court ruled that the member states must comply with EU law in these decisions.

The repackaging of Avastin for off-label use does not require a new marketing authorization as the process does not modify the product, is prescribed by a doctor in cases of individual prescription, and is undertaken by pharmacies lawfully authorized for medicinal products to be administered in hospitals, the court adjudged.

For the use of ARMD, Avastin must be packaged in its original vial and divided into single-use syringes for intravitreal injection.

Avastin is priced at €82 ($93) per dose whereas Lucentis averages €900 per dose. With cost a factor in AIFA reimbursement, Avastin is more often used.

The companies involved were not available for comment.