Bayer to appeal High Court AMD drug ruling
The pharmaceutical company is aiming to uphold patient access to licensed treatment options for wet AMD
Pharmaceutical company Bayer will appeal against a High Court decision that favoured a policy to offer an unlicensed drug for the treatment of wet age-related macular degeneration (AMD).
The policy to offer bevacizumab, which is marketed as Avastin by Roche, was adopted by 12 clinical commissioning groups in the north of England because of its price difference to other licensed drugs.
In September last year, the High Court ruled against Bayer and Novartis who challenged the lawfulness of the drug’s use for treating wet AMD.
Bayer is appealing the decision in order to uphold patient access to licensed and National Institute for Health and Care Excellence recommended treatments for wet AMD.
In a statement, Bayer said: “Patient need and safety remain Bayer’s highest priority and we are committed to ensuring patients have access to licensed medicines, adhering to regulatory frameworks that are designed to further innovation and protect public health.”
The company added that the appeal will consider whether different means of preparation and supply of bevacizumab for the use in the eye can be lawful.
Novartis is also appealing the High Court decision as it believes that if left unchallenged, the policy will have “profound implications for the regulatory system,” which could put patients at unnecessary risk.
In a statement, Novartis said: “The use of an unlicensed medicine in wet AMD when licensed options are available undermines a patient’s right to medicines that have met stringent regulatory requirements for efficacy, safety and quality and the well-established legal and regulatory framework that is there to protect patients and ensure health professionals can prescribe with confidence.”
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