ORK0338
Dr Sarah Wollaston MP
Chair, Health and Social Care Committee House of Commons
London SW1A 0AA
25 March 2019
Dear Dr Wollaston,
Re: Availability of Orkambi on the NHS – Orkambi inventory reserves
Thank you for your letter following up on the evidence given by Dr Leiden and Mr Arbuckle. During the hearing, you asked how much Orkambi (lumacaftor/ivacaftor) has expired and/or been destroyed in the UK in the past year.
We hold stock in the UK for the purposes of supplying medicine across the UK and numerous other countries. More than 80,000 packs of Orkambi have been distributed for commercial sale in the EU since licensing in 2015, and more than 11,000 packs of Orkambi have been supplied free of charge under the Vertex Managed Access Programme since the end of Phase 3 clinical trials. We have provided our medicines free of charge under this Programme to approximately 600 patients in England, all of whom qualified under certain criteria.
Vertex adheres strictly to legal frameworks governing medicinal products for human use, including the requirements on manufacturing and quality contained in Directive 2001/83/EC, Regulation (EC) No 726/2004, and associated Scientific Guidelines.
In 2018, 7,880 packs (each containing a 28-day supply) manufactured in 2015 and 2016 for the purposes of supplying 13 countries (including the UK) exceeded their expiry date and, consequently, were destroyed. We manage our medicinal stocks over a four-year timeframe because the final packaging and labelling of the medicines typically takes place up to two years from ordering of raw materials, and the finished product had a shelf life of two years under controlled room temperature conditions.
Vertex continues to hold significant inventory reserves of Orkambi to ensure that we can fulfil our obligations across the EU and also uphold our commitment to the Committee to supply medicines to every patient in England within four weeks of a successful resolution to our negotiations.
We are grateful for the opportunity to provide the information that you require following the hearing. If you require anything further, please do let me know.
Yours sincerely,
Simon Lem
Vice President & General Manager Northern Europe Region