Dear Department of Health and Social Care,
In september 2017 Keveyis had no Marketing Authorisation and was therefore an unlicensed medicine and the price of £4,110 per box was therefore set by the importing company Ranbaxy.
I would like to know therefore why the DOHSC agreed this price which would never be met by NHS England or any Primary Care on the grounds of excessive cost.
Mr B Elkington
Our ref: DE-1195120
Dear Mr Elkington,
Thank you for your correspondence of 24 October about medicines pricing.
I have been asked to reply, and apologise for the delay in doing so.
The Freedom of Information Act only applies to recorded information such
as paper or electronic archive material. As your correspondence asked for
general information, rather than requesting recorded information or
documentation, it did not fall under the provisions of the Act.
As the Department of Health and Social Care previously explained in
its Freedom of Information response of 14 February (our ref:
FOI-1163475) and other correspondence, the Department received a request
from Ranbaxy UK to launch Keveyis. However, because the product had not
received a marketing authorisation, it was only possible to consider the
price on a provisional basis. Several factors were taken into account in
concluding that the Department could agree a price of £4,110 for the
medicine. These included:
* the clear clinical need for the medicine;
* the medicine having orphan drug status for around 50 patients in the
UK, limiting the company's return;
* the level of ongoing costs involved in licensing the medicine;
* the additional clinical safety in having a licensed medicine
* the price of the medicine in other European countries.
Furthermore, the Department negotiated a price that brought the price of
the medicine to around 15 per cent below the price that it is
available at in other European countries.
Given that Keveyis remains an unlicensed medicine, the price of £4,110
cannot be described as the NHS list price. This price will become the
maximum price that the NHS would pay for this medicine if a marketing
authorisation is granted, but it would be possible for the NHS to seek to
negotiate discounts. However, the Department understands that on 2
October the company withdrew its application for a marketing
authorisation. Further details about this can be found at the following
Unlicensed medicines may be prescribed if no suitable licensed alternative
is available. The Department has responsibility for the cost of medicines
to the NHS. However, the Department does not control prices of unlicensed
medicines. The price of an unlicensed medicine would need to be
considered by the prescriber and
relevant clinical commissioning group that pays for the medicine.
I hope this reply is helpful.
Ministerial Correspondence and Public Enquiries
Department of Health and Social Care
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