Pricing of Keveyis

Mr B Elkington made this Freedom of Information request to Department of Health and Social Care

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was partially successful.

Dear Department of Health,
Following my request of the 23 April you advised that Officials of the Department of Health's Medicines and Pharmacy Directorate, Pricing and Supply were corresponding with Pierre-Henri Coulon of Sun Pharma in respect of their NHS list price for Keveyis.

I have since learnt that the price agreed with Sun Pharma for Keveyis is £4,010 per box of 100 50mg tablets.

Would you please let me know why such a high price was agreed given that the historical wholesale price for this product ( Dichlorphenamide )was only $25 per box.

All the development costs were borne by Merck who sold out to Taro in 1997 and this drug ( Dichlorphenamide ) was marketed by Taro from 1997 to approx 2010 at $25 a box.

Following the successful Hyp Hop Trial in Feb 2011 - Feb 2012 instigated by Dr Griggs at the University of Rochester NY in conjunction with Prof M Hanna at the National Hospital Queen Square, London, Dichlorphenamide was approved by the FDA for the treatment of Primary Hypokolaemic Periodic Paralysis in September 2015 and given Orphan Drug status by the FDA.

It was then re-launched back onto the US market, but as Keveyis at a cost of $13,360 a box of 100 tabs

Yours faithfully,

Bryan Elkington

Dear Department of Health,
I recently asked why the Dept of Health pricing team had agreed the price of £4010 for a box of Keveyis with Sun Pharma, and have not yet had a response. By law the authority should normally have responded promptly by the 27 |october

Yours faithfully,

Mr B Elkington

Do Not Reply,


Our ref: DE-1101850


Dear Mr Elkington,
Thank you for your email of 30 September about the pricing of Keveyis.  I
have been asked to reply.

I appreciate your concerns.


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.


Keveyis is yet to receive a marketing authorisation.  Therefore in
accordance with the Pharmaceutical Price Regulation Scheme, the Department
has informally considered the pricing application and has provisionally
agreed a launch price of £4,110.  The product will be marketed in the UK
by Ranbaxy UK Limited and when the Department is notified that the
marketing authorisation has been granted, it will formally confirm the NHS
list price.


As you may be aware, Keveyis was previously available for a different
indication at a lower price, and was being used off-label for periodic
paralysis.  The Department acknowledged that there were no satisfactory
methods authorised in the EU for the treatment of periodic paralysis and
in the absence of any direct comparators, it took several factors into
account before agreeing to the launch price.  These included:


* the clear clinical need for the medicine;

* the medicine having orphan drug status for around 50 patients in the

* the level of ongoing costs involved in licensing the medicine;

* the additional clinical safety in having a licensed medicine
available; and

* the price of the medicine across other European countries.

While the Department recognises the significant increase in price, it has
been able to negotiate a list price to around 15 per cent below the price
available in other European countries.


I hope this is helpful.

Yours sincerely,
Ola Adigun
Ministerial Correspondence and Public Enquiries
Department of Health



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