Same response from Earl Howe to my MP. At least Mr Burstow heard the question!!

I have written the following letter to Earl Howe after receiving a rather irritating reply similar to yours. see below:

I think that the FAD will be published at some time in early July, we have a 15 day deadline to then appeal should it be negative. The process for appealing a FAD is different in that you cannot appeal using the same grounds/arguments as used previously. We can appeal on very limited grounds--- unfairness to patients is NOT one of them.
Of course this is the perfect time for them to publish the FAD as it is holiday time. Let's hope for a positive finding in favour of both 2nd gen TKI's and HD imatinib.

copy of letter to EH on behalf of CMLSg:

Earl Howe,
Parliamentary Under Secretary of State
for Quality,
Department of Health,
Richmond House,
79 Whitehall,
London.
SW1 2NS

24th June, 2011

your ref:-----

Dear Earl Howe,

Thank you for your letter dated 16th June 2011.

Let me begin by clarifying that the letters sent to yourself and the Secretary of State Andrew Lansley, were sent by us as representatives of the Chronic Myeloid Leukaemia Support Group, a UK registered charity, rather than letters representing an amalgam of the personal views of myself and David Ryner, Chair and a fellow trustee of the group.

We are of course acutely aware of the preliminary status of the ACD as was made very plain in our letter to you dated 19th May 2011.

In your letter you have failed to recognise the core concern of our letter was, that there was a failure by this particular Appraisal Committee to conduct an objective appraisal, a point that was coupled with our more general complaint concerning the ineffectiveness of NICE when confronted with appraising products of innovative technologies.

We are not alone in taking this view. Professor John Goldman, a world authority on Chronic
Myeloid Leukaemia, stated when speaking of the Committee and their draft ACD in a recent interview:

“There must be a reason why intelligent people produce something that is crassly stupid”

Your argument that you do not have the power to intervene is simply untrue, since NICE, as an ALB, comes under your Ministerial direction and as such you are ultimately answerable for its performance.
Furthermore, the fact that the appraisal is ongoing, rather than completed, makes no difference if the Committee is not discharging its remit effectively.

Not one member of our group has as yet managed to obtain a single rebuttal or coherent answer to the many letters sent outlining in detail their criticisms of the Committee’s arguments they advanced to support of their preliminary negative recommendation.

As CML patients and fully competent citizens we were entirely aware that the draft guidance was open for public consultation until May 27th, and many individuals utilised the opportunity to comment on the ACD.
The CML Support Group, as an official consultee to the NICE MTA of dasatinib, nilotinib and high dose imatinib in IMR CML , has used this status to furnish the committee with a detailed comment, which was endorsed by the Leukaemia and Lymphoma Research Foundation, Leukaemia Care Charity and ACLT the African Carribbean Leukaemia Trust.

Four leading UK CML clinicians in a letter published in the Telegraph Newspaper letters page described the Committee's appraisal as 'perverse' and 'inconsistent'.

“Such oral self administered therapies also result in few additional costs other than occasional hospital check-ups. They also represent advances in advanced technologies, to which Britain, a world leader in the development of pharmaceutical products, has made a significant contribution.

Ninety countries, including Western Europe and Scotland, accept these therapies as so clinically effective that they are reimbursed. We find the Committee's arguments in support of this decision to be perverse, inconsistent and demonstrative of an organisation struggling to accommodate to the demands that such innovative therapies place upon procedures developed over a decade ago.

Whilst the Cancer Drugs Fund demonstrates the government’s awareness of the problem, it is vital that public bodies, like NICE, continue to retain the public’s confidence as impartial, evidence driven appraisers. This preliminary appraisal falls short of that.”

The unwillingness of anyone, including yourself and Secretary of State Andrew Lansley, to defend this draft ACD confirms our criticism that NICE is not fit for purpose in their ability to appraise innovative technologies, particularly in the rarer cancers/diseases field.

However, we note that you are at least willing to admit to “significant failings within the wider system for drug pricing and access”.
NICE is one part of the system you refer to here, which must also include the PPRS, as both are part of the demand/supply stimulus/regulator mechanism that is an embedded feature of the UK market in pharmaceuticals.

It is the systemic failure of NICE to incorporate a transparent and accountable mechanism for including innovation within its appraisal processes that contributes to the “significant failings” you have noted.

This has produced the preposterous statement made by the Committee which cites that neither nilotinib nor dasatinib represent innovation as they do not demonstrate “pharmacological progress”. This statement only serves to infuriate CML patients, their carers, doctors and others with a direct interest in this field.

It simply will not do to argue that the Cancer Drugs Fund is a last port of call, since this presupposes that some degree of tolerance should be granted to the NICE appraisal process, on both a particular and a general basis.

As we concluded in our original letters to both the Secretary of State for Health and yourself, the retention of public confidence that NICE is an impartial, evidence driven appraisal system is vital and any laxity of stance will further erode the government’s already precarious reputation in the healthcare sector.

Yours Sincerely, etc