KIDNEY CANCER UK CAMPAIGN-UPDATE
February 2009

DECISION BY NICE ON DRUGS FOR RCC, FEBRUARY 2009

KCUK has received news that NICE has issued a Final Appraisal Document (FAD) recommending sunitinib (sutent) as a first-line treatment for patients with advanced/metastatic RCC, who are suitable for immunotherapy and who have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1. But at the same time NICE has issued a second document, a further Appraisal Consultation Document (ACD), declining the use of bevacizumab (avastin), sorafenib (nexavar) and temsirolimus (torisel) as first-line treatments, and sunitinib and sorafenib as second-line treatments.

The qualifications attaching to the acceptance of sunitinib raise a number of important issues. Some patients have been asking what happens when first-line treatment has already been provided with another drug, like interferon. Does that mean the patient concerned is ineligible for sunitinib? This is a somewhat grey area; but KCUK's initial understanding is that the patient would still be eligible as long as he/she transfers to sunitinib, for first-line treatment, before the earlier drug had 'failed' in the sense of no longer conferring any benefit in combating the cancer. But there is still a big question over other patients, for whom the first drug has failed, but who were taking this drug simply because sutent was not at the time of their treatment being funded on the NHS. It is most important that such patients are not put at a disadvantage in this.

As for the ECOG performance ratings, the definitions are as follows:

  1. Fully active, able to carry on all pre-disease performance without restriction
  2. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg light housework, office work, etc.
  3. Ambulatory and capable of all selfcare but unable to carry out any work activities.
    Up and about more than 50% of waking hours.
  4. Capable of only limited selfcare, confined to bed or chair for more than 50% of waking hours<
  5. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.

Patients are strongly advised to seek any further information on all this from their doctors.

KCUK will continue to campaign on behalf of the three drugs not being recommended for NHS funding.

KIDNEY CANCER UK CAMPAIGN-UPDATE 15TH AUGUST 2008

Since publication of the article below in the May 2008 edition of KCUK’s INSIGHT magazine, there has clearly been a number of important developments.  The NICE appraisal of the 4 new drugs for kidney cancer – Sutent, Nexavar, Torisel and Avastin –reached the stage at which a consultation meeting was held in Manchester on July 9, which KCUK attended.  Following this NICE issued on August 7 its Appraisal Consultation Document (ACD) containing its draft recommendations.

Unfortunately these are that none of the 4 drugs are recommended for NHS funding.

Publication of the ACD was greeted by a veritable media storm.  There has been huge coverage, both intensive and extensive, across TV, radio and the press.  KCUK gave TV interviews on BBC1, for which the item was the lead story on its Breakfast Show and also on SKY television and BBC Midlands Today.  Several national newspapers covered the story in major articles on their front pages, including The Daily Telegraph and the Daily Mail; but virtually all the national dailies carried something on it.  As did the regional papers and local radio stations, many of which featured interviews with kidney cancer patients in their respective areas. 

The tenor adopted by the media seemed overwhelmingly hostile to the NICE position. 

 

At the same time the scale of media attention exceeded our wildest expectations, possibly due to the NICE document coming out as it did in a season of relatively scant news.  KCUK has been seeking to take full advantage of both these things.

The next date in the NICE appraisal is August 29, the deadline by which comments on the ACD must be submitted.

WE urge everyone with an interest in this to submit their views on the NICE website:
http://www.nice.org.uk/guidance/ind...cle&o=41473

THE MORE PEOPLE THAT SUBMIT THE BETTER

At the same time as all this is going on there is a review into the present restrictions placed on co-payments.  This review is being undertaken by Professor Richards the Government’s cancer tsar.  KCUK has made a submission, arguing for some liberalisation whilst not advocating complete laissez-faire.  But whatever is to be done about co-payments is very much secondary to KCUK’s prime objective of getting the new drugs accepted for NHS funding.

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KIDNEY CANCER UK CAMPAIGN - POSITION IN JANUARY 2007

DRUG FOR METASTATIC RENAL CELL CARCINOMA (MRCC)

Kidney Cancer UK has very recently decided to open up a campaign to lobby for NICE (National Institute for Clinical Excellence) approval for two important drugs; Sunitinib, whose brand name is Sutent; and Sorafenib, the brand name for which is Nexavar.  NICE approval should mean that the drugs can be prescribed and funded on the NHS across the country, except in Scotland, where the relevant authority equivalent to NICE is the Scottish Medicines Consortium whose approval will also be sought.

During recent weeks since it was decided to run a campaign, our organisation has responded to media opportunities as and when they have arisen.  However, the intention is to develop a full campaign strategy aimed at maximising Kidney Cancer UK’s impact on decision-making authorities.

The very first opportunity for gaining publicity came when Pfizer, the manufacturer of Sutent, announced that its drug had been granted a licence for use as a first line treatment for mRCC. Up until now, Sutent could only be used by patients who had first been prescribed Interferon-alpha and whose disease was still progressing.  Kidney Cancer UK issued a press release warmly welcoming this important advance and arguing strongly that the drug should now be freely available on the NHS.

The press release resulted in articles appearing in The Daily Mail, The Times, The Birmingham Post, The Manchester Evening News and the Western Mail (a regional newspaper).

 It also led to two Kidney Cancer UK members, Pat Hanlon and Mark Franklin, giving interviews on BBC Radio Wales during the station’s early evening “Drive” programme.  The news about Sutent and Kidney Cancer UK’s campaigning for it, was carried in a News Bulletin by various other news stations up and down the country that same day.   It is expected that a more in-depth feature‑article will appear in the Daily Mail next week; and in The Times as the Health Correspondent, Dr. Tom Stuttaford, is also planning to inclue a piece in his column either this week or next.

According to the NICE website, the Nexavar (Sorafenib) drug is shortly going to be reviewed by NICE.  The exciting opportunity that arises in this connection, is a forthcoming programme on ITV namely the “Tonight” documentary hosted by Sir Trevor MacDonald for which Kidney Cancer UK Trustee, Professor Tim Eisen, is granting an interview.  This is due to be screened on Friday 9th February 2007. 

Further updates will be provided in due course.

 

KIDNEY CANCER CAMPAIGN

Two new drugs have recently been licensed for use in the treatment of metastatic renal cell carcinoma; Nexavar (the brand name for Sorafenib) and Sutent (the brand name for Sunitinib).  Despite both drugs showing great promise for extending patients’ lives, neither has so far been approved by the relevant authorities as cost-effective drugs suitable for NHS funding.  The purpose of the campaign is to change that.

The campaign is being conducted along five fronts.

1. The Media

Over the past few weeks, a number of press releases have been issued, a number of radio and TV appearances have been made and many interviews have been granted generally.  These have resulted in some high-profile events such as Keith Ditchfield’s excellent showing on Sir Trevor MacDonald’s Tonight Programme on ITV.  There have also been some major articles in national and provincial newspapers including The Daily Mail, The Times, The Scotsman, The Glasgow Herald, The Aberdeen Press and Journal, The Western Mail, The Birmingham Post, The Northern Echo (which has been carrying a series of articles on kidney cancer drugs) and most recently, The Sunday Times.  There are already further articles in the pipeline and the intention is to step-up all kinds of exposure in the media.

2. On-line Petition

3. Legal Advice

In the discussion forum on the KCUK website, a petition to the Number 10 Downing Street Website has been set up.  At the time of writing, the petition has attracted 1308 signatures; and the number of signatures is rising fast.  If any KCUK member has not already signed this, we would encourage them to do so at their earliest convenience.  Also, please encourage friends and relatives.  (There is a facility which enables people to forward it to everyone in their address book). 

KCUK is considering the position of patients who are refused new drugs because of cost and the lack of any guidance from the cost-effectiveness authorities.  The example of the Alzheimer’s Society seeking a Judicial Review  has been noted.  As a first step, KCUK is taking advice from a QC on this matter.

4.The Cost-effectiveness Authorities

5. House of Commons Select Committee on Health

For England, the relevant authority is the National Institute for Health and Clinical Excellence (NICE).  KCUK is much exercised by the fact that NICE has been slow to review the new drugs for kidney cancer.  This is despite it having earlier been decided that NICE would not wait for a new drug before reviewing its cost-effectiveness.  Nexavar is actually being reviewed at present; but Sutent has not yet even made it onto the NICE list. 

KCUK has reacted sharply to the decision by the Scottish Medicines Consortium not to grant cost-effectiveness approval to Sutent.  The position that this leaves certain individual patients in Scotland is being investigated.

As for the Welsh Medicines Partnership, a comprehensive Briefing Note has been sent to a person who sits on the body as a kind of Patients’ Advocate.  This has been sent in readiness for the Partnership’s forthcoming meeting in Port Talbot.

KCUK is going to make a submission to this Committee when the Committee undertakes an enquiry into the work of NICE.  Two out of the five points in the Committee’s terms of reference appear especially relevant to the KCUK Campaign; that is, the evaluation process used by NICE and whether any particular groups are disadvantaged by the process; and the speed of publishing guidance.  The deadline for submission is the 23rd March.  It would be helpful if individual members seized the opportunity to lobby their own constituency MP’s on the matter of new kidney cancer drugs. 

KCUK members will be issued with further updates in due course and we hope to create a “Campaigning Section” on the KCUK website soon which will also feature regular campaign updates. 

Pat Hanlon
Trustee
Kidney Cancer UK

  

KCUK's Campaign for New Drugs