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NICE meets to decide about kidney cancer drugs - we were there

Posted Apr 09 2009 7:17pm
A kidney

NICE are deciding whether to fund four new drugs for advanced kidney cancer

35 experts, 7 administrators, 15 public observers… one very important decision. Last week, the National Institute of Health and Clinical Excellence (NICE) held a meeting in Manchester to finally decide whether or not to recommend four drugs for advanced kidney cancer on the NHS.

Regular readers of this blog will know that the original decision not to recommend these treatments back in August 2008 was met with outcry from kidney cancer patients and their doctors alike.

Cancer Research UK was also dismayed by this draft guidance - and through this blog we sought the views of the public to help shape how we would respond to NICE. Our response spelt out why we felt this decision was unfair - and we appealed to NICE to reconsider.

In keeping with NICE’s processes, a second appraisal meeting took place last September- where the responses from the manufacturers of the four drugs, and from other stakeholders - including Cancer Research UK - were discussed.

The final meeting was scheduled to take place in November 2008 - but due to some last minute clinical evidence submitted by the manufacturers of two of the drugs - Pfizer, who make sunitinib (Sutent) and Bayer, makers of sorafenib (Nexavar) - the meeting was postponed until January 2009.

Although Cancer Research UK was frustrated by this delay, we appreciated that NICE needed the extra time to assess this new evidence.

 

What’s the role of a ‘public observer’?

We were intrigued to see how these ‘ Technology Appraisal Committee ‘ meetings work, so applied for one of the ‘ public observer ‘  places at the meeting. There are three Technology Appraisal Committees, and ‘Committee C’ is looking after the kidney cancer drug decision.

The other public observers were made up of representatives of the pharma companies - as well as Pfizer and Bayer, the other companies are Roche - who make bevacizumab, and Wyeth - who make temsirolimus. There were also representatives from patient groups, including the Rarer Cancers Forum and Kidney Cancer UK.

These meetings are held in two parts. In part 1, the committee discusses the evidence presented to them, and is open to the public. Part 2 is when a decision is made, but this part of the meeting is closed to the public - usually because the decisions are commercially sensitive.

Prior to the meeting we were sent lots of information informing us of how to behave. We were told that as public observers, we could listen to the business of the meeting, except where confidential information was being discussed. But we would not be able to participate in the discussions, ask questions, take part in voting or put our views to the members of the committee.

We were told to arrive at the NICE offices in Manchester by 9.45am, as the meeting was due to start promptly at 10am. When we arrived, the ‘Meetings in Public’ Coordinator welcomed us and informed us that an item had to be discussed at the beginning of the meeting in private, so in the end, the public part of the meeting didn’t start until 10.45.

The committee members - 35 in total - were sat around a large table - and seven administrators from NICE were seated around the outside. We were directed to our seats at the back, in which an agenda and a list of names of the committee members were placed.

What did they discuss at this meeting?

 

As we entered the room, we received a brief welcome from the Chair and the business of the meeting began.

Because NICE have already held three meetings to discuss these drugs, there were no presentations from doctors or kidney cancer patients. This will have happened at earlier meetings.

So the Chair ran through a summary of what they know so far - about metastatic kidney cancer in general - how many people it affects and how many survive. He then gave a summary of the current marketing authorisations for each drug, a summary of the clinical and cost effectiveness of each drug and the rationale behind the original decision not to recommend the drugs on the NHS - namely that they are all clinically effective, but not all of them are cost effective - according to NICE’s models.

We then listened to a summary of the responses from consultees - including patient and carer groups, and professional groups like Cancer Research UK. The main argument put forward was that the only other available treatment for people with advanced kidney cancer - interferon - is old and cheap - meaning that financially, it would be harder for any new treatment to beat it in terms of cost.

But crucially, interferon doesn’t work for everyone, and there are no other clinical options for patients with advanced kidney cancer. The other arguments centred around the low total cost of recommending these drugs - because of the small patient population and that the model NICE uses to assess new treatments is inflexible for rare diseases as it’s more difficult to obtain robust clinical evidence.

It was then time to listen to the arguments against the original decision from the pharmaceutical companies, and the Chair read through the details of each response in turn. This included new evidence from the companies relating to the clinical effectiveness of the drug and a recalculation of the figures. In some cases they outlined new pricing agreements that have been made with the Department of Health since the draft guidance was published.

A great deal of technical and financial information was discussed during this session which wouldn’t be possible to relay here accurately.

After the Chair had been through the arguments from each pharmaceutical company, it was time for the committee to go though what was up for fresh discussion. Again, they went through company by company, with members of the committee discussing between them the new information that had been presented and asking members of the Assessment Group and the Decision Support Unit for points to be clarified. The main thing they had to decide on was whether the companies’ new evidence was plausible.

The Chair reminded the committee that they had to take the following points into consideration when making their judgement:

  • The impact of the drugs on survival and quality of life
  • The cost of end of life and best supportive care
  • The benefit for potential subgroups of patients (e.g. those for whom Interferon doesn’t work)
  • The impact of the potential sequential use of drugs on survival
  • The new ‘end of life’  guidance - supplementary advice which NICE introduced at the beginning of this year, in response to some of the debate around top-ups and improving access to cancer drugs. This states that treatments which can be shown to offer patients with short life expectancy at least an extra three months of life, where there are no alternatives, should be recommended–even if they don’t fit NICE’s strict cost-effectiveness criteria.

Further discussions ensued, particularly around the last point. The committee did acknowledge that the companies had presented further evidence of survival benefit that would fit this guidance, but expressed reluctance to place too much emphasis on the new ‘end of life’ guidance - primarily because, as one committee member suggested - people with rare diseases shouldn’t be treated any differently than those with a more common disease, for example lung cancer.

That discussion concluded the public part of the meeting. It’s difficult to tell from that meeting what the final decision will be. Within five weeks, we should know.

In the meantime, we wait with bated breath.

Emma

Emma Gilgunn-Jones is Cancer Research UK’s Science Press Manager

This entry was posted on Tuesday, January 20th, 2009 at 10:43 am and is filed under Cancer Treatment, Chemotherapy & Drugs, Drug approval, Kidney. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.


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