Could BCC clarify it's role as a NICE Stakeholder?

[Lemongrove]

Leah, two things:
(1) Thank you for clarifying whether commissioners are obliged to comply with NICE guidelines. I was under the impression that commissioners were obliged to implememnt guidelines within three months by both the technology and clinical group, so I'm interested to learn that it only applies to the technology appraisal group.

(2) With regard to whether registration with the Charity Commission hinders charities with regard to political activity. I stand by my original statement.
For example, the UK lags behind many other European Countries in terms of the drugs and treatments available, and survival rates. In my opinion, this has been caused by the political failure of successive governments, yet no cancer charity to my knowledge has mobilised cancer patients to demand action, lobby MP's, demonstrate, or call for the resignation of Health Ministers etc Similarly many cancer patients suffer as a result of the postcode lottery, yet I have never noticed BCC or any other cancer charity mobilising members to lobby PCT's or CCG's, or to demonstrate Another example is that of the new rules surrounding DLA, which have hit many cancer patients Yet again, other than lobbying Government, cancer charities have made no attempt, as far a I'm aware, to mobilise cancer patients to demonstrate, lobby MP's or call for resignations etc.

BCC and other cancer charities obviously would want to tackle these issues if they could, so why don't they? The answer I feel lies in section D3 and section C3 of the Charity Commissions Guidelines which outlaws organisations with a political purpose, and narrowly defines campaigning.

Section D3 reads:
" In order to be a charity, an organisation must have purposes which are charitable and for the public benefit. An organisation with a political purpose, such as promoting a change in the law, legally cannot be a charity. This applies even if the organisation has other purposes which are charitable. This would involve looking at ‘political’ questions, which neither we nor the courts are in a position to answer. Constitutionally, it is not possible for the Charity Commission or the Courts to make decisions about whether a change in the law or Government policy would be for the public benefit. However, organisations which are established to ensure that the law is observed, for example respecting certain fundamental human rights, will not automatically fall within this definition".

Section C3 which defines campaigning say's:
We use this word to refer to awareness-raising and to efforts to educate or involve the public by mobilising their support on a particular issue, or to influence or change public attitudes. We also use it to refer to campaigning activity which aims to ensure that existing laws are observed. We distinguish this from an activity which involves trying to secure support for, or oppose, a change in the law or in the policy or decisions of central government, local authorities or other public bodies, whether in this country or abroad, and which we refer to in this guidance as ‘political activity’. Examples of campaigning might include:

• a health charity promoting the benefits of a balanced diet in reducing heart problems;
• a refugee charity, emphasising the positive contribution that refugees have made to society and calling for Government to enforce existing legislation that supports the rights of refugees;
• a children’s charity, drawing attention to the dangers of domestic violence and child abuse;
• a human rights charity calling on a government to observe certain fundamental human rights, and for the practice of torture to be abolished;
• a charity concerned with poverty and the environment campaigning against investment by some banks in fossil fuel extraction projects; or
• a disability charity calling for existing legislation to be adhered to in order to ensure that all children with special educational needs receive the support they are entitled to in order to access learning.

I appreciate that BCC and other charities are involved in some political activity and campaigning, but this is largely making recommendations to Government and organisations such as NICE. But this is not really hard hitting political stuff is it? That is why in my opinion, cancer patients really need a political group to kick up a massive stink when politicians fail to deliver.

[Guest user]

Hi Lemongrove & Raechi

I've got some information from our policy team about this:

With regards to implementing NICE guidelines, it depends whether it is part of a technology appraisal or clinical guidelines.

The NICE Guide to the methods of technology appraisal states that “The Secretary of State for Health has directed that the NHS provides funding and resources for technologies that have been recommended through the NICE technology appraisals programme normally within 3 months from the date that the guidance is published.”

However, this only applies to recommendations coming out of technology appraisals (for example an appraisal of a breast cancer drug).

The NICE fertility guideline is not a technology appraisal (it is rather part of the NICE Clinical Guidelines), so you would have to look at the wording in this particular guideline to see how NHS bodies should take the recommendations within it forward (this may be different for different recommendations within this document) See http://publications.nice.org.uk/fertility-cg156/about-this-guideline for more information on this guideline.

The recommendation to extend treatment to women aged 40-42 does appear in the "key priorities for implementation" section http://publications.nice.org.uk/fertility-cg156/key-priorities-for-implementation#criteria-for-refer...

And this is what it says about implementation:

"This guidance represents the view of NICE, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summaries of product characteristics of any drugs.

Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties."


With regards to charity campaigning, here is the Charity Commission guidance on the subject: http://www.charity-commission.gov.uk/Publications/cc9.aspx

Some key points:

• "Charities can campaign for a change in the law, policy or decisions (as detailed in this guidance in section C4) where such change would support the charity’s purposes. Charities can also campaign to ensure that existing laws are observed."
• "In the political arena, a charity must stress its independence and ensure that any involvement it has with political parties is balanced. A charity must not give support or funding to a political party, nor to a candidate or politician."
• "A charity may give its support to specific policies advocated by political parties if it would help achieve its charitable purposes."
• "Can a charity organise demonstrations? The short answer: yes - a charity may in principle organise different kinds of direct action in support of charitable campaign activity." More info http://www.charity-commission.gov.uk/Publications/cc9.aspx#35

Hope that information helps.

Leah

[raechi]

I for one, would be happy to get my stomping boots on 🙂

[tors]

Hi lemongrove, I totally agree with you. I hate to prove your negative point too, but I really don't have capacity to organise a lobbying group cos every minute of my spare time (and not spare time too!) is being spent running the YBCN support site, and moving it forwards. However, we are growing everyday, with motivated concerned, well connected members, many of whom want to do something about the treatment we get as cancer patients, especially younger cancer patients, even if it's just writing letters, so I am more than happy to pull ideas/actions over to them if someone can suggest what is needed. We are just a user led group, not a registered charity, so no constraints there. X

[Lemongrove]

Rae, I was under the impression that once NICE approved a treatment or medicine, that PCT's/CCG's had to implement the decision within three months. Maybe BCC could clarify that for us?
The purpose of this thread was to consider how impartial charities can be when they are so closely linked to decision makers. Personally I feel that while charites such as BCC do an excellent job providing information, and support to cancer patients, they are not much good as pressure groups. The fact is that any charity registered with the Charity Commission is hindered by the type of campaigning the Charity Commission allow them to do. For example they cannot call for a change in government policy, criticise the government of the day, or organise demonstations etc - all they can really do is make recommendations, and raise awareness. The other problem is that a decline in public donations has forced many charities to accept government/helath service/local authority funding, and this raises questions about whether this compromises their position ( he who pay's the piper calls the tune etc).
I have felt for some time now that there needs to be an indepent pressure group for cancer patients. I think that if cancer patients got together and really kicked up a stink, resources would have been allocated and there would be a cure by now. Cancer patients always say, well I feel too ill or I've got too much on my plate to get involved in campaigning, but look at how those with HIV got together all around the world. Surely they must feel pretty naff as well, but they fought back and as a result HIV/AIDS has to a large extent gone from being a killer disease to being a chronic disease.

[raechi]

Hi Lemongrove,
I fully agree with your questions and comments. Thank you so much for asking them.
As a younger woman with breast cancer i feel all too often our voice is not heard and even recently i have had issues re: NICE and the new fertility guidance. (as a younger woman this is an issue).
Even though NICE have upped the age to 42 for treatment, authorities dont have to tkae that on and my health authority isnt. There is just no where to turn sometime and i wish there were more people like you that what question decisions made!
Rae
x

[Guest user]

Hi all - glad you're finding the discussion interesting. I managed to track Emma down again for a response - she's a very busy woman! Anyway, here it is.


Hi Lemongrove,

We have challenged NICE on numerous occasions (I think on almost every appraisal of drugs for secondary breast cancer in recent years) about the factors they take in to consideration. We have repeatedly raised the point you make, stressing the crucial importance of delayed progression in this setting. We have also released press statements highlighting this issue.

We have had some success - our lobbying influenced the decision by NICE to publish supplementary advice to the Appraisal Committees entitled ‘Appraising life-extending, end of life treatments’ in August 2009. This affords some flexibility in cases where the cost effectiveness ratio is in excess of the range normally approved. There is, of course, potential for further improvements, but I wanted to illustrate that there has been some impact of our involvement and to reassure you that we are not complacent within these processes.

Regarding your second question, the NICE guidance on re-testing receptor status (ER and HER2) is cited within ‘Advanced breast cancer’ published in 2009. NICE recently held a consultation about whether to renew this guideline (in total) and the outcome was deferral of an update. Re-testing receptor status was one of the numerous areas we made commentary on during the consultation. Unfortunately the majority consensus from the consultation was that there is insufficient evidence to update the full guideline at this time.

However, the NICE quality standard on breast cancer, published in September 2011, does allow for some clinician choice on re-testing receptors with its statement ‘People with newly diagnosed invasive breast cancer and, if appropriate, those with breast cancer that has come back or spread, have tissue from their tumour tested to find out its ‘oestrogen-receptor’ (ER) and ‘human epidermal growth receptor 2’ (HER2) status’. This effectively enables clinicians to re-test recurrent disease at their discretion, if they deem it is appropriate.

Emma

[scottishlass]

Thanks for asking the questions Lemongrove. I have been following this but my head is not in the right place at the moment to make any comments. But the discussion is good. Val

[Lemongrove]

Thank you again Leah and Emma for the reply. The reason for my original post was that I, and I suspect many other cancer patients are increasingly frustrated and concerned at the range of drugs and treatments which NICE have said should not be funded. Given that these decisions are often based on very poor science, and are frequently irrational, one wonders why stakeholders such as BCC have not taken a firmer stance.
Yes Avastin is indeed topical, because it really goes to the heart of the way charities like BCC seem to have adopted the case. Emma say's "NICE can only base their decisions on data from existing trials and on populations who have been given the drug. They would be unable to summise the outcomes of using the drugs in a different way". But lack of data is not the issue here. The issue is that NICE has reached it's decision by focusing on whether Avastin extends life (bang for buck), whereas if they had considered other factors, such as whether it delays progression (for which there is plenty of data too) a different conclusion may have been reached. So the question I would like to ask BCC, is why didn't they didn't press NICE to evaluate Avastin on it's ability to delay progression, rather than just it's ability to prolong life? I ask this question not to ruffle feathers, but because in reaching this decision, NICE have effectively thrown the baby out with the bathwater. The select population who, as Emma acknowledges, might have benefitted from a targeted therapy such as Avastin, will not now be able to do so.
The second question I would like to ask BCC is if they intend to ask NICE to reconsider the advice they have given about not performing biopsies on secondary metastases, given that there is now evidence that 32.4% of secondary cancers are unstable and change their receptor status. This is obviously important to ensure that secondary cancer patients receive appropriate treatment, and to prevent money being wasted on inappropriate treatment.
While I'm grateful to BCC for all it does for cancer patients, if I'm honest, I'm slightly disappointed when BCC describes itself as, working with NICE", and being a "trusted stakeholder", As a cancer patient I would prefer NICE to be slightly scared of cancer charities, not regard them as partners who can be relied on not to rock the boat too much. I appreciate that it's usually better to be friends rather than enemies, but where do cancer patient's fit in?

[Guest user]

Hi Lemongrove

I managed to catch Emma and show her your follow-up post. Here is her reply:

"We don’t regard challenging NICE decisions as beyond our remit and we have on several occasions challenged the basis upon which decisions are made. For example the inappropriateness of using significant gains in overall survival as a key factor in appraisals of drugs for second and third line use in secondary breast cancer.

Your example of Avastin is very topical. There is a fairly wide-held belief that targeted therapies may prove more effective if used on a select population at the appropriate time; but this is more of a reflection on study execution than data analysis. NICE can only base their decisions on data from existing trials and on populations who have been given the drug. They would be unable to summise the outcomes of using the drugs in a different way. If new trial data emerges from trials which evaluate the drugs in a different indication, these can be re-submitted to NICE for consideration.

Sometimes NICE decisions are subject to an appeal and we have attended these meetings and submitted commentary. We envisage continuing to work with NICE and SIGN and maintain our role as a robust and trusted stakeholder, challenging where appropriate, and basing our commentary on our clinical expertise and the experiences of our service users.


Best wishes

Emma"

[Lemongrove]

Leah, thank you for asking Emma Pennery for her comments. Just as a matter of interest, have BCC ever challenged NICE on their clinical evidence?
For example, Emma mentions that " remarking about the importance of quality of life for people with secondary breast cancer is unlikely to influence the outcome of an appraisal for a costly drug that does not improve overall survival". That might be the case, but many would argue that this is simply doing what lawyers call adopting the case ( accepting the point without challenge or adequate proof). For example, in the case of Avastin, some have argued that NICE have taken the wrong things into consideration. They argue that the main reason Avastin does not appear to extend life, is because it has mainly been given to people after other drugs have failed, have a heavy tumour burden, and are at the end of life - whereas Avastins real value is as an angiogenesis inhibitor, preventing disease from becoming established.

Of course, it could be BCC feel that challenging clinical evidence is beyond their remit, but it seems to me that there are some NICE guidelines which are so irrational that they should never have been approved, and I wonder why BCC and other charities have not challenged them. For example, guidance issued by NICE that secondary tumours should not be biopsied, unless the primary was never biopsied is very strange given that, 32.4% of secondary BC is unstable, and changes it's receptor status. How many cancer patients have died because doctors followed NICE guidelines, failed to perform a biopsy, and as a result were never able to provide appropriate treatment ?

The assumption that the general public seem to make (and BCC seem to make), is that NICE appraisal is research based and therefore beyond question. But in reality research is frequently flawed. For example, the Department of Health recently asked NICE (Medical Technologies Committee), to look at Cyberknife stereotactic radiotherapy . The trouble is, that when NICE evaluate a piece of equipment they actually strip it down, taking apart every nut and bolt to see what the particular widget adds over and above other technologies - and this approach is apt to completely miss the point. In the case of Cyberknife the thing that makes it so superior to conventional radiotherapy is the way all the various components work together to preserve healthy tissue ( so their approach is bit like concluding a Rolls Royce is the same as a Fiat Panda, because they both have stearing wheels and tyres).

While I would never criticise BCC (or other cancer charities), because they do so much to help cancer patients like me. But if I'm completely honest, I do wonder if they are a bit too cumfortable with NICE and their stakeholder role, and are not really as challenging as they could be.

[RevCat]

Thank you Leah and Dr Emma Pennery that's really helpful to know.

[Guest user]

(Posting on behalf of Dr Emma Pennery, Clinical Director at Breast Cancer Care, who oversees our relationship with NICE and SIGN.)

Breast Cancer Care has been involved in multiple responses for both NICE and SIGN in recent years. The nature of our involvement depends on the type of consultation. Sometimes we comment on clinical guidelines or quality standards, suggesting omissions, re-phrasing content or seeking clarification where there are ambiguities.



More commonly we take part in appraisals of drugs and other technology assessments. Initially these involve scoping exercises, where we remark on their relevance and importance to people with breast cancer. Our work in the full appraisals then involves commenting on draft guidance, attending appraisal meetings and occasionally appeals.



Each piece of work is led by a named member of the clinical team, who is involved in the appraisal from start to finish. We see our role very much as patient advocates. Our commentary considers the practical and emotional impact on the person and quality of life issues. We don’t input on cost effectiveness.



Sometimes our contributions have limited impact because of the nature of the appraisal. For example, remarking about the importance of quality of life for people with secondary breast cancer is unlikely to influence the outcome of an appraisal for a costly drug that does not improve overall survival. This can feel frustrating, particularly if the same drug is appraised several times and we are repeating our input each time.



However, other times we have made an impact. Some of our suggestions for the NICE breast cancer quality standard were used word for word. More recently, our team member working on the positive appraisal of denosumab spoke extensively about patient choice and adherence to oral and intravenous drugs. She was also asked about the importance of having other options for treatment for secondary breast cancer and about poorly addressed physical symptoms such as pain. These issues are not necessarily apparent from assessment of clinical and cost effectiveness but were clearly mentioned in the final appraisal document.



Emma Pennery

Clinical Director

[Guest user]

Hi Lemongrove & Revcat

I'll pass your question to our policy team and see what they say.

Best wishes

Leah

[RevCat]

That's an interesting question Lemongrove. Just a picky point in case anyone reading doesn't know, NICE does not apply in Scotland, there is something called SIGN (Scottish Inercollegiate Guidance Notes) which serves much the same purpose, and is often very similar to NICE but there are some differences. I have no idea (as I haven't looked) who the stakeholders are or how it works up here. It will be interesting to read responses/comments.

[Lemongrove]

I think most people on this forum know that there is an organisation called NICE, which evaluates various drugs, treatments and technologies, and issues guidelines as to what the NHS should fund. Doctors are not bound to follow NICE guidelines, but if they don't they have to provide a written explanation for not doing so. What people may not be aware of, is that charities such as BCC and Macmillan are actually involved in many of these appraisals (NICE describes these patient representation groups as stakeholders).
Given that NICE have over the years issued guidelines which effectively prevent the funding of various drugs and treatments, it would appear that the contribution made by organisations such as BCC do not count for much. It would be very interesting to hear from BCC, if they feel their contribution has ever had any impact on NICE recommendations, and how they view their role. (NICE partner, or patient advocate).
There is frequently criticism that cancer charities simply help to maintain the status quo, but I wonder if this is correct?