NICE have given a preliminary negative recommendation for the use of Erbitux + radiotherapy.

As some of you may have heard, NICE has recently published the first draft of its guidance on the use of Erbitux in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.This initial draft recommends that the treatment should NOT be funded on the NHS.

As we all know, there have been very few developments in the treatment of head and neck cancer over the years, so any treatment options are very important to those who could benefit. Furthermore, Erbitux has been approved for use in Scotland as well as Europe. So should this draft guidance remain unchanged, then people with head and neck cancer in England and Wales will be denied access to a treatment which is available in other areas of the UK.

I am sure that you will feel as strongly as I do that it is important that we speak out on the behalf of patients who have experienced cancer of the head and neck or who may be affected by it in the future. 24 of you voted for it being made available when I sought your views for submission to the Scottish Medicines Consortium which has approved it for patients in Scotland.

The draft is open to public consultation until 5pm on 26th February. So if you believe, like me, that it is important for patients to have access to this medicine, please register your views on this to NICE directly through this link. All the feedback on the draft which is submitted to NICE during this time is taken into account by its committee before the Guidance is issued.

Additionally, any comments that you would like to share with the Mouth cancer Foundation on this issue would be most welcome and will be taken into account in the charity’s response to NICE.

Best wishes
Vinod

This message has been edited. Last edited by: Dr Vinod K Joshi,

C,mon everybody, lets get this signed & off to this dreadful committee who hold lives in their hands. Thanks Vinod for bringing this to our attention.

My father was on Erbitux and it made his face break out like acne in the end this type of treatment did not work. This treatment does not work on all people unfortunatley

I had Erbitux and radiation 12 weeks ago. I interfaced with other head and neck cancer patients that were ahead of me in recovery at a time when Erbitux was not available. These patients went through horrendous complications from regular chemotherapy. The side effects of Erbitux are minimal in comparison. The statistics in the U.S. for 5yr plus survival outweigh the original therapy.

Any treatment is not 100% guaranteed but if the regimin and testing that our government puts new medications through has found this to be more beneficial statistically I cannot understand holding back on the release in England. What does this committee have to substatiate non approval?

Sandra

Hello Sandra

Our overall view on the draft is that the NICE committee has not looked at this in a pragmatic way or from the patients’ point of view. By denying access to this treatment, NICE does not truly understand the issues that are important to patients.

As NICE points out, the trial involving Erbitux resulted in robust findings that are very significant to patients in England and Wales with regard to the fact they will live months longer and will have an alternative should they not be able to tolerate chemoradiotherapy. NICE also notes that the treatment is cost effective.


We need to appeal to health professionals and patients to feedback to NICE on this draft guidance, which if unchanged, would deny access to the only new medicine in Head and Neck Cancer in many years for patients in England and Wales.

There are a small number of patients with Head and Neck Cancer who are set to lose a large amount if we do not act now.

Best wishes
Vinod

This message has been edited. Last edited by: Dr Vinod K Joshi,

I had to go ont never had Erbitux so cannot comment
But when i had Radiotherapy and my mouth was blistered and bleeding plus the swelling they still forced on the mask
I asked many times for omething to reliee the pain specially in my mouth you would have thought I was the only person having problem with radiotherapy I went on the Internet to find something for myself

apul

I am a member of the Oral Cancer Foundation Group and i have seen this treatment mentioned in posts many many times by oral cancer sufferers in the United States.I find the differences between available medications and treatments quite astounding ,and i if am not mistaken drugs have to undergo rigorous testing before they become available for use in America.Surely this must mean that it is of benefit in treatment of oral cancer and as such should be available to everyone no matter what country you live in.

ASCO: Cetuximab Plus Platinum Extends Head and Neck Cancer Survival
CHICAGO June 2 2007

quote:

The drug Erbitux prolongs survival in patients with advanced head and neck cancer by nearly three months, according to study results announced Saturday.

"This is the first systemic treatment in 25 years to show a survival benefit over platinum-based chemotherapy" for these patients, he said.

"We have now found for the first time--in a group of patients with a very poor outcome--a survival benefit that will change practice," said Dr. Jan Vermorken, oncology professor from the University of Antwerp in Belgium, in a prepared statement. The study results were unveiled at the annual American Society of Clinical Oncology (ASCO)conference.

The study tracked 222 patients with metastatic head and neck cancer who took Erbitux with chemotherapy, and 220 patients who took chemo without Erbitux. The Erbitux patients survived an average of 10.1 months, compared to 7.4 months for patients taking chemo without the drug.

"I was hopeful for this study but I was also very skeptical," Vermorken said at a press conference Saturday morning. He noted that head and neck cancer is notoriously difficult to treat. But he said the study exceeded the goal of prolonging survival by two months.

See also: Study: Erbitux prolongs cancer survival

This message has been edited. Last edited by: Dr Vinod K Joshi,

quote:

MEDIA ALERT – MOUTH CANCER DRUG MAY SOON BE AVAILABLE ON NHS
4th October 2007


Today, the Mouth Cancer Foundation came a step closer to making sure all Mouth Cancer patients have access to a new drug, currently not widely available on the NHS. The drug in question is called ‘Cetuximab’ and is a new cancer treatment available in Scotland since July 2006, but not England and Wales at present.

It is hoped that cetuximab in combination with radiotherapy can be used as an alternative in Mouth cancer patients for whom chemoradiotheraphy is in appropriate.

The charity successfully convinced the Appeal Panel of the National Institute for Health and Clinical Excellence (NICE) to ask its Appraisal Committee’s to reconsider its appraisal decision to ban the drug for head and neck cancer patients in England and Wales. The appraisal has now been returned to the Committee.
(click above link for pdf of the Result of the Appeal)

The Founder of the Mouth Cancer Foundation, Dr Vinod K Joshi, explained that the charity represented the views of its members constituting a wide population of patients with mouth cancer.

Four members of the Mouth Cancer Foundation, Mrs Brenda Brady, Mr John Spencer, Mrs Christine Piff and Mr Mike Cummins provided the Appeal Panel with personal accounts of the suffering caused by head and neck cancer and of the very unpleasant nature of their treatments. They stressed that it was important for the Institute to take patients’ views into account.

This the Appeal Panel did, and the debate centred on the efficacy of cetuximab. Currently both carboplatin and cisplatin are used for chemoradiotheraphy in the United Kingdom with horrific side effects. Carboplatin had fewer adverse effects than cisplatin, but was more likely to suppress the bone-marrow. Therefore, cisplatin was the preferred treatment. The Appraisal Committee accepted that cetuximab plus radiotherapy caused less severe adverse effects than either of the platinum-based chemoradiotherapy regimens.

The Appeal Panel considered that the Appraisal Committee had not given appropriate consideration to the issue of whether a chemoradiotherapy regimen of carboplatin alone was as effective as cisplatin, or that a regimen consisting of carboplatin plus fluorouracil would necessarily be suitable for the population identified in the decision problem in whom cisplatin was contra-indicated. The Panel found that, as a result, the Committee's conclusions were perverse in proposing a ‘carboplatin-based’ regimen for those in whom cisplatin was contra-indicated.

The Founder of the Mouth Cancer Foundation, Dr Vinod Joshi says “The Mouth Cancer Foundation is delighted that the decision has been referred back the Final Appraisal Determination to the Committee for reconsideration”.

Interviews Available: Founder of the Mouth Cancer Foundation Dr Vinod Joshi

To set up an interview please call Media Ambitions on 020 7482 3600

Thanks to all who supported us.

Best wishes
Vinod

This message has been edited. Last edited by: Dr Vinod K Joshi,

That's fantastic!
Lets hope they see sense!

Appraisal Committee's preliminary recommendations

• Cetuximab in combination with radiotherapy is recommended as a treatment option only for patients with locally advanced squamous cell cancer of the head and neck whose Karnofsky performance-status score is 90% or greater and for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated.
  
• People currently receiving cetuximab in combination with radiotherapy for the treatment of locally advanced squamous cell cancer of the head and neck who do not meet the criteria outlined in section 1.1 should have the option to continue therapy until they and their clinicians consider it appropriate to stop

Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation.

Ref: http://www.nice.org.uk/guidance/index.jsp?action=folder&o=39184
The key dates for this appraisal are:
Closing date for comments: 4 March 2008

Next Appraisal Committee meeting: 12 March 2008

Related News:

• UK's NICE backs ImClone's Erbitux, changes tack Reuters - USA
  Vinod Joshi of the Mouth Cancer Foundation said the about-turn by NICE was a "happy day" for patients since Erbitux, known generically as cetuximab, ...

This message has been edited. Last edited by: Dr Vinod K Joshi,

quote:

On 22 Jan 2009, at 15:25, David Bevan wrote:

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Single technology appraisal (STA)

Cetuximab for the treatment of metastatic and/or recurrent squamous cell carcinoma of the head and neck

• Appraisal consultation document

Dear Consultees and Commentators


You are invited to comment on the attached appraisal consultation document (ACD) for the above appraisal. A hard copy of the ACD and evaluation report is being sent to you.

Following instructions of the Court of Appeal we will now distribute executable models to consultees and commentators in all technology appraisals. We will release the model if it does not contain information that was designated confidential by the model owner, or if the confidential material can be redacted by the model owner without producing severe limitations on the functionality of the model.

The economic model for this appraisal was developed by the manufacturer. We are still discussing with Merck Serono whether it is possible to release their model. If you would like to request a copy of this model, so that you can comment upon it, please contact the project manager for this appraisal.

The Appraisal Committee is interested in receiving your comments on the ACD under the following general headings.

i) Do you consider that all of the relevant evidence has been taken into account?

ii) Do you consider that the summaries of clinical and cost effectiveness are reasonable interpretations of the evidence, and that the preliminary views on the resource impact and implications for the NHS are appropriate?

iii) Do you consider that the provisional recommendations of the Appraisal Committee are sound and constitute a suitable basis for the preparation of guidance to the NHS?

iv) Are there any equality related issues that need special consideration that are not covered in the ACD?

If you wish to comment on the evaluation report, please do so under a separate heading from your comments on the ACD.

We prefer to receive comments in electronic format, either by email to jeremy.powell@nice.org.uk or on compact or floppy disk. Please use Microsoft Office software products. Comments sent by post should be addressed to Jeremy Powell, Technology Appraisal Project Manager, at the above address.

Please note that your comments, along with a summary table of these comments and the action taken in response to them, will be released to consultees and commentators with the final appraisal determination (FAD) for this appraisal, and published on the Institute’s website.

In line with the Guide to Technology Appraisals Process (April 2004; sections 4.5.2.7 and 4.5.2.10), we do not expect you to submit any information which is commercial in confidence or academic in confidence with your comments on the ACD and evaluation report.

In the light of comments received, the Appraisal Committee will reconsider the ACD at a meeting on 3 March 2009. In order for your views to be included in the papers for this meeting, your comments must be submitted before 5pm on 19 February 2009.

The ACD and evaluation report will be posted on the Institute’s website on 29 January 2009. People who are not formal consultees or commentators for this appraisal can comment on the ACD through an email link on the website. However, we do not wish to receive comments from formal consultees and commentators via the website. Please send your comments directly to the Technology Appraisal Project Manager, either by email or by post.

I must emphasise that the documents enclosed with this letter, and their contents, are confidential until they are published on the Institute’s website. They are released to you only for the purpose of informing the Appraisal Committee’s consideration of this technology. Accordingly, the documents and their contents should only be divulged to those individuals within your organisation who need to see them to enable you to prepare your response. You must ensure that anyone who sees these documents is aware of their confidentiality.

The use of any information contained in the ACD to make investment decisions regarding any shares or other securities, or the passing of such information to someone else for such use, may constitute insider dealing, which is a criminal offence under section 52 of the Criminal Justice Act 1993. It may also be an offence to encourage someone else to deal in shares or securities, the price of which would be affected by the disclosure to the public of any information contained in the ACD.


Yours sincerely,

Dr Carole Longson
Director, Centre for Health Technology Evaluation

Dear Mr Powell

Thank you for giving the Mouth Cancer Foundation the opportunity to respond to the Appraisal consultation document (ACD) and the supporting Evaluation Report (ER) on Cetuximab for the treatment of recurrent and/or metastatic squamous cell cancer of the head and neck.

The Mouth Cancer Foundation is disappointed with the preliminary recommendation of the Appraisal Committee not to recommend the use of Cetuximab in combination with platinum-based chemotherapy for the treatment of recurrent and/or metastatic squamous cell cancer of the head and neck.

Here are our comments on the ACD, in response to the following general questions:

i. i. Do you consider that all of the relevant evidence has been taken into account?

ii. ii. Do you consider that the summaries of clinical and cost effectiveness are reasonable interpretations of the evidence, and that the preliminary views on the resource impact and implications for the NHS are appropriate?

The Mouth Cancer Foundation considers that while the relevant evidence has been taken into account, the ERG's reasoning is faulty in its interpretation of the material it considered. It appears to be biased and adversarial to material evidence in the manufacturer's submission. Our more detailed comments, keyed to various sections in the ACD, are below:

3.12 As a patient organisation, we would be disappointed if the manufacturer had not submitted clinical evidence to support the use of cetuximab plus platinum-based chemotherapy for the first-line treatment of patients with recurrent and/or metastatic SCCHN if its evidence shows that the added use of cetuximab improves outcome. Why does the ERG consider this a problem?

The ERG states that patients in the EXTREME trial may be younger and fitter (indicated by very high KPS scores) than patients with recurrent and/or metastatic SCCHN in the UK. However, perusal of the age categories in Table 4.6 of participants in the EXTREME trial shows that 82.4% were <65 years and 17.6% were >65 years. We would not read this to mean patients in the trial were younger unless ERG thinks those between 55 -64 are young! Our experience with patient members reflects very much the picture that most Head and Neck cancer patients are not over 65 years. There are increasing numbers of cases of younger patients in their 20’s – 40’s with recurrent and/or metastatic SCCHN and they should have access to this treatment that can prolong their life.

The ERG also expresses concern that no evidence was provided by the manufacturer to support the use of cetuximab plus platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN who were not cetuximab-naive. Is ERG not aware that the use of cetuximab for Head and Neck cancer patients is relatively new and not routinely available to them? One should expect that most patients with recurrent and/or metastatic SCCHN would inevitably be cetuximab-naive.

The ERG highlighted that for several subgroups, including metastatic disease, there appeared to be no survival benefit from cetuximab plus platinum-based chemotherapy. The corollary is that there is a survival benefit for some subgroups. As a patient organisation, we expect the ERG to support the use of cetuximab for these groups of patients but do not find the ERG doing this.

3.13 We feel that the ERG's own critique of the economic model submitted by the manufacturer is badly flawed. The ERG felt that the average BSA value of 1.7m2 used was incorrect and worked out a higher mean BSA of 1.83m2 to use in their own model from a 'recent survey of three UK cancer centres.' The reference (no 20) given in its Evaluation Report is to a BMJ awareness article on "Squamous Cell Carcinomas of the Head and Neck", not a survey. However, the average UK male BMA is 1.98 (based on average height of 178cm and weight of 80kg) and the average UK female BMA is 1.72 (based on average height of 162cm and weight of 67kg) and the average of the two gives 1.85. However derived, we would like to know if this 'survey' was of (1) Head and Neck cancer patients and (2) whether their BSA was recorded after initial treatment (surgery, radiotherapy) or before. Our patient members' experience is that they lost a lot of their normal weight after surgery and radiotherapy and their BSA was most definitely below the average UK male or female figure.

3.14 We feel that for rarer cancers like recurrent and/or metastatic SCCHN where patient numbers are smaller, the ERG should not readily dismiss data presented by saying that "some of the subgroups were too small to yield reliable projection models, casting doubt on the credibility of the cost-effectiveness results for those subgroups." If so dismissed, rarer cancers will always be disadvantaged by the approach employed.

We submit that exploratory analysis done using the ERG model amendments on all the patient subgroups were flawed and its conclusion that the use of cetuximab plus chemotherapy may not be cost effective at any price is perverse.

iii. Do you consider that the provisional recommendations of the Appraisal Committee are sound and constitute a suitable basis for the preparation of guidance to the NHS?

The Mouth Cancer Foundation is of the opinion that the Appraisal Committee's decision is unsound especially when it says in the ACD that:

4.2 Overall the Committee accepted the evidence from the clinical specialists that the results of the EXTREME trial would be applicable to the UK population.

4.3 The Committee accepted that the trial demonstrated the efficacy of cetuximab plus platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN

4.4 The clinical specialists and a patient expert advised the Committee that the adverse events reported for the trial were consistent with those seen in clinical The practice where cetuximab had been used for locally advanced SCCHN and colorectal cancer.

The Mouth Cancer Foundation hopes that the Appraisal Committee's will reconsider its decision as the concerns raised by the ERG in relation to its exploratory analyses undertaken by the ERG using alternative assumptions and parameters in the economic model (see section 3.16) are flawed. It is important that the Appraisal Committee recognise that oncologists who provide the treatment always consider the individual patient on a case-by-case-basis as not all patients will be suitable for this treatment. We are not sure if the model of costs reflects this.

iv. Are there any equality related issues that need special consideration that are not covered in the ACD?

The Mouth Cancer Foundation considers that all the following criteria in the supplementary advice from the Institute when appraising treatments which may be life-extending for these patients with short life expectancy, and which are licensed for indications affecting small numbers of patients with incurable illnesses, were met:

o The treatment is indicated for patients with a short life expectancy, normally less than 24 months.

o No alternative treatment with comparable benefits is available through the NHS.

o The treatment is licensed, or otherwise indicated, for small patient populations.

o In addition, when taking these into account the Committee must be persuaded that the estimates of the extension to life are robust and the assumptions used in the reference case economic modelling are plausible, objective and robust.

o There is sufficient evidence to indicate that the treatment offers an extension to life, normally of at least an additional 3 months, compared with current NHS treatment.

We would argue that the criteria that the treatment offers an extension to life, normally of at least an additional 3 months, compared with current NHS treatment is only guidance and so should be applied flexibly. The Committee observed that the trial data suggest that cetuximab plus platinum-based chemotherapy extends survival relative to platinum-based chemotherapy alone. The EXTREME trial showed a statistically significant increase in median overall survival for cetuximab plus chemotherapy of 2.7 months or 81 days. It would be perverse if this treatment is denied just because patients in the trial failed to live for an additional 9 days longer in order to meet this criteria. This is the first time in 30 years that a study has shown an increase in overall survival for these patients. The Committee should consider that the magnitude of this benefit is in keeping with the spirit of the supplementary advice for consideration of life-extending, end-of-life treatments. The Committee should conclude that cetuximab for recurrent and/or metastatic SCCHN be recommended.

The Mouth Cancer Foundation feels that it is important that clinicians are able to provide this current treatment modality if they decided it as most appropriate for their patient.

Kind regards

Vinod

--

Dr Vinod K Joshi

BDS(Singapore) DRDRCS(Edinburgh) FDSRCPS(Glasgow) FDSRCS(England)
Consultant in Restorative Dentistry
Restorative Dentistry Oncology Clinic
St Luke’s Hospital, Bradford
Pinderfields Hospital, Wakefield
United Kingdom

Founder and Chief Executive
Mouth Cancer Foundation