Hot Topic Presentation I want Herceptin

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Hot Topic PresentationI want Herceptin!

• Jonathan McKelvey
• 22/11/05

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I want Herceptin!

• I saw it on the news
• Its the best treatment for breast cancer
• You wont give me it because of the cost
• Im going to contact Andy Kerr
• Do you even know what Herceptin is?

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Headlines

• Balanced reporting?
• Wonderdrug is cure for breast cancer say
  doctors - The Times, 20/10/05
• Breast cancer drug hailed as stunning
  breakthrough - The Independent
• Drug could save my life.but health chiefs wont
  give it to me The Sun

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Other media stories

• Woman sells her house to pay for Herceptin in
  India
• Hewitt steps in to wonderdrug cancer row
• Consultant radiologist celebrates Herceptin
  victory The Times 17/11/05
• Summary its hot!

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What is Herceptin?

• Trastuzumab
• A type of monoclonal antibody
• Biologic response modifier
• Manufactured in lab
• Roche

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How does it work?

• Antibody antigen response
• Binds to antigen on certain cancer cells
• In this case Epidermal Growth Factor Receptor 2
  (HER2) which stimulates cell division
• Then the immune system attacks cancer cells

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Who is eligible (1)

• Must have breast cancer which over-expresses
  HER2.
• 15-25 of all breast cancer sufferers
• Useless for all other types

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Who is eligible (2)?

• Current license2 main indications according to
  BNF and NICE
• 1) In combination with paclitaxel for metastatic
  breast ca with tumours expressing HER2 if no
  chemotherapy before and cannot have anthracycline
  chemotherapy drugs

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Who is eligible (3)?

• 2) Used as monotherapy in metastatic breast ca
  after at least 2 cycles of chemotherapy
• ALL other uses are off license.
• If tumour is hormone receptor positive, hormone
  treatment should be tried first.

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What are the side effects?

• Potentially serious
• Allergic reactions
• Cardiac failure
• Breathing problems

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How is it given?

• IV infusion
• Initially 8mg/kg
• Then 6mg/kg
• Under specialist supervision

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Cost?

• Are you sitting down?
• 21 500 per patient per year

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History

• Herceptin was in news in 2002
• When initially marketed
• NICE criticised for being too slow to come to a
  decision about Herceptin

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Present day

• NICE again under spotlight
• Under political and media pressure
• Greater than 2002
• Why the delay?

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So why all the fuss?

• NEJM October 2005
• Research into Herceptin for early breast cancer
• Almost 50 reduction at 1 year of recurrence,
  spread or death in Herceptin group
• Dr Gabriel Hortobagyi..maybe

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What then is the problem?

• Why dont we just license Herceptin?
• Is there a problem?
• Is it NICE?
• Is it the media?
• What is the evidence?

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Evidence

• Where?
• NEJM October 2005
• Promising results from large study
• Results headlined as above
• Clamour for Herceptin to be given
• France bypassed official approval procedures to
  make it available

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What about the UK?

• NICE are evaluating results
• Must not be rushed into decision
• Independent
• Scientifically rigourous
• DOH want to speed up the process (political
  capital?)

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Are there reasons for caution?

• YES
• Lancet editorial 9/11/05
• So far interim efficacy analyses
• The two reports use different dosing regimens
• One paper combines results from two trials

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And theres more

• There is no data on overall survival
• There is no data on disease-free status
• Limited info is given on cardiotoxicity
• There is a small but significant increase in
  heart failure

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Lancet summary

• Available evidence is insufficient to make
  reliable judgements
• Profoundly misleading to suggest on published
  data that this is a cure
• Let NICE make their decision with proper analysis
  of all factors
• Too much media and political pressure
• Cool heads required

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What are the issues?

• For Herceptin
• Efficacy
• Cost-effectiveness
• In that order
• These must not be confused

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Cost

• There are several new cancer treatments in the
  pipeline
• They will be very expensive
• Will the NHS cope?
• Thats a hot topic for another day