Date        07/11/08
                                             Your Ref
                                             Our Ref     RM/1099
                                             Enquiries to Richard Mutch
                                             Extension 89441
                                             Direct Line 0131-536-9441
                                             Direct Fax 0131-536-9009



I write in response to your letter of 8 October 2008 (received 13 October 2008) requesting
some further detail in relation to your unfunded drug request for Sunitinib (Sutent) from Dr
Wall, Consultant Medical Oncologist - NHS Lothian.

Mr Ewan Morrison, Lead Pharmacist, South East of Scotland Cancer Network has
provided additional information to answers to your questions.

•   Is there any further information from the meeting regarding the decision that was taken
    and who attends these meetings?

    The previous response of 12 September contained the complete minutes from the
    meeting and no detail was omitted apart from some redacted information (the names of
    individual members of staff, in addition patient names were removed from all

    The Oncology Medicines Management Committee (OMMC) considers a variety of
    business at each of its two-weekly meetings and part of the agenda relates to
    applications from senior clinicians to use medicines that are currently classified as
    unfunded. These cancer medicines are not approved for use by, have not yet been
    considered by or are awaiting consideration by the NHS Lothian Formulary Committee.
    The OMMC is broad in its professional membership. I have listed the job titles of the
    individuals who sit on the committee to assist your understanding of the group.

       •    Consultant Medical Oncologist
       •    Consultant Clinical Oncologist
       •    Consultant Haematologist
       •    Head of Service for Cancer/Palliative Care
       •    Lead Pharmacist, South East of Scotland Cancer Network

                                              Deaconess House 148 Pleasance Edinburgh EH8 9RS

                                              Chair Dr Charles J Winstanley
Continued                                     Chief Executive Professor James Barbour O.B.E.
                                              Lothian NHS Board is the common name of Lothian Health Board
        •   Principal Pharmacist, Edinburgh Cancer Centre
        •   Finance Manager, Cancer Services

    At the meeting on the 14 May 2008 where your submission was considered a
    Consultant Oncologist was in attendance.

•   What is the rationale behind the current procedure including the requirement for a
    personal written submission on appeal?

    The consideration of funding requests for cancer medicines is a complex process and
    often involves the consideration of very different aspects for each application. It is
    important that each application is considered in a timely manner and that decisions are
    equitable for all patients and their clinicians.

    The appeal process is focused upon the application process not on the clinical data,
    unless new clinical information is available. Appeals are submitted by the patient with
    the support and guidance from the relevant consultant oncologist. In addition, the
    committee only considers, for example, whether:-

        o NHS Lothian procedures and policies were followed
        o all relevant factors were considered and did not take into account immaterial
        o a decision was taken that was not so unreasonable that it could be considered
          irrational or perverse in the light of the evidence.

    The process although seemingly complex is extremely efficient and effective and is
    acknowledged across the South East of Scotland Cancer Network. It is also
    recognised in the areas outside cancer therapeutics as an excellent example of an
    effective process. The most important consideration is to ensure equity throughout the
    process by utilising a consistent approach.

    We do realise that the treatment of cancer is a dynamic process and thus the OMMC
    reviews the application process regularly to ensure it meets the needs of patients and
    clinicians alike.

I hope this information answers your request.

If you are unhappy with our response to your request, you do have the right to request us
to review it. Your request should be made within 40 working days of receipt of this letter,
and we will reply within 20 working days of receipt. If our decision is unchanged following
a review and you remain dissatisfied with this, you then have the right to make a formal
complaint to the Scottish Information Commissioner.

If you require a review of our decision to be carried out, please write to Mr I Whyte, FOI
Reviewer at the address at the foot of this letter. The review will be undertaken by Mr
Whyte as he was not involved in the original decision making process.

FOI responses (subject to redaction of personal information) may appear on NHS
Lothian’s        Freedom          of        Information       website at     :-

Yours sincerely

Director of Human Resources
and Organisational Development
Cc: Chief Executive

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