FREEDOM OF INFORMATION SOUTH EAST SCOTLAND CANCER NETWORK

Transcription

1 Dear Date 06/02/09 Your Ref Our Ref RM/1220 Enquiries to Richard Mutch Extension Direct Line Direct Fax FREEDOM OF INFORMATION SOUTH EAST SCOTLAND CANCER NETWORK I write in response to your request of 14 January 2009 for information in relation to the South East Scotland Cancer Network (SCAN) cancer protocols. I have been provided with information to help answer your request by Mr Ewan Morrison, Lead Pharmacist, South East of Scotland Cancer Network NHS Lothian Mr Morrison advises that this request has been answered from a South East of Scotland Cancer Network (SCAN) perspective. This includes solid tumour protocols for all of the four constituent Boards (Lothian, Fife, Borders and Dumfries & Galloway) and Haematology protocols for all four except Dumfries & Galloway. I would like to know which of the following drugs is included for use in which of SCAN s regional cancer protocols: All of the following drugs are included in SCAN protocols:- Alemtuzumab (MabCampath) Anastrozole (Arimidex) Bevacuzimab (Avastin) Bortezomib (Velcade) Capecitabine (Xeloda) Cetuximab (Erbitux) Clofarabine (Evoltra) Dasatinib (Sprycel) Dexrazoxane (Cardioxane) Docetaxel (Taxotere) Erlotinib (Tarceva ) Fludarabine (Fludara) Gemcitabine (Gemzar) Gonapeptyl depot Headquarters Deaconess House 148 Pleasance Edinburgh EH8 9RS Chair Dr Charles J Winstanley Chief Executive Professor James Barbour O.B.E. Lothian NHS Board is the common name of Lothian Health Board

2 Ibritumomab tiuxetan (Zevalin) Imatinib (Glivec) Lanreotide (Somatuline LA) Lenalidomide (Revlimid) Letrozole (Femara) Liposomal cytarabine (DepoCyte) Mitotane (Lysodren) Nelarabine (Atriance) Nilotinib (Tasigna) Panitumumab (Vectibix) Pemetrexed (Alimta) Rituximab (MabThera) Sorafenib (Nexavar) Sunitinib (Sutent) Temozolomide (Temodal ) Topotecan (Hycamtin) Trabectedin (Yondelis) Trastuzumab (Herceptin) Vinorelbine (Navelbine Oral) Oncology medicines used within SCAN The regimens listed are those used as part of routine clinical practice. These cancer medicines may also be used in clinical trial protocols and as part of other regimens for individual patients, as approved by Edinburgh Cancer Centre (ECC) Medicines Management Committee (see later for more detail). Drug Capecitabine Protocol Regime n Indication Capecitabine 056 Breast or colorectal cancer Oxaliplatin and Dukes B colorectal cancer (metastatic & capecitabine 113 high risk B /C) (CapOx) ECX 129 Palliative gastroesophageal cancer Capecitabine & XRT 141 Rectal cancer MCX 144 Gastro-oesophageal cancer EOX 149 Gastro-oesophageal cancer ECarboX 159 Gastro-oesophageal cancer

3 ECX 182 Gastro-oesphageal: peri-operative Cetuximab Cetuximab 172 Head & neck Docetaxel Docetaxel 034 Non small cell lung cancer Docetaxel 055 Breast cancer FEC-T 140 Adjuvant breast cancer Docetaxel, Head & Neck cancer induction Cisplatin & 189 chemotherapy 5FU Docetaxel & prednisolone 203 Prostate cancer Erlotinib Erlotinib Non small cell lung cancer Imatinib Gemcitabine Pemetrexed Imatinib (single agent) Gemcitabine/ Carboplatin Gemcitabine Gemcitabine & fractionated Cisplatin Cisplatin & Gemcitabine Gemcitabine and Paclitaxel Cisplatin/peme trexed Carboplatin and pemetrexed 158 Gastro intestinal stromal cancer 049 Non small cell lung cancer 065 Pancreatic cancer 115 Bladder cancer 147 Inoperable Gastro-oesophageal cancer 225 Metastatic Breast 040 Mesothelioma 202 Mesothelioma

4 Temozolamide Temozolamid e Concurrent /adj Temozolamide 066 Glioma 128 Glioma Topotecan Topotecan 145 Ovarian Topotecan and cisplatin 222 Cervical cancer Trastuzumab Trastuzumab 082 Breast Vinorelbine (oral) Vinorelbine oral 224 Breast (metastatic) Haematology medicines used within NHS Lothian Regimens listed are those used in routine clinical practice within NHS Lothian. These medicines may also be used in clinical trial protocols and as part of other regimens in exceptional circumstances for individual patients, as approved by the Edinburgh Cancer Centre Medicines Management Committee. Drug Protocol Indication Alemtuzumab Flu-melp-campath Conditioning regimen for allogeneic Peripheral blood stem cell transplant, Chronic lymphocytic leukaemia Bortezomib Bortezomib & dexamethasone Relapsed / refractory multiple myeloma Dasatanib Dasatanib Relapsed / refractory Chronic myeloid leukaemia Fludarabine FC Flu-mel- campath Fludarabine (oral single agent) FMD Flamsa Chronic lymphocytic leukaemia / Relapsed follicular Non-Hodgkin s Lymphoma Conditioning regimen for allogeneic PBSCT Chronic lymphocytic leukaemia / Relapsed follicular Non-Hodgkin s Lymphoma Relapsed follicular Non-Hodgkin s Lymphoma Conditioning regimen for allogeneic Peripheral blood stem cell transplant Imatanib Imatanib Chronic myeloid leukaemia first line Nilotinib Nilotinib Relapsed / refractory Chronic myeloid leukaemia

5 Rituximab Rituximab R-CVP R-CHOP Used in combination with other lymphoma chemotherapy regimens Follicular Non-Hodgkin s Lymphoma (induction and maintenance) Follicular Non-Hodgkin s Lymphoma Diffuse large B-Cell lymphoma Lymphoma The following drugs are available for use in the approved indications within the NHS Lothian Joint Formulary ( ). o Anastrazole o Gonapeptyl depot o Lanreotide o Letrozole The drugs listed below are not used routinely within SCAN out-with a clinical trial protocols: o Bevacizumab o Clofarabine o Dexrazoxane o Ibritumomab tiuxetan o Lenalidomide o Liposomal cytarabine o Mitotane o Nelarabine o Panitumumab o Sorafenib o Sunitinib o Trabectedin What restrictions and accompanying advice is included on their usage? NHS Lothian has a strong record of governance in medicines management underpinned by policies and including the Lothian Joint Formulary (LJF) With increasing demands and expectations of patients, it is key that NHS Lothian maintain and improve on that record. It is important that cancer medicines are made available to patients in a timely manner and the NHS Lothian Formulary Committee ensures this in collaboration with clinicians and pharmacists.

6 When a cancer medicine has been approved for use by the Formulary Committee and it has been established how the medicine will be used, the number of patients likely to be treated, the patient group to be treated and any resource implications explored this medicine will be utilised in a protocol (as described in response to point 1). There are no restrictions on prescribing within the scope of the approved protocol. In addition, these medicines may be considered for clinical trials and prescribing to individual patients under exceptional circumstances. Where a consultant oncologist/haematologist believes that an individual patient will respond significantly differently to a cancer medicine than a general group of patients with the same disease then an application request to use the medicine in exceptional clinical circumstances can be submitted. Applications for the use of cancer medicines in this manner should include details of clinical evidence, patient information including treatment history and clear direction on the basis of exceptionality. These application are considered by the ECC Medicines Management Committee at their meetings, which occurs every two weeks. The membership of this multidisciplinary group is; o Consultant Medical Oncologist o Consultant Haematologist o Consultant Clinical Oncologist o Head of service for Cancer and Palliative Care o Lead Pharmacist, South East of Scotland Cancer Network o Principal Pharmacist, Edinburgh Cancer Centre o Management Accountant The cancer medicines described in response to point 1 - are utilised across SCAN and protocols used include accompanying clinical and technical advice. Advice for their use is incorporated into a master protocol and includes details of o The regimen (single-agent or in combination) o Investigations o Expected toxicities and an assessment of toxicity grade per patient visit o Dose modifications o Special precautions and contraindications o A record of key biochemical and haematological indices o The chemotherapy prescription chart

7 How are the decisions reached for the inclusion of medicines in protocols? Individual cancer medicines are included in protocols after a considerable period of clinical research and then submission of a dossier of evidence to the medicine licensing authorities. The licensing of medicines is covered by the Medicines Act 1968, as amended. The licensing bodies in the UK are the medicines and healthcare products regulatory agency (MHRA) and the European medicines evaluation agency (EMEA). Cancer medicines will be granted a full Marketing Authorisation (MA) after a full data evaluation by the MHRA or EMEA. The MA confers liability upon the holder for the cancer medicine in use when the terms of the license are followed. The majority of cancer medicines utilised in SCAN are prescribed within the terms of their MA. In Scotland, shortly after licensing, the Scottish Medicines Consortium (SMC) will provide advice on the use of a cancer medicine. There are three possible relevant outcomes. 1. The cancer medicine is approved for use in NHS Scotland by the SMC When a cancer medicine is approved for use by the SMC this advice will be immediately adopted by NHS Lothian and a protocol written and agreed. This is followed by an application to the formulary committee to obtain sign off and agreement on the resources required to support the managed access of the medicine into practice. NHS Lothian always considers SMC recommendations on cancer medicines with associated local guidance outlined in the NHS Lothian Joint Formulary (LJF). The LJF promotes safe, effective, and economic prescribing in both hospital and general practice with approved cancer medicines included in this publication. These recommendations are adopted, through mutual agreement, by the other constituent SCAN health boards. 2. The cancer medicine has been licensed but is awaiting consideration by the SMC. NHS Lothian policy is that cancer medicines awaiting guidance from the SMC should not be used until SMC guidance has been published. This is to prevent undermining of the SMC, a process to which NHS Lothian is committed, and also to support equity of treatment across SCAN and NHS Scotland. 3. Cancer medicines which the SMC have not recommended for use in NHS Scotland.

8 The Scottish Government Health Department expects NHS Boards to comply with SMC advice as set out in HDL (2003) 60 a strengthened role for the SMC. NHS Lothian always aligns with SMC recommendations on cancer medicines and thus SMC unapproved medicines will not be used in NHS Lothian cancer medicine protocols. New medicines will be added to a cancer protocol when they have been approved for use by the SMC and added to the NHS Lothian Joint formulary. 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 ALAN BOYTER Director of Human Resources and Organisational Development Cc: Chief Executive