Specialised Services Policy: CP68 Transarterial Chembolisation (TACE) Drug-eluting Doxyrubicin (DEBOX) for the Management of Unresectable, Metastatic Liver Document Author: Specialist Planner Cancer and Blood Executive Lead: Director of Finance Approved by: Management Group Issue Date: 13 th December 2012 Review Date: December 2015 Document No: CP68 Page 1 of 9
Document History Revision History Version No. Revision date Summary of Changes Updated to version no.: 0.1 05.02.2012 Review of evidence base and 0.2 discussion with Hepatobillary MDT and interventional radiology 0.2 13.06.12 Re-checking with Dr Chris Chick re: evidence base and status of the intervention as experimental 0.3 Date of next revision Consultation Name Date of Issue Version Number Dr Chris Chick 02.02.2012 0.1 Hepatobillary MDT 04.07.2012 0.2 Cancer Programme Team 27.06.2012 0.2 WHSSC Execs 05.07.2012 0.3 Cancer Programme Team 17.07.2012 0.3 Cancer Programme team 21.08.2012 0.4 Management Group 13.12.2012 0.4 Approvals Name Date of Issue Version No. Management Group 13.12.2012 1.0 Distribution this document has been distributed to Name By Date of Issue Version No. Page 2 of 9
Policy Statement Background Statement Treatment of unresectable, metastatic liver disease with TACE DEBOX The evidence for clinical and cost effectiveness for TACE DEBOX in this indication is currently insufficient to warrant routine funding. Therefore, at that point in time, the balance of benefits and risks of TACE DEBOX in the treatment of unresectable metastatic liver disease can not be established. Responsibilities Referrers should: In consideration of the paucity of evidence for clinical and cost effectiveness WHSSC will not fund TACE DEBOX, unless in the context of exceptionality according to the All Wales Individual Patient Funding Request Policy. TACE DEBOX is current considered experimental and patient, if appropriate should be recruited via a clinical trials programme Inform the patient that this treatment is not routinely funded outside the criteria in this policy Clinician considering treatment should: Discuss all the alternative treatment with the patient Advise the patient of any side effects and risks of the potential treatment Inform the patient that treatment is not routinely funded In exceptional circumstances submit an IPFR request Page 3 of 9
Table of Contents 1. Aim... 5 1.1 Introduction... 5 1.2 Relationship with other Policies and Service Specifications.. 5 2. Scope... 6 2.1 Definition... 6 2.2 Codes... 6 3. Access Criteria... 7 3.1 Clinical Indications... 7 3.2 Criteria for Treatment... 7 3.3 Referral Pathway... 7 3.4 Exceptions... 7 3.5 Responsibilities... 7 4. Putting Things Right: Raising a Concern... 8 5. Equality Impact and Assessment... 9 Page 4 of 9
1. Aim 1.1 Introduction The document has been developed as the policy for the planning of TACE DEBOX for Welsh patients. The policy applies to residents of all seven Health Boards in Wales. The purpose of this document is to: Set out the circumstances under which patients will be able to access TACE DEBOX; Clarify the referral process and; Define the criteria that patients must meet in order to access treatment. 1.2 Relationship with other Policies and Service Specifications This document should be read in conjunction with the following documents: Specialised Services Policy: Radiofrequency ablation for Metastatic Liver ; Specialised Services Policy: TACE DEBIRI; Specialised Services Policy: SIRTEX microspheres Specialised Services Policy: CP18 New Health Technologies Assessment Policy; and All Wales Policy: Making Decisions on Individual Patient Funding Requests (IPFR). Page 5 of 9
2. Scope 1. Purpose 2.1 Definition TACE is a combination of local drug infusion with selective embolisation of the feeding arteries of the liver metastases. The advantage of delivering chemotherapy by hepatic arterial infusion is the administration of a high-dose of the drug to the target. The aim of this therapeutic technique is to reduce the tumour size by ischemic necrosis and direct drug effects. Largely used for the treatment of hepatocellular carcinoma, it is also used in a neoadjuvant or palliative setting in patients with isolated liver metastases from colorectal cancer.. 2.2 Codes Y53.- Approach to organ under image control Note: Codes within category Y53.- are used as secondary codes to classify interventions that are percutaneous and require some form of image control: if the method of image control is unspecified, Y53.9 Unspecified approach to organ under image control is assigned. In addition the ICD-10 code C78.7 Secondary malignant neoplasm of liver would be recorded. Page 6 of 9
3. Access Criteria 3.1 Clinical Indications This policy covers patient with metastatic, unresectable liver disease following failure of conventional therapy. 3.2 Criteria for Treatment Patients with unresectable, metastatic liver disease. 3.3 Referral Pathway If the patient wishes to be referred to a provider out of the agreed pathway, an IPFR should be submitted. 3.4 Exceptions If the patient does not meet the criteria for treatment, but the referring clinician believes that there are exceptional grounds for treatment an Individual Patient Funding Request (IPFR) can be made to WHSS under the All Wales Policy for Making Decisions on Individual Patient Funding Requests (IPFR). If the patient wishes to be referred to a provider out of the agreed pathway, an IPFR should be submitted. Guidance on the IPFR process is available at www.whssc.wales.nhs.uk 3.5 Responsibilities Referrers should: Inform the patient that this treatment is not routinely funded. Clinician considering treatment should: Discuss all the alternative treatment with the patient; Inform the patient that treatment is not routinely funded. In exceptional circumstances submit an IPFR request. Page 7 of 9
4. Putting Things Right: Raising a Concern Whilst every effort has been made to ensure that decisions made under this policy are robust and appropriate for the patient group, it is acknowledged that there may be occasions when the patient or their representative are not happy with decisions made or the treatment provided. The patient or their representative should be guided by the clinician, or the member of NHS staff with whom the concern is raised, to the appropriate arrangements for management of their concern: When a patient or their representative is unhappy with the decision, of the gatekeeper, that the patient does not meet the criteria for treatment and that the patient is not an exceptional case, the patient and/or their representative has a right to ask for this decision to be reviewed. The review should be undertaken, by the patient's Local Health Board, in line with section 7 of the All Wales Policy: Making Decisions on Individual Patient Funding Requests; When a patient or their representative is unhappy with the care provided during the treatment or the clinical decision to withdraw treatment provided under this policy, the patient and/or their representative should be guided to the LHB for NHS Putting Things Right. For services provided outside NHS Wales the patient or their representative should be guided to the NHS Trust Concerns Procedure with a copy of the concern being sent to WHSSC. Page 8 of 9
5. Equality Impact and Assessment The Equality Impact Assessment (EQIA) process has been developed to help promote fair and equal treatment in the delivery of health services. It aims to enable Welsh Health Specialised Services Committee to identify and eliminate detrimental treatment caused by the adverse impact of health service policies upon groups and individuals for reasons of race, gender re-assignment, disability, sex, sexual orientation, age, religion and belief, marriage and civil partnership, pregnancy and maternity and language (welsh). This policy has been subjected to an Equality Impact Assessment. The Assessment has shown that there will be no equality impact due to the implementation of this policy. Page 9 of 9