Specialised Services Policy CP66: 68-gallium DOTA- peptide scanning for the Management of Neuroendocrine Tumours (NETs)

Transcription

1 Specialised Services Policy CP66: Management of Neuroendocrine Tumours (NETs) Document Author: Assistant Planner for Cancer and Blood Executive Lead: Director of Quality and Nursing Approved by: Management Group Issue Date: 01 April 2016 Review Date: April 2019 Document No: CP66 Page 1 of 10

2 Document History Revision History Version No. Revision date Summary of Changes Updated to version no.: Clinical criteria amended to reflect 0.2 consultation Clinical criteria amended to reflect 0.3 consultation Formatting Approved by Management Group Glossary of terms included 2.0 Referral pathway amended Referral criteria amended (note version control numbering issue at this point i.e. should be 1.1 but changed to 2.0) Document updated following on from the 2.0 consultation process Approved by Management Group 3.0 Date of next revision April 2019 Consultation Name Date of Issue Dr Aled Rees, Dr John Rees and Dr Patrick Fielding Neuroendocrine MDT WHSSC Executives Cancer Programme Team Cancer Programme Team Management Group Neuroendocrine MDT Dr Aled Rees, Dr John Rees and Dr Patrick Fielding Professor Sobhan Vinjamuri Professor Graeme Poston Cancer Programme Team Management Group Cancer Network NETs patient support group Version Number Approvals Name Date of Version No. Issue Management Group 1.0 Management Group Page 2 of 10

3 Policy Statement Background Summary of Access Criteria 68-Gallium DOTA-peptide PET/CT is used in staging newly diagnosed neuroendocrine tumours, and to assess for the recurrence of neuroendocrine tumours (NETs). The scan is useful, where in the opinion of the Neuroendocrine Tumours MDT it would provide information which is pivotal to inform the ongoing management and treatment of the patient. The use of 68-Gallium DOTA-peptide PET/CT is approved according to the criteria defined in this policy and audited outcomes for the service will be sent to WHSSC on at least an annual basis. Providers: South Wales - University College London Hospital. North Wales Royal Liverpool University Hospital. Responsibilities The Policy will be managed under gate keeping arrangements with the Neuroendocrine Tumour MDTs based at the University Hospital of Wales and the Royal Liverpool University Hospital. Clinicians considering investigation should: Discuss all the alternative scan modalities with the patient. Advise the patient of any side effects and risks of the potential scan. Inform the patient that the investigation is not routinely funded outside of the criteria in the policy. Confirm that there is contractual agreement with WHSSC for the treatment Page 3 of 10

4 Glossary of Terms and Acronyms Abbreviation or Topic DOTATATE DOTATOC DOTANOC 68-Gallium Definition A somatostatin analogue that can be bound to 68-Gallium or 177-Lutetium to diagnose or treat NET s. A somatostatin analogue similar to DOTATATE A somatostatin analogue similar to DOTATATE Positron emitting isotope of Gallium MDT NETs Octreoscan Multi Disciplinary Team Neuro Endocrine Tumours A nuclear medicine scan using 111Indium radiolabelled octreotide Peptide Receptor Radiolabelled Therapy (PRRT) Treatment which combines a somatostatin analogue with a radioactive substance. Used to control tumour growth and hormone production. PET-CT Positron Emission Tomography Computerised Tomography Somatostatin Analogue therapy Treatment used to slow down hormone production and neuroendocrine tumour growth Page 4 of 10

5 Table of Contents 1. Aim Introduction Relationship with other Policies and Service Specifications Scope Definition Codes Access Criteria Clinical Indications for 68-Ga DOTA-peptide scans Criteria for Treatment Improvements in therapeutic approach Effects on quality of life and tumour progression Importance of identifying the primary tumour site Planning for liver transplantation Referral Pathway Exclusions Responsibilities Putting Things Right: Raising a Concern Equality Impact and Assessment Page 5 of 10

6 1. Aim 1.1 Introduction The document has been developed as the policy for the planning of 68- Gallium DOTA-peptide scanning for the management of neuroendocrine tumours (NETs) in Wales. The purpose of this document is to: clearly set out the circumstances under which patients will be able to access 68-Gallium Scanning; clarify the referral process to the designated providers define the criteria that patients must meet in order to be referred. 1.2 Relationship with other Policies and Service Specifications This document should be read in conjunction with the following documents: Specialised Services Policy CP50: Positron Emission Tomography (PET) Specialised Services Policy CP67: Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumours (NETs); and All Wales Policy: Making Decisions on Individual Patient Funding Requests (IPFR) 2. Scope 2.1 Definition Although (18) F-fluorodeoxyglucose (18) F-FDG) is still the most widely used positron emission tomography (PET) radiotracer for most cancers, there are a few well-known limitations to its use. This policy covers the use of PET-CT with Gallium-68, for the labelling of peptides including, but not limited to, DOTATATE, DOTATOC and DOTANOC, for informing the management of patients with neuroendocrine tumours. 2.2 Codes ICD-10 Codes Well differentiated neuroendocrine tumours Page 6 of 10

7 C7A.1 is a billable ICD-10-CM code that can be used to specify a diagnosis. Applicable To Malignant poorly differentiated neuroendocrine tumour NOS Malignant poorly differentiated neuroendocrine carcinoma, any site High grade neuroendocrine carcinoma, any site ICD-10-CM C7A.1 is part of Diagnostic Related Group(s) (MS-DRG v28.0): 826 Myeloprolif disord or poorly diff neopl with maj o.r. proc with mcc 827 Myeloprolif disord or poorly diff neopl with maj o.r. proc with cc 828 Myeloprolif disord or poorly diff neopl with maj o.r. proc without cc/mcc 829 Myeloprolif disord or poorly diff neopl with other o.r. proc with cc/mcc 830 Myeloprolif disord or poorly diff neopl with other o.r. proc without cc/mcc 843 Other myeloprolif dis or poorly diff neopl diag with mcc 844 Other myeloprolif dis or poorly diff neopl diag with cc 845 Other myeloprolif dis or poorly diff neopl diag without cc/mcc 3. Access Criteria 3.1 Clinical Indications for 68-Ga DOTA-peptide scans 68-Ga DOTA-peptide scanning is used to support the staging of patients with neuroendocrine tumours (NETs) and the assessment of suspected recurrence, following discussion at the NETs MDT meeting where imaging is pivotal to patient management. All patients requiring consideration of 68-Ga-peptide imaging should be discussed either at the Neuroendocrine Tumour MDT, or with core MDT members (Nuclear Radiology, Endocrinology, Gastroenterology) if the request requires urgent consideration. Core MDT clinicians with expertise in the management of NETs may also refer directly without the need for MDT review. 3.2 Criteria for Treatment Page 7 of 10

8 In making the decision to refer a patient for a 68-Gallium DOTA-peptide scan the MDT will consider the following information, in relation to the individual patient Improvements in therapeutic approach Numerous studies point to the superior diagnostic accuracy of 68 Ga-DOTApeptide PET/CT compared to that of CT and somatostatin receptor scintigraphy (SRS; octreoscan ) to inform the management of patients with neuroendocrine tumours. More recently, studies have demonstrated that detection of additional sites of disease by this imaging modality can provide information which may lead to better decisions on treatment. In particular, this is achieved when unsuspected metastatic disease, local relapse or a previously unidentified primary NET is identified. In addition, the results of the scan may influence the decision to treat the patient with somatostatin analogue therapy or peptide receptor radiolabelled therapy (PRRT) Effects on quality of life and tumour progression Somatostatin analogue therapy is known to improve quality of life in patients with NETs, leading to a reduction in the signs and symptoms of hormone hypersecretion including flushing and diarrhoea (Rubin, Ajani, Schirmer, & al., 1999). Somatostatin analogues are thus recommended as first-line therapy in UK guidelines, for patients with functional NETs associated with hormone excess (Ramage, Ahmed, Ardill, & al., 2012). More recently, further studies (Rinke, Müller, Schade-Brittinger et al, 2009, Caplin, Pavel, Cwikla et al 2014) reported data which are supportive of a survival benefit of somatostatin analogue therapy. This is in keeping with data from a large Australian cancer registry (Townsend, Price, Yeend et al 2010) Importance of identifying the primary tumour site Identification of the primary NET site is central to treatment planning, and failure to detect the primary tumour may be associated with a higher mortality (Townsend, Price, Yeend, & al, 2010). Detection of the primary tumour may not lead to a change in stage in patients with metastatic NETs but, if detected and removed, can prevent significant local symptoms. In particular, small bowel NETs typically cause a scarring reaction leading to an increased risk of small bowel obstruction. UK guidelines thus recommend consideration of surgical resection to remove small bowel primary NETs (the Page 8 of 10

9 commonest site) even in the presence of distant metastases in order to reduce the chances of obstruction (Ramage, Ahmed, Ardill, & al., 2012). Furthermore, case series describe improved survival in patients who have undergone resection of their primary tumour, suggesting that this may also be associated with a prognostic benefit (Ahmed, Turner, King, & al., 2009) Planning for liver transplantation Although performed in only a minority of patients with NETs, liver transplantation may be considered in selected patients with metastatic welldifferentiated tumours which are confined to the liver. The improved sensitivity of 68 Ga-DOTA-peptide PET/CT over other imaging modalities for disease at sites outside the liver thus has the potential to avoid unnecessary and expensive transplantation surgery in a small number of patients (Ambrosini, Campana, Bodei, & al., 2010). Leading transplant units (Frilling, Malago, Weber, & al., 2006) and UK guidelines (Ramage, Ahmed, Ardill, & al., 2012) thus recommend that SRS be replaced by 68 Ga-DOTA-peptide PET/CT in all screening protocols. 3.3 Referral Pathway All patients requiring consideration of 68-Ga-peptide imaging should be discussed either at the Neuroendocrine Tumour MDT, or with core MDT members (Nuclear Radiology, Endocrinology, Gastroenterology) if the request requires urgent consideration. Core MDT clinicians with expertise in the management of NETs may also refer directly without the need for MDT review. 3.4 Exclusions There are no exclusions to the policy. 3.5 Responsibilities Clinicians considering a 68 Ga scan should: Discuss all the alternative scans with the patient. Advise the patient of any side effects and risks of the potential scan. Inform the patient that this scan is not routinely funded outside of the criteria in the policy. Confirm that there is contractual agreement with WHSSC for the investigation. Page 9 of 10

10 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. 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 impact. Page 10 of 10