Appendix I - NICE
Appendix I
Schedule 2 Part 1: Service Specifications
|Service |Hepatitis C Service |
|Commissioner Lead | |
|Provider Lead | |
|Period |2012 - |
| |
|1. Purpose |
| |
|Aims |
| |
|The aim of this service specification is to introduce a standardised, best practice care and referral pathway for patients who are |
|diagnosed with Hepatitis C across Greater Manchester. The introduction of a standardised, practice pathways for Hepatitis C will aim to: |
|improve productivity |
|release efficiencies |
|improve patient experience through the delivery of patient-centred care with effective, auditable outcomes |
|deliver high quality care through the delivery of best practice |
|provide equitable access by ensuring services are delivered closer to the patient |
|facilitate high quality referrals in line with agreed clinical thresholds |
|increase HCV treatment locations |
| |
| |
|Evidence Base |
| |
|The principles informing this specification are based on a comprehensive Stakeholder Consultation. 207 major stakeholders were consulted |
|including clinicians, patients from various high-risk groups, microbiologists, public health experts and commissioners. |
|The HPA carried out the initial needs assessment of local service provision using standard epidemiological, corporate and comparative |
|methodologies. This work has been further developed by the University of Manchester in their Joint Strategic Needs Assessment (2010) of |
|services which was funded by the GMHCVS. The epidemiological evidence presented has been developed jointly by the HPA and the University of|
|Manchester. The health equity evidence is from a GMHCVS funded University of Manchester Health Equity Audit (2010). |
|Shepherd et al (2005) (a systematic review commissioned by NICE) demonstrated that interferon combination therapy was cost effective when |
|compared with standard care for people with HCV. |
|NICE have also evaluated HCV treatment and recommend combination therapy for people with chronic hepatitis C. GM have developed local |
|Testing and Treatment Guidelines (2009) that form part of the Commissioning Framework. These guidelines are fully evidence based and build |
|on national guidance. Both sets of guidelines have been approved by local processes; the Microbiology NAG has approved the Testing |
|Guidelines and the Greater Manchester Medicines Management Group have approved the Treatment Guidelines. |
|The demographics and clinical activity information that informed this specification was obtained by an external baseline data review on a |
|subsection of a patient of patient case notes. The laboratory data was provided by the local laboratories. |
|The primary Care testing guidelines are from the Department of health: Quick Reference Guide for Primary Care (2009). |
|All documents are available from siobhan.fahey@hmr.nhs.uk or from |
|General Overview |
| |
|Hepatitis C is a blood-borne virus, in which 60% of patients with chronic infection develop liver fibrosis. Fibrosis may result in |
|cirrhosis which, if left untreated, could lead to death or to liver cancer. |
| |
|Hepatitis C most commonly affects people who have ever injected drugs and shared injecting equipment. However, a significant proportion of |
|local cases are among people who were born, or have lived, in high prevalence countries. There is no vaccine but there is an effective |
|treatment which has a high cure rate of up to 80%. |
| |
|Hepatitis C is an escalating public health issue and Greater Manchester has the highest levels in England due to the high prevalence among |
|the large local injecting drug using population. Local epidemiological modelling estimates there are between 14,000 and 15,000 cases of |
|chronic hepatitis C in Greater Manchester. The current epidemic is predicted to continue, increasing local prevalence and the resultant |
|disease burden. |
| |
|There have been a total of 1,400 patients who have been treated for HCV in the past five years. In the year 2009/10 400 patients were |
|treated. This equates to less than 10% of those with chronic infection being treated. |
| |
|1.4 Objectives |
|The objectives of the Hepatitis C service are as follows: |
|Reduce the incidence of liver disease resulting from Hepatitis C over the long term within the population |
|Provide care closer to home appropriate to the needs of the patient |
|Implement streamlined, efficient, best practice pathways for Hepatitis C |
|Improve patient experience and be patient focused |
|Ensure patients with Hepatitis C are provided with links to peer-led support |
|Be underpinned by informed decision making |
|Use high quality patient information |
|Provide equitable access |
|Increase choice |
|Work proactively with other health care professional to facilitate high quality referrals that are in line with local clinical thresholds |
| |
|1.5 Expected Outcomes |
|Increased number of people with hepatitis C completing treatment schedule |
|Decreased number of patients who do not attend first appointment |
|Defined activity level per annum |
|People with Hepatitis C are treated in accordance with GM HCV Treatment Guidelines and NICE Technology appraisals TA14 (2000), NICE |
|Technology appraisals TA75 (2004) and NICE Technology appraisals TA200 (2010) |
|People with Hepatitis C are treated according to Clinical Care Pathway (see 3.2) |
|Develop infrastructure that will allow treatment of patients in a peripheral setting |
|People with Hepatitis C are provided with information about Self Care Support Project / local support groups |
|Representatives of clinical staff to be members of the Greater Manchester Hepatitis C Strategy |
|Clinicians to take part in research/audit projects |
|Clinicians to provide support to patient support groups |
|Representatives of clinical staff take part in projects to raise awareness of hepatitis C as developed by Greater Manchester Hepatitis C |
|Strategy |
|Clinical staff to be active participants within a Greater Manchester Liver Clinical Network where relevant |
| |
|2. Service Scope |
| |
|2.1 Service Description |
|The Hepatitis C treatment service is for adults with a confirmed diagnosis of Hepatitis C. |
|Please note: refer children with Hepatitis C to CMFT or PAHT for assessment for treatment. |
| |
|2.2 Accessibility/acceptability |
|To access the services the patient should |
|Be aged over 16 |
|Have a diagnosis of Chronic Hepatitis C |
|Be aware of the referral and be willing to be assessed for treatment |
| |
|2.3 Whole System Relationships |
|The Hepatitis C treatment service should link with local drug and alcohol services, local primary care services, local Hepatitis C support |
|groups and local psychiatric services. |
| |
|2.4 Interdependencies |
|Patients and carers |
|Gastroenterology services |
|Hepatology services from CMFT and WWL |
|Infectious Disease services from PAT and UHSM |
|Radiology services |
|Histopathology services |
|Microbiology and Virology services |
|Public Health |
|Drug and alcohol services |
|Hepatitis C Trust |
|British Liver Trust |
| |
|2.5 Relevant networks and screening programmes |
|Greater Manchester Hepatitis C Strategy |
|British Society of Gastroenterology |
|The British Association for the Study of the Liver Nurse Forum |
|British Association for the Study of the Liver (BASL) |
|BASL British Viral Hepatitis Group |
| |
| |
|3. Service Delivery |
| |
|3.1 Service model |
| |
|NB Although this service specification will be enacted from 01 April 2012 – 2013, the service specification will be trialled 2011 – 2012. |
| |
|1) This document sets out minimum standards for the delivery of specialist Hepatitis C treatment. Consultation of major stakeholders |
|including clinicians, patients from various high-risk groups, microbiologists, public health experts and commissioners have described what |
|the service provision should look like. |
| |
|2) The HCV testing service, located in primary care, drug service, GUM clinic or secondary care, should have a clear pathway with no |
|unnecessary duplication of tests. The Suspected Hepatitis C pathway from Map of Medicine (Greater Manchester) should be followed. Testers |
|should have training if required. A discussion of the implications of the test should accompany the test. Testing should be offered to |
|family members who may have been at risk. A negative result should be seen as an opportunity to present harm reduction advice. Referral |
|should be made directly to a treatment centre. |
| |
|It is expected that the treatment centres will assist Primary Care in understanding the Suspected Hepatitis C pathway. |
| |
|3) There should be an identified Consultant(s) with a specialist interest in Hepatitis C treatment who has the following responsibilities: |
|Regular contact and review of patients with Hepatitis C Virus who have been referred for consideration of treatment |
|Annual update (as a minimum) on the treatment of Hepatitis C treatment due to the rapidly changing nature of the therapy, with timely |
|update in relation to any new NICE advice |
|The above responsibilities should all be provided in line with the Trust line management and clinical governance arrangements |
| |
|4) Patients should not be accepted for referral unless a minimum number of tests have been performed: |
|HCV Antibody |
|HCV PCR |
|Results must be sent with the referral. |
| |
|If referral is from a medical provider the following tests should be performed (although if not performed referral can be made without |
|these tests). |
|LFT |
|FBC |
|TFT |
|HIV |
|Coag Screen |
|HAV IgG (with vaccination where appropriate) |
|HBV surface antigen and HBV anticore antibody (with vaccination where appropriate) |
|HCV Genotype test |
|Results to be sent with referral. |
| |
|5) The referrer should aim to provide secondary care with information about the patient’s medical and psychiatric history, substance misuse|
|history, housing situation, support available from substance misuse, psychiatrist, social service and third sector. |
| |
|6) The patient should be informed of the date of their appointment with secondary care. The date of the first appointment should be within |
|18 weeks of decision to refer |
| |
|7) In providing HCV treatment services the following minimum standards should be considered: |
| |
|Services should be provided under the supervision of a Consultant with a special interest in HCV treatment. Whilst the services could be |
|directly delivered by the consultant it is often more cost effective for these to be provided by specialist nurses. |
|Regular multi disciplinary meetings should be held with the supervising Consultant and involve all practitioners involved in the delivery |
|of the treatment package |
|Staff working to deliver the HCV treatment service should access regular training. For information on training requirements for clinicians |
|please see Teaching and Training for Hepatitis C Specialist Nurses (2009) and Teaching and Training for Hepatitis C Consultants (2009). |
|Referral to GP for psychiatric services should be made for patients who require it. |
| |
|8) There should be access to non-invasive fibrosis assessment for all patients who require it. |
| |
|9) Staffing of the service should be based on a multi-disciplinary team that should include Consultant, Specialist Nurse and Administrator.|
| |
| |
|10) Treatment should be offered in a location that is accessible for patients |
| |
|11) Patient education and support on the managing the side-effects of the treatment and of self administration of subcutaneous treatment |
|are an essential component of any treatment provision. Evidence has shown that this can maximize adherence to the treatment programme and |
|reduce the numbers choosing to discontinue treatment. Access to this support should be provided on a regular basis and best practice has |
|demonstrated that nurses can most effectively support this role. The Specialist Nurse should also provide information on local support |
|groups and attend local support groups. |
| |
|12) Because of the large number of people with HCV in Greater Manchester, and because of the Commissioner led activity limits it is likely |
|that waiting lists for chemotherapy treatment will develop. Some patients with higher needs will need to be seen more urgently. These are |
|patient with: |
|Cirrhosis of the liver |
|HIV |
|Patients with acute infection |
| |
|For patients on the waiting list for chemotherapy treatment it is important that they are cared for within the following minimum |
|standards: |
|Patients should be provided with information about how long they will wait for treatment |
|6 monthly appointment with clinic to ensure that circumstances have not changed and to provide ongoing support |
|Referral to patient support projects |
| |
| |
|13) In order to monitor the HCV service data must be collected. This is an essential element of the contract. The data requirements are: |
| |
|Numbers of patients initiated on chemotherapy treatment reported quarterly/PCT or Clinical Commissioning Group |
|Numbers who completed chemotherapy treatment reported quarterly/PCT or Clinical Commissioning Group |
|Numbers who stop chemotherapy treatment due to none compliance reported quarterly/PCT or Clinical Commissioning Group |
|Numbers who stopped chemotherapy treatment due to clinical decision reported quarterly/PCT or Clinical Commissioning Group |
|By Genotype, numbers achieving SVR reported quarterly/PCT or Clinical Commissioning Group |
|By Genotype, numbers not achieving SVR reported quarterly/PCT or Clinical Commissioning Group |
|Numbers not attending to be tested for SVR reported quarterly/PCT or Clinical Commissioning Group |
| |
|3.2 Care Pathways |
| |
|This service specification is based on the adoption of a new model of care delivery which introduces new efficiencies into the system. The |
|clinical care pathway was developed by local treatment clinicians and two primary care physicians have agreed a Greater Manchester Clinical|
|Care Pathway. This pathway has been endorsed by: |
|The GM PEC Chair group |
|The GM DPH group |
|The GM Director of Commissioning group |
| |
| |
|The two main changes to the care pathway involve entrance and exit points. |
| |
|Entrance Point: In the new care pathway PCR test is to be carried out in primary care, and referrals are made direct to straight to |
|treatment centre. A leaflet is available to be printed out from Map of Medicine which explains the tests for patients and GP’s. |
| |
|Exit Point: Once treatment has been completed patients who have residual liver disease but have are SVR negative (cleared virus) should be |
|referred to their local Gastroenterology or Hepatotology service using a Consultant to Consultant referral. |
| |
|See Map of Medicine Greater Manchester Hepatitis C Care Pathways |
| |
|4. Referral, Access and Acceptance Criteria |
| |
|Geographic coverage/boundaries |
|For local definition |
| |
| |
|Location(s) of Service Delivery |
| |
|The treatment service should be based at XXXX hospital. |
| |
|Days/Hours of operation |
| |
|The service operates over 5 days per week |
| |
|Referral criteria & sources |
| |
|Referrals will be accepted from Primary Care practitioner, drug services, GUM clinics, Antenatal clinics and from secondary care |
|Consultants. Referrals will only be accepted with a standardised form/ template letter describing history and with blood results. The blood|
|results required for a successful referral are: |
|HCV Antibody |
|HCV PCR RNA |
| |
|If the referral is from a GP then additional test results should also be provided if possible: |
|LFT |
|FBC |
|TFT |
|HIV |
|Coag Screen |
|HAV IgG (with vaccination where appropriate) |
|HBV surface antigen and HBV anticore antibody (with vaccination where appropriate) |
|HCV Genotype |
| |
|The referral should also include information on the patient’s medical and psychiatric history, substance misuse history, housing situation,|
|support available from substance misuse, psychiatrist, social service and third sector. |
| |
|Referral route |
| |
|The Greater Manchester Hepatitis C treatment services should develop a standard Greater Manchester Hepatitis C referral form for use by |
|referrers (a letter containing the same information would also be acceptable). |
| |
|Exclusion criteria |
|Hepatitis C PCR result not recorded |
|Hepatitis C PCR negative |
| |
| |
|Response time & detail and prioritisation |
| |
|All patients should receive their first treatment appointment with secondary care clinicians within the time-frame defined by National |
|Waiting time guidelines. |
| |
| |
|5. Transfer of and Discharge from Care Obligations |
|Patients who have not completed treatment or started treatment due none attendance should be discharged back to their GP. |
|Patients who have completed treatment and have achieved a Sustained Viral Response and do not have significant fibrosis or cirrhosis should|
|be discharged back to their GP. |
|Patients who have not completed treatment due to side-effects or patient choice should remain within the treating service, and will be |
|offered an annual appointment. |
|Patients who have completed chemotherapy treatment but have not achieved a Sustained Viral Response and do not have significant fibrosis or|
|cirrhosis should remain within the treating service, and will be offered an annual appointment. |
|Patients who have completed treatment and have achieved a Sustained Viral Response but have cirrhosis should be referred to their local |
|gastroenterologist for Hepatic Cellular Carcinoma surveillance. This is an appropriate Consultant to Consultant referral. Patients who have|
|completed treatment but have not achieved a Sustained Viral Response and have cirrhosis should remain within the treating service, and will|
|be offered an six monthly appointment to ensure cirrhosis surveillance. |
| |
|6. Self-Care and Patient and Carer Information |
|The treatment centre has a responsibility to ensure patients are aware of the BHA Greater Manchester HCV Support Project. |
| |
|Specialist Nurse attend patient support groups on occasion and keep up to date with the local patient support community |
| |
|Refer patients who are on the waiting list for treatment, who do not have a sustained viral response to treatment, who have ongoing |
|cirrhosis due to Hepatitis C to the BHA Hepatitis C Self Care Management course. |
| |
|The treatment service should provide patients with leaflets and information about Hepatitis C and treatment in relevant languages. |
| |
|7. Quality Requirements |
|Performance Indicator |Indicator |Threshold |Method of Measurement |Consequence of breach |
|Quality | | | | |
|Domain 2: Health |EQ-5D Score |N/A first year |Baseline audit |Annual |
|related quality of life| | | | |
|for people with | | | | |
|long-term | | | | |
|conditions(EQ5D)** | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| |Ensuring people feel |N/A first year |Patient survey |Annual |
| |supported to manage their | | | |
| |condition | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| |Improving functionalability |N/A first year |Patient survey |Annual |
| |in people with long-term | | | |
| |conditions | | | |
| | | | | |
| | | | | |
| | | | | |
|Domain 4: |Improving people’s |N/A first year |The indicator will be |Annual |
|Ensuring that people |experience of outpatient | |‘patient experience of | |
|have a positive |care | |outpatient services’ | |
|experience of care (6) | | |derived from the | |
| | | |Outpatient Survey. | |
|Provide HCV training to|Number of staff trained and |25 staff per annum | |Annual |
|healthcare |content of training. | | | |
|professionals within | | | | |
|the provider service, | | | | |
|such as ward nurses and| | | | |
|midwives. | | | | |
|Provide training on |Number of staff trained and |25 staff per annum | |Annual |
|indications for HCV |content of training course. | | | |
|testing for all HCV | | | | |
|testing providers | | | | |
|including maternity | | | | |
|services, antenatal | | | | |
|clinics, hospitals, | | | | |
|drug services and | | | | |
|primary care. Voluntary| | | | |
|sector. | | | | |
|Research and audit |Ensure that members of the |one | |Annual |
|Project |clinical team participate in| | | |
| |a research or audit project| | | |
| |annually | | | |
|Performance & | | | | |
|Productivity | | | | |
|Treatment initiation |Numbers of patients |N/A first year |Baseline Audit |Quarterly |
|per PCT/Clinical |initiated on chemotherapy | | | |
|Commissioning Group |treatment reported quarterly| | | |
|Treatment completion |Numbers who completed |N/A first year |Baseline Audit |Quarterly |
|per PCT/Clinical |chemotherapy treatment | | | |
|Commissioning Group |reported quarterly | | | |
|Treatment stopped due |Numbers who stop |N/A first year |Baseline Audit |Quarterly |
|to non compliance per |chemotherapy treatment due | | | |
|PCT/Clinical |to none compliance reported | | | |
|Commissioning Group |quarterly | | | |
|Treatment stopped due |Numbers who stopped |N/A first year |Baseline Audit |Quarterly |
|to clinical decision |chemotherapy treatment due | | | |
|per PCT/Clinical |to clinical decision | | | |
|Commissioning Group |reported quarterly | | | |
|SVR per PCT/Clinical |By Genotype, numbers |N/A first year |Baseline Audit |Quarterly |
|Commissioning Group |achieving SVR reported | | | |
| |quarterly | | | |
|No SVR per PCT/Clinical|By Genotype, numbers not |N/A first year |Baseline Audit |Quarterly |
|Commissioning Group |achieving SVR reported | | | |
| |quarterly | | | |
|DNA SVR per |Numbers not attending to be |N/A first year |Baseline Audit |Quarterly |
|PCT/Clinical |tested for SVR reported | | | |
|Commissioning Group |quarterly | | | |
| |
| |
|8. Activity |
|8.1 – Activity to be defined after first annual report as data is not yet collected to allow activity monitoring. |
|Activity Performance Indicators |Threshold |Method of measurement |Consequence of breach |
| | | | |
| | | | |
| | | | |
| | | | |
|8.2 Activity Plan |
| |
| |
|8.3 Capacity Review |
| |
|9. Prices & Costs |
|9.1 Price |
| |
|Basis of Contract |
|Unit of Measurement |
|Price |
|Thresholds |
|Expected Annual Contract Value |
| |
|National Tariff plus Market Forces Factor |
|Hepatology / ID PbR tariff |
| |
| |
| |
| |
|Non-Tariff Price (cost per case/cost and volume/block/other)* |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
|Total |
| |
|£ |
| |
|£ |
| |
|*delete as appropriate |
| |
|9.2 Cost of Service by commissioner |
| |
|Total Cost of |Co-ordinating PCT Total |Associate PCT |Associate PCT |
|Service | |Total |Total |
|£ |£ |£ |£ |
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