Appendix I
Schedule 2 Part 1:
Service
Service Specifications
Hepatitis C Service
Commissioner Lead
Provider Lead
Period
2012 -
1. Purpose
1.1 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
1.2 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
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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 www.gmhepc.com
1.3 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
i.
Increased number of people with hepatitis C completing treatment schedule
ii.
Decreased number of patients who do not attend first appointment
iii.
Defined activity level per annum
iv.
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)
v.
People with Hepatitis C are treated according to Clinical Care Pathway (see 3.2)
vi.
Develop infrastructure that will allow treatment of patients in a peripheral setting
vii.
People with Hepatitis C are provided with information about Self Care Support Project /
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local support groups
viii.
ix.
Representatives of clinical staff to be members of the Greater Manchester Hepatitis C
Strategy
Clinicians to take part in research/audit projects
i.
Clinicians to provide support to patient support groups
ii.
Representatives of clinical staff take part in projects to raise awareness of hepatitis C
as developed by Greater Manchester Hepatitis C Strategy
iii.
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
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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:
o Regular contact and review of patients with Hepatitis C Virus who have been referred for
consideration of treatment
o 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
o 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
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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
5


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
4.1 Geographic coverage/boundaries
For local definition
4.2 Location(s) of Service Delivery

The treatment service should be based at XXXX hospital.
4.3 Days/Hours of operation
The service operates over 5 days per week
4.4 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:
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







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
4.5 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.
4.6 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).
4.7 Exclusion criteria
 Hepatitis C PCR result not recorded
 Hepatitis C PCR negative
4.8 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
1. Patients who have not completed treatment or started treatment due none attendance should
be discharged back to their GP.
2. 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.
3. 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.
4. 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.
5. 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.
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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
Quality
Indicator
Threshold
Method of
Measurement
Consequence
breach
Domain 2:
Health related
quality of life for
people with
long-term
conditions(EQ5
D)**
EQ-5D Score
N/A first year
Baseline audit
Annual
Ensuring people
feel supported to
manage their
condition
N/A first year
Patient survey
Annual
Improving
functionalability in
people with longterm conditions
N/A first year
Patient survey
Annual
Domain 4:
Ensuring that
people have a
positive
experience of
care (6)
Improving people’s
experience of
outpatient care
N/A first year
The indicator will
be ‘patient
experience of
outpatient
services’ derived
from the
Outpatient
Survey.
Annual
Provide HCV
training to
healthcare
professionals
within the
provider
service, such
as ward nurses
and midwives.
Number of staff
trained and
content of training.
25 staff per
annum
of
Annual
8
Provide training
on indications
for HCV testing
for all HCV
testing
providers
including
maternity
services,
antenatal
clinics,
hospitals, drug
services and
primary care.
Voluntary
sector.
Research and
audit Project
Number of staff
trained and
content of training
course.
25 staff per
annum
Annual
Ensure that
members of the
clinical team
participate in a
research or audit
project annually
one
Annual
Performance &
Productivity
Treatment
initiation per
PCT/Clinical
Commissioning
Group
Numbers of
patients initiated
on chemotherapy
treatment reported
quarterly
Treatment
completion per
PCT/Clinical
Commissioning
Group
Numbers who
completed
chemotherapy
treatment reported
quarterly
Numbers who stop
chemotherapy
treatment due to
none compliance
reported quarterly
Treatment
stopped due to
non compliance
per
PCT/Clinical
Commissioning
Group
Treatment
stopped due to
clinical decision
per
PCT/Clinical
Commissioning
Group
Numbers who
stopped
chemotherapy
treatment due to
clinical decision
reported quarterly
SVR per
PCT/Clinical
By Genotype,
numbers achieving
N/A first year
Baseline Audit
Quarterly
N/A first year
Baseline Audit
Quarterly
N/A first year
Baseline Audit
Quarterly
N/A first year
Baseline Audit
Quarterly
N/A first year
Baseline Audit
Quarterly
9
Commissioning
Group
SVR reported
quarterly
No SVR per
PCT/Clinical
Commissioning
Group
By Genotype,
numbers not
achieving SVR
reported quarterly
DNA SVR per
PCT/Clinical
Commissioning
Group
Numbers not
attending to be
tested for SVR
reported quarterly
N/A first year
Baseline Audit
Quarterly
N/A first year
Baseline Audit
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
Consequence of
measurement
breach
8.2 Activity Plan
8.3 Capacity Review
9. Prices & Costs
9.1 Price
Basis of Contract
National Tariff plus
Market Forces Factor
Non-Tariff Price (cost
per case/cost and
volume/block/other)*
Unit of
Measurement
Hepatology /
ID PbR tariff
Total
*delete as appropriate
Price
Thresholds
£
Expected Annual Contract
Value
£
9.2 Cost of Service by commissioner
Total Cost
Co-ordinating PCT Total
Associate
Associate PCT
10
of Service
£
£
PCT
Total
£
Total
£
11