Out of Hospital Systemic Anti-Cancer Therapy (SACT ... · Developed as part of a joint working...

UKIE-NPC-CARF-0818-066709e Date of preparation: October 2018

This project was initiated as part of the former Cancer Vanguard’s challenge to the pharmaceutical industry to work with the NHS to improve the availability and delivery of cancer drugs. Developed as part of a joint working agreement with Amgen, UCLH Cancer Collaborative led the project on behalf of its two partners in the former Cancer Vanguard – Greater Manchester Cancer Vanguard Innovation and RM Partners.

Out of Hospital Systemic Anti-Cancer Therapy (SACT) Chemotherapy Options

The Cancer Vanguard is a partnership between Greater Manchester Cancer Vanguard Innovation, RM Partners and UCLH Cancer Collaborative

2 UKIE-NPC-CARF-0818-066709eDate of preparation: October 2018

UCLH: Danielle Ohana, Tom Marler-Hausen, Rakesh Popat, Martin Forster, Eleanor Hellier, Simon Cheesman, Nishali Patel, Robert Urquhart

UCLH Cancer Collaborative: Simon Evans, Ben Goretzki, Sean Hession

The Royal Marsden: Caitriona Liebenberg, Anita McWhirter, Jane Crimmin, Jatinder Harchowal

The Christie: Victoria Burns, Robert Duncombe

Celesio UK: Jill Pritchard, Vivian de Vittoris

Hope for Tomorrow: Megan Broadley

Tenovus: Rhian Edwards

Amgen: Richard Jenkins, Jane Hill

Acknowledgements

Table of contents

Background 4

Drivers for change 5

Community models for the delivery of SACT 6

Mobile Care Unit (MCU) 7

Partnership with a community/district hospital 10

Partnership with a community pharmacy 12

Key considerations for implementation of Out Of Hospital (OOH) service models 14

Appendix 1 15

Appendix 2 19

Appendix 3 20

References 21

UKIE-NPC-CARF-0818-066709eDate of preparation: October 2018 3


The publication of the Five Year Forward View (FYFV) and Achieving World-Class Cancer Outcomes: A Strategy for England outlined a range of recommendations to drive improvement across the NHS (both generally and specifically in the cancer arena) in response to increasing population and budgetary pressures.1, 2 The practice of putting patients at the centre of their care to drive improved patient experience and outcomes was central in both publications.Importantly, the FYFV described how cancer care could be improved by developing networks of services over geographies, integrating different organisations and services around patients.1 In particular it highlighted that chemotherapy, support and follow up care can be delivered in patients’ local hospitals or primary care facilities whilst continuing to have access to world-leading facilities.1

The Cancer Vanguard was established to pilot and roll out new models of care (detailed in the FYFV) that would provide innovative high quality cancer care across the whole patient pathway. Spearheaded by leading oncology hospital trusts in London and Greater Manchester, the aim of the Cancer Vanguard was to develop transformational care-delivery models that can be replicated nationally.

One of the Cancer Vanguard workstreams was the establishment of a Joint Medicines Optimisation Group with the remit of transforming the delivery of medicines to patients. Part of this group’s work was to address and implement recommendations from the National Cancer Taskforce on improving access to chemotherapy and other medications used in oncology.

At the start of 2017, University College London Hospitals (UCLH) (in partnership with Amgen Ltd and Vanguard affiliates) initiated a project to evaluate how to deliver low risk systemic anticancer therapy (SACT) in the most patient-centred, efficient and cost-effective way.

This document summarises the information collected and developed throughout this 2017 project, specifically with a focus on evaluating different models of out-of-hospital (OOH) chemotherapy care.

For further information about Amgen, please contact Amgen Medical Information by email: [email protected]

For further information about UCLH Cancer Collaborative, please contact [email protected]

Background


Drivers for change

Patient experience and quality of care

When clinically appropriate, providing treatments closer to patients’ own homes has the potential to improve patients’ quality of life by, relieving individuals of the burden of long journeys, potentially lengthy waiting times and the need to delegate some of their personal commitments, like work or childcare, to others. They can also be spared the costs of travel to and from outpatient appointments which, according to Macmillan Cancer Support, affects nearly 70% of people with cancer and amounts to an average of £170 a month.3 By stratifying patients by level of risk, their regimen of care and taking their preference under consideration, the provision of an OOH model, may help to release capacity which could serve to improve scheduling and contribute to the improved quality of overall care.

Patient experience may be captured via:

• Analysis of patient geographical spread and the associated travel and clinic time with their treatment.

• Patient experience surveys. • National patient experience data available by Trust

(e.g. The National Cancer Patient Experience Survey).4

• Benchmarking performance versus key targets (e.g. 2 week wait, 31 day and 62 day target and definition).

Demand, capacity, utilisation and efficiency

Understanding and measuring demand, capacity, utilisation and efficiency of an outpatient chemotherapy service is challenging due to the increasing complexity of the service being delivered. Currently, the service delivers a large number and variety of chemotherapy treatment protocols to an ever-increasing number of patients, who often have a wide range of co-morbidities. Additional pressure manifests as newer more complex treatment protocols are being made available at an unpredictable rate. Another significant challenge across the whole NHS is that the IT systems in use make analysing service trends and forecasting future trends difficult.

Whilst this paper did not set out to solve this issue we have listed some important considerations that units should seek to understand to ensure there is a benchmark against which new service models can be measured.

A number of factors inform demand:

• Workforce: including medical, nursing and support staff, clinical and production pharmacy numbers.

• Environment: including the treatment space, number of infusion chairs/pumps, cytotoxic isolation rooms.

• Resources: skill set/experience of staff, availability of equipment, drugs, and devices. It is also important to recognise that the capacity of supportive services relied upon to facilitate treatment such as phlebotomy or the peripherally inserted central catheter (PICC) line service, impacts significantly on core capacity.

Measures of capacity utilisation can be used to build up a wider picture of the current service such as:

• Chair time utilisation.• Staff to patient ratio.• Staff skill mix and competency utilisation. • Drug batching and vial sharing feasibility in pharmacy

production.

However due consideration should be given to factors that are likely to affect future capacity and its utilisation:

• General patient number trends.• New drugs and therapies in the near horizon (e.g.

immunotherapies, chimeric antigen receptor T-cell (CAR-T) therapy) that will impact:

– Number of patients being treated. – Method(s) of administration. – Duration of treatment and monitoring times.• Clinical trials.• Differences/changes in formulation (e.g. oral SACT

replacing intravenous (IV), subcutaneous (SC) formulations replacing IV).

• System changes (e.g. e-referrals, IT booking systems etc.).

• Better supportive care and ambulatory regimens.• OOH treatment models.

Factors that affect efficiency are:

• Patient transport (can patients get into the unit before 9am or after 3pm?).

• Efficiency of systems and processes (both IT and pathways).

• Supportive care services (administrative support, blood results).

• Staffing (both number and quality of staff).

Measuring efficiency:

• Number of patients treated.• Patient waiting times.• Treatment times.


Innovation

Health innovation is a central FYFV theme, the document states the intent to accelerate ‘innovation in new ways of delivering care’.1 The National Cancer Vanguard agenda correspondingly makes reducing the care and quality gap through new models of delivery to improve patient experience a key priority.

Working with the wider local health economy, due consideration should be given to how innovations can be introduced to any new service models under consideration.

Challenges associated with the implementation of OOH service models

Presently there is relatively little published analysis on the different models being used to deliver OOH chemotherapy treatment.5 There is a critical need to devise strong measures of evaluation for any pilot projects or service developments undertaken to ensure that clinical effectiveness, patient experience and cost-effectiveness are accurately captured and can be used to inform decision making.

Subject to the model selected, where financial planning makes assumed savings based on a cost effective dispensing route, it will be important to take a long-term view of the regimens under consideration to ensure that changes are anticipated in financial planning e.g. the introduction of biosimilars, changes to administration etc.

Drivers for change

Community models for the delivery of SACT

Many modern treatments can be safely administered away from major cancer centres and acute hospital settings, allowing the design of new delivery models based on community administration.

Across the UK, local health environments are adopting community-based models of care which focus on providing those patients stratified as low-risk, with more local and convenient care. Some example models are as follows:

Chemotherapy clinics delivered in Community or District Hospitals, hospices or GP clinics by specialist chemotherapy nurses from a primary cancer centre

Chemotherapy clinics delivered in Community Pharmacies by third-party specialist chemotherapy nurses

Chemotherapy clinics delivered in a Mobile Care Unit by either Trust or third-party specialist chemotherapy nurses

Chemotherapy delivered to Patients’ Homes by either Trust or third-party specialist chemotherapy nurses

As part of this project, the three circled models have been examined to understand:

• Key features of the model.• Expected benefits.

• Anticipated risks.• Financial considerations.


Model overview

Mobile Care Units (MCU) are bespoke, transportable units (usually in the form of a bus or truck) that provide intimate clinic settings for the delivery of cancer care. The units can be set up in convenient community locations (such as public authority parks, supermarket car parks). Care is usually delivered by two specialist chemotherapy nurses (band 5–7 subject to Trust governance requirements) based on an average of four chairs per unit.

This project has looked at two examples of a MCU, both options are operated in partnership with charity organisations.

Mobile Care Unit (MCU)

Overview of a generic MCU pathway

STEP 1: The Cancer Services (at the Trust) define criteria for patients and regimens that are suitable for care in the community (see appendices for further details)

STEP 2: Reviewing clinicians assess patients against agreed criteria (including patient preference and consent) and patients are selected for the service

STEP 3: The service administrator books the patient on to the service* and confirms details with the patient

STEP 4: The prescription is sent to the Trust pharmacy and the treatment prepared in line with date of administration

OR the prescription is sent to a third-party provider and prepared for dispensing according to date of administration

STEP 5: The unit driver (usually Trust employed) will pick up the MCU from storage site, make checks and drive to the community location. The MCU is then parked and prepared to welcome patients and the nurse staff

STEP 6: The prescription is collected by the nurse team (working on the MCU) and transported to the MCU on the morning of administration^

OR the prescription is delivered to the MCU or collected by third-party nurses working on the MCU (on the day of the treatment)^

STEP 7: The patient arrives at the MCU, is checked in and receives treatment from Trust employed nurses**

OR the patient arrives at the MCU, is checked in and receives treatment from third-party nurses**

STEP 8: Patient is observed during and after treatment and findings recorded securely on the Trust IT platform. As per agreed protocol, any specific follow up activity will occur via the Trust otherwise the patient will return to the MCU for ongoing treatment

* Typically the patient will receive the first two courses of chemotherapy treatment in the Trust with the third and subsequent treatments being delivered on the MCU^ Specialist medicines are stored appropriately on the unit (i.e. in a medical fridge)** Patients requiring blood tests prior to treatment may attend the hospital for testing at pre-defined times (for their specific regimen) or blood tests can be undertaken on the unit with samples couriered to the

hospital labs. Blood tests results are then uploaded on the relevant system and can be accessed by nurses on the unit. Point-of-care testing (POCT) may be considered according to Trust governance policy



Expected benefits and opportunities associated with the delivery of SACT on a MCU

• Increases convenience, access and reduced travel time for patients using the MCU:

– The MCU can be located at community sites that provide free parking for patients and carers and close to community facilities such as cafes.

– The MCU can be located at multiple sites per week creating greater convenience according to the geographic spread of the population.

• All the above have the potential to positively impact on patient experience.

• Diverting a proportion of appropriate patients to the MCU, can help to release acute capacity.

• Enables nursing staff to work autonomously and gain experience in a different work environment.

• Encourages a more organised approach to prescribing, screening and preparing chemotherapy.

• Presents opportunities to make cost efficiencies: – Increases service capacity and corresponding income

generation.• Reduces Trust travel costs.• Potential for reduced running costs versus an equivalent

space in a Trust whilst earning the same tariff as onsite treatment.

• Cost effective dispensing route where treatment is dispensed and administered by a 3rd party provider.

• Minimises set up costs where partnership is agreed with a charity provider.

Key risks/considerations for the delivery of SACT on a MCU

• Reduces medical and multidisciplinary support on the MCU – governance arrangements should be established to ensure that any medical emergencies are managed in a timely and appropriate way. Clear escalation procedures are required.

• Potential reluctance from patients to receive care on the MCU – extensive engagement with patients prior to, and during service implementation should be undertaken to ensure patients feel comfortable with the treatment setting and can understand the benefits associated with the new care model.

• Potential reluctance from staff to working on a satellite unit should be explored extensively to understand and address concerns where possible. Increasing familiarity with the unit, using a staff rotation with the day unit or meeting other local health environments using this model may help to alleviate concerns.

– Where staff capacity or recruitment are key challenges, it may be beneficial to engage 3rd party nurses to deliver care.

• MCU operation requires significant logistical and driver support. Early in the planning process, it will be necessary to identify or employ administrative support to identify, check the appropriateness and secure these locations for the MCU service, as well as managing the booking process for the unit on an ongoing basis.

– Additionally, it is essential to hire an HGV driver to transport the unit and provide additional on- board support and interaction with patients.

• Whilst the MCU offers a more intimate setting for care, due to the reduced number of patients (versus a day unit), there is less scope to alter treatment last minute and potentially more scope for wastage from non-attendance.

– Minimising non-attendance and wastage should be considered in both governance policy and in projected running costs.

• Where the MCU is being delivered in partnership with charity providers, it is important to ensure that activity is sufficient to fill MCU capacity for the duration of any agreed contract e.g. 3–4 years.

• It is important to understand what current transport issues patients have in getting to treatment in the main cancer centre and whether an MCU would resolve these issues. For example are there good transport links to the main hospital? Is there sufficient parking for patients? Do patients live in isolated villages/cities away from the main cancer hospital?

• Changes will impact on pharmacy, they will need to receive confirmation of prescriptions and notification of any changes. All medications are required to be prepared in advance, allowing time for nurses to review on the morning of administration, please follow local protocols.



Financial considerations

Anticipated costs Notes

Workforce costs

2x chemotherapy nurses Likely to be band 5–7; subject to local governance a nurse and HDA combination might be possible.

1x HGV driver Likely to be band 3.

1x project manager/ administrative worker

Non-pay costs

Unit and car maintenance In partnerships with charity organisation, a support car for nurses may also be provided.

Fleet insurance (MCU and support car) This cost will likely be the Trust’s responsibility.

Fuel (MCU and support car) Cost will vary according to the distances covered by the unit.

Parking

The MCU will need to be kept in a secure site overnight – payment may be required for this if not within Trust grounds. Additionally, rental costs may be associated with sites used for service delivery. Community sites may also incur parking charges and arrangement costs, legal fees are also possible.

Consumables IV lines, dressings, venous access devices.

Patient refreshments Tea, coffee, water and, where appropriate, meals.

Pharmacy costs These may be considered pass through costs if the Trust pharmacy is preparing and dispensing treatments. However a fixed cost may be agreed with a 3rd party provider.

Treatment costs These may be considered pass through costs as drugs will be covered within the tariff payment.

Other E.g. waste disposal.

Set-up/transition costs

MCUThe cost of the MCU will vary according to type and specification and if a charity partnership is sought. In such cases, the charity may provide the bespoke unit with infusion chairs, pump stands, medical and non-medical fridges and toilets.

Support car In partnerships with charity organisation, a support car for nurses may also be provided.

Service equipment E.g. vital signs observation machine, approximately 4 IV pumps, defibrillator, crash trolley and consumables, service laptop, wifi connection, emergency bag and scales.

Storage or site adaptions E.g. electrical hook up points, generator, sluice, land reinforcement, water.

Staff training


STEP 1: The Cancer Services (at the Trust) define criteria for patients and regimens that are suitable for care in the community (see appendices for further details)

STEP 2: Reviewing clinicians assess patients against agreed criteria (including patient preference and consent) and patients are selected for the service

STEP 3: The service administrator books the patient on to the service* and confirms details with the patient

STEP 4: The prescription is sent to the Trust pharmacy and the treatment prepared in line with date of administration

OR the prescription is sent to the pharmacy at the partnering hospital and prepared for dispensing according to date of administration

STEP 5: The prescription is collected by the Trust nurse team and transported to the community hospital on the morning of administration

OR the prescription is collected from the pharmacy onsite either by Trust staff or community nurse staff

STEP 6: The patient arrives at the unit, is checked in and receives treatment from Trust employed nurses, chemotherapy trained community nurses or a combination of both**

STEP 7: Patient is observed during and after treatment and findings recorded securely on the Trust IT platform. As per agreed protocol, any specific follow up activity will occur via the Trust otherwise the patient will return to the community clinic for ongoing treatment

* Typically the patient will receive the first two courses of chemotherapy treatment in the Trust with the third and subsequent treatments being delivered in the community clinic** Patients requiring blood tests prior to treatment may attend the Trust for testing at pre-defined times (for their specific regimen) or blood tests can be undertaken at the community hospital and either couriered to

the Trust labs and processed in the community labs if available. Blood tests results are then uploaded on the relevant system and can be accessed by nurses on the unit

Partnership with a community/district hospitalModel overview

The partnership model can take a number of forms however this project has predominantly evaluated a hub and spoke model where a larger cancer centre partners with a community or district hospitals (who may or may not already be offering chemotherapy) to set up chemotherapy specific clinics in hospital locations which are more convenient for Trust patients. The clinic would be delivered

in a rented and where necessary, renovated space that accommodates the demand of the patient demographic i.e. the number of chairs and staff working in the clinic can be flexed to meet the anticipated demand.

This project has evaluated partnership with a community or district hospital, however research has highlighted that similar partnerships with hospices, or GP practices are in operation around the UK.

Expected benefits and opportunities associated with the delivery of SACT via a community hospital partnership

• Improves convenience, access and reduces travel time for appropriately selected patients using the community clinic.

– The partnering site should be selected to maximise convenience for the patient cohort whilst correspondingly offering more convenient parking or transport links.

• Potential opportunity to improve patient experience through a reduced waiting time.

• Subject to the selection of the site, the space may offer greater flexibility to change/alter the scope of what is being delivered in the spoke service.

• Diverting a proportion of appropriate patients to the community hospital clinic, can help to release onsite Trust capacity.

• Minimises risk associated with adverse events (AEs) with greater medical support offered on site

• Opportunity to maximise unused hospital facilities.• Enables Trust nursing staff to work autonomously and

gain experience in a different work environment; and subject to the chosen staffing mix, community nurses may gain the opportunity to upskill.

• Encourages a more integrated service model that spans organisational boundaries.

• Opportunities to make cost efficiencies: – Potential to increase service capacity and

corresponding income generation. – Reduces Trust travel cost.

Overview of a generic partnership with community hospital pathway


Partnership with a community/district hospitalKey risks/considerations for the delivery of SACT via a community hospital partnership

• Unwillingness or reluctance from partner hospital or the Trust to work in partnership with a separate organisation.

– Concerns associated with a loss of income.• Potential reluctance from patients to receive care at a

community hospital – extensive engagement with patients prior to, and during service implementation should be undertaken to ensure patients feel comfortable with the treatment setting, and the expertise of those delivering the service.

• Potential reluctance from staff to working at a satellite centre should be explored extensively to understand and address concerns where possible. Increasing familiarity with the unit, using a staff rotation with the day unit and/or engaging with the community hospital team may help to alleviate concerns.

• Early in the planning process, it will be necessary to identify or employ administrative support to manage the booking process for community clinic on an ongoing basis.

• The financial viability of the service should be carefully modelled prior to implementation to ensure that demand will match the required investment as this model may not provide as much scope for cost efficiencies such as reduced running costs and/or dispensing savings.


Anticipated costs NotesWorkforce costs

2x chemotherapy nurses Likely to be band 5–7; subject to local governance a nurse and HDA combination might be possible.

1x project manager/ administrative workerNon-pay costsSite/clinic area rental To be agreed with partner hospital. Support car maintenance In partnerships with charity organisation, a support car for nurses may also be provided.

Fleet insurance Where a support car is purchased for the service, alternatively nurses may be asked to use their own vehicle and reimbursed for expense/insurance.

Fuel (support car or nurse expense) Cost will vary according to the distances covered by the unit.

Consumables IV lines, dressings, venous access devices.Patient refreshments Tea, coffee, water and, where appropriate, meals.

Pharmacy costsThese may be considered pass through costs if the Trust pharmacy is preparing and dispensing treatments. However a contract or agreement with the partnership hospital might entail a set cost for dispensary.

Treatment costs These may be considered pass through costs as drugs will be covered within the tariff payment.Other E.g. waste disposal.Set-up/transition costsSite adaptions/ renovations

Subject to the facilities available, some renovations may be required to make the space fit for purpose.

Support carA support car may be purchased for the transport of the nursing staff and treatments, alternatively nursing staff may be asked to use their own vehicles and/or chemotherapy transport arranged.

Service equipmentSubject to the equipment available at the site, the following items may be required: vital signs observation machine, IV pumps and chairs, defibrillator, crash trolley and consumables, service laptop.

Staff training Where the service will be delivered in partnership with the community staff, training may be required to upskill and prepare community nurses for working in a specialised clinic.


Partnership with a community pharmacy

Model overview Working in partnership with a private community pharmacy provider network, patients would be offered chemotherapy in community pharmacy locations that provide convenience and greater proximity to their homes. Subject to the agreed location(s), the service would be provided in a consultation room, bespoke for purpose, with care provided by either specialist chemotherapy nurses or chemotherapy pharmacists. It is possible to have community pharmacists

deliver simple subcutaneous treatments however, chemotherapy treatments necessitating a cannula would generally be delivered by a nurse and so would involve either a 3rd party healthcare provider or a nurse from the central hospital delivering the treatments. Patients would be selected for the service via local Trust defined protocol informed by the specific selected treatment regimen, patient consent and patient suitability for care in the community.

Expected benefits and opportunities associated with the delivery of SACT via a community pharmacy

• Improves convenience, access and reduces travel time for appropriately selected patients using the community pharmacy.

– The partnering site should be selected to maximise convenience for the patient cohort whilst correspondingly offering more convenient parking or transport links.

• Potential opportunity to improve patient experience through reduced waiting times.

• Diverting a proportion of appropriate patients to the community pharmacy can help to release onsite Trust capacity both from the day unit and the pharmacy.

• Encourages a more organised approach to prescribing, screening and preparing chemotherapy.

• Opportunities to make cost efficiencies: – Increases service capacity and corresponding

income generation. – Reduces Trust travel costs. – Equivalent tariff and associated income will be

marginally reduced versus agreed service fee. – Cost savings where treatment is dispensed and

administered by a 3rd party provider. • Subject to the agreement of a contract; set up costs

would be paid by the community pharmacy provider and covered within a service fee charged throughout the duration of the contract thereby reducing upfront investment for the Trust.

– This may result in a reduced service fee upon extension of the initially agreed contract duration (usually 3 years).

The above is an illustrative overview of The Lloyds Pharmacy Community Healthcare Centre and Speciality Pharmacy Pathway (information courtesy of Lloyds Pharmacy, part of the Celesio UK group). Other community providers are available.

Operating model

STEP 1:Identify patient

STEP 2:Patient reviewed and referred

STEP 3:A member of the LloydsPharmacy clinical team registers the patient

STEP 4:Treatment day

STEP 7:Trust clinical review

STEP 6:Patient aftercare STEP 5:

Observations and outputs


Partnership with a community pharmacy

Key risks/considerations for the delivery of SACT via a community pharmacy

• Potential reluctance from patients to receive care at a community pharmacy – extensive engagement with patients prior to, and during service implementation should be undertaken to ensure patients feel comfortable with the treatment setting, and the expertise of those delivering the service.

• Early in the planning process, it will be necessary to identify or employ administrative support to manage the booking process for community clinic on an ongoing basis.

• The financial viability of the service should be carefully modelled prior to implementation to ensure that demand will match the fixed monthly service fee throughout the duration of the contract.

• Should focus on treatments that are quicker to administer allowing a service to achieve the economies of scale that will make the service financially viable.

• Clinical governance arrangements could become complex if services are outsourced to a pharmacy who then further outsource the nursing care to another provider.

• Communication and updates with the trust.


Anticipated costs Notes

Covered within the scope of the fixed monthly service fee, community pharmacy providers would commonly cover the following.

Workforce costs

Nursing staff The number of staff would be subject to the number of IV chairs and anticipated patients using the service. All nursing staff would be chemotherapy trained.

Pharmacy costs

Pharmacy staff Community Pharmacists will be available on site to provide additional support and information.

Pharmacy dispensary and delivery to site

These may be considered pass through costs if the Trust pharmacy is preparing and dispensing treatments. However a fixed cost may be agreed with a 3rd party provider.

Drug costs These may be considered pass through costs as drugs will be covered within the tariff payment.

Site renovation and maintenance

Selected pharmacies will be fitted according to the regimen chosen i.e. SC treatments versus IV treatments or both.

Trust financial considerations

Staffing Recruitment or identification of an administrative role to manage booking of patients on the service.

Equipment Provision of a service laptop with access to the relevant Trust platform – to allow direct update of patient information.


Key considerations for implementing OOH service modelsA number of key considerations were highlighted for any OOH service model development process:

Key considerations Mobile Care Unit

Partnership with community

hospital

Partnership with community

pharmacy

Establish good lines of communication between different providers or partners to support service planning, allocation of responsibility and management of any hurdles 3 3 3Agree treatment regimens that will be used in the service, ensure input from clinical staff that will be responsible for the running of the service. Agree a date for review within the first six months and thereafter

3 3 3Define the patient selection process, booking, patient communication and pharmacy ordering early and where possible trial the process prior to service initiation 3 3 3Identify service site(s) early and ensure critical adaptions are made:• E.g. for a MCU ensure the access is sufficient for entry/

exit, paving is flat secure etc. 3 3 3

Identify a secure location for overnight storage of vehicles and make any required adaptions:• E.g. for a MCU install an electrical socket and create a

sluice for waste disposal3

Map how the space will be used and in close collaboration with staff, ensure that key equipment and storage requirements are identified 3 3 3

Order equipment early 3 3 3Be exhaustive in cascading information, processes and timelines early and on an ongoing basis to staff, patients and the local health economy 3 3 3Finalise repatriation, infection control and waste disposal arrangements as part of the service SOP 3 3Where new staff will be required, e.g. CNS, a driver etc. – start the recruitment process early 3 3Where sites are remote or internet connection is not yet established, ensure that provision is made to connect the service with the Trust IT platform to avoid double working on patient notes

3 3 3Consider other elements of care or efficiencies that could be incorporated into the service e.g. satellite services used for prescription pick up, blood tests, counselling or surveys conducted with patients during their treatment

3 3 3


Appendix 1 – Out of Hospital IV chemotherapy suitability evaluation criteria

MOBILE UNIT/COMMUNITY HEALTHCARE FACILITIES

Key Factors – IV chemotherapy

UCLH The Royal Marsden The Christie Notes/Rationale

Prior assessment All patients to be assessed on:• Venous access• Mobility• Concomitant treatment

e.g. cold cap• Co-morbidities and

performance status• Fitness for treatment

• All patients to have venous access assessment and deemed to have good venous access prior to any treatment

• Patient mobility i.e. able to climb steps, although there is a lift there is limited space to be able to accommodate a wheelchair

• No previous reactions to chemotherapy (regimen dependent)

• Cold capping (no facility for cold capping on a MCU)

• If unable to administer treatment due to unsuccessful cannulation the patient will be booked for a further vessel health assessment which will include consideration of CVAD

• Less than 4 hours treatment length

• MCU: Patient must be mobile i.e. must be independent with toileting and be able to transfer into a treatment chair from a wheelchair. The MCU has a lift but no hoist facility

• Performance status 1-2• Stable on previous

treatments with controlled side effects

• Can sit in a chair comfortably for duration of treatment

• No previous reactions to treatment

• No scalp cooling or cold mitts available

• MCU: treatment less than 4 hours in length

• Patient does not have known infection e.g. MRSA or require isolation

• Venous access – good venous access or CVAD in place

Pre-medication The unit should be equipped with a sufficient supply of pre-, post-medications such as antiemetics, steroids, H1/2 antagonists, IV fluids, atropine, paracetamol

• MCU: stock of all pre-medications drugs that may be required on the unit

• Home: nurses carry all that is required for each patient where appropriate, or delivered with drug via courier

Prior to treatment • Clinical assessment (at least 2 days prior to treatment)

• Blood test 1-2 days prior to administration to measure full blood count (results to be available for day of treatment). Unless Point of Care (POC) available see overleaf

• Prescription: Prescribed and screened 1 day prior to treatment

• A minimum 2-day pathway - bloods and clinical assessment as per protocol for each treatment

• Patients on zoledronic acid should have blood tested at a minimum of 5 days before appointment on MCU

• 2-day pathway for MCU and home

• Bloods with or without medical review prior to day of treatment. Nurse to prep the day before for patients for home and MCU. If no medical review required nurse assessment on day of treatment as per protocol

• Blood tests arranged at local Trusts where possible and accessed by nurses electronically

• Prescriptions completed at least 4 days in advance where possible

• No clinical trials currently


Appendix 1 – Out of Hospital IV chemotherapy suitability evaluation criteria (continued)




Monitoring • If available on site, a POC machine to conduct full blood count (i.e. for weekly treatment regimens) Vital signs and blood sugar measurements, urine output and urine dipstick measurements would be acceptable on the day

• No cardiac monitoring

• No POC testing available on the unit

• Dynamap to record vital signs and NEWS score

• Suction and emergency bag containing required meds

• Observation only if patient unwell or required as part of the treatment protocol

• No point of care testing• Emergency equipment

and drugs available to nurses

• Blood test requirements would be subject to the frequency of the chemotherapy administered

Length of treatment • 3-4 hourly max• Likely to look at

shorter treatments (i.e. subcutaneous (S/C)1-hour max) as there is less chair space

• Less than 4 hours • MCU: Less than 4 hours

• S/C, Intramuscular (IM) injections currently

• Moving to IV infusion of no more than one hour

• Acceptable length of treatment will vary according to the location and the number of staff members available (i.e. shorter treatments if only one infusion chair is available)

• Length of treatment should take into account pre and post care

• N.B Long treatments may necessitate availability of refreshments/ lunch etc

Hypersensitivity risk • Do not administer out of hospital where there is a potential for the patient to react to the drug

• Avoid drugs that are high risk or for a patient that has previously reacted to their medication

• Mild/moderate risk of hypersensitivity reaction

• No re-challenges• Some drugs only

suitable from cycle 3 on the MCU

• No patients that have had previous sensitivity

• No re-challenges• Certain drugs only

given after two uneventful doses at main site

• Each centre should agree the level of risk acceptable within their clinical governance policy

Cycle number • Cycle 2+ - to ensure that no reactions occur

• Regimen dependent – some regimens given earlier if evidence suggests risk of reaction on earlier cycle is low

• Certain low risk drugs given from Cycle 1 – the rest given from the second dose

• Care with carboplatin. Increased risk of reaction with cumulative dose

• Patients are at higher risk of reaction if heavily pre-treated, re-treatment interval > 2 years or 2nd cycle after reintroduction

Concomitant medication

• No chemoRAD • No concomitant radiotherapy

• No concurrent chemo and radiotherapy

• Assessing concomitant medication would be part of the patient assessment






Preparation • Consider mAbs safety profile and look at which drugs can be re-constituted in the clinical area (dose banded, easy to reconstitute). Would recommend vial safety device

• Need > 24 hour expiry for chemotherapy drugs

• Dose banded drugs may help with supply issues

• Expiry of chemotherapy ≥ 24 hours – where drugs have a 24 hour expiry, they can be prepared for administration on the MCU but the number of such drugs booked on a single session on the MCU should be limited, as this will impact on the ability for aseptics to prepare them the day before

• No prep of drugs on unit. Drugs prepared by third party

• Trust moving to dose banding

• Drugs delivered to MCU and home by third party courier

• Consider storage of drugs to ensure secure cold chain and adequate sized storage area. Fridge must be monitored

Treatment type • All treatments to be approved by local governance structure for suitability of administration off site

• Novel agents can be used providing a comprehensive safety profile is known, and staff are familiar with the therapy

• IV and sub cut – approved list of regimens agreed in consultation with the MCU and Consultant leads. Regimen list reviewed regularly

• Approved drug list (see appendices)

Specific condition/diagnosis excluded?

• Should develop a patient assessment, dependent on the treatment being given

• All patients on a community pathway, either home or MCU, must be two-stop i.e. clinical confirmation and bloods conducted at least 24 hours prior community appointments

• Individual assessment• No patients with

tracheostomies

Regimen cost • Compare the cost of hospital manufacture of drugs per dose against manufacture of outsourced drugs including any VAT saving

• Ensure hospital agreements for drug costs are taken into account

• Compare overhead

• Drugs marked as HIGH COST must undergo especially careful consideration of whether the patient is suitable for MCU treatment - unused drugs cannot be returned once transported to the MCU – discussion with pharmacy required in advance

• Home – all high cost drugs

• MCU – a mix of regimens are used (with due consideration high cost drugs can be used)

• Hospital expenditure: Drug cost + VAT+ fixed costs (staffing/building/running unit)

• Hospital Income: Procurement and delivery HRG

• Drug cost includes VAT, vial sharing savings, PAS schemes, local procurement agreements

Trials • No trials (even if patient is on standard treatment arm)

• No patients on trial • No patients on trial • Subject to the trial protocol and associated setting for administration; trial regimens may not be appropriate for an OOH setting unless approved by local clinical governance procedures





Other • Needs to be a 2-day pathway

• Need to ensure consistent staff training of chemotherapy and venous access (e.g. port access)

• Extravasation risk?

• Any patient who has requested use of the scalp cooling will need to be treated in the day unit – no space for cold capping machine on MCU

• Patient to be seen in clinic and assessed with blood test, the regimen is then ordered and administered 2 days later

• Assessment in hospital, time to review bloods, order and make the chemo in advance

Specialist equipment For Sub/Cut injections• Vital signs machine• Emergency equipment

(defibrillator, oxygen supply, suction machine)

• Nebuliser• Look at a point of

care full blood count machine

Assuming IV infusions • Cold cap should be

provided if the drugs being given cause alopecia and there is a patient wish. Would need to exclude if there is insufficient space on the mobile unit

• IV infusion pump arm warmer/blanket

• Defibrillator • Oxygen• Suction• Emergency bag –

including adrenaline

• Defibrillator (MCU)• Oxygen• Suction (MCU)• Infusion pumps (MCU)• Dinamap• Thermometer



Appendix 2 – Example OOH regimens in use (The Royal Marsden – mobile unit)

SACT approved regimens for the Royal Marsden Hospital MCU (reviewed May 2018)

Regimen Cycle # Note Regimen Cycle # Note

Carboplatin 3 1st line treatment only Gemcitabine 1

Bevacizumab 3 Gemcitabine and Capecitabine 1

Caelyx Gemcitabine and Carboplatin 3

Capiri 3 Gemcitabine and Cisplatin 3 Short regimens only

Carboplatin and Capecitabine 3 1st line

treatment only Goserelin 3

Cetuximab 3 Irinotecan 1 Single agent only

Degramont IRMDG 1

Denosumab 1 Mitomycin 1

Docetaxel 3 Nintedanib 3

Doxorubicin 3 Oxaliplatin 3 No re-challenges

Doxorubicin and Cyclophosphamide 3 Paclitaxel 1 D15 If reaction occurs,

refer back to MDU

EC 1 PCV 3

EOX 3 Pemetrexed and Carboplatin 3

1st line treatment only

Epirubicin 1Single agent – no scalp cooling on MCU

Pertuzumab 3

Eribulin 1 TC 3

FEC 1 Trastuzumab IV and SC 3

Folfiri 3 Trastuzumab-emtansine (Kadcyla®) 3

Folfirinox 3 Weekly Paclitaxel and Carboplatin 3

Folfox 3 Zoledronic Acid 1

Fulvestrant 1


Appendix 3 – Example OOH regimens in use (The Christie - nurse-led outreach sites)

Approved regimens for The Christie nurse-led outreach service (reviewed September 2018)

• Carboplatin single agent 1st line only (Cycle 3 onwards)• Carboplatin and Capecitabine 1st line Carboplatin only (Cycle 3 onwards)• Denosumab (Cycle 1 onwards)• Docetaxel (Cycle 3 onwards)• Doxorubicin (Cycle 3 onwards)• Doxorubicin and Cyclophosphamide (Cycle 3 onwards)• Epirubicin single agent (Cycle 1 onwards)• Epirubicin and Cyclophosphamide (EC) (Cycle 1 onwards)• Epirubicin, Oxaliplatin and Capecitabine (EOX) (Cycle 3 onwards)• Fluorouracil, Epirubicin and Cyclophosphamide (FEC) (Cycle 1 onwards)• Fulvestrant injection (Cycle 1 onwards)• Gemcitabine (Cycle 1 onwards)• Gemcitabine and Capecitabine (Cycle 1 onwards)• Gemcitabine and Carboplatin 1st line Carboplatin only (Cycle 3 onwards)• Gemcitabine and Cisplatin (Cycle 3 onwards)• Irinotecan single agent (Cycle 1 onwards)• IRMDG (Cycle 1 onwards)• Mitomycin (Cycle 1 onwards) • MDG (Cycle 1 onwards)• Oxaliplatin single agent 1st line only (Cycle 3 onwards)• OXMDG 1st line only (Cycle 3 onwards)• PCV (Cycle 3 onwards)• Quasar (Cycle 1 onwards)• Trastuzumab IV and SC (Cycle 3 onwards)• Weekly Carboplatin 1st line only (Cycle 3 onwards)• Weekly Paclitaxel (Week 3 onwards)• Weekly Paclitaxel and Carboplatin 1st line Carboplatin only (Week 3 onwards)• Zoledronic Acid (Cycle 1 onwards)• Bevacizumab single agent – ovarian protocol only (Cycle 3 onwards)• Paclitaxel protein-bound (Cycle 3 onwards)• Aflibercept (Cycle 3 onwards)• Cabazitaxel (Cycle 3 onwards)• Liposomal doxorubicin (Cycle 3 onwards)• Cetuximab single agent (Cycle 3 onwards)• Eribulin (Cycle 3 onwards)• Nivolumab (Cycle 3 onwards)• Panitumumab (Cycle 3 onwards)• Pembrolizumab (Cycle 3 onwards)• Pemetrexed (Cycle 3 onwards)• Pemetrexed and Carboplatin 1st line Carboplatin only (Cycle 3 onwards)• Pertuzumab (Cycle 3 onwards)• Trastuzumab-emtansine (Cycle 3 onwards)

NO RE-CHALLENGES OF OXALIPLATIN OR CARBOPLATIN

For further information about Amgen, please contact Amgen Medical Information by email: [email protected]

For further information about UCLH Cancer Collaborative, please contact [email protected]

References

1. NHS England. Five Year Forward View. July 2014. Available at https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf. (Last accessed September 2018)

2. NHS England. Achieving World-Class Cancer Outcomes: Taking the Strategy Forward. May 2016. Available at: https://www.england.nhs.uk/wp-content/uploads/2016/05/cancer-strategy.pdf (Last accessed September 2018)

3. Macmillan UK. Cancer’s hidden price tag: revealing the costs behind the illness. 2012. Available at: http://www.macmillan.org.uk/_images/Cancers-Hidden-Price-Tag-report-England_tcm9-270862.pdf. (Last accessed September 2018)

4. NHS England. National Cancer Patient Experience Survey (2016 Results). Published July 2017. Available at: http://www.ncpes.co.uk/reports/2016-reports/national-reports-1/3572-cpes-2016-national-report/file (Last accessed September 2018)

5. Corbett M et al. National Institute for Health Research (NIHR). The delivery of chemotherapy at home: an evidence synthesis. Health services and delivery research. 2015; 3(14)

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