1 Name of the proposal
(Policy, proposition, programme, proposal or initiative.)
Systemic anti-cancer therapy (SACT) treatment breaks.
2 Brief summary of the proposal in a few sentences
The policy is to confirm the ongoing management of the systemic anti-cancer therapies (SACT) treatment break policy and will supersede the previous NHS England approach to treatment breaks which was suspended during the COVID19 pandemic and replaced by the NICE COVID-19 rapid guideline for the delivery of SACT, (NG161).
The scope of the policy includes all types of SACT, including traditional cytotoxic drugs, targeted therapies, monoclonal antibodies, antibody drug conjugates, cancer immunotherapy and enzyme/hormonal treatments with anti-cancer actions.
The policy applies to patients having a planned treatment break of greater than six weeks (or 12 weeks for immunotherapy) beyond the cycle length of their SACT regimen.
This is in-keeping with NG161, and the previous NHS England circular, requests relating to continuation of funding for systemic anti-cancer therapy (‘chemotherapy’) following a break in treatment (SSC 1918) which increased the period of the treatment break from four to six weeks.
The aspects of the policy which are different from the previous NHS England approach are the inclusion of the treatment break for cetuximab and panitumumab regimen for solid tumours, including metastatic large bowel cancer within the policy, and being more explicit about the inclusion and exclusion criteria, and removal of the interim COVID position of allowing treatment to restart even if there is evidence of disease progression if the break was due to COVID related reasons.
The policy is in keeping with the previous NHS England specialised circular SSC 1918, to support unplanned SACT treatment breaks to occur enabling SACT drug toxicity related side effects to resolve or improve.
The current proposed policy and previous circular also support elective, planned treatment breaks for patients to undergo and recover from surgery or radiotherapy treatments.
Resumption of the same SACT regimens will not be approved if the patient’s disease has progressed, or if the treatment break has been greater than six weeks (or 12 weeks for immunotherapy).
NICE NG161 states where treatment breaks would be approved for the same SACT regimen, even if the patient’s disease has progressed, providing the clinician indicates there is a reasonable chance that disease control can be regained on restarting treatment.
This is different from the proposed policy which states the use of an elective, planned intermittent treatment strategy which is beyond the Summaries of Product Characteristics (SmPCs) for the medicines and scenarios where NICE or NHS England have received any evidence to support such a strategy would not be approved.
3 Main potential positive or adverse impact of the proposal for protected characteristic groups summarised
Please briefly summarise the main potential impact (positive or negative) on people with the nine protected characteristics (as listed below).
Please state N/A if your proposal will not impact adversely or positively on the protected characteristic groups listed below. Please note that these groups may also experience health inequalities.
Protected characteristic group: Age
(older people, middle years, early years, children and young people)
Summary explanation of the main potential positive or adverse impact of your proposal
The policy applies to individuals of all ages who are taking SACT, including all protected characteristics groups.
It is not expected that the policy will adversely impact on protected characteristics groups.
Main recommendation from your proposal to reduce any key identified adverse impact or to increase the identified positive impact
The policy outlines that any patient on SACT is eligible for a treatment break of greater than six weeks (12 weeks for immunological therapeutic agents) to allow drug related toxicities to improve.
Disability
(physical, sensory and learning impairment, mental health condition, long-term conditions)
Impact
Following a diagnosis of cancer, the individual is defined as having a disability under the Equality Act 2010. The policy will apply to any patient who meets the inclusion criteria.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
Gender reassignment and/or people who identify as Transgender
Impact
Although people who are or have undergone gender reassignment are at greater risk of some cancers, the policy will apply to anyone who meets the inclusion criteria.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
Marriage and civil partnership
(people married or in a civil partnership)
Impact
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
Pregnancy and maternity
(women before and after childbirth and who are breastfeeding)
Impact
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
Race and ethnicity*
Impact
Although ethnicity and race do affect the incidence of some cancers, the application of the treatment break policy is not affected by ethnicity or race as anyone is able to access treatment breaks in line with the SACT inclusion criteria detailed in the policy.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
Religion and belief
(people with different religions/faiths or beliefs, or none)
Impact
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
Sex
(men, women)
Impact
The incidence of some cancers is affected by gender. However, implementation of the policy will apply to any person who fulfils the inclusion criteria and is medically advised to commence SACT related treatment breaks.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
Sexual orientation
(Lesbian, Gay, Bisexual, Heterosexual)
Impact
Lesbian, gay, bisexual or transgender people are more likely to smoke tobacco and consume larger amounts of alcohol compared to the heterosexual community, which increases their risks of some cancers (MacMillan 2014).
As the treatment break policy will apply to anyone who meets the inclusion criteria, it is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
*Addressing racial inequalities is about identifying any ethnic group that experiences inequalities. Race and ethnicity includes people from any ethnic group incl. BME communities, non-English speakers, Gypsies, Roma and Travelers, migrants etc. who experience inequalities so includes addressing the needs of BME communities but is not limited to addressing their needs, it is equally important to recognise the needs of White groups that experience inequalities. The Equality Act 2010 also prohibits discrimination on the basis of nationality and ethnic or national origins, issues related to national origin and nationality.
4 Main potential positive or adverse impact for people who experience health inequalities summarised
Please briefly summarise the main potential impact (positive or negative) on people at particular risk of health inequalities (as listed below).
Please state N/A if your proposal will not impact on patients who experience health inequalities.
Please note – many groups who share protected characteristics have also been identified as facing health inequalities.
Group facing health inequalities: Looked after children and young people
Summary explanation of the main potential positive or adverse impact of your proposal:
The policy applies to patients of all ages who are receiving SACT following a cancer diagnosis.
It is not expected that the policy will adversely impact on protected characteristics groups.
Main recommendation from your proposal to reduce any key identified adverse impact or to increase the identified positive impact:
N/A
Carers of patients
(unpaid, family members)
Impact
Carers of patients on SACT may benefit from the treatment break policy to allow drug toxicities to improve. It will also allow treatment of other cancer treatment modalities and potentially reduce hospital appointments.
The policy should have a positive impact on any patients who provide caring responsibilities, as it will enable symptoms associated with drug related toxicities to improve, leading to improvements in patient’s quality of life.
Recommendation
Common drug toxicities include nausea, vomiting and gastric intestinal impacts. Allowing these to improve should allow carers to be less impacted by these side effects on the person they are caring for or enable patients who are carers to continue or resume caring responsibilities.
Homeless people
(people on the street, staying temporarily with friends/family, in hostels or B&Bs)
Impact
People experiencing homelessness are more likely to face a range of barriers in accessing health and care and are more likely to suffer from a physical health problem (The King’s Fund, Feb 2020).
Homeless people will need to be receiving secondary NHS Care to receive SACT. Homeless people may struggle to cope with the side effects associated with SACT drug related toxicity. The treatment break policy may prevent homeless people struggling with their drug toxicities in alternative accommodation; and it may prevent the need to care for homeless people in hospital settings to allow SACT related drug toxicities to improve.
The policy, by supporting a break in treatment to allow SACT related toxicities improve, should have a positive impact on patients in these protected characteristics group.
Recommendation
N/A
People involved in the criminal justice system
(offenders in prison/on probation, ex-offenders)
Impact
Offenders in prison will have access to prison health services and if met the inclusion criteria are able to access the policy. Offenders and ex- offenders in the community can access the treatment break policy with the remainder of their cancer care.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
People with addictions and/or substance misuse issues
Impact
People with additions or substance mis-use issues are more susceptible to some cancers than the remainder of the population. However, the policy will apply to any patient with a cancer diagnosis who meets the inclusion criteria and is medically recommended to utilise the treatment break policy by their cancer care specialists.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
People or families on a low income
Impact
Cancer treatment is known to have a financial impact on patients with cancer; with 4 in 5 people affected by financial difficulties and incurring, on average, costs of £570 per month (Macmillan Cancer Care, 2017).
People on low incomes may benefit from the reduction in the number of hospital visits which can be associated with administration of SACT, or treatment of SACT related drug toxicities.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
People with poor literacy or health literacy
(eg poor understanding of health services, poor language skills)
Impact
The policy is for patients with a confirmed cancer diagnosis and are already receiving SACT, although providers may need to ensure additional support is available to support patient in this protected characteristic group to understand the parameters of the treatment break.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
People living in deprived areas
Impact
Approximately 40% of all cancers in the United Kingdom are considered preventable by modification in lifestyle factors (e.g. smoking, obesity, alcohol use) (Cancer Research UK 2022). People living in deprived areas may benefit from the reduction in the number of hospital visits associated with administration of SACT, or in responding to the side effects of SACT related drug toxicities.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
People living in remote, rural and island locations
Impact
People in rural or remote/island locations may benefit from the reduction in the number of hospital visits associated with administration of SACT, or in responding to the side effects of SACT related drug toxicities.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
Refugees, asylum seekers or those experiencing modern slavery
Impact
The policy is for patients who are receiving SACT following a confirmed cancer diagnosis. Providers may need to ensure additional support is available to support patients in this protected characteristic group to understand the parameters of the treatment break policy.
It is not expected that the policy will adversely impact on protected characteristics groups.
Recommendation
N/A
5 Engagement and consultation
a. Have any key engagement or consultative activities been undertaken that considered how to address equalities issues or reduce health inequalities?
Yes
b. If yes, please briefly list (up to) the top three most important engagement or consultation activities undertaken, the main findings and when the engagement and consultative activities were undertaken.
1. Stakeholder testing
Separate report of engagement results is available. March 2022
2. Bowel Cancer UK (BCUK)
Following earlier engagement with BCUK, it was agreed the policy would specifically be shared with them during the engagement process. March 2022
6 What key sources of evidence have informed your impact assessment and are there key gaps in the evidence?
Published evidence
Sources
Individual SACT Summary of Product Characteristics (SPC) available at https://www.medicines.org.uk/emc/ and https://products.mhra.gov.uk, NICE guidance and NHS England and Improvement treatment criteria available at https://www.england.nhs.uk/cancer/cdf/.
Gaps
N/A
Consultation and involvement findings
Sources
Existing guidelines (as circular not policy format) updated by consultation involving NHS England and Improvement Chemotherapy Clinical Reference Group, Cancer Programme of Care and Cancer Drugs Fund Team.
Gaps
N/A
Research
Sources
N/A
Gaps
N/A
Participant or expert knowledge
Sources
Through the Cancer Programme of Care and its Clinical Reference Group structures supporting the policy working group with its expert knowledge.
Gaps
N/A
7 Is your assessment that your proposal will support compliance with the Public Sector Equality Duty?
Please add an ‘x’ to the relevant box below.
| Tackling discrimination | Advancing equality of opportunity | Fostering good relations | |
| The proposal will support | X | X | |
| The proposal may support | X | ||
| Uncertain whether the proposal will support |
8 Is your assessment that your proposal will support reducing health inequalities faced by patients?
Please add an ‘x’ to the relevant box below.
| Reducing inequalities in access to healthcare | Reducing inequalities in health outcomes | |
| The proposal will support | X | X |
| The proposal may support | ||
| Uncertain whether the proposal will support |
9 Outstanding key issues/questions that may require further consultation, research or additional evidence.
Please list your top three in order of priority or state ‘N/A’.
| Key issue or question to be answered | Type of consultation, research or other evidence that would address the issue and/or answer the question |
| 1. None noted | N/A |
| 2. | |
| 3. |
10 Summary assessment of this EHIA findings
The policy is likely to provide an overall positive impact on people who require treatment breaks for treatment related toxicities to improve or to allow treatment with other treatment modalities such as surgery or radiotherapy. Implementation of the policy should allow for symptom relief and improved quality of life for people with treatment related toxicities.
11 Contact details re this EHIA
| Team/unit name: | Cancer Programme of Care and Commercial Medicine |
| Division name: | Specialised Commissioning |
| Directorate name: | Finance |
| Date EHIA agreed: | 8 December 2022, reviewed June 2023 |
| Date EHIA published if appropriate: | 16 June 2023 |