The systemic anti-cancer therapy (SACT) dataset

The systemic anti-cancer therapy

(SACT) dataset

NDRS Webinar Series – 4th November 2020

Presenters

2

NDRS webinar series - SACT

Nicola WOOD

SACT Impact and

Communications [email protected]

Claire JOUSSOT

SACT Project [email protected]

Rebecca SMITTENAAR

Partnership Analytical [email protected]


Objectives of the session

Provide an overview of the SACT dataset to increase awareness and

understanding of the team’s work

Demonstrate the use of SACT data and showcase analytical outputs

3 NDRS webinar series - SACT

Summary

Part 1 – The SACT dataset

1. The SACT dataset: background and contents

2. The SACT dataset and the Cancer Drugs Fund (CDF)

3. Data reporting and access

4. Resources

Part 2 – SACT analysis

1. 30 day post SACT mortality

1.1 Rapid Data Review

1.2 Case Mix Adjusted Rates

2. Immunotherapies in Melanoma


Summary – Part 1




4. Resources


Health Improvement Directorate

Health Improvement Directorate


National Disease Registration Service

The National Cancer Registration &

Analysis Service (NCRAS)

The National Congenital Anomaly and

Rare Disease Registration Service

(NCARDRS)

COSD SACT

Molecular PROMS CWT

RTDS

Other datasets

Background

Congenital anomaly registration

Rare disease registration

Congenital anomaly legacy dataset

Screening analysis (FASP & NIPT)

Sickle cell & thalassaemia (SCT)

data collection

Molecular & genomic data collection

The SACT dataset – a world first


• Previously there was no evidence of

whether there was variability across

the country

• The ‘Cancer Reform Strategy’ in 2008

stated the need for an agreed dataset

• National Cancer Intelligence Unit

(NCIN) was established in 2008

• NCIN and cancer registration service

merged in 2016 to create NCRAS

• In 2011 a pilot was completed to

achieve proof of concept

The SACT dataset links to a whole range of other datasets, to

build a complete picture of the cancer patient’s pathway.

We collect data on:

• All systemic anti-cancer therapies

• Adult and paediatric

• Acute inpatient, day case, outpatient setting and delivery in

the community

• All solid and haematological malignancies

• Includes clinical trials

Background

NHS trusts in England


133 NHS trusts split across 3 regions

Staff involved with data collection:

• Pharmacists

• Cancer data managers and staff

• Cancer services managers and staff

• Chemotherapy nurses

• Clinical and medical oncologists

Background

The SACT dataset


World’s first comprehensive

cancer drug treatment database

Allows assessment of resources

required for service provision and

support commissioning

decisions

Supports patients and clinical teams

in choosing appropriate

treatments and care to improve

outcomes

Links to other data sources to provide a

complete cancer pathway

SACT data supports the re-appraisal of

drugs in the ‘Cancer Drugs Fund’ (CDF)

The SACT dataset is a mandatory

data collection for all NHS trusts in

England who deliver systemic anti-

cancer therapy (SACT) treatments.

NHS Trusts in England submit

monthly data files to a secure

portal with information on patients

who have been treated with SACT

for a specified date period.

What does it offer?How does it work?

Background

Data collected

1. Patient and tumour characteristics

2. Trust and consultant details

3. Treatment characteristics including drug names and drug combinations (regimens)

4. Outcome fields

Data

structure:

10

SACT dataset v3.0 • Launched in September 2019

• 44 data items (previously 43)

• Removed items that were captured in other datasets, no

longer clinically relevant or had low accuracy levels

• Additional data items requested by the clinical community

• Amendments to allow for more accurate recording

What data do we collect?

Key information from the prescribing setting, which then links

with other datasets that capture other areas of the patient

journey


Background

www.academic.oup.com/ije/article/49/1/15/5538002

http://www.academic.oup.com/ije/article/49/1/15/5538002

Putting security and confidentiality first


Background

Cancer data is highly sensitive and patient level

➢ Security and patient confidentiality are paramount

NCRAS has legal permission to

collect patient information without

needing consent

• Granted under Section 251 of the

Health and Social Care Act of

2006 (annually renewed)• Must have a medical purpose

• Be in the public interest or interest of

improving care

• Be compliant with DPA/GDPR

Data is aggregated, anonymised or

de-personalised wherever possible

Patient can opt out at any time

Yearly review with the Confidentiality

Advisory Group – Health Research

Authority (HRA)

What is the SACT data used for?


Routine activity reporting Clinical review

& governance

Understanding

patterns of care

Supporting cancer

commissioning and

policy making

Summary – Part 1




4. Resources


The Cancer Data Partnership

The Cancer Data partnership on SACT data was established in September 2016

The partnership conducts work to:


CDF

Inform initiatives to monitor

and improve patient

outcomes

Ensure that patients

receive optimal treatment

for their cancer wherever

they are treated

Support NHSE-I in

planning the delivery of

specialised services

Provide an evaluation

using routinely collected

data on specific treatments

made available through

the CDF

SACT data in the CDF

15

Ongoing

clinical trial

SACT real

world data

collection

SACT data provides a “real world” assessment of treatment patterns and outcomes in

routine practice in the NHS to help answer NICE committee uncertainties

Cancer Drugs

Fund

Data collection

for specified

time period

Review of

technology

appraisal

Managed access

CDF


What does SACT data do for the CDF?


PHE collect data on cancer patients

from all NHS treatment providers in England

PHE use this routinely collected cancer data to evaluate real world outcomes for all patients treated through the CDF

A team of data liaison officers support NHS providers to

improve SACT data quality and completeness and follow

up any missing CDF patients

PHE developed and published standard methodologies for CDF analysis. Standard analysis focuses on real world patient characteristics, treatment patterns and outcomes such as overall survival and treatment duration

Linkage to other PHE / NHS datasets allows additional outcomes e.g. proportion of patients receiving a stem cell transplant

Interim updates to NICE and the relevant pharmaceutical

company, detailing case ascertainment and data

completeness

Final report produced at the end of data collection

1. Data collection

2. Analysis

3. Reports

CDF

The CDF in numbers

17

0

5

10

15

20

25

30

N (

tre

atm

en

ts in C

DF

)

Date

Number of indications in the CDF

18Have exited data collection

(including 4 with a final

decision)

3/4Went on to be routinely

available in the NHS

CDF


Reporting SACT data in the CDF


• A drug will stay in the CDF for as long as needed to answer NICE uncertainty. This is agreed before the start

of data collection.

• Typical duration 2-5 years

• SACT team provide interim reports to NICE, NHSE-I and the relevant pharmaceutical company throughout

data collection

SACT CDF reporting schedule *Quarterly report

Annual reports

Final report

CDF

The importance of real-world outcomes


✓ Geographically diverse

✓ Varied patient characteristics

✓ Greater numbers

✓ Longer duration of follow-up

One of the key questions around clinical

trials is the ability to generalise results

observed on a small cohort of patients

to the wider population.

The SACT data provides

real-world evidence to

assess this

CDF

Summary – Part 1




4. Resources


Data reporting


Reporting

Data reporting allows us to share data back with the clinical community for reviewing the care they provide

The importance of data reporting


Review of internal care

Data reported back to NHS trusts

Good data quality and completeness

Clinical engagement

Governance

Planning

Clinical review

• Data liaison work

• Newsletter,

webinars, blog

posts, trainings,

workshops,

working groups

Feedback loop

Reporting

SACT CancerStats2 overview


COVID-19 dashboard

Data completeness

reports

Routine activity reports

SACT coverage

CTYA reporting suite

SACT deadlines

SACT data completeness

targets

Adult haematology

reporting suite

Core target reports

Regimen level

Drug level

Outcomes level

Haem regimen level

Haem drug level

Haem outcomes level

All data completeness

Dose banding report

Compliance reports

SACT v3 compliance

Adult oncology reporting suite

SACT COVID-19 activity

Cancer Drugs Fund (CDF)

reports

CDF application

activity

CDF SACT completeness

Reporting

Data completeness and core targets


FiltersAge group

Area team / trust

Route of administration

Tumour group

Cancer alliance

• Identify issues with SACT data completeness and improvement priorities

• Increase the accuracy and value of the SACT data and other activity reports

Reporting

Data completeness by tumour group for key data items SACT activity vs SUS (secondary uses services dataset) activity

Treatment activity


FiltersAge group

Area team / trust

Cancer alliance

Tumour group

Performance status

Regimen

Drug group

Admin group

• Provides detailed activity reports using data submitted by all NHS trusts

• Regimen, drug and outcomes level

Reporting

Number of patients treated on certain days of the week Regimens used for a certain tumour site, by NHS trust

SACT CancerStats2 overview


COVID-19 dashboard

Data completeness

reports

Routine activity reports

SACT coverage

CTYA reporting suite

SACT deadlines

SACT data completeness

targets

Adult haematology

reporting suite

Core target reports

Regimen level

Drug level

Outcomes level

Haem regimen level

Haem drug level

Haem outcomes level

All data completeness

Dose banding report

Compliance reports

SACT v3 compliance

Adult oncology reporting suite

SACT COVID-19 activity

Cancer Drugs Fund (CDF)

reports

CDF application

activity

CDF SACT completeness

Reporting

COVID dashboard


FiltersArea team/Trust

Cancer Alliance

Tumour group

Age group

Intent of treatment

Administration route

Drug modality

• Developed with support from the clinical community

• Reviews activity during the pandemic and help NHS trusts rebuild services

Reporting

Monthly comparison of patient numbers for 2020 vs 2019

New patients by tumour group, per month

Note: data complete as follows: March 2020: 96% of trusts have submitted data, 93% for April 2020,

87% for May 2020, 78% for June 2020

SACT Covid-19 dashboard – key findings


Reporting

Note: interim findings only

Proportional

Increase in Oral

administrations (vs

IV)

Slight increase in

proportion of

curative treatments,

decrease in

palliative

Accessing SACT data

• Straightforward simple

requests: [email protected]

• Patient identifiable and

pseudonymised data: Office for Data Release

[email protected]

• One-off analysis projects: start with an

enquiry to [email protected];

can be followed by NCRAS project proposal

route

• Analytical partnerships and academic

collaborations

Or contact us at [email protected] NDRS webinar series - SACT

Further information

We are working on making

more data publicly available

where possible (considering

confidentiality constraints)

➢ A version of our Covid-19

dashboard will be made

public later this year

Our CDF analysis becomes

publicly available on the NICE

website as part of the final

committee papers

mailto:[email protected]



Summary – Part 1




4. Resources


Further information


SACT website www.chemodataset.nhs.uk

Data Resource Profile www.academic.oup.com/ije/article/49/1/15/

5538002

Further information

http://www.chemodataset.nhs.uk/

http://www.academic.oup.com/ije/article/49/1/15/5538002

Part 2: SACT Analysis

NDRS Webinar Series – 4th November 2020

Summary – Part 2







SACT 30 day mortality study – The Lancet

http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30383-7/abstract

Background

Mortality post SACT30-day mortality may be a measure of avoidable harm in patients who have received

treatment where the harm could be treatment-related or due to poor patient selection


Background

b. Case-mix adjusted

for performance comparison

Palliative patients

Curative patients

Appropriate cessation of treatment

Management of toxicity

Trust feedback revealed that 30-day mortality data must be:

a. Timely

for rapid review of data

Summary – Part 2






30-day mortality post SACT Rapid Data

Review (RDR)

• The RDR provides data on patients who have died within 30-days post SACT

• Trusts may not be aware of patients who have died outside of a hospital setting


Rapid Data Review

Support routine clinical audit i.e. M&M meetings in

trusts reviewing for safety and quality of care

1. Audit

Generate trust user stories to showcase best practice

2. User stories

Aim

Provide data to

Rapid Data Review


Rapid Data Review

✓ NHS number of 30 day deaths

✓ Consultant GMC code

✓ Intent of treatment

✓ ICD-10 code

Oct

‘19

Nov

‘19

Dec

‘19

Jan

‘20

Feb

‘20

Mar

‘20

Apr

‘20

May

‘20

Jun

‘20

Jul

‘20

Aug

'20

Sep

'20

Oct

'20

Nov

'20

Dec

'20

Jan

‘21

Data

released

Data

released

Data

released

Data

released

Treatment period

Data submitted by trusts

and processed through

ENCORE

Treatment period



ENCORE

Treatment Period



ENCORE

Treatment period



ENCORE

Using SACT data to support clinical practice


National Chemotherapy Board

Rapid Data Review

Morbidity and Mortality within 30-Days of

Systemic Anti-Cancer Therapy (SACT):

Review of Current Practice suggested

Standardised Review Process May 2016

Summary – Part 2






Case mix adjusted 30-day mortality post-

SACT rates (CMAR)


• Age

• Co-morbidity

• Deprivation Status

• Ethnicity

• Performance Status

• Sex

• Stage

The rates are adjusted for:

Rates adjusted for key variables

• Comparison between trusts and

within trusts over time

• Support of clinical governance

• Identifying areas where clinical

governance could be improved

This allows for:

Generate Performance Indicator to compare trusts

Aim

Provide data to

Case Mix Adjusted Rates

Case mix adjusted 30-day mortality

post-SACT rates (CMAR)



http://www.chemodataset.nhs.uk/reports/

August 2020:

• Lung

• Pancreas

• Gastric

• CUP

November 2020:

• Ovarian

• Breast

• Bowel

• Myeloma

Future releases:

• ALL, AML, Prostate (Feb 2021)

• Bowel, Breast, Lung (June 2021)

• Follicular Lymphoma (Sept 2021) etc.

Case mix adjusted 30-day mortality post-SACT

rates (CMAR)



Case mix adjusted 30-day mortality post-SACT

rates (CMAR)



Lung Pancreas CUP Gastric Bowel Breast Myeloma Ovarian

30-day mortality

England average 9.8% 14.1% 14.1% 7.9% 4.7% 4.6% 15.7% 8.3%

Number of outliers 2 1 0 1 1 0 4 2

Summary – Part 2







SACT metastatic melanoma study – IJC

https://onlinelibrary.wiley.com/doi/full/10.1002/ijc.33266

Melanoma


Background

Melanoma

SACT & linked databases used to explore:

• Eligibility criteria associated with RCTs don’t always reflect real world populations

Patient outcomes in real world settingsPrescribing patterns


Methods

Melanoma

Melanoma patients in England Patients

Public Health England data sources:Data

Drugs:First line therapy

- Diagnosed April 2010 - December 2017

- SACT treatment record between April 2014 - March 2018

- Cancer Registration Database

- Systemic Anti-cancer Therapy (SACT)

- Hospital Episodes Statistics (HES) In-patient and A&E Datasets

- Personal Demographics Service

- Pembrolizumab

- Nivolumab

- Ipilimumab

- Ipinivo (Ipilimumab + Nivolumab)


Melanoma

2014

IpilimumabNICE TA 319

July 2014

IpilimumabFDA Mar 2011

EMA Nov 2013

NivolumabFDA Nov15/Jan16

EMA Feb 2016

IpinivoFDA Oct15/Jan16

EMA May 2016

20162015

PembrolizumabNICE TA 366

Nov 2015

PembrolizumabFDA Dec 2014

EMA July 2015

NivolumabNICE TA 384

Feb 2016

IpinivoNICE TA 400

July 2016

2016

Immunotherapy drugs


Melanoma

Patient Characteristics

52

1Wolchock JD, et al. NEJM 2017;377:1345-56

Ipilimumab Nivolumab IpiNivo

3 year overall survival

SACT 32%

[95% CI: 28%,35%]

1CheckMate 067 34%


SACT 51%

[95% CI: 28%,70%]

CheckMate 067 52%


SACT 56%

[95% CI: 49%,62%]

CheckMate 067 58%

Overall Survival


Melanoma


1Robert C et al. Lancet Oncol 2019;20:1239-51

Pembrolizumab

Overall Survival


SACT 40%

[95% CI: 37%,43%]

1KeyNote 006 51%

RCT SACT

Age, median (range) 63

(22-89)

72

(23-97)

PS 0 68% 38%

PS 1 32% 40%

Melanoma

Toxicity


Melanoma


What complications are patients developing?

• Colitis - K521, K529, A099

• Hepatitis - E059, E222, E230, E231, E236, E871

• Endocrinopathy - K711,K712, K716, K718, K754, K759

• Nausea/vomiting/constipation - R11X, K590

ICD-10 codes

Melanoma


Conclusions

1. Different patient demographics in each drug cohort

2. 3 year overall survival was consistent with RCTs for Ipi, Nivo, Ipinivo

3. 3 year overall survival for Pembro was lower than RCTs, different patient characteristics

4. Rates of emergency/hospital admissions after starting ipinivo were higher

5. Colitis - most frequent immune related adverse event leading to hospital attendance

Melanoma


Take home

SACT data can be linked to a variety of healthcare databases to

explore patterns of treatment and patient outcomes

Acknowledgments

• Dr Pippa Corrie

• Dr Ruth Board

• Dr David Chao

Melanoma


‘Use My Data’ asked us….

In August 2016 it was stated that “the [SACT] resource we have will allow us to

monitor the quality of chemotherapy treatment given to all patients across the

NHS in near real-time.” How has this been done and what are the future plans?

• 30-day mortality post SACT – Rapid Data Review (RDR) for service

providers

• Specialised services quality dashboard (SSQD) for commissioners and

service providers

SSQD


Specialised Services Quality Dashboard (SSQD)

• Introduction: SSQDs are tools designed by the Quality Surveillance Team (QST) to provide a quality

assurance mechanism for NHS England specialised services commissioners and health care providers

Inform and audit clinical decision making

Aim

Provide data toIdentify areas for performance improvement

Identify reasons for excellence

• Output: Quarterly (6-month lag) provision of counts of patients in the review quarter who:

• 30-day mortality - palliative intent

• 30-day mortality - curative intent

• Proportion of intravenous chemotherapy administrations which result in incident

form for all degrees of SACT extravasation

• Unplanned emergency admissions within 30 days of SACT

SSQD

Any questions?

Please use the chat box for discussion now.

To follow up on these discussions or enquire about the data feeds, please

email us at [email protected]


Thank you for listening


The systemic anti-cancer therapy (SACT) dataset

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