Upgrading the SACT dataset and EBMT registry to enable outcomes-based reimbursement in oncology in England: a gap analysis and top-level cost estimate

Figures & data

Figure 1. Data sources feeding into the National Cancer Registration and Analysis Service (NCRAS).

Table 1. Clinical outcomes explored in the data capture and gap analysis*.

Outcome	Description	Types of data points required
Overall survival	Time between treatment and patient death	Survival status, date of death
Response	Degree of change in cancer presence after treatment	Notes from scan or test results (e.g., morphology) before and after treatment
Remission	No signs of cancer on scans or tests after treatment	Notes from scan or test results (e.g., morphology)
Progression-free survival	Time between treatment (aimed at shrinking or controlling the cancer), and signs that it has started to grow again	Date of remission, notes from scan or test results (e.g. morphology), date of progression
Molecular remission	Assessment of cancer cells presence on a molecular level after treatment	Notes from bone marrow test (polymerase chain reaction or immunophenotyping flow cytometry)
Adverse events (AEs) or toxicity	Details on specific AEs or toxicities experienced by the patient during or after treatment	Notes specifying type of AE, date of AE, grade of AE

* For all clinical outcomes, the date of treatment (e.g., first, previous, final) is required.

Figure 2. Select key assumptions used in the top-level cost estimates.

* The number of NHS trusts in which ATMPs in oncology adopted through an OBR scheme. ** The number of ATMPs in oncology adopted with an OBR in each of the trusts above.

Figure 3. SACT data completeness (2017–18) for select data fields relevant to OBR [22].

Abbreviations: M = ‘Mandatory’ data field (i.e., has to be completed in order for the submission to be accepted); R = ‘Required’ (must be included ‘where available or applicable’); TNM = Primary tumor (T), Regional lymph nodes (N), Distant metastasis (M); OPCS code = Classification of Interventions and Procedures.

Table 2. Gap analysis of outcomes that can be collected through the current data fields included in the SACT database and EBMT registry.

	Relevant data fields in place (Y/N)
Outcomes	SACT	EBMT
Overall survival (OS)	N	Y
Response	N	Y
Remission	N	Y
Progression-free survival (PFS)	N	Y
Molecular remission	N	N
Adverse events (AEs) or toxicity	N	Y

Figure 4. Top-level cost estimate for upgrading SACT and EBMT (using a manual workaround) to enable OBR in oncology in England.

(A) = Patient-level assessment at national level; (B) = Patient-level assessment at trust level; (C) = Cohort-level assessment at national level; (D) = Cohort-level assessment at trust level

Figure 5. Top-level cost estimate for upgrading SACT and EBMT (using part automation) to enable OBR in oncology in England.

Figure 6. Cumulative costs* of upgrade Scenarios A (manual workaround) and B (part automation) for SACT and EBMT over time.

* Future costs discounted at an annual rate of 3.5%Low = Outcomes assessed at the cohort/national level; High = Outcomes assessed at the patient/trust level.

Systemic Anti-Cancer Therapy (SACT) Dataset. Data completeness report: april 2017 – march 2018. 2018 [cited 2019 Feb 25]. Available from: http://www.chemodataset.nhs.uk/view?rid=268

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