Dapagliflozin for treating chronic kidney disease

Chronic kidney disease has substantial effects on quality of life

3.1 Chronic kidney disease (CKD) is a complex progressive disorder with loss of nephrons causing kidney function to decline over time. This eventually leads to end-stage renal disease and death. CKD happens because of systemic disease affecting the kidney, such as type 2 diabetes, hypertension or cardiovascular disease, or from primary kidney disease such as glomerulonephritis. Conditions such as type 2 diabetes, hypertension and cardiovascular disease can also be caused by CKD. CKD varies in severity and the NICE guideline for chronic kidney disease: assessment and management (NG203) recommends classifying CKD in adults using a combination of glomerular filtration rate (GFR) and albumin-to-creatinine ratio (ACR). GFR is a measure of kidney function, estimated using a creatinine blood test (eGFR). eGFR is categorised from G1 (eGFR more than 90 ml/min/1.73 m²), defined as no reduction in kidney function, to G5 (eGFR less than 15 ml/min/1.73 m²), defined as kidney failure. ACR is a marker of kidney damage, measured using a urine sample (uACR). uACR is categorised from A1 (uACR less than 3 mg/mmol), defined as normal or mild damage, to A3 (uACR more than 30 mg/mmol), defined as severe damage. Around 1.9 million adults in the UK have CKD with an eGFR category of G3a to G5, and it is likely there are many more undiagnosed. Patient experts highlighted that CKD has huge implications on a person's quality of life. They explained that CKD affects mental health and emotional wellbeing, capacity to stay in work and the ability to maintain relationships. People with CKD must spend a significant amount of time in hospital, especially when having dialysis treatment. The committee noted the additional support people need with daily activities and treatment, and the impact of this on carers. It concluded that CKD represents a significant burden for people and can substantially affect both physical and psychological aspects of quality of life.

There is an unmet need for more effective treatments for CKD and a new treatment option would be welcomed

3.2 The patient and clinical experts highlighted that CKD is incurable with limited pharmacological options for delaying progression. The clinical experts explained that the main aims of treatment are to prevent disease progression and reduce cardiovascular morbidity and mortality. They explained that the current treatment pathway for CKD is not particularly well defined, and the evidence is rapidly changing. However, there is a general alignment of treatment practice with NG203. Angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) are standard pharmacological management for CKD, but these only slow disease progression. Patient experts reiterated that preventing disease progression and delaying the need for a kidney transplant are particularly important for people with CKD. The committee noted that with current best practice for managing CKD, most CKD still progresses to end-stage renal disease. It concluded that there is an unmet need for more effective therapies for treating CKD, and that patients and clinicians would welcome a new treatment option.

Dapagliflozin would be used as an add-on to optimised standard care, including an ACE inhibitor or ARB

3.3 In its original submission the company positioned dapagliflozin for people having optimised standard care, which may or may not have included an ACE inhibitor or ARB. The ERG highlighted that this was inconsistent with the main source of clinical evidence for dapagliflozin in treating CKD, the DAPA‑CKD trial (see section 3.7). This is because 97% of people were either having an optimised ACE inhibitor or ARB in DAPA‑CKD. In response to technical engagement the company updated its positioning to people who were having an optimised ACE inhibitor or ARB. The committee was aware that NG203 recommends sodium-glucose cotransporter‑2 (SGLT2) inhibitors for people with CKD and type 2 diabetes who are having optimised ACE inhibitors or ARBs, and that more evidence was needed for people not having these optimised therapies. The clinical experts agreed that although dapagliflozin would likely have some benefit for people not having ACE inhibitors or ARBs, it should be used as an add-on to these treatments. They explained that most people should already be having ACE inhibitors or ARBs and would likely continue having these until needing dialysis. The committee concluded that dapagliflozin would be used as an add-on to optimised standard care, including an ACE inhibitor or ARB unless these are contraindicated or not tolerated.

Standard care is an appropriate comparator for dapagliflozin

3.4 In its submission the company compared dapagliflozin plus standard care with standard care alone. The company represented standard care using the placebo arm of DAPA‑CKD (see section 3.7). This comprised of background therapies including ACE inhibitors or ARBs, statins and antiplatelets. The ERG agreed with the company's description of how CKD is currently managed in the UK. The committee concluded that standard care is an appropriate comparator for dapagliflozin.

Canagliflozin is a relevant comparator in people with CKD who also have type 2 diabetes

3.5 Canagliflozin is another SGLT2 inhibitor with a marketing authorisation for type 2 diabetes. The company did not consider canagliflozin a relevant comparator for dapagliflozin in CKD, because it noted that canagliflozin is not widely used for treating CKD with type 2 diabetes in the UK. However, the company did an indirect treatment comparison of dapagliflozin and canagliflozin in people with CKD and type 2 diabetes (see section 3.10). The clinical experts noted that canagliflozin is being increasingly used by nephrologists, but acknowledged that the guidelines supporting the use of SGLT2 inhibitors in people with CKD were relatively new. NG203 recommends offering an SGLT2 inhibitor to adults with CKD and type 2 diabetes, in addition to an ACE inhibitor or ARB, if their ACR is more than 30 mg/mmol and they meet the criteria in the marketing authorisation. The committee noted that the comparator in the NICE scope was established clinical management without dapagliflozin. The committee considered that, since canagliflozin was recommended in NG203 and is being used to some extent in clinical practice, it represents established clinical practice for people with CKD and type 2 diabetes. It concluded that canagliflozin is a relevant comparator for people with CKD and type 2 diabetes.

It is appropriate to make recommendations for dapagliflozin based on uACR levels

3.6 In its updated economic model, the company split the population into subgroups based on uACR level and type 2 diabetes status (see section 3.13). NG203 recommends measuring proteinuria with uACR in adults with an eGFR of less than 60 ml/min/1.73 m², or in adults with an eGFR of more than 60 ml/min/1.73 m² if there is a strong suspicion of CKD. The clinical experts explained that uACR testing is not done consistently in clinical practice. They noted that although the test is simple to do, there is some hesitancy about doing urine tests in secondary care, particularly when there may be a delay before getting the results. The committee heard from a patient expert who explained that they would not hesitate to provide a urine sample, particularly if this ensured they had the best treatment. The clinical experts added that urine protein-to-creatinine ratio (uPCR) tests are more widely done than uACR tests, particularly in secondary care, but it is difficult to map one value to the other accurately. They explained that in their experience, uACR is no more difficult to measure than uPCR, but would need a change in practice. The committee acknowledged that uACR testing is not currently implemented consistently. If this did not change, limiting dapagliflozin to subgroups based on uACR levels may negatively affect patient access. However, uACR testing is easy to do, has value in identifying people with CKD who are likely to benefit from dapagliflozin, and is recommended in NG203. Therefore the committee concluded that the current low levels of uACR testing should not prevent it from being included as a criterion in recommendations for dapagliflozin.

DAPA-CKD suggests that dapagliflozin is more effective than standard care, but the evidence does not cover the full marketing authorisation

3.7 The main clinical evidence for dapagliflozin in the company submission came from DAPA‑CKD. This was a randomised, double-blind trial in adults with CKD, with or without type 2 diabetes. DAPA‑CKD compared dapagliflozin plus standard care (n=2,152) with placebo plus standard care (n=2,152) over a median follow-up period of 2.4 years. DAPA‑CKD included people with an eGFR of 25 ml/min/1.73 m² to 75 ml/min/1.73 m² and a uACR of 22.6 mg/mmol or more. In DAPA‑CKD, 97% of people were having optimised therapy with an ACE inhibitor or ARB. The trial did not include people with CKD who had type 1 diabetes or who had an organ transplant. The primary outcome in DAPA‑CKD was a composite outcome of a sustained eGFR decline of 50% or more, end-stage renal disease or death from renal or cardiovascular causes. Results showed that dapagliflozin was associated with a statistically significant risk reduction of 39% (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.51 to 0.72) for the primary composite outcome. Clinical advice to the ERG suggested that the management of CKD in DAPA‑CKD was broadly generalisable to UK clinical practice. However, the ERG highlighted that DAPA‑CKD did not give clinical efficacy evidence for some groups of people with CKD who would be included in the marketing authorisation for dapagliflozin. These included people:

The clinical experts considered that there would likely be benefits in starting dapagliflozin in people with an eGFR of between 15 ml/min/1.73 m² and 25 ml/min/1.73 m², despite the lack of clinical evidence. However, they noted the uncertainty in this population, as well as concerns with the impact of a transient decrease in eGFR associated with SGLT2 inhibitors at lower eGFR levels. The committee concluded that the results from DAPA‑CKD suggest that dapagliflozin plus standard care is more effective than standard care alone. But, it noted that DAPA‑CKD tested dapagliflozin only in an enriched population with greater potential to benefit from treatment. The results may therefore not necessarily be transferrable to the groups of people with CKD excluded from DAPA‑CKD.

DECLARE-TIMI-58 and DAPA-HF provide evidence for some people excluded from DAPA-CKD, but evidence gaps remain

3.8 The company presented additional clinical evidence from 2 randomised controlled trials, DECLARE‑TIMI‑58 (n=17,160) and DAPA‑HF (n=4,744). This was to provide renal outcome data across a broader population. DECLARE‑TIMI‑58 included people with type 2 diabetes who had, or were at high risk of, cardiovascular events and had an eGFR of more than 60 ml/min/1.73 m². However, 7% of people (n=1,100) had an eGFR of less than 60 ml/min/1.73 m². DECLARE‑TIMI‑58 did not restrict inclusion in the trial based on uACR levels. DAPA‑HF included people with heart failure with reduced ejection fraction, regardless of the presence or absence of comorbid type 2 diabetes. People in DAPA‑HF had to have an eGFR of 30 ml/min/1.73 m² or more, and uACR was not measured. Both DECLARE‑TIMI‑58 and DAFA‑HF included some people with comorbid CKD. Neither study included people with type 1 diabetes or who had an organ transplant. Results from DECLARE‑TIMI‑58 and DAPA‑HF suggested that dapagliflozin plus standard care is more effective than standard care alone across the broad CKD population, regardless of uACR and eGFR levels. However, the ERG highlighted that there remained some subgroups of people with CKD for which there was no evidence of clinical effectiveness for dapagliflozin. These included:

The ERG also noted that the data from DAPA‑HF was not used in the company's economic model. The committee concluded that DECLARE‑TIMI‑58 and DAPA‑HF showed that dapagliflozin was clinically effective in some subgroups of people with CKD outside of DAPA‑CKD. However, the size of benefit in subgroups outside DAPA‑CKD was uncertain, and important uncertainties and evidence gaps remained.

The company's simulated outcomes analysis does not resolve the evidence gap for people with low uACR levels without type 2 diabetes

3.9 In response to technical engagement, to address the lack of clinical effectiveness evidence for dapagliflozin in people with a uACR less than 22.6 mg/mmol (see section 3.7), the company provided an additional analysis. This estimated outcomes for people with low uACR levels, split by whether or not they had type 2 diabetes. The company did a simulated treatment outcomes analysis using a Poisson model to fit an estimated yearly event rate conditional on uACR as the continuous variable from DAPA‑CKD, with a uACR range extended from 3.39 mg/mmol to 565 mg/mmol. The results are academic in confidence and cannot be reported here. The ERG explained that such an analysis only supported a hypothesis that dapagliflozin might work in this population. The company had extrapolated event rates to a population in which there was no actual clinical evidence of dapagliflozin efficacy. The committee agreed that in the absence of robust trial evidence the company's simulated treatment outcomes analysis did not resolve the evidence gap in people with low uACR levels without type 2 diabetes.

Dapagliflozin and canagliflozin are likely to be equally effective in people with comorbid type 2 diabetes, and the least costly option that meets individual patient needs should be used

3.10 Although it did not consider canagliflozin a relevant comparator (see section 3.5), the company presented an indirect comparison to estimate the efficacy of dapagliflozin compared with canagliflozin for people with CKD and type 2 diabetes. The company did an anchored matching-adjusted indirect comparison using data from the DAPA‑CKD and CREDENCE trials. CREDENCE was a randomised, double-blind trial of people with type 2 diabetes and albuminuric CKD (uACR of more than 33.9 mg/mmol) having canagliflozin or placebo. The results of the indirect comparison suggested equal efficacy between dapagliflozin and canagliflozin in people with CKD and type 2 diabetes. The ERG explained that the selection of covariates in the matching-adjusted indirect comparison was overly complex. It also highlighted that the assumption of proportional hazards (that is, the relative risk of an event is fixed irrespective of time) may not be satisfied. Therefore, the Cox proportional hazard model used by the company may not be appropriate. However, the ERG considered that despite the limitations with the indirect comparison, the overall conclusion of equal efficacy was reasonable. The clinical experts explained that there was likely to be a class effect for SGLT2 inhibitors in treating CKD. The committee considered the company's indirect comparison with canagliflozin acceptable for decision making, and that a conclusion of equal efficacy for dapagliflozin and canagliflozin in people with CKD and type 2 diabetes was reasonable. It noted that it had not been presented with any evidence suggesting a distinction between dapagliflozin and canagliflozin for people with CKD and type 2 diabetes. It concluded that the least costly option of the 2 that meets individual patient needs should be used.

The adverse event profile of dapagliflozin for CKD is consistent with other licensed indications for dapagliflozin

3.11 The adverse event profile of dapagliflozin for treating CKD in the company submission was informed by evidence from DAPA‑CKD. Dapagliflozin was associated with fewer deaths resulting from adverse events. There were also fewer serious adverse events with dapagliflozin compared with placebo. However, dapagliflozin was associated with a higher rate of serious adverse events among people with type 2 diabetes compared with those without type 2 diabetes. Nobody experienced diabetic ketoacidosis with dapagliflozin, and people having dapagliflozin had lower rates of major hypoglycaemic events, renal events, amputations, fractures and symptoms of volume depletion compared with placebo. The ERG explained that the adverse event profile of dapagliflozin for CKD from DAPA‑CKD was generally consistent with other indications such as diabetes and heart failure. The committee concluded that the adverse event profile of dapagliflozin in CKD was consistent with the other licensed indications for dapagliflozin.

The company's economic model structure is appropriate

3.12 The company developed a de novo health economic model to assess the cost effectiveness of dapagliflozin plus standard care compared with standard care alone for people with CKD. The model used a cohort-level state transition approach with 6 health states defined according to CKD stages 1 to 5 (including stages G3a and G3b), with additional states for dialysis, kidney transplant and death. It used a lifetime horizon and a cycle length of 1 month. A yearly discount rate of 3.5% was applied to costs and outcomes. Clinical Practice Research Datalink (CPRD) data informed patient baseline characteristics. CPRD is a real-world research service that collects patient data from a network of general practices across the UK. It links this to a range of other health-related data to provide a longitudinal, representative UK population health dataset. Some event risks in the model (mortality, hospitalisation for heart failure, and acute kidney injury) were also adjusted to match the CPRD data. However, the probabilities of transitioning between CKD stages were not similarly adjusted. The ERG and its clinical advisers considered the company's overall model structure to be reasonable, but noted concerns about the overall survival predictions (see section 3.15). The company assumed that dapagliflozin would not need any additional appointments or tests beyond those already associated with managing CKD. The committee was uncertain whether this would be the case, particularly for people without type 2 diabetes. Therefore, the costs for dapagliflozin may have been underestimated in the model for these people. However, the committee concluded that the company's overall model structure was appropriate.

Given the differences in available evidence, the 3 subgroups should be considered separately during decision making

3.13 To address ERG concerns at technical engagement about the lack of clinical evidence in some groups of people with CKD (see section 3.7), the company provided an updated economic model. The updated model included a revised patient population having optimised ACE inhibitors or ARBs, and the CPRD population used by the company to adjust the model was updated to reflect this. Also, the model used data from a subgroup of people with CKD from DECLARE‑TIMI‑58. The company presented a weighted economic analysis for the following subgroups according to their prevalence in the updated CPRD dataset:

The updated model re-estimated patient characteristics, mortality risks and transient event risks for each subgroup based on the relevant CPRD dataset. The ERG highlighted that subgroup 1 most closely reflected the DAPA‑CKD population and that DECLARE‑TIMI‑58 also provided clinical evidence for subgroup 2, but there was no direct clinical evidence in subgroup 3. The company's updated model assumed that the CKD stage transition probabilities in subgroup 3 were the same as subgroup 2. It also assumed that the overall survival model was the same in all 3 subgroups, except a non-type 2 diabetes adjustment factor was applied for subgroup 3. The ERG did not consider the company's weighted analysis to be appropriate, given the differences in the availability and strength of the evidence for each subgroup. Subgroup 1 was closest to DAPA‑CKD but represented a small proportion of the overall weighted economic analysis, with most of the quality-adjusted life years (QALYs) and costs in the model informed by subgroups 2 and 3. The committee was concerned that subgroup 3 accounted for over one third of the company's weighted population in the cost-effectiveness analyses, in which there is no direct clinical evidence for dapagliflozin. It agreed with the ERG that the 3 subgroups should be considered separately in decision making.

The higher mean ages used in the ERG's analysis are preferred

3.14 In its economic model the company used a mean (average) age of 64 years from a separate CPRD dataset. This included people with an eGFR less than 90 ml/min/1.73 m² who were taking ACE inhibitors or ARBs but did not need to have a formal diagnosis of CKD. This was lower than the mean ages from the CPRD datasets used to adjust the 3 subgroups in the model, which ranged from around 74 to 78 years. The company noted that clinician input supported using the lower mean age, as did registry data. However, the ERG explained that the company's approach was inconsistent. This was because all other baseline characteristics and event risk adjustments in the model were based on subgroup-specific CPRD datasets all needing a formal CKD diagnosis. Therefore, it was inappropriate to include a mix of patient characteristics from separate groups of people from different CPRD datasets. The ERG preferred to use the higher mean ages from the subgroup-specific CPRD datasets informing the baseline characteristics and event risk adjustments for each subgroup in the model. The clinical experts noted that although there was uncertainty about what the mean age of people was in clinical practice, it was likely to be higher than that used by the company. They explained that although the mean age of people with CKD seen in secondary care was likely to be closer to the company's estimate, this may not fully represent those who would have dapagliflozin in clinical practice because patients receiving treatment in primary care may be older. They also noted that ACE inhibitors and ARBs are used for conditions other than CKD. A Public Health England report suggested that CKD was far more prevalent in people aged 75 and over than in people aged 64 and under. But the committee acknowledged that this report was limited to CKD stage 3 to 5 and did not fully reflect the target population in the company submission (people with CKD having optimised ACE inhibitors or ARBs). The committee considered that ACE inhibitor and ARB use (with eGFR less than 90 ml/min/1.73 m²) was not an appropriate surrogate for a diagnosis of CKD. It felt that the mean age estimate from the separate CPRD dataset was inappropriate, because it was likely that many people in this dataset did not have CKD. In contrast, the committee noted that the higher mean age estimates from the subgroup-specific CPRD datasets represented people with a formal diagnosis of CKD, who may plausibly be offered dapagliflozin. It considered that a population including people without a diagnosis of CKD less plausibly represented those likely to be offered dapagliflozin. Also, applying a lower age estimate in a dataset with characteristics and risks estimated from an older population was inappropriate. This is because younger people do not have the same characteristics and risks as older people. So, because of the relative plausibility of the estimates, for consistency in using the CPRD data, and to better reflect the available evidence, the committee preferred the higher mean age used in the ERG's analysis.

Despite limitations in the company's approach to overall survival modelling, its impact on the cost-effectiveness estimates is likely to be small

3.15 The company modelled the treatment effect of dapagliflozin on overall survival through 2 mechanisms:

The ERG highlighted that when the adjustment to the CPRD dataset (see section 3.12) was removed, the company's model overestimated overall survival compared with the data from DAPA‑CKD. The ERG was uncertain about the cause of this, but it may have been because:

However, the ERG noted that even if the issues identified in the company's approach to overall survival modelling were resolved, the incremental cost-effectiveness ratio for dapagliflozin compared with standard care would likely remain below £20,000 per QALY gained in the DAPA‑CKD population. The committee concluded that despite the limitations with company's approach to overall survival modelling, its impact on the cost-effectiveness estimates was likely to be small.

Dapagliflozin is cost effective in the population represented in DAPA-CKD

3.16 The committee recalled that it would consider the company's 3 subgroups separately in decision making (see section 3.13). It considered the cost effectiveness of dapagliflozin plus standard care compared with standard care alone in subgroup 1 (people with a uACR of 22.6 mg/mmol or more, with or without type 2 diabetes). The exact results are commercial in confidence because they included the confidential discounts for some comparator or subsequent treatments. Using its preferred assumption for mean age (see section 3.14), dapagliflozin plus standard care dominated standard care in this subgroup (that is, it was more effective and less costly than standard care). However, the committee recalled that the evidence was weaker for dapagliflozin outside of the eGFR levels in DAPA‑CKD. It also noted that dapagliflozin was likely to have a large impact on NHS resources given the size of the patient population (see section 3.1), and so it needed to see robust clinical and cost-effectiveness evidence. It concluded that the cost-effectiveness estimate for dapagliflozin in subgroup 1 was an acceptable use of NHS resources. The recommended population should be limited to the eGFR and uACR levels included in DAPA‑CKD (see section 3.7) to match the available evidence.

Dapagliflozin is cost effective for people with a uACR of 3 mg/mmol or more and type 2 diabetes

3.17 The committee considered the cost effectiveness of dapagliflozin plus standard care compared with standard care alone in subgroup 2 (people with a uACR of less than 22.6 mg/mmol and type 2 diabetes). The committee noted that, using its preferred assumption for age (see section 3.14), the cost-effectiveness estimate of dapagliflozin plus standard care compared with standard care alone in subgroup 2 was comfortably within what NICE considers an acceptable use of NHS resources. The committee understood that an update to the NICE guideline on type 2 diabetes in adults: management - SGLT2 inhibitors for chronic kidney disease is currently in development. Draft recommendations in this guideline state that an SGLT2 inhibitor should be either offered or considered for people with type 2 diabetes and CKD, in addition to an ARB or an ACE inhibitor, if their ACR is 3 mg/mmol or higher. Although it was aware of this broader context, the committee was mindful that its remit was to appraise the clinical and cost effectiveness of dapagliflozin. It consequently focused its decision making on the evidence provided for this technology appraisal. It recalled that the benefit of dapagliflozin in people with a low uACR was uncertain (see section 3.9). It also noted that subgroup 2 represented a large proportion of costs and QALYs in the weighted economic analysis (see section 3.13). So, the consequences of decision error were high (see section 3.1). But the committee also took into account the evidence from DECLARE-TIMI-58, which included people with lower uACR levels than in DAPA-CKD. It concluded that dapagliflozin could be recommended for people with a uACR of 3 mg/mmol or more and type 2 diabetes.

Dapagliflozin cannot be recommended in people with a uACR less than 22.6 mg/mmol who do not have type 2 diabetes

3.18 The committee recalled that there was no direct clinical evidence informing subgroup 3 in the company's model (people with a uACR less than 22.6 mg/mmol without type 2 diabetes). This generated considerable uncertainty in the plausibility of the cost-effectiveness estimates for this population. Using the committee's preferred assumption for mean age (see section 3.14), the cost-effectiveness estimate of dapagliflozin plus standard care compared with standard care alone in subgroup 3 was higher than what NICE considers a cost-effective use of NHS resources. The committee concluded that dapagliflozin cannot be recommended for the population in subgroup 3.

Dapagliflozin is an innovative treatment for CKD, but all relevant benefits are reflected in the cost-effectiveness estimates

3.19 The company considered dapagliflozin to be innovative because it addresses a significant unmet need in CKD, which is associated with a significant clinical and economic burden and for which standard care is inadequate for many people. The patient and clinical experts highlighted the lack of effective pharmacological management for CKD and the importance of slowing down disease progression. Patient experts felt that dapagliflozin offers a step change for treating CKD, because its ability to delay disease progression offers real hope. Clinical experts highlighted that the benefits of dapagliflozin are distinct from a blood glucose reduction alone, and that reducing progression to end-stage renal disease will increase quality of life. The committee acknowledged the new benefits offered by dapagliflozin and other SGLT2 inhibitors as additional treatment options for CKD. However, it concluded that it had not been presented with evidence of any additional benefits that were not captured in the QALY measurements.

There are no equalities issues relevant to the recommendations

3.20 No equalities issues were raised during scoping stage. However, during technical engagement, patient and clinical expert submissions highlighted that CKD mostly affects people from black, Asian, and minority ethnic groups and lower socioeconomic backgrounds. People from these groups are also more likely to have CKD that progresses quicker to kidney failure and die earlier. However, the committee noted that issues related to differences in prevalence or incidence of a disease cannot be addressed in a technology appraisal. It did not consider these to be equality issues that could be resolved by this appraisal. No other potential equality issues were raised. The committee concluded that there were no equalities issues relevant to the recommendation.