Health Technology Assessment of Scheduled Procedures Surgery for end-stage arthritis of the hip in adults July 2014
Safer Better Care
Health Technology Assessment of Scheduled Procedures: Surgery for end-stage arthritis of the hip in adults Health Information and Quality Authority
About the Health Information and Quality Authority The Health Information and Quality Authority (HIQA) is the independent Authority established to drive high quality and safe care for people using our health and social care services. HIQA’s role is to promote sustainable improvements, safeguard people using health and social care services, support informed decisions on how services are delivered, and promote person-centred care for the benefit of the public. The Authority’s mandate to date extends across the quality and safety of the public, private (within its social care function) and voluntary sectors. Reporting to the Minister for Health and the Minister for Children and Youth Affairs, the Health Information and Quality Authority has statutory responsibility for:
Setting Standards for Health and Social Services – Developing personcentred standards, based on evidence and best international practice, for those health and social care services in Ireland that by law are required to be regulated by the Authority. Supporting Improvement – Supporting health and social care services to implement standards by providing education in quality improvement tools and methodologies. Social Services Inspectorate – Registering and inspecting residential centres for dependent people and inspecting children detention schools, foster care services and child protection services. Monitoring Healthcare Quality and Safety – Monitoring the quality and safety of health and personal social care services and investigating as necessary serious concerns about the health and welfare of people who use these services. Health Technology Assessment – Ensuring the best outcome for people who use our health services and best use of resources by evaluating the clinical and cost effectiveness of drugs, equipment, diagnostic techniques and health promotion activities. Health Information – Advising on the efficient and secure collection and sharing of health information, evaluating information resources and publishing information about the delivery and performance of Ireland’s health and social care services.
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Health Technology Assessment of Scheduled Procedures: Surgery for end-stage arthritis of the hip in adults Health Information and Quality Authority
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Health Technology Assessment of Scheduled Procedures: Surgery for end-stage arthritis of the hip in adults Health Information and Quality Authority
Table of contents ABOUT THE HEALTH INFORMATION AND QUALITY AUTHORITY ............. 3 1
HIP ARTHROPLASTY .................................................................. 6 1.1 Scope of this health technology assessment ..................................... 6 1.2 Surgical indications .................................................................. 6 1.3 Surgical procedures, potential complications and alternative treatments ... 8 1.4 Current practice in Ireland ........................................................ 11
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CLINICAL REFERRAL/TREATMENT THRESHOLD ........................... 16 2.1 Review of the literature ........................................................... 16 2.2 Clinical evidence.................................................................... 17 2.3 Cost-effectiveness evidence ...................................................... 24 2.4 Budget impact and resource implications ...................................... 25
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ADVICE ON CLINICAL REFERRAL/TREATMENT THRESHOLD .......... 27
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DISCUSSION ........................................................................... 29
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REFERENCES ........................................................................... 31
APPENDICES ................................................................................. 37 Appendix 1.1 – Examples of guidelines for the conservative management of osteoarthritis ....................................................................... 37 Appendix 1.2 – HIPE ICD-10AM/ACHI list of intervention codes for hip arthroplasty procedures .......................................................................... 39 Appendix 1.3 – Western Canada Waiting List Project – Hip and Knee Replacement Surgery, Priority Criteria Tool(60)................................................. 40 Appendix 1.4 – The Oxford Hip Score ................................................... 42 Appendix 1.5 – Primary Care Trust Thresholds and UK Commissioning Guide for Knee Arthroplasty.................................................................. 44
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Health Technology Assessment of Scheduled Procedures: Surgery for end-stage arthritis of the hip in adults Health Information and Quality Authority
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Hip arthroplasty
1.1 Scope of this health technology assessment This health technology assessment (HTA) evaluates the appropriateness and potential impact of introducing clinical referral and or treatment thresholds for selected scheduled hip arthroplasty procedures (including total hip replacement, hemiarthroplasty [partial hip replacement] and hip resurfacing) for adults with endstage arthritis of the hip. These are routine scheduled surgical procedures provided within the publicly-funded healthcare system in Ireland. The effectiveness of hip arthroplasty may be limited unless undertaken within strict clinical criteria. This report is one of a series of HTAs of scheduled procedures. Details of the background to the request by the Director General of the Health Service Executive (HSE), Mr Tony O’Brien, and the general methodology, are included in the separate ‘Background and Methods’ document.(1) The scope of this HTA is to recommend clinical referral and treatment thresholds to be used in the assessment, referral and surgical management of patients for whom hip arthroplasty is being considered. Input from an expert advisory group as well as a review of international guidelines, international policy documents and thresholds, and economic evaluations were used to inform the referral criteria. In addition, the resource and budget impact were assessed where appropriate.
1.2 Surgical indications According to Arthritis Ireland, there are some 915,000 people living with arthritis in Ireland, making it the single biggest cause of disability.(2) Osteoarthritis is the most common form of arthritis. Also known as degenerative joint disease and osteoarthrosis, osteoarthritis is a chronic joint disease characterised by joint pain, and varying degrees of functional limitation and reduced quality of life.(3) All tissues of the joint are involved, although loss of articular cartilage and changes in adjacent bone are the most striking features. To this extent, osteoarthritis represents failure of the joint as an organ, analogous to cardiac or renal failure.(4) Osteoarthritis may occur in any joint, but is most common in the hip, knee, and the joints of the hand, foot, and spine. Osteoarthritis may be classified as primary (idiopathic) or secondary. The former occurs in the absence of an identifiable prior condition or event, whilst secondary osteoarthritis occurs on a background of preceding trauma, pre-existing disease or deformity.(5) Postulated risk factors have been divided into systemic (increasing age, 6
Health Technology Assessment of Scheduled Procedures: Surgery for end-stage arthritis of the hip in adults Health Information and Quality Authority
female gender, genetics, diet) and local (previous injury to a joint, occupation, involvement in sports, joint laxity or malalignment).(6) Although obesity has been strongly linked with onset and progression of knee osteoarthritis, the data concerning its relationship with hip osteoarthritis is less conclusive.(7) The Guideline Development Group for National Institute for Health and Care Excellence (NICE) Guideline 177 on osteoarthritis published in 2014 noted three factors which it felt represented a clinician’s working criteria for a diagnosis of peripheral joint osteoarthritis:
age 45 years old and over has activity-related joint pain has either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes.(8)
The European League Against Rheumatism (EULAR), meanwhile, published guidelines for the diagnosis of knee osteoarthritis in 2010. This suggested that a confident diagnosis of knee osteoarthritis can be made based on the presence of six clinical signs (crepitus, restricted movement, and bony enlargement) and symptoms (persistent knee pain, limited knee stiffness [less than (30kg/m2) undergoing total joint arthroplasty are at increased risk for perioperative complications and this needs to be discussed with every patient prior to considering total joint arthroplasty.
The data for total hip arthroplasty (compared to that for knee arthroplasty) appear to be less clear. There are fewer studies that report on obesity and total hip arthroplasty, and there is much less consensus on a threshold above which complications increase. It would seem reasonable to extrapolate data from the total knee arthroplasty group, and recommend that patients with a BMI >40kg/m2 be counselled regarding weight loss prior to surgery, but a strong recommendation cannot be made.(47)
International referral thresholds thus uniformly suggest the need for conservative management in the first instance, prior to referral for consideration for arthroplasty. It is clear that while some organisations have adopted scoring tools or patient23
Health Technology Assessment of Scheduled Procedures: Surgery for end-stage arthritis of the hip in adults Health Information and Quality Authority
reported outcome measures to aid in the surgical prioritisation process, at present these are neither uniformly employed nor sufficiently evidence-based to warrant implementation in Ireland. There thus remains a subjective element to the referral process, but a number of factors which are common across thresholds, and which were enumerated in the international guidelines outlined earlier, have been identified, and these are reflected in the final developed threshold.
2.3
Cost-effectiveness evidence
A study by O’ Shea et al. examined practices at Cappagh National Orthopaedic Hospital, Dublin, in 1999. Based on a mean hospital stay of 16.4 days they estimated that the cost of a total hip replacement (THR) at that time was £6,472.06 Irish punts (£IRL). For a male and female between the ages of 60 and 69 undergoing THR, the cost of a Quality Adjusted Life Year (QALY) was estimated at IRL£1,863.55 and IRL£1,467.27, respectively. Similarly, for a male and female between the ages of 70 and 79, the respective costs were IRL£3,152.00 and IRL£2,454.90 per QALY gained, respectively.(49) The authors concluded that total hip replacement was a worthwhile and efficient investment of health resources. Fordham et al. retrospectively examined the difference in costs between a cohort of 938 patients undergoing an ‘Exeter’ THR between 1999 and 2002, with a hypothetical ‘no surgery’ group, over a period of five years.(50) Average length of stay was 10.8 days (SD 7.3) and the median estimated cost per patient was £5,084 (IQR: £4,588-£5,812) British pounds (£GBP). Due to a lack of a control group, the QALY gain could only be compared hypothetically with the Quality of Life (QoL) estimates that might have prevailed without surgery. For this the authors employed patients’ pre-operative QoL as the counterfactual scenario. 90.7% of patients gained positive QALYs compared to no surgery. The mean QALY gain was 0.8 (95% CI 0.76-0.84), and the mean cost per QALY gained was GBP£7,182 (95% CI GBP£6,740-£7,678). Using the Oxford Hip Score (OHS) as a marker of preoperative disease severity, the authors reported significant differences in the QALY gain and the cost per QALY gained between those with mild (QALY gain =0.61, cost per QALY =GBP£9,188 [£7,893-£10,915]) and severe disease (QALY gain =0.98, cost per QALY =GBP£5,924 [£5,189-£6,826]) preoperatively. The authors also noted that their figures were probably conservative as they had assumed a zero cost for no surgery when in reality other treatment costs would be incurred in this cohort.(50) Therefore surgery was cost-effective in this study. A number of other papers have demonstrated the relative value of total hip replacement (Table 2.2 on the following page).
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Health Technology Assessment of Scheduled Procedures: Surgery for end-stage arthritis of the hip in adults Health Information and Quality Authority
Table 2.2. Summary of economic evidence from other papers Author
Country (Currency)
O’ Shea(49)
Ireland (Punts) UK (GBP) Australia (AUD)
Fordam(50) Higashi(51)
Year costed (Discount rate) 1999 (-) 1999-2002 (-) 2003 (3%)
Perspective
QALY gain
Cost per QALY*
Cost per DALY*
DALY averted
Payer
-
-
-
Payer
0.610.98 -
€2,633€5,659 €7,837€12,146
-
-
€5,682€13,50 7 -
1.7
Payer
Rasanen(5
Finland 2003 Payer 0.77€5,682(EURO) (5%) 1.83 €13,507 Tso(53) Canada 2009 Payer 2.78 €2,398(CD) (3%) €12,535 Lawless(54) U. States 2008-09 Payer €9,411(USD) (3%) €12,156 Key: AUD – Australian dollars; CD – Canadian dollars; USD – United States dollars; QALY – quality adjusted life year; DALY – disability adjusted life year. *Costs have been inflated to 2013 values and converted to euro. 2)
Given the reduction in morbidity and mortality associated with hip arthroplasty in recent years, together with the reduction in average length of stay, it might be argued that surgery has become more cost-effective than that reported in these historical studies. That said, these savings may have been offset by the introduction of new, more expensive prostheses and other surgical technologies. Historically, the threshold at which a given technology is considered to be cost-effective has varied between €20,000 and €45,000 per QALY gained. Whilst there are potential issues with the generalisability of cost data across healthcare systems, currencies, and time frames, all of the studies above have reported costs per QALY less than the lower threshold of €20,000, and hence it appears reasonable to concur with their conclusions that hip arthroplasty is a cost-effective procedure.
2.4
Budget impact and resource implications
The number of hip arthroplasty procedures provided through the publicly-funded healthcare system has remained relatively stable since 2005. As noted in Section 1.4, elective hip arthroplasty was associated with an average length of stay of 6.9 days in 2012. The current estimated annual national cost of elective hip arthroplasty procedures is €37.3 million, with an average weighted cost per case of €11,403, based on the latest Casemix costs (Table 2.3 on the following page).
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Health Technology Assessment of Scheduled Procedures: Surgery for end-stage arthritis of the hip in adults Health Information and Quality Authority
Table 2.3. HSE inpatient and day case acute hospital activity and costs for elective hip arthroplasty procedures summarised by diagnosisrelated group (based on 2011 costs and 2012 activity)(65) DRG code I03B I03A I08B
I01B
I01A
Description Hip replacement W/O catastrophic CC Hip replacement W catastrophic CC Other hip and femur procedures W/O catastrophic CC Bilateral or multiple major joint Pr of lower extremity W/O revision W/O catastrophic CC Bilateral or multiple major joint Proc of lower extremity W revision or W catastrophic CC Other procedures*
Number carried out
% of hip arthroplasty procedures
Cost/ inpatient (€)
3,118
95%
10,931
99
3%
20,096
16
0.5%
10,340
12
0.4%
15,734
8
0.2%
37,771
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Key: DRG – diagnostic-related group; W – with; W/O – without; CC – complication or comorbidity. Data summary from HSE National Casemix Programme Ready Reckoner, 2013 based on the 2011 inpatient and day case costs reported by 38 hospitals participating in the programme that year. Activity is based on the latest 2012 HIPE data. *Note the remaining diagnosis-related groups accounted for five or fewer of the procedures each.
It is noted that average length of stay has declined from 12.3 days in 2005 to 6.9 days in 2012, with the system achieving the target of 7.0 days established by the National Clinical Programme for Surgery, albeit with some local and regional variation. In addition, the number of hip arthroplasty procedures provided by the publicly-funded system has remained constant for several years. However, demand for care is anticipated to increase due to changing demographics. The cost per episode of care is also anticipated to increase due to increasing levels of obesity. As noted in section 1.2, complication rates following hip arthroplasty are significantly higher in those who are obese (BMI >30kg/m2), potentially delaying hospital discharge or necessitating return to surgery. Cost of care may also be increased due to the need to acquire or adapt mobility aids and other equipment and the need for additional therapy staff to safely mobilise obese patients.(66)
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Health Technology Assessment of Scheduled Procedures: Surgery for end-stage arthritis of the hip in adults Health Information and Quality Authority
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Advice on clinical referral/treatment threshold
Taking account of the available evidence that exists in relation to osteoarthritis of the hip in adults, and the role of arthroplasty in its management, the following threshold criteria are advised for referral and treatment within the publicly-funded healthcare system in Ireland. These criteria are designed to distinguish between patients who would derive additional benefit from elective hip arthroplasty over conservative management in the primary care setting. Patients who present with ‘red flag’ signs or symptoms, suggestive of, for example, a fractured hip, septic arthritis or malignancy, should continue to be referred for emergency or urgent assessment in secondary care. All patients should have timely access to routine radiological investigations via primary care services. For those suspected of having hip osteoarthritis, plain film Xray should be performed within three months. The majority of patients with hip osteoarthritis should be managed conservatively in the first instance. Where conservative management is indicated, this should be made available to patients at a time when they are most likely to derive benefit from this management. The conservative management plan should be individualised following holistic assessment of individual patient need, and should include both pharmacologic and non-pharmacologic components. Referral for opinion regarding the need for hip arthroplasty should be considered for patients:
whose condition has not improved sufficiently following at least three months of optimal conservative management in the primary care setting
AND who have severe symptoms
AND have radiographic evidence of hip osteoarthritis
AND who express a desire to proceed to surgery following discussion of the implications of undergoing hip arthroplasty.
AND OR moderate to severe functional limitation, significantly affecting their quality of life AND who have a BMI less than (
