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Keywords:

  • backdoor PSA screening;
  • economic impact;
  • costs

Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

OBJECTIVE

To determine the economic burden and additional cost on one hospital within the UK National Health Service secondary to prostate-specific antigen screening by a private recruitment company for a clinical drug trial.

PATIENTS AND METHODS

Data were reviewed from all patients who were excluded from the trial and referred across by the recruitment company between May 2004 and April 2005. The additional cost for all their investigation and treatment was calculated.

RESULTS

There were 87 interventional procedures (transrectal prostate biopsy, radical prostatectomy and radical radiotherapy), 27 diagnostic scans (magnetic resonance Imaging and bone scan) and 240 additional outpatient visits (new and follow-up) over the 1-year period. The calculated cost was approximately £271 500.

CONCLUSION

This study highlights the significant increase in the workload and financial burden in one centre within the UK National Health Service. Many other hospitals are likely to be in a similar situation and the total cost to the health service will be much greater.


Abbreviations
PRC

patient recruitment company

RP

radical prostatectomy

(R)RT

(radical) radiotherapy

DoH

Department of Health

PIN

prostatic intraepithelial neoplasia

TRUS-B

TRUS-guided biopsy.

INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

Prostate cancer is now the most frequently diagnosed cancer in men in England and Wales (excluding skin cancer), with an incidence of 26 798 in 2003 [1]. This compares with 20 842 in 1999 [2] and 18 201 in 1997 [3]. The increasing incidence might be attributable to increased PSA testing of men who present with LUTS, and to ad hoc screening by physicians [4]. However, there is currently no conclusive evidence that deaths from prostate cancer will be reduced by screening for this disease. The NHS Prostate Cancer Programme, launched in September 2000 states that ‘Until there is clear evidence to show that a national screening programme will bring more benefit than harm, the NHS will not be inviting men who have no symptoms for prostate cancer screening’[5]. As further clinical evidence is needed about the relative effectiveness of different treatments and the diagnostic techniques, the current economic evidence is poor and does not support population screening.

A patient recruitment company (PRC) in the UK was appointed by a pharmaceutical company to recruit patients into a prostate cancer prevention study that had multicentre research ethical committee approval to randomize men to two main groups: group 1, placebo; and group 2, active drug. Men were recruited via GP lists and advertising campaigns to have a PSA test after counselling and consent, with a view to prostate biopsy and entry into the drug trial.

If the PSA level was 3–10 ng/mL the patients then had a TRUS-guided prostate biopsy (TRUS-B). If the biopsy was positive for malignancy, showed atypical or abnormal histology, patients were excluded from the trial and referred to the local NHS hospital. Those found to have a PSA level >10 ng/mL were also excluded and referred across for further investigation and management. The aim of the present study was to highlight the significant additional workload and economic burden this had on the NHS. This is the first study to document and calculate such costs.

PATIENTS AND METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

We analysed the records of all patients who were referred to us between May 2004 and April 2005 as a result of PSA screening by the recruitment company; in all, 80 were identified (mean age 63.5 years, range 45–76). The patients were stratified into four groups based on their referral letter. Group I, patients referred directly to our hospital (with the histology slides) having already been diagnosed with prostate cancer after TRUS-B; group II, referred directly to our hospital (with the histology slides) having been found to have an abnormal biopsy after TRUS-B; group III, with a PSA level of ≥10 ng/mL, and who were excluded from the study and referred to us by their GP based on recommendations by the recruitment company. These patients had not had any prostate biopsies before referral; group IV, with a PSA level of 2.5–10 ng/mL who deferred TRUS-B and were referred to us by their GP, based on recommendations by the recruitment company.

Upon referral, all patients in group I and II were discussed at the urology multidisciplinary team meeting attended by the urologist, histopathologist, uroradiologist and clinical oncologist, where a management plan was made. The histology slides were reviewed independently by the histopathologist to confirm the original findings by the recruitment company. Repeat prostate biopsies (12-core systematic) were advised if the histopathologist did not agree with the initial diagnosis. Patients were then seen in the outpatient clinic to discuss their further management options. The protocols for the investigation of patients during diagnosis and follow-up were based on European Association of Urology guidelines [6]. Patients in groups III and IV were initially seen in the outpatient clinic, where the significance of an elevated PSA level was explained and TRUS-B offered. If the biopsies (primary or repeat) were positive for prostate cancer, patients were staged and appropriate treatment options discussed (active monitoring, radical prostatectomy, RP, or radical radiotherapy, RRT). If the prostate biopsies were negative, patients were monitored every 4–6 months with serial PSA testing. Patients with prostatic intraepithelial neoplasia (PIN), equivocal or suspicious biopsies, were kept under regular review using PSA testing and a DRE.

The number of outpatient visits over the 1-year period were monitored and cost for each new and follow-up appointment calculated. The individual cost for each diagnostic TRUS-B, 99mTc bone scan, MRI and therapeutic (RP, RRT or hormone manipulation using cyproterone acetate and goserelin) procedure was obtained. The individual cost for RP, TRUS-B, new and repeat consultations were obtained from the National Tariff 2004/2005 published by the Department of Health (DoH) [7]. All other costs were calculated based on the Hospital Price Index (Lancashire Teaching Hospitals Local Tariff). A record of additional incurred finances, including review of histopathology slides, radiographs, haematological and biochemical tests, was also obtained from the Hospital Price Index, and are thought to be typical of most Trusts across the UK. The cost for each procedure and the total economic burden is presented in Table 1. The individual cost for each patient was calculated by dividing the cumulative cost incurred by the total number of cases referred.

Table 1.  The total calculated costs of patients referred by the PRC
ProcedureCost/procedure, £N performedTotal, £
  • *

    Slide review, hormonal manipulation, blood tests, radiographs, antibiotics, etc.

RP34712586 775
RRT500023115 000
TRUS-B4014116 441
MRI430156 450
Bone scan350124 200
Consultation; new1418011 280
Consultation; repeat7116011 360
Miscellaneous*  20 000
Total  271 506

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

The individual results for each group are presented below while the overall outcomes are summarized in Fig. 1. In group I, 39 patients were referred with a diagnosis of prostate cancer; their mean (range) age was 63 (45–74) years and PSA level 5.67 (3.3–9.9) ng/mL). Only four patients had a PSA level of <4 ng/mL. In all, 24 patients were referred with Gleason grade 6, 13 with Gleason grade 7 and one each with Gleason grade 8 and 9, respectively.

image

Figure 1. The outcome of all patients referred by the PRC.

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After local slide review, 36 patients were confirmed to have prostate cancer by the histopathologist. The other three patients were reported to have suspicious biopsies, but not diagnostic. Their PSA levels were 4.2, 5.9 and 7.6 ng/mL, respectively, with benign findings on a DRE. On repeat biopsy, two patients continued to have suspicious biopsies, while it was normal in the third. Of the 36 patients with confirmed prostate cancer, 31 had organ-confined disease (T1c), four had locally advanced disease and one had metastatic prostate cancer diagnosed by a positive bone scan.

Of the 31 patients with organ-confined cancers, 18 had RP and 12 RRT; of the other six, one opted for active surveillance, four had a combination of hormone manipulation and RT, and one started on hormone manipulation alone.

In group II, 14 patients were referred by the PRC with abnormal prostate biopsies; eight were diagnosed with PIN and six had biopsies that were suspicious but not diagnostic for prostate cancer. The mean (range) age was 61.5 (49–69) years and the PSA level 5.65 (3.5–9) ng/mL). After local slide review, 12 patients had a repeat TRUS-B and the other two were followed with further PSA testing. Five were diagnosed with prostate adenocarcinoma (Gleason 6 in all cases), two with PIN and a normal biopsy in five. Three patients had RP and two opted for active surveillance, while the remaining nine were followed by PSA surveillance.

In group III, of the 80 patients, 18 were referred with a PSA level of >10 ng/mL; they had not had any prostate biopsies taken by the PRC, as they were excluded from entering the trial. Their mean (range) age was 65.7 (56–76) years and the PSA level was 31.9 (11.3–209) ng/mL). In all, 17 patients had biopsies at our hospital while one had a normal repeat PSA level and was not biopsied. Twelve patients were diagnosed with prostate carcinoma (locally advanced in four), one with PIN and four were normal. Of the 12 patients with a new diagnosis of prostate carcinoma, two had RP while four patients had RRT; three had a combination of hormone manipulation and RT, while one was only hormonally manipulated. The remaining two patients were managed with watchful waiting.

Group IV comprised nine patients, with a mean (range) age of 64.6 (55–73) years and PSA level of 6.96 (2.5–10) ng/mL, but they deferred biopsy when it was offered by the PRC. All nine patients agreed to have TRUS-B locally; the biopsy was positive for prostate carcinoma in four, of whom two had RP and two opted for watchful waiting. The other five patients were followed with regular PSA testing.

For all groups, of the 80 patients referred by the PRC, 57 patients were eventually confirmed to have prostate cancer. Histology slides from 53 patients (groups I and II) were reviewed locally by the histopathologist. In all, 41 patients had TRUS-B at our hospital, i.e. 26 new and 15 repeat biopsies. In all, 15 MRI scans, 12 bone scans and 11 plain radiographs were taken in all to stage these patients.

Of the 57 patients with prostate cancer, 25 had RP, 16 had RRT and seven had a combination of hormone manipulation and RT, while two started on hormone manipulation alone; watchful waiting was the treatment of choice in the other seven. Of the remaining 23 patients, no biopsies were taken in three, two had suspicious biopsies, three had PIN and biopsies were normal in 15.

Over the 1-year period there were an additional 80 new and 160 follow-up appointments offered to investigate, diagnose and treat these patients. The mean cost of managing a patient referred by the PRC was £3394, with a total increase in the financial burden of £271 506 to the local NHS hospital (Table 1).

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

Prostate cancer is now the most commonly diagnosed cancer in men and the second most common cause of death from cancer in men in England and Wales, with 9169 deaths reported in 2004 [8]. Recently there has been considerable media focus on the disease, along with calls for the introduction of a national prostate cancer screening programme. For a screening programme to be effective, it has to do more good than harm, at a reasonable cost, with cost being determined not only financially but also in terms of what else the health service could do with the resources that would be expected on screening [9].

There are currently no available data on the additional burden imposed on the NHS by PRCs. One of the greatest management challenges facing the NHS is that of balancing valuable resources with growing demand. Patients excluded from enrolling in a trial are frequently referred back to their GP or local hospital for further investigation. With more privately funded studies and a greater awareness by the public about PSA screening, there are likely to be more men coming forward to be involved in such trials. A national prostate screening programme is likely to generate significantly greater requirements for resources. In the UK, there are no estimates as to the likely cost of a prostate cancer screening programme. The economic burden on the health services of the diagnosis, management and treatment of prostate cancer in England and Wales was projected to be at least £45 million/year, in a report published in 1997 [10]. More recently, Sangar et al.[11] estimated the 5-year treatment cost of managing patients with prostate cancer diagnosed over a 1-year period (2001–2002) in the UK to be £92.8 million.

In the present study alone, 80 additional cases were referred to the local NHS hospital in a 1-year period, at a cost of just over £0.25 million. These are likely to have been underestimates of the true expenditure, as further follow-up investigations and treatments have not been considered. These include the less easily quantifiable costs such as that of the adverse effects of prostate biopsy, morbidity of therapy, psychological cost of false-positive test results, and the impact on community costs. At the time of the present study, payment to hospitals was not based on individual items of service but instead negotiated annually as a block contract between each NHS hospital and the purchasers (Primary Care Trust). This gives little or no allowance for any increased funding in the event of a sudden unpredictable increase in workload. Payment by results, introduced by the DoH in April 2005, ensures that payment will be linked to activity and adjusted for case mix. Importantly, this system ensures a fair and consistent basis for hospital funding, as the Primary Care Trusts would bear costs for any additional procedures undertaken in the hospital, but this simply transfers the financial burden. However, it is difficult to determine the number of patients in this screened, asymptomatic group who might have otherwise have presented to the hospital in future due to urinary symptoms or disease progression. The PRC would not provide details of the number of men screened for this study, or those who refused biopsy or randomization.

Early detection might help to reduce the death rates from prostate cancer, as a result of early diagnosis, and prevent the morbidity from symptoms associated with urological function, obstruction and bleeding, and pain associated with metastases. The advantage gained from future medical savings from treating earlier cancer, reduced suffering from prevention of advanced disease, and the value of reassurance from a negative test, cannot be ignored. However, the benefits of making a diagnosis of cancer must be weighed against the side-effects of radical treatment, and the possibility that the cancer might otherwise not have progressed to become clinically significant. The much awaited long-term results by the Scandinavian Prostate Cancer Study Group comparing RP and watchful waiting has yielded statistically significant differences in both the primary endpoint of death from prostate cancer and the secondary endpoints of death from any cause [12]. It is possible that the short-term increase in cost and workload of patients referred by PRCs might be outweighed by the long-term financial savings due to the early detection of prostate cancer, death from distant metastases, and local progression, as well as costs related to palliative care and social services.

The National Cancer Plan, published by the DoH in September 2000, outlined several commitments and targets relating to waiting times for treatment [13]. This includes the ‘2-week cancer referral’ rule (a maximum 2-week wait for an urgent GP referral for suspected cancer, to the date first seen for all suspected cancers), the ‘31-day target’ (a maximum 1-month wait from the decision to treat to first definitive treatment of cancer) and ‘62-day target’ (a maximum 2-month wait from GP referral under ‘2-week rule’ to first definitive treatment). Meeting these targets has become an emphasis and priority of hospital managers. Unfortunately, any additional workload secondary to ‘backdoor’ PSA screening is not considered. The total number of RPs undertaken locally at our hospital in 2004/05 more than doubled over that in the previous 3 years (Table 2). As a result, national benchmark studies of the local NHS trust against other organizations in the UK, comparing the performance for prostate cancer against these government targets, are likely to be affected. Currently, prostate cancer is the only cancer with a government spending target for research. The NHS Prostate Cancer Programme, launched in September 2000, confirmed an increase in DoH directly commissioned funding for prostate cancer; the target of £4.2 million was reached in 2003/04, a 20-fold increase since 1999 [5]. In addition, the DoH announced a provision of £100 000 in 2005 towards a public awareness programme [14].

Table 2.  The number of RPs undertaken annually; information obtained from the local Hospital Cancer Registry
YearNumber of RPs
2001/0231
2002/0335
2003/0440
2004/0592

The future cost of managing prostate cancer is likely to increase, with a greater demand for screening and increasing public awareness. Sangar et al.[11] calculated that prostate cancer had an investment of £2818 for every pound spent on disease management per patient. Companies involved in recruiting and conducting trials that involve screening for prostate cancer might perhaps help bear the financial burden of this disease in the future. In addition, it is the responsibility of local and national ethical committees to assess the financial impact that any study will have on the health economy, and to ensure that appropriate measures are in place to manage and disperse such costs. Vigorous measures need to be undertaken to ensure that such financial burdens are met by the principal investigators of any research study.

To date, the present is the first study assessing the increased financial burden and workload as a result of PSA testing by PRCs. There are likely to be other hospitals that have also been subjected to a similar increase in cost and activity, and we hope to highlight the significant impact this has on NHS resources. Perhaps a national database or a separate coding system will enable auditing and monitoring of such cases in future on a national level.

REFERENCES

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES