Cost-effectiveness of inguinal hernia surgery

Quality-adjusted life years (QALYs) are an important measure in calculating the cost-effectiveness of treatment. One QALY corresponds to one year in perfect health. As very many diseases are not fatal, but instead may lower the patients’ QoL, survival alone is not enough to evaluate the effect of a treatment. In diseases like inguinal hernia, QALYs are typically used in estimating the effect of surgical treatment. The cost of treatment may be then divided by the QALYs gained, and thus the price/QALY is evaluated. A threshold value of £30,000/QALY has been set by the National Institute of Clinical Excellence (NICE) in Great Britain as a limit to what is an acceptable price for a treatment (McCabe et al. 2008). When calculating the price/QALY, usually only direct hospital/healthcare costs are included, but the costs of convalescence are omitted.

Relatively few publications have addressed the cost-effectiveness of inguinal hernia surgery from a societal perspective. Most cost analyses have not taken into consideration any societal costs such as convalescence from work. In addition, data on QALYs gained from inguinal hernia surgery are still scarce. For open inguinal hernia mesh repair, gained QALYs vary between 0.13 and 0.95 for the first year (Coronini-Cronberg et al. 2013, Palmqvist et al. 2013, Sgourakis et al.

2013). Laparoscopic repair provides approximately 0.70-0.92 QALYs (Coronini-Cronberg et al.

2013, Sgourakis et al. 2013). The most extensive cost-effectiveness analysis thus far is based on over 17,000 inguinal hernia patients returning patient-reported outcome-measure (PROM) questionnaires pre- and postoperatively. This analysis concludes that on average laparoscopic inguinal hernia surgery provides 0.92 QALYs as opposed to 0.82 QALYs for open repairs. The price per QALY was £1,540 (€2,053) for laparoscopic and £1,746 (€2,328) for open repairs, thus indicating that laparoscopic repair is more cost-effective (Coronini-Cronberg et al. 2013).

According to another analysis, the prices per QALY were $1,942 (€1,618) for Nyhus repair, $1,948 (€1,623) for Stoppa repair and $2,011 (€1,675) for TEP repair (Sgourakis et al. 2013). Both of these analyses have only included in-hospital costs to their analyses, not taking into consideration costs of convalescence or potential complications.

Table 8. Previous studies evaluating the costs of open flat mesh versus laparoscopic hernia repairs. ublicationCountry Study typeaPatientsHernia typesbTechniquescInstitutional costs Costs of complications Costs of convalescence OpenLAPOpenLAPOpenLAP yne 1994USARCT100AL vs. TAPP US$ 2 494US$ 3 093- - - - eikkinen 1997FinlandRCT38AL vs. TAPP US$ 1 367US$ 1 884- - US$ 3 952US$ 2 912 eikkinen 1998FinlandRCT40U, PL vs. TAPP 3 915 FIM5 976 FIM- - 22 113 FIM14 742 FIM eikkinen 1998FinlandRCT45M, U, P L vs. TEPUS$ 782US$ 1 239- - US$ 3 892US$ 2 747 ellwood 1998 UKRCT400AL vs. TAPP 272 £ (GB) 675 £ (GB) 140 £ (GB) 72 £ (GB) - - ganini 1998dItalyRCT108AL vs. TAPP US$ 306US$ 1 249- - - - ieren 1998dGermanyRCT160U, PP&P vs. TAPPUS$ 124US$ 1 211- - - - achristouGreece RS320APHS vs. TAPP vs. TEP484 €763 € (TAPP) 573 € (TEP)- - - - ndersson 2003eSwedenRCT168M, UL vs. TEPUS$ 2 817US$ 1 726 incl.incl.US$ 2 682US$ 1 940 chneider 2003fUSARCT56AL vs. TEPUS$ 2 009 (3 999)

US$ 2 861 (5 509)- - - - ildebrandt 2003GermanyPS138?AL vs. TEP1 988 €2 428 €- - - - nadol 2004Turkey RCT50M, U, P L vs. TAPP US$ 629US$ 1 100- - - - hajanchee gUSARS85U, Popen flat mesh vs. TEPUS$ 666 (1 385)US$ 795 (3 064)- - - - ynes 2006hUSARCT1395M, mostly U and PL vs. TAPP/TEP US$ 773US$ 1 589incl.incl.- - utler 2007jUSARCT66U, PL vs. TAPP vs. TEP US$ -1 2000 (TAPP) US$ +125 (TEP)

- - - - ngeveld 2010NetherlandsRCT660A (mostly M, U, P)L vs. TEP1 333 €1 758 €- - 1 839 €1 327 € lund 2010kSwedenRCT1370M, U, P L vs. TEP1 952 €2 663 €23 €108 €2 270 €1 767 € ang 2013ChinaRCT252NSL vs. TAPP vs. TEP 5 852 RMB9 504 RMB (TAPP) 9 351 RMB (TEP)

- - - - a RCT = randomized controlled trial; RS = retrospective series; PS = prospective series b A = all hernias (both genders, uni- and bilateral, primary and recurrent); M = men; U = unilateral hernias; P = primary hernias; NS = not specified c L = Lichtenstein; P&P = plug&patch; PHS = Prolene Hernia System d In-hospital costs only include the cost of disposables e the costs of complications requiring re-operation were included in the in-hospital costs f patient charge rate in parentheses g reimbursement rate in parentheses h the costs of complications were included in the total 2-year costs of medical service use j absolute prices were not given for the procedures k the cost calculations were based on an average of 27 patients/group from a single hospital participating in a multicenter trial

TABLE 8 ON THIS PAGE PLEASE!

2.6.2 Cost-effectiveness of inguinal hernia surgery

Quality-adjusted life years (QALYs) are an important measure in calculating the cost-effectiveness of treatment. One QALY corresponds to one year in perfect health. As very many diseases are not fatal, but instead may lower the patients’ QoL, survival alone is not enough to evaluate the effect of a treatment. In diseases like inguinal hernia, QALYs are typically used in estimating the effect of surgical treatment. The cost of treatment may be then divided by the QALYs gained, and thus the price/QALY is evaluated. A threshold value of £30,000/QALY has been set by the National Institute of Clinical Excellence (NICE) in Great Britain as a limit to what is an acceptable price for a treatment (McCabe et al. 2008). When calculating the price/QALY, usually only direct hospital/healthcare costs are included, but the costs of convalescence are omitted.

Relatively few publications have addressed the cost-effectiveness of inguinal hernia surgery from a societal perspective. Most cost analyses have not taken into consideration any societal costs such as convalescence from work. In addition, data on QALYs gained from inguinal hernia surgery are still scarce. For open inguinal hernia mesh repair, gained QALYs vary between 0.13 and 0.95 for the first year (Coronini-Cronberg et al. 2013, Palmqvist et al. 2013, Sgourakis et al.

2013). Laparoscopic repair provides approximately 0.70-0.92 QALYs (Coronini-Cronberg et al.

2013, Sgourakis et al. 2013). The most extensive cost-effectiveness analysis thus far is based on over 17,000 inguinal hernia patients returning patient-reported outcome-measure (PROM) questionnaires pre- and postoperatively. This analysis concludes that on average laparoscopic inguinal hernia surgery provides 0.92 QALYs as opposed to 0.82 QALYs for open repairs. The price per QALY was £1,540 (€2,053) for laparoscopic and £1,746 (€2,328) for open repairs, thus indicating that laparoscopic repair is more cost-effective (Coronini-Cronberg et al. 2013).

According to another analysis, the prices per QALY were $1,942 (€1,618) for Nyhus repair, $1,948 (€1,623) for Stoppa repair and $2,011 (€1,675) for TEP repair (Sgourakis et al. 2013). Both of these analyses have only included in-hospital costs to their analyses, not taking into consideration costs of convalescence or potential complications.

Table 8. Previous studies evaluating the costs of open flat mesh versus laparoscopic hernia repairs. ublicationCountry Study typeaPatientsHernia typesbTechniquescInstitutional costs Costs of complications Costs of convalescence OpenLAPOpenLAPOpenLAP yne 1994USARCT100AL vs. TAPP US$ 2 494US$ 3 093- - - - eikkinen 1997FinlandRCT38AL vs. TAPP US$ 1 367US$ 1 884- - US$ 3 952US$ 2 912 eikkinen 1998FinlandRCT40U, PL vs. TAPP 3 915 FIM5 976 FIM- - 22 113 FIM14 742 FIM eikkinen 1998FinlandRCT45M, U, P L vs. TEPUS$ 782US$ 1 239- - US$ 3 892US$ 2 747 ellwood 1998 UKRCT400AL vs. TAPP 272 £ (GB) 675 £ (GB) 140 £ (GB) 72 £ (GB) - - ganini 1998dItalyRCT108AL vs. TAPP US$ 306US$ 1 249- - - - ieren 1998dGermanyRCT160U, PP&P vs. TAPPUS$ 124US$ 1 211- - - - achristouGreece RS320APHS vs. TAPP vs. TEP484 €763 € (TAPP) 573 € (TEP)- - - - ndersson 2003eSwedenRCT168M, UL vs. TEPUS$ 2 817US$ 1 726 incl.incl.US$ 2 682US$ 1 940 chneider 2003fUSARCT56AL vs. TEPUS$ 2 009 (3 999)

US$ 2 861 (5 509)- - - - ildebrandt 2003GermanyPS138?AL vs. TEP1 988 €2 428 €- - - - nadol 2004Turkey RCT50M, U, P L vs. TAPP US$ 629US$ 1 100- - - - hajanchee gUSARS85U, Popen flat mesh vs. TEPUS$ 666 (1 385)US$ 795 (3 064)- - - - ynes 2006hUSARCT1395M, mostly U and PL vs. TAPP/TEP US$ 773US$ 1 589incl.incl.- - utler 2007jUSARCT66U, PL vs. TAPP vs. TEP US$ -1 2000 (TAPP) US$ +125 (TEP)

- - - - ngeveld 2010NetherlandsRCT660A (mostly M, U, P)L vs. TEP1 333 €1 758 €- - 1 839 €1 327 € lund 2010kSwedenRCT1370M, U, P L vs. TEP1 952 €2 663 €23 €108 €2 270 €1 767 € ang 2013ChinaRCT252NSL vs. TAPP vs. TEP 5 852 RMB9 504 RMB (TAPP) 9 351 RMB (TEP)

- - - - a RCT = randomized controlled trial; RS = retrospective series; PS = prospective series b A = all hernias (both genders, uni- and bilateral, primary and recurrent); M = men; U = unilateral hernias; P = primary hernias; NS = not specified c L = Lichtenstein; P&P = plug&patch; PHS = Prolene Hernia System d In-hospital costs only include the cost of disposables e the costs of complications requiring re-operation were included in the in-hospital costs f patient charge rate in parentheses g reimbursement rate in parentheses h the costs of complications were included in the total 2-year costs of medical service use j absolute prices were not given for the procedures k the cost calculations were based on an average of 27 patients/group from a single hospital participating in a multicenter trial

3 Aims of the study

The aims of this study were to evaluate the outcome and complications of open and laparoscopic hernia repair surgery, and to determine the cost of treatment. The specific aims were as follows:

1. To compare open and laparoscopic inguinal hernia repair in treating recurrent inguinal hernias, with a specific focus on long-term outcomes.

2. To evaluate the potential of preoperative MRI in predicting the outcome of laparoscopic inguinal hernia repair of overwhelmingly painful inguinal hernias.

3. To assess the QoL in patients with painful inguinal hernias, and the change in QoL following laparoscopic TEP repair of the hernia.

4. To evaluate the possibility of predicting postoperative pain with preoperative pain and QoL scores.

5. To assess the complication profiles of open and laparoscopic inguinal hernia repair by using national registry data.

6. To compare cost and outcome of open mesh and laparoscopic inguinal hernia repairs in a single surgical unit.

3 Aims of the study

The aims of this study were to evaluate the outcome and complications of open and laparoscopic hernia repair surgery, and to determine the cost of treatment. The specific aims were as follows:

1. To compare open and laparoscopic inguinal hernia repair in treating recurrent inguinal hernias, with a specific focus on long-term outcomes.

2. To evaluate the potential of preoperative MRI in predicting the outcome of laparoscopic inguinal hernia repair of overwhelmingly painful inguinal hernias.

3. To assess the QoL in patients with painful inguinal hernias, and the change in QoL following laparoscopic TEP repair of the hernia.

4. To evaluate the possibility of predicting postoperative pain with preoperative pain and QoL scores.

5. To assess the complication profiles of open and laparoscopic inguinal hernia repair by using national registry data.

6. To compare cost and outcome of open mesh and laparoscopic inguinal hernia repairs in a single surgical unit.

4 Patients and methods