Viabilidad y actores involucrados

Laparoscopic surgery is a minimally invasive technique used to treat a wide range of colorectal diseases and is an alternative to traditional surgical procedures.

Empirical evidence suggests that laparoscopy achieves the same results as traditional surgery, but patients recover faster and experience less pain. A recently published study on 73 patients operated in a single centre in Italy confirmed the reliability of laparoscopic procedures in the treatment of tumours of the colon42.

Despite the positive clinical results, laparoscopic colorectal surgery has experienced a fairly limited uptake (recent evidence suggests that only about 25% of all procedures being undertaken laparoscopically in Great Britain and Ireland, even though NICE has recommended laparoscopic resection as a valid alternative to open surgery for patients with colorectal cancer43. It has been argued that there are two main reasons for this limited diffusion: higher costs of supplies and lack of training.

With regards to the first, it should be specified that laparoscopic colorectal surgery is performed with the use of several different medical devices: hardware, considered as capital equipment, instruments that may be disposable or reusable devices. Consequently, it is possible to perform the procedure only in hospitals with advanced technological equipment that allow for the use of highly precise surgical instruments and imaging.

In addition to the necessary technological requirements, laparoscopic surgery can only be performed by surgeons who have completed appropriate training in the technique, and who perform this procedure often enough to maintain their competence.

Similarly to all other inpatient services, the procedure is included in the national health baskets both in Italy and Spain, even though not explicitly mentioned in the decrees defining the packages (see previous sections). Data on the actual diffusion and uptake of the laparoscopic colorectal procedure in the two countries are not readily available.

42

For further information see Napolitano et al. Laparoscopic colectomy in colon cancer. A single clinical experience. Giornale Chirurgia 2007, April 28: 126-33

43

Schwab et al. The Uptake of Laparoscopic Colorectal Surgery in Great Britain and Ireland: a questionnaire survey of consultants members of ACPGBI. Colorectal Dis 2008, June

In 2005, a study was conducted to assess the degree of development and level of acceptance of laparoscopic surgery in Spain44. Even though almost 50% of surgeons considered laparoscopic surgery the preferred approach for colon cancer, only 25% reported performing this type of procedure on their patients.

In Italy, some estimates suggest that the diffusion rate is similar to the UK and Spain, which is approximately 25% of all procedures (source: industry representative). Facing the lack of data on the number of laparoscopic procedures performed in Italy, some aggregate figures regarding the total number of procedures performed are presented below. The objective is to give a preliminary insight into the number of procedures performed in Italy and trends over the years.

Considering that the laparoscopic colorectal surgery in Italy is reimbursed through several different DRG tariffs (as explained below), this preliminary analysis focused on the principal DRG - DRG 148: Major procedures on large and small intestine, with complications. As already mentioned, the DRG tariffs currently adopted do not differentiate between the open and laparoscopic procedures so the numbers reported here refer to the total number of procedures reimbursed by DRG 148 (open and laparoscopic).

Graph 11 shows that the total number of procedures has increased steadily from 2002 with more than 37.000 procedures performed in 2005. The highest percentage growth was nevertheless registered in the biennium 2003-2004 (6.4%).

Graph 11 DRG 148: Number of total procedures per year (2002-2005)

33,529 34,255 36,442 37,216 30,000 32,000 34,000 36,000 38,000 2002 2003 2004 2005

As far as the distribution of procedures in the Italian Regions is concerned (Graph 12), data highlight a quite relevant variability among geographical areas, specifically between northern

44

Feliu X, Targarona EM, Garcia-Agusti et al, The development of laparoscopic surgery in Spain. Dig Surg 2004, 21:421-5

Laparoscopic colorectal surgery 100 and southern Regions. As a matter of fact, given the national average of 631 procedures per million inhabitants, almost the totality of southern regions are set below the average (with the exception of Molise), whereas central-north regions – especially Liguria, Emilia Romagna and Toscana – register the highest number of procedures.

Graph 12 Distribution of procedures (DRG 148) per million inh. across Regions

686.3 830.2 815.3 542.9 528.6 559.4 728.0 1078.3 975.1 819.0 643.8 721.6 621.6 452.6 801.4 377.6 460.9 378.8 353.9 454.4 422.4 0.0 631.0 1262.0 Piemonte Valle d'Aosta Lombardia Bolzano Trento Veneto Friuli Venezia Giulia Liguria Emilia Romagna Toscana Umbria Marche Lazio Abruzzo Molise Campania Puglia Basilicata Calabria Sicilia Sardegna Procurement

It was mentioned above that performing laparoscopic colorectal surgery implies the use of specific equipment that includes both hardware equipment (financed through capital investment) and different instruments, which can be either disposable or reusable (Table 31).

Table 31 Equipment used during a laparoscopic colorectal procedure

TYPE OF DEVICE DESCRIPTION TYPE OF USE

Laparoscopic camera (Camera head and Control Unit) Light Source & Connections

Insufflator & Tubings

Hardware (capital equipment)

Electrosurgery Device (Vessel Sealing – Ligasure, ultrasound cut and coagulation or similar)

Trocar Disposable or Reusable

Laparoscope Reusable

Endo Linear Cutters Disposable

Ligsure Atlas handpiece Disposable

Endo Babcock Disposable or reusable

Atraumatic Graspers Disposable or reusable

Endo Disector Disposable or reusable

Endo Clip Optional, disposable

Sutures Endo Linear Stapler Disposable

Endo Linear Stapler with articulation Disposable

Endo Clip Applier Disposable

Lap Bowel clamps Disposable

Endo Scissors Disposable

Instruments

Lap needle holder Reusable

In both countries, open public tender procedures are applied for the purchasing of the devices needed for the procedure. Negotiations usually take place at a local level with single hospitals defining volumes and unit prices with manufacturers, although even in this field regional authorities are increasingly promoting centralised procurement strategies at either regional or inter provincial level with the aim of leveraging economies of scale and scope.

Laparoscopic colorectal surgery 102

Reimbursement Italy

Italian hospitals are mainly financed though the DRG system. As explained in the previous sections, the third part payer, the Region or the LHU (depending on the Region) reimburses the hospital the amount defined in the DRG tariffs, which are used to cover the expenses related to operating costs of hospitalization, including the cost of the devices and the services (computers, technician) that the manufacturer provides to assist the surgeon during the procedure. DRG tariffs are not expected to cover capital costs of public hospitals because there are specific budget lines for capital spending. Thus, the hardware component for the laparoscopic colorectal surgery (laparoscopic camera and so on) is typically financed through capital investments, and is excluded from the DRG tariff. In practice, however, those budget lines make available very limited funds and providers are forced to fund capital investments from operating revenues.

There are six DRG tariffs that are used to reimburse the procedure differentiated by type and complexity: major/minor procedures on large and small intestine, with/without complications and rectal resection with/without complications. They do not differentiate between laparoscopic and traditional (open) surgical procedures. Consequently, the same amount is reimbursed regardless of the materials and technologies used in the intervention.

Table 36 presents the relevant tariffs used in laparoscopic colorectal surgery, even though without specific reference. The table shows the amounts defined in the national fee schedule, updated in December 2006 (MD 12/09/2006) for two different regimes of hospitalization: inpatient and day surgery.

Table 32 Detail of the main DRGs used for colorectal surgery (€)

DRG Description Inpatient Day surgery

148 Major procedures on large and small intestine, with complications

9667 1853

149 Major procedures on large and small intestine, without complications

5.137 1.297

152 Minor procedures on large and small intestine, with complications

4.979 1.321

153 Minor procedures on large and small intestine, without complications

3.491 1.090

146 Rectal Resection, with complications 9.190, 1.839 147 Rectal Resection, without complications 5.835 1.453

Spain

Reimbursement mechanisms used for all inpatient services applies also for laparoscopic colorectal surgery. In short, hospitals are reimbursed through global budgets defined annually in a programme-contract between the Health Service Department (fictitious purchaser) and a hospital (provider). The contract contains the catalogue of services that the centre is obliged to supply to the patients belonging to a specific health care area during one year, as well as the volume of activity agreed and the quality objectives. Thus, the global budget is used by the hospital to cover the costs of durable equipment (hardware) as well as disposable and reusable medical devices needed for the laparoscopic colorectal surgery.