Parámetros de Diseño

Coverage

Knee prostheses are included in the national benefit basket as specified the Real Decreto 1030/06 (15/9/2006). More specifically, the national benefit catalogue in which knee prostheses models are explicitly listed is the Appendix VI which regulates Orthoprosthetic services. Knee prostheses are included in the list of therapeutic Surgical Implants. The catalogue, in particular, includes all types of knee endoprostheses, listing explicitly the following macro categories (Figure 3):

• Unicompartmental Primary Knee Prosthesis (cemented and cementless); • Total Primary Knee Prosthesis (cemented, cementless and hybrid); • Revision Total Knee Prosthesis (cemented, cementless and hybrid); • Tumoral Knee Prosthesis

All implants with CE marks are included in Appendix VI; for surgical implants it is necessary for the producers to provide all the information with instructions and recommendations, contraindications and precautions.

Figure 3. Taxonomy Of Knee Prostheses in Spain

Orthoprosthetic services (Appendix

VI RD 1030/06) Surgical implants External Prosthesis Wheel chairs Ortesis Special Prosthesis Therapeutic surgical implants Diagnostic surgical implants Ostearticular Knee prosthesis Hip prosthesis Ankle prosthesis Feet prosthesis Elbow prosthesis Shoulder prosthesis Wrist prosthesis Hand prosthesis Ligament and tendon

Primary Revision Unicompartimental Total Cemented Cementless Cemented Cementless Hybrid Total Cemented Cementless Hybrid Tumora

Procurement

Even though several initiatives have been promoted at the regional level, public tenders at provider-hospital level remain the most common method for procurement of knee endoprostheses. The size of the tender is usually defined on the basis of the volumes specified in the program-contract annually negotiated between the single healthcare provider and the regional health care authority. The tender is usually structured in lots, with the indication of the volume, the maximum price per unit and per lot and the surgical instruments that are required to be provided free of charge together with the devices.

In order to illustrate more in depth the features of public tenders for knee endoprostheses in Spain, two specific and very recent examples are analysed: tenders for knee prostheses in the Hospital Clinico Universitario of Vallaloid in Castilla y Leon (Hospital Vallaloid 2008) and in Hospital La Paz in Madrid (Hospital La Paz 2007). For illustrative purposes, we report some details published in tender of a teaching hospital de Vallaloid in 2008 (Table 10).

Table 10 Example of a tender for knee prosthesis in Spain

LOT ORDER CODE QUANTITY

MAXIMUM PRICE PER PDT (€) TOTAL BUDGET OF THE TENDER (€)

1: cemented tibial base 018646 250 723 180,750 2: cemented femoral component 016868 250 1,084 271,000 3: cemented patellar component … 250 196 49,000 4: condyle insert …. 250 327 81, 750 5: polyethylene insert …. 15 418 6,270 6: …. ….. 25 62 1,550 1 TOTAL KNEE CEMENTED PROSTHESES 7: ….. …. 15 119 1,785 TOTAL LOT 1 1,592,105.00 8 ….. 016911 50 635 31,750 9 …… 018654 50 1350 67, 500 2 ……. ……. ….. …. …. …..

Source : (Hospital Vallaloid 2008)

As shown in the Table 10, the quantities of the devices and its components are explicitly defined in the tender. It is worth mentioning that the quantities included in the tender are usually estimated amounts. If the estimates were unrealistic and surgeons needed more knee prosthesis than the amount specified in the tender, extra devices can either be purchased on a

Results –Knee Endoprostheses Spain 50 one-by-one basis from the same manufacturer to whom the tender had been adjudged, or the hospital might opt for an extension of the previous tender. In the former case, no discounts are applied, as the price and the invoice is per procedure and not per volume.

The length of the contracts usually ranges from one to three years. In the latter case the tender indicates not only the total budget of the tender, but also the detail per year that may vary across years.

Tenders are usually adjudicated on the basis of the most advantageous economic offer, with criteria for price and quality explicitly indicated in the tender. Given the special characteristics of knee prosthesis’ components – which show a relatively higher degree of standardization compared to other implantable devices such as stents and ICDs - the weight assigned to price component may be higher than that for quality. This is the case of a tender issued in Hospital La Paz in Madrid in 2007 (Table 11).

Table 11 Tender for knee endoprosthesis in Spain – an example of adjudication criteria

CRITERIA WEIGHT NOTES

A. PRICE 60

Lowest Offer 60

Remaining offers

Scores are defined on the basis of the following formula: PSI = P_P MPS

I MIN∗

Where:

PSI = Price score to be assigned to the offer I PI = price of the offer I

PMIN = price of the lo west offer MPS = maximum price score

B. QUALITY OF THE

DEVICES OFFERED 35

Excellent 35 The product fully meets the required technical characteristics and exceeds the average quality of the other offers

Good 25 The product meets the required technical characteristics

Regular 5 The product meets the required technical characteristics but below the average of the other offers

Insufficient 0 The product does not meet the required technical characteristics

C. CRITERIA OF

“offer enhancement” 5

Excellent Adaptation 5 Very good adaptation 4 Good adaptation 3 Normal adaptation 2 No adaptation 1 The bidder does not

provide any offer 0

The bidder can enhance the offer, providing for instance free units (or discounts) if the order exceeds a certain volume etc…

From the interviews conducted with Spanish clinicians, it emerged that a key role in the procurement process of knee endoprostheses (as well as for the other implantable technologies analysed in the current research) is played by clinicians who contribute to the definition of the technical characteristics specified in the tender22 and the evaluation of the offers, in regards not only to the features of the device (such as quality, reliability, availability) but also to the service as a whole – assistance of company’s technicians in the theatre room, investment in professional training and education and so on. In case clinicians ask for the purchase of new devices or technologies that exceed the maximum prices indicated in the tender, they are required to provide scientific evidence of therapeutic efficiency of the device in front of an internal commission, composed by both clinicians and managers (e.g. the hospital manager, the healthcare manager and assistant manager, the nursing manager, and the purchasing manager).

22

Results –Knee Endoprostheses Spain 52

Reimbursement

As with all medical devices provided at inpatient level in Spain, knee endoprostheses are reimbursed through global budgets. The main features of the system have been described above.

It has been argued (also in the interviews conducted) that the system of global budgets may have some important implications on the accessibility and availability of services across the country. As a matter of fact, even though universal access is officially guaranteed by law, several disparities emerge in real practice, due to the existence of long waiting lists that act as entry barriers to public health care services. The standard defined by law - 6 months for a knee replacement - is hardly observed, and data collected (even if official statistics underestimate the real values), provide several examples of hospitals registering waiting lists longer than 2 years (as in the case of Catalunia). The search for measures to reduce the time waited to receive surgical treatments remains always on the top of the political agenda of reforms; nevertheless, for the time being, few have been concretely adopted to address the problem.