PROYECCION DEL ESTADO PARA EL AÑO

Coverage

Urinary Incontinence (UI) pads are currently included in the national benefit basket regulating prosthetic assistance. The national benefit catalogue is the Ministerial Decree 27th August 1999, n.332, which defines the list of medical devices (prosthesis, orthesis and aids) supplied directly to patients and reimbursed by the Italian NHS.

The document updates the previous 1992 legislation, introducing changes both in the classification (categorisation of devices on the basis of the international classification ISO 9999) and in the reimbursement mechanisms, with the abolition of national reimbursement tariffs for selected categories of aids, including incontinence pads.

UI are included in List 2 – an attachment that lists appliances (technical aids) produced whose provision doesn’t require a technician’s intervention38. The document defines the types of reimbursable UI pads (with explicit indication of functional characteristics such as material and absorption rate) and fixes the maximum quantities per each category. Three different models (and relative sizes) are identified: i) anatomic-shaped pads; ii) rectangular pads and iii) under pads. The details are presented in Table 24.

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MD 332/99 has 3 attachments: List one regulates all technical appliances produced ad hoc (or in series without specialist prescription/orthopaedic technician required). Goods are classified in 10 classes according to ISO 9999. Reimbursement tariffs are set. The third list includes goods directly purchased by LHU and provided to invalid patients.

Table 24 Urinary incontinence pads included in the national benefit catalogue (Decree 332/99)

Although the list was supposed to be updated regularly (every three years), only a marginal modification was introduced in 2001 (MD 321 31/12/01) with the introduction of “stabilized incontinence” as a patient’s condition for reimbursement.

The current list includes predominantly obsolete models, i.e. rectangular pads, which are no longer sold in European countries. One of the critical consequences is the high number of inappropriate prescriptions: physicians tend to predominantly prescribe the largest (and most costly) sizes causing negative externalities both on the patient (increase in the number of complications such as decubitus ulcers) and on the NHS (higher costs born by the system). Some Regions introduced modifications in the regional regulation. Piedmont, for instance, added four new models in the list of reimbursable pads: i) anatomically-shaped pads for light incontinence, ii) anatomically-shaped pads for light incontinence for men, iii) pants discreet and iv) pants flex.

DESCRIPTION code ex D.M.

28/12/92

CLASSIFICAT ION CODE ISO

Maximum n. reimbursed per

patient

INCONTINENCE PADS (ISO 9949) 09.30.04

UNDER PADS

Description and functional requisites

• Size big (waist measure between 100 and 150 cm) • Size medium (waist measure between 70 and 110 cm) • Size small (waist measure between 50 a 80 cm)

101.21.01 101.21.03 101.21.05 09.30.04.003 09.30.04.006 09.30.04.009 120 pc monthly 120 pc monthly 120 pc monthly ANATOMIC SHAPED

Description and functional requisites • Big Size • Medium Size • Small Size 101.21.17 101.21.19 101.21.21 09.30.04.012 09.30.04.015 09.30.04.018 120 pc monthly 120 pc monthly 120 pc monthly RECTANGULAR PADS

Description and functional requisites

• Unique size 101.21.23 09.30.04.021 150 pc monthly

SUPPORTS AND CLAMPS FOR INCONTINENCE (ISO 9949)

Paint elasticized reusable

- size big 101.21.11 09.30.09.003 3 pc monthly

- size medium 101.21.13 09.30.09.006 3 pc monthly

Results – Urinary Incontinence Pads Italy 84

Procurement

According to Article 3, of Decree 332/99, medical devices included in the List 2 (e.g. UI) must be purchased through public procurement mechanisms. Regions are required to ensure: (i) widespread distribution in their own territory; (ii) compliance with quality standards, and (iii) availability of a variety of models suitable to satisfy patients’ requirements.

The level of negotiation is mainly local; nevertheless some Regions - mainly Emilia Romagna (Intercenter), Veneto and Friuli Venezia Giulia (Centro Servizi Condivisi) - are introducing centralised procurement mechanisms.

In Italy, the UI pads are distributed in both inpatient (hospitals and nursing homes) and out patient settings (LHU and pharmacies/sanitary shops) that follow different procurement procedures. The most important distribution channel is LHU (54% of the market), as illustrated in Figure 6.

Figure 6 UI market segmentation by distribution chain

Inpatient setting

UI can be purchased either by nursing homes or by hospitals.

In case of nursing homes, two different types of processes may be adopted:

i) LHU explicitly indicates the lot reserved to nursing homes within the general regional tender (eg. Piedmont)

ii) Nursing homes are provided with pro capita budget (for patients resident in the territory) and they are free to choose the manufacturer through autonomous tenders. (e.g Emilia Romagna, Lombardia and Veneto)

54% 8% 23% 15% LHU Hospitals Pharmacies and Sanitary Shops Nursing Homes

Nursing homes represent a high potential market for manufacturers, while the hospital market represents a relatively marginal segment (Figure 6). In addition, the hospital market is predominantly subjected to cost containment policies and the price/quality ratio in adjudication criteria can reach 80:20.

Outpatient setting

UI can either be directly purchased by LHU or by local pharmacies.

In case of LHU, public tenders are compulsory and UI pads can be delivered through three different channels:

i) LHU facilities: patients receives UI directly in the LHU (so called direct distribution);

ii) Home delivery: patients receive UI directly at home. Delivery costs are borne by the manufacturer; price usually includes also additional services (free assistance etc.). The relevance of this distribution channel is increasing;

iii) Local pharmacies or sanitary shops: pharmacies are final distributors of the UI purchased by the Region/LHU through public tender.

In case UI are directly purchased by pharmacies, private direct negotiations take place between manufacturers and pharmacies; reimbursement agreements are afterwards defined between the LHU and pharmacies.

Reimbursement

As illustrated in the first section, reimbursable pads are listed in the DM 332/99, with explicit indication of the models, the technical and functional requisites, as well as the maximum number of pads reimbursable per patient per month (120-150 according to the type of pad). Medical prescription is required; physician specifies the model, size and number of pads that the patient requires (on the basis of the categories of the Nomenclature). In case a public tender has taken place at LHU level, the commercial pads sold is that of the manufacturer to whom the tender has been adjudged. In case of innovative products physician can indicate the commercial name of the product (e.g in Piedmont) and LHU must authorize the reimbursement. If pharmacies directly purchase pads from manufacturers, reimbursement prices are generally agreed between professional associations (i.e. Federfarma – the National

Results – Urinary Incontinence Pads Italy 86 Pharmacist Association) and the LHUs. Some LHU still apply the national reference price list included in the prior version (1992) of the Nomenclator.

According to our informants, an increasing tension to lower reimbursement tariffs to pharmacies has been witnessed in recent years therefore causing a vicious circle directly impacting on quality of products distributed (i.e. with lower reimbursement tariffs, pharmacies tend to purchase less costly, lower quality pads).

The current reimbursement system therefore hardly promotes innovation due to short term focus on cost containment, increasing length of the tenders and tendency towards the centralisation of the procedures at regional/inter provincial level that rise the risk of manufacturer’s monopoly and increase bipolarisation between public (reimbursed) and private (out of pocket) market.

Medical Aids: