| reimbursement class: H; ex factory price (excluding VAT): euro 2,000.00; retail price (VAT included): € 3,300.80. Obligatory discount on the ex factory price, to be applied to public health facilities, including private health facilities accredited with the National Health Service, as per negotiated conditions. An overall expense ceiling on the former factory is applied to the medicinal specialty in question, net of discounts, starting from the date of entry into force of the determination that incorporates the conditions set out in the negotiation agreement. In case of exceeding the negotiated threshold, the company is called to the counter of the breakthrough through payback. For the purposes of determining the amount of any breach, the calculation will be determined on the basis of consumption and on the basis of turnover (net of any paybacks of 5 percent and 1.83 percent and of the actual paybacks paid, at the time of verification of the breach, deriving from the application of the envisaged MEAs) transmitted through the traceability flow, referred to in the decree of the Minister of Health of 15 July 2004, for the hospital and direct channels and DPC, and the OSMED flow, established pursuant to law no. 448/1998, subsequently amended by ministerial decree no. 245/2004, for the Agreement. In any case, the party is obliged to provide the sales data on the products subject to the cap and the relative consumption trend in the period of validity of the agreement every six months, reporting, if necessary, any breaches even before the contractual expiry. . For the purposes of monitoring the expenditure ceiling, the reference period, for products already marketed, will start from the month of the publication of the provision in the Official Gazette of the Italian Republic, while, for newly authorized products, from the month of actual marketing commencement. In the event of automatic renewal of the contract, for the years following the second, the ceiling envisaged for the second year is applied. In the event of a request for renegotiation of the expenditure ceiling that involves an increase in the total amount attributed to the medicinal product and / or molecule, the reimbursement price of the same must be renegotiated in reduction. compared to the previous values. The expenditure ceilings, or the turnover thresholds that may be set, refer to all the amounts to be paid by the SSN, including, for example, those deriving from the application of law no. 648/1996 and the extension of the indications resulting from changes. The current conditions will be valid until the new ones come into force and any breakthrough will be calculated by monthly reparametrating the ceiling envisaged for the second year. Validity of the contract: twenty-four months. |