Reclassification Of The Medicinal Product For Human Use «Oralair ' Within The Meaning Of Art. 8, Paragraph 10, Of The Act December 24, 1993, # 537. (Determines # 109/2015).

Original Language Title: Riclassificazione del medicinale per uso umano «Oralair» ai sensidell'art. 8, comma 10, della legge 24 dicembre 1993, n. 537.(Determina n. 109/2015).

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The DIRECTOR-GENERAL having regard to articles 8 and 9 of legislative decree July 30, 1999, # 300; Visto l'art. September 30, 2003, 48 of Decree-Law n. 269, converted into law November 24, 2003, n. 326, establishing the Italian medicines agency; Having regard to the Decree of the Minister of health in consultation with the Ministers for public administration and Economics and finance dated September 20, 2004, n. 245 laying down the rules of organisation and operation of the Italian Medicines Agency, pursuant to paragraph 13 of article. the aforementioned 48 as amended by order No. 53 of the Minister of health, in consultation with the Ministers for public administration and simplification and of economy and Finance of the March 29, 2012; Having regard to the Legislative Decree March 30, 2001, n. 165; Having regard to act July 15, 2002, # 145; Having regard to the Decree of the Minister of health of November 8, 2011, recorded by the Central Office of the budget to the register "visas", sheet # 1282, dated November 14, 2011, with which he was appointed Director General of the Italian Medicines Agency. Luca Pani, as from November 16, 2011; Having regard to act December 24, 1993, no. 537 concerning "public finance corrective" with particular reference to art. 8; Visto l'art. 1, paragraph 40, December 23, 1996, law n. 662 on "rationalization measures of public finance", which identifies the margins of distribution for pharmaceutical companies, wholesalers and pharmacists; Visto l'art. 48, paragraph 33, November 24, 2003, law No. 326, which has negotiating the price for products reimbursed by authorisation holders between agency and S. N.; Having regard to the Legislative Decree of April 24, 2006, n. 219, published in the Gazzetta Ufficiale della Repubblica italiana n. 142 of June 21, 2006 on the introduction of Directive 2001/83/EC (and subsequent amending directives) on the Community code relating to medicinal products for human use and Directive 2003/94/EC; Having regard to the Decree-Law no April 28, 2009 39, converted into law June 24, 2009, # 77, with whom art. 13 paragraph 1, point b) is restated the share attributable to drug companies, as provided for in art. 40 paragraph 1 of law December 23, 1996, n. 662, 58.65 percent of the retail price exclusive of value added tax; Having regard to the 1 February 2001 CIPE; View the determination October 29, 2004 "Notes AIFA 2004 (Revision Notes CUF)", published in the ordinary supplement to the official journal # 259 of November 4, 2004 as amended; View AIFA'S determination of July 3, 2006 published in the official journal, General series No 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal, General series No. 227, September 29, 2006 concerning "maneuver for Government subsidized and non-subsidized pharmaceutical expenditure"; Given the decree by which the company STALLERGENES S.A. It was cleared for placing the medicinal product on ORALAIR; Having regard to the application with which the firm STALLERGENES S.A. has applied for reclassification of AIC code packs # 039857014, AIC # 039857026, AIC # 039857038; Having regard to the opinion of the scientific and Technical Advisory Committee of October 21, 2014; Having regard to the opinion of the pricing and reimbursement of December 22, 2014; Having regard to resolution No. 1 of January 30, 2015 AIFA's Board of Directors adopted on the proposal of the Director General;
Causes: Art. 1 Classification for the purposes of new listings is the medicine ORALAIR in packages below is classified as follows: "300 100 IR IR 31" sublingual tablets and tablets in PA/AL/PVC AIC # 039857014 (10) 160BVQ (based on 32) new listings class ': A former factory Price (excluding VAT): € 66.65 retail price (VAT included): € 110.00 300 IR "Box" sublingual tablets 30 tablets in PA/AL/PVC AIC # 039857026 (10) 160BW2 (based on 32) class of new listings is: A former factory Price (excluding VAT): € 66.65 retail price (VAT included): € 110.00 Pack "IR sublingual tablets 300" 90 tablets in PA/AL/PVC AIC # 039857038 (10) 160BWG (based on 32) new listings class ': A former factory Price (excluding VAT): € 199.95 retail price (VAT included): € 330.00 validity of the contract: 12 months Discount required to public facilities on the price Ex Factory as per contractual terms. Total cost cap on price Ex Factory: € 2.1 million/12 months. The contract is renewed on the same conditions if one of the parties does not send to each other at least ninety days before the expiration of the contract, a proposal amending the conditions; up to the end of the proceedings remains the previous agreement. For the purposes of determining the amount of any breakthrough on the same calculation will be determined on consumption and by revenue (net of eventual Payback of 5% and gross of Payback of 1.83%) passed through the flow of Hospital channels and direct traceability and DPC, and flow OSMED for an agreement. It did, however, obliged companies to provide six-monthly sales data relating to products subject to the constraint of the roof and its trend in consumption during the period considered, pointing out, in case any breakthroughs even before the agreed maturity. For the purposes of monitoring the expenditure ceiling, the reference period, for products already marketed will start since the publication of the measure in o.j., while, for products of new permission, since the beginning of effective marketing. In the case of a request for renegotiation of the expenditure ceiling which results in an increase of the total amount allocated to the medicinal product and/or molecule, the redemption price thereof (including any discount required to SSN) must be renegotiated in reduction compared to previous values. The roofs of expenditure, i.e. the turnover thresholds where appropriate, refer/do not refer to all amounts however the NHS, including, for example, those arising from the application of the law 648/96 and the extension of the indications resulting from adaptations of AIFA'S Notes.