Renegotiation Of The Medicinal Product For Human Use ' Mestinon ', For The Meaning Of Article 8, Paragraph 10, Of The Act December 24, 1993, # 537. (Resolution No. 238/2015).

Original Language Title: Rinegoziazione del medicinale per uso umano «Mestinon», ai sensidell'articolo 8, comma 10, della legge 24 dicembre 1993, n. 537.(Determina n. 238/2015).

Read the untranslated law here:

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 law no 289/2002 (budget 2003); 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 «simple» 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 action with particular reference to art. 8; Visto l'art. 1, paragraph 40, December 23, 1996, law n. 662 laying «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 the national health service between agency and marketing authorisation holders; Visto l'art. 5 of law No 222/2007 published in the Official Journal No. 279 of November 30, 2007; 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 1 February 2001 CIPE; View the "notes October 29, 2004 determination 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-# 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal-General series-# 227 of September 29, 2006 concerning "maneuver to the Government subsidized and non-subsidized pharmaceutical shopping»; Having regard to the causes with which the company «Meda Pharma S.p.a.» has obtained authorisation for the medicinal product ' Mestinon '; Having regard to the application with which the firm «Meda Pharma S.p.a.» He demanded the renegotiation of the price of the medicinal product ' Mestinon '; Having regard to the opinion of the scientific and Technical Advisory Committee of December 22, 2014; Having regard to the opinion of the Committee at its meeting of January 26, 2015 and reimbursement rates; Having regard to resolution No. 5 of February 18, 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 MESTINON is renegotiated under the conditions mentioned below: box: «180 mg prolonged-release tablets» 50 tablets, A.I.C. # 009286042 (10), 08VDDU (32); new listings ' class: «A»; ex factory price (excluding VAT): €71.98; price (VAT included): €118.79. Validity of the contract: 24 months. Total cost cap on price ex factory: € 1,175,000/12 months from January 2015. 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 decision in the Official Gazette, whereas, 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 the national health service) 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 any amounts still borne by the national health service, including, for example, those arising from the application of law No. 648/1996 and the extension of the indications resulting from adaptations of AIFA'S notes.