New Listings And Price Regime As A Result Of New Therapeutic Indications Of A Medicinal Product For Human Use «Soliris». (Determines No 1553/2014).

Original Language Title: Regime di rimborsabilita' e prezzo a seguito di nuove indicazioniterapeutiche del medicinale per uso umano «Soliris». (Determina n.1553/2014).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-08&atto.codiceRedazionale=15A00027&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

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 No 269, converted into law no 326 November 24, 2003, 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, # 245 laying down rules on the organisation and the functioning 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 «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; Having regard to the December 14, 2000, law # 376 laying "discipline of health sports and activities in the fight against doping '; 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.; 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; Having regard to Council Regulation No 726/2004/EC; 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 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 to the Government subsidized and non-subsidized pharmaceutical shopping»; Having regard to the application by which the Alexion Europe S.A.S. has applied for classification, for the purposes of new listings '; Having regard to the opinion of the scientific and Technical Advisory Committee at its meeting of September 10, 2013; Having regard to the opinion of the pricing and reimbursement at its meeting of July 29, 2014; Having regard to resolution No. 40 on November 6, 2014 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 new therapeutic indications: SOLIRIS (eculizumab) is indicated for the treatment of patients with hemolytic uremic syndrome (ahus)-medicine SOLIRIS (eculizumab) refunded as follows: box: "300 mg concentrate for solution for infusion-intravenous» 1 vial (glass) 30 ml (10 mg/ml)-A.I.C. # 038083010/E (10) 14B6G2 (based on 32);
New listings class is: "H";
Price ex factory (incl. VAT): €4,600.00;
Price (VAT included): €7,591.89.
Validity of the contract: 24 months. Discount required to public facilities on the price Ex Factory as per contractual terms. Free supply of # 2 vials for each new patient, both EPN that SEUa, subjected to treatment with SOLIRIS upon receipt of meningococcus vaccination vaccination certificate and/or antibiotic prophylaxis of the patient. For the purposes of the NHS prescriptions, users specifically identified by the regions, will have to complete the computerized data collection of enrollment indicating eligible patients and follow-up, applying negotiation conditions according to the guidelines that are published on the Agency website, web platform-to the address https://www.agenziafarmaco.gov.it/registri/which form an integral part of this determination.
Pending the full implementation of the Register web-based tracking, prescriptions, relating solely to claims reimbursed by the NHS through this determination must be made in accordance with the criteria of eligibility and appropriateness prescriptive documentation available on the Agency's institutional Portal reported: http://www.agenziafarmaco.gov.it/it/content/registri-farmaci-sottopos ti-monitoring data relating to the processing operations carried out from the date of entry into force of this determination through the modalities indicated above shall be subsequently given in temporary web platform, according to modalities which will be listed on the site: http://www.agenziafarmaco.gov.it/it/content/registri-farmaci-sottopos ti-monitoring