New Listings And Price Regime As A Result Of New Therapeutic Indications Of A Medicinal Product For Human Use "abraxane» (Paclitaxel-Albumin). (Resolution No. 57/2015).

Original Language Title: Regime di rimborsabilita' e prezzo a seguito di nuove indicazioniterapeutiche del medicinale per uso umano «Abraxane»(paclitaxel-albumina). (Determina n. 57/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-06&atto.codiceRedazionale=15A00779&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 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, # 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 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; 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-# 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal-General series-# 227, September 29, 2006 concerning "maneuver to the Government subsidized and non-subsidized pharmaceutical shopping»; Having regard to the application with which the firm Celgene Europe Limited 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 July 21, 2014; Having regard to the opinion of the pricing and reimbursement at its meeting of November 5, 2014; Having regard to resolution No. 43 on November 28, 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: Abraxane in combination with Gemcitabine is indicated for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas of medicine ABRAXANE (paclitaxel-albumin) shall be reimbursed as follows: package: «5 mg/ml-powder for suspension for intravenous infusion-use-100 mg vial (glass)» 1 vial-A.I.C. # 039399011/E (10) 15LCM3 (based on 32). New listings ' class: h. €245.00 ex factory Price (excluding VAT). Price (VAT included) €404.35. Therapeutic innovation important to know: in combination with Gemcitabine for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, no temporary reductions of law application. Discount required to public facilities on the price ex factory for all indications reimbursed, as negotiating conditions. Payment by results as negotiating conditions. For the purposes of the requirements at the expense of the national health service, the centers are specifically identified by the regions, users must fill out the computerized data collection card 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 national health service 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 contract validity: 24 months.