Regime Of New Listings And Price Of The Medicinal Product For Human Use "kalydeco (Ivacaftor)". (Resolution No. 494/2015).

Original Language Title: Regime di rimborsabilita' e prezzo del medicinale per uso umano«Kalydeco (ivacaftor)». (Determina n. 494/2015).

Read the untranslated law here:

For new listings and sales price of the medicinal product KALYDECO (ivacaftor)-authorized centrally by the European Commission with the European decision of July 23, 2012 and included in the Community register of medicinal products with numbers: 1/12/782/001/EW 150 mg film coated tablet-oral-bottle (HDPE)-56 tablets;
EU/1/12/782/002 150 mg film coated tablet-oral-blister (ACLAR/ALU)-56 tablets.
A.I.C. Holder: Vertex Pharmaceuticals (UK) LTD.
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 «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.; 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 1 St October 2007, n. 159, converted, with amendments, by law November 29, 2007, n. 222 laying down "urgent action on economic development and social equity finance» and in particular art. 5, paragraph 2 (a)), with whom he was expected to fund the expense of innovative drugs and paragraph 3, point a), containing provisions on the shelf of the breakthrough due to the passing of the Fund predicted; 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 of September 29, 2006 concerning "maneuver to the Government subsidized and non-subsidized pharmaceutical shopping»; Having regard to the application with which the firm has applied for classification, for the purposes of new listings '; Having regard to the opinion of the scientific and Technical Advisory Committee with regard to the medicinal product KALYDECO; Having regard to resolution No. 6 on March 25, 2015 AIFA's Board of Directors adopted on the proposal of the Director General; Whereas for the proper management of the various stages of deployment, the medicinal product should be assigned a national identification number;
Causes: Art. 1 Description and attribution number A.I.C. The medicinal product KALYDECO (ivacaftor) in the packages shown are awarded the following national identification numbers: packaging: 150 mg film coated tablet-oral-bottle (HDPE)-56 tablets;
A.I.C. # 043519014/E (10) 19J316 (based on 32). Packaging: 150 mg film coated tablet-oral-blister (ACLAR/ALU)-56 tablets;
A.I.C. # 043519026/E (10) 19J31L (based on 32). Medical indications: Kalydeco is indicated for the treatment of cystic fibrosis (CF), in patients age 6 years or more who have one of the following gating (class III) mutations in the CFTR gene: G178R, G551S, G1244E, G1349D, G551D, S1251N, S1255P, S549N or S549R.