New Listings And Price Regime, As A Result Of New Therapeutic Indications Of A Medicinal Product For Human Use "gilenya». (Determines No 411/2015).

Original Language Title: Regime di rimborsabilita' e prezzo, a seguito di nuove indicazioniterapeutiche, del medicinale per uso umano «Gilenya». (Determina n.411/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-27&atto.codiceRedazionale=15A03054&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, 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; Having regard to the December 14, 2000, law # 376 on "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. 5 222/2007 law 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 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"; Having regard to the application with which the company Novartis Europharm Ltd 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 November 26, 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 dated 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 new therapeutic indications: Gilenya is indicated as monotherapy, as disease-modifying drug, in relapsing-remitting multiple sclerosis with high activity in the following groups of adult patients: patients with high disease activity despite treatment with at least one disease modifying therapy (see sections 4.4 and 5.1 for exceptions and information on washout periods). These patients may be defined as those who have not responded to a full and adequate treatment (normally at least one year of treatment) with at least one disease modifying therapy. Patients must have had at least 1 relapse in the previous year while they were in therapy, and have at least 9 T2-hyperintense lesions on MRI gadolinium-enhancing lesions cerebral or at least 1. A patient not responding can also be defined as a patient presenting, compared with the previous year, a relapse rates unchanged or increased or presenting serious relapses, or patients with relapsing remitting MS severe such rapid evolution, defined by two or more disabling relapses in a year, and with 1 or more gadolinium enhancing MRI brain lesions or with a significant increase in lesion load in T2 compared to a previous RM recently made of medicine GILENYA (fingolimod hydrochloride) shall be reimbursed as follows: packaging: "0.5 mg-capsules-oral-blister (PVC/PVDC/ALU)" wallet from 28 capsules-AIC # 040949036/E (10) 171P9D (based on 32). New listings ' class: Note 65. Ex factory price (excluding VAT): €1800.00. Price (VAT included): €2970.72. Packaging: "0.5 mg-capsules-oral-blister (PVC/PVDC/ALU)" box of 28 capsules-AIC # 040949051/E (10) 171P9V (based on 32). New listings ' class: Note 65. Ex factory price (excluding VAT): €1800.00. Price (VAT included): €2970.72. Validity of the contract: 24 months. Discount required to public facilities on the price Ex Factory as per contractual terms. 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. The data relating to the processing operations carried out from the date of entry into force of this determination, through temporary mode above, should then be listed in the web platform, according to modalities which will be listed on the site: http://www.agenziafarmaco.gov.it/it/content/registri-farmaci-sottopos ti-monitoring.