Replies to post #3368 on GTC Biotherapeutics (fka GTCB)

[alia]

re: Lucentis and German reimbursement
What you describe appears to me (without knowing more) to fall into the category of expensive drugs like etanercept, in that it requires a special authorization for extra funds in Germany, so what you are saying does not contradict what I said, you are merely confirming what I said for that special case. I had a quick look at the Swiss situation and price for Lucentis (direct link doesnt work, so go to http://www.santesuisse.ch and check the 'Spezialitätenliste' which gives you an alphabetical list of drug prices and indications and then search for Lucentis) it says (In German, French and Ital., text below) that Lucentis is only to be given by ophalmologists at special centers of care etc during an evaluation phase until that and that date. In Switzerland, drug prices are centrally negotiated, in Germany they are not. Perhaps Atryn will be distributed in Germany like what is described for Lucentis in Switzerland, though, in which case off-label use might be more restricted, but that is/was not clear to me from the info I have read about Atryn so far. In any case, if that were the case, off-label use might be restricted within a year of comign onto the market, but safety-data permitting, perhaps not after.

Lucentis in Switzerland: (text from link above)

Lucentis NOVARTIS PHARMA SCHWEIZ AG
(Ranibizumab.)
(L) Vitr. 0.3 mg/ml
18483 1 Vitr. 3 mg/0,3 ml 1832.00 {1792.00} [57664 001] (324 08 39) 01.01.2007, B
Limitatio: Während einer Evaluationsphase (bis zum 31. Dezember 2008) darf LUCENTIS ausschliesslich durch qualifizierte Ophthalmologen der A-, B- und C-Zentren/Kliniken (gemäss der Liste der Weiterbildungszentren der FMH) zu Lasten der Grundversicherung angewendet werden.
Die gleichzeitige Behandlung beider Augen eines Patienten bedarf der Bewilligung des Vertrauensarztes.
Das Zentrum ist verpflichtet, über die Anwendungen von LUCENTIS eine geeignete Dokumentation zu führen, welche auf Verlangen des BAG vorzuweisen und welche zudem in Intervallen von sechs Behandlungsmonaten in Kopie an NOVARTIS Pharma Schweiz AG, Postfach, 3001 Bern, Fax [phone] einzusenden ist. Das entsprechende Formular ist zu finden unter: www.lucentis.ch.
Preisberechnung aufgrund des Fabrikabgabepreises inkl. MWST zuzüglich einer Fixmarge von Fr. 40.-- wegen der speziellen Verteilersituation (praktisch kein Zwischenhandel).
Pendant une phase d'évaluation (jusqu'au 31 décembre 2008), LUCENTIS ne doit être utilisé que par des ophtalmologues qualifiés dans les centres/cliniques A, B ou C (selon la liste des centres de formation continue de la FMH), à la charge de l'assurance de base.
Le traitement simultané des deux yeux d'un(e) patient(e) nécessite l'autorisation du médecin conseil.
Le centre est soumis à l'obligation de remplir une documentation correspondant à l'utilisation de LUCENTIS. Cette documentation doit être remise sur demande de l'OFSP et une copie doit être envoyée tous les 6 mois de traitement à Novartis Pharma Schweiz AG, Case postale, 3001 Berne, fax [phone]. Le formulaire correspondant est disponible sur: www.lucentis.ch.
Calculation des prix sur la base des prix "ex factory" y compris la TVA plus une marge de fr. 40.-- à cause de la situation particulière de distribution (pratiquement pas de commerce de grossiste et détailliste).
Durante la fase die valutazione (fino al 31 dicembre 2008), LUCENTIS può essere usato esclusivamente da oftalmologi qualificati delle cliniche/centri A, B e C (secondo l'elenco dei centri di perfezionamento professionale della FMH) a carico dell'assicurazione di base.
Per il trattamento contemporaneo di entrambi gli occhi di un paziente è necessaria l'autorizzazione del medico di fiducia.
Il centro è obbligato a documentare in maniera adeguata l'uso di LUCENTIS; tale documentazione deve essere esibita a richiesta dell'UFSP e, inoltre, inviata in copia a intervalli di sei mesi di trattamento presso la Novartis Pharma Schweiz AG, Casella postale, 3001 Berna, fax [phone]. È possibile trovare il modulo corrispondente alla pagina
internet: www.lucentis.ch
I prezzi sono calcolati sulla base del prezzo di fabbrica per la consegna (IVA inclusa) e di un margine fisso di 40.-- fr. a causa della situazione particolare della distribuzione (che avviene in pratica senza intermediari).