Nonacog gamma, a novel recombinant factor IX with low factor IXa content for treatment and prophylaxis of bleeding episodes.

Nonacog gamma is a new recombinant factor IX to treat factor IX deficiency. It is indicated for control of bleeding episodes, perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia B. Nonacog gamma was first approved in the USA in June 2013 under the trade name RIXUBIS followed by market approvals in Australia and the EU in 2014, and marketing authorization decision is pending in Japan. Nonacog gamma is derived from a recombinant Chinese hamster ovary cell line using a state of the art biotechnological manufacturing process. Recombinant factor IX is produced by Baxter's protein-free fermentation technology, which was first developed for ADVATE. The product is purified and formulated in the absence of any human or animal-derived protein. Nonacog gamma was characterized both in comprehensive in vitro and in vivo non-clinical studies as well as in an extensive clinical trial program.

[Cardiac rehabilitation in Austria. A need to treat analysis]. / Kardiologische Rehabilitation in Osterreich. Eine Bedarfsanalyse.

The aim of this analysis is to survey the general demand and current supply of cardiac rehabilitation in Austria on the basis of best evidence practice and to produce recommendations for a cost-effective structure of the entire cardiac rehabilitation system. Following the standards of indication of the Austrian Society of Cardiology an analysis of demand of cardiac rehabilitation has been carried out and juxtaposed with the current supply of facilities for cardiac rehabilitation. According to hospitalizations in the year 2000, 11,630 patients per annum would require inpatient phase II rehabilitation, 6,270 patients institutional based outpatient phase II rehabilitation and 14,319 patients institutional based phase III rehabilitation. In the year 2000, 14,746 patients received treatment in the 9 Austrian inpatient cardiac rehabilitation centres. This number is compared with an annual demand of 11,630 admissions for phase-II treatment. It follows that an equilibrium can be argued for the supply of and demand for inpatient cardiac rehabilitation in Austria. At present, 10 approved institutions in Austria offer outpatient cardiac rehabilitation services. The maximum number of positions for treatment per institution is currently 200-250. Consequently, maximally 2,000-2,500 patients per annum can be treated. In comparison, there exists a calculated demand for 6,270 patients in institutional based outpatient phase II rehabilitation and 14,319 patients in institutional based phase III rehabilitation. Altogether this amounts to a demand for 20,588 positions for treatment per annum. In Austria, the expenditures for inpatient phase II rehabilitation of a patient given an average duration of stay of 28 days, are [symbol: see text] 4,774.-. Presuming 100% compliance, the institutional based outpatient phase II rehabilitation program costs [symbol: see text] 2,760.- per patient. The costs for institutional based phase III rehabilitation services are [symbol: see text] 2,990.- per patient. This number is accompanied by a potential effective reduction of risks for the patients and a potential effective reduction of costs for the carrier as the number of rehospitalizations and recurrent procedures would decrease significantly. At present, the supply of cardiac rehabilitation in Austria is sufficient for inpatient phase II, but insufficient for the institutional based outpatient phase II and mainly phase III. Thus, a striking asymmetry exists between supply and demand. In view of the enduring effects of institutional based phase III rehabilitation, the individual and social use and finally the expected efficiency in terms of costs, this program should at least be offered without limits to all eligible patients.