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Daclatasvir in Spain
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Daklinza, el nuevo f‡rmaco contra la Hepatitis C a un precio "asequible"
http://isanidad.com/44734/daklinza-el-nuevo-farmaco-contra-la-hepatitis-c-a-un-precio-asequible/
English Translation......
Daklinza, the new drug against hepatitis C at an "affordable" price
January 30, 2015
The third drug which for months has been talking to eradicate efficiently the Hepatitis C, is already on the market, is that Daclatasvir or Daklinza (trade name) was presented last Wednesday at a press conference by Dr. Juan Berenguer, Unit of Infectious / HIV Disease Hospital Universitario Gregorio Mara–—n, Madrid; Dr. Ramon Planas, Chief of Gastroenterology, Hospital Germans Trias i Pujol in Badalona; Antonio Bernal, president of the National Federation of Patients and Liver Transplant (FNETH); Dr. Jose Cabrera, medical director of Bristol-Myers Squibb (BMS), the company behind this product, and Elisa Borrego, Director of Market Access BMS in Spain.
The drug, whose approval was announced by the Minister of Health, Alfonso Alonso, last December 16 in the Senate, adds to the already approved throughout 2014, simeprevir ('Olysio' Janssen) and Sofosbuvir ('Sovaldi' Gilead). All in different combinations depending on the genotype of the virus and the degree of development of the disease, cure rates can be achieved above 90 percent. Furthermore, treatment is reduced from 48 to 24 and even 12 weeks.
"What has happened with this virus is most dramatic has happened in medicine in recent years. Progress may be slow, but not stop, "said Planas, who asked that" national strategy in which the expert group appointed by the Ministry works allows to treat all patients starting with those who can not wait and are in a more serious situation".
These patients, as detailed Planas, are those with significant fibrosis in phase F3 or F4, or have developed cirrhosis, and account for 40% percent of the nearly 85,000 patients have in Spain treatable.
However, Planas acknowledges that "survival is not achieved today for tomorrow" and deaths continue to be recorded in Spain (12 day) are not associated with lack of access to these therapies but that "have developed a cancer is impossible to stop or because they have a superdescompensada cirrhosis, but received the drug could not be resolved ".
Assumable prices rather exorbitant
During the press conference, experts insisted that the laboratories that develop these drugs must provide "assumable" for public health prices. "The labs are entitled to make a living, but can not set exorbitant prices, nor give them away," according Planas.
Given the controversy in recent weeks about the high price of these new drugs, Bristol-Myers Squibb has been reluctant to report the price you Daklinza in Spain, merely ensure that it is "competitive" and "affordable". Nor have they indicated whether they have agreed on a spending ceiling, as it has done with other drugs Health last generation.
"We are a regulated industry and we can not talk about price," says Elisa Borrego, Director of Market Access BMS in Spain, which recognizes that negotiations with the Ministry still open and make public the price may affect these negotiations, and as those that are taking place with other countries. It has also ensured that the final price will depend on the number of patients treated with this drug, which is used in combination with 'Sovaldi'.
For now, as announced by the medical director of the company, Jose Cabrera, have received this drug in Spain more than 700 patients by means of compassionate use in about 40 centers. The company expects to continue to use this (free for those at risk of death) therapeutic avenue until May. He has also reported that Spain is one of the first countries to incorporate this drug, which is also available in Nordic countries, Germany, Austria or Switzerland.
..Emilio Ramirez
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La ultima terapia en hepatitis C es "asequible"
http://www.estusanidad.com/secciones/pacientes/la-ultima-terapia-en-hepatitis-c-es-asequible-5439
English Translation.....
Some 10,000 patients may benefit from Daclatasvir
The company Bristol-Myers Squibb (BMS) has presented the Daclatasvir drug (Daklinza) to treat hepatitis C approved for marketing makes only a week and funding "will be affordable for the NHS, because the company is committed sustainability "as told Jose Cabrera, medical director of BMS.
The company is still in negotiations with the Ministry of Health to set a price and financing, which depends on the number of patients treated. This figure is reflected in the strategic plan on hepatitis C being developed by the government.
The Chief of Gastroenterology, Hospital Germans Trias i Pujol, Badalona, Ramon Planas, recalled that the Ministry of Health calculated the number of patients who should receive urgent treatment this year in 6000, while it amounted to 30,000 hepatologists. "Possibly, the figure is half, about 10,000, which would be acceptable by the NHS," according Planas.
The red line is hepatologists in patients at an advanced stage of the disease with cirrhosis. However, the experts call for new treatments are extended to all those affected, for which we have to wait about a year. It is estimated that globally, 85,000 people are susceptible to the drug, but must "stratified entry, since there is a budgetary limit," he stresses.
"Increasingly means to treat patients"
The first study of Daclatasvir shows that the use of this drug in patients with genotype 1 (no pretreatment or no response to earlier) is 98 percent effective in killing the virus, so far not reached more than 48 percent. For genotype 2 is 92 percent and for genotype 3, 89 percent. On the other hand, only one percent of patients had to discontinue treatment because of adverse effects, where so far this proportion rose to 15 percent.
The advantage of Daclatasvir, as has assured Wednesday Dr. Juan Berenguer, Unit infectious / HIV disease Hospital Gregorio Maranon de Madrid, is that it can be applied to all patients, regardless of genotype submit.
"In principle can be treated all genotypes," says Juan Berenguer, Unit of Infectious / HIV Disease Hospital Universitario Gregorio Mara–—n. Meanwhile, Antonio Bernal, president of the National Federation of Patients and Liver Transplant (Fneth), asked patients to have confidence in hepatologists, "in which our specialist we will prescribe the best treatment," he says. It has concluded that there is "a therapeutic arsenal" today and you can have "increasingly means to treat patients."
So far, 700 patients in Spain have applied for compassionate use Daclatasvir, which runs until May or June. It is the first drug against hepatitis C throwing BMS after more than 14 years of work and an investment of 1.4 billion dollars in research.
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La hepatitis C estar’a controlada en 2030 con un uso adecuado de los nuevos f‡rmacos
http://www.laregion.es/articulo/sociedad/hepatitis-c-estaria-controlada-2030-uso-adecuado-nuevos-farmacos/20150128151730518924.html
english translation....
Hepatitis C would be controlled in 2030 with an appropriate use of new drugs
28/01/2015
Hepatitis C can be controlled and "stop being a problem for the Spanish health" in 2030 if the national plan against the disease being developed by the Ministry of Health ensures that at least 10,000 to 12,000 patients are treated each year with medicines last generation that are appearing.
This was asserted member of the Spanish Association for the Study of the Liver (AEEH) and Head of Department of Gastroenterology, Hospital Germans Trias i Pujol, Badalona, Ramon Planas, during the press conference of presentation of the last of these new drugs has been authorized in Spain, the Daclatasvir, marketed as 'Daklinza' by Bristol-Myers Squibb (BMS), and the first to inhibit virus NS5A complex.
The drug, whose approval was announced by the Minister of Health, Alfonso Alonso, last December 16 in the Senate, adds to the already approved throughout 2014, simeprevir ('Olysio' Janssen) and Sofosbuvir ('Sovaldi' Gilead). All in different combinations depending on the genotype of the virus and the degree of development of the disease, cure rates can be achieved above 90 percent. Furthermore, treatment is reduced from 48 to 24 and even 12 weeks.
"What has happened with this virus is most dramatic has happened in medicine in recent years. Progress can be slow, but not stop," has defended hepatologist, which calls for national strategy in which the group works of experts chosen by the Ministry allows treating all patients beginning "for those who can not wait," and in a more serious situation.
These patients, as detailed Planas, are those with significant fibrosis in phase F3 or F4, or have developed cirrhosis, accounting for 40 percent of the nearly 85,000 patients have in Spain treatable.
"There are patients who must already treated and can not wait a year," coincided Juan Berenguer, Unit of Infectious Diseases, Hospital Gregorio Maranon de Madrid, which nevertheless considered "reasonable" in those patients in whom the is less advanced disease can expect as "your health is not in danger."
Both experts agreed that the Ministry's strategy "late" and argue that it should also go progressively expanding the use of these new therapies for all patients, including less severe, and that ends up being more beneficial in the long term.
In fact, estimate that in 2030 the disease could be controlled and mortality virus is reduced by up to 60 percent, while "if only it is a minority, the reduction in mortality is only 20 percent ".
SURVIVAL "NOT AVAILABLE TODAY FOR TOMORROW"
However, Planas has acknowledged that "survival is not achieved today for tomorrow" and deaths are still occurring in Spain --12 diarias-- are not associated with lack of access to these therapies but that "have developed a cancer that is impossible to stop or because they have a superdescompensada cirrhosis but received the drug could not be resolved ".
"Do not die because they are not given medication, but because in his day were not given proper treatment and the disease has progressed to a range which is causing deaths. This is the great drama of the disease," he defended this hepatologist.
However, to achieve these figures both experts have insisted that the laboratories that develop these drugs must provide "assumable" for public health prices. "The labs are entitled to make a living, but can not set exorbitant prices, nor give them away," according Planas, recognizing that similar efficacy to the price can influence the choice of either combination.
BMS SAYS ITS PRICE IS "COMPETITIVE", BUT DOES NOT PUBLIC
Despite this influence, and given the controversy in recent weeks about the high price of these new drugs, the company that organized the presentation has been reluctant to report the price you 'Daklinza' in Spain and merely has to ensure that is "competitive" and "affordable" despite continuing questions from reporters. Nor have they indicated whether they have agreed on a spending ceiling, as it has done with other drugs Health last generation.
"We are a regulated industry and we can not talk about prices," defended Elisa Borrego, Director of Market Access BMS in Spain, which has acknowledged that negotiations with the Ministry still open and make public the price can affect this negotiation as well as those that are taking place with other countries.
It has also ensured that the final price will depend on the number of patients treated with this drug, which is used in combination with 'Sovaldi'.
For now, as announced by the medical director of the company, Jose Cabrera, have received this drug in Spain more than 700 patients by means of compassionate use so that communities, responsible for finance drugs in Spain, pay nothing and the full cost is borne by the laboratory.
He has also reported that Spain is one of the first countries to incorporate this drug, which is also available in Nordic countries, Germany, Austria or Switzerland
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