Negli USA le prescrizioni di Gilenya (Fingolimod) rallentano, perchè è dificile poter monitorare i pazienti alla prima dose per 24 ore, contrariamente alle 6 ore previste prima della morte di un "somministrato".
Ma in Italia stanno rispettando questo nuovo limite?
Ma in Italia stanno rispettando questo nuovo limite?
Fonte: http://www.facebook.com/matteo.scibilia
Novartis’ (NYSE:NVS) multiple sclerosis (MS) pill Gilenya faces slowing prescriptions in New York because of a lack of facilities to perform first-dose observations, neurologists told Biopharm Insight. However, Novartis has been in contact with a number of clinicians and is working on increasing the number of sites.
A US Food and Drug Administration (FDA) review was initiated after a patient died within 24 hours of taking the first dose of Gilenya. Regulatory authorities also re-evaluated study data regarding the drug’s effect on heart rate and blood pressure.
Gilenya is now contraindicated for use in patients with certain pre-existing or recent heart conditions or stroke, or those taking certain antiarrhythmic drugs, according to FDA. Extended monitoring is recommended in patients with QT prolongation and in patients who are already taking medication that slows heart rate. Observation includes continuous overnight electrocardiography (ECG) monitoring.
A Novartis spokesperson said via email the company is committed to helping healthcare providers implement the updated prescribing information recommendations.
Gilenya sales in 2011 reached USD 494m.
Monitoring requirements and set up
There is no official Novartis-arranged facility in Manhattan to perform first-dose observations at this time, but this is likely to change in the very near term, according to Dr Stephen Krieger, assistant professor of neurology, Corinne Goldsmith Dickinson Center for MS, Mount Sinai Medical Center, New York. Dr David Snyder, director of the Multiple Sclerosis Center at New York Hospital Queens, added there is no facility available in New York City. “There is a facility in Secaucus, New Jersey, where one [of my] patients in New York is going,” he noted.
At his hospital, Snyder noted that he is not in a position to do an ECG. He noted that patients need to be referred to a cardiologist to assess if the patient can take Gilenya. “We don’t repeat the ECGs in our office, but now the new guidelines indicate that you do need to get ECGs before and after dosing. We cannot do that,” Synder explained.
He said the same issue is likely to affect other private practice neurologists. Dr Aaron Miller, professor of neurology at the Mount Sinai School of Medicine, said there are one or more sites in New York that have been identified to conduct monitoring. “We work directly with Novartis to find a site,” he said.
Novartis currently has a system in place with a “nurse navigator” to facilitate arranging monitoring and first dosing, Krieger noted. He said he believed this program is being updated to arrange first-dose centers that meet the new, heightened requirements.
If a neurologist wishes to arrange the first-dose observation themselves, then either hospital admission or contracting with a facility that can perform continuous monitoring can be done, Krieger added.
This would likely be akin to Biogen Idec’s (NASDAQ:BIIB) “TOUCH-certified” infusion centers for Tysabri administration in the US, he added. The TOUCH program monitors deaths, and physicians know the risks with Tysabri, stated Dr Karen Blitz-Shabbir, director of the North Shore MS Care Center in East Meadow, New York.
Physicians can stratify risks with Tysabri, while Gilenya is more difficult because we do not know how people are dying, she said. Blitz-Shabbir said two of the 11 deaths associated with Gilenya were from drowning and appear to be cardiac-related. There has been no information given to physicians about the cause of these patients’ deaths, she noted.
Novartis needs to expand its Gilenya Go program to a more comprehensive case-management system for doctors and patients to be able to efficiently use the drug, said Dr Daniel Kantor, president of the Florida Society of Neurology, who was an investigator on Gilenya. Kantor said he is currently trying to figure out what to do for patients who need hospitalization. In the US, Novartis continues to offer pre-tests and first-dose observation capabilities at a network of clinical centers that provide assessments and screenings, but not 23 hour observations, that may be needed by patients taking Gilenya called the Gilenya Assessment Network (GAN), the spokesperson said. It currently comprises close to 250 sites around the country, and sites are accessible within 30 miles of Novartis’ customers and growing rapidly, the spokesperson added.
Gilenya’s efficacy is still great, but it’s really the logistical factors associated with the drug, Kantor noted. The safety data suggests that despite some questions in clinical practice, Gilenya is overall associated with a very low chance of cardiac signs or symptoms, noted Kantor. Because of recent events, Snyder said his prescribing process has slowed down somewhat. If patients are doing well on the current injectables, Snyder said he would not switch to an oral drug just because of patient convenience. In terms of the number of unexplained deaths, one US patient who was on Tysabri and then was switched to Gilenya, developed progressive multifocal leukoencephalopathy (PML) shortly after the change, Snyder said.
Declining use
MS centers are using it less frequently, and it’s mostly used by general neurologists rather than MS specialists, Blitz-Shabbir said.
Gilenya’s efficacy is still great, but it’s really the hassle factor associated with the drug, Kantor noted. Because of recent events, Snyder said his prescribing process has slowed down somewhat. If patients are doing well on the current injectables, Snyder said he would not switch to an oral drug just because of patient convenience. In terms of the number of unexplained deaths, one US patient who was on Tysabri and then was switched to Gilenya, developed progressive multifocal leukoencephalopathy (PML) shortly after the change, Snyder said.
Some of the unexplained deaths were due to inappropriate patient selection by the physicians involved, Snyder stated. “I emphasized that the patients that we select for Gilenya use are young, free of any CV disease, and are not on any medications that would affect the heart.”
As neurologists refine the concept of the “appropriate patient” for Gilenya, with limitations regarding cardiac history and concomitant medicines that can impact heart rhythm, there may be a modest slowing of prescriptions, said Krieger.
The likely approval of Sanofi’s (EPA:SAN) teriflunomide and Biogen’s BG-12 in the coming year may also impact use of Gilenya, as it may cause neurologists to hold off on switching a patient to this oral medication in anticipation of additional options, said Krieger.
Gilenya is a very interesting drug and it affects the S1P receptor, which is on every cell, and every organ in the body, Blitz-Shabbir explained.
A neurologist on background said one concern when Gilenya was approved was the fact that the circulating white cells decrease, so nobody really knows the long-term effects.
The reason why patients are willing to go on Tysabri is because it’s the most efficacious drug on the market, Blitz-Shabbir claimed. She said she was unsure whether Gilenya is the best drug, adding it doesn’t warrant the risk. Dr Samuel Hunter, a neurologist at the Advanced Neurosciences Institute in Tennessee, said Gilenya will be a “huge pain” for the majority of patients. Costs have been increased and inconvenience thousands of people for the benefit of rare individuals who are easily identified as being at risk by history and ECG, he said. Physicians do not want to take the time or trouble to screen these issues, especially unnecessarily, he added.
Novartis’ (NYSE:NVS) multiple sclerosis (MS) pill Gilenya faces slowing prescriptions in New York because of a lack of facilities to perform first-dose observations, neurologists told Biopharm Insight. However, Novartis has been in contact with a number of clinicians and is working on increasing the number of sites.
A US Food and Drug Administration (FDA) review was initiated after a patient died within 24 hours of taking the first dose of Gilenya. Regulatory authorities also re-evaluated study data regarding the drug’s effect on heart rate and blood pressure.
Gilenya is now contraindicated for use in patients with certain pre-existing or recent heart conditions or stroke, or those taking certain antiarrhythmic drugs, according to FDA. Extended monitoring is recommended in patients with QT prolongation and in patients who are already taking medication that slows heart rate. Observation includes continuous overnight electrocardiography (ECG) monitoring.
A Novartis spokesperson said via email the company is committed to helping healthcare providers implement the updated prescribing information recommendations.
Gilenya sales in 2011 reached USD 494m.
Monitoring requirements and set up
There is no official Novartis-arranged facility in Manhattan to perform first-dose observations at this time, but this is likely to change in the very near term, according to Dr Stephen Krieger, assistant professor of neurology, Corinne Goldsmith Dickinson Center for MS, Mount Sinai Medical Center, New York. Dr David Snyder, director of the Multiple Sclerosis Center at New York Hospital Queens, added there is no facility available in New York City. “There is a facility in Secaucus, New Jersey, where one [of my] patients in New York is going,” he noted.
At his hospital, Snyder noted that he is not in a position to do an ECG. He noted that patients need to be referred to a cardiologist to assess if the patient can take Gilenya. “We don’t repeat the ECGs in our office, but now the new guidelines indicate that you do need to get ECGs before and after dosing. We cannot do that,” Synder explained.
He said the same issue is likely to affect other private practice neurologists. Dr Aaron Miller, professor of neurology at the Mount Sinai School of Medicine, said there are one or more sites in New York that have been identified to conduct monitoring. “We work directly with Novartis to find a site,” he said.
Novartis currently has a system in place with a “nurse navigator” to facilitate arranging monitoring and first dosing, Krieger noted. He said he believed this program is being updated to arrange first-dose centers that meet the new, heightened requirements.
If a neurologist wishes to arrange the first-dose observation themselves, then either hospital admission or contracting with a facility that can perform continuous monitoring can be done, Krieger added.
This would likely be akin to Biogen Idec’s (NASDAQ:BIIB) “TOUCH-certified” infusion centers for Tysabri administration in the US, he added. The TOUCH program monitors deaths, and physicians know the risks with Tysabri, stated Dr Karen Blitz-Shabbir, director of the North Shore MS Care Center in East Meadow, New York.
Physicians can stratify risks with Tysabri, while Gilenya is more difficult because we do not know how people are dying, she said. Blitz-Shabbir said two of the 11 deaths associated with Gilenya were from drowning and appear to be cardiac-related. There has been no information given to physicians about the cause of these patients’ deaths, she noted.
Novartis needs to expand its Gilenya Go program to a more comprehensive case-management system for doctors and patients to be able to efficiently use the drug, said Dr Daniel Kantor, president of the Florida Society of Neurology, who was an investigator on Gilenya. Kantor said he is currently trying to figure out what to do for patients who need hospitalization. In the US, Novartis continues to offer pre-tests and first-dose observation capabilities at a network of clinical centers that provide assessments and screenings, but not 23 hour observations, that may be needed by patients taking Gilenya called the Gilenya Assessment Network (GAN), the spokesperson said. It currently comprises close to 250 sites around the country, and sites are accessible within 30 miles of Novartis’ customers and growing rapidly, the spokesperson added.
Gilenya’s efficacy is still great, but it’s really the logistical factors associated with the drug, Kantor noted. The safety data suggests that despite some questions in clinical practice, Gilenya is overall associated with a very low chance of cardiac signs or symptoms, noted Kantor. Because of recent events, Snyder said his prescribing process has slowed down somewhat. If patients are doing well on the current injectables, Snyder said he would not switch to an oral drug just because of patient convenience. In terms of the number of unexplained deaths, one US patient who was on Tysabri and then was switched to Gilenya, developed progressive multifocal leukoencephalopathy (PML) shortly after the change, Snyder said.
Declining use
MS centers are using it less frequently, and it’s mostly used by general neurologists rather than MS specialists, Blitz-Shabbir said.
Gilenya’s efficacy is still great, but it’s really the hassle factor associated with the drug, Kantor noted. Because of recent events, Snyder said his prescribing process has slowed down somewhat. If patients are doing well on the current injectables, Snyder said he would not switch to an oral drug just because of patient convenience. In terms of the number of unexplained deaths, one US patient who was on Tysabri and then was switched to Gilenya, developed progressive multifocal leukoencephalopathy (PML) shortly after the change, Snyder said.
Some of the unexplained deaths were due to inappropriate patient selection by the physicians involved, Snyder stated. “I emphasized that the patients that we select for Gilenya use are young, free of any CV disease, and are not on any medications that would affect the heart.”
As neurologists refine the concept of the “appropriate patient” for Gilenya, with limitations regarding cardiac history and concomitant medicines that can impact heart rhythm, there may be a modest slowing of prescriptions, said Krieger.
The likely approval of Sanofi’s (EPA:SAN) teriflunomide and Biogen’s BG-12 in the coming year may also impact use of Gilenya, as it may cause neurologists to hold off on switching a patient to this oral medication in anticipation of additional options, said Krieger.
Gilenya is a very interesting drug and it affects the S1P receptor, which is on every cell, and every organ in the body, Blitz-Shabbir explained.
A neurologist on background said one concern when Gilenya was approved was the fact that the circulating white cells decrease, so nobody really knows the long-term effects.
The reason why patients are willing to go on Tysabri is because it’s the most efficacious drug on the market, Blitz-Shabbir claimed. She said she was unsure whether Gilenya is the best drug, adding it doesn’t warrant the risk. Dr Samuel Hunter, a neurologist at the Advanced Neurosciences Institute in Tennessee, said Gilenya will be a “huge pain” for the majority of patients. Costs have been increased and inconvenience thousands of people for the benefit of rare individuals who are easily identified as being at risk by history and ECG, he said. Physicians do not want to take the time or trouble to screen these issues, especially unnecessarily, he added.
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