NICE (UK) - Final guidance recommendations for Sovaldi & Olysio
Cinnamon Girl said
Mar 2, 2015
mallani wrote:
Hi Jill,
The UK is ahead of Australia in this, but it seems odd to be still talking about the out-dated, expensive Simeprevir. Harvoni is a cheaper and better option.
I'm appalled that 50% of HCV cases remain undiagnosed. A recent survey here put that figure at ~10%. Cheers.
Thanks Malcolm, and I agree about Simeprevir.
I was reading an article recently which suggested that there could be as many as 1.1 million undiagnosed cases of HCV in the UK,out of a population of about 63 million! This was based on the results of a one week pilot scheme in ten A & E departments in England and Scotland whereby every patient was offered the opportunity to be tested for HCV, HBV and HIV. It was only a snapshot but it does suggest that there`s a huge number of people living with HCV without being aware of it.
Here`s a link to the article. from the Hep C Trust website...
Thanks for you comments, Nirmalee, much appreciated.
According to these guidelines, once NHS England has released the funding, the only patient groups who will be able to access Sovaldi + Riba without Interferon will be Gen 2`s who are tx experienced, or tx naive who are interferon intolerant or ineligible, and Gen 3`s who are either tx naive or tx experienced and who have cirrhosis and who are interferon intolerant or ineligible.
Everyone else, all Gen 1`s, 4, 5, and 6, will need to do Sovaldi + Peg/riba, as is the case in the U.S.
Even so that is an improvement on the existing treatment protocols and the people who, like yourself, are in the greatest need for an all oral tx with Sovaldi and Daclasvir or with Ledipasvir, will still be eligible for priority treatment.
It`s true that interferon and ribavirin are old drugs now and they are known to cause lingering post tx health issues in some people but they are still the backbone of treatment for many countries and will be for some time to come. They have also cured many, many people, myself included, and I`m very thankful for that.
Let`s hope that the situation will continue to improve and that many more people will be treated with better drugs, shorter tx durations and minimal side effects.
dragonfly said
Mar 1, 2015
.Following this post it appears that only those who have undergone 2 lots of Interferon/Riba etc will be considered: I know my medical team are lobbying for this criteria to be changed. The fact is that although the older treatments gain you time, they cause a lot of damage For those in the UK who are waiting for this treatment please get in touch with the Hep C Trust as they have an advocacy arm, also with your MP - mine (Sadiq Khan) wrote a letter of support when I went for my 2nd lot of Inteferon; before that I was told that there was no chance of being retreated. I remain totally grateful for this opportunity and will fight for others to receive this life-changing drug regime.
mallani said
Feb 28, 2015
Hi Jill,
The UK is ahead of Australia in this, but it seems odd to be still talking about the out-dated, expensive Simeprevir. Harvoni is a cheaper and better option.
I'm appalled that 50% of HCV cases remain undiagnosed. A recent survey here put that figure at ~10%. Cheers.
Cinnamon Girl said
Feb 28, 2015
Yes Tig, it gives hope for many people over here to see that things are moving forwards, even if slowly.
The delay by the NHS in allowing Sovaldi to be used is purely about the cost, of course, but at least the deadline is only a few months away now and by later this year it should be available to a lot more people who qualify.
All progress is good progress!
Thanks, Jill
Tig said
Feb 28, 2015
Jill,
I'm happy to hear that the process is moving forward and the NHS has a set period in which to make their decision. Every additional treatment approved in the UK is good news for those needing a new or different protocol. I hope the approval comes sooner than later! Every approval like this is one more chunk out of the Dragon's armor...
Tig
Cinnamon Girl said
Feb 28, 2015
Healthcare guidance body NICE has today published final guidance recommending sofosbuvir (Sovaldi, Gilead Sciences) and simeprevir (Olysio, Janssen) as treatment options for some people with chronic hepatitis C.
Sofosbuvir has a marketing authorisation in the UK for use in combination with other medicinal products for treating chronic hepatitis C in adults. The guidance on sofosbuvir recommends its use in combination with ribavirin, with or without peginterferon alfa, as an option for some people with genotypes 1- 6 chronic hepatitis C.
Simprevir has a marketing authorisation in the UK for use in combination with other medicinal products for treating adults with genotype 1 or 4 chronic hepatitis C. The guidance on simeprevir recommends its use, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.
Following a request from NHS England and consultation with stakeholders, the period during which NHS England has to comply with the recommendations for sofosbuvir is extended to 31 July 2015.
The period during which NHS England has to comply with the recommendations for simeprevir has not been extended.
Full press release article and details of recommended treatment options...
Thanks Malcolm, and I agree about Simeprevir.
I was reading an article recently which suggested that there could be as many as 1.1 million undiagnosed cases of HCV in the UK,out of a population of about 63 million! This was based on the results of a one week pilot scheme in ten A & E departments in England and Scotland whereby every patient was offered the opportunity to be tested for HCV, HBV and HIV. It was only a snapshot but it does suggest that there`s a huge number of people living with HCV without being aware of it.
Here`s a link to the article. from the Hep C Trust website...
http://www.hepctrust.org.uk/hunting-silent-killer
Thanks for you comments, Nirmalee, much appreciated.
According to these guidelines, once NHS England has released the funding, the only patient groups who will be able to access Sovaldi + Riba without Interferon will be Gen 2`s who are tx experienced, or tx naive who are interferon intolerant or ineligible, and Gen 3`s who are either tx naive or tx experienced and who have cirrhosis and who are interferon intolerant or ineligible.
Everyone else, all Gen 1`s, 4, 5, and 6, will need to do Sovaldi + Peg/riba, as is the case in the U.S.
Even so that is an improvement on the existing treatment protocols and the people who, like yourself, are in the greatest need for an all oral tx with Sovaldi and Daclasvir or with Ledipasvir, will still be eligible for priority treatment.
It`s true that interferon and ribavirin are old drugs now and they are known to cause lingering post tx health issues in some people but they are still the backbone of treatment for many countries and will be for some time to come. They have also cured many, many people, myself included, and I`m very thankful for that.
Let`s hope that the situation will continue to improve and that many more people will be treated with better drugs, shorter tx durations and minimal side effects.
.Following this post it appears that only those who have undergone 2 lots of Interferon/Riba etc will be considered: I know my medical team are lobbying for this criteria to be changed. The fact is that although the older treatments gain you time, they cause a lot of damage For those in the UK who are waiting for this treatment please get in touch with the Hep C Trust as they have an advocacy arm, also with your MP - mine (Sadiq Khan) wrote a letter of support when I went for my 2nd lot of Inteferon; before that I was told that there was no chance of being retreated. I remain totally grateful for this opportunity and will fight for others to receive this life-changing drug regime.
Hi Jill,
The UK is ahead of Australia in this, but it seems odd to be still talking about the out-dated, expensive Simeprevir. Harvoni is a cheaper and better option.
I'm appalled that 50% of HCV cases remain undiagnosed. A recent survey here put that figure at ~10%. Cheers.
Yes Tig, it gives hope for many people over here to see that things are moving forwards, even if slowly.
The delay by the NHS in allowing Sovaldi to be used is purely about the cost, of course, but at least the deadline is only a few months away now and by later this year it should be available to a lot more people who qualify.
All progress is good progress!
Thanks, Jill
Jill,
I'm happy to hear that the process is moving forward and the NHS has a set period in which to make their decision. Every additional treatment approved in the UK is good news for those needing a new or different protocol. I hope the approval comes sooner than later! Every approval like this is one more chunk out of the Dragon's armor...
Tig
Healthcare guidance body NICE has today published final guidance recommending sofosbuvir (Sovaldi, Gilead Sciences) and simeprevir (Olysio, Janssen) as treatment options for some people with chronic hepatitis C.
Sofosbuvir has a marketing authorisation in the UK for use in combination with other medicinal products for treating chronic hepatitis C in adults. The guidance on sofosbuvir recommends its use in combination with ribavirin, with or without peginterferon alfa, as an option for some people with genotypes 1- 6 chronic hepatitis C.
Simprevir has a marketing authorisation in the UK for use in combination with other medicinal products for treating adults with genotype 1 or 4 chronic hepatitis C. The guidance on simeprevir recommends its use, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.
Following a request from NHS England and consultation with stakeholders, the period during which NHS England has to comply with the recommendations for sofosbuvir is extended to 31 July 2015.
The period during which NHS England has to comply with the recommendations for simeprevir has not been extended.
Full press release article and details of recommended treatment options...
https://www.nice.org.uk/news/press-and-media/nice-guidance-recommends-sofosbuvir-sovaldi-gilead-sciences-and-simeprevir-olysio-janssen-for-treating-hepatitis-c