We've got some good news for multiple myeloma patients and caregivers in Europe.
A key advisory committee has recommended that the European Medicines Agency approve Kyprolis for the treatment of relapsed multiple myeloma. The European Commission (EC) will make the final decision on the matter, but it generally follows the recommendations of its advisory committee.
The EC's decision is expected within about three months.
Here is a link to a press release with information about the advisory committee recommendation.
"Amgen Receives CHMP Positive Opinions For Two New Treatment Options For Patients With Blood Cancer In Europe," Amgen press release, Sep 25, 2015.
The press release notes that the European approval would be based on the results of the ASPIRE trial. Those results are described at length in the press release.
If the advisory committee decision is followed, Kyprolis would be approved in Europe for use in combination with Revlimid and dexamethasone in myeloma patients who have had at least one prior therapy.
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Re: Kyprolis recommended for approval in Europe
That is good news for the EU, and I hope that many countries would fund the drug if approved also.
Kyprolis is also being reviewed by Health Canada, and I really hope it gets approved here also. If it were to be granted a DIN (drug identification number), then individual provinces would decide whether or not to fund Kyprolis, but the pricing would be worked out at a national level. People with private drug insurances might be able to get it before provincial approvals though.
I read recently that in the UK, at least for some patients, Revlimid and Pomalyst may no longer be funded. I hope that is not so!
Kyprolis is also being reviewed by Health Canada, and I really hope it gets approved here also. If it were to be granted a DIN (drug identification number), then individual provinces would decide whether or not to fund Kyprolis, but the pricing would be worked out at a national level. People with private drug insurances might be able to get it before provincial approvals though.
I read recently that in the UK, at least for some patients, Revlimid and Pomalyst may no longer be funded. I hope that is not so!
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Kyprolis recommended for approval in Europe
Yes Nancy
It seems that the basis on which Revlimid and pomalidomide were funded for relapsed myeloma could be changed.
Although we have a national health system it does not serve all illness equitably. The high cost of some cancer drugs to the health system have come under intense scrutiny recently. The national body which approves their use in particular clinical situations undertakes its own 'financial and clinical' assessment in relation to the cost/ benefit of each drug iand restricts use. Cancer patients with rarer cancers /incurable cancers have more expensive treatment regimes so are an easy target when health budgets are constrained.
Patients are getting upset about this situation and a petition has been launched.
Each health care system has its own problems for patients, some envy the UK system others here see the USA as offering more choice. The latter deemed so because patients are 'consumers' purchasing their care through their insurance. The degree to which I see some Beacon contributors 'shop' around for their treating doctors is not possible in the UK. Second opinions are about as far as one can go- unless one pays privately for health.
The UK does not feel a good place to be for myeloma patients at present. It is just as worrying for the haem oncologists who treat them.
Edna
It seems that the basis on which Revlimid and pomalidomide were funded for relapsed myeloma could be changed.
Although we have a national health system it does not serve all illness equitably. The high cost of some cancer drugs to the health system have come under intense scrutiny recently. The national body which approves their use in particular clinical situations undertakes its own 'financial and clinical' assessment in relation to the cost/ benefit of each drug iand restricts use. Cancer patients with rarer cancers /incurable cancers have more expensive treatment regimes so are an easy target when health budgets are constrained.
Patients are getting upset about this situation and a petition has been launched.
Each health care system has its own problems for patients, some envy the UK system others here see the USA as offering more choice. The latter deemed so because patients are 'consumers' purchasing their care through their insurance. The degree to which I see some Beacon contributors 'shop' around for their treating doctors is not possible in the UK. Second opinions are about as far as one can go- unless one pays privately for health.
The UK does not feel a good place to be for myeloma patients at present. It is just as worrying for the haem oncologists who treat them.
Edna
Re: Kyprolis recommended for approval in Europe
Thanks Edna for clarifying that upsetting news, since now chemotherapies are not funded, that previously were funded. I guess this is a cost cutting measure, but sort of short sighted. Chemotherapies can prolong life, and improve QOL also. I hope that the petition is successful. My source of this information originally was from a patient's blog, so I think that word is getting out about it! Some of the cancers were not rare, such as prostate, and bowel, but blood cancers were also included. I tried to link the article from the Daily Telegraph, but couldn't ...guess my computer skills are limited.
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Kyprolis recommended for approval in Europe
Nancy the issue upsets myeloma patients because they are aware of new treatments being approved / in the pipeline which can extend life with quality of life and are unable to have them, unless accessed through a trial. The doctor at my centre told me they do not generally put forward people for trials until they have had 3-4 lines of treatment if the person had not had an ASCT. So even if I want to add a monoclonal antibody at this early stage of effective treatment regime I cannot.
The national assessment body does not appear to recognise the significant increase in life expectancy since these newer treatments were introduced, they focus mainly on the costs vs benefit to average patients. They fail to recognise averages of extra months of life do not give a picture of the very wide range of survival times with significant increases for a great many. The clonality and changeability of the disease also is not factored in anywhere for recognition that averages are not real life people with real life individual outcomes.
I also think myeloma is being seen as an older persons disease and yet the senior nurse at my treating hospital said they had noticed many more much younger people with the disease. Old people are very lucky indeed if they get good care in the UK from my own parent's experiences of poor care in the health and care system when in hospital.
The concern we as myeloma patients have is knowing new treatments are available and being approved in Europe but with little hope of any likelihood of receiving them. It is clear the improvements in life expectancy for multiple myeloma will reverse in the UK if these decisions are not reversed. This is not medical progress and is inhuman. As my general physician stated yesterday to me in discussion, if the prime minister or his family had this disease they would not be denying themselves all available treatment options. So why deny others?
The issue reported in a national news paper is that the drug companies are charging the US and UK health system far far more for cancer drugs than they charge in other countries. So without drug companies being held to account and making the charges realistic we are going to suffer.
If patients did not enter trials drug companies and clinical researchers would have problems assessing treatments with a drug. We as patients I feel need to make a stand and demand the terms on which we will engage in clinical trials- for the rapid benefit of the majority of patients through cost price of drugs plus a small percentage profit when drugs are sold to the health system. That is my view, as we will all start to come against these unfair decisions if nothing is done.
The national assessment body does not appear to recognise the significant increase in life expectancy since these newer treatments were introduced, they focus mainly on the costs vs benefit to average patients. They fail to recognise averages of extra months of life do not give a picture of the very wide range of survival times with significant increases for a great many. The clonality and changeability of the disease also is not factored in anywhere for recognition that averages are not real life people with real life individual outcomes.
I also think myeloma is being seen as an older persons disease and yet the senior nurse at my treating hospital said they had noticed many more much younger people with the disease. Old people are very lucky indeed if they get good care in the UK from my own parent's experiences of poor care in the health and care system when in hospital.
The concern we as myeloma patients have is knowing new treatments are available and being approved in Europe but with little hope of any likelihood of receiving them. It is clear the improvements in life expectancy for multiple myeloma will reverse in the UK if these decisions are not reversed. This is not medical progress and is inhuman. As my general physician stated yesterday to me in discussion, if the prime minister or his family had this disease they would not be denying themselves all available treatment options. So why deny others?
The issue reported in a national news paper is that the drug companies are charging the US and UK health system far far more for cancer drugs than they charge in other countries. So without drug companies being held to account and making the charges realistic we are going to suffer.
If patients did not enter trials drug companies and clinical researchers would have problems assessing treatments with a drug. We as patients I feel need to make a stand and demand the terms on which we will engage in clinical trials- for the rapid benefit of the majority of patients through cost price of drugs plus a small percentage profit when drugs are sold to the health system. That is my view, as we will all start to come against these unfair decisions if nothing is done.
Re: Kyprolis recommended for approval in Europe
Thank you Edna for sharing your knowledge here. I jumped in on the 'Kyprolis in the EU thread' since it seemed to me that there is a disconnect between approvals and reality in the UK. I am really sorry to hear about this too. It seemed that in this case the decision not to fund drugs was across the board, and affected many different cancers. But often, since myeloma is a rare cancer (only 1% of cancer diagnoses are myeloma), the drugs could be very expensive since there is not a large market for them, relatively speaking.
I think that in the U.S. there is an 'orphan drug' designation for rare diseases, and some sort of legislation to help with that. Here there is a push to have a legal system like that too, but as far as I know it is not in place yet. This is just straight advocacy work for concerned citizens who are affected by many rare diseases. Since my diagnosis, I have learned quite a bit about advocacy, but there is always more to learn too. I just feel fortunate that I have been able to learn enough (and am well enough) so far to at least write letters to government! We do that in our support group ... we write on topics of concern to our group of myeloma / amyloidosis patients. I think it is a good idea to do that. Sometimes I wonder if legal challenges will be made to relieve pressure points of the problems of getting drugs to patients who really need them.
I think that in the U.S. there is an 'orphan drug' designation for rare diseases, and some sort of legislation to help with that. Here there is a push to have a legal system like that too, but as far as I know it is not in place yet. This is just straight advocacy work for concerned citizens who are affected by many rare diseases. Since my diagnosis, I have learned quite a bit about advocacy, but there is always more to learn too. I just feel fortunate that I have been able to learn enough (and am well enough) so far to at least write letters to government! We do that in our support group ... we write on topics of concern to our group of myeloma / amyloidosis patients. I think it is a good idea to do that. Sometimes I wonder if legal challenges will be made to relieve pressure points of the problems of getting drugs to patients who really need them.
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
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