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Archive for Alpharadin (radium-223)

According to Prostate Cancer UK The National Institute for Health and Care Excellence (NICE) has released its second draft decision on the availability of radium-223 (Xofigo). Different from the original draft this draft recommends that radium-223 be made available on the NHS for men with advanced prostate cancer that no longer responds to hormone therapy (castrate resistant prostate cancer) that has also spread to the bones. However, they only recommend it for these men if they’ve already been treated with chemotherapy.

The Scottish Medicines Consortium (SMC), which operates independently of NICE, hasn’t yet considered radium-223 availability on the NHS in Scotland. So at the moment men north of the border still are not able to have this treatment.

Radium-223 is given by injections into the vein, where it travels in the blood system and then finds its way to the bones. It mimics calcium and is taken up by active bone cells and since the cancer cells are more active than regular bone cells the cancer cells are more likely to pick up the radium-223. Once absorbed by the cancer cells the radioactivity kills them. The upside of this is that the side effects are minimal because healthy cells aren’t damaged.

In March, NICE said that they couldn’t recommend radium-223 be made available on the NHS. They said that Bayer, the pharmaceutical company who made the drug, hadn’t given them enough evidence of how well radium-223 performed compared to appropriate treatments currently available. Bayer did supply the requested information to allow NICE to reverse their guidance.

Malecare agrees with Prostate Cancer UK that this is good news, but only limited good news as men will still not be able to access radium-223 until they have had chemotherapy exposure. This condition means that men will have to suffer with bone pain when it might not be necessary, some men are not able to have chemotherapy because their disease has progressed making them too frail and sick to have chemotherapy and others elect not to have chemotherapy because of its side effects. Not only will this cause increased and unnecessary suffering, it will also deny men who do not have chemotherapy for any reason the possible life extension that radium-223 might offer them.

NICE decided not to make radium-223 available before chemotherapy because they didn’t think it was as cost-effective as it would be after chemotherapy. This is a faulty conclusion because in their analysis the group of men who hadn’t had chemotherapy, they measured the cost against ‘best supportive care’ (in other words no drugs), so of course radium-223 was more expensive. When they assessed its use after chemotherapy exposure radium-223 was compared to abiraterone (which is more expensive than no drugs), so radium-223 appeared to be a relatively good value.

Malecare appreciates this decision, but would like to see NICE re-evaluate it so that men who have not had chemotherapy could also access the treatment.

Joel T. Nowak, M.A., M.S.W.

A few weeks during a devistating manufactoring problem and eventual shut down of all production many men who were relying on Xofigo (radium-233 dichloride) were put into the untenable position of missing their scheduled doses. There was mass confusion about what to do in this circumstance. Men and their doctors didn’t know if they should just continue to wait for the problem’s resolution or to move on to a different drug. When the problem was resolved there was no evidence based information that could guide men if they should just start taking their Xofigo where they left off or perhaps attempt to start the protocol again from the beginning.

In reality we will never know what was the best course nor what the actual result of the shortage of the drug wil be for the men who missed their treatment.

Yesterday there was a joint media release from Bayer HealthCare and Cardinal Healthcare announcing that thet have entered into an agreement which will have Cardinal build a new 64,000 square foot plant in Indianapolis to manufactor Xofigo. The plan calls for the product made by this plant to be distrbuted in both the United States and in Canada. The plant s scheduled to come on line in 2017.

At the time of the crisis Malecare was told that there were plans to build a new plant in the United States. This announcment clearly fufills this promise, but it still falls short as a perfect solution to another large plant shutdown.

The current plant in Norway will continue to manufactor Xofigo, but as the drug continues to grab market share it would not be capable of picking up the slack if there is another shut down.

We applaud Bayer HealthCare and their affirmative action. But, we also ask them to consider building another, third plant that might be able to step into a problem and mediate the affects of one plant being closed. Putting all your eggs into one basket isn’t always the best solution.

See the press release: http://ir.cardinalhealth.com/m/#/Press_Releases/b1986ef2-849c-4297-9123-e2ce10a75f05

The world wide supply of Xofigo (radium Ra-223 dichloride) available for patients will run out on October 10, 2014. Xofigo is the newly FDA approved treatment for men with castrate resistant metastatic prostate cancer (CRPC) with bone metastases without any known visceral metastases.

Individual batches of drugs are inspected prior to release to patients. Bayer’s regular inspection process found that two batches contained material unrelated to Xofigo.

The FDA posted a notice about a Xofigo shortage on October 7, 2014. Malecare obtained more information from Ms. Gissoo Decotis, Deputy Director of Oncology Advocacy Relations and Joseph Germino, MD, PhD, Vice President of United States Medical Affairs for Bayer HealthCare, LLC.

Dr. Germino assured Malecare that all doses of Xofigo that have been released to either their commercial patients or to men in clinical trials, have passed all inspections and are completely safe. Dr. Germino said, “patients should not be worried or concerned about the quality of the material that has been shipped or administered. “

Bayer is in the process of informing all physicians who do administer Xofigo about the production halt, said Ms. Decotis. If you are a man currently taking Xofigo or are interested in starting Xofigo, contact your doctor today.

In a way, this is good news. The drug inspection and safety process seems to work. Bayer not only seems to have acted quickly, but is keeping Malecare informed so that we can keep you informed. The bad news is that as of today, no one at Bayer knows what caused this contamination, according to Ms. Decotis. Some men might not receive Xofigo on schedule and others will need to delay their treatment. Indeed, some…if not, many, men…might not live long enough to see the supply replenished.

The length of time it will take for Bayer to resolve the problem and then to restart production will be of concern to men who have partially completed the protocol. Xofigo is delivered as an injection into a vein once a month (every 28 days) over a six month period for a total of six injections. Ms. Decotis reports that the total shelf life of radium-223, the main component of Xofigo, is approximately four weeks and its half-life is approximately 11 days.

Paragraph removed. Please click here to see October 10 posting explaining why.

According to Ms. Dicotis, Bayer’s statement is, “At this time, Bayer is unable to anticipate when distribution of Xofigo can be resumed.”

Xofigo is manufactured by only one plant, in Norway.

BOTTOM LINE

1- Bayer has assured us that any drug received by anyone to date is safe and meets all quality standards.
2- How long this production shut down will last is unknown.
3- Men in the middle of receiving Xofigo should contact their physicians to discuss what, if any, alternative treatments might be appropriate at the present time.

Malecare will continue to monitor the situation and make sure that all of our readers are kept fully informed as we learn more about this situation.

Joel T. Nowak, M.A., M.S.W. and
Wendy A. Lebowitz, Ph.D., M.P.H.

Somehow I have been negligent and not let people know that I have written and posted a major update of my “Guide to Advanced Prostate Cancer.” As in the past, it is available as a free download from the Malecare web site. Helping me to update the book was prostate cancer survivor Craig Pynn and my own caretaker, Wendy Lebowitz.

Anyone reading the first edition will be surprised when you see how many changes and updates this edition has included. It now has a very extensive conversation about living in the world as a cancer survivor as well as more information on how to deal with your doctors. There is additional information about the newest drugs and treatments available to those of us living with advanced prostate cancer.

This book is different from anything else you have read about prostate cancer. It is written squarely from the survivor perspective with multiple tips and out of the box ideas about coping with prostate cancer and its treatments. Prostate cancer survivors suggest many of the ideas and “fixes” as they share how they have dealt with the disease and the treatment side effects.

This book is not doctor oriented or doctor written. It is accurate and honest. It deals with the real issues we as prostate cancer survivors face on a daily basis.

Due to the support of Malecare it is offered without any charge. To download the book go to the Malecare web site (www.malecare.org) and then click on the tab marked Advanced Prostate Cancer. There you can sign up by providing your email address to receive the link to download the book.

The first edition was downloaded over 50,000 times. I received many very positive reviews, but I believe this updated edition is much better.

Joel T Nowak, M.A., M.S.W.

Officials from the National Institute for Health and Care Excellence (Nice) have made a preliminary decision not to recommend covering the drug radium-223 dichloride (Xofigo) for use for men with prostate cancer that has spread to the bone.

This latest draft guidance from Nice states that Bayer has not provided information on how Xofigo performs in contrast to other currently available drugs for use in the health service in England and Wales.

Malecare is urging that Bayer provide the required information prior to NICE making their final determination so that men in need will not be denied this safe and effective drug.  We know that Xofigo can extend survival by 3.6 months and improve the quality of life with only minor side effects.

Men qualifying for Xofigo are already have very progressed disease with multiple bone metastases.  It is nothing short of criminal that they be denied this proven treatment, especially when they are in a position where there are so little alternatives and often suffering with significant pain.

According to Nice chief executive Sir Andrew Dillon: “Clinical specialists told the committee that radium-223 (Xofigo) would be used as an alternative treatment option to docetaxel as an initial treatment, and abiraterone as a second-line treatment when the disease has progressed. However, Bayer did not to provide the committee with any data on how well radium-223 works compared to docetaxel or abiraterone or, only comparing it to a placebo.”  I find this confusing, as Xofigo should not be used as an alternative to docetaxel or abiraterone, but as an additional treatment.

Joel T Nowak, M.A., M.S.W.

Most people don’t know of the great work that has been carried out by group of determined advocates on behalf of men with advanced prostate cancer. These hard working advocates, who reach out across different advocacy groups (Malecare, PCRI , PHEN, PAACT and USTOO) have formed a committee they call the The Early/Expanded Access Committee (EAP).

The EAP meet with pharmaceutical companies on a regular basis to encourage them to make their promising drugs and treatments available to individuals before they have formally received FDA approval. They do this by the way of a vehicle they call the Early Access Program (EAP). The EAP identify drugs that are designed to treat men with advanced prostate cancer, that during their phase III trials clearly demonstrate great safety profiles and excellent efficacy, but have not yet received formal FDA approval.

As mentioned, the EAP meet with pharmaceutical company representatives to open the door for drug access, they help identify doctors who are willing to use these drugs, under the FDA guidance as a EAP clinical trial so that men don’t need to wait around for formal FDA approval. Not only does this program offer early access, it provides the pharmaceutical company and the FDA with a wealth of additional material about the safety and efficacy of the treatment which can be factored into their ultimate decision about approval.

THE EAP provides new hope for families around the world, they provide a paradigm that will be used in prostate and all other cancers in a short period of time.

The EAP has had three major successes to date, abiraterone, enzalutiamide and radium 223. Each of these drugs was made available to men in need prior to their receiving approval from the FDA, with the blessing of the FDA. The EAP recently performed an analysis of their impact with each of these drugs.

Jan Manarite (PCRI) who is an active member of the EAP, for the EAP “After the Expanded Access Committee had some success promoting and encouraging Expanded Access with our 3rd drug (radium 223), I always wanted to get the numbers, just to see what we did. Here’s what it looks like. I continue to think that small groups with simple goals can do big things….”

————————————————————————————————————————————

EAP Numbers – Patients Served

abiraterone *-    432 men received the treatment under the EAP from 33 states and the District of Columbia from Oct 2010 – Apr 2011

enzalutamide ** 508 men received the treatment under the EAP from  25 states and 6 Canadian Provinces from May 2012 – Aug 2012

radium 223***   200 men received the treatment under the EAP from 18 states from Jan 2012 – May 2013

TOTAL MEN SERVED –     1140

Sources:

* Joanne M. Vanak, RN, MSN, Senior Director, Scientific Advocacy, Janssen – 1/16/14

** Nahla Hasabou, MD, CCRP, Medical Monitor, Oncology Medical Science, Astellas – 9/3/13

*** Svetlana Babajanyan MS MD, Medical Director, Bayer HealthCare Pharmaceuticals Inc. – 8/5/13

This program is a roaring success fostered by the hard work from a number of different prostate cancer advocacy organizations as well as a number of dedicated physicians and researchers.  One also needs to acknowledge the supportive role that the FDA has decided to take in encouraging these Early Access Trials.

Joel T. Nowak, M.A., M.S.W.