Anxiously Waiting
 

Apparently Barbs doctor has called Genentech and asked for compassionate access to TDM-1. They have responded with an OK to give her the drug so now we are waiting for the hospital treatment center here and Genentech to hammer out the details. We are told there is a lot of paper work, Barb will be the first patient to receive the drug here. My only concern at this point is the financial end, were not sure what to expect. Is there any experience out there with compassionate use of TDM-1? How does most insurance handle this? I dont want to call my insurance company just yet they have been known to slam the door on us in the past.

Re: Anxiously Waiting
 

Are there costs associated with expanded access, sometimes called "compassionate use"?

Investigational drugs are expensive to manufacture. Some companies provide the drug for free to patients. Other companies charge patients costs associated with the manufacture of the drug. Most insurance companies will not pay for access to an investigational drug. In addition, there may be additional costs associated with administration and monitoring of the investigational drug by healthcare professionals.

http://www.fda.gov/ForConsumers/ByAu.../ucm176098.htm

It's probably wise to discuss who will carry burden of cost for treatment with Genentech.

Re: Anxiously Waiting
 

Mike, that's a win! Yes! Please keep us posted on your progress, and I hope Barb is feeling well. You wrote an incredibly moving post on "Who We Are." You really need this break.
Warmly,
Karen

Re: Anxiously Waiting
 

I/insurance doesn't pay Genetech for the drug for compassionate use to the best of my knowledge, Genetech pays to administer it and collect data... I am only responsible for travel (I go from TX to CO every 3 weeks) and insurance is responsible for scans (every 12 weeks I have to get a CT of neck down and an Echocardiogram of the left ventricle - LVEF, done by my cardiologist... it has to record above 50%).

Best of luck.

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Keeping my fingers crossed for you !!

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Mike, when I was on the TDM1 EAP, Indid not pay for anything except my scans, I did have to sign aa lot of paperwork, and was monitored quite closely...even my LVEF was below 50 but the Dr persisted and Iwas still able tomet the drug...hoping you get it soon with no issues, and that it is the perfect drug!

Re: Anxiously Waiting
 

Now were told it will take 6 weeks to get the TDM-1 under compassionate use at our location. Apparently the drug has never been administered here so there are some hoops that have to be jumped through. I cant imagine us sitting back for six weeks and doing nothing. Her doctors office went so far as to recommend looking into the Th3resa Study but my understanding is Barbs enrollment in the Emelia study last year would exclude her even though she technically did not participate because she was randomly assigned the Tykerb leg and we already had a script for the Tykerb. We decided to not get the Tykerb filled because it would have excluded her from the Emelia Study. It really is ridiculous to have to go through all this to get a drug that could really help. I was also told by an administrator at the hospital that if we pursue the Trial she would be excluded from further compassionate use. So if I understand all the crap they have thrown at us today we have no choice but to sit and wait 6 weeks for compassionate use.

Re: Anxiously Waiting
 

Mike
Just wanted to say how sorry I am to hear that you will have 6 more anxious weeks to wait till you get this drug. It is soul destroying that we have to jump through numerous hoops to get potentially life saving drugs,it's just so unfair.
Please try and not let this blip grind you down.
Ellie

Re: Anxiously Waiting
 

Mike,

I see you are in Shelby NC. Where are you receiving treatment?

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If she is on Tykerb, like your signature shows, then there would be a washout period anyway from the Tykerb? Ask your Onc about this while you are waiting for your location to be set up. There may be a silver lining...

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Mike and Barb you are in my prayers. Gods blessings to you. Peace

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Talked to the Hospital coordinator and the Onco Nurse were still waiting for the final word. Apparently this drug has never been administered here so theres a lot of hoops to jump through. Barbs Onco. was under the impression there was a three week clean out period so she hasnt had anything since the end of June. The three week clean out appears to apply to clinical trials Emelia and Th3resa. Compassionate access doesnt require this. She will start back on the Navelbine and Herceptin till the TDM-1 comes in were told possible another week or two.

Re: Anxiously Waiting
 

Mike,

I wanted to let you know that papers for me to cross over to TDM1 were waiting for me two weeks ago when I went to the oncologists. Women who got the Xeloda and Tykerb are be considered to get the drug now. Something was said about data in October and the medicine in December. I need the medicine sooner. Please let me know if you hear anything about this.

Amelia

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See if Sonali at Genentech has any info for you... she is a patient advocate and extremely helpful.

Sonali Padhi, MBA, MPH
Associate Director, Advocacy Relations
Genentech, Inc.
Office: 650.467.0842
Mobile: 415.269.7040
sonalip@gene.com

Re: Anxiously Waiting
 

My wife is doing excellent on t dm-1 , in her 21st month. wirks best in straight up high her2 overexpression, but may not work as well w/ other hormone factors mixed in , ER + for ex.
My understanding is that Gen. pays for the drug itself in comp use, but ins, must pay for scans, labs etc.
If you are in NC, are you near Duke ? Thats where the principal investigator for EMILIA, Dr. Kim Blackwell, did her work. So thyey may do comp use quicker.
If you are in NC, call your Sen Hagans office , ask for the aide who works w/ healthcare issues, and call their counterpart in thier DC office. She seems to be intersted in helping cancer pts , is sponsoring a Bill , the TREAT ACT , to overhaul FDA approval process. She is on HELP Committee , which oversees FDA. Remember, if This FDA had done its job in 2010, T DM-1 would have been approved then. And we wouldnt be in this struggl;e. Put in a word for us as activists w/ Sen Hagan. my wife , Lorraine , and I, Phil McCartin, are well known by our senators staff, Sen. Kerry, ( megan thompson ) Sen. Brown ( chris holt ) . We have asked thier staff to arrange for us to meet w/ Sen hagan about her Bill. But we are not from her home state , so its dragging out . Good luck. have your Sen. push your hospital IRB too , ( internal review board , who approve " off protocol ", and comp use at thier facility ), and push your ins co , if they give you trouble . We had our Sen offices call Gen. , and later our hospital IRB , it helps to let Big Business, Big Govt, Big Hospitals, and Big Ins , know that they are being watched for thier roles in the War On Cancer . think about contacting media too, to expose the awful hassles that curent comp use bureaucracy causes us.
So if your hosp[ital drags it out much more, maybe sw itch to a research hosp like Duke ? if your wife hasnt been on navelbine before, it worked for my wife for about 9 months, ( tykerb worked for about 6 months , s/e were bad, i think comp use may only require a2 week washout ?, and i dont hink using tyk or nav precludes comp use ? , not sure ). good response w/ Nav. or Tyk gets you closer to the t dm-1 approval time-frame . Maybe by Dec. We activists will continue to Push This FDA to make it evn quicker .

Re: Anxiously Waiting
 

Brenda;
I talked to Sonali today she was very helpful, I also heard from our hospital. Barb had an echo done this afternoon this was needed for the FDA approval of comp. use. They are telling us if all goes well we should see the drug sometime next week. Barb has had several echos done in the last two years and has had no problems at all. Hopefully we will get good news next week.
Phil
Thanks for your response I will see what I can do to talk to Kay Hagan I really appreciate all you have done and continue to do for this cause. I wish I could be as proactive as you have been it just seems like I get paralyzed at times and dont know where to turn.

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Mike you are doing an awesome job taking great care of your wife? Your great love for her shines through every post you write! God, love knowledge and support is your best defense. Awesome!

Barb and you are in my prayers. Gods blessings to your beautiful family.

Peace my friend,

Nancy

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We are so happy that your wife gets a shot at this wonderful drug ! I will never forget the look on our onc's face when she came back from San Antonio 's Conference in 2009 ! 2009 ! saying ' this could be a home run ' for pts w/ strong overexpression of her 2. For Lorraine , she was exactly right so far ! For me, I was ready to get it. my first wife and i talked our way into atrial in 90. so i already had some experience w/ the "System ". So i looked into comp use, called FDA in Spring , 2010. What arude awakening ! N0 help whatsoever. So we tried to get it at farber. All set to go ; FDA pulled the rug out in Sept 2010 ! talked w/ anurse at farber. Nurses tell it like it is, they dont have to kiss This FDA or Big Business you know what , like the Silent docs in this country. Again , i'll never forget the look on Lorraines face after talking w/ the nurse. Tough Southie RN, Said " Honey , we share trial slots w/ 3 other hospitals, it could be months . If you have to go to Va to get this drug , GO , GET THE DRUG ! " The tone of voice said it all ! So there we were in DC, down the street from Cap Hill. Give Lorraine the credit, still suffering fro another battle w/ adria, riding the chilly subway to the Hill. You should have seen the look on the Senate aides faces when they heard her story ! Your story has Power . You t dm-1 success stories need to Meet them , tell your story to media, Congress. Mike , right now your job is to fight for your wife and family, you will tell your story later , im sure . God Bless ! You have our Prayers for more Healing , Blessings !

Re: Anxiously Waiting
 

Wonderful Mike... glad Sonali was able to help you!

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Heres the latest on Barbs situation, we met with her Dr. Monday afternoon. Right now the FDA is asking for a written statement from Genentech stating Barb may have the TDM-1. We already know the Dr. has talked to Genentech and they said yes but apparently thats not prim and proper to the FDA GRRRRR. We also learned that Barbs white count is slightly low so if we had the TDM-1 today she couldnt have it and her Dr. will be out of town for 1 week next week so it will be at least the 20th before she can get TDM-1 if all goes well. Shes scheduled for Navelbine next week after a week off but were told if the TDM-1 is approved to pass on the Navelbine and clean out so she can have the good stuff when he gets back.

Re: Anxiously Waiting
 

I keep a notebook titled " FDA Blocks Life saving Drug ". You may already do the same. helps me to jot down chronological delays due to FDA , and includes the other " players " in this System, including Genentech , Partners IRB , Congress, Media, Doctors, Big Advocacy , etc. Focus on This FDA, who talks with you , who refuses to ( the decision-makers ), etc. For a future reckoning, perhaps via Sen Hagan , others.
Most importantly , we went through a similar crazy few weeks in 2010 , thankfully our doc was completely in our corner, ( once she saw we wrer comitted enough to go Va. just for enrollment ) giving low dose adria, considered tyk too, checking labs like white count , LFT's etc. every week, to get Lorraines counts up to standards, right up to the 2 week washout that exp access required . be assertive , politely question EVERYTHING , i. e. what is their expected washout time frame ? , etc. I personally would think it mimics exp access , 2 weeks. Be the " squeaky wheel ". e-mail me at pmccartinjr@comcast.net , if you want. we can talk.

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See on another thread , some say t dm-1 could be approved Sept 15 , hope thats true, but i know first hand that even oncologists pass along rumors .
If true it would be AWESOME !! I'll believe it when we see it . By This FDA standards it would be very quick, i dont know that they have even gotten the final data from Gen yet. It is Coming !!

Re: Anxiously Waiting
 

If I understand and am not wrong, a clin trial coordinator I know says that a look at data would be potentially in Nov/Dec at the earliest for TDM1... they have to file a BLA first, and that usually takes up to 6 months. If FDA likes what they see, they it would gain approval. Don't know where it is in the pipeline right now, but I will ask.

Re: Anxiously Waiting
 

Finally heard from Barbs doctors office today, the FDA finally approved her for the TDM-1 compassionate access. We were told some papers had to be signed by lawyers representing the practice administering the drug which should happen in the next 24 to 48 hours and we should see the drug here next week. We canceled here scheduled treatment today for Navelbine and Herceptin knowing that she wouldnt be able to do TDM-1 soon if she had Herceptin today. She and I are excited to get this in her system and were praying it does what its designed to do. Thanks again for all the encouraging words.

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Mike, so happy for Barb that she can get tdm-1. Glad she can start next week--hoping she sees a great response to this drug.

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OH, SO glad to read this latest positive development. I am sure it was time consuming and a lot of work, but that is the only way to punch through such barriers.

I believe that Brenda is right about the time frame for T-DM1 approval - Sept 15 is several months TOO early. Once Genentech has something more difinitive, I am sure we will be hearing on this board.

Re: Anxiously Waiting
 

Happy for you and your wife, it is a powerful drug for those w/ high overexpression of her2 . My wife is well into her 21st month , about 10 months NED. Some others are twice as far along as her.
Sept 1 will mark TWO Years of FDA delay on T DM-1 . It galls me to hear Pres. Obama last week , " making a pitch to women voters " , ( Boston Globe ) , saying that healthcare issues " resonate " w/ him because of his mothers battle w/ breast cancer 20 yrs ago, " I often think about what might have happened if a doctor had caught her cancer sooner ". I feel for anyone whos lost a family mbr to cancer, but if he only knew what His FDA is doing w/ drug approvals ! Someday soon he will !

Re: Anxiously Waiting
 

Mike,
This is such exciting news! I'm so happy for both of you!

Please give Barb my best, and remind her that we're all behind her...praying for her, and sending warm thoughts.

Clearly, you are a devoted, and loving husband! Your relationship is inspiring, and I'll be adding prayers for you too!

All the best,
Denise

Re: Anxiously Waiting
 

You are an amazing guy---so happy for your family that Barb at least gets a chance at a drug that might work. That is all any of us want--just a chance. Could they make this any more stressful?

I wonder if you would be willing to share the letter that finally got compassionate use approved for your wife. If approval doesn't happen soon I am going to try this route and I would like to see how to write a request that gets a yes answer. Thank you. My e-mail is nana@lamarca.org.

Your family is in my prayers.

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Great news Mike! So happy for Barb and your family.

all the best
caya

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Mike, how wonderful for you and Barb! I will be hoping and praying it works quickly for her. Gods blessings to your family.

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Im so happy for you both. Every time someone fights and wins, it's a victory for us all. The time will come when I will need this drug, and many others, and you are paving a road others may need to follow until this drug gets approved. Please keep us updated on how it all goes...Im certainly sending lots of prayers and positive energy. :)

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Mike,

Thanks for sharing the good news. There're always obstacles in life. But 'love never fails'...

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So much for 24 to 48 hours! We were told last Tuesday that thats how long it would take to get the papers signed. After several calls Monday and Tuesday I recieved a call late yesterday saying the papers were hand delivered to someone in Charlotte and we should hear something by the end of the week. You have to wonder if it was their husband or wife if it would take a week to get the papers signed. So here we are again anxiously waiting to hear when Barb can go get her first TDM-1 treatment. Its all been approved we just cant seem to get it here fast enough. I was told a long time ago that praying for patience can have painful consequences but I sooooo need some right now.

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This seems like a good time for my favorite mantra, "keep the faith" You have been such a soldier, so stalwart. I know this good thing will happen for you both. God bless.

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TDM-1 will be here tomorrow 8/24 appointment with Onco Monday 8/27 for labs and sign consent to be a guinea pig and 8/28 Start TDM-1
Hallelujah

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Yippee!!

all the best
caya

Re: Anxiously Waiting
 

Yay!
Thanks so much for letting us know!
All the best to both of you!
You made my day!
Denise

Re: Anxiously Waiting
 

Hallelujah is right!

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At last! Woohoo!