How long does MSK take to get approval to install HAI pump?

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Zod
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How long does MSK take to get approval to install HAI pump?

Postby Zod » Sun Sep 29, 2019 12:22 am

How long does MSK take to get approval to install HAI pump? Are they able to get whatever approvals are needed quickly once they decide to use the pump on a particular patient?

My understanding is that there can be a 1-2 month wait to sort out paperwork with FDA if getting a HAI pump elsewhere. Wonder if MSK as the same constraint.

radnyc
Posts: 390
Joined: Tue Apr 06, 2010 6:32 pm

Re: How long does MSK take to get approval to install HAI pump?

Postby radnyc » Sun Sep 29, 2019 10:30 am

Hi, I don’t get your question. Based on your case they decide whether the HAI protocol is appropriate or not. I actually hadn’t heard of the treatment at all. I was on chemo for a three months, my tumors shrunk and the next thing I know I was going in for pump placement. I don’t think you can ask upfront that you want the pump, it’s decided on a case by case basis.
DX Jan '10, at 47
Feb - colon resection - 2/17 nodes
April - liver mets - Stage 4
3 months Folfox chemotherapy
August '10 liver resection and HAI pump
7 months chemo FUDR HAI and Folfiri systemic
NED since August 2010
Last treatment April '11
HAI Pump removed Dec '15

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ginabeewell
Posts: 315
Joined: Wed Oct 24, 2018 10:30 am

Re: How long does MSK take to get approval to install HAI pump?

Postby ginabeewell » Sun Sep 29, 2019 11:16 am

radnyc wrote:Hi, I don’t get your question. Based on your case they decide whether the HAI protocol is appropriate or not. I actually hadn’t heard of the treatment at all. I was on chemo for a three months, my tumors shrunk and the next thing I know I was going in for pump placement. I don’t think you can ask upfront that you want the pump, it’s decided on a case by case basis.


Actually my experience is that unless you’re being treated at MSK, you won’t get the pump UNLESS you ask for it. Nobody at Northwestern, U of Chicago or Cleveland Clinic even mentioned the possibility to me. That said, agree it needs to make sense with your specific case.
45 year old mom of twins (8) and lucky stepmom of 14 and 16 year olds
9/17/18 DX stage 4 CRC w inoperable liver mets
9/20/18 CEA 931
10/1/18 FOLFOX + Vectibix planned 12 rounds
12/12/18 CT scan showed typhlitis (7 days in hospital) but largest met down to 5 cm. Chemo holiday.
12/26/18 CEA 4.6
1/14/18 Resume chemo (#6-8)
3/27/19 HAI pump placement / colon resection
4/8/19 Resume chemo (#9-19) FOLFOX (no OX) + Vectibix
5/20/19 CEA 1.3
7/19/19 1st liver resection
10/16/19 2nd liver resection

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juliej
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Re: How long does MSK take to get approval to install HAI pump?

Postby juliej » Mon Sep 30, 2019 7:32 pm

Zod wrote:How long does MSK take to get approval to install HAI pump? Are they able to get whatever approvals are needed quickly once they decide to use the pump on a particular patient?

My understanding is that there can be a 1-2 month wait to sort out paperwork with FDA if getting a HAI pump elsewhere. Wonder if MSK as the same constraint.

There's no FDA approval required for getting an HAI pump anywhere. It's not an experimental procedure or anything. It just depends on your specific case, a CT scan of your liver to look for non-standard anatomical features, and things like that. It's an approved procedure under most insurance plans.

Hope this helps.
Juliej
Stage IVb, liver/lung mets 8/4/2010
Xelox+Avastin 8/18/10 to 10/21/2011
LAR, liver resec, HAI pump 11/2011
Adjuvant Irinotecan + FUDR
Double lung surgery + ileo reversal 2/2012
Adjuvant FUDR + Xeloda
VATS rt. lung 12/2012 - benign granuloma!
VATS left lung 11/2013
NED 11/22/13 to 9/23/2019, CEA<1

Zod
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Joined: Wed Aug 28, 2019 2:56 pm
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Re: How long does MSK take to get approval to install HAI pump?

Postby Zod » Tue Oct 08, 2019 9:30 pm

There's no FDA approval required for getting an HAI pump anywhere.


I'm told that the combination of Medtronic pump and Codman catheter is off-label and therefore needs FDA approval.

Want to confirm or deny that.

I expect that MSK has a "bulk approval" of some sort maybe? Or perhaps as you said, it isn't necessary.

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ginabeewell
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Joined: Wed Oct 24, 2018 10:30 am

Re: How long does MSK take to get approval to install HAI pump?

Postby ginabeewell » Wed Oct 09, 2019 12:14 am

Zod wrote:
There's no FDA approval required for getting an HAI pump anywhere.


I'm told that the combination of Medtronic pump and Codman catheter is off-label and therefore needs FDA approval.

Want to confirm or deny that.

I expect that MSK has a "bulk approval" of some sort maybe? Or perhaps as you said, it isn't necessary.


If my case required FDA approval, I was not made aware of that. I had a consult in February and they scheduled me for surgery in late March. Timing was driven by the desire to do some additional rounds of chemo vs any sort of approval, unless I was unaware of something.

mpbser
Posts: 927
Joined: Wed Apr 19, 2017 11:52 am

Re: How long does MSK take to get approval to install HAI pump?

Postby mpbser » Wed Oct 09, 2019 6:08 am

"I'm told that the combination of Medtronic pump and Codman catheter is off-label and therefore needs FDA approval."

Yes, the combination of Medtronic pump and Codman catheter is off-label and is in the process of investigation (trial) at NIH and MSK. That does not mean that doctors cannot use the combination. They just do so "off-label." Some insurance companies deny coverage for the pump these days on the basis that the combination is investigatory. Well, it is. That's an irrefutable fact. However, Dr. Kemeny at MSK appears to be able to get insurance coverage anyway. She did for my husband.
Wife 4/17 Dx age 45
5/17 LAR
Adenocarcinoma
low grade
1st primary T3 N2b M1a
Stage IVA
8/17 Sub-total colectomy
2nd primary 5.5 cm T1 N0
9 of 96 nodes
CEA: < 2.9
MSS
Lynch no; KRAS wild
Immunohistochemsistry Normal
Fall 2017 FOLFOX shrank the 1 met in liver
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI 1 liver met
3/7/19 Resection & HAI
4/1/19 Folfiri & FUDR
5/13/19 HAI pump catheter dislodge, nearly bled to death
6-7 '19 5FU 4 cycles
NED

mpbser
Posts: 927
Joined: Wed Apr 19, 2017 11:52 am

Re: How long does MSK take to get approval to install HAI pump?

Postby mpbser » Wed Oct 09, 2019 6:10 am

I don't think that any paperwork requirement makes a dent in the time it takes to schedule an implantation surgery at MSK. My husband decided that he wanted to go ahead with the pump on or around February 2nd and he was offered a surgery date of February 14th. Maybe "paperwork" was started before his decision but it was no earlier than January 22nd because that was his first appointment with his surgeon.
Last edited by mpbser on Thu Oct 10, 2019 7:18 am, edited 1 time in total.
Wife 4/17 Dx age 45
5/17 LAR
Adenocarcinoma
low grade
1st primary T3 N2b M1a
Stage IVA
8/17 Sub-total colectomy
2nd primary 5.5 cm T1 N0
9 of 96 nodes
CEA: < 2.9
MSS
Lynch no; KRAS wild
Immunohistochemsistry Normal
Fall 2017 FOLFOX shrank the 1 met in liver
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI 1 liver met
3/7/19 Resection & HAI
4/1/19 Folfiri & FUDR
5/13/19 HAI pump catheter dislodge, nearly bled to death
6-7 '19 5FU 4 cycles
NED

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juliej
Posts: 3048
Joined: Thu Aug 05, 2010 12:59 pm

Re: How long does MSK take to get approval to install HAI pump?

Postby juliej » Wed Oct 09, 2019 6:31 pm

Zod wrote:I'm told that the combination of Medtronic pump and Codman catheter is off-label and therefore needs FDA approval.
Want to confirm or deny that.

The clinical trial says this:

This study is being done to answer the following question:
Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?

It's not technically off-label if you're part of the clinical trial. My guess is FDA approval will be necessary to allow the Medtronic pump to be the new standard (replacing the Codman) when the trial is over (September 2020). The Medtronic pump was never used for this purpose, but the catheters are the same ones from Codman. Some large insurance companies like Aetna cover it anyway. ("Aetna considers intra-hepatic chemotherapy (HAI pump) medically necessary for members with liver metastases from colorectal cancer.")

Codman was an idiot for discontinuing the pump! :evil:

https://clinicaltrials.gov/ct2/show/NCT03693807
Stage IVb, liver/lung mets 8/4/2010
Xelox+Avastin 8/18/10 to 10/21/2011
LAR, liver resec, HAI pump 11/2011
Adjuvant Irinotecan + FUDR
Double lung surgery + ileo reversal 2/2012
Adjuvant FUDR + Xeloda
VATS rt. lung 12/2012 - benign granuloma!
VATS left lung 11/2013
NED 11/22/13 to 9/23/2019, CEA<1

FightCRC
Posts: 38
Joined: Fri May 25, 2018 10:39 pm

Re: How long does MSK take to get approval to install HAI pump?

Postby FightCRC » Wed Oct 09, 2019 8:47 pm

Just FYI, the Codman pump is coming back. Bought by private group. Both UCSF and CIty of Hope are aware of this development, and ready to go once the pumps are back in production. I presume MSK knows of this, too.

radnyc
Posts: 390
Joined: Tue Apr 06, 2010 6:32 pm

Re: How long does MSK take to get approval to install HAI pump?

Postby radnyc » Thu Oct 10, 2019 11:04 am

FightCRC wrote:Just FYI, the Codman pump is coming back. Bought by private group. Both UCSF and CIty of Hope are aware of this development, and ready to go once the pumps are back in production. I presume MSK knows of this, too.


GREAT NEWS! It's an effective, inexpensive and proven piece of equipment. I had written before, months ago that MSK or someone else should buy the rights and production of this device. Let’s hope whoever got it doesn’t jack-up the cost. They were going for less than $10000 before. Let’s keep an eye on that.
DX Jan '10, at 47
Feb - colon resection - 2/17 nodes
April - liver mets - Stage 4
3 months Folfox chemotherapy
August '10 liver resection and HAI pump
7 months chemo FUDR HAI and Folfiri systemic
NED since August 2010
Last treatment April '11
HAI Pump removed Dec '15


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