California Technology Assessment Forum recommendation on ADR

[mmglobal]

Yesterday, I went up to San Francisco to attend a meeting of the California Technology Assessment Forum. What I write here are my impressions as a patient attending this meeting. I give you my impressions, and will relay the information as I perceive it. I can not vouch for the veracity of the information I received. It was a tough decision to go. Airfare at the last minute is not cheap and I wasn't even sure I'd get in, no less speak. Fortunately, I was able to put myself on the agenda to testify before the panel.

The CTAF forum is supposed to be an independent review board that reviews new technologies to determine if a medical technology improves health outcomes and is safe and effective. I'm not 100% certain of the relationship between the insurer and the 'independent panel', but everything I could discover seemed to indicate that CTAF is funded by BC/BS California. I will update this thread if I discover otherwise.

This meeting was not only for Artificial Disc Replacement. Other topics were; Laparoscipic Adjustable Gastric Banding, Low Dose Spiral CT Screening for Lung Cancer, and Drug-Eluting Stents: an Update with a Focus on Safety.

The ADR session started with a comprehensive review of the status of Charite' and ProDisc data by Jeffrey A. Tice, M.D. from UCSF. Dr. Rick Delamarter then presented ProDisc data. I'd say that the major theme of his presentation was, ProDisc is not Charite'.

(This is Mark's assessment, not Delamarter's presentation: After all of the problems with the roll-out of the Charite', who can blame Synthes for such an approach. They have learned from the mistakes of DePuy Spine and are doing a much better job of packaging that data. Where the Charite' study was designed to demonstrate non-inferiority to fusion, the ProDisc data is said to demonstrate superiority. ProDisc numbers are somewhat better than Charite' data. I believe that there are 2 major reasons for this. First, the lessons learned from the early months of the Charite' study were shared with the ProDisc investigators. The state of the collective knowledge in the US surgeon community at the start of the Charite' study was almost zero. Lessons learned regarding implant sizing, positioning, patient selection, access related complications, etc... were all carried into the ProDisc study. Second, with the roll-out of Charite' after the study population was filled and after FDA approval we saw a lot of surgeons with little experience, only recently trained, experiencing their 'learning curve' with little oversight. Synthes did a much better job of making sure that quality surgeons were properly trained and would not release the device for extreme. Only the most experienced ProDisc surgeons have been allowed to do multi-level cases. There are much tighter controls, self-imposed by Synthes.)

After Dr. Delamarter, Dr. Tim Peppers of Core Orthopaedics in San Diego spoke. He's got a couple of hundred ADR's of several different varieties under his belt and provided his positive data. After Dr. Peppers spoke (10, 2, 4), I took my turn. I'd prepared some notes that I'll include below. However, speaker guidelines (that I'd only received 1/2 hour before) and time constraints got in the way. I got most of it in and I believe provided a unique perspective, not only from my personal experience as a Blue Shield customer with multi-level ADR, but also from my perspective as a professional spine patient advocate with hundreds of clients with all different types of spine surgery.

Having lived in the spine patient community for almost a decade now, I could tell that we were in trouble as soon as my presentation was over and the discussion began. An MD came up to the audience mike and began talking about a new training regimen called 'pilandes, or something like that.' He'd tried it, strengthened his abdominal muscles and it improved his back pain. Maybe we should try that? From that point on, I felt like I was on another planet and that these critical decisions would be make by people who have little or no understanding of what we face as spine patients. I understand that they see negative outcomes. I understand that it would be nice if there was a sure fix for our problem, but there isn't. Denying us access to the best technology available because it is less than perfect does so much more harm than good.

Edit to add: There were some comments by some, stating that they don't believe that fusion results meet the approval criterion either. IMHO, back in the day when fusion was even worse than it is now, many came to believe that fusion is a bad idea and don't believe that they are warranted. The draft recommendations mentions the studies that have demonstrated that long term results for conservative treatment demonstrated numbers similar to fusion results.
End of edit.

Dr. Charles Wilson made a motion that they agree to bifurcate the discussion of ADR and vote on two separate recommendations; Charite' and ProDisc. It was agreed and they then voted separately on motions (also made by Dr. Wilson) to continue to recommend that the use of Charite' and ProDisc doesn't not meet Technology Assessment Criterion 4 and 5 for safety, effectiveness and improvement in health outcomes when used to treat pain and disability from degenerative disc disease of the lumbar spine.

The vote was unanimous against Charite'. (I believe that there were about a dozen or so voting members. I'll correct the count when I get the minutes.)

There were three votes for ProDisc. I guess that's progress.

---------------


The materials handed out before the meeting included a draft recommendation. Here are the five criteria and the assessment of the forum:

Technology Assessment (TA) Criterion 1: The technology must have the appropriate regulatory approval. Met

TA Criterion 2: The scientific evidence must permit conclusions concerning the effectiveness of the technology regarding health outcomes: Met

TA Criterion 3: The technology must improve the net health outcomes. Met.

TA Criterion 4: The technology must be as beneficial as any established alternatives. Not met.

TA Criterion 5: The improvement must be attainable outside the investigational setting. Not met.

From the conclusion of the draft recommendation, "... despite the promising results of the two randomized trials, it is not clear that the possible benefits fo the artificial discs outweigh the attendant surgical risks and the possibility of log-term device failure."

I guess they've never experienced years of unrelenting, severe, chronic pain.

I'll post my presentation later. Gotta go now... tickets to see Bob Seger tonight. Going to a concert is something I could not have conceived of doing in the years before my ADR surgery. "Thank you Dr. Zeegers, I love my artificial discs!"

Mark

[Poncho]

Mark,

I'm trying to wrap my mind around criterion 4 & 5... The numbers in the studies I have read proved to be as beneficial as the "golden standard" of fusion.

I'm not sure what they mean that improvement must be obtainable outside the clinical study. My impression is that there must be some sort of measurable improvement of the patient population after the 2 year study is completed???

I'll think it through a bit more...

Have fun at the concert.

Poncho

[mmglobal]

I forgot an important point. Before Dr. Wilson made his motion, he and others made some comments stating that they don't believe that fusion results meet the approval criterion either. IMHO, back in the day when fusion was even worse than it is now, many came to believe that fusion is a bad idea and don't believe that they are warranted. The draft recommendations mentions the studies that have demonstrated that long term results for conservative treatment demonstrated numbers similar to fusion results.

More later,

Mark

[letteski]

Dr. Wilson should be ashamed of himself for not looking at what technology can do and how it can change people’s lives. I can’t wait for the day my fellow ADR study patents and I grow up and prove him wrong. I will do every thing I can as a ProDisc study patent to make this happen. He will be down right embarrassed that he made statements like this that robed people of a change to get their lives back.

Mark can’t wait to here more about this forum meeting.

See you soon.

[dshobbies]

For once, I have no comment. I am astounded and disappointed. I was one of the fortunate ones who could afford to go to Germany, the U.S. cost being double or more.

So if fusion doesn't meet the criteria either, what are we supposed to do for relief? Maybe we can enter the Twilight Zone where they put our head on someone else's otherwise healthy body... a body transplant!

I actually do have a comment but it's not printable.

Dale

[mmglobal]

There is another CTAF meeting today in Los Angeles. ADR is not on the agenda, but PLLD is. (Percutaneous Laser Disc Decompression)

I was not planning on going, but I can't resist. I'm interested to see if the anti-spine surgery bent I witnessed when ADR was the topic applies to MISS procedures as well.

I'll report back tonight.

In case anyone is interested and hasn't already seen it, here is the assessment from the ProDisc session last year. (From the ctaf.org website)