New MS Phenotypes

[MrsBones]

I have mixed feelings on them, though I do think there is a greater potential for a more accurate description of just what is happening for each person.

Instead of lumping together everyone who has relapses and remissions together, there are now modifiers to describe an individual's disease activity. The terms "active" and "non-active" now will be added to RRMS to reflect relapse activity and "progressing" and "not progressing" will show disability.

So, say there's a person who has lots of relapses but little disability, they will have Active, Not Progressing RRMS. A person with the opposite will still have RRMS , but it will be more accurately called Non-Active, Progressing RRMS. This will account for all the folks who do have RRMS, but have vastly differing experiences. It even covers the so-called "benign" MS, which I suppose would now be Non-Active, Non-Progressing MS.

In addition, CIS is now in while PRMS has been dropped and will now be know as Active PPMS.

My hope is that insurance companies will get on the ball with the new sub-types. I have PRMS and have never had an issue with coverage of DMDs, even with PRMS being in my records. I have a small, teeny, tiny concern that insurance companies may only see the primary progressive part of active primary progressive until this all catches on. I know my dr will do what he has to to make sure I'm on the meds I should be, but I don't want any flies in the ointment.

Read more here: http://www.healthline.com/health-new...defined-061714

[Marco]

There is another thread on the same topic:http://www.msworld.org/forum/showthread.php?t=133316

I also have mixed feelings about this and what impact the changes may have on our community. There is already so much confusion surrounding types of MS and this only complicates it. I think they doctors need to answer the fundamental question, "Is MS a progressive disease or not?" If they answer MS is a progressive disease they should leave off the modifiers.

From the study results "We recognize that either relapsing or progressive disease may be characterized by severity of signs and symptoms, frequency of relapses, rate of worsening, residual disability, and impairment. However, there are insufficient data to further characterize an active disease course in this way."

We know that MRI technology is not anywhere close to being 100% accurate. A person could have gray matter, white matter and cord lesions and the MRI miss them all. Again, we see the over-reliance of MRI and disregard of subjective symptoms. How many patients failed to recognize relapses prior to diagnosis? Even doctors miss relapses, often labeled "stress" or "depression."

Heck, I already get insurance letters a few times of year attempting to determine if my medical care was necessary, or the result of an accident or injury the insurance company could subrogate against someone else. Is it correct, that a patient could be admitted to the hospital, have a clean MRI, and be categorized as "inactive" and/or "not progressing?" Why should an insurance company pay for DMTs for a patient that is labelled inactive or not progressing? I guarantee you life and disability insurance providers are not going issue policies based on an "inactive" or "not progressing" diagnosis. Maybe I'm pessimistic or jaded, but I think this could easily create more confusion and have unintended consequences that negatively impact us.

[HobbitHead]

You summed my feelings up Marco. My first reaction was that this is a way for the insurance companies to get out of paying for dmts. Booo.

[misslux]

Yeah not sure this benefits patients and looks like an easy way for insurance companies to start denying DMTs.

So under the new modifiers, am I "progressing PPMS"? I have continuous progression. It certainly isn't non-progressing!

[fairpace]

I agree with all of you. My underlying feeling is that nothing good can come of this for us as patients. It's just another way for insurance companies to manipulate their way out of paying for treatments.

I appreciate the desire to track trends and sort out the differences in this disease... but I don't like that it will be attached to medical billing requirements. It's too much information for the insurance and not necessarily going to be accurate. I don't like it at all!

[Tawanda]

Yuck

I've always hated the existing labels and I hate these subcategories even more! This is not the kind of disease that can be stuffed under one tidy little category. It is just way too MeSsy for that!

[Jules A]

I agree with all of you. My underlying feeling is that nothing good can come of this for us as patients. It's just another way for insurance companies to manipulate their way out of paying for treatments.

I appreciate the desire to track trends and sort out the differences in this disease... but I don't like that it will be attached to medical billing requirements. It's too much information for the insurance and not necessarily going to be accurate. I don't like it at all!

But MS presentation is such a gray area that I'm confident providers will be able to legally and ethically work around diagnostic criteria to circumvent some of the insurance companies push back.

[rdmc]

Lots of good questions to think about when considering this "news."

What I'd want to know is how do they know when you've had "lots" of relapses. Sometimes we don't even know if we're having a relapse. And some of us that don't take steroids never report a relapse to the doctor.

All too subjective in my book. Just another way of dismissing someone's disease as active/non-active,or prorgressing/non-progression.

And if you've been in this game long enough, you know it may be non active or non progressing...until it's not. Too many pigeon holes, and we're not pigeons.

[onlyairfare]

I agree with the sentiment that this will be yet another way for insurance company to deny coverage for DMT. Why should they pay for an expensive medication when it says right on your medical records that you are "not progressive" or "not active"?

I spent 12 years as a health insurance company executive, and believe me, most of them are suits with no clinical knowledge whatsoever, so the finer points of "not progressive" and "not active" would be lost on them. They understand the bottom line (making money) quite well.

Most good health insurance companies employ licensed MD's as medical directors to help them avoid such stupid mistakes. Still, at one insurance company meeting I attended, the medical director for one well-known national insurance company got up in front of the crowd to announce that some stupid or greedy MSers deliberately chose the most expensive medication instead of one of the much cheaper choices. He said people at the meeting should be working to reduce such unnecessary expenditures.

This was in the "CRAB" era when there were only 4 medications - Copaxone, Rebif, Avonex, and Betaseron - all priced almost exactly the same. I and one other MSer in the audience stood up and told him that there were NOT cheap or expensive choices, there were only 4, all of them expensive, unpleasant injectables that no one would want to take if they didn't have to, and they all cost the same. He did not know that, and he was a trained and licensed MD making coverage decisions! He was more than a little embarrassed.

BTW, this meeting was in Colorado, where there is a high incidence of MS to begin with, and there is also the well known Rocky Mountain MS Center in Denver, yet the medical director knew nothing about MS and its treatments!

This is what we are up against in dealing with insurance company, and one reason I am no longer an insurance executive. I have "benign MS" (until I don't of course) and I will be wary of any attempt to label me "not active," "benign," or "non-progressive" and therefore not in need of any (expensive) medications.

[KatieAgain]

No mixed feelings here. I don't like the new phenotypes...as if we don't have enough about all this category stuff...which I hate. Can't we just say this person has MS. These categories are like a social class system.

While this certainly has potential to be explosive, I doubt the DMD denial will ever be an issue over these new phenotypes for several reasons.

1) This is possibly will first turn into a ground war between Big Pharma and Insurance Companies. My bet is on Big Pharma. These new phenotypes are going to affect most of us...but we still need drugs to help us remain inactive and not progress.

2) Can you imagine the publicity this would create? With the media today? Denying MSers a DMD all because of very subjective criteria? It would truly cause a public uproar through a wide array of various lobbying groups and human interest organizations to include the NMSS. I know a lot will disagree with me, but the American Public is quite empathetic about Multiple Sclerosis.

3) All MSers who are Veterans have exceptionally powerful Military Organizations lobbying for their medical care. This in the end benefits ALL MSers because it quickly becomes very public and quite ugly...there are currently over 17,000 military vets with MS. We don't knock on doors...we kick them in!

4) Nueros...well let's say most Neuros will not put their patients in a position of being denied DMDs.

5) Montel Williams will completely go ballistic...he takes Copaxone. IMHO, he has the most influence of all MSers out there. With Richard Cohen coming in a close second. And the Romneys and Osbournes...BOOM. Both Ann and Jack are on Copaxone. And even though all these people have the resources to pay for their own drugs...they have a highly public social platform to speak from...and they will.

6) A brilliant group of lawyers would come up with some reason to file a class action suit on everyone's behalf. I can see the Commercial now, "Have you or your loved one been diagnosed with MS and are being denied medical treatment? If so..."

This would be like telling a person with HIV that they could no longer have their medications because they have not progressed to full blown AIDS after 5 years.

No, I don't think we will get to that point. 400,000 angry Americans with MS have a very powerful voice...collectively. But of course...I have been standing out in left field before with only me, myself and I.

Just my opinion.

[Marco]

Today, a multiple sclerosis (MS) diagnosis should adhere to the 2010 Revised McDonald Diagnostic Criteria for MS. Unfortunately; it is common to visit multiple neurologists and obtain differing diagnosis and assigned various phenotypes. This lack of standardization causes angst and confusion in the MS community and for this reason; I understand the existing phenotypes need clarification. A number of neurologists have stated they intentionally used an incorrect CPT code to ensure a patient remains financially or otherwise eligible for a specific therapy. This practice suggests that insurance companies often refuse to pay for treatments based on diagnostic codes. This is exactly why patients are rightfully concerned about the changes. I received an email from a member of the committee informing me that insurance and other matters were "beyond the scope" of the committee.

Here are some additional thoughts on the topic:

Clinically Isolated Syndrome (CIS) and Radiologically Isolated Syndrome (RIS)
The McDonald criteria already allows for the diagnosis of MS with only a single episode for patients that meet the other relevant criteria. Like RIS patients, CIS patients that lack clinical signs and symptoms should not be diagnosed with MS. "Suspicion of MS" or "high risk for meeting diagnostic criteria for MS" does not equal MS. Terms like “possible MS” and “probable MS” are also used for patients that do not meet the McDonald criteria. Prematurely, and possibly incorrectly, labeling CIS patients with MS phenotype will ultimately add to the confusion and is a disservice to the patient. Incorrectly labeling a patient with MS can limit a patient’s opportunity to obtain gainful employment, insurance, and causes unnecessary and undue stress on a patient and their family. Even without treatment, not all RIS patients develop into CIS and not all CIS patients develop into Clinically Definite MS. An alternative approach would be to diagnose CIS/RIS patients under CPT codes 341.8/341.9 (Other disorders of the central nervous system) and not 340 (Multiple Sclerosis). MS medications could then be made available to patients with these CPT codes. Both RIS and CIS patients should be followed prospectively until they meet the clinical grounds required for a MS diagnosis. These changes would put many of the limbo patients into the MS category and the MS population would balloon. Who would this benefit? Hmm ...

Question: Under the new phenotype system, would a CIS patient ever be able to remove the stigma of MS? Example; after 5 years of no activity or progression would the patient be able to move to a different category and therefore be eligible to obtain life, disability or other insurance?

MS Phenotype Modifiers
The premise behind using modifiers is to more accurately describe the state of MS worsening or progression. That is exactly what the terms ‘benign’ and ‘malignant’ attempted to do. The committee has suggested these labels should not be widely used due to the lack of standardization, and the increased confusion they cause. Ironically, the committee decided to introduce new modifiers that would also not be uniformly applied and only lead to additional confusion. Due to the unpredictable nature of MS, the terms not active and not progressing belies the very nature of a chronic, progressing disease and therefore is a potentially misleading concept. Patients would potentially be labeled as “not active” and/or “not progressing” when they know the disease has progressed. MS is defined as a chronic progressing disease and the use of terms like ‘not active’ and ‘not progressing’ belies this definition. As the study suggests, there is much to be discovered in detecting activity and progression. Replacing the terms benign and malignant with not active, active, not progressing, progressing corrects one problem to only add another. Because our existing technology cannot determine progression or activity does not mean there is none. Until there is a reliable biomarker for progression could these categories be premature? A major concern is how insurance and disability companies could deny coverage based on an incorrect assessment of progression or worsening.

Example: a MS patient undergoes MRI examination at 3T and no lesion activity is detected. The same patient takes a MRI at 7T and numerous lesions are clearly visible.

In addition to MRI machines missing lesions, relapses can be so subtle that they are missed by the patients. How many MS patients had a relapse misdiagnosed by a doctor as patient “stress or depression.”

Questions:
· Why would a patient that is ‘not active’ and ‘not progressing’ ever take on our onerous MS medications?
· Why should an insurance company pay for a medication for the patient that has no disease worsening or progression?
· Considering how narrow the criterion for progression is defined it might be worthwhile to include MRI cord monitoring. Unfortunately, the committee recommends to not perform cord MRI as part of routine monitoring potentially misses both activity and progression.

Questions about the elimination of the Progressive-relapsing multiple sclerosis (PRMS) category:
· Would PRMS patients still be able to obtain medications not afforded to the current PPMS group?
· Would PPMS patients now qualify for medications available to PRMS patients?

[rdmc]

I read Marco's post and a couple anecdotal examples come to mind, and these phenotypes sound so subjective that I, too, wonder what criteria would be used to determine active/non active, or progressing/non progressing. How would disease activity be judged...by MRI evidence, or by clinical evidence/EDSS score.

I've posted a gazillion times the MRI images of the man who had lesions, coming and going, in a time lapse MRI taken 24 times in a single year. He did not report any flares during the entire year, yet his MRI, taken a certain periods of time would have definitely classified the patient as active, yet his clinical evidence would be non active. http://www.msdiscovery.org/news/news...more-meets-eye

On the other hand, you have someone like "wheelchair kamikaze" whose MRIs have remained the same since he was diagnosed, basically 1 lesion, and yet his disease as progressed at a steady pace. His MRIs have not changed since he was diagnosed, his EDSS and clinical manifestation of the disease is progressive (in Marc's case there is the issue if he does in fact have MS or some other unknown diagnosis.) This was his experience as of 2011, but it has had more progression since then, yet unchanged MRIs. http://www.wheelchairkamikaze.com/20...rosis-and.html

I just think it will add confusion to what already is confusing enough, and of course "new patients" may revel in the news they're typed non active or non progressing, while some will despair because they're labeled active or progressive RRMS. And what does any of that mean anyway in a disease that can change on a dime from being non active to active, or non progressive to progressive.

[Tawanda]

I read Marco's post and a couple anecdotal examples come to mind, and these phenotypes sound so subjective that I, too, wonder what criteria would be used to determine active/non active, or progressing/non progressing. How would disease activity be judged...by MRI evidence, or by clinical evidence/EDSS score.

I've posted a gazillion times the MRI images of the man who had lesions, coming and going, in a time lapse MRI taken 24 times in a single year. He did not report any flares during the entire year, yet his MRI, taken a certain periods of time would have definitely classified the patient as active, yet his clinical evidence would be non active. http://www.msdiscovery.org/news/news...more-meets-eye

On the other hand, you have someone like "wheelchair kamikaze" whose MRIs have remained the same since he was diagnosed, basically 1 lesion, and yet his disease as progressed at a steady pace. His MRIs have not changed since he was diagnosed, his EDSS and clinical manifestation of the disease is progressive (in Marc's case there is the issue if he does in fact have MS or some other unknown diagnosis.) This was his experience as of 2011, but it has had more progression since then, yet unchanged MRIs. http://www.wheelchairkamikaze.com/20...rosis-and.html

I just think it will add confusion to what already is confusing enough, and of course "new patients" may revel in the news they're typed non active or non progressing, while some will despair because they're labeled active or progressive RRMS. And what does any of that mean anyway in a disease that can change on a dime from being non active to active, or non progressive to progressive.

excellent post! I especially like the part about the psychological implications of labels. I don't know what's in my file, but my neurologist has never labeled me to my face.

[misslux]

I am 100% fine with the current four types since PPMS *does* differ greatly than RRMS in course and expectations (at least early on).

You guys are obviously free to disagree, but getting the PPMS diagnosis pretty much explained everything and helped me greatly to accept and move on.

The new descriptors though, no.

[bjrnewlife2013]

I see nothing good happening with this. So if I don't have a relapse 3 or 4 times a year, they'll try to take the meds away that will keep me that way? I'm not liking this at all.