The RheumNow Week In Review - Nonadherence And Astronomic Costs %285.11.18%29 Save
The RheumNow Week In Review - Nonadherence And Astronomic Costs %285.11.18%29 by Dr. Cush
Transcription
It's the 05/11/2018. This is the RheumNow We Can Review. Hi, I'm Doctor. Jack Cush, executive editor of roomnow.com. This week in the news, the FDA and regulatory information, footballers and injuries and arthritis, and non adherence to our drugs.
Imagine that. And guess what? It's not due to astronomical cost. At the top of the news is a study from Australia that looked at something they call gluteal tendinopathy, something we call trochanteric bursitis. And it was an interesting randomized trial that looked at which is more effective, either education and exercise or local steroid injection or taking a wait and see attitude.
Turns out that at eight weeks, the education and exercise was as good as anything else, actually better than everything else when it comes to pain and global scores overall. And then when you look out to week fifty two, still education and exercise looked the best. Although the pain benefit was a little bit less, still, it was the exercise and education that seemed to shine through. So again, there may be a role for steroids, and one reader on our site correctly pointed out that maybe the use of steroids might get you faster responses while education and exercise can take over for longer responses. But it's interesting data on how we may manage trochanteric bursitis.
There was an interesting report this week about tofacitinib being used in an animal model of large vessel vasculitis. It was novel in that it was an animal model, and what they did show giving tofacitinib, not surprisingly, reduced JAK2 and JAK1 sorry, JAK2 and JAK3 cytokine dependent signaling, suppressed the amount of tissue memory T cells and the pathology that would normally be seen with a giant cell arteritis, a large vessel vasculitis, and all this being due to the use of tofacitinib, a JAK inhibitor, suggests that maybe we might see some studies using JAKs in patients with large vessel vasculitis. As you know, the big breakthrough in the last two years is JAKTA and tocilizumab, but there are also some encouraging data coming about using abatacep in that condition, and now maybe there's even more. So it's good that large vessel vasculitis is getting the attention of companies who have targeted therapies. Regulatory information comes from AbbVie who announced that it has submitted its BLA to the FDA for Rizenkizumab, their IL-twenty three monoclonal antibody, for use in patients with plaque psoriasis.
That's going to be, I think, another advantage for those patients, and we'll see where that goes. The FDA may know this, but I thought it was worth repeating on the website, to date the FDA has approved nine biosimilars for use in The United States. Now, it turns out that not all of them are being marketed for one reason or another, legal battles, still issues on patent, etc. But this includes Zarxio, which is the first one that was approved a few years ago. And then a number of them that are used in the rheumatology space that includes the Inflectra, Irelzi, Amjavida, Renflexis, Zytelso, and Inphyxi.
But then there are two others that are outside the rheumatology space. That includes Muvasi, which is an Avastin biosimilar, and Ogrivy, which is a Herceptin biosimilar. So I think it's interesting that the numbers have grown. They're going to start to creep into the clinic. I know that the Inflectra biosimilars, of which there are three now on the market, have already started to make a change in a number of places.
This will be interesting to see how this progresses in The United States, especially when cost and the price of drugs is such a big issue. The FDA announced this week that they may be getting into the safety business by getting into the electronic health record business. As you know, the FDA has this big initiative called Sentinel where it's trying to get real time safety data, not just rely on, safety event reporting from the manufacturers of drugs and also from the MedWatch system, the adverse event reporting system, which requires voluntary reporting by patients and doctors of events that may occur. But using other measures, including social media, including being tied in with large data sets from electronic records, that this new Sentinel effort is trying to get a new perspective on safety. Well, I think the FDA has correctly made the move and has requested $100,000,000 funding in 2019 to develop an EHR initiative where they would make available an EHR much like they have in the VA system.
It would be functional and usable, but the cost of admission for the clinician would be being connected to the FDA when it comes to safety events. It's not clear how this is going to really play out, but I think it's a nice idea and probably should go forward. There's a UK study that looked at ex footballers, and that means soccer players in The UK, and what happens to them? They compared 1,200 footballers to 4,000 control mage match men and showed that knee OA, including knee replacement for OA, was two to three times higher in the football players compared to the general population, suggesting, of course, that the trauma, repeated trauma, is a major risk factor. And this is important when it comes to one dealing with ex footballers or ex athletes, that you need to be involved in those sort of traumatic sports to get such injuries.
And this could be important for people who are considering these kind of sports in their children and adolescents. We do know that running, for instance, does not cause knee OA if you have a structurally normal joint and normal mechanics. If you have an abnormal joint, it's been damaged or hurt or torn meniscus or something like that, or your mechanics are not right, then you get abnormal wear and tear and osteoarthritis. An interesting report comes from Jeff Curtis and his coworkers that says your patients may not be filling their prescriptions for methotrexate, biologics, and tofacitinib. What they found was they actually tied up EHR records along with claims data and saw when EHR recorded a prescription for these drugs, that they looked within a window of time to find out if the drug was in fact billed at the pharmacy, that being at least some measure of compliance.
What they found was I believe shocking that thirty seven percent of people prescribed methotrexate failed to initiate methotrexate within two months of receiving the prescription. Fairly good evidence that they're not taking it. Also, when they looked at tofacitinib and biologics, the number was forty point six percent failed to initiate therapy with those drugs within three months, suggesting there's a real issue here that we're not really addressing and needs to be addressed. The predictors for non adherence, at least to methotrexate, was age, race, region, body mass index, the number of drugs that you're on, and the number of comorbidities you may have. But it'd be helpful to know who's maybe at higher risk here.
It'd be helpful to know who's not filling the prescriptions. I don't know why pharma actually has data on my patients and what prescriptions they're filling when I don't really know that. I think it's something that should change. Lupus is in the news with some nice longitudinal data that looked at what's happened to lupus nephritis, and specifically biopsy evidence of lupus nephritis, over a forty six year period ending in 2016. And what they showed looking at three different years that it looks like the severity of lupus is declining.
What they did show that although the histologic class and the activity index did not change over this period, the chronicity index did significantly decrease from 1970 to 2016. And when they look at the people who did not develop end stage renal disease, obviously a failure or a bad outcome with lupus nephritis, it was a good number in ERA one, in the first ten years or so, eighty seven percent in Era one. It actually improved to ninety four percent Era two, in the most recent era, going up to 2016, ninety nine percent of patients fail to develop ESRD, end stage renal disease. And the same was seen when you looked at twenty year intervals, suggesting that we're doing better either at diagnosing it, intervening, and actually preventing the outcomes. Those that unfortunately did develop renal disease and stage renal disease included those who were male.
These are risk factors, having arterial hypertension, no immunosuppressive therapy, obviously a baseline creatinine increase, and a renal biopsy with evidence of a high activity and chronicity index. Lastly, there's a nice report from sixty Minutes that appeared and we wrote about it in RheumNow. It is actually a review of the sixty minute report on the drug ACTH. We wrote about this previously when the New York Times noted that ACTH was one of the most expensive drugs it was paying for under Medicare, where it was paying almost a half billion dollars a year for over 3,000 patients receiving it at a cost of 16,002 Sorry, it's actually $162,000 a patient per year. So what the problem here is that Leslie Stahl actually focused on the city of Rockford, Illinois, and the mayor was complaining and noting that their drug costs were skyrocketing.
And they're a municipality where they actually are self insured and pay for their own medicines, but they noticed this tremendous skyrocketing of healthcare costs, especially prescription drugs, and noted that a lot of it came from two patients and one drug. These were two children with infantile spasms who were being treated with Acthar. And then it went on to talk about why this seems a little absurd in that Acthar used to cost almost nothing. When it was approved in 2001, it was $40 a vial. Now it is $40,000 a vial, which is a 100000% of an increase.
So it goes on to talk about some of the history of this, some of the problems of Acthar, and we end the article with a listing of the indication from the website. And my question to the audience is, would you use this very, very, very expensive medicine, which has not been proven to work for any of these indications really, because the drug was grandfathered in. These indications are when the drug was first FDA approved in 1952, when then the only issue was to demonstrate that the drug was safe, not necessarily effective. So it didn't go through the ways you get the drug approved currently. So these are grandfathered in and you could theoretically use this drug to treat the things that are listed lupus, multiple sclerosis, obviously infantile spasms, proteinuria associated with nephrotic syndrome, dermatomyositis and polymyositis, symptomatic sarcoidosis, any inflammatory arthritis and inflammatory allergic eye disease as well.
Obviously we have choices here and there are many other forms of steroid therapy that are out there, but I think that this is a problem for the manufacturer of this or the company that owns this right now, Mallingrot. And for those of us who have to consider this, is this cost effective and reasonable therapy? I guess this will play out over time. I'll end with two quotes from the website from this past week. My favorite quote from first myself is, Not all symptoms merit a diagnosis or disease.
Some are just evidence of human imperfection. And the second, I heard last night from Andrew, a friend, where he's quoting the comedian Steven Wright, who said in his very deadpan way, I'm addicted to placebos. I'd give them up, but it wouldn't make any difference. That's it for this week on RheumNow. Make sure you tell your friends about the podcast.
Follow us. Tune in next week for more good news in rheumatology. Take care.
Imagine that. And guess what? It's not due to astronomical cost. At the top of the news is a study from Australia that looked at something they call gluteal tendinopathy, something we call trochanteric bursitis. And it was an interesting randomized trial that looked at which is more effective, either education and exercise or local steroid injection or taking a wait and see attitude.
Turns out that at eight weeks, the education and exercise was as good as anything else, actually better than everything else when it comes to pain and global scores overall. And then when you look out to week fifty two, still education and exercise looked the best. Although the pain benefit was a little bit less, still, it was the exercise and education that seemed to shine through. So again, there may be a role for steroids, and one reader on our site correctly pointed out that maybe the use of steroids might get you faster responses while education and exercise can take over for longer responses. But it's interesting data on how we may manage trochanteric bursitis.
There was an interesting report this week about tofacitinib being used in an animal model of large vessel vasculitis. It was novel in that it was an animal model, and what they did show giving tofacitinib, not surprisingly, reduced JAK2 and JAK1 sorry, JAK2 and JAK3 cytokine dependent signaling, suppressed the amount of tissue memory T cells and the pathology that would normally be seen with a giant cell arteritis, a large vessel vasculitis, and all this being due to the use of tofacitinib, a JAK inhibitor, suggests that maybe we might see some studies using JAKs in patients with large vessel vasculitis. As you know, the big breakthrough in the last two years is JAKTA and tocilizumab, but there are also some encouraging data coming about using abatacep in that condition, and now maybe there's even more. So it's good that large vessel vasculitis is getting the attention of companies who have targeted therapies. Regulatory information comes from AbbVie who announced that it has submitted its BLA to the FDA for Rizenkizumab, their IL-twenty three monoclonal antibody, for use in patients with plaque psoriasis.
That's going to be, I think, another advantage for those patients, and we'll see where that goes. The FDA may know this, but I thought it was worth repeating on the website, to date the FDA has approved nine biosimilars for use in The United States. Now, it turns out that not all of them are being marketed for one reason or another, legal battles, still issues on patent, etc. But this includes Zarxio, which is the first one that was approved a few years ago. And then a number of them that are used in the rheumatology space that includes the Inflectra, Irelzi, Amjavida, Renflexis, Zytelso, and Inphyxi.
But then there are two others that are outside the rheumatology space. That includes Muvasi, which is an Avastin biosimilar, and Ogrivy, which is a Herceptin biosimilar. So I think it's interesting that the numbers have grown. They're going to start to creep into the clinic. I know that the Inflectra biosimilars, of which there are three now on the market, have already started to make a change in a number of places.
This will be interesting to see how this progresses in The United States, especially when cost and the price of drugs is such a big issue. The FDA announced this week that they may be getting into the safety business by getting into the electronic health record business. As you know, the FDA has this big initiative called Sentinel where it's trying to get real time safety data, not just rely on, safety event reporting from the manufacturers of drugs and also from the MedWatch system, the adverse event reporting system, which requires voluntary reporting by patients and doctors of events that may occur. But using other measures, including social media, including being tied in with large data sets from electronic records, that this new Sentinel effort is trying to get a new perspective on safety. Well, I think the FDA has correctly made the move and has requested $100,000,000 funding in 2019 to develop an EHR initiative where they would make available an EHR much like they have in the VA system.
It would be functional and usable, but the cost of admission for the clinician would be being connected to the FDA when it comes to safety events. It's not clear how this is going to really play out, but I think it's a nice idea and probably should go forward. There's a UK study that looked at ex footballers, and that means soccer players in The UK, and what happens to them? They compared 1,200 footballers to 4,000 control mage match men and showed that knee OA, including knee replacement for OA, was two to three times higher in the football players compared to the general population, suggesting, of course, that the trauma, repeated trauma, is a major risk factor. And this is important when it comes to one dealing with ex footballers or ex athletes, that you need to be involved in those sort of traumatic sports to get such injuries.
And this could be important for people who are considering these kind of sports in their children and adolescents. We do know that running, for instance, does not cause knee OA if you have a structurally normal joint and normal mechanics. If you have an abnormal joint, it's been damaged or hurt or torn meniscus or something like that, or your mechanics are not right, then you get abnormal wear and tear and osteoarthritis. An interesting report comes from Jeff Curtis and his coworkers that says your patients may not be filling their prescriptions for methotrexate, biologics, and tofacitinib. What they found was they actually tied up EHR records along with claims data and saw when EHR recorded a prescription for these drugs, that they looked within a window of time to find out if the drug was in fact billed at the pharmacy, that being at least some measure of compliance.
What they found was I believe shocking that thirty seven percent of people prescribed methotrexate failed to initiate methotrexate within two months of receiving the prescription. Fairly good evidence that they're not taking it. Also, when they looked at tofacitinib and biologics, the number was forty point six percent failed to initiate therapy with those drugs within three months, suggesting there's a real issue here that we're not really addressing and needs to be addressed. The predictors for non adherence, at least to methotrexate, was age, race, region, body mass index, the number of drugs that you're on, and the number of comorbidities you may have. But it'd be helpful to know who's maybe at higher risk here.
It'd be helpful to know who's not filling the prescriptions. I don't know why pharma actually has data on my patients and what prescriptions they're filling when I don't really know that. I think it's something that should change. Lupus is in the news with some nice longitudinal data that looked at what's happened to lupus nephritis, and specifically biopsy evidence of lupus nephritis, over a forty six year period ending in 2016. And what they showed looking at three different years that it looks like the severity of lupus is declining.
What they did show that although the histologic class and the activity index did not change over this period, the chronicity index did significantly decrease from 1970 to 2016. And when they look at the people who did not develop end stage renal disease, obviously a failure or a bad outcome with lupus nephritis, it was a good number in ERA one, in the first ten years or so, eighty seven percent in Era one. It actually improved to ninety four percent Era two, in the most recent era, going up to 2016, ninety nine percent of patients fail to develop ESRD, end stage renal disease. And the same was seen when you looked at twenty year intervals, suggesting that we're doing better either at diagnosing it, intervening, and actually preventing the outcomes. Those that unfortunately did develop renal disease and stage renal disease included those who were male.
These are risk factors, having arterial hypertension, no immunosuppressive therapy, obviously a baseline creatinine increase, and a renal biopsy with evidence of a high activity and chronicity index. Lastly, there's a nice report from sixty Minutes that appeared and we wrote about it in RheumNow. It is actually a review of the sixty minute report on the drug ACTH. We wrote about this previously when the New York Times noted that ACTH was one of the most expensive drugs it was paying for under Medicare, where it was paying almost a half billion dollars a year for over 3,000 patients receiving it at a cost of 16,002 Sorry, it's actually $162,000 a patient per year. So what the problem here is that Leslie Stahl actually focused on the city of Rockford, Illinois, and the mayor was complaining and noting that their drug costs were skyrocketing.
And they're a municipality where they actually are self insured and pay for their own medicines, but they noticed this tremendous skyrocketing of healthcare costs, especially prescription drugs, and noted that a lot of it came from two patients and one drug. These were two children with infantile spasms who were being treated with Acthar. And then it went on to talk about why this seems a little absurd in that Acthar used to cost almost nothing. When it was approved in 2001, it was $40 a vial. Now it is $40,000 a vial, which is a 100000% of an increase.
So it goes on to talk about some of the history of this, some of the problems of Acthar, and we end the article with a listing of the indication from the website. And my question to the audience is, would you use this very, very, very expensive medicine, which has not been proven to work for any of these indications really, because the drug was grandfathered in. These indications are when the drug was first FDA approved in 1952, when then the only issue was to demonstrate that the drug was safe, not necessarily effective. So it didn't go through the ways you get the drug approved currently. So these are grandfathered in and you could theoretically use this drug to treat the things that are listed lupus, multiple sclerosis, obviously infantile spasms, proteinuria associated with nephrotic syndrome, dermatomyositis and polymyositis, symptomatic sarcoidosis, any inflammatory arthritis and inflammatory allergic eye disease as well.
Obviously we have choices here and there are many other forms of steroid therapy that are out there, but I think that this is a problem for the manufacturer of this or the company that owns this right now, Mallingrot. And for those of us who have to consider this, is this cost effective and reasonable therapy? I guess this will play out over time. I'll end with two quotes from the website from this past week. My favorite quote from first myself is, Not all symptoms merit a diagnosis or disease.
Some are just evidence of human imperfection. And the second, I heard last night from Andrew, a friend, where he's quoting the comedian Steven Wright, who said in his very deadpan way, I'm addicted to placebos. I'd give them up, but it wouldn't make any difference. That's it for this week on RheumNow. Make sure you tell your friends about the podcast.
Follow us. Tune in next week for more good news in rheumatology. Take care.
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