Wednesday, 29 March 2017

#NewsSpeak: an eagle called ocrelizumab has landed

FDA licenses ocrelizumab for both relapsing and primary progressive forms of MS. #MSBlog #NewsSpeak #Ocrelizumab

Yesterday was a pretty momentous day for people with MS (pwMS). The FDA licensed ocrelizumab for people with PPMS. The killjoys amongst you will say 'What? The efficacy of ocrelizumab is so small in PPMS that it won't make a difference'. My response to them would be 'Bullshit!' If you have PPMS you would no doubt be celebrating. When innovation happens it is often small and in incremental steps. The ocrelizumab in PPMS trial shows that we can modify the more advanced stages of MS. What you have to realise that the small differences over 2-3 years would become much larger over 5-10, and possibly 20, years. In addition, ocrelizumab was almost twice as effective in preserving arm and hand function (9HPT) when compared to lower limb function (EDSS and T25FW) in the PPMS trial. The latter is explained by our length-dependent axonopathy, therapeutic lag and asynchronous progressive MS hypotheses

This should be a time for quite reflection, deep thought and then asking the question where next? I think most of us at Barts-MS would say we should be taking ocrelizumab into more advanced MS, including wheelchair users (#ThinkHand), and as a combination therapy with add-on neuroprotectants and drugs to target the intrathecal plasma cell. 




CoI: multiple, I am a member of the phase 3 ocrelizumab steering committee

97 comments:

  1. And it will cost $65,000/year. Does the data justify this price?

    http://www.nbcnews.com/health/health-news/new-ms-drug-ocrevus-wins-fda-approval-n739776

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    1. I was expecting the list price to be higher; I think it is in the same ball park as most of the other DMTs in the US. Looks like Genentech/Roche are going after the whole MS market.

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    2. Please note that the list price is not what the insurance companies pay for the drug. They will do a deal and get a large discount.

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    3. Ocrevus will own the relapsing and progresive patients. They could have priced it even lower and still made huge profits.

      "Rebif, sold in the United States by the German company EMD Serono, carries a list price of about $86,000. In a statement, Genentech noted that the price of drugs to treat multiple sclerosis had risen sharply in recent years."

      “We feel that the industry needs to start to reverse this trend, and believe that pricing Ocrevus 25 percent less than the comparator in our trials is an important first step,” the company said.

      https://www.nytimes.com/2017/03/28/health/fda-drug-approved-multiple-sclerosis-ocrevus.html

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  2. I just received this question via email: "Should we have any optimism re Ocrelizumab or has my wife's MS progressed too far?"

    Yes, I do have optimism. We live in a remarkable era; the era when we are unpacking human biology at such a rapid rate. Who knows what lays ahead?

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    1. Absolutely and so well said Prof. G

      If I might add, the 'remarkable era' also extends to many advances in medicine. Not too many years back, what happened to me (as you know) had rather poor prospective prognosis.

      Yet hear I am, hopeful, thanks to folks just like you unseen to many yet as Steve Jobs once put it, "Making a dent in the universe"

      I am so grateful that you are you.

      Delete
    2. As someone with PPMS, so am I.

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    3. I must admit to being one of those 'Killjoys' but I think it's more of a defence mechanism born out of being a pessimistic optimist.
      One point I did find very interesting was this.....
      """"""""""The focus on T cells grew in part from researchers’ longtime use of a mouse model with a T cell-driven condition called experimental allergic encephalomyelitis, or EAE, to study and develop drugs for the disease.
      Like multiple sclerosis, EAE is characterized by inflammation of the brain and spinal cord, but there, the similarities end. Hauser’s mentor, the late Harvard neurologist Dr. Raymond Adams, told him there was little resemblance between the two conditions.
      “It really didn’t look like MS at all,” Hauser said. So his first task was to develop a new animal model for the disease."""""""

      Thoughts please Prof G , MD & MD2

      Regards as always

      Delete
    4. First task was to develop a new animal model....which was em EAE.

      If anyone has ever looked at EAE it is not MS...end of story, if you look at Mouse EAE it is not Rat EAE it is not Guineapig EAE either.

      However as it was EAE in non-human primates (Marmosets). Then it means he goes up the hit list as far as nutter, militant, anti-vivs goes.
      Luckily he is based in the US where this is not such a hot topic.

      However why did one need animals it was already known that it inhibit a numbe of autoimmune disease

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    5. MD, I can't understand what you've written / garbled. Off to the MS Trust for my info. again.

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    6. Bye then:-).
      Simply put there was no need for Dr Hauser to work in monkeys it was already known that rituximab inhibited autoimmunities in humans.

      Delete
  3. Great news. Also great news is that today the UK let's the EU know that we no longer want to be part of that club - we a sovereign nation not a puppet of Brussels.

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    1. Precisely that has *thrown away* the sovreignity of the UK - no longer do we have a say about how we trade with the EU, they tell us now. We are but free-loaders on the periphery, by-standers. We can only ask nicely as a xenophobic country with delusions of bygone grandeur. And no-one, not even the PM knows how it is going to be for the UK, including vulnerable people with MS.

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  4. Language, language....there may be children reading this post (dr. Dre):-)

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  5. When do you think EMA will approve ocrelizumab? After which Nice? Is it worth waiting instead og going down alemtuzumab? I'm thinking remortgaging my house to have it done in the states. Since health is real wealth !

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    1. MS Trust website 29 March 2017. News:

      Ocrelizumab is currently being assessed for drug licensing by the EMA (European Medicines Agency) for both relapsing remitting and primary progressive MS. It will then be appraised for cost and effectiveness as an NHS treatment for both types of MS. If these steps are successful ocrelizumab could be available on the NHS by 2018 at the earliest. The FDA decision does not affect the European assessment.


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  6. If you have any guts, do a good study of rituximab to test your axonopathy hypothesis. With rituximab biosimilar hitting the market in a few months, that could make a treatment option available to everybody, not only those who can get Ocrevus with some healthcare system sponsoring it.

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    Replies
    1. I think we have answered the question with other drugs already, starting with methotrexate, interferon-beta, GA, natalizumab and ocrelizumab. What we now need to do is a trial in wheelchair users. Rituximab would be a good choice, but better with a licensed product as it will allow earlier and more widespread adoption.

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    2. Given that rituximab has been available for a very long time and that it's very similar to ocrelizumab, isn't it a crime that it hasn't been licensed for PPMS, who were left without a drug?

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    3. Unfortunately we have to agree to disagree, prof G. :-)
      Ocrevus will be prescribed to the lucky few, could you afford it as an out-of-pocket expense year after year?
      I cannot complain on my salary, but I have two kids and a house (that is a lot of bills to pay) - and a drug like that would be totally out of reach if I did not live in a Scandinavian country that has a generous healthcare system. And let's face it, most healthcare systems have less resources.

      Delete
  7. "as a combination therapy with add-on neuroprotectants and drugs to target the intrathecal plasma cell. "

    How would that work?

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    Replies
    1. Every time you guys say this I obsessively search the blog for neuroprotectants and plasma cell posts. These are some of the things I see mentioned here:

      **Giovanni: Do more than deplete B cells. We need to clear intrathecal plasma cells, render pwMS OCB-free, switch off hot microglia and then add-in a neuroprotectant.

      What are the neuroprotectants on the horizon? Are there any available off-license?

      What about:
      1. mitochondria aids like Mito-Q or
      2. focusing on diet/microbiome with probiotics and a diet that can improve short-chain fatty acids?

      Both of these have been feature in academic research on MS in recent years. How do either of those two options help with hot microglia or intrathecal plasma cells?

      Some other things I've saved from the blog:

      Patient comments on blog: Intrathecal Elotuzumab (CNS plasma cells) + TLR4 inhibitor like LDN/Valganciclovir or minocycline (microglia) + Simvastatin (inflammatory cytokine release inhibitor from activated microglia).

      laquinimod - decreases progression – perhaps microglia
      ibudilast – decreases progression – perhaps microglia

      Giovanni - For PPMS – right now the combination supported by data is rituximab and laquinimod

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    2. Can you share with us some ideas, or shall we just sit back and take your words ant face value?

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    3. We have been doing a trial for the past 3 years on this very issue.

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    4. and?

      Do you get the feeling that we are enjoying the suspense?

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    5. ProfG certainly hasn't, he was having nightmares about the slow recruitment. The last person has been recruited so we now have to wait a year.

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  8. If PPMS and SPMS have exactly the same disease, based on your hypothesis for advanced MS, shouldn't ocrelizumab be licensed for those classified as SPMS too?

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    1. dt, it cannot be licenced for SPMS unless somebody does a trial and proves that it actually is of benefit to those patients ( in other words, that the benefits outweigh the risks, because like all drugs it has its risks and side effects). Plus the payers need to see what they are paying for before they pick the bill (65,000 USD a year is not cheap).

      Delete
    2. I agree, but it has been stated many times in this blog that SPMS and PPMS are exactly the same thing. The only difference is that PPMSers didn't have a lesion to an eloquent location early enough to be diagnosed with MS.

      Delete
  9. It is a great news. I am also surprised by their price strategy: "25 percent less than the comparator", for a drug with superiority is very unusual. Eventually they are willing to please Trump administration, restore pharma image and still try to get a premium price in Europe, to avoid US being the innovation payer.
    With your (very) pink glasses, I hope that they start a new trend for the benefits of patients and sustainability of health care systems.

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    1. If market for Copaxone is $ billion, Avonex 3 billion, could be taking the CRAB drug market. I could easily make it a best seller.

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    2. I AM UNFORTUNATELY NOT SURPRISED ABOUT ROCHE´s PRICE STRATEGY -

      And the administrators of this blog should spell it out for all readers, the real reason to why Roche have this price strategy:

      Ok here goes:

      Please read this - I quote:


      " In a market already bulging with expensive drugs for that form of MS, Roche set an annual price of $65,000 for the twice-a-year infusions. A study in the journal Neurology in 2015 that looked at nine of about a dozen MS drugs that modify the course of relapse-remitting disease found that none was priced under $50,000 a year, not including drug company rebates. Prices have generally risen since.

      Roche acknowledged concerns about drug pricing in disclosing the amount, saying that the National Multiple Sclerosis Society recently noted that MS medicines cost almost four times what they did 12 years ago. Roche said its list price is 25 percent less than Rebif, the drug ocrelizumab outperformed in two of of the major studies leading to approval. Rebif lists for $86,000 a year, the company said, adding that the “industry needs to start reversing” the pricing trends. "

      Source:
      https://www.statnews.com/2017/03/28/multiple-sclerosis-ms-drug-ocrelizumab/


      My comment:
      I am on Rituximab myself, which is essentially the same drug as ocrelizumab - Yes it is. But of course Roche will do anything in their power to differ it from low priced Rituxan / Rituximab - rest assured that!


      Now it makes me really, really furious, that Big Pharma, out of respect for MS-patients can not be really honest even at this moment.


      Roche state in statements, that the drug will be priced lower than other drugs, because ms-drug prices have to come down. They really talk bullshit, and the market department at Roche know it.


      THE ONLY REASON they say this, is that they fear competition from low priced Rituximab. You will never find these kind of reasoning and arguing with Roche´s other new drugs .... unless, of course, there is a similar competition issue /problem as with Ocrelizumab versus Rituximab ...


      All the doctors out there know this marketing trick, but when Roche state this, they addresses themselves to the patients. Such hypocrites.

      I thought at least the administrators of this blog would spell the real truef behind Roche "so kind" price strategy. But no comments about this ... yet.


      Not even in this moment, Big Pharma Roche can be straight and honest towards the ms-patients.


      As for me, I stay on Rituximab.


      So, cry no tears for Big Pharma Roche

      Warm regards

      Elisabeth

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    3. I had not seen the post and so have not commented, I've been too busy as I had a couple of 38hour days this week. CD20B posting at 2am I could have responded when I lauched it a 3.

      However I cannot guess on what decision was made to price the drug at 3$20-30,000 less than interferons. I was expecting a price in the natalizumab range.

      But as to the cost of drugs in the US, we are somewhat removed.
      There can be no question that Big Pharma is fleecing the MS community in the US. We have said this before. Nearly $90,000 for something that was $50,000 a couple of years ago is outrageous. The simple solution would be to stop buying the expensive and seemingly inferior product. Then they can charge as much as they like, if no one buys it, it matters not.

      As for rituximab, we will see how Roche plays this one. Roche will try and play the humanised is better than chimeric chestnut and show that ocrelizumab is better. The could withdraw rituximab.

      The issue that will affect us is how much they will charge NHS UK after the 2-3 year process it takes to go through NICE. This will be lesss than is paid in the US.

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    4. It seems that everyone is citing this article

      https://www.statnews.com/2017/03/28/multiple-sclerosis-ms-drug-ocrelizumab/

      Just a little bit of referencing to debunk some of the rubbish said about the animals in that article

      First good on Dr hauser for seeing it through and he has been around since the phase II studies, but was the marmoset the solution and the key reason to look at B cells?

      First the suggestion that you can't get EAE in marmoset with T cells is not the case. Marmosets are born as twins and so they can be used to transfer T cells from one twin to the other.

      This was done by the Gernain/Hauser lab in 1992
      https://www.ncbi.nlm.nih.gov/pubmed/7521889

      The next bit is the suggestion of B cell involvment. I think this was reported in about 1995 https://www.ncbi.nlm.nih.gov/pubmed/7717689. This efffect was also shown in the rodents 8 years earlier.
      https://www.ncbi.nlm.nih.gov/pubmed/3259787.

      B cell depleting in marmosets was reported 2--5 years after studies in humans. https://www.ncbi.nlm.nih.gov/pubmed/20739677 by the dutch group.

      I remember watching tele in the 1990s when I saw that docs reporting efficacy of B cell depletion in arthritis. It does not take a rocket scientist to see what could happen in MS. Someone would try an available reagent in MS, indeed I think there were reports of rituximab in MS by Mike Racke and Anne Cross, 3 years before the Hauser report although that was a big trial.

      Just as I sae that on TV I suspect someone will try the vagal nerve stimulation in MS that was reported last year of the year before that in arthritis.

      Mouse EAE does not look like MS, but Mouse EAE does not look like rat EAE and does not look like guinea pig EAE and that you get nice demyeliniation in marmosets is also perhaps a product of time.

      In mouse EAE disease is there in a couple of weeks before a strong antibody response has formed. In contrast EAE in marmosets often takes weeks to materialise. If you look in guinea pig relapsing EAE which takes months to materialise the demyelination is very good.

      Marmosets have a better developed brain than the rodents they get nice demyelination, but I have to say Marmosets did not predict what happened when BAFF/ApRIL was blocked, which worsened MS.

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    5. The pricing strategy may make complete sense

      1. If Ocrevus is as effective in the real-world as shown in trials and its safety profile remains decent it stands to gain significant market share.

      2. I would imagine if priced in the area of Alemtuzumab insurers would be pressing for it to be more a second line therapy, which still may happen again given a safety profile.

      3. To an MS patient and insurer(s) two infusions and move on through the year(s) with better efficacy at a lesser cost is more attractive than pills, injections, monthly infusions etc. Again, give a good safety profile ongoing.

      4. Given efficacy remains intact and again, safety profile, at this costing Roche takes command of MS med pricing, period. They would essentially own the "in demand" DMT.

      5. I would estimate this is exactly what Roche believes they have.

      6. For PPMS patients its the only FDA approved med now. The PPMS market is considerably smaller than that of RRMS. Pricing way out there might result in insurers going, "Sorry. No. Its efficacy profile in PPMS does not warrant cost" and they cant well price different for disease course.

      ---

      As with every MS med everything will hinge (IMHO) on the safety profile. I would imagine there are concerns going both ways.

      That is to say, should its efficacy profile in trials stand up in the real world and safety profile stay or get better it stands to become the #1 MS drug (pending others in the pipeline at least, so grab marketshare while one can). A concern would be if its efficacy profile is as good as stated then WHAT does that do to research towards other meds and even perhaps research in academic form?

      How long will said real-world profiles take? Two years? Five?

      If the med lives up to its present profile then indeed, other DMT's costing will surely come downwards.

      This would be assuming that these specialty drugs do not have a change in the formats of sale. That is to say the deductions afforded taxable revenues. The "Lanky" deal that exists provides patient/clinical choice .vs. much more insurer control. If it were not for the "lanky" deal(s) then every RRMS patient in the US would be starting on Copaxone or Interferon at its legacy costing. Thats why chicken wings are chicken wings.

      Delete
  10. Both my neuros -- very prominent in the U.S. -- still prefer Rituximab for my PPMS due primarily to the alarming reports of cancer in the Phase III trials. I am a mother of a very young child and not willing to risk it until more is known about the cancer risks involved with Ocrevus.

    Now many of us in the US will be fighting with our insurance companies to approve off-license Rituximab, which will be FAR cheaper than Ocrevus and less risky, in terms of cancer.

    I wish this article in STAT -- which includes a very nice profile of Hauser and his research, including his earlier Rituximab work -- addressed the issue of how patents made Rituximab less attractive as a drug to develop. The story of Ocrevus is largely about the bad incentives created by a system based on for-profit companies leading almost all research and development in the US.

    This is a moment to celebrate, though, and many patients will not be as risk-averse as I am (kids are grown, different priorities regarding the tradeoff between mobility/independence v. risk of death). Although there is a long way to go, it seems like there is so much promising research. I would love to see a really talented science journalist take on the entire world of MS research right now and cover the next 10-20 years of research.

    https://www.statnews.com/2017/03/28/multiple-sclerosis-ms-drug-ocrelizumab/

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    1. "I am a mother of a very young child and not willing to risk it until more is known about the cancer risks involved with Ocrevus."

      Spot on. But such risks are glossed over on this blog.

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    2. scary!

      Team G: what are the cancer risks on Ocrelizumab?

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    3. We have reported on the data from the trials

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    4. On the MS Trust website. News about MS:
      Drug for primary progressive MS licensed in the USA.
      29 March 2017

      About ocrelizumab

      Ocrelizumab is taken as an intravenous infusion (drip) every six months. It reduces the number of B cells, a type of white blood cell, or lymphocyte thought to be involved in the abnormal immune response that attacks the myelin coating of nerve cells.
      In primary progressive MS, people taking ocrelizumab were 24% less likely to have an increase in their disability than those taking placebo
      In relapsing remitting MS, ocrelizumab reduced relapse rates by approximately 50% compared to beta interferon
      Infusion-related reactions, chest infections and herpes (oral herpes and shingles) were more frequent in those taking ocrelizumab
      Neoplasms (abnormal growth of tissues which can be benign or malignant), including several cases of breast cancer, were reported more frequently in those taking ocrelizumab.

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    5. It is interesting how times have changed...and we may have alemtuzumab to thank for this, as it has changed the regulators view. The cancer risk issue from one trial sunk movectro.

      Merck are now back at the regulators and the result will be this year. Does anyone know the new name or is is going to be called movectro still? I suspect it will get a new identity so it can shake off the past. Maybe pheonixo? It it gets approved will they compete with ocrelizumab or price with the pack.

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    6. Your right... I never even thought of this. Very astute thinking MD!

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  11. Wonderful. Now the more pressing question. For so many of us on Tysabri what will the washout protocol be so we too can switch?? I asked my Neuro last month and he told me they do not have consensus on this yet.

    I am already on extended dosing (7 weeks) and doing well.

    Debbie

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    1. There are people that have transitioned off natalizumab and on to rituximab, that surely can give insight but numbers are what is needed Remember those B cells are accumulated in the blood on Nataliumab ready to get into the CNS.

      The sequencing of switch is going to another issue that is going to affect drug selection...where do you go next.

      Delete
  12. I am 67 years old; had one attack when I was 21. I like to think it is the treatment I take every other day since 1982; Snake Venom.

    Sure; it might be just placebo; I don’t think so but if it is so what! It costs me £50 for 4 years supply.

    Still were talking about ocrelizumab a vast step in the right direction. Whether I am PPMS or some strange form of the dreaded lurgy I don’t know and don’t really care.

    George Goodger

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  13. "If you have PPMS you would no doubt be celebrating."

    I'm in my early 40s, have had PPMS for quite some years, and no - I am not celebrating. This drug is just another pretty crude way to bludgeon part of the immune system and it carries an unquantified cancer risk.

    The sales pitch would be more convincing, Prof G., if you dropped the expletive from your rebuttal of the very justifiable cyncicism surrounding this drug.



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  14. Pricing it 25% less than comparator - wow!
    This shows Genentech's confidence in the produc

    I expect Ocrevus to totally take over the market, "if the safety profile holds up"

    https://www.nytimes.com/2017/03/28/health/fda-drug-approved-multiple-sclerosis-ocrevus.html?_r=0

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    1. Which competitor?

      Did you see how much rituximab sells for?

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    2. Now all we need is to show it is an Induction therapy/PIRT and there you have if.

      Delete
    3. Yes Anon 4:38, I know the price and it is certainly very high

      But this is the first time that a new MS DMT has been priced lower than the competition.

      See this comment from 2012:
      Comment on "Is the MS market a cartel?"
      "The first company to reduce DMT prices is likely to gain a lot of market share, and perhaps earn higher profits in the short term.
      In the long therm this will force a reaction and the others will have to lower their prices too, so market share will even out again.
      Ultimately they will all have lower profits and that's a lose-lose situation.
      ...
      IMO a company will risk a drastic price reduction only if they are confident their product is much better than the competition. In that case they know they will be able to hold on to the extra market share even after the others reduce prices too."




      Delete
    4. If the safety profile holds up....I suspect it is a matter of time until a serious infection occurs, it has already happened in the past in the arthritis/lupus studies

      Delete
    5. yep, PML was looming in the background, but never developed to the levels of natalizumab. Frankly, any drug that is immunosuppressive will carry some infection risk, some more than others and some with more focus on one type of infection.

      Delete
  15. From following this blog I assume the mechanism of action of ritux/ocrelizumab is depletion of CD20+ B cells that are EBV+. As rituximab/cidofovir has been shown to be effective in treating posttransplant lymphoproliferative disease caused by EBV following allogenic HSCT will the effectiveness of anti-CD20 therapies fuel the fire that MS is in part an EBV related disease.

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  16. Prof G and MouseDoctors!
    Ok we have a PPMS therapy, but what holds the future for SPMSer?
    I heard about Siponimod, MIS416, Mastinib, Amiloride, Ibudilast etc... Will we have breaktrough therapy in this field of MS? I watched some viedos about MIS416 seems to be very promising..)

    What are your opinion about the SPMS eagles?

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    1. I suspect the Siponomod eagle will land soon

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    2. No, MD, FK506 is working through T cells and we don't like that...

      Delete
    3. T cells control the B cell infected EBV. At some point
      T cell exhaustion(ageing) that can't target cancer could be cause of progressive ms it seems. Cancer and progressive ms both come in middle age+.

      Defective elimination of EBV-infected B cells by CD8+ T cells might cause MS by allowing EBV-infected autoreactive B cells to accumulate in the brain.

      http://www.nature.com/cti/journal/v6/n1/abs/cti201687a.html

      http://www.sciencedirect.com/science/article/pii/S0165572817300553

      Delete
    4. If I can hijack the thread a little. If you look at the YouTube videos of MIS 416, the patients testimonials all sound like anecdotal remarks, lessening of brain fog, feeling more energetic, blah blah. Not one mention of an improvement in EDSS, the only thing that matters. Sorry to be a negative Nelli

      Delete
    5. What about the neuroprotective effect of FK506? IS that T cells?

      Rapamycin is not in phase III trial so that eagle aint going to land anytime soon

      Nice though Adam

      I have line this up to post for ProfG to commen on a couple of times, Prof Pennder is presenting at AAN.

      Delete
  17. Hmm I posted a rather critical post - but maybe I destroyed the party or Roche were not so happy about my post ...

    I give it one more try, it could be a bug that blocked it.

    Ok, her we go: I quote the following:

    " In a market already bulging with expensive drugs for that form of MS, Roche set an annual price of $65,000 for the twice-a-year infusions. A study in the journal Neurology in 2015 that looked at nine of about a dozen MS drugs that modify the course of relapse-remitting disease found that none was priced under $50,000 a year, not including drug company rebates. Prices have generally risen since.

    Roche acknowledged concerns about drug pricing in disclosing the amount, saying that the National Multiple Sclerosis Society recently noted that MS medicines cost almost four times what they did 12 years ago. Roche said its list price is 25 percent less than Rebif, the drug ocrelizumab outperformed in two of of the major studies leading to approval. Rebif lists for $86,000 a year, the company said, adding that the “industry needs to start reversing” the pricing trends. "

    Source:
    https://www.statnews.com/2017/03/28/multiple-sclerosis-ms-drug-ocrelizumab/


    My comment:
    I am on Rituximab, which is essentially the same drug as ocrelizumab - Yes it is. But of course Roche will do anything in their power to differ it from low priced Rituximab - rest assured that!


    Now it makes me really, really furious, that Big Pharma, out of respect for MS-patients can not be really honest even in this moment.


    Roche state in statements, that the drug will be priced lower than other drugs, because ms-drug prices have to come down.


    THE ONLY REASON they say this, is that they fear competition from low priced Rituximab. You will never find these kind of reasoning and arguing with Roche´s other new drugs .... unless their is a similar competition issue as with Ocrelizumab versus Rituximab ...


    All the doctors out there know this marketing trick, but when Roche state this, they addresses themselves to the patients. Such hypocrites.


    Not even in this moment, they can be straight and honest towards the ms-patients.


    Why does not the administrators of this blog, MD and Professor Gavin make a comment on this. Big try to present themselves as angels, lowering the price, but there is a strict commercial reason for this - namely its cheap sister Rituximab, that cost just a fraction of what Ocrevus costs.



    So cry no tears for Big Pharma Roche, They have to deal with competition from much cheaper Rituximab.

    Regards

    Elisabeth

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    1. Elisabeth, you are raining on the Ocrelizumab parade. "The eagle has landed" but not without a choppy flight. The specter of rituximab casts a pallor over the glow of ocrelizumab and its high price which was the central theme in this drug's story:-(

      Delete
    2. Most certainly there is marketing involved, it is afterall a product.

      As with all products goals are towards capturing market shares. Right and wrong seldom enter into the equation.

      I can cite car/suv tires for example. One of my fiance's long time friends is management at a tire manufacturer. The average tire is about $15-$18 to produce, yet, one can pay upwards of $140-$200+ each.

      To create a video game costs far more than the .12 to produce the physical DVD and $1.50 of packaging.

      Marketing is far far more complex than price, its highly complex in fact.

      Is pharma wealthy? Absolutely. But lets take a moment and compare it to say Facebook, who collects and sells everything they can muster about users and are richer than any singular pharma by quite some margin. Or, Walmart, Walmart consigns 99% of everything they sell. They dont buy it and resell it. They consign it under Net terms, mark it up. A $5 DVD at Walmart has a cost of goods less than .40 cents.

      Now understanding the "meds" game gets complex. Pricing is complex. If one views Interferon's and Copaxone pricing of years back one see's $8000 or so. Had those prices stayed where they were now what is an insurer going to say? "Before attempting the $30,000 Gilenya we want you on one of these for a year, perhaps two."

      The rather "knit" pricing is based upon MANY factors including provider/patient choice. Insurer's would be the first people to YELL!!!! foul on all this. But, they get perks against taxable revenues. The "free access" programs where insurers wont pay is part in all this as well.

      A former Ohio (USA) assistant attorney general gave me an up and down skivvy on this stuff. Its far far far more complex than meets the eye of the patient.

      If it were automobiles instead of life saving meds, every attorney general in the land be all over it wanting massacre all entities involved.

      But, here's the thing. Most people (not all) pay quite minimal for the MS meds via insurers. I pay $35 a month for Tecfidera. Do I really need blow my wig that Pharma, insurers and government have found a way in paper revenues to make that work?

      Do I really want that gone? So my Tecfidera is now $28,000 a year and I have a co-pay of $500 a month?

      Are there some Pharma's who have jumped in on it to rape and pillage, yep.

      Ocrevus is not the exact same medication as Ritux just like a Lincoln towne car is not the exact same as a Ford Crown Victoria even though the two cars are 95% identical. One costs far less than the other.

      Some like compare the US to Canada in MS Meds. Canada is quite different, a real national care system, not a hybrid and choice is FAR more limited as is even access into care.

      Also remember, it was the US citizens WANT years back to have changes in the care system which spring forth the HMO which now people dislike. They want personalized care now, thats what they had pre-HMO and disliked due to expense and more.

      Delete
    3. Aubagio and its close cousin' in RA is a rather repurposed med.

      I do not cry tears for Pharma and MS medication access for MS in the USA is better than anyplace in the world by a very significant factor.

      I do cry for people in places such as India where they are literally at the mercy of the disease. I cry for people in the UK, Canada, Europe and elsewhere as their care systems and patients are limited by their care system due to costing which is a direct result of the system in the USA that allows me my medication for $35 a month.

      Since what do people in the USA care SO MUCH about insurance companies seeing a bill of $65,000 a year that is paper (not hard asset).

      Let's say tomorrow a effective PPMS therapy comes along. Would you rather it be $20,000 a year and pay $300 a month co-pay or would you rather pay $40 a month and let insurers and pharma get paper assets of $60,000 part of which is profit, part of which is written off against taxable revenues yet also counted as revenue?

      I can cite' Brilinta. Its $800 a month uninsured twice a day. With my fiance's co-pay, $12. Or, take a look at the supplements industry which is enormous, unregulated, not accountable yet people jam the things into their body thinking its safe because its not regulated. Completely untrue. I know people who wish they never heard the word "curcummin" with MS as they have underwent surgery for bile duct cancer.

      Prices in the USA (health care and then some) also help drive economics of care systems globally and research in both good and bad ways.

      If however monetary rape is a concern of people then lets also start taking a look at Facebook, one of the largest revenue makers in the globe. They rape your information, sell it to the point of becoming one of the largest profit makers on the planet and give you absolutely nothing in return.

      Or, Walmart who just made $11 on that heating pad for doing nothing other than taking it from one box, putting it on a shelf and cashing you out and giving you a bag to put it in.

      OR! My personal favorite. The wireless phone provider who's cost of your call, text, web surf is fractions of fractions of a penny but wants hit you up for $600 or more annually.

      Or, that expensive iPhone made up of $15 in parts.

      People equate these med costs with what THEY could buy with that money. At $70,000 a year I can have a house and a ferrari and and...

      Well, for the $40,000 I pay for the car I could have two of them. For the $300,000 I pay over my 30 year mortgage for my $90,000 home I could have three homes.

      Welcome to capitalism.

      Delete
    4. Dear Elisabeth
      Can I suggest that you read the posts above i.e under Lady in Red and you can see your post and responses there

      Delete
  18. The God Effect said

    Yawn. Another DMD that barely registers on the progressive scale. Emphasis, like all the other DMDs, on slowing progression, I.e you will still progress and have a wheelchair to look forward to sometime down the line. We need (XXXXXXXXXXX SOUNDS LIKE AN ADVERT) that has been shown to reverse established disability. (SORRY AN IMPROVEMENT (IN SOME) IS NOT A REVERSAL) Interesting how that's never mentioned. We need to function again, not just slow deterioration. Am I the only one who is this jaded?

    ReplyDelete
  19. I am appalled that articles including this one are being published without mentioning the following: ocrelizumab is NOT an innovative drug. It is essentially identical to an existing drug (rituximab). It has essentially identical side effects and efficacy. Also, ocrelizumab does not have the 20+ year safety history that rituximab has. Ocrelizumab may be overdosed (based on the results of the Sweedish trial suggesting that 500mg rituxan once every 6 months is highly efficacious in relapsing MS). Also, there is a possible increased risk of cancer in the ocrelizumab arm compared to the placebo arm in one of the trials (though this may be coincidental). I understand that many neurologists do not have access to rituxan, but I implore the authors of this site to edit this article to include this information. The authors of this site should encourage everyone to prescribe off label rituxan rather than ocrevus if they have the opportunity to do so.

    ReplyDelete
    Replies
    1. We have discussed these issues endlessly on the blog. Yes, you can use rituximab if you want, but you have to realise we don't quite know what dose to use and how often to use the drug.

      Ocrelizumab is not the same drug as ocrelizumab. They may have the same target, but there other differences that are not so subtle. The main differences is the incidence of anti-drug antibodies. As ocrelizumab is a more humanised antibody the level of anti-drug antibodies is lower.

      On the other side of the coin is innovation. You need to ask Genentech/Roche what are they going to do with the profits they make on ocrelizumab? I assume some of the profits they have made on rituximab have gone into developing ocrelizumab, various cancers, etc. I am aware they are also working on treatments for Parkinson's disease and Alzheimer's disease, etc. Do we want them withdraw ocrelizumab from the market and close down their R&D department?

      Our politicians, and society in general, have a deal with Pharma. We allow them to make profits on innovative drugs for a period of time, before they come off patent, and society then gets them at a cheaper price. However, we expect the profits made from these drugs to be used to develop new therapies and not to reward their staff with outlandish bonuses, etc.

      Delete
    2. Well said Proff. G.

      Delete
    3. I think the point Anonymous 2:31 is making is that ocrelizumab is not innovative. And it is not, it is a "me too drug" because we already have a drug that uses the same mechanism(rituximab) and we know that rituximab works in MS(thanks to the Swedish and some brave Americans) who have been using it for some time.
      And while rituximab is a wonderful innovation that has changed the lives of many people around the world (thank you, Roche!), ocrelizumab is not adding a lot of new value/innovation, but comes with a new price tag ( Roche, this is ugly!). Reminiscent of the Avastin/Lucentis story. (also Roche).
      They are powerful, they know how to lobby the both the politicians and how to dance around the so called Key Opinion Leaders.
      The truth is, the more pharma gets, the less there will be in the pot for other things - like help for a teenager looking after a sick mother.

      Delete
    4. As we have posted on the blog numerous times the only drugs that we innovative for MS is natalizumab or copaxone for all others the mechanism of action has been poached from other conditions.
      We appreciate that people are new to the blog but there is written gold in the six thousand posts we have made. We can't keep repeating everything with the same intensity or enthusiasm.

      Delete
  20. Why has there been PML cases with Rituximab but not Ocreclizumab ?

    ReplyDelete
    Replies
    1. Re: "Why has there been PML cases with Rituximab but not Ocreclizumab ?"

      Ocrelizumab has not been around long enough and the population that is being treated with ocrelizumab is at relatively low-risk of PML. Almost all the PML cases associated with Rituximab have been exposed to other immunosuppressive drugs or have lymphomas. In other words the PML-risk is due to the other factors and not the rituximab.

      In summary, the risk of PML with anti-CD20 therapies is likely to be low. Why? Anti-CD20 therapy leaves the CD8+ anti-JCV cytotoxic T-lymphocytes unscathed; these are the cells that protect you from getting PML.

      Delete
  21. How many people on the trial where JCV positive with a high titre? I start a trial in Australia next week , this will be my first DMD and I am JVC positive with a high titre . I'm concerned about the possibility of PML !

    ReplyDelete
    Replies
    1. In general, PML risk with anti-CD20 therapies will be low.

      Delete
    2. Just a general question Prof G.

      As I understand it PML is not difficult to blast but the problem is getting medication to the infection.

      In Australia some patients have received injections directly into the CSF with good results.

      My question is, while I understand (sorta) the clinical trial progress what forms of regulatory measure exist in respect to procedures such as this. Obviously a patient with PML can accrue significant CNS damage given current protocols.

      Delete
    3. I'm not sure of the treatment but PML is a rare occurance and one centre is not going to have many cases and you probably will find that procedures are done on an experimental basis and the patient has to be concented to the study. It will not be a formal trial as we know it..

      Delete
    4. Personally, I am a bit worried about the patients who were on natalizumab previously and had to stop because of high JC virus antibody titres. How are they going to do on ocrelizumab/rituximab long term?

      Delete
  22. How many infusions do you need before the changes are permanent like alemtuzumab or is this just theory and no clinical evidence?

    ReplyDelete
    Replies
    1. Please reach our posts on the EBiodmedicine paper, there is some data there but the commany has not do the studies to make it an induction therapy

      Delete
  23. Where can I get rituximab for of label off label in uk or Europe other than going to india where medicines are not always the real McCoy. Can anyone recommend a clinic?

    ReplyDelete
    Replies
    1. As we have said many times you can get it as a private prescription administered within the NHS.

      Delete
    2. Please may I ask how much this might cost (approximately)? Do you just oay for the drug itself or anybtests associated with having a non-NHS funded treatment?

      Delete
  24. What about rituximab? Does that also induction type effect? Should be plenty of evidence given its 20 years?

    ReplyDelete
    Replies
    1. Read the very first paper there was disease control 1 year after the last dose. As you say the data must be out there it needs someone to collate it. The Swedes have a massive register of rituximab users.

      It should be looked at as a matter of urgency, because we should put safety ahead of company profits, if you do not have to keep dosing for ever we should not because we know that doing for every will at some stage kill someone. The evidence is there in when used in Lupus and arthritis there were infection related deaths.

      Delete
    2. Yes, MD, but in arthritis you get a relapse of activity when the effect of rituximab wears off. It takes 9 months in some patients, 12 months in some others, but eventually we do get into trouble. And, believe me, if you had arthritis you would not like to wait for new relapse at 9-12 months intervals - because that has serious consequences for the quality of life, family life, employment etc.

      I hope the story is different for MS, but I will believe it when I see it :-)

      Delete
    3. This may be the case and i fully accept that but should we not do a trial to check. You could complement with enough imaging so you see awakening before relapses show their ugly head. Then re treat it works in nmo. Maybe we can monitor memory B soluble CD27.

      If not we can do cladribine and induction,it is just round the corner for some.

      Delete
    4. Why must you do do a trial to check? Why not just check the Swedish data?

      Personal experience is:
      the effect lasts between 6 months and a year. Then the patient starts to feel problems, though the imaging shows nothing at all.

      The problems that appear are really subtle and hard to convince the doctor about. Seems it isn't so much that symptoms reappear, it is more that the patient starts to notice them again and finds it harder to deal or live with them

      Delete
    5. Thanks for sharing your experience, maybe it is not induction and roche are happy and genzyme are happy as ocrelizumab may not kill

      i'ld love to see the Swedish data if there is data that can inform lets see it. However from what you are say

      Delete
  25. Thank u so much MouseDoctor taking time to answer questions that may seem dumb and repeated. Me and sure others really appreciate the work and patience shown by all your team.

    ReplyDelete

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