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    ocrevus approved

    FDA Approves Genentech’s OCREVUS™ (Ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis


    Ocrevus will be available by mid-April.

    Key data in RMS patients treated with OCREVUS showed:

    A 46 percent and 47 percent relative reduction in the annualized relapse rate (ARR) compared with interferon beta-1a over the two-year period in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
    A 40 percent relative risk reduction in confirmed disability progression (CDP) sustained for 12 weeks compared with interferon beta-1a in a pooled analysis of OPERA I and OPERA II, as measured by the Expanded Disability Status Scale (EDSS) (p=0.0006).
    A 94 percent and 95 percent relative reduction in the total number of T1 gadolinium-enhancing lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
    A 77 percent and 83 percent relative reduction in the total number of new and/or enlarging T2 lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
    Key data in PPMS patients treated with OCREVUS showed:

    A 24 percent relative risk reduction in CDP sustained for at least 12 weeks compared with placebo, as measured by the EDSS (p=0.0321).
    A -0.39 cm3 mean change in volume of brain hyperintense T2 lesions compared with a 0.79 cm3 mean change in volume of placebo-treated patients over 120 weeks (p<0.0001).
    A 25 percent relative risk reduction in the proportion of patients with 20 percent worsening of the timed 25-foot walk confirmed at 12 weeks.



    http://www.businesswire.com/news/hom...apsing-Primary

    #2
    A friend just messaged me with the article, so I thought I would come and post here. Marco beat me to it, lol. Good job! Will have to ask my neuro about it next visit.

    Comment


      #3
      Thanks, Marco! (You also beat me to posting this ) Think it will prbably be my next option.
      Kimba

      “When you change the way you look at things, the things you look at change.” ― Max Planck

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        #4
        Thanks Marco, this is what I have been waiting for, although it's scary to start a new med.

        Calling my neuro to set up appointment.

        Been missing you Marco
        God Bless Us All

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          #5
          Thanks Marco. I am so happy.

          My neurologist's office called me yesterday morning to remind me that I am supposed to have another infusion of rituximab next month. The first infusion did nothing for me and I am getting weaker every day so I am praying that he and insurance will allow me to go on ocrelizumab. My appointment is next week so fingers crossed.

          My goal right now is to try to get out of the wheelchair and use my walker again. The graduation ceremony where my son will receive his masters degree in geology is in August. I would love to be able to stand and give him a real big hug!

          Comment


            #6
            Thanks Marco for Posting!

            The "Finally Some PPMS Love" post you made is also very helpful:
            http://www.msworld.org/forum/showthr...some-PPMS-Love

            I spoke with Genentech Patient Advocacy today, and OCREVUS is manufactured in Switzerland and should be available by the end of next week (April 7) in the U.S.

            Not sure about insurance coverage / formularies right now, but I understand there is something called a "honeymoon period" for newly approved drugs. (Perhaps one of you knows something about this.)

            Here's an article from the NY Times about this approval, including pricing:
            http://www.nytimes.com/2017/03/28/he...s-ocrevus.html

            I agree with Marco: Finally Some PPMS Love!
            And the results looks good for RRMS; hopefully, the safety profile will continue to be good over time.

            Another choice for patients and doctors to consider is good.

            Alan

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              #7
              $65,000 an infusion?

              Is it true that it will co$t $65,00 and infusion per month?

              I left in love, in laughter, and in truth, and wherever truth, love and laughter abide, I am there in spirit.

              Bill Hicks

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                #8
                $65,000 for infusion every 6 months

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                  #9
                  Originally posted by alanpgh View Post
                  Not sure about insurance coverage / formularies right now, but I understand there is something called a "honeymoon period" for newly approved drugs. (Perhaps one of you knows something about this.)

                  I agree with Marco: Finally Some PPMS Love!
                  And the results looks good for RRMS; hopefully, the safety profile will continue to be good over time.

                  Another choice for patients and doctors to consider is good.

                  Alan
                  Thank you, Alan. Haven't heard about a "Honeymoon period" before, but doesn't necessarily mean there isn't something like that. It's already being added to some private insurance companies from what I've seen. (I think it might have something to do with the extended FDA ruling date, was first expected last December). Then there's the delay waiting for prior authorization once your neuro agrees and writes the script, and has filled.out and sent in the required documentation form before insurance will agree to pay for it. (And like Tysabri, infusion center costs are not included in that price). Individual insurance will dictate whether or not this will be approved as a first line treatment for RRMS (same as Tysabri) even though FDA has approved it as one.

                  Many questions about Ocrevus are answered in this News from the National MS Society, including that there will be a patient assistance program. Hope those interested in Ocrevus will take the time to read through all of it. http://www.nationalmssociety.org/Abo...izumab)-as-the

                  Good luck to everyone who makes the decision with their neuroIogist to go on this drug!
                  Kimba

                  “When you change the way you look at things, the things you look at change.” ― Max Planck

                  Comment


                    #10
                    Thanks, Marco!!!

                    This is a day I have been waiting for. It's so nice, too, that you have dropped in to visit us again. I got an email from MSSA with the news.

                    I've read everything I can get my hands on about Ocrelizumab but still can't find any information on how people who have been on Tysabri do on it if they switch. Guess I just have to be patient. It will come.

                    In the meantime, take care of yourself. You have given everyone on this site so much. We hope to have a chance to be a comfort to you, too, if you ever need it.

                    Comment


                      #11
                      Originally posted by DorOMA View Post
                      $65,000 for infusion every 6 months
                      Saw this in an article. "The list price for one year of treatment, which consists of two annual infusions, is $65,000."

                      I think it may "only" be $65k a year. Already saving 50%. What a bargain!

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                        #12
                        Ocrevus trial still recruiting

                        https://clinicaltrials.gov/ct2/show/...ow_locs=Y#locn

                        I´m in this trial and got my first dose today. So far minimal side effects- the benadryl IV gave me a nap and towards the end of the infusion I got some itchy spots on my head which have gone away. Was able to transport myself there and homeward. Do visit more than one test site if you can - the people matter way more than the facility.

                        They are still recruiting 150 more people.

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                          #13
                          Great share Macro....65K is a year is huge

                          Comment


                            #14
                            Originally posted by AmyForever View Post
                            Great share Macro....65K is a year is huge

                            65k makes Ocervus the second cheapest drug that we have. Only Glatopa, generic Copaxone, is cheaper for the medication. For Ocrevus you still need to add two days in the infusion center to the price .. something pills and self-injections do not have.


                            Like all other MS medications, Ocrevus does have a financial assistance program: https://www.ocrevus.com/patient/financial-support.html

                            Comment


                              #15
                              I saw my neuro today and he is very excited about Ocrevus. He is testing my blood and he wants me to have an mri just to have as a starting point. It will go thru the medical part of ins. and they are checking to see if my ins. (which is medicare) will cover it. If everything is go, it will probably be May until they will start infusions.
                              God Bless Us All

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