Ocrelizumab

[Myoak]

Ocrevus Assessment Report European Medicines Agency November 2017

http://www.ema.europa.eu/docs/en_GB/...C500241126.pdf

I believe it is prudent to monitor closely for breast cancer since there were more cancer cases, and especially breast cancer, which showed up with Ocrevus during trials than with the two comparators which were Rebif and placebo.

We should remember that in trials… RRMS Ocrevus (n-825, the number taking it) was compared to Rebif (n-826) and in PPMS (n-486) Ocrevus was compared to placebo (n-239).

Quoting from page 140 (the italics are mine) … QUOTE “Malignancies
RMS (relapsing MS) … the rate per 100PY (PY = patient years) of malignancy was 0.14 … for the IFN (Rebif) group and 0.28 for the OCR (ocrelizumab) group.”

PPMS (Primary Progressive MS) The rate per 100PY of malignancy events was 0.30 … for the placebo group and 0.92 for the OCR group.” End Quote

Quoting, from pages 149 and 150

“At least 1173 MS patients have been exposed to the proposed dose 600 mg dose for more than 95 weeks. However, long-term exposure data do not allow conclusive evaluation of the risk of malignancies as well as rare risks, such as PML. The RMS and PPMS patient population included in the controlled MS trials is a selected patient population, not entirely representative of the MS patient population target of the two claimed indications.

For instance median age of PPMS enrolled patients was 46 years...

There is no information regarding patients older than 55 years. The absence of safety data in patients ≥55 years of age requires a more cautious approach with regard to the observed imbalance in malignancies, including breast cancer, observed in OCR-treated patients relative to comparator (IFN or placebo), as it is well known that the risk of malignancies increases with age.” End Quote


I quote page 172 broken into paragraphs for readability …

3.5 Uncertainties and limitations about unfavourable effects

“More than 1173 MS patients were exposed to the proposed dose 600 mg dose for more than 95 weeks with a total of 4485 patient years of exposure to ocrelizumab in the MS population. However, even if this is a large safety database rare adverse events or adverse events likely to occur later might not have been captured. In particular, available long term exposure data do not allow to conclusively evaluate both the risk of malignancies as well as PML.

Moreover, the exclusion of patients >55 years old, prevents the assessment of the safety profile of OCR in the elderly, in particular with respect to malignancies, the risk of which is known to increase with age.

Patients with a history of recurrent or chronic infections or immunodeficiency, and patients with a history of ischemic cerebrovascular disorders were excluded from the pivotal trials.

Cardiovascular disease was not among exclusion criteria, but there was only one enrolled patient with a history of cardiovascular disease (SMQ cardiac failure). The safety of OCR in the presence of the above mentioned morbidities is thus not assessable at present.

Opportunistic infections, but not PML were seen in the RA population where ocrelizumab exposure corresponds to 7324 patients years albeit in dose levels ranging from 20 mg to 2000 mg. Opportunistic and serious infections was also seen in the SLE and LN population and 6% and 3%, respectively died in these population due to infections.

It is uncertain if safety data from these patient populations can be extrapolated to the MS population as patients in the RA, SLE and LN population also received additional immunosuppressant treatment, had different comorbidities and the RA population was older than the MS population.

It is thus unknown if prior or current immunosuppressant treatment in the MS population will increase the risk of infections. It is also unknown, had the safety database been as large as in RA, if cases of opportunistic infections would have occurred in the MS population.

Up to the 30 Jun 2016, there were in total 26 cases of malignancies reported in MS patients treated with ocrelizumab. There was an imbalance in the incidence of malignancies in the ocrelizumab groups compared to IFN and placebo with a cluster of breast cancers in the ocrelizumab groups.

There were no cases of breast cancer in the IFN or placebo groups whereas there were 3 cases in the RMS ocrelizumab group and 4 cases in the PPMS ocrelizumab group...

In randomised controlled trials only about 20% of randomized RA patients received more than 2 OCR doses and only 38 patients received up to 8 OCR doses in the open label part.

The higher incidence of malignancies, with a cluster for breast cancer, observed in OCR-treated patients relative to comparator (IFN or placebo) is a cause of concern, particularly as age >55 years was an exclusion criteria.

Additionally, long-term safety has not been investigated, and for this reason the applicant will perform post-approval studies to address this issue.”

Quoting page 176, “The safety profile of ocrelizumab shows an increased frequency of malignancies compared to control groups, which seem to be driven by a cluster of breast cancer. However, the incidence was not higher as compared to epidemiological data and available data do not allow to definitely establish - nor rule out - a clear causality to ocrelizumab treatment.” End Quotes.


Only time and data can definitely establish if cancer is more of a risk with Ocrevus. Breast cancer appeared more frequently than other types in trials. Prudence dictates those taking Ocrevus should closely monitor for cancer, especially breast cancer.

[Myoak]

I´m going for infusion no. 3 this week. For me the results have been good- no relapses...

I´ve gotten serious about going to yoga and the improvements are very heartening. It is helping with strength, balance and flexibility.

Wow! That is such a great report! Slowing down MS and improving strength, balance, and flexibility is wonderful! I am thrilled for you!

[Temagami]

For those that are using or trying Ocrevus, I have some questions about your results.
1. Have your results been good or bad?
2. If you have had bad results, what were they?
3. If you have seen improvements, how long did it take for them to show up?

I´m going for infusion no. 3 this week. For me the results have been good- no relapses, return of normal sensation (within weeks of first infusion and I´m counting the split initial dose as one) in a place that had been off since diagnosis in 2011. Had an MRI last week and will hear this week the results of that. Still get muscle spasms, lack of body temperature control, cog fog and fatigue. I highly recommend considering this drug. The only adverse reaction I have had was on the first dose my scalp got itchy near the very end. Other than that, nothing.

If you do- treat yourself to one of those travel neck pillows b/c the benadryl treatment knocks ya out and your neck will droop to one side for a long time.

I´ve gotten serious about going to yoga and the improvements are very heartening. It is helping with strength, balance and flexibility.

[penguins]

Results of Ocrevus

For those that are using or trying Ocrevus, I have some questions about your results.
1. Have your results been good or bad?
2. If you have had bad results, what were they?
3. If you have seen improvements, how long did it take for them to show up?

[timeuponaonce]

I'm currently on Tysabri and have been since 2013, JCV titres have actually dropped from 430 antibodies Mmol/L to less than 200 which is negative. Saw my neurologist yesterday and he's wanting to start me on Ocrelizumab in October when it's able to be prescribed in this country for pensioner prices. Apparently he's got permission to prescribe, monitor and research 10 patients and he's saved a spot for me. Now originally I was pretty happy about the decision because I'm becoming increasingly nervous about developing PML despite the fact that my JCV titres are negative. The thought of less frequent infusions is also appealing BUT I was told that there's NO risk of developing PML on Ocrelizumab. Now I've read up about it and apart from the more convenient less frequent infusions I am still freaked out by the possibility of fatal side effects. Has anyone on here been in the same situation changing from Natalizumab to Ocrelizumab? If so what are your thoughts and experiences please?

The decision to change meds is up to you and your healthcare team. But, I have a few questions: (Just trying to be helpful.)
Has Tysabri been working for you? Have you had new lesions in your MRI's or changes in your MS symptoms?

You are JCV negative right now. Correct?

If stable on Tysabri and JC negative, did your Neuro suggest a change to Ocrelizumab?

Do you know if your Neuro an MS Specialist?

Best Wishes!

Time

[RButterworth]

Ocrelizumab

I am excited for ALL of you! I'm still a Tysabri gal every 56 days you know, if it ain't broke don't fix it My best wishes

I'm currently on Tysabri and have been since 2013, JCV titres have actually dropped from 430 antibodies Mmol/L to less than 200 which is negative. Saw my neurologist yesterday and he's wanting to start me on Ocrelizumab in October when it's able to be prescribed in this country for pensioner prices. Apparently he's got permission to prescribe, monitor and research 10 patients and he's saved a spot for me. Now originally I was pretty happy about the decision because I'm becoming increasingly nervous about developing PML despite the fact that my JCV titres are negative. The thought of less frequent infusions is also appealing BUT I was told that there's NO risk of developing PML on Ocrelizumab. Now I've read up about it and apart from the more convenient less frequent infusions I am still freaked out by the possibility of fatal side effects. Has anyone on here been in the same situation changing from Natalizumab to Ocrelizumab? If so what are your thoughts and experiences please?

[hunterd]

It is all over the news. Ocrevus will be on market very soon (in US). I looked up the drug and am curious, SPECIFICALLY, about the JC virus as one of the side effects is PML. I have the JC virus so am quite disheartened at this.

I had an appointment yesterday with my MS specialist and she told me that before I was to start this drug I would have to take the J C virus test again to test for the possibility of PML. She also said that this drug was very similar to the drug Rituxan

[Fishytrout]

IT WILL BE HERE IN 2 WEEKS

It is all over the news. Ocrevus will be on market very soon (in US). I looked up the drug and am curious, SPECIFICALLY, about the JC virus as one of the side effects is PML. I have the JC virus so am quite disheartened at this.

[pennstater]

For all of our PPMS members, I hope you have the opportunity to try this Rx and halt your progression. I know it has been a long wait! I pray you find success. Will look for member updates!

Still RRMS diagnosed, but possibly SPMS. Will Stick with Tysabri, but have conversation next neuro appointment in summer.

I am really excited that this treatment sounds so promising with fewer risks. Lots of reading to do.

[Kimba22]

Patient Assistance Programs

They say it will cost $65,000 per treatment. Does that mean per monthly infusion?
Will they have co-pay assistance considering most if not all MSers with PPMS do not work.

Hi durgastiger,

The drug assistance programs are different for all the the Disease Modifying Therapies, so what exactly what this will be remains to be seen. There are also differences what you can qualify for, whether you have private insurance, or government related insurance (Medicare, Medicaid, or Veteran's), and can include income requirements for eligibility. But, since now Ocrevus has been approved by the FDA as the only DMT available for PPMS, it should be an available option under most, if not ALL, prescription plans. These are excerpts from the National MS Society:

FDA Approves Ocrevus (Ocrelizumab) for People with Primary Progressive MS or Relapsing MS -- First Disease-Modifying Therapy for Primary Progressive MS


For more information, people with MS can contact Genentech at: 1-844-OCREVUS (9am-8pm Eastern)

For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions: (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.

Comment on Pricing
The approval of Ocrevus is an exciting milestone for people with primary progressive MS and an encouraging new option for people with relapsing forms of the disease. The National MS Society applauds Genentech for their leadership in setting the wholesale acquisition cost (or list price) of Ocrevus at $65,000 per year -- nearly 20 percent below the current market average for an MS treatment. The continually escalating prices of MS disease-modifying therapies are creating barriers to people with MS getting these life-changing medications. Through its action on Ocrevus, Genentech is changing industry dynamics so that more people can access the life-changing treatments they need to live their best lives. We encourage other companies to follow suit, creating a drug pricing trend that keeps patients first.

FAQ About FDA Approval of Ocrelizumab – brand name Ocrevus™ – for Primary Progressive and Relapsing Forms of MS

Q. How is ocrelizumab taken?
A. Ocrevus is administered by intravenous (into a vein) infusion every 6 months. At the beginning of treatment there are two doses separated by 14 days. After that, there is a single infusion every 6 months.

Q. When will ocrelizumab be available by prescription?
A. According to Genentech, people may talk to their MS doctors now about taking Ocrevus. The company expects supplies of the therapy to be available in about two weeks (around the week of April 4, 2017). Accessing the medication also depends on issues related to an individual’s health insurance.

Q. What if I no longer live in my own home. Can I still get Ocrevus if I live at an assisted living facility or a nursing home?
A. Whether you live at home or in a facility should not affect your ability to be on Ocrevus. However, insurance coverage may impact access to the medication.

Q. What will Ocrevus cost?
A. The list price has been announced as $65,000 per year. However, the price of Ocrevus to an individual who has MS will depend on the provisions of his or her insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs.

Q. What is the National MS Society’s response to the posted price of Ocrevus?
A. The approval of Ocrevus is an exciting milestone for people with primary progressive MS and an encouraging new option for people with relapsing forms of the disease. The National MS Society applauds Genentech for their leadership in setting the wholesale acquisition cost (or list price) of Ocrevus at $65,000 per year — nearly 20 percent below the current market average for an MS treatment. The continually escalating prices of MS disease-modifying therapies are creating barriers to people with MS getting these life-changing medications. Through its action on Ocrevus, Genentech is changing industry dynamics so that more people can access the life-changing treatments they need to live their best lives. We encourage other companies to follow suit, creating a drug pricing trend that keeps patients first.

Q. Will my health insurance cover Ocrevus?
A. Coverage will depend on individual insurance plans. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions: (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.

Q. Where can I get information about the support that Genentech will provide to help people gain access to Ocrevus?
A. Physicians and people with MS can contact Genentech for information about access at Genentech Access Solutions: (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.


http://www.nationalmssociety.org/Abo...izumab)-as-the

[durgastiger]

Ocrevus

They say it will cost $65,000 per treatment. Does that mean per monthly infusion?
Will they have co-pay assistance considering most if not all MSers with PPMS do not work.

[alanpgh]

Yes, that is what it means.
Access before official FDA approval.

[Seasha]

When you say expanded access do you mean access to the drug before FDA approval.

Sounds like it, but not sure. A brief explanation here - https://clinicaltrials.gov/ct2/help/expanded_access

[palmtree]

Depending on where you live, you might be able to get on the Expanded Access program for this drug.

just google ocrelizumab expanded access.

let us know how this works out and if you have any other questions.

good luck!

When you say expanded access do you mean access to the drug before FDA approval.

[JerryD]

Thanks, everyone, for the great suggestions ! I am tired of waiting for any treatments. I had Lemtrada infusions, last month ! I'm doing great and feeling great ! No more waiting ! Good luck, everyone !