What Every MS Patient Should Know About Ocrevus and Its Use

What Every MS Patient Should Know About Ocrevus and Its Use

With the recent approval of Ocrevus (ocrelizumab) for both primary progressive and relapsing multiple sclerosis (MS), interest in the medication is peaking. To help readers of Multiple Sclerosis News Today better understand this new medication and how it works, as well issues dealing with access, use, and potential side effects, here is a summary of the most relevant information now available about Ocrevus.

Comments and concerns expressed by many readers on our different platforms were taken into consideration in writing this article.

The basics

Ocrevus is a prescription medication, so people considering the treatment should discuss with their physicians whether it may be suitable for them.ocrevus

Genentech — Ocrevus’ developer — is working to make sure that patients receive adequate information about the therapy. The company has set up a website — www.ocrevus.com — with detailed information. Patients can also call 1-844-627-3887 (Ocrevus Connects, Monday to Friday, from 9 am to 8 pm ET) with questions concerning this therapy.

The drug is an antibody that acts by depleting a certain immune B-cell — those B-cells carrying a molecule called CD20 on their surfaces, and thought to be involved in the processes that cause brain damage in MS.

Antibodies are proteins, and as such they cannot be administered like a pill. Just like proteins in food, antibodies would be chopped up by the digestive system, and do little good as disease treatment. Ocrevus needs to be administered as an intravenous infusion at a clinic.

Access and pricing

When Ocrevus was approved by the FDA on March 28, Genentech announced it would be available across the U.S. within two weeks (meaning, early April). The list price for one year of treatment, which consists of two annual infusions, is $65,000. At this time, Multiple Sclerosis News Today has no information about how the drug will be reimbursed.

Genentech is trying to make sure that all eligible patients can access the treatment. The company’s Access Solutions program is designed to help patients who are prescribed Ocrevus navigate the access and reimbursement process.

This program assists patients in several ways. First, it helps in finding out if a patient’s health insurance plan covers Ocrevus. It also allows patients to estimate out-of-pocket costs for the treatment.

Second, for patients who lack health insurance or cannot afford out-of-pocket costs, Access Solutions provides financial assistance options that could help these people cover the cost of treatment.

Finally, Genentech works closely with pharmacies and clinics to make treatment available in places where patients live.

In addition to the website — hwww.genentech-access.com/patient/brands/ocrevus.html —  Access Solutions can be reached by phone at 866-422-2377.

The procedure

As mentioned, Ocrevus is given by an intravenous infusion.

Before beginning treatment, patients are tested for the presence of active Hepatitis B infection. People with Hepatitis B infection should not be treated with Ocrevus. If a patient has another type of infection, doctors wait with providing the medicine until the patient has recovered.

Since the drug interferes with the processes leading to the creation of an immune memory response, vaccinations with live-attenuated or live vaccines need to be given at least six weeks before the start of Ocrevus treatment.

Like other biological drugs administered by infusion, Ocrevus can give rise to infusion-related reactions. To minimize this risk, pre-treatment with methylprednisolone or another corticosteroid is recommended. This pre-treatment is given as an intravenous injection about half an hour before the infusion.

The risk of infusion-related side effects can be further minimized by taking an antihistamine between 30 and 60 minutes before the Ocrevus infusion. Adding a fever-reducing drug, such as acetaminophen, can also be considered.

Ocrevus is given every six months. The initial treatment is administered in two sessions, two weeks apart. At each of these sessions, the patient receives 300 mg of Ocrevus over an at least 2.5-hour infusion time.

All following infusions are given as a single 600 mg infusion, lasting for at least three hours, every six months. If a patient has an ongoing infection, this treatment will be delayed until recovery, and the next dose is then rescheduled for six months after the last.

After the infusion, doctors are advised to monitor a patient for at least one hour, checking for side effects linked to the infusion procedure.

Is Ocrevus for everyone?

Each MS patient considering Ocrevus treatment should discuss with a physician if the treatment is a suitable option, as there are certain groups of patients who should not take the medication.

People who have been infected with the Hepatitis B virus should not receive Ocrevus. In specific cases, a liver disease expert may be consulted to consider if an exception is possible.

People who have had an allergic reaction to ocrelizumab, or to any of the components in the infusion solution, should not take Ocrevus.

Pregnancy and breastfeeding

Women of childbearing age may wonder if it is possible to use Ocrevus during pregnancy. Ocrevus has not been studied in pregnant women, but when given to pregnant monkeys in preclinical studies, the drug did cause toxic effects in fetuses without harming the mother.

Ocrevus depleted B-cells in these fetuses, with some dying of bacterial infections upon birth. Researchers also observed kidney damage, abnormal lymph structures in the bone marrow, and reduced testicular weight.

Data on other drugs that also deplete this type of B-cell reported that human babies born to treated mothers temporarily showed “transient” reductions in B-cell and white blood cell counts at birth.

Women of childbearing age are advised to use adequate contraception while being treated with Ocrevus.

Animal data also showed that Ocrevus passes into breast milk. For women wishing to breastfeed, the health benefits a baby receives from breastfeeding need to be weighed against the mother’s need for Ocrevus treatment and potential risks to the infant.

Side effects

Ocrevus is considered a relatively safe medication. That does not mean that it is free of side effects.

Infusion-related reactions

Among the most common side effects are those related to the infusion. Even though pre-medication can reduce the risk of such reactions, or make them less severe, it does not eliminate that risk.

In the clinical trials leading up to Ocrevus’ approval, 34% to 40% of patients experienced infusion reactions. They are, however, most likely to appear after the first infusion, with the risk dropping with subsequent administrations. Although doctors should monitor their patients during, and one hour after, the infusion, these reactions can occur up to 24 hours after the treatment.

Symptoms include skin itching, rash and reddening, difficulties breathing, and throat irritation or swelling, flushing, blood pressure drops, fever, fatigue, headache, dizziness, nausea, and a racing heartbeat.

Most of these reactions are mild to moderate, but 0.3% of patients in the trials experienced severe side effects linked to the infusion.

Infections

During the trials, Ocrevus was linked to a higher risk of developing airway, skin, and herpes infections.

Most airway infections were mild or moderate, and were mostly common colds or bronchitis. Herpes infections included shingles as well as oral and genital herpes.

During the clinical studies, more patients in the Ocrevus treated groups developed cancer. These numbers were low — making up 0.5% of all patients in the two trials of relapsing MS, and 2.3% in the trial of primary progressive MS.

Genentech recommends that patients who receive Ocrevus adhere to routine breast cancer screening, based on a patient’s age and family history of cancer.

Progressive Multifocal Leukoencephalopathy (PML)

Other MS treatments have been linked to the development of PML, an infection caused by the John Cunningham virus. This is a condition that most often leads to death or severe disability.

So far, there has been no case of PML among Ocrevus-treated patients. Since the infection has been seen in people treated with similar, B-cell depleting drugs, however, there is no guarantee exists Ocrevus does not cause PML.

Immunocompromised patients — including those combining a disease-modifying treatment with immunosuppressant drugs — are particularly at risk.

Magnetic resonance imaging (MRI) brain scans often detect signs of PML before symptoms appear. Symptoms can vary, but often include progressive weakness on one side of the body, clumsiness, vision problems, and changes in thinking, memory, and orientation leading to confusion and personality changes. These symptoms can developing over days or weeks.

At the first indication of PML, patients need to contact their physician, and withhold any further infusions.

Many patients might wonder if switching to Ocrevus from their current medication would be beneficial. Since each patient, and her or his disease, is different, it is crucial for patients to discuss any changes in treatment with a physician.

The full prescribing information on Ocrevus can be found by clicking this link.

19 comments

  1. Paul kuyp says:

    65,000$’s per year! What’s the point? How are we supposed to afford that when most are on disability? What a waste of time & research!

    • Brian says:

      They are going to have $0 co-pay programs and foundations available. The nice thing is that Ocrevus is for RRMS also so those who are still working and have medical insurance other then medicare, ss, and medicaid will help us who can’t work and have no private insurance. It isn’t remyelination but I personally think it is better to target these B cells then wiping out my white-blood cells like Tecfidera is doing.

    • Janice says:

      I am on lifetime disability and my insurance in Medicare although I am 50 years old. My plan thru medicare AARP covers all my prescription costs wth the accepting of a couple of dollars. They paid out over 40k last year. I think medicaid would prob pay for it also. If you are on disability I would think you’d be getting one of Mr the other

    • Christie T says:

      I’m on disability and my Medicare insurance has either completely covered my MS meds. The avonex I take now and it runs $52,500 a year. The drug companies also work to help out. They want you to be treated. Don’t make it a pity party for yourself. Enable yourself and do what you need to. This drug is going to help hundreds of people. Think about those that have passed on that didn’t have the opportunity to use these meds to better their lives. It may not be for you but stay positive. No amount of research is a waste of time!!!

  2. Kathy deering says:

    Good news for ocrevas. But realistically how do you pay $65,000 for 1 dose 2 doses every 6 months . $260,000 a year. . I realize they have to pay for research but even w insurance how is it possible for anyone to pay this?

    • CORI GRINSTEAD says:

      I read it as $65,000 a year not per dose… cheaper than the Gilenya I’m on now at $6500 a month totaling $78,000 a year. I’m sure they will have a program like the other drug companies to help with copays. Thank God it is finally approved!!!!

      • Kay says:

        I am going to try to this drug but according to my Dr that cost is the drug cost only and there will be additional charges for giving it. there will be help from the drug company hopefully

    • Kim t says:

      I believe you may have misread the article.

      “be available across the U.S. within two weeks (meaning, early April). The list price for one year of treatment, which consists of two annual infusions, is $65,000.”

    • L Jones says:

      The article says two infusions per year costing $65,000. Not each, this would be for both. It’s cheaper than Tecfidera that is around $90,000 per year. The article also said there is an assistance program. Not that I think that these drugs aren’t overly priced, but they do help so many people.

  3. Chris says:

    I wouldn’t worry about the cost of the meds. I’ve been on Rebif for a decade and this new drug is actually cheaper. Essentially all of these drug companies offer assistance programs which make the meds affordable. I’ve pretty much never paid a dime for Rebif.

  4. Maz says:

    Can someone please tell me with all the drug company assistance programs what the difference in out of pocket costs for most MS drugs is with the following senerios?
    1. Medicaid?
    2. Private Insurance ie: Blue Cross?
    3. No insurance?

  5. Tammy says:

    My husband takes Copaxone. The cost is about $72,000 per year .

    When first diagnosed we had Premera Blue Cross. At that time we paid nothing for Copaxone.

    He currently has Medicare. Our co-pay now is $10 per month. (I’m not sure if Medicaid would be different)

    Shared Solutions is the name of the company who has assisted us with our co-pays.

    Shared Solutions 800-887-8100
    They help with the drug Copaxone. They will ask what type of insurance you have. If you have private insurance they will help you directly. If you have Medicare they will transfer you to a different department. The process was super easy. We use Walgreens specialty pharmacy, it’s all done through the mail. I tell you that because if you pick it up yourself in a pharmacy your co-pays are more.

    To my understanding if you don’t have insurance Shared Solutions won’t pay anything. And I’m not sure if there’s a program that will help without insurance. These programs pay your maximum out-of-pocket and then once your maximum out-of-pocket is paid for then the drug company is receiving 100%. So it’s a win-win for them .

    • Marianne says:

      Shared solutions is owned by Teva (the makers of Copaxone) so it’s not going to help you with Ocrevus. Contact Genentech for their patient assistance program (I’m sure it’s on their website as well).

  6. Janet J. says:

    Thank you for posting such a clear, concise and easy to understand article. I have friend suffering from this disease and your article enabled her to understand the pros and cons of the drug and prepared her for a conversation with her Neurologist.

  7. Rich says:

    I wonder if a person who is considered secondary-progressive qualifies for this treatment (Ocrevus). I am a young 64 year old male. I’ve had MS for 32 years… I’m still on my feet, can walk short distances (using a cane), drive my car, and go to the supermarket. Not much increase in disability over the years, just nasty sensory flare ups, i.e., numbness, vibrating-throbbing legs, etc. The next 10 years of life are crucial…I hope my doctor agrees to prescribe this medication for me.

  8. Eva says:

    Has anyone switched to Ocrevus from Tysabri?
    My risk of PML has increased to 1:100 … so I’m considering the switch.
    I’m wondering about the herpes risk … I already have genital herpes … will Ocrevus increase my break outs (I get almost none right now)? Will it be more likely to cause Shingles, since I already have the herpes virus in me?
    So many questions.

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