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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.
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Ocrevus is a prescription medication, so people considering the treatment should discuss with their physicians whether it may be suitable for them.
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.
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.
Ocrevus is considered a relatively safe medication. That does not mean that it is free of side effects.
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.
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.