In March 2017, the U.S. Food and Drug Administration made history when it approved Ocrevus® (ocrelizumab) Indication and Important Safety Information, a first-in-class B-cell targeted therapy for multiple sclerosis (MS). This milestone was the beginning of a new era for the MS community.

When we launched Ocrevus, we set the annual list price at $65,000 per year – 25% less than interferon beta-1a (a clinical trial comparator) and nearly 20% below the average list price for MS medicines at the time.

As Genentech was preparing to enter the MS field, we were determined not to follow some of the historical pricing actions that have plagued the MS space for years. Setting high launch prices followed by annual double-digit price increases drives an expectation from payers and pharmacy benefit managers to provide rebates. The flawed rebate system was driving up profits for middlemen while interfering with prescribing decisions. The consequences of these actions are high out-of-pocket costs for patients.

We recognize that actions speak louder than words and take our commitment to responsible and meaningful pricing actions very seriously. We priced Ocrevus to reflect the value it could bring to people living with MS and society. In addition, after listening to the MS community and learning about challenges and barriers to care, we knew it was important to price it in a way that would help facilitate swift and broad access for patients. We took a thoughtful and meaningful pricing approach at the time of approval – which we are proud of – to do what we could as a drug manufacturer to change the high pricing trends seen in the MS space throughout the past two decades. Additionally, we did not take a price increase for nearly 3 years after launch, and ultimately when we did it was less than the historical average of price increases in the MS class and below the rate of inflation. Today, the annual list price is $71,000 per year – which continues to be substantially lower than other MS treatment options – as the cost of those medicines has increased in price.

THE EVOLVING PRICING LANDSCAPE

After five years on the market, the pricing landscape in the MS space continues to evolve. We are seeing external forces beyond a manufacturer's control – such as hospital markups – driving up costs for patients and the healthcare system, and impeding access. In 2019, the estimated total economic burden of MS in the U.S. was $85.4 billion.¹

In reaction to marketplace expectations, competing incentives and systemic challenges in the healthcare system, we have been required to adjust our pricing strategy to support physician choice and patient access to Ocrevus. Despite Genentech’s best intentions to price responsibly, in some instances, we have entered into access contracts to enable continued access to Ocrevus.

SYSTEMIC FLAWS IN THE HEALTHCARE SYSTEM

The current state of our healthcare system is not working for patients, and there remains a critical need to address the many systemic issues along the delivery chain to make health care more affordable and accessible for everyone.

Given these dynamics, we support policies that provide:

• More meaningful transparency in the healthcare system
• Rebate reform aimed at reducing patient costs and ensuring savings reach the patients
• Assurance patients benefit from financial assistance by prohibiting Copay Accumulator or Maximizer Programs that interfere with a patient’s ability to adhere to, and remain on, medically necessary and appropriate medications prescribed by their doctors
• Benefit designs that ensure cost and structure are not barriers to appropriate care

MULTIPLE SCLEROSIS AND BEYOND

More than 250,000 people globally – in clinical trials and real-world settings – have been treated with Ocrevus. We constantly strive to optimize the care for people with MS and improve the experience that patients and physicians have with our medicine such as providing different options for how Ocrevus is administered.

We continue to advance science and use real-world insights to close treatment gaps and improve ways to support people living with MS. There are more than 30 ongoing Ocrevus clinical trials designed to help us better understand MS and its progression, including a specific study in people with radiologically isolated syndrome (or pre-symptomatic MS) and a separate Phase IV study designed to help us better understand MS treatment in Black and Latin / Hispanic people with MS. We have several ongoing research collaborations designed to help us better understand COVID-19 infection and vaccine response in people taking Ocrevus. Expanding beyond our extensive research into the B-cell approach in MS, we are also exploring a clinical trial program investigating a Bruton Kinase inhibitor for the potential treatment of RMS and PPMS.

PATH FORWARD

As long as patients can’t afford or access the medicines they need, patient-centered reforms must be a priority for everyone along the drug delivery and distribution supply chain – from the pharmaceutical industry to hospitals, health insurers, pharmacy benefit managers, policymakers and employers.

We all must work together to create and implement effective, long-term solutions that will reduce patient out-of-pocket costs and improve access to the most appropriate care.

Genentech is committed to responsible pricing actions and we support drug pricing reforms that require meaningful transparency and ensure patients directly benefit from the billions of dollars in negotiated rebates and discounts. We have long advocated for change and stand ready to be part of the solution.

*Relapsing Multiple Sclerosis (RMS) includes clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active or relapsing, secondary-progressive MS (SPMS).

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What it Treats

What is OCREVUS?

OCREVUS is a prescription medicine used to treat:

• Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
• Primary progressive MS, in adults.

It is not known if OCREVUS is safe and effective in children.

Who should not receive OCREVUS?

Do not receive OCREVUS if you have an active hepatitis B virus (HBV) infection.

Do not receive OCREVUS if you have had a life-threatening allergic reaction to OCREVUS. Tell your healthcare provider if you have had an allergic reaction to OCREVUS or any of its ingredients in the past.

Important Safety Information

What is the most important information I should know about OCREVUS?

OCREVUS can cause serious side effects, including:

• Infusion reactions: Infusion reactions are a common side effect of OCREVUS, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
• itchy skin
• rash
• hives
• tiredness
• coughing or wheezing
• trouble breathing
• throat irritation or pain
• feeling faint
• fever
• redness on your face (flushing)
• nausea
• headache
• swelling of the throat
• dizziness
• shortness of breath
• fatigue
• fast heart beat

These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

• Infection:
  • OCREVUS increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Infections are a common side effect, which can be serious. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away. Signs of herpes include cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of OCREVUS. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with OCREVUS until your infection is gone.
  • Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving OCREVUS.
  • Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability, and has been reported with OCREVUS. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
• • thinking
  • eyesight
  • strength
  • balance
  • weakness on 1 side of your body
  • using your arms or legs
• Decreased immunoglobulins: OCREVUS may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Before receiving OCREVUS, tell your healthcare provider about all of your medical conditions, including if you:

• have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS.
• have ever had hepatitis B or are a carrier of the hepatitis B virus.
• have a history of inflammatory bowel disease or colitis.
• have had a recent vaccination or are scheduled to receive any vaccinations.
• You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with OCREVUS. You should not receive ‘live’ or ‘live attenuated’ vaccines while you are being treated with OCREVUS and until your healthcare provider tells you that your immune system is no longer weakened.
• When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with OCREVUS If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with OCREVUS, talk to your healthcare provider.
• If you have a baby and you received OCREVUS during your pregnancy, it is important to tell your baby’s healthcare provider about receiving OCREVUS so they can decide when your baby should be vaccinated.
• are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm your unborn baby. You should use birth control (contraception) during treatment with OCREVUS and for 6 months after your last infusion of OCREVUS. Talk with your healthcare provider about what birth control method is right for you during this time.
• Pregnancy Registry. There is a pregnancy registry for women who take OCREVUS during pregnancy. If you become pregnant while receiving OCREVUS, tell your healthcare provider right away. Talk to your healthcare provider about registering with the OCREVUS Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Your healthcare provider can enroll you in this registry by calling 1-833-872-4370 or visiting www.ocrevuspregnancyregistry.com
• are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take OCREVUS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of OCREVUS?

OCREVUS may cause serious side effects, including:

• Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
• Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
• Diarrhea (loose stools) or more frequent bowel movements than usual
• Stools that are black, tarry, sticky or have blood or mucus
• Severe stomach-area (abdomen) pain or tenderness

These are not all the possible side effects of OCREVUS.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 For more information, go to www.OCREVUS.com or call 1-844-627-3887.

Please see additional Important Safety Information throughout and click here for full Prescribing Information and Medication Guide