The Urgent Unmet Need In DLBCL and What Payers Should Know About Treatment Coverage

Each year nearly 30,000 people receive the devastating cancer diagnosis of diffuse large B-cell lymphoma (DLBCL)–the most common type of non-Hodgkin lymphoma. Fortunately, close to 60% of these patients have the hope of a cure through an aggressive combination of therapies called R-CHOP. For the remaining one-third whose cancer comes back or does not respond to initial treatment, until recently, had limited therapeutic options.

Early last year, our companies–MorphoSys and Incyte–formed a partnership to address this urgent unmet medical need through co-developing and commercializing tafasitamab–a novel immuno-oncology therapy. Ultimately, our shared goal is to change the paradigm of care for patients facing DLBCL and other B-cell malignancies and improving patient outcomes.

Tafasitamab, or Monjuvi^® (tafasitamab-cxix) as we now call it, in combination with lenalidomide was granted a Breakthrough Therapy Designation by the US Food & Drug Administration (FDA) and received accelerated approval in July 2020 as the first and only treatment for adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT).

The approval of Monjuvi was a significant achievement, but the timing was complicated by the world changing in ways none of us could have imagined. In the face of the constraints of the global COVID-19 pandemic, the need for new DLBCL therapies remained as urgent as ever. We knew patients were waiting.

We anticipated an early decision and were well-prepared and laser focused to launch. Our teams quickly launched Monjuvi virtually–a new model for our industry over the last year. Most of our teams were hired virtually for the launch and many of them have still not met in person. Together our companies adapted to and overcame many COVID-19-related hurdles to drive engagement with physicians ahead of expectations.

Within 10 days of approval, we achieved major launch milestones that otherwise could have taken weeks and months: the National Drug Code (NDC) for Monjuvi was listed, the first Monjuvi order was received and shipped, the first center placed Monjuvi on its formulary, and most importantly, the first patient was infused with Monjuvi on day 10.

Patients were waiting; we were ready.

Payers and Guidelines

Government and commercial payers were provided with information about Monjuvi’s approval and its labeled indication on the first business day after the launch and saw the first payer confirmation for coverage to label, and have since seen virtually universal coverage. We were also very pleased with the speed that Monjuvi was included in the National Comprehensive Cancer Network^® (NCCN^®) guidelines, which not only increases awareness of the treatment within the oncology community, but also drives certain formulary decisions.

On April 1, 2021, the U.S. Centers for Medicare & Medicaid Services (CMS) established a new, permanent J-code for Monjuvi, simplifying billing and facilitating reimbursement in the hospital outpatient and physician’s office setting. J-codes are reimbursement codes used by Medicare, Medicare Advantage, other government payers and commercial plans for drugs like Monjuvi that are administered by a physician. The code, J9349, is specific to Monjuvi with the descriptor, Injection, tafasitamab-cxix, 2mg.

Patient Assistance During a Global Pandemic

We understand how important it is to support patients throughout their treatment journeys and are committed to helping remove barriers to patient care, including launching a robust patient support program called “My Mission Support” immediately following Monjuvi’s approval. This program offers services such as benefit investigation, prior authorization and claims & billing support, ongoing education and other resources to eligible patients and their caregivers who are prescribed Monjuvi in the US.

The pandemic caused additional levels of hardship on cancer patients and their caregivers who had to juggle many moving parts. My Mission Support was quick to adapt to address these issues when possible. For example, it was important that patients felt comfortable arriving at a healthcare facility. To address this, we sent PPE kits with latex gloves, masks and sanitizer. Additionally, MorphoSys and Incyte partnered with The Leukemia & Lymphoma Society (LLS)–along with several other health care, pharmaceutical, biotechnology and consumer product companies–to help fund the LLS COVID-19 Patient Financial Aid Program. The Program provided $250 to eligible patients experiencing economic hardship presented by the pandemic to help offset non-medical expenses such as rent, mortgage payments, utilities and food.

The patient caregiver relationship is often the foundation of a patient’s successful treatment journey. Our teams are currently developing materials to address the unique challenges and many moving parts that caregivers face—everything from communicating with a patient, to treatment scheduling and reminders, to medical billing and meals.

Our industry best serves patients when we are committed to addressing the needs of the whole patient and caregivers touched by their illness.

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