On March 24, 2020, Chartwell Pennsylvania, LP, became the first provider in the nation to administer teprotumumab-trbw (Tepezza), a breakthrough medication for the treatment of thyroid eye disease (TED), in a home-infusion setting. This incredible achievement in the treatment of a potentially debilitating autoimmune disease took place less than a week after Pennsylvania Governor Tom Wolf ordered a statewide shutdown of all non-life-sustaining businesses in the early stages of the COVID-19 pandemic.

The following weeks saw the number of coronavirus disease 2019 (COVID-19) cases grow exponentially, launching an unprecedented public health response that included shelter-in-place orders and business restrictions that affected more than 90% of the nation’s populace. Throughout the pandemic, Chartwell Pennsylvania, LP—one of the nation’s largest providers of home infusion, specialty pharmacy, and enteral nutrition and a limited partner with UPMC Health System—continued to receive teprotumumab-trbw referrals.

Currently, Chartwell serves 14 teprotumumab-trbw patients, and half of that number received their first treatment in the comfort of their own home.

“In the wake of the COVID-19 outbreak, access to home infusion therapy is more important than ever,” said Chartwell COO David Benedict, PharmD, BCPS. “Many home infusion patients are considered at higher risk of severe reaction to COVID-19 due to age, chronic illness, and/or an immunocompromised condition. Treatment at home effectively minimizes the chance of infection for both patients and staff.”

Infusion Milestone
Teprotumumab-trbw is administered once every 3 weeks for a total of 8 infusions. Patients are screened on a case-by-case basis to determine their eligibility to receive the first dose in either a controlled setting, such as a hospital or outpatient infusion center, or in the home.

A number of factors play a role in determining whether a patient is a good candidate to receive the initial infusion in the home, including comorbidities such as diabetes or irritable bowel syndrome (IBS), and other factors such as age, medication allergies, and whether the patient is a smoker or plans to become pregnant.

The first patient to receive the initial dose in the home setting, representing an important milestone in Chartwell’s teprotumumab-trbw home infusion process, took place just 2 weeks into the state-mandated quarantine. Ophthalmology specialist Charles Kent, MD, MMM, Everett & Hurite Ophthalmic Association, served as the prescribing physician.

“During the COVID-19 crisis, home infusion just makes sense,” Kent said. “It keeps patients out of the hospital setting. Spending hours in the hospital among other patients and employees is not practical when this infusion can be administered safely in the home.” 

Another prescribing physician for multiple Chartwell teprotumumab-trbw patients, Jenny Yu, MD, clinical assistant professor of Ophthalmology, University of Pittsburgh, called the situation “the perfect storm” for many patients with TED. Yu, who also serves on the UPMC Orbital, Oculoplastic, and Aesthetic Surgery Service, cited not only the pandemic, but also the importance of timing in the patient’s treatment.

“The drug in treatment is time-sensitive, in terms of catching the patient in the inflammatory phase,” Yu said. “Of course, we also had COVID-19 to tend with. Home infusion limits the kind of exposure to infection that you would find in a hospital or outpatient setting. Younger patients without many other comorbidities are excellent candidates for the initial infusion in the home.”

“For these Graves patients, many of them would simply defer treatment rather than go to the hospital during the pandemic,” Kent added. “That is clearly not in their best interest if we want them to get treatment as soon as possible.”

In addition to easing the burden of care placed on hospitals and other health care facilities, home infusion creates a unique level of convenience for the patient and caregiver. Horizon Therapeutics’ Joe Nemuras, marketing director, Payer and Site-of-Care, Ophthalmology Business Unit, said that “given the clinical profile of Tepezza, the therapy can be administered at any site of care,” including the patient’s home.

“With [TED], the patient often has vision impairment and is unable to drive themselves, making it even more difficult to travel to a hospital, an academic medical center, or an outpatient facility,” Nemuras said.

According to Yu, Chartwell’s wide network is also a contributing factor when specifying site-of-care.

“I see a lot of patients from other UPMC locations coming into Pittsburgh for a specialty evaluation,” Yu said. “To be able to bring the treatment options closer to the patient’s home or in their home—it just makes sense.”

TED
Approved on January 21, 2020, teprotumumab-trbw is the first and only FDA-approved medicine for the treatment of TED, a rare and serious autoimmune disease with vast variability in duration and symptom presentation. The term “thyroid eye disease” is often used in conjunction with Graves' disease, an autoimmune disorder that causes hyperthyroidism, although the 2 are sometimes distinct conditions.

“It’s often interchangeable,” Yu said. “About 85% of TED patients have Graves’ Disease; the other 15% are associated with other thyroid disorders.”

TED can lead to a wide array of vision-threatening impairments, such as dry eye disease; diplopia, which is misalignment of the eyes; visual acuity and visual field defects; facial disfigurement; and optic neuropathy in 6% to 9% of patients, according to statistics from manufacturer Horizon Therapeutics.

“Part of the problem with treatment of thyroid eye disease is it is rare to have 2 patients whose symptoms present exactly the same,” Nemuras said. “Patients often have some level of diminished functionality, such as the inability to drive, the inability to use a computer. We see a spike in disability and unemployment rates. The result of the disease is catastrophic to many.”

Teprotumumab-trbw has a novel mechanism designed to block the insulin-like growth factor-1 receptor (IGF-1R), which is the key mediator of TED. The treatment received Priority Review, Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA.

Teprotumumab-trbw is unique among other immunosuppressants, Yu explained, referencing the initial teprotumumab trials and the subsequent study published in 2017 by noted surgeons Raymond Douglas, MD, PhD, aesthetic orbital and oculoplastic surgeon, and Terry Smith, MD, professor of Ophthalmology and Visual Sciences, University of Michigan.

“This therapy does not affect the immunoresponse of a patient who is fighting an infection, like other immunosuppressants that we’ve seen,” Yu said. “It’s a much more specific bioagent that is targeting IGF-1R receptors.”

Chartwell Clinical Pharmacy Specialist Kayla Szabo, PharmD, BCNSP, said that other immunosuppressant drugs “have a direct effect on certain cells in the immune system, causing patients to be more susceptible to illness.”

Teprotumumab-trbw does not cause patients to become immunocompromised, nor does it put them at a higher risk for serious illness with infections, such as COVID-19.

Referral Process
Once physicians such as Kent and Yu prescribe teprotumumab-trbw, Horizon Therapeutics’ expert patient services team contacts the patient to review the “Tepezza story,” according to Horizon Regional Business Manager Wendy Kusler. This process includes both clinical education, benefits review, and financial assistance, dependent on the patient’s insurance.

“Horizon patient services offers an incredibly diverse suite of services for the patient,” Kusler said. “Their role is to support the patient every step of the way.”
Horizon Therapeutics and Chartwell work hand-in-hand to accommodate the physician’s site-of-care orders and find every avenue of financial assistance. Chartwell Hospital Account Manager Robin McMillin-Robb serves as the single point of contact for teprotumumab-trbw referrals.

“Once I’ve verified benefits and get authorization, I let the Horizon staff know the cost for the patient,” McMillin-Robb said. “They help the patient sign up for co-pay assistance cards or find foundation or grant money to help alleviate the cost that insurance doesn’t cover. It’s an open line of communication between Horizon and Chartwell for each patient.”

Following their preliminary success, Chartwell clinicians are currently working to loosen the restrictions that determine whether a patient receives the initial teprotumumab-trbw infusion in the home. This would only apply to cases where the patient, the ordering physician, and Chartwell pharmacists are comfortable with pursuing a first dose in the home, according to Szabo.   

“With more Tepezza patients on service now, we are going to trend their blood glucose levels to see if we can loosen the criteria for diabetic patients in order for them to start infusion in their home,” Szabo said.  

About the Author
Drew Hardman is a communications specialist at Chartwell Pennsylvania, LP.