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Study examines modifiable determinants of health disparities
For patients newly diagnosed with multiple myeloma, time is of the essence for initiating treatment. Promptly starting antimyeloma medications such as lenalidomide helps mitigate the risk of myeloma-related bone fractures, kidney damage and disease progression. Yet a recent study found that the median time from the date of diagnosis to initial prescription fill was 28 days. A higher percentage of older patients and Black patients as well as patients who were diagnosed while inpatient faced delays in time to treatment with oral antimyeloma medications.
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A team of researchers secured a National Cancer Institute grant to determine modifiable determinants of disparities. “We wanted to take a practical approach, not just documenting disparities but finding actionable ways to do something about them,” says Hamlet Gasoyan, PhD, study co-author and an investigator at Cleveland Clinic Center for Value-Based Care Research.
The study included a retrospective analysis of 720 adult patients newly diagnosed with multiple myeloma between January 1, 2017 and December 31, 2021. The study examined the time it took to fill an oral antimyeloma treatment (excluding corticosteroids) from the date of diagnosis. Researchers also looked at factors such as age of diagnosis, race, gender, type of insurance and whether the diagnosis occurred during an inpatient admission.
During the study follow-up, 543 patients filled a prescription for an oral antimyeloma medication other than corticosteroids. Among those, the median time to initial prescription fill was 28 days. For a quarter of patients, the time to treatment with immunomodulatory drugs was ≥2 months. After controlling for relevant socio-demographic and clinical variables, researchers found there remained notable disparities in time to treatment among Black patients, patients who were older at the time of their diagnosis as well as patients who were first diagnosed while in the hospital.
Key barriers that impede swift time to treatment include:
• High medication costs. The most commonly prescribed oral antimyeloma medication is lenalidomide, which can cost upwards of $18,000 for a 21-day supply. Even the generic version costs around $13,000 a month. “There are barriers that unfortunately can’t be broken down until the cost of these medications is significantly less,” says study co-author Jason Valent, MD, who is a hematologist and director of the Multiple Myeloma team at Cleveland Clinic Cancer Institute.
Even for patients with private insurance, they may still be responsible for a sizeable portion of the cost of the medication. For example, in 2018, the median out-of-pocket cost during the first year after myeloma diagnosis was $3,711 for privately insured patients and up to $5,623 for patients with high-deductible health plans.
• Administrative hurdles. The process of gaining approval for antimyeloma medications is highly complex, often involving completion of patient and physician surveys, securing prior authorization and filling out additional REMS paperwork. If something goes wrong with even one of these steps, it can cause a delay.
• Working with external specialty pharmacies. Medications like lenalidomide can only be filled by specialty pharmacies. However, studies have found delays in the time it takes to fill prescriptions when an external specialty pharmacy is involved.
“Assessment for eligibility for external funding goes smoother with an in-house specialty pharmacy as opposed to an external pharmacy,” explains Joslyn Rudoni, PharmD, BCOP, a clinical pharmacy specialist in the myeloma clinic at Cleveland Clinic. “It is exponentially more difficult to communicate directly with personnel at external pharmacies to facilitate timely prior authorization and triage billing issues, such as assessment of affordability of patient copays and coordination of grant applications or patient assistant programs, all of which our internal specialty pharmacy tackles seamlessly on behalf of our providers to streamline the process. The communication barriers with external pharmacies make the ability to expedite prescriptions uniquely challenging and often unattainable."
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Alleviating these delays is a complex process but is not insurmountable. Several practices that could make a profound difference for patients include:
Providing specialty pharmacy capabilities internally. Cleveland Clinic built its own in-house specialty pharmacy that is now authorized to dispense these medications, as long as the patient’s insurance allows it. “We feel that having an in-house specialty pharmacy we can communicate with directly will make a big difference for patients,” says Dr. Valent.
Accelerating treatment initiation and prescriptions for newly diagnosed patients in the inpatient setting. In this situation, the available medications, including bortezomib, cyclophosphamide, dexamethasone and in rare instances daratumumab, can be started during the inpatient stay. At the same time, the hospital can start the process of the lenalidomide prescription and work with the specialty pharmacy to expedite the drug availability. (Note: Daratumumab has a high cost and may not be reimbursed when administered during an inpatient stay.)
Improving appointment access. At Cleveland Clinic Cancer Institute, once diagnosis is established, patients are given an appointment as quickly as possible to discuss the treatment strategy. “During the same visit, we complete the diagnosis process, including staging workup, education about medications and side effects,” says Faiz Anwer, MD, co-author of the study and a hematologist at Cleveland Clinic Cancer Institute. “We may also prescribe steroids that can be started the same day or next day, so that even if there’s a delay in other medications, the patient is able to start this treatment swiftly to gain anti-myeloma and anti-inflammatory effects.”
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Enacting common-sense policies. The federal government could negotiate the cost of myeloma medications like many other countries have done, and/or implement policies to improve coverage for patients. For example, providing coverage for cancer therapies, regardless of whether it’s intravenous or oral, could relieve patients of the copay burden they currently face.
Providing patient navigators. “When patients are left to deal with the administrative burden themselves, certain groups like minorities and older patients face more of a delay,” says Dr. Gasoyan. It’s estimated that there are thousands of people across the country who don’t have access to patient support systems, yet supports are essential to helping patients through these complex administrative issues.
For example, centers like Cleveland Clinic have teams that help patients access copay assistance programs; apply for Medicaid, the Hospital Care Assurance Program or other appropriate insurance; and more. “We make it a priority to ensure patients receive treatment and that we can remove barriers to getting the medication they need,” says Dr. Anwer.
“It’s been a very exciting decade of scientific advances in multiple myeloma treatment, and survival has improved significantly,” says Dr. Gasoyan. “With that, it becomes even more important to understand the barriers to timely initiation of care.”
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