Multiple Myeloma Practice Pearls: Improving Patient Access to Oral Oncolytics

In a Specialty Pharmacy Times® Practice Pearls video series, expert panelists convened to discuss the challenges and best practices for dispensing multiple myeloma medications.

Affecting approximately 100,000 individuals in the United States, multiple myeloma is the second most common hematologic malignancy, even though it is considered a rare disease. With multiple FDA-approved regimens, a personalized approach to treatment is key to obtaining the best outcomes in patients.

Cheryl Allen, MBA, BSPharm, vice president of industry relations at Diplomat, and Noa Biran, MD, attending physician and medical oncologist in the Myeloma Division at John Theurer Cancer Center, focused on 4 critical best practice strategies to ensure that patients receive access to important therapies.

Pearl 1: Identify potential challenges and out-of-pocket costs.

Multiple myeloma is currently the second most expensive cancer to treat, making access to therapies difficult for many patients. Branded oral oncolytics drive most of that cost. “We have a lot of patients where their co-pay, even though it might be 10%, 10% of $10,000 is a whole lot of money every single month,” Biran said.

Patients who are commercially insured can use co-payment cards, which manufacturers offer to support the out-of-pocket expense. However, these co-pay assisters are available only to commercially insured patients, not those who are government insured. Additionally, some payers have taken a stance against the use of co-pay cards because of a potential conflict of interest. For government-insured patients, 501(c)(3) foundations can provide assistance based on economic need and disease state. However, decreasing funds and increasing patients seeking assistance have posed barriers to improving access.

In addition, oral parity laws attempt to ensure equality across the oral space versus the infused space, so payers have to recognize both products and both routes of administration. Still, Allen and Biran noted difficulties surrounding pricing because many of the oral products do not have biosimilars.

Pearl 2: Dedicate resources and trained staff to fulfill risk evaluation and mitigation strategy (REMS) requirements.

The manufacturer administers the FDA-mandated REMS program to ensure that prescribers and patients understand the safety risks of their drug products. The program was initially created because of the teratogenic effect of thalidomide to ensure the safety of lenalidomide when it was approved. In the series, the panelists explained the steps to fulfilling REMS requirements.

Essentially, the provider writes a prescription, and the patient fills out and signs a form to enroll in a REMS program. Prescribers must be certified by the program to prescribe these drugs, and patients must be counseled by a certified prescriber on the risks and benefits, according to Allen.

“Once the patient has been counseled by a certified prescriber on the risks and the benefits, if the decision is made to move forward to the drug therapy, then the prescriber and the patient sign off on an agreement form and send that in to the REMS administrator,” Allen said. That’s all men need to do, but women must fill out a separate questionnaire. Then the prescriber completes a questionnaire prior to authorization. Patients enrolled in the program are required to complete a verbal survey by the manufacturer every month.

Once the requirements have been completed, the prescriber gets an authorization number to prescribe the product. This is separate from the prior authorization (PA) by the patient’s insurance, which occurs simultaneously.

The REMS program represents a common stumbling block, Allen said, emphasizing the importance of being cognizant of the authorization timelines with REMS products. With agents in multiple myeloma, the initial authorization for some patients is just 7 days; for others, 30 days. This is especially crucial for certain patients, such as women with pregnancy potential. “Those are the patients for whom we really have to make sure that it’s like clockwork,” Allen said.

Pearl 3: Understand payer protocols to proactively address prior authorization.

The panelists discussed how understanding what the payer is looking for can help avoid delays in the PA process. To streamline, the pharmacy must understand payer requirements.

“If oncology is and specialty is approaching half the spend of a payer, then they have to look at the utilization and keep their finger on the pulse of that utilization,” Allen said.

In the oncolytic space, she explained, supplying information to the payer based on how the prescriber is following the guidelines often leads to PA approvals. Additionally, for some oral oncolytics, programs in place can provide a drug in an emergency setting within 3 to 5 days.

“Ultimately, I believe that for the most part in oncology, patients do get the therapy. It can take a long time,” Allen noted.

The panelists agreed that obtaining authorization is becoming increasingly difficult. For a specific combination regimen needed after several lines of therapy, many payers want to see its use supported by a randomized phase 3, rather than a phase 2, study. For example, Biran pointed to a drug that’s typically used for lymphoma but also works 95% of the time in patients with refractory multiple myeloma. Getting authorization to use it in these patients is difficult even though it is approved for lymphoma. “It’s incredibly difficult because the data published on this [involve fewer] than 100 patients. It’s not a phase 3—it’s not a phase 2—yet,” she said.

An entire team works to get patients their treatment, with several staff members conducting only PA and many who focus on grants to help with out-of-pocket expenses, Biran added.

According to Allen, the requirement for PAs in the oncology space will not end anytime soon. “So, within the payer space, I think that we have to take a broader view and kind of balance the individual patient to overall taking care of all patients perspective,” she said.

Pearl 4: Implement a collaborative care plan to optimize patient experience and outcomes.

Collaborative care plans can help provide patients with the optimal treatment, according to the panelists.

With an efficient staff, Biran said, his team can typically obtain PAs for treatments in 48 hours; many oncology practices take approximately 1 week. Providing enough documentation is key to receiving approval from a payer, and designating staff to help patients get access to specific treatments leads to appropriate use. “We all talk immediately, but we have a woman who does only IV [intravenous drugs with] prior authorization,” Biran said. “We have 1 person who does only imaging with prior authorizations. We have 1 or 2 women or men who do oral drugs with prior authorization.”

Regarding collaboration between providers, Allen described an online portal used by some specialty pharmacies that allows the prescriber or physician to track what’s happening with patients within the system. “Here, you’ve got a click-to-chat feature and you can resolve something—you can answer the chat in 5 seconds and then resolve an issue in 20 minutes, when it would have taken a day and a half,” Allen said.

Overall, the care team needs to work efficiently and collaboratively to ensure that patients get timely access the therapies they need.