Therapeutics

Pharmacists Address Ways to Monitor Patients, Reduce Waste Through Medically Integrated Pharmacy Model

Pharmacists representing diverse health systems discussed their role in the transition to a medically integrated pharmacy model for oral cancer therapies at a session of Patient-Centered Oncology Care^® 2018.

Moderator Michael J. Reff, MBA, RPh, executive director and founder, National Community Oncology Dispensing Association, began by noting the geographical and system-level diversity the 4 panelists represented. He asked each person to discuss examples of progress and benefits of the medically integrated pharmacy model within their health systems, focusing on management of oral therapies for cancer.

Allison Trawinski, PharmD, MBA, specialty pharmacy manager and PGY1 community residency director, University of Rochester (UR) Medical Center, explained that integrating 6 clinical pharmacists integrated the clinic leads to more personalized services. Each patient has 1 dedicated pharmacist and 1 dedicated pharmacy technician, so patients know exactly who to go to when they need help.

For Neil Nebughr, RPh, previously at Utah Cancer Specialists, now associate director, Market Acces and Strategic Accounts at Sanofi, marker of success is simple: getting patients their medications. The practice sees 50% to 60% of the cases at its 9 locations, making it Utah’s largest independent oncology practice. It has worked with regional payers to help accomplish the goal of patient access.

Eileen Peng, PharmD, pharmacy manager and director, pharmacy services at Regional Cancer Care Associates, described how the community-based oncology organization created a collaborative pharmacy team to work with care providers, triage nurses, and patients to ensure safe, effective treatment.

According to Howard Cohen, MS, BSPharm, FASHP, director, oncology pharmacy, Smilow Cancer Hospital at Yale New Haven Health, the transition to a medically integrated pharmacy model came about when the academic health center realized it needed to better support its patients after discharge and throughout the entire care continuum.

“We’re dealing with hazardous medications,” Cohen said, referring to oral oncology therapies, “so we have to provide the same level of vigilance for those patients even though they’re transitioning from care to the home.”

When Reff asked about efforts to “go beyond the first fill” by extending continuity of care via a medically integrated pharmacy model, most of the panelists mentioned that the model helped them review each order and monitor each patient. Eventually, the pharmacists focused on following pathways based on clinical circumstances, not just filling prescriptions for the sake of filling them. They also described how medical integration allowed prescribers to quickly adapt dosing regimens to address any toxicities that might arise.

The experts stressed the importance of receiving buy-in from all stakeholders, including pharmacists, payers, and drugmakers. Trawinski described how the pharmacists in her system took the lead on creating treatment plans for the new and improved care pathways, which helped standardize care, and Nebughr said that the state pharmacy board and retail pharmacists came on board with the model because they saw that it resulted in high-quality care and filled an important need.

For Peng, information from the electronic health record (EHR) was crucial in getting payers to buy in to the integrated model. By showing payers data on how the pharmacists stopped unnecessary fills for patients on medication holidays or adjusted regimens for those who experienced toxicity, they proved to payers that “being able to give patients the best and the most appropriate treatment, safe treatment, improved outcomes,” she said.

“These are tremendous examples of leading institutions that are promoting this medically integrated pharmacy team model,” Reff said. “The benefits transcend all of the stakeholders but are centered solely on the patient.” By having the right systems and people in place to prevent unnecessary fills, he said, “you remove the cost and the toxicities, and you’re promoting a better collaborative relationship with the payers or employers.”

He asked the panelists to describe the major challenges they face with the integrated model and how these might change as cancer therapies evolve. According to Trawinski, the biggest barrier is access to medication, but the UR program has a leg up on the competition in the eyes of drug manufacturers: “[It’s] important to them that we have a fast turnaround time, that we have a lower abandonment rate, and that we’re able to manage [adverse] effects a lot faster and easier than the mail-order pharmacies.”

The discussion also covered the challenge of financial toxicity and obtaining assistance for patients, especially in light of diminishing foundation support. None of the panel- ists had easy solutions for this issue; Peng noted that her staff spends more time getting financial support than providing clinical services. Nebughr said that Utah Cancer Specialists has doubled the number of employees who help with obtaining financial assistance. However, he said, a benefit of the medically integrated pharmacy model is that if a patient cannot afford a certain medication, their provider will be informed right away and can choose an alternative therapy.

Cohen reported that capturing prescriptions is a challenge for organizations that are spread out across a state, but being medically integrated and having a single EHR helps address that challenge. After creating a pathway for oral chemotherapy treatment plans, Smilow Cancer Hospital implemented a system that automatically sends each prescription order to a basket, after which they are reviewed by a clinical oncology pharmacist for clinical appropriateness and then sent to their specialty pharmacy.

“In doing this, we’re able to capture those prescriptions, and we’re able to monitor those patients whether the patient gets that prescription filled or not at our site,” he explained.

Reff summarized, based on the panelists’ stories, that if a pharmacy wants to become medically integrated, it must leverage the power of the EHR—otherwise, it’s no better than any other pharmacy. Leveraging that internal power, he said, is “critical to elevating our collective games to tell a story of quality and value.”

The Doctor as Patient: Life During and After CAR T-Cell Therapy

For 38 years, Brian Koffman, MDCM, DCFP, DABFM, MS Ed, was a family physician—caring for patients young and old, rich and poor, and, as he wrote in his blog, “those with poor health choices and health fanatics, many omnivores and a few fellow vegans, professional athletes, weekend warriors, and couch potatoes.”¹

For nearly 4 years, he wore a second hat—that of chief medical officer and executive vice pres- ident of the nonprofit CLL Society.² It’s a job he never expected to have but one he embraced after founding the group following his own diagnosis with chronic lymphocytic leukemia (CLL) in 2005. In December 2018, Koffman gave up private practice to focus on the CLL Society full-time.

A month prior, he shared with the audience at Patient-Centered Oncology Care^® what it was like to be a doctor who was also a patient, and no ordinary one at that. Koffman was the 37th of 40 patients in a clinical trial at the Fred Hutchinson Cancer Research Center in Seattle, Washington, where he received treatment with an experimental chimeric

antigen receptor (CAR) T-cell therapy developed there in collaboration with Juno Therapeutics (since acquired by Celgene and, in turn, Bristol- Myers Squibb).^3,4

For Koffman, CAR T-cell therapy has meant a complete change of fortune. “I had every bad marker in CLL,” he said, outlining his journey with a very aggressive form of cancer, including a trial and ultimate failure on ibrutinib. “If you look at the data, I’m supposed to have been dead 10 years ago.”

Koffman likened both the process of getting treatment and its effects to “the worst flu you could get.”

When the treatment is first administered, it seems very “anticlimactic,” he said. But then, the waiting begins, and patients know they are anticipating the flu-like symptoms to appear to show that the cancer cells are being attacked.

Things can turn ugly quickly, Koffman said. He stayed in a hotel near Fred Hutchinson and was hospitalized twice, and his wife intervened when the cognitive effects left him unable to make decisions. Admittedly, for a physician, that was tough.

He doesn’t sugar-coat the ordeal that CAR T-cell treatment is, but afterward, “I was in the deepest remission you could possibly get,” he said.

“Does that mean I’m cured? We don’t know.”

Because the inflammatory response of the therapy, cytokine release syndrome (CRS), can be so severe, patients receive cardiac and psychological screening before the expensive therapy is administered (approved products cost as much as $475,000 for just 1 dose of the treatment). A caregiver is required; Koffman’s wife saw him through stretches where he experienced neurotoxicity so severe, “I [believed I] was in some museum in [Washington State’s] Olympic peninsula, talking to monks in caves.”

Therapies are now available to reverse some of the harshest effects of CRS, Koffman explained. Also, he said, scien- tists now understand that they can tone down the blast of T cells that patients receive without losing the treatment’s effect. “There used to be some hesitance,” he said. “There is less hesitancy now. You don’t want to lose the patient to save the cure.”

At one point, Koffman developed an arthritic condition and had to go through physical therapy to regain his strength. But it was worth it.

“CAR T-cell therapy is not a wimpy therapy,” he said. “The adverse events I wouldn’t wish on anybody, but they’re almost always reversible.” And, unlike with transplants, there is almost no graft-to-host response.

Physicians are making progress in stratifying who will have the harshest CRS responses and learning to prevent them (results of studies presented in December 2018 at the American Society of Hematology meeting showed that using ibrutinib with CAR T-cell therapy can miti- gate reactions).⁵ As his life returned to normal, Koffman turned his attention to sharing his experience with other physicians and patients. He even served as a coauthor on an article about his own case.⁶ Through the CLL Society, he travels to meet with patient groups and has set up a program by which patients who don’t live near a major academic center can consult with experts remotely.

He has spoken with officials at CMS, where reimbursement for CAR T-cell therapy remains unresolved and means some children in Medicaid with acute lymphoblastic leukemia cannot gain access to treatment.

Right now, “hospitals are losing money doing this therapy,” he said. “This [therapy] is game-changing. Prices will come down as more people enter the market.”

REFERENCES:

1. Koffman B. Closing one door, opening another. Learning from and about cancer (chronic lymphocytic leukemia or CLL). CLL Society website bkoffman.blogspot.com/. Published December 12, 2018. Accessed January 15, 2019.
2. CLL Society website. cllsociety.org/. Accessed January 15, 2019.
3. Juno Therapeutics highlights progress with best-in-class strategy in B-cell malignancies at ASH [news release]. Seattle, WA: BusinessWire; December 6, 2016. businesswire.com/news/ home/20161206006261/en/Juno-Therapeutics-Highlights-Progress-Best-in-Class-Strategy-B-Cell. Accessed January 15, 2019.
4. Pagliarulo N. Bristol-Myers’ gamble on Celgene pipeline products. BioPharma Dive website. biopharmadive.com/news/ bristol-myers-gamble-on-celgene-pipeline-prospects/545244/. Published January 4, 2019. Accessed January 15, 2019.
5. Columbus G. Ibrutinib/CAR T cell combo active in CLL. OncLive® website. onclive.com/conference-coverage/ash- 2018/concurrent-ibrutinib-and-cd19targeted-car-tcell-therapy-shows-early-tolerability-high-orr-in-cll. Published December 2, 2018. Accessed January 15, 2019.
6. Chung SH, Hughes G, Koffman B, Turtle CJ, Maloney DG, Acharya UH. Not so crystal clear: observations from a case of crystalline arthritis with cytokine release syndrome (CRS) after chimeric antigen receptor (CAR)-T cell therapy [published online October 5, 2018]. Bone Marrow Transplant. doi: 10.1038/ s41409-018-0357-4.

Download PDF: Therapeutics