Cardinal HealthTM Advanced Therapy SolutionsHow community...

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Cardinal HealthTM Advanced Therapy Solutions How community oncologistsview CAR T-cell therapy possibilities and challenges Historically, the mainstays of cancer treatment have been surgery,chemotherapy and radiation therapy. While this is still the case, for almost a decade now, newer treatments have transformedoutcomes for cancer patients — especially those for whom traditionaltreatments were unsuccessful or had worse side effects. Modern cell and gene therapies, such as the cellular immunotherapy called ChimericAntigen Receptor (CAR) T-cell therapy, are partof this new class of treatments. Currently, six CAR T-cell therapies are FDA-approved for treating bloodcancers, including lymphomas, some types of leukemia and multiplemyeloma. Recent large clinical trials have led medical-communityexperts to predict that CAR T-cell therapy could soon replaceadditional chemotherapy as the standard second-line cancer treatment.

Provider perceptions of cell therapy CAR T-cell therapy is one of the modern cell and gene therapieswidely adopted by the medical community in the United States.Since the first products received FDA approvals in 2017, it became anestablished part of the standard of care for certain blood cancers. At a recent Cardinal Health Specialty Summit, 83 oncology healthcareprofessionals were surveyed on provider perceptions of CAR T-celltherapy and its evolving role in cancer patient management. Sixty-nine of the respondents were physicians, while the rest were non-physician healthcare professionals. The survey found that most physicians (82%) are very comfortableor somewhat comfortable referring eligible patients for cell or genetherapy. This comfort level is reflected in practice when it comes toCAR T-cell therapy. Over half of the physicians surveyed (54%) hadprescribed or referred commercial CAR T-cell therapy for one to threepatients over the past year, while an additional 28% had referredmore than three — sometimes more than 10 patients — to receivethe treatment. As apparent in the survey, most physicians are willing to prescribeCAR T-cell therapies. However most do not have a structured processto refer patients from the community settings to administeringtertiary care institutions. Just over one-third of physician respondents(37%) at the Cardinal Health Specialty Summit reported they have aformal process for CAR T-cell therapy referrals. During the early years of a novel cancer therapy’s adoption intostandard practice, there can be a steep learning curve andextensive time required to understand the intricacies of the clinicaltrial data. Physician awareness and education is necessary not only to gain comfort but to apply in practice too. This delays theestablishment of fixed approaches to identifying patients most likelyto benefit from the treatment and the best ways and centers to referthem to. How many patients have you prescribed orreferred for treatment with commercial CAR T-celltherapy in the past 12 months? Number of patients1-3 7-9 I am not involved in theordering/prescribing ofCAR T-cell therapy Physicians (%) (n=57) 54%7%4% 0 14% 4-6 14% 10 or more 7%

Challenges faced

Access to CAR T-cell therapy is important for the estimated sixmillion patients diagnosed with blood cancers globally. But despitephysicians’ willingness to prescribe and refer eligible patients, somesignificant barriers impede the extent of its real-world patient impact.

Physicians surveyed at the Cardinal Health Specialty Summit wereasked: Of the patients you have prescribed or referred for commercialCAR T-cell therapy in the past 12 months, what percentage havereceived therapy?

Only 39% of physician respondents had more than 60% of patients goon to receive the prescribed or referred CAR T-cell therapy. For 51% ofthe physicians, less than 60% of referred patients eventually receivedthe treatment.

High costs and limited access

The top two barriers when referring or administering CAR T-cell therapyselected by both physician and non-physician respondents surveyedwere the cost of the therapy and the logistics of traveling to a CAR T-celltherapy center.

Because CAR T-cell therapy requires the personalized engineering
of each patient’s T-cells, it is very costly upfront. Research puts thetreatment cost of CAR T-cell therapy between $373,000 to $475,000per patient dose— excluding additional procedures, facility costs,monitoring costs and potential side effect treatments.

Accessing sites of administration where the treatment can beadministered is also challenging for patients. CAR T-cell therapy cantypically only be administered in certified tertiary medical centers as itis a highly complex process that requires highly specialized staff. TheseCAR T-cell therapy centers also require patients to remain inpatient atthe centers or reside close by (within 30 minutes to 2 hours of traveltime), so they can be properly monitored and treated for adversereactions after the infusion.

Patients are also generally restricted from driving for eight weekspost-therapy and can often be required to have a caregiver at hand
for the month following the therapy. Although these requirements
are essential for monitoring and safety, they can take much work
to meet. Unless the costs are covered by insurance, pharma or afoundation, patients who live far from the centers have to incur traveland temporary housing costs. Getting paid caregiving can also beexpensive for patients with limited financial resources. And whileunpaid care provided by family and loved ones may be more accessible,it can exert considerable physical, financial and emotional strain on

all parties involved. Until these travel and caregiving challenges arealleviated, and the significant patient access issues are addressed, wemay continue to see a drop-off in the number of patients who receiveCAR T-cell referrals and the number who receive the treatment.

Low clinical trial referral rates

During the Cardinal Health Specialty Summit survey, 64% of physicianrespondents indicated they had not referred any patients for a clinicaltrial focused on engineered T-Cell Receptor (TCR) therapy in the past year.

There are various reasons behind this low clinical trial referral rate.Research shows that a high proportion of physicians and nurses indifferent medical specialties are interested in referring patients toappropriate clinical trials and discussing and providing information
on them. However, generally, they are insufficiently exposed to clinicalresearch in school and professional meetings. They have limited accessto clinical trial information and need more time to evaluate and exploreclinical trial options with patients.

Of the patients that you have prescribed or referredfor treatment with commercial CAR T-cell therapyin the past 12 months, what percentage havereceived therapy?

Percentage of patients1-20%
41-60%

I am not involved in theordering/prescribing ofCAR T-cell therapy

Physicians† (%) (n=57)

14%11%

11%

0%

14%

21-40%

12%

61-80%	18%
81-100%	21%

†Percentages do not sum to 100% due to rounding

To learn more, visit cardinalhealth.com/cellandgene
or email us at [email protected]

Key takeaways for pharma

Despite the high rates of referral/prescribing for cell therapies
like CAR T-cell therapy by physicians, there remains a chasmbetween this and the number of patients that eventually receive
the treatment. Fifty-one percent of physicians surveyed during theCardinal Health Specialty Summit had less than 60% of their referredpatients go on to receive the cell therapy. Approaches that can helpbridge this gap include:

• Increasing patient support: Cancer patients and theircaregivers need to better understand the process of receivingcell therapies through well-designed patient services andassociated infrastructure.

• Promoting access across regions: Manufacturers should pursuelocal development of CAR T-cell therapy. For instance, allowinglocal academic medical centers already experienced in producingindividual patient cell therapies to manufacture CAR T-cells —improving patient access and reducing costs.

• Adapting traditional healthcare sites: Most CAR T-celltreatments are provided in inpatient settings at certified tertiarymedical centers. While close monitoring is needed, it is alsoburdensome for patients who often must travel far and bear
  the associated costs. If appropriate training and patient safetycan be ensured at traditional healthcare settings, then thenumber of centers certified as treatment centers for CAR T-cell-based therapies will increase, and the treatment will becomesignificantly more accessible to patients.

• Increasing physician engagement: Engaging physicians onclinical trials through educational workshops, seminars andinformational material is an essential mechanism for increasingpatient enrollment in cell therapy clinical trials.

CAR T-cell therapy is a cutting-edge cancer treatment that hassignificantly improved blood cancer outcomes and harbors immensepotential for treating solid malignancies.

Providers express optimism regarding the therapy’s unprecedentedefficacy in certain cancer types but retain reservations due tosubstantial financial burdens and its complex administration.Addressing these concerns requires a collaborative approach,combining efforts from healthcare professionals, policymakers,payers and pharma industry representatives. Together, we mustcultivate an environment conducive to sharing knowledge, refiningadministration protocols, optimizing cost-effectiveness, andultimately enhancing the accessibility and safety of CAR T-cell therapyfor patients worldwide.

Cardinal Health Advanced Therapy Solutions offers tailored solutions that simplify andstreamline complexities of cell and gene therapies (CGT). From clinical development tocommercialization, our experts will partner with you every step of the way to ensure yourtherapy is in the hands of patients who need it most.

** Not all physicians answered every question in the survey.

Data from Cardinal Health Specialty Summit June 2023

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