W H I T E PA P E R

Creating access and supporting cell and gene therapy patients through the treatment journey

While much attention has been given to the novel science behind cell and gene therapies, ultimately the success of every precision medicine starts and ends with the patient. Even the best-planned product launch can be derailed if the manufacturer doesn’t have a clear strategy for facilitating access to the therapy and supporting patients through the treatment journey. This is true for almost every specialty product, but it is especially important for cell and gene therapies, given the high cost and complexity of administering these innovative new therapies.

Tara Herington, Vice President of Cardinal Health Sonexus™ Access and Patient Support, says that precision medicine needs to be as much about personalizing the treatment experience for patients as it is about personalizing the therapy itself.

“Many factors can stand in the way of a patient getting the full benefit of treatment,” says Herington. “Psychosocial, economic, caregiver-support, transportation and other issues can impact how each patient responds to a therapy. It’s only by understanding these challenges, and wrapping patients in high-touch, individualized services to remove them, that we can ensure that each patient has a chance to receive the full benefit of the therapy.”

Patient support hubs, which provide comprehensive services to help patients through their treatment journeys, play a critical role in developing strong, individualized, personal relationships with patients — the kind of relationships that earn the confidence of patients. Having the opportunity to fully understand the challenges each patient faces is critical to manufacturers.

Having led patient support services for several innovative precision medicines over the past year, Herington recommends a few critical steps when developing a program of this kind.

Psychosocial, economic, caregiver-support, transportation and other issues can impact how each patient responds to a therapy. It’s only by understanding these challenges, and wrapping patients in high-touch, individualized services to remove them, that we can ensure that each patient has a chance to receive the full benefit of the therapy.”

Tara HeringtonVice PresidentSonexus™ Access and Patient Support

“

White paper: Creating access and supporting cell and gene therapy patients through the treatment journey 1

• Invest in creating personalized, high-touch relationships with each patient.

“By the time a patient is a candidate for an advanced therapy, she has usually been through multiple other regimens. Every time a new therapy is recommended, it represents new hope. If a medication fails to adequately treat the patient’s condition or stops working, the patient loses some of that hope and experiences disappointment. Patients who have experienced medical disappointment in the past may be reluctant to try new therapies,” says Herington.

One of the most important roles a patient hub can play is to educate patients, answer their questions about the therapy and help address their fears of the unknown. Building personalized relationships is key to establishing the kind of trust with patients that enables manufacturers to identify challenges that stand in the way of access or adherence.

• Provide intensive support to help patients navigate reimbursement challenges.

Most cell and gene therapies are high-cost and many payers are still trying to determine how they will build these therapies into their reimbursement models. Even for those payers that do have models for reimbursing these specialized therapies, the process the patient needs to navigate to secure approval often can be long and overwhelming.

A multifaceted prior authorization process is typically required, and it is common that several levels of appeals are needed for therapy approval. Securing approval for the wraparound care that each patient requires creates yet another layer of complexity.

“With precision therapies, payers demand a great deal of detailed, highly specialized documentation to confirm that a patient needs the therapy, and that the patient has already failed to respond to other, less costly regimens,” says Herington. “Navigating the reimbursement process can be so daunting that many patients, left unassisted, lose weeks or months of valuable time trying to get approved.”

White paper: Creating access and supporting cell and gene therapy patients through the treatment journey 2

Considering that most patients who require precision medicines are dealing with very serious illnesses, each day that’s lost to reimbursement complexity is a day that can have significant negative impacts on that patient’s health.

One of the advantages that an experienced patient hub can provide is that they are experts in each payer’s reimbursement pathway — and in helping patients navigate that journey. The team learns the specific documentation, lab results, prior treatment histories and other evidence each payer requires prior to authorizing a patient to receive a therapy. They also provide expertise when it comes to completing the complex paperwork, to avoid costly delays.

They also have deep knowledge of each therapy’s patient assistance programs and can help patients complete the application process to gain access to these medicines, in cases when they qualify.

“An experienced patient services hub does much more than helping to secure reimbursement for a single dose of medication,” says Herington. “We work with pharmacy and medical benefits providers to support the patient through the ongoing complexities of the reimbursement process.”

• Think beyond the therapy.

Considering the cutting-edge research and development that goes into creating cell and gene therapies, manufacturers can’t allow something as seemingly simple as lack of patient transportation stand in the way between a patient and a life-saving therapy. This is especially true with medications that have very small target populations, for whom it’s critical to have individualized patient support plans in place to address even the seemingly smallest obstacles.

“Sometimes, that means we need to work with a third party to help the patient arrange for transportation” said Herington. “For other patients, lodging may be a consideration — particularly if they and their caregivers need to remain nearby the infusion site for several days after administration, so the provider can monitor their response to the therapy.”

In other instances, the patient hub provider may need to coordinate housing for care partners for a period of time, or for an in-home nurse. These may seem like small issues, but for patients who have endured prolonged illness, troubleshooting these challenges can be critical to their ability to receive the therapy prescribed by their physician.

White paper: Creating access and supporting cell and gene therapy patients through the treatment journey 3

• Ensure alignment between the patient services hub, the logistics team and the site-of-care.

For some precision medicines, like CAR-T therapies, the process for developing the drug, transporting it and administering it to a patient is highly complex — and it revolves around a patient whose health is fragile and ever-changing. That’s why deep collaboration between the patient hub and logistics teams is critical to precisely schedule every step in the process.

For example, the hub services team may need to coordinate transportation, lodging and other services to ensure the patient can be at the site-of-care at a very precise time, so cells can be harvested and quickly and compliantly transported by the logistics team from the site-of-care to the manufacturer. For certain types of therapies, there’s a very limited window between when the patient-specific dose is manufactured and when it needs to be administered to the patient. The hub services and logistics team need to work closely together to ensure that patient will return to the site-of-care at a very precise time, when the medication can be administered.

If any obstacles arise — if the patient’s arrival time at the site-of-care must change, or if the patient’s health condition changes, if weather or other conditions will impede medication administration — that information needs to be shared in near real-time, so the plan can be adjusted.

“There are so many variables involved in developing and administering a patient-specific dose of medication, that deep, ongoing collaboration between all partners in the process is the only way to effectively minimize the potential for errors,” says Herington.

• Leverage hub-collected data to inform the patient support strategy.

In the process of helping to coordinate care for patients, hubs collect valuable data from patients. If analyzed appropriately, that data can deliver critical insights to help manufacturers make adjustments in their interactions with patients to support improved outcomes. For example, if data shows that patients are consistently falling off therapy after the third treatment, an additional intervention can be scheduled at that time.

This demonstrates why it is advantageous for manufacturers to partner with a hub services provider that can easily, seamlessly and compliantly share de-identified patient data with healthcare analytics experts who can cull through it to generate actionable insights.

“Every day, we’re collecting patient-specific data related to demographics, prior medication histories, diagnosis codes, barriers to access, reasons why patients stopped complying with a regimen, side effects and outcomes. There are literally hundreds of data fields, specific to each therapy we support,” says Herington.

While hub services providers use that data to create customized care plans to support each individual patient, that data can be immensely helpful to scores of other patients, if leveraged correctly and compliantly. In addition, hubs can be used to collect data for patient-reported outcomes studies, which can help substantiate real-world value to payers and providers..

• Start early when planning your patient support strategy.

Manufacturers should select a hub services partner and map out the patient support strategy no less than 12 months prior to launch, and preferably longer so a well-developed patient engagement plan can be built well in advance.

“Many manufacturers think that if a hub services program will only target a small number of patients, they don’t need much time to create it,” says Herington. “But when it comes to hub services, it’s not about the number of patients. It’s about the complexity of the reimbursement process and the number of partners and stakeholders that need to be aligned to support the patient journey. It’s about bringing together legal, IT, compliance, insurance, logistics, medical and other experts together to identify potential barriers and create comprehensive, flexible and adjustable plans that address those challenges.”

Contact usTo learn more about how the experience and expertise of Cardinal Health Sonexus™ Access & Patient Support can help you tailor patient services with the same personalization as the medicines themselves, please visit cardinalhealth.com/sonexus

© 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, Sonexus, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Lit. No. 1SS19-1021439 (9/2019) 4