Understanding the Gene and Cell Ecosystem

At AllianceRx Walgreens Pharmacy, we believe a successful patient gene and cell treatment journey begins with the outcomes in mind: Providing the precise therapy for the right patient at the right site of care at the right time. Our organization recognizes there are a number of stakeholders in the gene and cell ecosystem who partner together to ensure the successful delivery of these complex therapies. This article introduces this team of stakeholders and the value each brings to the overall journey of a patient receiving gene and cell therapy.

• The Patient. Patients with a rare and orphan disease are typically on legacy therapies to maintain or manage diseases that generally do not have cures. These conditions usually progress and further debilitate the patient, and can even lead to death. Many of these therapies are for small, complex genetic diseases that require a high level of knowledge to the patient journey, the disease burden, the disease itself, and will require expert and dedicated teams to make sure we’re managing those patient populations appropriately. As you look at multi-million dollars of cost for a singular dose of therapy, we know there is no room for error or defect as we look at bring the product to the site of care, and to the patient. 

• The Provider and Site of Care. Only specially-trained providers and certified centers have access to many gene and cell therapies. Because of this, patients often must travel a great distance to seek treatment. This can impede access to local care and ultimately impact the success of a patient’s treatment. Helping ensure patients have access to knowledgeable providers and certified centers is paramount to their success. 

• The Pharmaceutical Manufacturer. Manufacturers develop gene and cell therapies that treat many genetic or rare and orphan diseases. Currently, there are 1300 therapies in various stages of clinical trials – 50 to 80 of these drugs are expected to be approved in the next 3 to 5 years. These milestone therapies are typically single dose therapies and seek to cure the underlying genetic abnormality by editing, replacing or deleting the defective gene sequence.  Additionally, cell therapy can use donor or patients cells which are then modified and reintroduced into the patient’s body.  

• The Payer. Payers, or health plans, bring new hope to patients by seeking to offer them access to these potentially curative gene and cell therapies. Some of the ways health plans do this is by  reviewing appropriate drug utilization, risk-pooling across large populations, contracting value-based arrangements, and helping to alleviate suffering from these rare and orphan diseases.  

• Manufacturer HUB. Hub services are a growing market of offerings that allow manufacturers to maintain a connection with patients during all phases of the prescription delivery process. These servicesrange from benefits investigation, prior authorization assistance, financial and co-pay assistance, patient education, compliance with risk evaluation and mitigation strategies (REMS), data reporting, and bridge supplies or prescription triaging. For manufacturers of specialty drugs, the ability to have a single point of contact for their therapies helps ensure efficient medication  

distribution. 

• Gene and Cell Specialty Pharmacy. The specialty pharmacy, in conjunction with its vast resources, brings everything together. The gene and cell specialty pharmacy accepts the patient referral from the pharmaceutical hub; verifies the benefits with the payers; contracts the Letter of Agreements (LOA); and is the exclusive or limited distributor of the therapy from the manufacturer. The gene and cell specialty pharmacy also prepares, coordinates and counsels the caregiver and patient for the milestone therapy; monitors the safe logistics of the drug delivery to site of care; and monitors the patient annually for long-term outcomes over the next 10 to 15 years.  

AllianceRx Walgreens Pharmacy as the Gene & Cell Specialty Pharmacy 

What roles do we at AllianceRx Walgreens Pharmacy provide as the specialty pharmacy? Each step of the gene and cell process requires enhanced services, skills and technologies. Dedicated and highly trained teams are necessary to manage and support these rare and orphan disease patients and their caregivers. The contracting departments must be highly skilled at efficiently completing LOAs for each patient after receiving benefit approval. And, the facility requires special cryo and ultra-low storage freezers, as well as advanced logistic capabilities, to protect the viability of the product.  

Gene and cell pharmacies are low-volume prescription centers with high-touch patient clinical models. They also require the ability to accept unique payment arrangements, such as pay over time, and typically bill the medical benefit versus adjudicating a prescription.  

At AllianceRx Walgreens Pharmacy, we understand our critical role within the gene and cell ecosystem and look forward to telling you more about it in the coming months.  

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