Manufacturers whose products treat rare diseases take on higher complexity, more risk, and a greater purpose – helping patients who have no other treatment options.
Streamlining trials takes worldwide infrastructure and local expertise while increasing access to life-changing therapies takes demonstrating clinical and economic value.
Ensuring continuity of care takes integrated teams who recognize the barriers and challenges patients face and execute high-touch support services designed to address the needs of the whole patient.
Maximizing efficiency takes third-party logistics and tailored distribution strategies from a partner who has played a key role in the North American commercialization of nearly every successful specialty product in the last decade.
Patients and caregivers battling with a rare disease understand that every patient matters. So do we.
AmerisourceBergen’s Signature® Commercialization Strategies are designed around individual products and the unique needs of patients, providing end-to-end support for each step of the product and patient journey.
It takes experience, commitment and AmerisourceBergen to ensure your rare disease treatment reaches those who need it most.
Many orphan drug trials require specialized logistics to reach small populations in often geographically challenging locations. Fully integrated GxP-compliant temperature-controlled transport, storage and distribution solutions protect pharmaceuticals requiring cold chain logistics. Efficient management of integrated supply chain logistics improves quality and accountability in transportation, dispensing and storage. Additionally, a strategic partnership with the Medical Research Network offers a highly integrated model for both clinical trials and ongoing home healthcare. Particularly for patients requiring at-home storage, (helping to increase patient recruitment and retention while ensuring the integrity of trial products) technology can make all the difference. The RFID- enabled product storage system CubixxCT® ensures medication utilization and patient-reported outcomes can be tracked during in-home clinical trials, and beyond. The right partner, fully integrated transport, storage and distribution create efficiencies in clinical trials, bringing treatments one step closer to the patient.
By demonstrating incomparable product value and developing a market access strategy that is tailored to the requirements of local decision makers, manufacturers can overcome increased payer scrutiny. This requires a full understanding of the patient journey. Manufacturers must demonstrate how the product fits into the overall treatment experience, including better outcomes and a reduction in the patient’s total cost of care. This takes gathering insights from patients, caregivers and patient advocates who give voice to the unique needs of the patient population. While in parallel collaborating with physician KOLs to understand their awareness for the new treatment, identify factors that may limit utilization, and create plans to overcome any barriers.
Dedicated consultants, with expertise in the U.S., Canada, and key European markets, aid in developing customized strategies that keep these key stakeholders in mind while considering the complex and evolving reimbursement and competitive landscapes specific to orphan products. Additionally, burden-of- illness studies provide credible data that raise payers’ awareness of unmet needs within their own patient populations. With more of the treatment costs shifting to patients, and providers facing more administrative burden than ever before, designing patient and provider support services that make it easier to navigate a complex reimbursement landscape is more critical than ever. Whether it is evolving the product message as real-world data emerges or tapping patient advocates and advisory boards to stay abreast of payer perception and provider education, monitoring and strategic planning must continue post-launch to drive continued product access.
Making a difference can start before the product is even available. Because diagnosis and treatment is particularly arduous for patients with a rare disease, expanded access programs offered prior to FDA approval can provide much- needed support. By preparing providers, patients and caregivers with disease state education, as well as access to registries, manufacturers can build a patient base in advance of the launch of an ultra-orphan therapy. Once a treatment decision has been made, patients and their caregivers must turn their attention to overcoming barriers to access and affordability. Knowledgeable advocates who understand the patient journey, the reimbursement landscape for a specific product, and who are empowered to solve problems, serve as a vital lifeline.
Advocates help patients realize the full benefit to customizable patient support by ensuring they are aware of all the services that provide education and advocacy within the rare disease community – improving speed to therapy, streamlining communications, and creating a consistent patient experience by connecting manufacturers, payers, patients and other healthcare stakeholders. They may assist with enrollment into the support program and provide education so patients and caregivers understand a particular therapy and its intended impact on their disease. Advocates also play an important role by providing logistics support for care coordination and free goods product shipments such as first dose, bridge products and patient assistance programs. Additionally, for patients using a provider-administered product, proactive advocates who navigate the access challenges that often accompany site of care changes enable better adherence to therapy.
Specialized logistics offerings, including finished goods warehousing, inventory management, ordering, shipping and financial services, are tailored to enable a seamless journey – improving speed to market, product access, and logistics ROI. Options such as enhanced 3PL services can help mitigate financial risks. Serving as the sole customer, a third-party logistics partner reduces the need for additional staff and increases speed-to-market with nationwide licensing. This maintains manufacturer control of customer relationships and product branding, while protecting and creating visibility to important data. Actionable intelligence enables the right decisions in real time, and that results in a better patient experience.
As the largest distributor of specialty pharmaceuticals reaching hospitals, physician practices, as well as specialty and retail pharmacies, our commercialization experts have the experience and insights to navigate complex distribution decisions. REMS programs, customized contracts and data solutions are just a few of the options that improve patient safety and enhance visibility to both the patient base and product sales trends. Tailored distribution strategies and patented inventory management technology designed with the patient’s treatment experience in mind improve product access while also achieving cost and logistical efficiencies.
As an example, Cubixx® Solutions technology automates inventory logistics and management functions so healthcare providers benefit from greater efficiency and control. This creates more time for what matters most: patient care. Additionally, an in-home version offers life-saving medications right at the patient’s fingertips.
With the largest collection of specialty physician GPO networks, access is available to thousands of providers across a wide range of specialties. GPO programs raise prescribers’ awareness of breakthrough treatments for rare diseases and enable consistent communication so critical prescribers are aware of not only information related to your products’ indications, but also its coverage, coding, and patient access support programs.
And as a result of continuous investment in national distribution centers, your customers benefit from advanced technologies that ensure integrity, stability and next-day delivery of critical specialty pharmaceuticals. Extensive training, as well as a commitment to a best-in-class customer experience, equip our associates with specialty product knowledge so they can quickly respond to your customers and resolve any challenges that could impede product access.
Enhancing the patient journey requires caring and knowledgeable pharmacy teams that understand the therapy, condition and unique needs of each patient. Specialty services such as financial assistance support improve product access and increase speed to therapy so patients obtain the greatest benefit from treatment. While collection and reporting of adverse events, patient-reported outcomes, and other data elements provide insights used to reduce risk and improve care. Comprehensive inventory management and pharmacist quality checks ensure orphan medications are dispensed properly, maximizing valuable therapies that may be manufactured in small quantities. Technology solutions increase pharmacy transparency, providing manufacturer partners with real-time access to detailed program information and strategic insights throughout the product lifecycle.