Get the Most From Outsourced Service Providers
Rather, products need to demonstrate ongoing effectiveness, safety and value for the entire healthcare system. Developing a new drug, from synthesis to approval, often takes 10 or more years,1 and while on that path, manufacturers will face myriad hurdles that can be mitigated with the help of outsourced positions from leading industry experts. According to EY forecasts, the outsourcing market is estimated to grow 7.5% annually due in part to manufacturers’ desire to optimize costs, improve quality and focus resources on their core interests.2
AmerisourceBergen’s strategic consultancy and patient support services companies, Xcenda and Lash Group, work with manufacturers to determine their outsourcing mix using more than 80 unique, end-to-end models. Whether keeping services in-house, outsourcing to an experienced partner or using a blend of both, manufacturers should keep these four things in mind:
1. Engage early.
The preclinical and clinical trial stages are critically important to the success of a specialty pharmaceutical product. There are many competing priorities that need to be addressed once a product is approved, including safety, efficacy (both short- and long-term), provider education, market access, patient access and more. Engaging with a partner that can address those needs early in the product’s development can help ensure a product’s smooth launch. For example, one study showed that when a sample of 210 new molecular entities was examined, an estimated two-thirds failed to meet prelaunch sales expectations for their first year on the market. Reasons varied depending on the product, but included lack of awareness, lack of market understanding, pricing barriers and inability to react and course-correct.3 As more and more complex, small, niche manufacturers produce specialty products, those sales expectations can mean the difference between the entire company’s success and failure. Partnerships with outsourcing companies can help manufacturers seek out and prepare for potential hurdles to a successful launch.
In years past, manufacturers have engaged teams at Xcenda or Lash Group three months pre-approval. Now, most manufacturers approach us about six to nine months in advance; however, the ideal engagement begins 12 to 18 months pre-approval and launch. It is important to anticipate specific services a product may need, determine timing and identify if manufacturers are equipped with the resources to build out corresponding services in-house or if they need to look to outside partners.
As more and more complex, small, niche manufacturers produce specialty products, those sales expectations can mean the difference between the entire company’s success and failure.
2. Begin with the end in mind.
As a company engages an outsourcing partner, it is important to outline a clear idea of what success will mean once a product launches. While clinical efficacy and safety criteria are crucial for success, total product value and real-world, quality of life outcomes are increasingly critical for success. Reimbursement support is the key that can make the difference for successful product launches. In a cautionary example, one product launched in the last decade lost months of sales due to a lack of reimbursement code from Medicare.
Manufacturers that consider how their product will ultimately be accessed during the launch period create a smoother path for providers and patients. Additionally, manufacturers should consider what the healthcare landscape could be at launch as the following factors may change over time: direct competitors, provider education and uptake. Finally, the manufacturer should consider the most unpredictable factor of all: the patient. All of the services a great outsourcing partner might recommend are to ensure a manufacturer understands the patient perspective of access to their product. Success and widespread adoption is challenging if a product launches with the perception that it is difficult to access. Manufacturers should consider deploying specifically trained resources—such as field reimbursement teams—to mitigate these issues.
3. Know the product landscape.
Once a patient begins a therapy, manufacturers will shift their focus to optimizing adherence, mitigating side effects and monitoring outcomes. Manufacturers need to evaluate the product landscape—patient populations, competitors and existing reimbursement and access services—to ensure they are on par or exceeding current offerings. Regardless of the financial pathway, once a clinical decision is made, the right outsourcing partner will provide high-touch support to help patients get on therapy fast. Sometimes, that does not mean having the widest group of pharmacies or providers educated. Rather, it’s assembling a team of highly dedicated and specialized patient services liaisons to work directly with patients.
This is especially true for patients on orphan drugs, where providers and pharmacies may need to be educated on what to expect, how to keep accurate records and anticipating payer needs. As a whole, there are more than 30 million Americans with a rare disease—a large population, to be sure—but patient populations in specific rare disease states can be as small as in the hundreds. Orphan products as a whole are receiving more payer scrutiny and they are increasingly considering options such as higher cost sharing by patients and more aggressive step therapy protocols, despite the crucial need for treatment in these very small patient populations. Companies like AmerisourceBergen are able to leverage the collective knowledge of businesses like Xcenda and Lash Group to help manufacturers understand where their product fits in the larger healthcare landscape and design programs that can ensure a patient is able to access therapies once they receive a prescription. Solutions like managed care account executives and high-tech, smart-touch patient support services are just a few of the many services that can be customized to meet manufacturer and patient needs.
Companies like AmerisourceBergen are able to leverage the collective knowledge of businesses like Xcenda and Lash Group to help manufacturers understand where their product fits in the larger healthcare landscape
4. Measure success and be flexible.
1 “Cost of Developing a New Drug”, Tufts Center for the Study of Drug Development, November 18, 2014.
2 De Simone F. An overview of the CMO / CDMO market: a growing industry. February 16, 2017.
3 “Beyond the storm” McKinsey & Co. Analysis of Evaluate Pharma data, March 2014. Available online at http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/the-secret-of-successful-drug-launches