How can your biopharmaceutical manufacturing company’s next drug launch exceed expectations? The answer lies in your supply chain and your patient access support services, according to R’Kes Starling, Vice President of Specialty Pharmacy Services at Studiomaca.
In this edition of Ask a Supply Chain Expert, we asked Starling how your supply chain can support your drug launch. We also discussed why the services you offer patients, prescribers, and other stakeholders impact your drug’s success during a launch—and well after it enters the market.
What are you responsible for in your role at Studiomaca?
Starling: I head up the non-commercial pharmacy business for Studiomaca Specialty Pharmacy Solutions. We offer a variety of customizable pharmacy services to biopharmaceutical manufacturing companies. This includes patient assistance, clinical drug management, drug distribution and patient access support. When I’m not on the road visiting clients, I spend most of my time at our pharmacy in Irving, Texas. I work with our internal patient access teams across Studiomaca to help biopharma customers slay the dragons that keep them from providing patients access to their drugs.
What “dragons,” or biopharma company supply chain challenges, do you deal with most?
Starling: We’re assisting biopharma companies most with new drug launches. The big challenge there is ensuring that we have patient access solutions for the drug that factors in all key considerations and stakeholders in launching a new brand. When it comes to dragons, the biggest challenges are helping to remove potential barriers for patients and providers and supporting clinical and marketing objectives for our clients. We also often see accurate market forecasting as a huge challenge for new drug launches. How can you predict what’s going to happen after your drug enters the market? Only about one-third of drug launches meet their first-year forecasts. That means about two-thirds miss their mark – which ultimately means patients aren’t able to access these therapies. Our job is to make sure your drug isn’t in those two-thirds.
How can biopharma companies make new drug launch forecasts more accurate?
Starling: It’s a combination of experience and data. What have you learned from your experience with other launches? What can you learn from past launches of similar drugs? How did health plans cover a drug for the same condition? What are the chances that your new drug will get a favorable market access and formulary position? You have to take all these things into account.
What are patient access support services and how do they help forecasting?
Starling: Patient access support services are what you, as the drug’s manufacturer, offer to patients and prescribers to make sure that both can access your new drug. That could be helping patients navigate their prescription drug benefits. That could be a patient assistance program that offers co-pay help or discount coupons. That could be preauthorization help for doctors who need health plan approval to prescribe your new drug. Patient access support is unique to each drug. You should base your support on the needs of the patient. That requires a deep understanding of that patient’s journey to determine the most effective services.
When should biopharma company patient access support be in place?
Starling: It should be in place well in advance of the drug launch. These programs are becoming tablestakes and have a significant impact on overall brand and patient experience. So the strategies should be well-planned. Patient access support also has a major impact on your market share experience. What you’re doing is making it easier for stakeholders—whether it’s patients, prescribers or payers—to engage with your product. When you can do that, the chances of a successful launch and commercialization of your drug are much higher.
Are there other services biopharma companies should offer patients?
Starling: Yes, enhanced clinical services. These can be part of your launch plan, but they generally don’t start until physicians and patients have access to your new drug. An example would be adherence services. You’re educating patients about your new drug and teaching them how to take it properly, especially if it’s an injectable. Then you’re following up with patients to make sure that they adhere to the prescribed therapy regimen and care plan. You’ve worked hard to get them access to your new drug. Now you need to work just as hard to make sure that they’re getting the health benefits from using and staying on your new drug. What’s good for patients is good for your business.
How does the supply chain support the launch and commercialization tactics you’ve described?
Starling: The supply chain and overall distribution strategy are critical to everything I’ve talked about. The supply chain is how your company delivers your drug and all the services surrounding your product. The most obvious piece is distribution. You should match your distribution to the attributes of your drug. Is it an orphan drug with limited distribution to particular settings? Does it have special shipping, handling, delivery and storage needs? Are there regulatory compliance requirements you need to meet? It needs to be the right distribution strategy for that drug which includes the needs of the patient, physician and office staff, especially if it is a buy-and-bill product that physicians are purchasing. The supply chain can serve as the hub to coordinate your patient access support services at launch and your clinical support services after launch. All of these discussions on how to use your supply chain should take place well before your product hits the market.
How can the supply chain improve drug launch forecasting?
Starling: Biopharma companies should focus on gathering data and improving their analytics at each point in the supply chain process. That’s everything from logistics to sales to adherence. Your data should also include real world evidence from health economics and outcomes research. That will tell you how prescribers and patients are using your drug and what effect your drug is having on the health of patients. You can feed all of that data into your forecasting model to make more accurate predictions on how well your drug will perform.
What supply chain trends should biopharma companies watch and stay on top of?
Starling: There are two that should be on their radar. First, biopharma companies are raising the bar on patient access services. They are making meaningful investments in patient access services, which includes medication delivery support and distribution. Another trend is value-based reimbursement models, both present and future. This involves health plans paying you based on how well your drugs perform. Every supply chain process will need to completely support your clinical outcomes. It won’t just be about making on-time deliveries.
What will be different about the biopharmaceutical supply chain five years from now?
Starling: What will be different in the supply chain’s role is a shift from brand experience to total patient experience. By that I mean it’s not simply about price or whether the drug worked. It will be about access, convenience, service, supply, lifestyle, prescribers and other factors that affect a patient’s experience with a drug. Supply chain functions will be less about selling a product and more about researching a patient’s journey and making sure you’re in a position to deal with any issue that comes up along that journey.
What do you like most about working with biopharma companies?
Starling: It gives me great joy to help design and implement solutions that help our biopharma customers bring new and innovative therapies and products to the marketplace. We play a key role in ensuring patients have access to these critical therapies that can truly change someone’s life - maybe even save someone’s life. For me, it is truly noble work and I am blessed that I get to be a part it. For me, slaying dragons to make that possible is a worthwhile cause.
Related: Learn more about Studiomaca’s specialty pharmacy services for biopharma manufacturers