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Rob Beese

• April 27

11 Market Access Questions to Address Prior to Launching Your First Specialty Drug

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Market access considerations can be complex to navigate and overwhelming to address for biopharmaceutical commercial teams launching their first specialty drug.

Picture this scenario… Your commercial team has the challenge of bringing a specialty pharmaceutical drug to market promptly after FDA approval. Market access is a high priority. Ultimately, you just want to ensure that products can efficiently and effectively get into the hands of patients, but how do you ensure that happens and what’s your first step? Which types of organizations should you partner with? Who do you have to partner with? Who did your boss work with previously and already reach out to ahead of time? How do you effectively sort through the maze of 3PL organizations, distribution partners, and pharmacies; not to mention HUB providers, serialization partners, and data analytics providers?

Perhaps you’re even overlooking a critical partner in the supply chain. Third-party service organizations are aware of your upcoming PDUFA date, so it’s likely that calls have been coming in fast and furious from various sources. You may have considered distributing the drug directly to avoid having to partner with so many third parties.

In my previous role distributing specialty drugs, that last statement would have generated utter outrage as I was busy making those fast and furious calls. How could a manufacturer ever think they could replicate my organization’s role as picker, packer, shipper, banker, compliance stalwart, customer service expert, data steward, and an indispensable part of the supply chain that ensured precious drugs were being delivered overnight to the practitioners on the front lines of our shared war against disease?

It’s All About Partnerships

Now that I have graduated to my new role as a consultant to biopharma clients looking to bring new pharmaceuticals and medical devices to the US market, I realize it is important to remember that every phone call you receive is from a potential partner who strongly believes, as I did, that they can help you on the road towards commercialization.

Most of them will be correct.

The actual composition of those partnerships is what requires the most consideration. You may have already started working on the sales aspect of how to convince doctors to prescribe or administer your drug. You may also be working on the payer aspect to convince insurers to pay for the drug. But now it’s time to focus on how the product successfully reaches the patient.

11 Key Questions to Guide Your Decision-Making

Below are 11 key questions you will need to ask before you decide which organizations you need to partner with:

1. What will be the target patient population for your product? Keeping the answer to this question at the forefront of your mind will help focus and prioritize the answers to each of the remaining questions.

2. What will be the site of care or dispensing entity for your product? In some cases, the doctor’s office will administer your drug onsite. In other instances, your drug will be dispensed from a pharmacy and sent home with the patient. This matters because it determines whether your drug is billed through a medical or pharmacy benefit.

3. How will your drug flow from manufacturing facilities to those sites of care? This process can be convoluted, and the level of complexity is partially dependent on your product’s ultimate destination (i.e., site of care). Launch strategies will likely include distributors, third-party logistics providers (3PLs), and specialty pharmacies—you’ll need to partner with each type of organization involved in the process.

4. How will my product’s quality and temperature need to be managed on its journey to the patient? Many expensive drugs need to be refrigerated throughout the distribution process. This impacts distribution costs and could lead to waste if done incorrectly. COVID-19 vaccines, which need to be kept at -80 degrees, are a timely example.

5. Will my product be administered at the site of care or dispensed for self-use by the patient at home? It’s important to consider your product’s mode of administration because this impacts which type of billing goes into effect, for example, Medicare Part B or Part D.

6. How will the patients’ financial needs be met? If patient access and affordability is a priority—which it should be for biopharma companies—then considering how a patient will pay (e.g., cash, copay, etc.) and who will pay (e.g., the patient themselves, commercial insurance, government entity) will help determine if patient services such as a copay discount program could be useful.

7. What will my data requirements be for full market transparency? As you can see from the questions above, there are several dynamics and sources of information in play for any given drug. Understanding your commercial success and future decision-making is highly dependent on having data and analytics. You’ll need to decide whether you’ll gather that data directly or leverage third-party service providers. These providers will gather the data from wholesalers and pharmacies. Oftentimes your 3PL will gather this for you since they’re already managing those external interactions.

8. What will be my key payer contracts and affiliations? The payer landscape has grown increasingly complex as managed care organizations and pharmacy benefit managers continue working to control costs and access as part of a value-based system. You’ll need to decide on your payer affiliations and with whom you’ll negotiate specific contracts to ensure formulary access at some level—perhaps preferred access and hopefully not excluded from formulary altogether.

9. How will my regulatory and compliance requirements be satisfied? Some products have REMS (risk evaluation and mitigation strategies) programs or black box warnings in place from the FDA. These safety and risk programs come with compliance and reporting requirements that must be considered.

10. Who will act as my serialization or aggregation partners? The Drug Quality and Security Act was put in place in 2013 to give the FDA more authority to regulate and monitor the manufacturing of compounded drugs. To help facilitate that oversight, biopharma must place unique serial numbers on every bottle or package containing product. A case of those individual bottles is then given another aggregated serial number so that each bottle doesn’t necessarily need to be tracked individually. Biopharma companies must have serialization and aggregation partners secured sooner than later due to a November 2023 deadline.

11. What is more critical to your commercial success: access or control? On one hand, broad-scale patient access requires a large-scale network potentially including many wholesalers, pharmacies, and distributors. There’s somewhat of a loss of control on your behalf when there are many partners in place. On the other hand, if you choose to have more direct control over your product, including how it’s distributed, dispensed, and how related data is gathered, then you may opt for a more limited number of partners. This could mean that your product will reach fewer patients. Your decision should ultimately tie back to the patient population identified in the first question.

The answers to these eleven questions will guide you towards the most beneficial partnerships for your product. In some ways, the first and last questions can be the most important. If your patient population is large and diverse, then the payer mix and number of sites of care will also be extensive. This means the number of potential distributors and pharmacies could be extensive as well.

More distributors and pharmacies mean more data and more product in transit. More patients mean more need for financial support—both for that patient and the caregiver. Thus greater access CAN mean less control unless care is shown in picking the right mix of partners who can provide the services and data transparency you need. The good news: you will generally only need one 3PL and one hub partner. But again, picking the right one can be critical!

Pharmaceutical consulting companies like Archbow Consulting work day-in and day-out to help manufacturer clients answer these questions and develop their distribution strategies. If your team is preparing to launch a new specialty drug, we can help.

Click here to watch the archived webinar on this topic.

For additional insights on this topic, you may also enjoy the following:

How to Maximize Relationships with Distribution Partners

How Healthy is Your Pharmaceutical Distribution Network?

Are Pharma and Biotech Companies Asking Potential 3PL Partners the Right Questions?

Archbow Consulting helps pharmaceutical and biotech companies in the USA and Europe design, build, and optimize product distribution and patient access strategies. Archbow was founded by industry veterans to meet a need in the marketplace for consulting options that offer diverse real-world experience, are able to leverage deep connections across the industry, and can also provide actionable strategic guidance. We invite you to learn more about our team, services, and clients’ success, and connect with us via email, LinkedIn or subscribing to this blog which you can do below.

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