Specialty Drug Commercialization Process and Considerations

As specialty drugs move through clinical trials and preparations for commercialization begin, significant attention is warranted to this process considering the massive investments that would have been already made in the product up to this point.

The specialty pharmacy drug pipeline is a rapidly growing segment of the pharmaceutical industry that primarily focuses on the development of novel, complex, and likely high-cost products. These medications tend to treat disease states that affect smaller patient populations and are often prescribed primarily by specialists.

Drugs in the specialty pipeline typically are biotech products, medications that require special handling, products with unique administration routes, or drugs that require significant extra monitoring. As these drugs move through clinical trials and preparations for commercialization begin, significant attention is warranted to this process considering the massive investments that would have been already made in the product up to this point.

Considering all of these complexities, it is not surprising that the process associated with bringing these drugs to market is multifaceted and requires a significant amount of special attention and planning to ensure the profitability and success of the product. This preparation is vital because a new product launch is fraught with hurdles, such as regulations, barriers with payers, supply chain issues, and potential competitor products.

For these reasons, an important first step in the drug commercialization process that cannot be forgotten is to create a launch plan or a checklist of required activities. Although the process is not necessarily extremely hard, it is quite complex, and an error or oversight could be very significant, putting a successful product launch at risk.

One of the first decisions a pharmaceutical company will need to make is regarding the specialty pharmacy network they plan to use for their product. Manufacturers may opt for many types of distribution, such as open, limited, or exclusive.

Open distribution would allow any pharmacy to access and dispense the product, whereas limited—as the term suggests—allows only certain pharmacies access. The number of pharmacies in the network can vary from very small to much larger depending on how the manufacturer wishes to proceed.

Exclusive networks naturally include just one specialty pharmacy. In these networks, the manufacturer works directly with the sole pharmacy to dispense their product and manage all patients.

There are many advantages to each of these types of networks and deciding which to employ for drug commercialization will depend largely on the actual product and the potential market size of the patient population as well as storage requirements for the product.

There are many additional considerations that are required when planning for the overall distribution and dispensing of the product. For example, when making the previously discussed network decisions, manufacturers will also have to determine what type of pharmacies they plan to include in the network (independent, specialized, pharmacy benefit manager-owned, etc).

Another consideration along the same lines is whether the manufacturer will use a specialty hub service or not. Hub services provide significant patient and manufacturer support and can be quite meaningful for ensuring patient adherence and support.

Specific services often provided by a hub include benefits investigation, prior authorization processing, co-pay assistance, patient counseling and education, and significant data collection for the manufacturer.Investing in a hub service to ensure the highest levels of patient compliance and satisfaction may pay off greatly for a drug manufacturer.

Other early decisions that need to be made also involve the planned manufacturing and distribution process, including determining what partner company will actually produce the product, if a third-party logistics partner will be used to outsource elements of the distribution as well as which partner to choose, warehousing and fulfillment, and whether the company will be partnering with wholesalers or selling directly to pharmacies.

Another group of decisions that are required early in the commercialization process involve drug pricing and marketing. Companies will need to determine a pricing strategy early on for their new product.

This strategy should be driven by potential patient population size, costs associated with developing and creating the product, and the competition that exists in the market. Oftentimes, novel specialty drugs are priced initially based on what the market can bear as the research, development, and testing for these products is so significant.

This explains why specialty drugs are often so expensive and typically much more than more traditional types of therapies. Companies will also need to determine what type of pricing support they will offer to prospective patients, for example via co-pay assistance programs.

These programs, for obvious reasons, are quite common in the specialty space and make a big difference in the ability of patients to start and stay on these drugs, ultimately leading to better data for the company and, eventually, higher revenues. Another important consideration companies must consider is regarding the marketing plan for the product once available on the market.

Competition in the pharmaceutical industry can be quite strong, and if companies are not prepared with focused and strategic marketing strategies, they will likely have a hard time breaking into any disease state’s market, especially if there are other similar drugs currently or soon-to-be available.

In all these ways and more, we now see there are many decisions that need to be made early in the drug commercialization process that are vital to a product’s success once on the market. Considering the entire new drug development process, it is clear it truly takes an entire multidisciplinary team effort for a successful launch.

The entire process requires many individuals from scientists who develop and test new drug molecules to those focused on business, logistics, and strategy who work to successfully bring the drug to market.

About the Author

Molly Gombos earned her Doctor of Pharmacy degree from the University of Pittsburgh in 2014 and her Master of Pharmacy Business Administration (MPBA) in 2021 from the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Molly has spent the last 7 years working in community pharmacy, initially as a pharmacist and pharmacy manager and most recently working in pharmacy operations. Her current role is working in the patient safety and clinical space with focus on clinical decision support.