Molly C. Gombos, PharmD, MPBA

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 

 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.

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.

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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.  

Specialty Drug Commercialization Process and Considerations

For many patients, allergy season can be a dreaded time of year. Seasonal allergies affect 10%-30% of Americans on a yearly basis and can cause a plethora of symptoms, ranging from sneezing, runny nose, and itchy, watering eyes to shortness of breath, wheezing, swelling, and rash.

Luckily for these patients, there are many effective treatment options for mild to severe allergies available both OTC and by prescription. In fact, there are so many available treatment options that patients may often need guidance to choose the best products for their symptoms, which is the primary place the pharmacist comes in. There are many places in a patient’s allergy treatment journey where a pharmacist can plan an important role.

To begin, pharmacists are often involved in the management of a patient’s allergies from the very start. Many patients will approach a pharmacist for guidance on making a self-diagnosis based on symptoms.

Because seasonal allergies may affect patients differently year-to-year and even day-to-day, sometimes identifying these symptoms can be nuanced and difficult. Similarly, allergy symptoms often mimic the symptoms of a common cold.

Patients with new seasonal allergies may believe at first that they are suffering from a virus, and though treatment options may overlap in some ways for colds and allergies, correctly identifying the ailment and starting the most appropriate regimen immediately will certainly allow patients to feel better much sooner.

For most of these patients, allergies can be treated completely with OTC medications, requiring no visit to a physician and no prescription. This places pharmacists in a unique and important position for getting allergy patients started on the correct OTC therapies for their symptoms as there are so many products to choose from.

Because pharmacists are the most accessible health care providers and likely the most knowledgeable regarding OTC products, our role here is quite clear. Pharmacists can help patients acquire the right oral antihistamines or decongestants, steroid or decongestant nasal sprays, and/or eye drops based on symptoms.

Pharmacists can also help direct patients to potentially useful and cost-saving combination products that will address the correct symptoms while not overmedicating. Helping patients new to seasonal allergies deal with their symptoms OTC is not the only place a pharmacist plays a significant role in helping patients manage this disease state.

For many patients, OTC treatments will not successfully resolve their symptoms, requiring them to seek further care from either a primary care provider or an allergy specialist. These patients will likely receive prescriptions for rescue and/or steroidal inhalers, oral steroids, or leukotriene inhibitors.

For these patients, a pharmacist can assist in a more traditional sense by alleviating any burdens associated with adjudicating and dispensing their prescription medications. This role can also be significant because many of these medications, especially the inhaler products, can be quite costly and may often require prior authorization. Additionally, first-time inhaler users will greatly benefit from counseling from a pharmacist regarding how to properly use an inhaler to get the most from the therapy.

The pharmacist’s role in seasonal allergy management does not stop here. Although most patients will be able to use simple OTC remedies or commonly prescribed pharmaceutical products to manage their allergies, an appreciable sector of allergy patients need more specialized medications to properly treat this disease state.

These patients will likely see a specialist and will require less commonly used treatment options, such as immunotherapy injections, sublingual immunotherapy products, or biological medications. Many of these rarer and newer-to-market therapies often fall under the umbrella of specialty medications.

A specialty pharmacist’s role here is equally as important as in the other more common treatment scenarios. Patients who require specialty medications often need more support than other patients because of the complex nature of the medications as well as the specialty pharmacy process.

Although most allergy specialists are likely familiar with the specialty prescription dispensing process, some may not be. Therefore, it may take significant pharmacist intervention to ensure the prescription arrives at an appropriate specialty pharmacy where it can be successfully billed and dispensed. This can take several days or attempts, depending on the situation and the patient’s insurance.

Specialty pharmacists play a very important role in ensuring allergy patients can afford their medications which are typically quite expensive but might be less expensive after an insurance intervention or manufacturer coupon or rebate. Additionally, these patients will need thorough education and counseling regarding their new medications, which often have unique administration and/or storage requirements as well as more significant adverse effects.

In summation, there is clearly a wide range in the type of support patients will need in managing their seasonal allergies. Luckily for these patients, pharmacists are skilled and able to assist from the start of the process with symptom recognition and diagnosis to making OTC recommendations to helping those with severe symptoms manage a complex situation, as well as in the many situations in between.

Similarly to many other disease states or conditions, the role of pharmacists is vital and ever present in helping the many Americans who fight seasonal allergies navigate and successfully treat their symptoms.

 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.

Pharmacists can help patients with allergies acquire the right oral antihistamines or decongestants, steroid or decongestant nasal sprays, and/or eye drops based on symptoms.  