Specialty drugs are generally more complicated to manufacture, distribute, dispense and deliver (administer) when compared to traditional prescription drug products readily available in community-based and retail pharmacies. Below is an overview of important elements in this process:
Distribution
Drugs, biologics and other pharmaceutical products produced by manufacturers are made available through a variety of distribution channels. Distributors of specialty drugs are typically held accountable for patient safety by manufacturers as required by the FDA through REMS.
Dispensing
Specialty pharmacies provide broad-based distribution of specialty drugs to health care delivery systems and are operated by pharmacy benefit managers, retail chains, health plans, pharmaceutical wholesalers, physician practices, hospital systems, and other organizations. There are also many independent specialty pharmacies. A specialty pharmacy is accountable for patient safety and provides extensive care management, counseling and one-to-one patient education, case management and coordination of care with other stakeholders involved in a patient’s treatment. In the U.S., the number of accredited specialty pharmacies has more than doubled since 2015.
Manufacturers can also play a significant role in limiting the number of specialty pharmacies that will have access to a drug for distribution. So-called “limited distribution” drugs (most often for rare conditions) may be sourced to only one or as many as three pharmacies for the entire country.
Site of Care for Drug Administration
Specialty drugs are administered in a variety of ways. Some require injection or intravenous infusion by a health care professional who can monitor the patient to ensure their safety. This often takes place in a traditional medical setting, but can also occur in a non-traditional site-of-care environment.
Specialty drugs may also require specific diagnostic and monitoring tests before or after they are administered. Additional drugs may be required prior to receiving the dose to augment safety and efficacy of the therapy such as nausea, vomiting and blood cell count enhancement.
Some specialty drugs, including oral tablets, injectables and inhalants can be self-administered by the patient. However, there are various site-of-care options where specialty drugs can be administered and there can be significant cost differences between options depending on network contracts and the reimbursement formula agreed upon. Not all specialty drugs may have an option for use at different sites of care or have other REMS limitations.
Examples of site of care options and cost differences include:
- Hospital outpatient facility ($)
- Physician’s office (affiliated with a hospital outpatient facility ($)
- Physician’s office (affiliated with a hospital outpatient facility ($)
- Physician’s office ($)
- Freestanding infusion center or clinic ($ – $)
- Worksite medical clinic ($ – $)
- Home-based mobile infusion therapy provider ($ – $)
- Retail clinic ($ – $)