Module 9
9.1: Introduction to Specialty Medications
In general, specialty medications are high cost medications used for treating complex disease
... [Show More] states. They can be
challenging to both manufacture and administer, and they often require significant patient education and close
monitoring to ensure their safe and appropriate use. Although specialty medications were once a very small piece of the
pharmaceutical industry, there has been a significant change over the last 20 years and especially within the last decade.
Specialty medications are now the fastest growing segment of the pharmaceutical industry. Common characteristics
associated with specialty medications are listed in Table 9.1.
Table 9.1 Specialty Medication Characteristics
High Cost Potential for limited or exclusive availability for
distribution
Complex treatment regimen that require ongoing
monitoring and patient education
Treat rare diseases
Special handling, storage, or delivery requirements Treat diseases known to have long term or severe side
effects or increased fatality
Biologically derived and available in injection, infusion, or
oral form
Payers may define what they consider to be a specialty
medication for reimbursement and contracting purposes.
With the increase in specialty medications over the last two decades, a whole new approach to dispensing these
medications emerged called specialty pharmacies. Generally, specialty medications are not available at typical
community pharmacies, so patients must obtain them through specialty pharmacies. There are many reasons for this:
some practical, some financial, and some clinical. Traditional retail pharmacy is not designed to handle these complex,
costly medications. First, the high cost alone, in many cases, would prohibit retail pharmacies from stocking the
medication. Second, the often-busy nature of a retail pharmacy does not align itself well with being able to appropriately
manage and support the needs of patients with complex disease states. For these reasons, the first specialty pharmacies
began in the early 2000s. Specialty pharmacies are typically required, through their contract with health insurance
companies, to meet unique requirements that are not part of their contracts with retail pharmacies. Examples of these
requirements are listing in Table 9.2.
Table 9.2 Examples of Specialty Pharmacy Services
Coordinating care and facilitating the drug access Case management- disease state management
Facilitating mail order delivery logistics Product device training when applicable
Working with health insurance to determine coverage
and help coordinate any requirements of the insurance
company
Data management of technical and clinical patient care
services.
Investigating patient assistance programs for patients
without insurance or lack of coverage
Call center development
Patient Experience
A patient receiving a prescription for a specialty medication should be aware that the process for getting the medication
is going to look different than the normal retail pharmacy experience. However, the system is designed so that the
patient has the best chance of successfully obtaining and using the medication safely and appropriately. The prescription
would first be sent to the specialty pharmacy. The specialty pharmacy then takes responsibility for making sure the
patient gets the medication, understands the risks and benefits, is able to afford it, able to take it appropriately, and will
follow through with any necessary monitoring. The patient may be connected with a case manager that will call them on
a monthly basis to make sure there are no issues with the medications, check to see if they had any required monitoring [Show Less]