Understanding the Criteria: What Qualifies as a Specialty Medication?

October 9, 2025 •

4 min read

Specialty drugs now account for 51% of total prescription drug spending, despite being used by only about 2% of the population [1.3.1]. Understanding what qualifies as a specialty medication is crucial for patients navigating complex and chronic health conditions [1.2.1].

Quick Summary

A specialty medication is defined by its high cost, complexity, and use for chronic or rare conditions like cancer and multiple sclerosis. These drugs often require special handling, administration, and intensive patient monitoring [1.2.1, 1.2.4, 1.2.5].

Key Points

High Cost: A primary qualifier is a high price, with some drugs costing over $84,000 annually [1.3.1].
Complex Conditions: They treat complex, chronic, or rare diseases like cancer, multiple sclerosis, and rheumatoid arthritis [1.2.1].
Special Administration: Many are injectable or infused, often requiring administration by a healthcare professional [1.7.1, 1.7.3].
Intensive Support: Patients require 'high-touch' care, including monitoring and education from specialty care teams [1.2.5].
Specialized Distribution: These drugs are dispensed through specialty pharmacies, not typical retail pharmacies, due to special handling needs [1.2.7].
Biologic Nature: Many are biologics, derived from living organisms, which contributes to their complexity and cost [1.2.1].
Access Hurdles: Access often requires navigating a complex prior authorization process with insurance companies [1.6.3, 1.8.2].

Defining a New Class of Treatment

While there is no single, universally accepted definition, a consensus has formed around several key characteristics that classify a drug as "specialty" [1.2.5]. These are not your typical prescriptions picked up at a local pharmacy; they represent a category of advanced, high-touch medical therapies designed for complex, chronic, or rare health conditions [1.2.3, 1.4.2]. The number of these drugs has grown significantly, from only ten on the market in 1990 to over 400 today [1.4.6]. This class of medication is a primary driver of rising healthcare costs, with spending projected to reach $375 billion by 2025 [1.3.1].

Key Qualifying Characteristics

A medication typically falls into the specialty category if it meets several of the following criteria:

High Cost: This is one of the most consistent identifiers. The annual cost for a single specialty medication can average over $84,000 [1.3.1]. Medicare, for instance, uses a cost-based definition, classifying drugs with a monthly cost of $670 or more as specialty [1.2.4].
Treatment of Complex, Chronic, or Rare Conditions: These drugs are prescribed for serious and often life-threatening conditions such as cancer, rheumatoid arthritis, multiple sclerosis, cystic fibrosis, hemophilia, and hepatitis C [1.2.1, 1.4.3].
Complex Administration: Many specialty drugs cannot be taken as a simple pill. They are often injectable or require intravenous (IV) infusion, which may need to be administered by a healthcare professional in a clinical setting [1.7.1, 1.7.3]. Some can be self-injected, but this requires significant patient training [1.2.2].
Special Handling and Storage: Many specialty drugs are biologics—medicines made from living organisms—that require special handling, such as refrigeration to maintain a specific temperature range from manufacturing to administration (a process known as the "cold chain") [1.2.4, 1.7.6].
Intensive Patient Monitoring and Support: Patients using these drugs often need close monitoring by their healthcare team to manage side effects, ensure the medication is working, and adjust dosages. This is often referred to as a "high-touch" approach [1.2.3, 1.5.6].
Limited Distribution: To ensure proper handling and oversight, manufacturers may limit distribution to a small network of specialty pharmacies. These drugs are generally not stocked at most retail pharmacies [1.2.7, 1.6.1].

Common Conditions Treated by Specialty Medications

Specialty medications are at the forefront of treating many debilitating diseases, offering hope where few options existed previously. Some of the most common conditions include:

Oncology (Cancer) [1.4.3]
Inflammatory Conditions (e.g., Rheumatoid Arthritis, Crohn's Disease, Psoriasis) [1.2.1]
Multiple Sclerosis (MS) [1.4.2]
Hepatitis C [1.4.1]
Rare Genetic Disorders (e.g., Cystic Fibrosis, Hemophilia) [1.2.2, 1.4.3]
Human Immunodeficiency Virus (HIV) [1.2.2]

Examples of well-known specialty drugs include Humira® (adalimumab) and Enbrel® (etanercept) for autoimmune disorders and various oral and infused therapies for cancer [1.4.1].

Specialty vs. Traditional Medications: A Comparison

The differences between specialty and traditional drugs extend across the entire treatment experience.


Feature	Traditional Medication	Specialty Medication
Cost	Generally low to moderate	Very high, often thousands of dollars per month [1.2.1, 1.2.4]
Conditions Treated	Acute and common chronic conditions (e.g., high blood pressure, infections)	Complex, chronic, and/or rare diseases (e.g., cancer, MS) [1.2.3]
Administration	Mostly oral (pills, capsules)	Often injectable or infused, may require professional administration [1.7.3]
Distribution	Widely available at retail pharmacies	Limited network of specialty pharmacies [1.2.7]
Patient Support	Minimal; basic pharmacist counseling	Intensive; dedicated care teams, adherence monitoring, side-effect management [1.2.2, 1.2.5]
Handling	Standard room-temperature storage	Often requires special handling like refrigeration ("cold chain") [1.2.4]

The Critical Role of Specialty Pharmacies

Due to their complexity, specialty drugs are dispensed through specialty pharmacies, not regular ones. These pharmacies provide a comprehensive, patient-centric model of care [1.5.3]. Their services go far beyond just dispensing medication and include:

Care Coordination: Working directly with doctors and insurance providers [1.5.6].
Patient Education and Training: Providing instructions on self-injection techniques and managing side effects [1.2.2, 1.5.6].
Adherence Programs: Proactive outreach to ensure patients stick to their treatment schedule [1.2.5].
Navigating Financial Barriers: Assisting patients with the complex prior authorization process and connecting them to financial assistance programs from manufacturers or foundations [1.5.2, 1.5.5].

Navigating Access: The Prior Authorization Hurdle

One of the biggest challenges for patients is gaining access to these medications, primarily due to the prior authorization (PA) process [1.6.3]. A PA is a requirement from an insurance provider for advance approval before they will cover the cost of the drug [1.8.2]. Insurers use this process to control costs and ensure the medication is medically necessary [1.8.4]. This process can be a significant barrier, causing delays in treatment that can last from days to weeks [1.8.3]. In fact, more than half of physicians report that the PA process often or always delays access to necessary care [1.6.3]. Specialty pharmacy teams play a crucial role in managing this administrative burden for both patients and doctors [1.5.2].

Conclusion

What qualifies as a specialty medication is a combination of factors, with high cost, complexity, and the need for high-touch patient support being the most prominent. These advanced therapies are vital for managing some of the most challenging diseases today. While they bring new hope, they also introduce significant challenges related to cost and access. The specialized ecosystem of specialty pharmacies and dedicated care teams has evolved to help patients navigate this complex landscape, ensuring they can safely and effectively access these life-changing treatments.

For more information from an authoritative source, you can visit the National Association of Specialty Pharmacy (NASP).

Frequently Asked Questions

Specialty medications are expensive due to high research and development costs, complex manufacturing processes (many are biologics made from living cells), a lack of therapeutic alternatives, and the extensive patient monitoring and support required [1.4.1, 1.2.4].

Typically, no. Specialty medications require special handling, storage, and expert counseling, so they are distributed through a limited network of specialty pharmacies [1.2.1, 1.2.7].

A biologic is a type of drug produced from or containing components of living organisms, like proteins or sugars. They are created through highly complex manufacturing processes and include treatments like vaccines and cell therapies [1.2.1, 1.4.5].

Prior authorization is a process where your doctor must get approval from your health insurance company before it will agree to cover the cost of the medication. It's used to verify medical necessity and control costs, but can cause treatment delays [1.8.2, 1.8.4].

While some are oral, most specialty drugs are administered via injection or intravenous (IV) infusion. This may be done by a healthcare professional at a clinic or, after training, self-administered by the patient at home [1.7.3, 1.7.4].

Specialty pharmacies offer a high level of support, including 24/7 access to trained pharmacists, patient education, injection training, side-effect management, medication adherence reminders, and help with navigating insurance and financial assistance programs [1.2.2, 1.5.4, 1.5.5].

For biologic specialty drugs, there are no identical generics. Instead, there are 'biosimilars,' which are highly similar to an existing FDA-licensed biologic. Biosimilars are often less expensive but may not be automatically interchangeable like traditional generics [1.2.1].

Common challenges include the high cost of the therapy, navigating complex insurance requirements like prior authorizations, and logistical issues related to administration (e.g., traveling to infusion centers). These barriers can lead to significant delays in starting treatment [1.6.1, 1.6.2].