A Closer Look: Understanding Specialty Medications

A Closer Look: Understanding Specialty Medications
March 11, 2025 Sue Riordan
Woman reading pill bottle in front of computer

Specialty medications are part of a growing trend in health care. Recent data suggests they account for close to 50 percent of overall prescription drug costs. In recent years, the number of patients relying on specialty medications has also been increasing. Typically, specialty medications are used to treat to rare, chronic or complex conditions, from certain autoimmune and genetic disorders to cancer. Here, we’ll take a closer look at understanding specialty medications, why they’re important and how they differ from other prescription medicines.

What is a specialty medication?

A specialty medication is a drug approved by the Food and Drug Administration (FDA) to treat complex or chronic conditions. Examples of conditions they can treat include rheumatoid arthritis, multiple sclerosis (MS), psoriasis, rare genetic disorders and cancer. Most often, specialty medications aren’t taken in pill form, they are injected or infused. Because of this, patients who take specialty medications may need extra monitoring and support. Due to their complexity, specialty drugs are usually very high in cost.

What classifies a drug as specialty?

The FDA may classify a drug as a specialty drug if:

    • It’s used for a complex medical condition. This means a drug may require a custom medication management program, which includes medication use review, patient training, coordination of care and adherence management for successful use. Certain medicines (“orphan drugs”) may be used to treat rare, genetic diseases which occur in less than 200,000 people in the U.S. (known as “orphan diseases”).
    • It’s high in cost. Specialty drugs can be very expensive, often exceeding a cost of $1,000 per month.
    • It requires special administration, handling, shipping or storage. Specialty drugs may require special handling, storage or shipping requirements. Some also need to be specially administered by a trained clinician. Specialty drugs are usually dispensed through a specialty pharmacy, not a traditional retail pharmacy.
    • There’s limited access or it requires a certified health care professional. Sometimes specialty drugs are part of a Risk Evaluation and Mitigation Strategy (REMS) program mandated by the FDA for safety reasons. Therefore, a certified individual may be needed to prescribe, administer or dispense the medication.
    • It may require prior authorization (PA) before being covered by an insurance plan. A doctor may need to provide more information to an insurance company or pharmacy benefit manager (PBM) on why a member needs a specialty medication.
Specialty versus retail pharmacies

Retail pharmacies, also called community pharmacies, focus on supplying prescription medications to treat common health conditions. This means providing over-the-counter (OTC) medicines to the general public for everyday ailments or concerns. They may dispense medicines for things such as high blood pressure, allergies, infections and pain relief.

Specialty pharmacies primarily dispense medications to treat serious health conditions that require complex drug treatments. This means providing drugs requiring more clinical support, ones higher in cost and those needing special handling or administration. Specialty pharmacies often offer clinical services that go above and beyond what retail pharmacies provide. This includes offering specialized support to optimize treatment for people living with complex, chronic and rare conditions.

 Did you know?
    • Specialty pharmacies stock many of the drugs not usually found in a local community or traditional retail pharmacy.
    • Some medications are required by the FDA to be prescribed and dispensed only by certified doctors and pharmacists. Specialty pharmacies may provide these drugs, along with required education and monitoring.
    • A specialty pharmacy takes a high-touch approach to patient care. They have a dedicated, trained staff of professionals to help review, dispense and monitor medication treatment in a personalized way. They can also connect patients with financial assistance programs to help with costs.
    • Medications can oftentimes be conveniently mailed to patients. Specialty pharmacies can deliver to homes or a physician’s office in many instances.
    • Patients who receive specialty medication treatments require continuous and ongoing patient education, monitoring and medication management.
We Can Offer Extra Support

Our teams at Meritain Health Pharmacy Solutions (MPS) make it easier for patients to manage their conditions and enjoy a better quality of life. This is done through the experienced support of our dedicated clinical teams and programs. Specifically, the CARE Program included through MPS is a proactive effort to guide members and clients towards cost savings and assist with management of specialty medications. It’s a no-cost program, meaning it doesn’t cost anything extra and has no access fees.

Resources:

CVS Specialty; https://www.cvsspecialty.com/faq.html

American Pharmacists Association; https://www.pharmacist.com/Practice/Patient-Care-Services/Specialty

National Association of Specialty Pharmacy; https://naspnet.org/wp-content/uploads/2019/08/What-Is-Specialty-Pharmacy-090718.pdf