What is a specialty drug?

Overview

Overview

The definition of a specialty drug continues to evolve as the specialty drug pipeline advances and expands. These drugs are best defined by the full range of each product’s attributes, rather than solely by cost and route of administration. A specialty drug possesses any number of these common attributes:

  • Prescribed for a person with a complex or chronic medical condition, defined as a physical, behavioral, or developmental condition that may have no known cure, is progressive, and/or is debilitating or fatal if left untreated or under-treated;
  • Treats rare or orphan disease indications;
  • Requires additional patient education, adherence, and support beyond traditional dispensing activities;
  • Is an oral, injectable, inhalable, or infusible drug product;
  • Has a high monthly cost;
  • Has unique storage or shipment requirements, such as refrigeration; and
  • Is not stocked at a majority of retail pharmacies.
Evolving Pipeline

Evolving Pipeline

Pharmaceutical research and discovery have undergone a dramatic shift in the last decade. Historically, manufacturers focused research efforts on small-molecule drugs that treat common conditions like high blood pressure, acid reflux, and pain.

However, market forces and developments in science, manufacturing processes, and biotechnology have led drug companies to focus on creating more complex specialty drugs, many of which are biologics, that treat diseases such as multiple sclerosis, rheumatoid arthritis, hepatitis C, and certain forms of cancer. Recently, companies have begun developing specialty drugs for more common conditions, such as high cholesterol.

Specialty drugs are often more targeted and effective than the broad-spectrum drugs they are replacing as first- or second-line treatments. When introduced to the market, these drugs typically have little or no competition, therefore allowing manufacturers to set high prices.

Complex Logistics

Complex Logistics

Early versions of specialty drugs were typically administered via injection or infusion in a physician’s office, clinic, or infusion center. Today however, many specialty drugs are provided as injections or oral medications that can be self-administered by patients in their homes.

These drugs require complex patient care and logistics. Since biologic specialty drugs are made of delicate sugars, proteins, nucleic acids, and living entities such as cells and tissues, they are very fragile drugs, susceptible to heat and microbial contamination. Therefore, they require special administration, monitoring, and handling.

Stocking and dispensing these fragile biologics often requires complex distribution channels, including climate-controlled shipping and meticulous storage with specific protocols and documentation. Patient safety is the biggest concern.

Complex Patient Monitoring

Complex Patient Monitoring

PBMs and specialty pharmacies offer patients a comprehensive suite of clinical programs that promote safe and effective medication therapy to improve health. Through these programs, specialty pharmacies give patients the information and clinical support they need to make decisions about their health care and derive the most value from their treatment.

Using a holistic approach, specialty pharmacies provide high-touch comprehensive support for patients with complex or chronic conditions to improve medication adherence and compliance, including:

  • Medication adherence programs
  • Medication Therapy Management
  • Drug utilization reviews

These programs are designed to improve patient outcomes and reduce the overall cost of care. By leveraging new technologies, these payer and PBM-affiliated specialty pharmacies improve patients’ experience and provide multiple avenues to increase patient engagement. Through these specialty pharmacy programs, patients receive tailored care for high-risk and high-cost conditions.

Why a specialty pharmacy?

Why a specialty pharmacy?

Specialty pharmacies were established in direct response to the industry’s need to better procure, store, and dispense specialty drugs, as well as better manage therapy for patients on specialty drugs. Among other things, these pharmacies specialize in the unique storage and shipping requirements that oral, injectable, inhalable, and infusible products require.

Pharmacists and personnel working for these specialty pharmacies provide patient education and clinical support beyond the capabilities of a traditional retail pharmacy.

Since retail and manufacturer-affiliated pharmacies are not typically equipped to manage the full range of products and services that PBMs and payers require for the distribution and management of specialty drugs, they rely on the technology and expertise of specialty pharmacies to properly dispense these drugs.

Visit the What services do specialty pharmacies provide? card stack to learn more.

Resources & References

Resources & References

  • Specialty Pharmaceuticals: Policy Initiatives to Improve Assessment, Pricing, Prescription, and Use.Health Affairs. October 2014.
  • What’s Special About Specialty Pharmacy? Express Scripts. July 2015.
  • Specialty drugs and pharmacies, Report 355. National Center for Policy Analysis. May 22, 2014.
  • Issue brief: Specialty drugs – Issues and challenges. America’s Health Insurance Plans. June 2014.
  • White Paper: The Management of Specialty Drugs. sPCMA. February 2016.