There is no one widely accepted definition of what a specialty medicine entails. The definition of a specialty medicine can vary depending on the person, organization, or other entity.
A specialty medicine can also take many forms. Some are taken orally, others are injected, a variety are implanted, and others are applied topically.
Yet, in general, specialty medicines are considered across the disciplines of medicine and pharmacy to simply be high-cost medicines that are typically utilized to treat complex medical conditions. They often can also be difficult to administer, require significant patient monitoring, and/or necessitate special storage and handling conditions.
There are many different disease states and conditions that specialty medicines can be used to treat. Some examples of these are Crohn’s disease, hemophilia and other bleeding disorders, hepatitis, HIV/AIDs, infertility, multiple sclerosis, ophthalmic disorders, rheumatoid arthritis, ulcerative colitis, many different types of cancers, and countless others.
In many cases, patients with these more complex disease states require additional treatment options for their condition(s) aside from what can be found in an everyday pharmacy. So, drug manufacturers and the United States Food and Drug Administration (FDA) together continue to produce and approve, respectively, more and more medicines that can be used to treat these complex conditions.
Due to expensive and extensive research and development (R&D) processes (there are large costs for developing and meeting the regulatory approval requirements for a new drug), smaller patient pools, patent concerns, etc, the finances behind getting a specialty medicine to the market can be astronomical for manufacturers. As a byproduct of this, the post-approval cost of a specialty medicine becomes very expensive for patients and insurance entities alike.
Access to care is one of the biggest barriers to obtaining specialty medicines. This is most commonly due to the sheer cost of these medications. A common reference parameter that is used amongst healthcare professionals is that specialty medicines can cost $1,000 per month or more. However, most specialty medicines far surpass this amount; in 2017, the average annual cost for a specialty medicine was $78,781.
Insurance companies and pharmacy benefit managers are key players in helping patients obtain access to specialty medicines. Specialty medicines are commonly administered at a hospital or clinic and/or they are dispensed from a specialty pharmacy. However, this is not the focus of the current article (that will be discussed in a future Pharmacist Consult article).
Another access to care challenge comes via the bottleneck of limited distribution networks. Unlike non-specialty medicines (which are most medicines found at everyday pharmacies), it is common for a specialty medicine to be sourced through only a small number of distributors. Because of this, it is commonplace for only certain specialty pharmacies/organizations to be able to dispense and/or administer these products.
It is arduous to find a singular list that describes every FDA-approved medicine that is considered to be a specialty medicine. To see specific examples of specialty medicines, it helps to instead reference different lists (formularies) of specialty medicines. Some examples are listed below:
- This formulary from CVS Specialty, a subsidiary of CVS Health
- This formulary from Aetna, a subsidiary of CVS Health
- This formulary from Accredo, a subsidiary of Express Scripts
- This formulary from Cigna
- This formulary from Blue Cross Blue Shield (BCBS) of North Carolina
- This formulary from MagellanRx Specialty Pharmacy, a subsidiary of Magellan Health
Over the past few decades, the specialty pharmacy landscape has developed significantly. Ever since the Orphan Drug Act of 1983, which helped to increase profitability for manufacturers through tax benefits and market exclusivity agreements for producing medicines for rare disease states, more and more specialty medicines have been produced. The FDA Modernization Act and the FDA Safety and Innovation Act have helped to continue this progression.
The number of specialty medicines on the market has increased from less than 30 medicines in the early 1990s to now more than 500 specialty medicines in 2020. This number will only continue to increase as times goes on, so it’s important to have a basic working background of what a specialty drug entails.
References:
- 2020 Specialty Pharmacy Survey Snapshot. LexisNexis Risk Solutions. Accessed 14 September 2020.
- Kober S. The Evolution of Specialty Pharmacy. Biotechnology Healthcare. Published August 2008. Accessed 14 September 2020.
- Galante D, Blandford L. Accreditation Explosion Among Top Specialty Pharmacy Trends. J Clin Pathways. 2018;4(7):35-38. doi:10.25270/JCP.2018.09.00037.
- Raper A. The Rise of Specialty Medications: Hope for Patients, Hurdle for Health Care. Published 14 March 2019. Accessed 14 September 2020.
- Meyer L. Something Has to Give: Balancing Specialty Drug Cost With Value. Pharmacy Times. Published 11 March 2019. Accessed 14 September 2020.
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