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Special attention for specialty pharmaceuticals

Specialty pharmaceuticals are the talk of the town: in 2016, specialty sales rose to $181 billion and 50% of drugs sold in the United States are expected to be specialty pharmaceuticals in three years. Specialty drugs are defined, in part, by their high cost: often $1,000 or more per month — and spending on them is growing 15% to 20% a year.

The high price tag is derived from various influences, but generally, the drugs treating complex conditions are advanced in composition and often have unique handling needs. The latter is where specialty pharmacy comes in: the experts manage requirements for quick delivery, temperature-controlled storage and shipping, and biologic demands such as injection or infusion administration. The pharmacists, in turn, also manage the increased human needs of the advanced treatment regimens, including patient and caregiver education, chronic disease symptom management — sometimes with the addition of other pharmaceuticals such as controlled substances — and complex consultation scenarios.

Who’s involved
Patients can’t always simply pick up these cutting-edge pharmaceuticals — whether taken orally, injected or infused — at their local retail pharmacy. Specialty pharmaceuticals are prescribed mainly for patients with serious chronic diseases and rare genetic conditions such as multiple sclerosis, cancer, rheumatoid arthritis, severe dermatitis, psoriasis, inflammatory bowel disease, HIV, hemophilia and hepatitis C. These patients, who are able to reap the benefits of advanced therapeutics, require more than a stop at the pharmacy counter: specialty pharmacists must carefully explain and review proper administration, side effects, and other regimen demands and considerations. Specialty treatments are often quite different from patients’ previous or existing regimens.

The specialty pharmacists themselves work in a variety of practice settings under various ownership entities. About half of all specialty pharmacies are independently owned, while others are under the umbrella of healthcare providers, health plans, or pharmacy benefit managers (PBMs); a small percentage are wholesalers or retailers. The various channels are jockeying for control of distribution in this specialty market.

The task of distribution is not a simple one: disease journeys are complex and both pharmacists and clinicians must ensure patients have the appropriate understanding, dosage, and coping mechanisms to handle the protocol and the condition at large.

What’s involved
When discussing specialty pharmaceuticals, one topic comes up again and again: high costs. Health plans and PBMs pay particular attention to the use of specialty drugs, which also have a growing list of restrictions and requirements both at the federal and state level. Prescriber validation, substance verification and reimbursement claims collection need to become part of the specialty pharmacy daily workflow if it is to manage risk and ensure payments for ultra-costly therapies. This operational and compliance aspect will only become more important as more specialty medications become available and there are more patients to serve.

Prescription validity verification
While large, chain pharmacies may have systems in place for prescription validation, many specialty pharmacies currently rely on “mix-and-match” data and technology that have glaring gaps and inefficiencies. As specialty pharmacy grows, it should be able to perform real-time, comprehensive checks within existing workflows. The purpose of the checks is not only to verify prescriptive authority but also to mitigate the risk of regulatory fines, and maintain compliance with federal licensing, state credentials and controlled substance regulations.

Prescriber verification is also a vital step in ensuring patient safety. Specialty pharmacists need to know who the prescribers are and if they can authorize controlled substances, which sometimes accompany therapies for complex diseases like cancer.

Next steps

What was once just a tiny segment of the pharmaceutical industry is now promising widespread innovation and further advancement. As more and more specialty drugs enter the market, pharmacies must consider how data-driven validation will enable a growth and operational success. This is not the place for pharmacies to falter on compliance or verification: patients requiring high-touch care first require trust.
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