Specialty drugs are high-cost prescription medications typically used to treat chronic conditions. Most often, they require specialty handling and administration by the dispensing pharmacy and prescribing physician. At a glanceComplex Large Molecules and Biologic Drugs Biology-based molecules that structurally mimic compounds found within the body. High Cost per Prescription Average cost of $3,000 per month. […]
Specialty drugs are high-cost prescription medications typically used to treat chronic conditions. Most often, they require specialty handling and administration by the dispensing pharmacy and prescribing physician.
At a glance
Complex Large Molecules and Biologic Drugs
- Biology-based molecules that structurally mimic compounds found within the body.
- High Cost per Prescription
- Average cost of $3,000 per month.
Special Handling and Distribution
- Temperature control
- Hazardous-materials considerations
- Injection training
- Risk evaluation and mitigation strategy (REMS) counseling
- Data reporting
Multiple Dosage Forms
- Self-administered injectables
- Professionally-administered injectables / infusions
- Oral medications
Trends
The specialty-drugs market has experienced robust growth within the last five years, predominantly driven by average wholesale price inflation, increases in utilization / intensity, and new drugs entering the market. These factors have contributed to what today is estimated to be a 20 percent price increase for 2016, 2017, and 2018. What’s most startling is that while specialty drugs account for less than 1 percent of drugs dispensed for most employer groups, the corresponding spending makes up 25 percent of total costs, on average.
It is expected that specialty drugs will account for 40 percent of total drug spending by 2018. Furthermore, 40 percent to 50 percent of drugs in late-stage FDA approval are specialty drugs, representing potentially 200 new drugs in the next couple years. Thus, there is not a lot of relief on the horizon for employers and their benefit plans.
The role of the pharmacy benefit manager
Prior Authorizations — A strong pharmacy benefit manager (PBM) partner first helps clients manage the costs associated with specialty medications through a prior-authorization process. A robust prior-authorization process is intended to be used as a tool to ensure the medication is appropriate for the diagnosis. Along with requiring documentation demonstrating medical necessity, case reviews should also be done to be sure other options, where appropriate, have been tried. In some cases during the prior-authorization process, reviewers will identify an opportunity where possibly an alternative medication should be considered. Your PBM should then work with the physician to discuss the option(s) to see if they are appropriate for the patient.
Clinical Review / Intervention — In some instances, medications will be prescribed for conditions or at dosages outside of what is currently FDA-approved. Unless substantiated by convincing and proven medical and/or clinical data, these medications are considered experimental in nature in the treatment of the particular diagnosis and will be denied. In these cases, your PBM should conduct an in-depth review of the medication and evidence available before deciding whether the medication will be approved or denied. If the medication is in fact denied, a written letter explaining the denial is sent to both the physician and plan member. This letter should also outline the process of appealing the decision should the physician decide to do so. This extension of the prior-authorization process ensures that the right medication and dosage is selected for each patient.
The role of the dispensing specialty pharmacy
Clinical management — Your partnering specialty pharmacy should provide clinical-management programs that are designed to increase compliance and adherence to therapy. The clinical staff should have extensive training regarding the monitoring of side effects and manufacturer policies for each specialty medication that is dispensed. The goal of these programs is to educate patients on the medications they are taking, prevent adverse effects, identify potential side-effects, and promote overall health and wellness.
Comprehensive programs — Comprehensive programs should start with a basic assessment of each patient. From there, additional educational materials are identified that may help support a patient’s adherence to their medication regimen. At the same time, a patient can be scheduled for a follow-up assessment by a registered pharmacist or registered nurse. These follow-up assessments often take place at the time of coordination for delivery of the patient’s next refill, and they can also occur at an appropriate frequency based on the needs of the patient and/or the plan.
Robust fulfillment & delivery — The ideal specialty pharmacy will provide a full benefit and co-pay assistance investigation with every script that is filled. Value-adds include: free ancillary supplies such as sharps containers, syringes, alcohol swabs, and bandages. Due to the complexities of some specialty drugs, your specialty pharmacy should ship packages for next-day delivery to your home, physician’s office, or place of work.
Erison Rodriguez is the regional sales and marketing director for ProAct, Inc. — a pharmacy-benefit management company headquartered in DeWitt. It is a division of KPH Healthcare Services, Inc., which also operates Kinney Drugs. Contact Rodriguez at ErisonRodriguez@ProActRx.com