In addition to having a major impact on patient health outcomes, medications can have significant cost implications for all stakeholders; insurers and employers need to work with their pharmacy benefit managers to ensure that the right patients are getting the right medications at the right time.
The annual spring ritual of pharmacy benefit managers (PBMs) releasing their drug trend reports has begun, and one area of great interest has always been in answering the question, “What are my top drugs?”
Over the last few years, we have seen a greater number of specialty medications find their way into payers’ top 10 lists, and drugs for inflammatory or autoimmune diseases, such as Embrel and Humira, have increasingly become some of the most prevalent. Data from Prime Therapeutics show that use of this class of medications increased by over 10% from 2015 to 2016.1
Further, the recently released Express Scripts 2016 Trend Report stated that, for their clients, the trend for this class rose by 26.4%.2
Today, there are only 15 medications that can be classified as anti-inflammatory drugs. Drugs for anti-inflammatory diseases will find new competitors over the next few years, yet 10 years ago, there was a paucity of medications to treat these significant illnesses. As more medications become available, there will be more choices for the patient and payers to choose from.
However, it is not only new brand medications coming to market worth considering; an increasing number of biosimilars will also become available. It is unknown at this time how biosimilars affect this class of medications and its associated trend, but the 3 most common drugs—Remicade, Humira, and Enbrel—will soon have biosimilar versions available.
When looking at drug trends, most organizations focus on the individual components of drug utilization, cost, and mix. Another study from Prime Therapeutics found that there was a 38% increase in use between 2012 and 2015 for anti-inflammatory medications.3
One of the reasons commonly thought to increase the use of anti-inflammatory medications was the change in healthcare provider' decision to begin using these medications earlier in a patient’s treatment. Subsequently, this created a situation where higher-cost medications were being utilized without knowing if lower-cost medications would be effective.
In addition to an increase in utilization and mix of the medications used, the costs of these medications also increased by 102% during the same period. The last year alone showed a 15% increase in unit cost (ESI Trend Report 2016)2; thus, the inflationary price increase caused additional financial impact.
In particular, the anti-inflammatory class of drugs will soon see a number of biosimilars enter the market. Last fall, Inflectra, a biosimilar for Remicade, came to market; to date, the uptake of this biosimilar has been in the low single digits.
Biosimilars for 2 other drugs in the class—Enbrel and Humira—were approved by the FDA, but have not yet been launched due to patent disputes. There is a great deal of contention on whether biosimilars will make a significant difference in the utilization and cost implications in this class and across the board in the US pharmaceutical market. In the European market, where biosimilars have existed for more than 10 years, the experience has been mixed: although there has been moderate uptake, the greater effect has been on the muting of brand costs.
What does this all mean?
1. You, as the insurer or employer, need to work with your PBM to ensure that the right patients are getting the right medications at the right time. Guidelines from societies such as the American College of Rheumatology help to focus recommendations—23% of which are strong and 77% are conditional—to promote better decision making on proper courses of treatment and to take into account the needs of the patient.4 Additionally, employers and insurers should put processes in place (eg, prior authorization or step therapy) to make sure that the medications being prescribed are used at the appropriate times.
2. Initial fill strategies should also be implemented. It is not unusual when a new medication is started that it is found to be either ineffective or to cause adverse effects that create a situation where the medication needs to be discontinued. In that situation, costs are incurred unnecessarily and medication is wasted.
3. By putting in place an initial fill program, you create a check in between the patient and their physician at end of the second week of the new medication to assure that the medication is working and that there are no side effects that would require changing the medications.Have a biosimilar strategy in place. Although there are only a few biosimilars on the market, it is not too early to work with your PBM to determine how biosimilars will be handled in your plan design. You will want to think about several things, including:
a. Whether biosimilars will have their own tier or be on a preferred tier.
b. Whether biosimilars will be utilized as part of a step therapy.
c. Whether patients will be required to switch to a biosimilar.
d. Whether patients already on a name brand specialty drug be grandfathered on their drug.
Please be clear, I am not suggesting that anti-inflammatory medications are not valuable; rather, I believe that these medications have been found to be quite valuable clinically, and in some cases, they have changed the outcomes of patients with significant health conditions.
Instead, I am stating that these medications can have significant cost implications to all stakeholders, and we need to make sure that we are utilizing them in the right way.
1. Prime Therapeutics research finds nearly half of members discontinue costly rheumatoid arthritis drug after one year [press release]. St. Paul, MN: Prime Therapeutics; September 27, 2016. https://www.primetherapeutics.com/en/news/pressreleases/2016/xeljanzamcp-release.html. Accessed February 2017.
2. 2016 drug trend report. Express Scripts website. https://lab.express-scripts
.com/lab/drug-trend-report. Published February 2017. Accessed February 2017.
3. Prime Therapeutics finds autoimmune specialty drug spend has doubled, account for 10 percent of drug expenses [press release]. St. Paul, MN: Prime Therapeutics; September 30, 2016. https://www.primetherapeutics.com/en/news/pressreleases/2016/autoimmuneamcp-release.html. Accessed February 2017.
4. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2016;68(1):1-25. doi: 10.1002/acr.22783.