Over the last year and a half, the FDA approved several new formulations of existing medications that are commonly prescribed in workers’ compensation claims. Some of these new formulations have already been released to the market by their manufacturers and others are expected to be available later this year.
Newly formulated medications which are currently available include:
- Butrans Transdermal Patch is the first non-injectable formulation of Buprenorphine approved for the treatment of moderate to severe pain in patients requiring around-the-clock pain management on a chronic basis. One patch is applied weekly, which will be an advantage for those patients now taking pain medications requiring multiple doses throughout the day by supplying the continuous release of medication to control the patient’s pain.
- Sprix (Ketorolac) Nasal Spray is approved for the treatment of moderate to severe pain, but should not be used for longer than five consecutive days due to the risk of increased adverse effects. This product would be an appropriate alternative for patients who are using the injectable formulation, but will likely not be utilized as frequently as the oral/injectable forms due to its considerably higher cost.
- Duexis (Ibuprofen/Famotidine) Tablet is a new combination anti-inflammatory, anti-ulcer medication approved for the treatment of rheumatoid arthritis and osteoarthritis. Its utilization will likely remain low since there is no clinical advantage to prescribing it over similar OTC medications and would only serve to increase costs for the workers’ compensation carrier.
- Oxecta (immediate release Oxycodone) is the first abuse-resistant formulation of immediate release Oxycodone monotherapy approved for the management of acute and chronic moderate to severe pain. It has been formulated to turn to a gel-like substance when crushed or dissolved to prevent it from being inhaled or injected.
- Intermezzo (a lower strength sublingual Zolpidem) is approved for the treatment of insomnia with “middle-of-the-night” awakening. This formulation will allow for a more rapid onset of action; however its clinical significance has yet to be established.
New medication formulations that have been approved by the FDA, but not currently available are:
- OP Oxycontin (long acting Oxycodone) and the new Opana ER (long acting Oxymorphone) are both tamper-resistant formulations of existing opioid pain medications. These medications were reformulated to prevent them from being cut, crushed, chewed, or dissolved to release more medication. These new formulations should lead to a decrease in abuse, misuse, addiction and overdose, all of which can drive up prescription as well as medical costs.
- Fortivo XL (Bupropion extended release) is approved for the treatment of major depression and is available at the recommended maximum daily dose of 450mg in a single dose tablet. The availability of a single dose tablet could lead to increased compliance with a more effective clinical outcome than when the patient is prescribed Bupropion formulations requiring multiple doses.
The medications previously mentioned are all Brand name medications, but a generic formulation of Quetrapine Fumarate was also recently approved. Quetrapine Fumarate (generic immediate release Seroquel) is approved for the treatment of bipolar disorder, mania, schizophrenia and depression. Brand Seroquel was listed in the top 20 brand medications by total transactions in the workers’ compensation industry in the PMSI 2012 Annual Drug Trends Report. Therefore, the availability of the generic formulation will definitely have an impact on prescription costs within the workers’ compensation industry.
2012 is already proving to be a busy year for new medication releases and formulations. As the year progresses, PMSI will continue to keep the industry informed of prescription drug updates and how they will impact workers’ compensation claim costs.