Roy Franco
November 6, 2010

By Alvena Ferreira, RN, CCM, CNLCP, MSCC and Katie A. Fox, MSCC

On November 5, 2010 the FDA approved Cymbalta (duloxetine hydrochloride), an antidepressant, to treat chronic back pain as well as osteoarthritis. The dosage that can be prescribed is 60 mg/day.  Previously, Cymbalta was only authorized for the treatment of diabetic peripheral neuropathy, generalized anxiety disorder, and fibromyalgia.  The expansion of health conditions this drug now covers will impact the pricing of a Workers’ Compensation Medicare Set-aside Arrangement (WCMSA).

The anticipated increase cost is because of the previously limited way Cymbalta was allocated in the WCMSA.  Centers for Medicare & Medicaid Services (CMS) policy requires included drugs to be used for FDA approved purposes only.

For a Part D drug to be covered by Medicare, and thus included properly in a WCMSA, the drug should be prescribed for an outpatient use that is approved under the Federal Food, Drug, and Cosmetic Act.  See CMS Memo, 5/14/2010.

As a result, Cymbalta was excluded from WCMSAs unless the compensated health condition included diabetic neuropathy, anxiety disorder, or fibromyalgia.   Although Cymbalta provided a therapeutic benefit for back pain and osteoarthritis, it could not be included in the WCMSA.  Its off-label use would not be accepted.  That all changed with this FDA announcement.

Going forward, Cymbalta can now be included (and allocated accordingly) in a WCMSA, where it involves a compensated condition for chronic back pain or osteoarthritis.  Furthermore, the allocation will probably cover the Claimant’s lifetime as this drug is now approved for chronic pain treatment.

How much could this increase the cost of a WCMSA?  Significantly!  The 2010 Redbook Average Wholesale Price (AWP) for Cymbalta 60 mg per day is approximately $144 per month or $1728 each year. If Claimant’s life expectancy is 20 years, then this would add $34,000 to the overall cost of the WCMSA.

However, that may not be the only cost.   For example, Cymbalta has known serious side-effects.  One is the potential for possible liver damage. Thus, it would be appropriate to include a yearly chemistry test as part of the WCMSA, or another $15-20 per year.

Generics may provide some price relief if it were available.  However, patents for Cymbalta won’t expire until 2013.  Even when it does come to market, the name brand may still be required as part of the WCMSA allocation.  That’s because where the physician can actually specify the name-brand medication in writing, the claimant or his attorney can make the same demand in the WCMSA.  This is the rule according to CMS Memo, dated 4/22/2010.

Is it still possible to control the costs of the WCMSA that involves Cymbalta?  Absolutely!  While the added treatment use for Cymbalta has expanded there are tools that can be used to control it.  Treatment duration letters as well as proactive case management are key.   Also, annuities can play a significant role.  Let the Medicare Set-aside Arrangement professionals at Franco Signor LLC show you how.  It is important your MSA vendor stay informed to anticipate these costs and work with you on strategies to mitigate it.