Brand alternative to opioid-induced constipation medication Amitiza® (lubiprostone) arrives to market

A lower price is now available for a common workers’ compensation medication as its brand alternative hit store shelves in January. Amitiza^® is approved by the U.S. Food and Drug Administration (FDA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain and for chronic idiopathic constipation (the cause of constipation is unknown) in adults, at a standard dose of 24 mcg twice daily. Amitiza is also FDA-approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older, at a standard dose of 8 mcg twice daily.

Amitiza (lubiprostone) is considered second-line therapy for treatment of OIC and is not recommended until after non-pharmacologic therapies (including increased dietary fiber intake, adequate hydration, and regular exercise) have been established and first-line medications have failed to alleviate OIC symptoms. First-line agents for OIC include osmotic laxatives (e.g., polyethylene glycol and lactulose) and stimulant laxatives (e.g., senna or bisacodyl). See the price comparison between brand Amitiza and the new brand alternative, lubiprostone, below.

Potential effect on Workers’ Compensation Medicare Set Asides (WCMSAs)

Optum continually monitors RED BOOK^® Average Wholesale Price (AWP) for the most common medications seen in Workers’ Compensation Medicare Set Asides (WCMSAs) to identify pricing changes that may have an impact on WCMSAs and settlements.

Price impact for conversion from brand Amitiza to brand alternative lubiprostone for WCMSAs

Please note that RED BOOK AWP is subject to change.

The price reduction with the brand alternative is only about 10% of the cost of brand Amitiza. However, as more manufacturers release lubiprostone, market competition will drive further price reductions. We will continue to monitor for additional manufacturers entering this market.

Please note, when claimants have a history of brand medication use, the Centers for Medicare and Medicaid Services (CMS) generally requires generic or brand alternative medication fills reflected on pharmacy invoices to allow allocation for the lower cost product in a WCMSA. 

What you can do

It is our recommendation that carriers, TPAs and claim handlers flag cases where brand Amitiza has been prescribed to determine if brand alternative lubiprostone is prescribed in the near future. It is expected that over the next several months we will see prescriptions for brand Amitiza converted to lubiprostone. If not, it is recommended that a request be made to the treating physician to initiate a trial of the brand alternative medication.  

Future updates

As an established Medicare Secondary Payer (MSP) compliance services provider, Optum strives to keep clients and the property and casualty insurance industry informed of changes affecting MSP compliance and WCMSAs. We will continue to update the industry regarding medication price changes that affect WCMSAs as well as generic medications that come to market.

Sources:
1. RED BOOK - https://www.ibm.com/products/micromedex-red-book (Subscription required)
2. WCMSA Portal - https://www.cob.cms.hhs.gov/WCMSA/login
3. ODG by MCG Treatment Guidelines [database online]. An MCG Health Company. Accessed on February 10, 2021.
4. Amitiza® (lubiprostone) [package insert]. Bedminster, NJ: Sucampo Pharmaceuticals, Inc.; November 2020.