New generic for long-acting opioid analgesic Hysingla® ER arrives to market ― lower price to impact WCMSAs

April 28, 2021 · Medicare Insights Team

The generic of Hysingla ER, hydrocodone bitartrate extended-release (ER) tablets, was released in March 2021 and became available for allocation in Workers’ Compensation Medicare Set-Asides (WCMSAs) as of early April 2021.

Long-acting opioid analgesics such as Hysingla ER are not recommended as a first-line treatment for chronic pain, but are only recommended for the management of chronic severe pain in patients who have failed and/or not tolerated non-opioid analgesics or short-acting opioid analgesics. Hysingla ER is approved for treatment of chronic, severe pain in patients who require daily, around-the-clock, long-term opioid analgesic treatment. Hysingla ER and the new generic are available in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg strength tablets.

The average wholesale price (AWP) of the new generic is 14% lower than the brand-name formulation.

Price impact for conversion from brand-name Hysingla ER to generic hydrocodone bitartrate ER for WCMSAs, using April 2021 WCMSA portal pricing

Generic Hydrocodone Bitartrate ER strength and formulation	NDC Code	AWP Unit Price	Price Reduction from Brand-name Hysingla ER
20 mg ER tablet	47781-0392-60	$10.18	$1.72
30 mg ER tablet	47781-0393-60	$14.87	$2.50
40 mg ER tablet	47781-0394-60	$20.03	$3.37
60 mg ER tablet	47781-0395-60	$27.74	$4.66
80 mg ER tablet	47781-0396-60	$37.40	$6.29
100 mg ER tablet	47781-0397-60	$47.59	$8.00
120 mg ER tablet	47781-0398-60	$52.74	$8.86

Please note that RED BOOK® AWP is subject to change.

AWPs of the brand-name Hysingla ER formulations increased by 5% in early April 2021, and this price increase will be reflected in WCMSAs beginning in early May 2021.

Although the cost of the new generic hydrocodone bitartrate ER tablets are still high, market competition will likely drive further price reductions as more generic manufacturers release their generic versions. We will continue to monitor for additional manufacturers entering this market.

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

What you can do

It is our recommendation that carriers, TPAs and claim handlers flag cases where brand-name Hysingla ER has been prescribed to determine if generic hydrocodone bitartrate ER tablet is prescribed in the near future. It is expected that over the next several months we will see prescriptions for brand-name Hysingla ER transitioned to the generic formulation. If not, it is recommended that a request be made to the treating physician to initiate a trial of the generic medication.

Future updates

Optum continually monitors RED BOOK AWP for the most common medications seen in WCMSAs to identify pricing changes that may have an impact on WCMSAs and settlements, and we will continue to update the industry as applicable.

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 April 9, 2021.
4.     Hysingla® ER (hydrocodone extended-release tablet) [package insert]. Stamford, CT: Purdue Pharma L.P.; March 2021. Available at https://hysinglaer.com/. Accessed on April 13, 2021.