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Orexo provides ZUBSOLV market access update on agreement with CVS Caremark

Orexo announced changes to ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) managed care formulary POSITION for patients suffering from opioid dependence.

Today the PBM, CVS Caremark published their 2016 Standard Formulary List of Excluded Drugs for their commercial clients. Effective from January 1, 2016 Zubsolv has been removed from the preferred position and excluded from the high controlled commercial plans where ZUBSOLV has been the only branded alternative since January 2014.

Based on Orexo’s experience with CVS Caremark during the past 18 months the high controlled plans impact a minority portion of the overall opioid dependency market within the account. At this time Orexo estimates the direct impact today would effect approximately 10-15 percent of Zubsolv gross sales (0.6 – 0.8 share points).

Since January 2014 while Zubsolv has been the exclusive branded alternative, the main branded competitor who had the incumbent position maintained a higher than expected market share of CVS Caremark commercial business, showing the opportunity to maintain market share, while being excluded from the highly controlled plans.

During this 18 month period patients and physicians have had a choice to select the generic alternatives and have chosen and been loyal to Zubsolv as their preferred brand, providing Orexo with a good platform to maintain market share.

Orexo continues to progress the discussions with multiple payers in both public and private segments and have signed a multi-year exclusive agreement with a PBM in Managed Medicaid, with the potential to exceed the market share loss that may develop due to the 2016 change in CVS Caremark commercial plans. As previously communicated, Managed Medicaid plans provide a strategic opportunity for ZUBSOLV however the rebates in this managed public segment are typically higher than in the privately insured plans.

For all PBMs, both in commercial and Managed Medicaid, the impact of an agreement and change in formulary position is dependent on the implementation by their insurance clients and both timing and impact on sales is associated with significant uncertainties.

"The news and decision from CVS Caremark to exclude Zubsolv from their highly controlled plans came as a surprise to Orexo, we have continued to gain market share and have benefited from the collaboration since January 2014. Although this decision is disappointing, we are pleased to see market share gains across all payers during July taking Zubsolv to new all-time-high levels and to announce a new agreement has been signed in Managed Medicaid which is likely to more than compensate for the loss from CVS Caremark commercial business in terms of market share", said Nikolaj Sørensen, CEO and President, Orexo AB.