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Orexo AB has made changes to Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII) managed care formulary position with CVS Caremark for patients suffering from opioid dependence. Zubsolv's position has changed from excluded from reimbursement to reimbursed as a preferred product.

CVS Caremark, one of the largest PBMs in the United States, published their 2018 Exclusion Template Formulary List of Covered Drugs for their commercial clients. Effective January 1, 2018, Zubsolv will be placed in a preferred parity position with the market-leading branded product and the generic will remain in the generic tier. This formulary position places Zubsolv on the national managed care formulary for all exclusion template commercial clients which is the largest portion of CVS Caremark's commercial membership providing pharmaceutical benefits for over 25 million patients. Further, this change in formulary for 2018 means that Zubsolv increased its unrestricted access to over 90 percent of all commercial managed care lives in the United States.

While Zubsolv had been excluded from the CVS Caremark formulary effective January 2016, the loss of market share from CVS Caremark prescriptions has been around 0.8 share points nationally. With the regained preferred status Orexo will be able to compete in a preferred parity formulary position with another brand. Many patients and physicians following the CVS Caremark formulary change have during the last two years remained loyal to Zubsolv maintaining the product as their brand of choice. This patient retention and physician commitment provides Orexo with a platform to recover some of the lost market share. The previous agreement (until December 2015) had Zubsolv as the exclusive branded product on the CVS Caremark exclusion template formulary. The new agreement places Zubsolv in a co-preferred parity formulary position with another brand, which limits the immediate positive impact on market share as there will be no forced switching to Zubsolv.

I am very pleased with this positive news and the decision by CVS Caremark to again include Zubsolv as a co-preferred product. We have maintained a strong confidence that we would regain the lost preferred position and through significant efforts from our US commercial organization we have succeeded. To be able to compete in the US market, market access is the cornerstone of our commercial strategy in helping patients in the growing opioid epidemic. The inclusion of Zubsolv on the CVS Caremark formulary is a significant step forward to secure Zubsolv gains universal coverage for all patients with commercial insurance and continued profitable growth for Orexo. said Nikolaj Sorensen, CEO and President Orexo AB.

Orexo has a policy of communicating changes in managed care coverage in the Interim Reports. Due to the significant effect on Orexo[acute accent]s share price when the announcement was made to exclude Zubsolv from the CVS Caremark managed care formulary effective January 1 2016, the company has made a decision to make an exception from this policy regarding the announcement of above.


ZUBSOLV (buprenorphine and naloxone) sublingual tablet (CIII) is a prescription medication used to treat adults who are addicted to opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy. Treatment should be initiated under the direction of healthcare providers qualified under the Drug Addiction Treatment Act.

About Orexo

Orexo develops improved pharmaceuticals based on innovative drug delivery technologies. The focus is primarily on opioid dependence and pain but the aim is to address therapeutic areas where our competence and technologies can create value. The main market today is the US market for the treatment of opioid dependence where the product Zubsolv is commercialized by Orexo. Other products are commercialized by license partners, including Zubsolv in markets outside of the US. Total net sales for 2016 amounted to SEK 705.9 million and the number of employees was 102. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) index and is available as ADRs on OTCQX (ORXOY) in the US. The head office, where also research and development is performed, is located in Uppsala, Sweden.

For more information about Orexo, visit

About Orexo US, Inc.

Orexo US, Inc. is an emerging specialty pharmaceutical company marketing improved treatments for opioid dependence using proprietary drug delivery technology.

For more information, visit or call 855/982-7658.
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Publication:Worldwide Biotech
Date:Sep 1, 2017

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