Diagnosis: Opiate abuse disorder
Issue under review: Formulary exception for Suboxone 8-2MG SL film
The insurer denied the Formulary exception for Suboxone 8-2MG SL film.
The denial is upheld.

No, the health plan should not cover the proposed formulary exception for Suboxone 8-2MG sublingual (SL) film.

The patient is a female with opiate abuse disorder being treated with Suboxone.

The patient is a female with a history of chronic pain and opiate abuse disorder who has been prescribed Suboxone. There is no documentation that the patient cannot try or has failed formulary alternative buprenorphine- naloxone sublingual tablets. There is no documentation in the literature that supports superiority of Suboxone film to buprenorphine-naloxone sublingual tablets. Therefore it is not unreasonable for the patient to have failed the formulary alternatives prior to coverage of the requested medication. In a randomized multicenter trial, buprenorphine naloxone tablets were shown to have a better bioavailability then buprenorphine naloxone film and was found to be equally efficacious. In another randomized controlled trial comparable clinical outcomes were seen between the two formulations. Given the above, the health plan should not cover the proposed treatment - formulary exception for Suboxone 8-2MG SL film.