Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Anxiety. 
Treatment: Cymbalta 30 milligrams (mg) Capsule. 

The insurer denied coverage for Cymbalta 30mg Capsule. 

The denial is overturned. 

From the information provided by the doctor an alternative is likely to cause an adverse reaction.  Given the documents reviewed, the formulary/generic of Cymbalta 30mg (duloxetine) is likely to cause an adverse reaction. Per notes reviewed, the patient did try duloxetine 30mg and 60mg and had increased anxiety and depression which resulted in an emergency room visit.  Given this information, it is quite likely that the patient could have a similar reaction or an increase in her symptoms.  Based on the documents reviewed, it is likely that a formulary drug could result in an adverse reaction such as psychiatric destabilization or relapse. 

Notes reviewed clarify patient has been on Cymbalta 30mg for years and her anxiety is managed. In general, if medication changes are made during the course of treatment when a patient with a chronic illness is stable, there is a risk that symptoms will relapse. If a patient has a chronic illness and is stable on a treatment, with a history of relapse off medications or on different medications, it is clinically unadvisable to change to an alternative medication. 

The formulary drug of duloxetine has been ineffective based on the notes from the doctor.  The doctor documented a trial of duloxetine 30mg and 60mg which resulted in an increase in anxiety/depression and an emergency room visit. 

The notes reviewed provide information that the patient is stable on the non-formulary drug and did not tolerate the formulary drug.  Documents reviewed indicate the patient had a relapse in anxiety and depression on the formulary drug-generic duloxetine which resulted in an emergency room visit.  It is unadvisable to switch a patient that is stable and doing well to an alternative medication.  This could result in destabilization and severe psychiatric symptoms.  Other formulary options such as desvenlafaxine and venlafaxine are not appropriate.  This patient is stable on Cymbalta and not all medications are equivalent pharmacologically and are not always tolerated equally. Each individual patient is unique in how they metabolize medications. Based on each individual pharmacogenomics, the metabolization and pharmacodynamics of medications differ from individual to individual.  Therefore, a formulary suggestion maybe unadvisable in a patient that has a pharmacogenomic profile that is not compatible with the "formulary suggestion." Also, generics can vary in their bioequivalence the result of which is that generics can be less tolerable or less efficacious.  When an individual's unique pharmacogenomic profile is mixed with a variation in bioequivalence- differences in tolerability and efficacy can be prominent and cause side effects or increase in symptoms. 

In summary, generics can vary in bioequivalence from the name brand causing lack of efficacy or side effects. In addition, all medications   in the same class are not necessarily always tolerated equally or provide efficacy equally. 

The formulary drugs are expected to cause adverse effects. 

The formulary drugs were tried, and the patient did have an adverse reaction or contraindication. 

The formulary drug is expected to be ineffective. 

The not formulary drug is expected to be more effective than the formulary alternatives. 

The carrier's denial of a request for a Formulary Exception for Cymbalta 30mg Capsule is reversed.