Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Hypersalivation

Treatment: Formulary Exception for Glycopyrrolate

The insurer denied coverage for the Formulary Exception for Glycopyrrolate.

The denial is upheld. 

This is a male patient who was in the psychiatric hospital for 10 months due to psychotic symptoms. The patient presented with grossly psychotic symptoms including disorganized thinking and behavior, paranoid delusional thinking, bizarre and strange behavior, agitation, and poor hygiene, and he reportedly was recently discharged from the hospital. The patient has a diagnosis of Schizophrenia. It was reported that the patient's medications were fluphenazine, clozapine, Depakote, propranolol, benztropine, and lorazepam. The request was for glycopyrrolate.

There is no specific documentation in the medical records stating that the patient tried and failed treatment with or had experienced adverse effects with the insurer's formulary medications such as dicyclomine, darifenacin, flavoate, hyoscyamine, methscopolamine, oxybutynin, tolterodine, or trospium. It was reported that the patient tried atropine for hypersalivation without reported significant efficacy and though he was taking benztropine, has requested coverage for glycopyrrolate medication. 

Glycopyrrolate is Food and Drug Administration (FDA)-approved for anesthesia for the reduction of salivary, tracheobronchial, or pharyngeal secretions or blockage of cardiac inhibitory reflexes during anesthesia and intubation, or intraoperatively to counteract surgically or drug induced or vagal reflex associated arrhythmias, or protection against peripheral muscarinic effects of anticholinergic agents to reverse neuromuscular blockage, as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effects are desired, and also is approved for problem drooling associated with a neurological condition in patients of a certain age range. In this case, there was no reported documentation that this medication was being used for any of the above FDA-approved usages. It appears that this medication is being requested for hypersalivation related to medication use.  

The American Psychiatric Association (APA) Practice Guidelines for the Treatment of Patients with Schizophrenia reports that some patients treated with antipsychotic medications develop clinically significant extrapyramidal side effects in one form or another and that medications with anticholinergic or dopamine agonist activity often reduce the severity of side effects. Also, hypersalivation is a possible reported side effect of clozapine, which is a medication that this patient is taking. Thus, it seems that this patient's treating psychiatrist is trying to treat the patient's hypersalivation with glycopyrrolate. Although this medication has anticholinergic activity, there is no reported documentation to support that this patient tried and failed at least 3 of the formulary medications such as dicyclomine, darifenacin, flavoate, hyoscyamine, methscopolamine, oxybutynin, tolterodine, or trospium mentioned by the patient's insurer first. There is no reported specific evidence to support that formulary medications would likely cause adverse effects or would be ineffective for this patient's treatment. Also, there is no reported specific evidence to support that this requested medication, glycopyrrolate, would be more effective than the formulary medications for treatment of hypersalivation. 

The carrier's denial of Request for Formulary Exception for Glycopyrrolate should be upheld.