Myobloc (rimabotulinumtoxinB) — Medical Mutual

Initial criteria

• Patient is age ≥ 18 years; AND
• Patient does not have a hypersensitivity to any botulinum toxin product; AND
• Patient does not have an active infection at the proposed injection site; AND
• Patient evaluated for any disorders which may contribute to respiratory or swallowing difficulty; AND
• Patient is not on concurrent treatment with another botulinum toxin (i.e., abobotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA, daxibotulinumtoxinA, etc.); AND
• Cervical Dystonia: Patient has a history of recurrent involuntary contraction of one or more muscles in the neck and upper shoulders; AND Patient has sustained head tilt OR abnormal posturing with limited range of motion in the neck; OR
• Chronic Sialorrhea: Patient has a history of troublesome sialorrhea for at least a 3-month period; OR
• Prophylaxis for Chronic Migraines: Patient is utilizing prophylactic intervention modalities (i.e. avoiding migraine triggers, pharmacotherapy, behavioral therapy, or physical therapy, etc.); AND Patient has a diagnosis of chronic migraines defined as 15 or more headache days per month for > 3 months; AND Patient has had at least five attacks with features consistent with migraine (with and/or without aura); AND On at least 8 days per month for > 3 months: headaches have characteristics/symptoms consistent with migraine OR suspected migraines are relieved by a triptan or ergot derivative; AND Patient has failed at least an 8-week trial of two oral preventive medications OR had previous treatment with a CGRP antagonist used for prevention; OR
• Severe Primary Axillary Hyperhidrosis: Patient has tried and failed ≥ 1 month trial of a topical agent (e.g., 20% aluminum chloride, glycopyrronium, aluminum zirconium trichlorohydrate, etc.); AND Patient has a history of medical complications such as skin infections or significant functional impairments; OR Patient has a significant burden of disease or impact to activities of daily living; OR
• Overactive Bladder: Patient has symptoms of urge urinary incontinence, urgency, and frequency; AND Patient has failed a 1 month or longer trial of two medications from either the antimuscarinic or beta-adrenergic classes

Reauthorization criteria

• Patient continues to meet the universal and indication specific criteria as identified in section III; AND
• Absence of unacceptable toxicity (e.g., symptoms of toxin spread effect, serious hypersensitivity reactions, etc.); AND
• Cervical Dystonia: Improvement in the severity and frequency of pain; AND Improvement of abnormal head positioning; OR
• Upper Limb Spasticity: Decrease in tone and/or resistance of affected areas based on a validated measuring tool; OR
• Prophylaxis for Chronic Migraines: Significant decrease in number, frequency, and/or intensity of headaches; AND Improvement in function; AND Patient continues to utilize prophylactic intervention modalities; OR
• Chronic Sialorrhea: Significant decrease in saliva production; OR
• Severe Primary Axillary Hyperhidrosis: Significant reduction in spontaneous axillary sweat production; AND Improvement in activities of daily living; OR
• Overactive Bladder: Significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided per micturition; AND Patient’s post-void residual periodically assessed as medically appropriate

Approval duration

12 months