Pharmacy Prior Authorization Criteria

Botox (onabotulinumtoxinA)

Indications for Prior Authorization

Botox (onabotulinumtoxin A)

• For diagnosis of Overactive Bladder
  Indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

• For diagnosis of Detrusor Overactivity associated with a Neurologic Condition
  Indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

• For diagnosis of Neurogenic Detrusor Overactivity (NDO)
  Indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medications.

• For diagnosis of Chronic Migraine
  Indicated for the prophylaxis of headaches in adult patients with chronic migraine (greater than or equal to 15 days per month with headache lasting 4 hours a day or longer). Important Limitations: Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies.

• For diagnosis of Spasticity
  Indicated for the treatment of spasticity in patients 2 years of age and older.

  Limitations of use: Botox has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture.

• For diagnosis of Cervical Dystonia (Spasmodic Torticollis)
  Indicated for the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

• For diagnosis of Primary Axillary Hyperhidrosis
  Indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents. Limitations: The safety and effectiveness of Botox for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive Botox for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease. Safety and effectiveness of Botox have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.

• For diagnosis of Blepharospasm and strabismus
  Indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders (involving muscles of the face) in patients 12 years of age and above.

• For diagnosis of Chronic Low Back Pain [2, 3]
  Used in the treatment of chronic low back pain.

• For diagnosis of Other Uses [2, 3]
  Used in the treatment of achalasia, chronic anal fissures, dynamic muscle contracture in pediatric cerebral palsy patients, sialorrhea, hand tremor, and oromandibular dystonia.

Botox Cosmetic (onabotulinumtoxin A)

• For diagnosis of Cosmetic Uses
  [Non-approvable Use] Indicated in adult patients for the temporary improvement in the appearance of: 1) Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity 2) Moderate to severe lateral canthal lines associated with orbicularis oculi activity 3) Moderate to severe forehead lines associated with frontalis muscle activity

  **Please Note: The request for Botox (onabotulinumtoxin A) injections to treat the appearance of facial lines is not authorized given that this use is for cosmetic purposes only.

Criteria

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Neuromuscular and Autonomic Disorders

• Diagnosis of one of the following:
• Blepharospasm associated with dystonia (e.g., benign essential blepharospasm)
• Cervical dystonia (also known as spasmodic torticollis)
• Spasticity
• Strabismus
• VII cranial nerve disorders (hemifacial spasms)

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Reauthorization)

Length of Approval: 3 Month(s)
For diagnosis of Neuromuscular and Autonomic Disorders

• Patient demonstrates positive clinical response to therapy
AND
• At least 3 months have or will have elapsed since the last treatment

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Initial Authorization)

Length of Approval: 1 Time(s)
For diagnosis of Primary Axillary Hyperhidrosis

• Diagnosis of primary axillary hyperhidrosis [G]
AND
• One of the following:
• Score of 3 or 4 on the Hyperhidrosis Disease Severity Scale (HDSS) [A, 1, 4]
OR
• Skin maceration with secondary infection [5]
AND
• Trial and failure, contraindication, or intolerance to topical prescription strength drying agents [e.g., Drysol, Hypercare, Xerac AC (aluminum chloride hexahydrate)]

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Reauthorization)

Length of Approval: 1 Time(s)
For diagnosis of Primary Axillary Hyperhidrosis

• At least a 2-point improvement in HDSS [1, 4]
AND
• At least 3 months have or will have elapsed since the last series of injections [1, 4]

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month [B]
For diagnosis of Chronic Migraine

• Diagnosis of chronic migraines [I]
AND
• Medication overuse headache has been considered and potentially offending medication(s) have been discontinued [M]
AND
• Patient is 18 years of age or older [N]
AND
• Patient has greater than or equal to 15 headache days per month, of which at least 8 must be migraine days for at least 3 months [1, 13-16, L]
AND
• Prescribed by or in consultation with one of the following specialists:
• Neurologist
• Pain specialist
• Headache specialist
AND
• Two of the following: [H, J, O, P, Q, R]
• One of the following:
• History of failure (after at least a two month trial) or intolerance to Elavil (amitriptyline) or Effexor (venlafaxine)
• Patient has a contraindication to both Elavil (amitriptyline) and Effexor (venlafaxine)
OR
• One of the following:
• History of failure (after at least a two month trial) or intolerance to Depakote/Depakote ER (divalproex sodium) or Topamax (topiramate)
• Patient has a contraindication to both Depakote/Depakote ER (divalproex sodium) and Topamax (topiramate)
OR
• One of the following:
• History of failure (after at least a two month trial) or intolerance to one of the following beta blockers: atenolol, propranolol, nadolol, timolol, or metoprolol
• Patient has a contraindication to all of the following beta blockers: atenolol, propranolol, nadolol, timolol, or metoprolol
OR
• One of the following:
• History of failure (after at least a two month trial) or intolerance to Atacand (candesartan)
• Patient has a contraindication to Atacand (candesartan)
AND
• Trial and failure, contraindication or intolerance to one of the following:
• Aimovig
• Ajovy

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Reauthorization)

Length of Approval: 3 Month(s)
For diagnosis of Chronic Migraine

• Patient has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity [19]
AND
• Use of acute migraine medications (e.g., NSAIDS, triptans) has decreased since the start of therapy
AND
• Prescribed by or in consultation with one of the following specialists:
• Neurologist
• Pain specialist
• Headache specialist
AND
• Patient continues to be monitored for medication overuse headache (MOH) [M]
AND
• Trial and failure, contraindication or intolerance to one of the following:
• Aimovig
• Ajovy

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Urinary Incontinence associated with a Neurologic Condition OR Overactive Bladder with Symptoms OR Neurogenic Detrusor Overactivity (NDO)

• One of the following conditions: [1, 3, E, F]
• Urinary incontinence that is associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis)
• Overactive bladder with symptoms (e.g., urge urinary incontinence, urgency, and frequency)
• Neurogenic detrusor overactivity (NDO)
AND
• Prescribed by or in consultation with a urologist
AND
• Trial and failure, contraindication, or intolerance to at least one oral anticholinergic (antispasmodic or antimuscarinic) agent [e.g., Bentyl (dicyclomine), Donnatal (atropine/ scopolamine/ hyoscyamine/ phenobarbital), Levsin/Levsinex (hyoscyamine), Ditropan (oxybutynin), Enablex (darifenacin), or VESIcare (solifenacin)]
AND
• Patient is routinely performing clean intermittent self-catheterization (CIC) or is willing/able to perform CIC if he/she has post-void residual (PVR) urine volume greater than 200 mL

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Reauthorization)

Length of Approval: 3 Month(s)
For diagnosis of Urinary Incontinence associated with a Neurologic Condition OR Overactive Bladder with Symptoms OR Neurogenic Detrusor Overactivity (NDO)

• Patient demonstrates positive clinical response to therapy
AND
• At least 3 months have or will have elapsed since the last treatment

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Chronic Anal Fissure (Off-Label)

• Diagnosis of chronic anal fissure [8, 9]
AND
• At least 2 months of one of the following symptoms:
• Nocturnal pain and bleeding
• Postdefecation pain
AND
• Trial and failure, contraindication, or intolerance to one of the following conventional therapies:
• Topical nitrates (e.g. Glyceryl trinitrate (Nitroglycerin))
• Topical calcium channel blockers (CCBs) (e.g., diltiazem, nifedipine)

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Reauthorization)

Length of Approval: 3 Month(s)
For diagnosis of Chronic Anal Fissure (Off-Label)

• One of the following:
• Incomplete healing of fissure
• Recurrence of fissure
AND
• Patient demonstrates positive clinical response to therapy
AND
• At least 3 months have or will have elapsed since the last series of injections

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Initial Authorization)

Length of Approval: 1 treatment session (series of injections) [K]
For diagnosis of Chronic Back Pain [D] (Off-Label)

• Diagnosis of low back pain
AND
• Low back pain has lasted for greater than or equal to six (6) months
AND
• Prescribed by or in consultation with one of the following specialists:
• Neurologist
• Neurosurgeon
• Orthopedist
• Pain specialist
AND
• Trial and failure (at least 3 months), contraindication, or intolerance to both of the following conventional therapies: [10-12]
• At least one oral NSAID medication
• At least one opioid medication
AND
• Trial and failure or inadequate response to one of the following: [10]
• Physical therapy
• Nonpharmacologic therapy (e.g., spinal manipulation, massage therapy, transcutaneous electrical nerve stimulation (TENS), acupuncture/acupressure, and surgery)

Botox (Excluded: Botox Cosmetic)

Authorization will not exceed more than two treatment sessions total per year (including initial authorization).

Prior Authorization (Reauthorization)

Length of Approval: 1 treatment session (series of injections) [K]
For diagnosis of Chronic Back Pain [D] (Off-Label)

• Patient demonstrates positive clinical response to therapy
AND
• At least 3 months have or will have elapsed since the last series of injections
AND
• Treatment has not exceeded two treatment sessions total per year

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month [C]
For diagnosis of Achalasia (Off-Label)

• Diagnosis of achalasia
AND
• One of the following:
• High risk of complication from or failure to one of the following: [6, 7]
• Pneumatic dilation
• Myotomy
OR
• Prior dilation caused esophageal perforation
OR
• Patient has an increased risk of dilation-induced perforation due to one of the following:
• Epiphrenic diverticulum
• Hiatal hernia

Botox (Excluded: Botox Cosmetic)

Prior Authorization (Reauthorization)

Length of Approval: 6 Month [C]
For diagnosis of Achalasia (Off-Label)

• Patient demonstrates improvement or reduction in symptoms of achalasia (i.e., dysphagia, regurgitation, chest pain)
AND
• At least 6 months have or will have elapsed since the last series of injections [C]

Botox (Excluded: Botox Cosmetic)

Prior Authorization

Length of Approval: 6 months unless the FDA-approved treatment duration is less than 6 months. If FDA-approved treatment duration is less than 6 months, utilize the FDA-approved duration for authorization period.
For diagnosis of All other diagnoses

• One of the following:
• Both of the following:
• Diagnosis is consistent with an indication listed in the product’s FDA-approved prescribing information (or package insert)
AND
• Additional requirements listed in the “Indications and Usage” and “Dosage and Administration” sections of the prescribing information (or package insert) have been met (e.g.: first line therapies have been tried and failed, any testing requirements have been met, etc)
OR
• Meets the off-label administrative guideline criteria
AND
• Trial and failure, contraindication, or intolerance to two appropriate formulary alternatives (if available)

All Products

Prior Authorization

For diagnosis of Cosmetic Use

• Requests for coverage of any Botox product for treating the appearance of facial lines are not authorized and will not be approved. These uses are considered cosmetic only.

P & T Revisions

2023-10-31, 2023-06-15, 2022-07-21, 2022-04-06, 2021-06-15, 2021-05-25, 2021-04-07, 2020-12-02, 2020-09-01, 2020-06-30, 2019-11-05, 2019-09-03

References

1. Botox Prescribing Information. Allergan, Inc. Madison, NJ. August 2022.
2. AHFS Drug Information (2005) website. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/pdh_f/130028?searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3DBotox%26t%3Dname%26va%3DBotox. Accessed June 13, 2023.
3. DRUGDEX System [Internet database]. Greenwood Village, CO: Thomson Micromedex. Updated periodically. Accessed June 13, 2023.
4. Lowe NJ, Glaser DA, Eadie N, Daggett S, Kowalski JW, Lai PY. Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: a 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety. J Am Acad Dermatol. 2007;56:604-611.
5. Naumann M, Lowe NJ. Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial. BMJ 2001;323:596-9.
6. Vaezi MF, Pandolfino JE, Vela MF. American College of Gastroenterology Practice Parameter Committee. Diagnosis and management of achalasia. Am J Gastroenterol advance online publication, 23 July 2013.
7. Pasricha PJ, et al. Intrasphincteric botulinum toxin for the treatment of achalasia. N Engl J Med 1995;332:774-8.
8. American Society of Colon and Rectal Surgeons. Practice Parameters for the Management of Anal Fissures (3rd Revision). Dis Colon Rectum 2010; 53: 1110–1115.
9. Brisinda G, et al. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med 1999;341:65-9.
10. Ney JP, Difazio M, Sichani A, Monacci W, Foster L, Jabbari B. Treatment of chronic low back pain with successive injections of botulinum toxin A over 6 months: a prospective trial of 60 patients. Clin J Pain 2006;22(4):363-369.
11. MayoClinic. Back pain. Available at: www.mayoclinic.com. Accessed June 13, 2023.
12. Naumann M, So Y, Argoff CE et al. Assessment: botulinum neurotoxin in the treatment of autonomic disorder and pain (an evidence-based review): report of the Therapeutics and Assessment Subcommittee of the American Academy of Neurology. Neurology 2008;70:1707-1714.
13. Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalagia. 2010;30:793-803.
14. Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalagia. 2010;30:804-814.
15. Dodick DW, Turkel CC, DeGryse RE, et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010;50:921-936.
16. Per clinical consultation with neurologist, January 7, 2011.
17. Silberstein SD, Holland S, Freitag F, et al; Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology 2012 Apr 24;78(17):1337-45.
18. Loder E, Burch R, Rizzoli P.The 2012 AHS/AAN Guidelines for Prevention of Episodic Migraine: A Summary and Comparison With Other Recent Clinical Practice Guidelines. Headache 2012;52:930-945.
19. Per clinical consultation with neurologist, July 20, 2015.
20. International Headache Society (IHS); Headache Classification Committee. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013; 33: 629-808.
21. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May 10;86(19):1818-26.
22. Per Clinical Consultation with a Neurologist. January 24th, 2018.
23. National Institute for Health and Care Excellence. Management of migraine (with or without aura). April 17th, 2018. Available at: https://pathways.nice.org.uk/pathways/headaches/management-of-migraine-with-or-without-aura#path=view%3A/pathways/headaches/management-of-migraine-with-or-without-aura.xml&content=view-node%3Anodes-prophylactic-treatment. Accessed August 14, 2020.
24. Botox Cosmetic Prescribing Information. Allergan, Inc. Irvine, CA. February 2021.

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End Notes

1. Hyperhidrosis Disease Severity Scale • The HDSS is a 4-point scale designed to assess the severity of hyperhidrosis in everyday clinical practice or in clinical research and the effectiveness of treatment. • The HDSS can be administered by an interviewer or self-completed by the patient. • The HDSS assess disease severity based on the extent of sweating-related impairment of daily activities. (1) Question - My (underarm) sweating is never noticeable and never interferes with my daily activities, Score - 1; (2) Question - My (underarm) sweating is tolerable but sometimes interferes with my daily activities, Score - 2; (3) Question - My (underarm) sweating is barely tolerable and frequently interferes with my daily activities, Score - 3; (4) Question - My (underarm) sweating is intolerable and always interferes with my daily activities, Score - 4
2. This recommendation is based on results from the PREEMPT 2 trial. The primary endpoint of PREEMPT 2 was the mean change from baseline in frequency of headache days for the 28-day period ending with week 24. [13, 14]
3. Approximately 50% of achalasia patients relapse and require repeat treatments at 6 to 24-month intervals. [6]
4. An evidence-based review by the American Academy of Neurology (AAN) concluded that botulinum neurotoxin (BoNT) is possibly effective for the treatment of chronic predominantly unilateral low back pain (LBP) [one Class II study]. The AAN recommends that BoNT may be considered as a treatment option for patients with chronic predominantly unilateral LBP (Level C). [12]
5. An evidence-based review by the AAN established BoNT as safe and effective for the treatment of neurogenic detrusor overactivity (NDO) in adults (one Class I study and one Class II study). Data on the use of BoNT is probably safe and effective for the treatment of detrusor sphincter dyssynergia (DSD) in patients with spinal cord injury (2 Class II studies). On basis of one Class I study, BoNT does not provide significant benefit for the treatment of DSD in patients with multiple sclerosis (MS). The AAN recommends that BoNT should be offered as a treatment option for neurogenic detrusor overactivity (Level A), and that BoNT should be considered for DSD in patients with spinal cord injury (Level B). [12]
6. BoNT is not effective in patients with DSD due to multiple sclerosis in a multicenter, double-blind, placebo-controlled trial; however, in patients with DSD due to spinal cord injury, open-label clinical studies showed improvements in urodynamic parameters [recommendation for DSD: Adult, Class IIb, Category B]. For NDO, the use of BoNT (refractory to antispasmodics) in a randomized, double-blind, placebo-controlled clinical trial of 59 patients (n = 53 with spinal cord injury and n = 6 with multiple sclerosis) showed significant improvement in daily incontinence episodes in weeks 1 through 24 (except for weeks 12 and 18) compared to placebo [recommendation for NDO: Adult, Class IIb, Category B]. [12]
7. The safety and effectiveness of Botox for hyperhidrosis in areas other than the axillae have not been established. [1]
8. Clinical benefit from prophylactic therapy may take as long as 2 to 3 months to manifest. [17, 18] Recommended first-line agents for the prevention of migraine headache are atenolol, nadolol, propranolol, timolol, amitriptyline, venlafaxine, topiramate, divalproex sodium, and sodium valproate. [17]
9. Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies. [1] An evidence-based review by the American Academy of Neurology determined that, based on available evidence, Botox was probably ineffective in episodic migraine and tension-type headaches, and should not be considered in patients with these conditions. [12]
10. The effects of Botox in reducing the frequency of headache days in the PREEMPT trial and in the pooled analysis of the PREEMPT trials were very modest. Given the experience and evidence we have for other prophylactic treatments in the management of migraine, which are supported by national guidelines, it is reasonable to require failure with other prophylactic treatments before approving use of Botox. [17]
11. A single small randomized trial (n = 31) compared paravertebral injections of botulinum toxin with saline injections and found significant benefit of botulinum toxin up to eight weeks after injection. There is currently no consensus on number of injections or treatment length for low back pain. [12]
12. The International Classification of Headache Disorders, 3rd addition (beta version) distinguishes chronic and episodic migraine [20]. Chronic migraine is described as headache occurring on 15 or more days per month for more than 3 months, which has the features of migraine headache on at least 8 days per month. Episodic migraine is not clearly defined, but is applied when a patient is diagnosed with migraine but does not meet criteria for chronic migraine.
13. Medication overuse headache (MOH) is defined as headache occurring greater than or equal to 15 days per month. It develops as a consequence of regular overuse of acute or symptomatic headache medication for more than 3 months [20]. Current evidence suggests the best treatment strategy is withdrawal of the offending medication.
14. The safety and effectiveness of Botox for chronic headache in patients below the age of 18 years have not been established. In a 12-week, multicenter, double-blind, placebo-controlled clinical trial, 123 adolescent patients (ages 12 to below 18 years) with chronic migraine were randomized to receive Botox 74 Units, Botox 155 Units, or placebo, for one injection cycle. This trial did NOT establish the efficacy of Botox, compared with placebo, for the prophylaxis of headaches in adolescents with chronic migraine. [1]
15. The American Academy of Neurology supports the use of the following medications for the prevention of episodic migraine in adult patients (with level A or B evidence): antidepressants [i.e., Elavil (amitriptyline), Effexor (venlafaxine)], antiepileptics [i.e., Depakote/Depakote ER (divalproex sodium), Topamax (topiramate)], and beta-blockers [i.e., atenolol, propranolol, nadolol, timolol, metoprolol] [21]. They also support the use of Botox (onabotulinumtoxin A) as an efficacious treatment option for chronic migraine. Botox (onabotulinumtoxin A) is not however recommended for episodic migraine treatment.
16. The US Headache Consortium Consensus (Table e-1) recommends that therapy be initiated with medications that have the highest level of evidence-based therapy while also taking into account patient specific comorbidities [17]. Each medication should be given an adequate trial, it may take two to three months to achieve clinical benefit, and six months to achieve maximal benefit.
17. The OptumRx clinical team consulted with a neurologist [22]. He confirmed that preventative treatment for chronic migraine and episodic migraine are similar. The choice of preventative medication will not vary much between the episodic vs chronic subtypes. The choice of agent will largely depend more on patient specific factors.
18. The National Institute for Health and Care Excellence guidelines for the management of migraine recommend Botox (onabotulinumtoxin A) as an option in chronic migraine after failure of at least three other prophylactic medications and that the patient is being managed for medication overuse [23].

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Revision History

• 2023-10-31: update guideline eff 1/1/2024
• 2023-06-15: Annual review - added criterion "treatment has not exceeded 2 treatment sessions total per year" to chronic back pain reauth criteria per PA team request. Updated references.
• 2022-07-21: Annual review - updated references.
• 2022-04-06: Added Atacand (candesartan) as a T/F prerequisite for chronic migraine to align with CGRP inhibitors guideline.
• 2021-06-15: Annual review - no changes.
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-07: Updated guideline with new FDA-approved indication for NDO. Updated background and references.
• 2020-12-02: Update to replace "15 migraine headache days" with "15 headache days" to align with the language in the label/CGRP inhibitors guideline. Added "headache specialist" to align with other migraine agents.
• 2020-09-01: Updated spasticity indication and criterion. Updated references.
• 2020-06-30: Annual review - removed drug name from reauthorization criteria for consistency. Updated background.
• 2019-11-05: Added new indication for pediatric spasticity. Updated references.
• 2019-09-03: Added Botox Cosmetic GPI to the guideline and created new criteria section stating that cosmetic use will not be approved.

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