effective date: replaces effective policy dated: page ... toxin (botox, dysport ... but not limited...

Department of Origin: Pharmacy

Approved by: Pharmacy and Therapeutics Quality Management Subcommittee

Date Approved: 04/18/18

Department(s) Affected: Integrated Healthcare Services and Pharmacy

Effective Date: 04/19/18

Pharmacy Policy Description: Botulinum Toxin (Botox, Dysport, Myobloc, and Xeomin)

Replaces Effective Policy Dated: 06/23/17

Reference #: PC/B003 Page: 1 of 7

PRODUCT APPLICATION:

PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Community Health Plan (PCHP) PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group

PURPOSE: The intent of the Botulinum Toxin criteria document is to ensure, if benefits are available, that the intended use is medically necessary and prescribed after conservative treatment has failed. GUIDELINES: Medical Necessity Criteria - Must have one of the following: I or II I. Indications that are considered acceptable medical practice and require prior authorization: A or B

A. Initial Use Indications – one of the following: 1 - 7

1. Alternative therapy for refractive and chronic debilitating pain syndromes - must have: a or b a. For headache syndromes – obtain the following documentation: Letter of medical necessity from a

neurologist or headache specialist recommending the use of botulinum toxin that includes all of the following: i-iii i. Intractable migraine headaches (with or without aura) occurring eight or more days a month

or chronic daily headache defined as members experiencing more than 15 days of headache per month; and

ii. Documented attempts at formal behavioral or physical therapy treatment (such as, but not limited to, home exercise program, massage); and

iii. Member has failed trials of at least three preventative pharmacological headache therapies unless documented to be contraindicated (such as, but not limited to, angiotensin [ACE] inhibitors, angiotensin receptor blockers [ARB], beta blockers, calcium channel blockers, anticonvulsants, and antidepressants) after titration to maximally tolerated doses.

b. For all other pain syndromes – obtain the following documentation and refer to physician review -

Letter of medical necessity from a pain specialist physician that includes all of the following: i-iv i. Diagnosis; and ii. Known medical treatment in the last 12 months; and iii. Evidence of impairment to activities of daily living; and iv. Clear evidence from submitted documentation that the pain/symptoms are persistent and

disabling and the member has not responded to, is intolerant to, or is a poor candidate for other conventional forms of medical therapy.

[Note: Documentation of functional impairment to activities of daily living secondary to chronic pain syndrome (such as, but not limited to, missed school or work days) may be required from the member if not evident in the requesting letter of medical necessity or available in the medical record.]









2. Gastrointestinal disorders – one of the following: a or b

a. Chronic anal fissure and documentation demonstrates the member has not responded to, is intolerant to conservative therapeutic measures (such as, but not limited to, diet modification, sitz baths, topical medication); or

b. Achalasia which has failed dilation therapy or surgical myotomy, or in members who are poor

surgical candidates.

3. Ptyalism/sialorrhea (excessive salivation) secondary to other medical conditions that is disabling (such as, but not limited to, cerebral palsy, etc.) and the member has not responded to, is intolerant to, or is a poor candidate for other medical therapy.

4. Neurogenic/ overactive bladder (associated with conditions such as, but not limited to, spinal cord

injury, multiple sclerosis, etc.) unresponsive to anticholinergics. 5. Non-neurogenic/idiopathic overactive bladder associated with detrusor muscle overactivity – member

has not responded to, is intolerant to, or is a poor candidate for both of the following: a and b a. Anticholinergics; and

b. Behavioral therapy.

6. Focal primary hyperhidrosis – must have: a, and either b or c

a. Member has not responded to, is intolerant to, or is a poor candidate for topical AND systemic treatments (such as, but not limited to, aluminum chloride/extra-strength antiperspirants, anticholinergics, beta-blockers, or benzodiazepines); and

b. The condition significantly interferes with member’s ability to perform age-appropriate activities of daily living (ADLs); or

c. The condition is causing persistent or chronic medical disorders (such as, but not limited to,

acrocyanosis of the hands, skin maceration, dermatitis, or fungal infection/s).

7. Raynaud phenomenon (intra-digital and palmar temporary chemical sympathectomy) – both of the following: a and b a. Presence of digital ulceration with critical ischemia; and

b. Failure of oral and/or topical vasodilatory therapy for improvement in digital blood flow.

B. Continued Use - must have at least one of the following documented improvements with botulinum toxin

use: 1-6 1. Decrease in medication use; or

2. Decrease in emergency room visits; or

3. Decrease in missed days at work; or 4. Decreased pain frequency and severity; or









5. Increased activities; or 6. Documented improvement in symptoms.

II. Indications that are considered acceptable medical practice and do not require further review: A –H

A. Cervical dystonia

B. Fragments of torsion dystonia:

1. Blepharospasm 2. Orofacial dyskinesia 3. Spasmodic torticollis

4. Organic writer’s cramp 5. Other fragments of torsion dystonia

C. Idiopathic torsion dystonia

D. Spasticity

E. Other disorders of the central nervous system:

1. Muscle spasms due to demyelinating diseases (such as, but not limited to, multiple sclerosis, neuromyelitis optica, Schilder’s disease)

2. Spastic/congenital hemiplegia 3. Hereditary spastic paraplegia 4. Infantile cerebral palsy 5. Facial nerve disorders (such as, but not limited to, hemifacial spasm [does not include trigeminal

neuralgia – see III. Exclusions])

F. Spasmodic dysphonia (laryngeal spasm)

G. Strabismus and other disorders of binocular eye movements H. Symptomatic torsion dystonia









EXCLUSIONS: Any of the following: I-III I. Cosmetic indications II. Allergic rhinitis III. Use for trigeminal neuralgia is considered investigative (see Investigative List) DEFINITIONS: Achalasia: A failure of the muscles between the esophagus and the stomach (cardiac sphincter) to open thus preventing food from passing through into the stomach. The condition is also known as cardiospasm. Acrocyanosis: Blueness of the hands and feet due to the narrowing of the small arterioles (small arteries) found towards the end of the hands and feet. Neurogenic Overactive Bladder: Neurogenic bladder is the loss of normal bladder function caused by damage to part of the nervous system. The damage can cause the bladder to be underactive, in which it is unable to contract and unable to empty completely, or it can be overactive, in which it contracts too quickly or frequently. Alternate names for over activity of the bladder: detrusor hyperreflexia, detrusor instability, overactive bladder, spasmodic bladder, unstable bladder. Pain Specialist Physician: Pain specialists, or pain medicine doctors, are experts at diagnosing the cause of pain and then treating it. Anesthesiologists, neurologists, and neurosurgeons most frequently specialize in pain management. Some physiatrists also specialize in pain management. Torsion Dystonia: A disease characterized by painful muscle contractions resulting in uncontrollable distortions. This specific type of dystonia is found in children, with symptoms starting around the ages of 11 or 12. It commonly begins with contractions in one general area such as an arm or a leg that continue to progress throughout the rest of the body. It takes roughly 5 years for the symptoms to completely progress to a debilitating state. BACKGROUND: This criteria document is based on U.S. Food and Drug Administration (FDA) approved indications, expert consensus opinion and/or available reliable evidence. The FDA has issued a boxed warning for these products. The effects of botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably the greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.

http://www.webmd.com/pain-management/guide/cause-chronic-pain

http://www.webmd.com/pain-management/default.htm

http://www.webmd.com/pain-management/ss/slideshow-reasons-for-pain









Botulinum toxin is produced by the anaerobic organism clostridia botulinum. There are several distinct serotypes designated as type A, B, C-1, D, E, F and G. They are injected intramuscularly to reduce muscle tone and interfere with release of acetylcholine from nerve endings. The FDA has approved botulinum toxin for several indications. Botulinum toxin has also been used “off-label” for a wide variety of disorders characterized by spasticity or dystonia. Botulinum toxin injections are commonly required every 2-6 months depending on response, with an average approximating 90 days, but exact frequency is dependent on multiple patient variables. The use of botulinum toxin is indicated only when it is determined to be medically necessary for the treatment of a medical condition, and the use of botulinum toxin has been shown to be effective for that condition. Botulinum toxin is not considered medically necessary for cosmetic uses.









FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes – for all indications listed in I. Initial - Authorize up to 4 four injections over a 12-month period. Continued use – Authorize up to 8 injections over a 24-month period, unless clinical documentation supports a need for injections more frequently than every 3 months Coverage is subject to the member’s contract benefits. CODING: HCPCs J0585 onabotulinumtoxinA, 1 unit (Botox, Botox Cosmetic) J0586 abobotulinumtoxinA, 5 units (Dysport) J0587 rimabotulinumtoxinB, 100 units (Myobloc) J0588 incobotulinumtoxinA, 1 unit (Xeomin) Coverage is subject to the terms of a member’s pharmacy benefit plan and formulary. To the extent there is any inconsistency between this criteria document/policy and the terms of a member’s pharmacy benefit plan and /or formulary, the member’s pharmacy benefit plan and formulary govern. Approval of a drug under this criteria document does not ensure full coverage of the drug. RELATED CRITERIA/POLICIES: Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria Medical Policy: MP/C002 Cosmetic Treatments Medical Policy: MP/I001 Investigative Services Medical Criteria: MC/G008 Hyperhidrosis Surgery Medical Criteria: MC/N005 Torticollis and Positional Plagiocephaly REFERENCES: 1. Botox [package insert]. Irvine, CA: Allergan Inc; 2017. 2. Dysport [package insert]. Wrexham, UK: Ipsen Biopharm Ltd; 2017. 3. Myobloc [package insert]. South San Francisco, CA: Solstice Neurosciences, Inc; 2009. 4. Xeomin [package insert]. Dessau-Rosslau, Germany: Merz Group Services GmbH; 2015. 5. Argus. Botox (onabotulinumtoxinA): Prior Authorization Policy. 4/25/2016. 6. Argus. Dysport (abobotulinum toxin type A): Prior Authorization Policy. 10/15/2017. 7. Argus. Myobloc (rimabotulinumtoxinB): Prior Authorization Policy. 4/7/2016. 8. Argus. Xeomin (incobotulinumtoxinA): Prior Authorization Policy. 3/1/2016. 9. Fregene A, Ditmars D, Siddiqui A. Botulinum toxin type A: a treatment option for digital ischemia in patients

with Raynaud’s phenomenon. Journal of Hand Surgery 2009 March 34(3):446-52. 10. Kossintseva I, Barankin B. Improveemnt in both Raynaud disease and hyperhidrosis in response to botulinum

toxin type A treatment. Journal of Cutaneous Medicine and Surgery. 2008 Jul-Aug. 12(4):189-93. 11. Mahajan ST. Use of botulinum toxin for treatment of non-neurogenic lower urinary tract conditions. 2017.

UpToDate. Retrieved from http://www.uptodate.com/contents/use-of-botulinum-toxin-for-treatment-of-non-neurogenic-lower-urinary-tract-conditions?source=see_link

http://www.uptodate.com/contents/use-of-botulinum-toxin-for-treatment-of-non-neurogenic-lower-urinary-tract-conditions?source=see_link

http://www.uptodate.com/contents/use-of-botulinum-toxin-for-treatment-of-non-neurogenic-lower-urinary-tract-conditions?source=see_link









12. Perry WB, Dykes SL, Buie WD, Rafferty JF. Practice parameters for the management of anal fissures (3rd

revision). Dis Colon Rectum 2010; 53: 1110–1115. doi: 10.1007/DCR.0b013e3181e23dfe 13. Smith CC, & Pariser D. Primary focal hyperhidrosis. 2018. UpToDate. Retrieved from

http://www.uptodate.com/contents/primary-focal-hyperhidrosis?view=print 14. Wigley FM. Treatment of the Raynaud phenomenon resistant to initial therapy. 2017. UpToDate. Retrieved

from http://www.uptodate.com/contents/treatment-of-the-raynaud-phenomenon-resistant-to-initial-therapy?source=search_result&search=tratment+of+the+raynaud&selectedTitle=2%7E150

15. Van Beek A, Lim P, Gear A, Pritzker M. Management of vasospastic disorders with botulinum toxin A. Plastic and Reconstructive Surgery 2007 Jan. 119(1):217-26.

16. Clemens JQ. Urinary incontinence in men. 2018. UpToDate. Retrieved from https://www.uptodate.com/contents/urinary-incontinence-in-men?search=urinary%20incontinence%20dubeau&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1

17. Lukacz ES. Treatment of urinary incontinence in women. 2018. Retrieved from https://www.uptodate.com/contents/treatment-of-urinary-incontinence-in-women?search=urinary%20incontinence%20dubeau&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2

DOCUMENT HISTORY:

Created Date: 07/03 Reviewed Date: 05/17/06, 04/24/13, 04/16/14, 04/16/15, 04/15/16, 04/10/17, 02/02/18

Revised Date: 05/18/05, 04/18/07, 04/23/08, 09/23/08, 06/11/09, 06/01/10, 09/30/10, 05/16/11, 04/24/12, 12/17/12, 3/16/13, 04/24/13, 12/23/13, 04/16/15, 04/27/17, 03/12/18

http://www.uptodate.com/contents/primary-focal-hyperhidrosis?view=print

http://www.uptodate.com/contents/treatment-of-the-raynaud-phenomenon-resistant-to-initial-therapy?source=search_result&search=tratment+of+the+raynaud&selectedTitle=2%7E150

http://www.uptodate.com/contents/treatment-of-the-raynaud-phenomenon-resistant-to-initial-therapy?source=search_result&search=tratment+of+the+raynaud&selectedTitle=2%7E150

https://www.uptodate.com/contents/urinary-incontinence-in-men?search=urinary%20incontinence%20dubeau&source=search_result&selectedTitle=1%7E150&usage_type=default&display_rank=1



https://www.uptodate.com/contents/treatment-of-urinary-incontinence-in-women?search=urinary%20incontinence%20dubeau&source=search_result&selectedTitle=2%7E150&usage_type=default&display_rank=2



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PCHP:Provides free aids and services to people with disabilities to communicate effectively with us, such as:

• Qualified sign language interpreters• Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:• Qualified interpreters• Information written in other languages

If you need these services, contact a Grievance Specialist.

If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Grievance SpecialistPreferredOne Community Health PlanPO Box 59052Minneapolis, MN 55459-0052Phone: 1.800.940.5049 (TTY: 763.847.4013)Fax: [email protected]

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services200 Independence Avenue, SWRoom 509F, HHH BuildingWashington, D.C. 202011-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

PreferredOne Community Health Plan Nondiscrimination Notice

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PreferredOne Insurance Company (“PIC”) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PIC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex.

PIC:Provides free aids and services to people with disabilities to communicate effectively with us, such as:

• Qualified sign language interpreters• Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:• Qualified interpreters• Information written in other languages

If you need these services, contact a Grievance Specialist.

If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Grievance SpecialistPreferredOne Insurance CompanyPO Box 59212Minneapolis, MN 55459-0212Phone: 1.800.940.5049 (TTY: 763.847.4013)Fax: [email protected]

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services200 Independence Avenue, SWRoom 509F, HHH BuildingWashington, D.C. 202011-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

PreferredOne Insurance Company Nondiscrimination Notice

Language Assistance Services

NDR PIC LV (10/16)

effective date: replaces effective policy dated: page ... toxin (botox, dysport ... but not limited...

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