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ph-1096

Hyperhidrosis Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1096

This program applies to Blue Partner, Commercial, GenPlus, NetResults A Series and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
10-01-2024	04-01-2019

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Qbrexza® (glycopyrronium) Cloth	Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older		1
Sofdra™ (sofpironium) Gel	Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older		7

Agent(s)

FDA Indication(s)

Notes

Ref#

Qbrexza®

(glycopyrronium)

Cloth

Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

Sofdra™

(sofpironium)

Gel

Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Hyperhidrosis

Hyperhidrosis is defined as overactive sweating that can be up to four to five times more than necessary, causing embarrassment, discomfort, and anxiety.(5) There are two types of hyperhidrosis, primary and secondary. Primary focal hyperhidrosis refers to excessive sweating that is not caused by another medical condition and usually affects the axillae, palms, soles, face, and head. Secondary generalized hyperhidrosis is defined as excessive sweating caused by another medical condition or as a side effect of medication(s).(6)

Diagnosis of primary focal hyperhidrosis should be made only after excluding secondary causes of excessive sweating.(2,3) The following are recommended diagnosis criteria for primary focal hyperhidrosis:(2,6)

Focal, visible, excessive sweating of at least 6 months duration without apparent cause with at least two of the following characteristics:
- Bilateral and relatively symmetric
- Impairs daily activities
- Frequency of at least one episode per week
- Age of onset less than 25 years
- Positive family history
- Cessation of focal sweating during sleep

The first line therapy for axillary hyperhidrosis is topical antiperspirants.(2,4) Treatment with prescription antiperspirants (e.g., 20% aluminum chloride hexahydrate) may provide adequate therapy for individuals who have failed to respond to nonprescription antiperspirants, though “clinical strength” 20% aluminum zirconium trichlorohydrex products are now available over-the-counter.(4) Second line therapy includes botulinum toxin injection, topical glycopyrronium, and microwave thermolysis.(2,4) For patients who cannot be managed with first or second lines of therapy, alternative therapies (suction curettage, followed by systemic agents, then endoscopic thoracic sympathectomy) may be considered.(4)

Glycopyrronium cloth was studied in two randomized, vehicle-controlled, multicenter trials involving 697 patients. The co-primary endpoints were the proportion of subjects having at least a 4-point improvement from baseline in the weekly mean Axillary Sweating Daily Diary (ASDD) item #2 (a patient reported outcome instrument scored from 0 [no sweating] to 10 [worst possible sweating]) score at Week 4 and the mean absolute change from baseline in gravimetrically measured sweat production at Week 4. Both trials found that more patients in the glycopyrronium tosylate groups achieved the specified ASDD measure of response than in the vehicle groups; pooled response rates were 60 versus 28 percent. In the second trial, patients in the glycopyrronium tosylate group had a greater mean absolute change in sweat production compared with the vehicle group.(1)

Safety

Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).(1)

Sofdra is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Sofdra (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).(7)

REFERENCES

Number	Reference
1	Qbrexza prescribing information. Journey Medical Corporation. November 2022.
2	Hornberger J, Grimes K, Naumann M, et al. Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-286.
3	Diagnosis Guidelines. International Hyperhidrosis Society: Official Site. Available at: https://www.sweathelp.org/about-hyperhidrosis/diagnosis-guidelines.html.
4	Primary Focal Axillary Hyperhidrosis Clinical Guideline. International Hyperhidrosis Society: Official Site. Available at: https://www.sweathelp.org/treatments-hcp/clinical-guidelines/primary-focal-hyperhidrosis/primary-focal-axillary.html.
5	Defining Hyperhidrosis. International Hyperhidrosis Society: Official Site. Available at: https://www.sweathelp.org/home/defining-hyperhidrosis.html.
6	Two Types of Hyperhidrosis. International Hyperhidrosis Society: Official Site. Available at: https://www.sweathelp.org/home/types-of-hyperhidrosis.html.
7	Sofdra prescribing information. Botanix SB Inc. June 2024.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

Qbrexza	glycopyrronium tosylate pad	2.4 %	M ; N ; O ; Y	N
Sofdra	sofpironium bromide gel	12.45 %	M ; N ; O ; Y	N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

Qbrexza	Glycopyrronium Tosylate Pad 2.4% (Base Equivalent)	2.4 %	30	Each	30	DAYS
Sofdra	sofpironium bromide gel	12.45 %	1	Pump Bottles	30	DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Qbrexza	glycopyrronium tosylate pad	2.4 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Sofdra	sofpironium bromide gel	12.45 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Qbrexza	Glycopyrronium Tosylate Pad 2.4% (Base Equivalent)	2.4 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Sofdra	sofpironium bromide gel	12.45 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Initial Evaluation Target Agent(s) will be approved when ALL of the following are met: The patient has a diagnosis of primary axillary hyperhidrosis defined by BOTH of the following: Focal, visible, excessive sweating of at least 6 months duration without apparent cause AND TWO of the following characteristics: bilateral and relatively symmetric, impairs daily activities, frequency of at least one episode per week, age of onset less than 25 years, positive family history, cessation of focal sweating during sleep AND ONE of the following: The patient has tried and had an inadequate response to 20% aluminum based topical antiperspirant (e.g., Drysol, OTC) OR The patient has an intolerance or hypersensitivity to 20% aluminum based topical antiperspirant OR The patient has an FDA labeled contraindication to 20% aluminum based topical antiperspirant AND If the patient has an FDA approved indication, then ONE of the following: The patient’s age is within FDA labeling for the requested indication for the requested agent OR The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 3 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. Renewal Evaluation* Target Agent(s) will be approved when ALL of the following are met: The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND The patient has had clinical benefit with the requested agent AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

The patient has a diagnosis of primary axillary hyperhidrosis defined by BOTH of the following:
1. Focal, visible, excessive sweating of at least 6 months duration without apparent cause AND
2. TWO of the following characteristics: bilateral and relatively symmetric, impairs daily activities, frequency of at least one episode per week, age of onset less than 25 years, positive family history, cessation of focal sweating during sleep AND
ONE of the following:
1. The patient has tried and had an inadequate response to 20% aluminum based topical antiperspirant (e.g., Drysol, OTC) OR
2. The patient has an intolerance or hypersensitivity to 20% aluminum based topical antiperspirant OR
3. The patient has an FDA labeled contraindication to 20% aluminum based topical antiperspirant AND
If the patient has an FDA approved indication, then ONE of the following:
1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 3 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
The patient has had clinical benefit with the requested agent AND
The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Quantity limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR ALL of the following: The requested quantity (dose) exceeds the program quantity limit AND The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR ALL of the following: The requested quantity (dose) exceeds the program quantity limit AND The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND The prescriber has provided information in support of therapy with a higher dose for the requested indication Length of Approval: Initial: 3 months; Renewal: 12 months

Module

Clinical Criteria for Approval

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
ALL of the following:
1. The requested quantity (dose) exceeds the program quantity limit AND
2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
ALL of the following:
1. The requested quantity (dose) exceeds the program quantity limit AND
2. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: Initial: 3 months; Renewal: 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

ALBP _ Commercial _ CSReg _ Hyperhidrosis__PAQL _ProgSum_ 10-01-2024 _