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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 |
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)
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:
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:
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:
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 _
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