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Nocturia Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1102
This prior authorization applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10/1/2022 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Nocdurna® (desmopressin acetate) Tablet |
Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Nocturia |
The International Continence Society (ICS) defines nocturia as the complaint that the individual wakes at night one or more times to void. Nocturnal polyuria occurs when an increased proportion of the 24-hour urine output occurs at night.(2) Evidence suggests nocturia becomes bothersome to patients at two or more voids per night.(3) The prevalence of nocturia is equal in both genders, however age distribution differs between genders. One-third of young women (18-29 years old) in a study reported nocturia at least once per night, compared to 1 in 9 of young men. Moreover, the prevalence of nocturia increases with age twice as rapidly in men compared to women. By the sixth decade of life, the percentage of nocturia reported in both genders is the same. Population studies have confirmed that nocturia increases with age and is common in the elderly. It was found that the majority of elderly men and women experience clinically significant nocturia: 29% to 59.3% in men and 28.3 to 61.5% in women aged greater than or equal to 70 years experienced 2 or more voids per night.(3) Evaluation for nocturia should focus on patterns of fluid intake, other urinary symptoms, symptoms of possible underlying causes, and a focused physical examination. Nocturnal polyuria is defined as the excretion of greater than or equal to 35% of the 24-hour urine output during the hours of sleep. Management of nocturia may require multifaceted approach. Treatment of underlying medical conditions should be optimized and may reduce nocturia symptoms. Nocturia has been associated with many comorbidities including hypertension, diabetes, obstructive sleep apnea, and major depressive disorder.(3) First line management of nocturia involves behavior modifications such as reduction in alcoholic or caffeinated beverages, afternoon naps, compression stockings, and restriction of evening fluid intake.(3,4) Several pharmacologic options are used for nocturia. 5-alpha reductase inhibitors (i.e., dutasteride, finasteride) are commonly used in men for treatment of prostatic obstruction and lower urinary tract symptoms. Alpha-blockers (i.e., alfuzosin, doxazosin, tamsulosin, terazosin) have shown modest effects on nocturia. Anticholinergic agents (i.e., oxybutynin, tolterodine) are useful in treatment of overactive bladder and also used in the treatment of nocturia.(3,4) Loop diuretics (i.e., furosemide, bumetanide) are also used to regulate urine production in the daytime in order to decrease urine production during sleep.(4) Desmopressin use aims to increase vasopressin in patients with nocturia, which results in reduced urine production by the kidneys.(3,4) Desmopressin therapy is not recommended for use in patients with baseline hyponatremia or impaired renal function (eGFR less than 60mL/min).(3) |
Efficacy |
One hundred and twenty-seven people, with greater than or equal to 2 voids nightly, were randomized to receive either an escalating dose of desmopressin or placebo. After 3 weeks, a clinically significant reduction (greater than 50% reduction in mean number of voids) was found in 33% of the treatment arm, compared to 11% of the placebo arm (P = 0.0014).(4) A study examined the efficacy of desmopressin, which was maintained for the duration of long-term treatment. Patients taking varying doses (25, 50, or 100 micrograms) of desmopressin sublingual “melt” tablets for 52 weeks had a mean decrease in the number of nocturnal voids of 1.4, 1.8, and 2.1 voids, respectively.(4) For Nocdurna, two studies were completed, one for women and one for men. In Study 1, 237 women with nocturia were randomized to receive Nocdurna 27.7mcg (n=121) or placebo (n=116) every night one hour before bedtime for 3 months. In Study 2, 230 men with nocturia were randomized to receive Nocdurna 55.3 mcg (n=102) or placebo (n=128) every night one hour before bedtime for 3 months. In both studies, endpoints were 1) the change in number of nocturia episodes per night from baseline and 2) a “33% responder status”, which was defined as a subject with a decrease of at least 33% in the mean number of nocturnal voids compared to baseline. In Study 1, Nocdurna patients had a -1.5 change from a baseline of 2.9 versus -1.2 for placebo. This equated to a -0.3 difference from placebo with a 95% CI of -0.5, -0.1. Probability of 33% responder status was 0.78 for Nocdurna compared to 0.62 with placebo, leading to a 2.15 odds ratio with a 95% CI of 1.36, 3.41. In Study 2, Nocdurna patients had a -1.3 reduction from a baseline of 3.0. Placebo patients had a reduction of -0.9, leading to a -0.4 difference from placebo (95% CI=-0.6 to -0.2). Probability of 33% responder status was 0.67 on Nocdurna versus 0.50 on placebo, leading to an odds ratio of 2.02 (95% CI=1.30, 3.14).(1) |
Safety |
Nocdurna has a boxed warning for hyponatremia. Nocdurna is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids. Ensure serum sodium concentration is normal before starting or resuming Nocdurna. Measure serum sodium within 1 week and approximately 1 month after initiating therapy, and periodically during treatment (and more frequently in patients 65 years of age and older and in patients at increased risk of hyponatremia). If hyponatremia occurs, Nocdurna may need to be temporarily or permanently discontinued.1 A normal serum sodium level is between 135 and 145 mEq/L or mmol/L. Nocdurna is contraindicated in patients with the following conditions due to an increased risk of severe hyponatremia:(1)
Nocdurna is contraindicated in patients with the following conditions because of fluid retention increases the risk of worsening the underlying condition:(1)
Nocdurna is not recommended for the treatment of nocturia in pregnant women. Nocturia is usually related to normal, physiologic changes during pregnancy that do not require treatment with Nocdurna.(1) |
REFERENCES
Number |
Reference |
1 |
Nocdurna prescribing information. Ferring Pharmaceuticals. November 2020. |
2 |
Abrams P, Cardozo L, Fall M, et al. The Standardisation of Terminology in Lower Urinary Tract Function: Report from the Standardisation Sub-Committee of the International Continence Society. Urology. 2003;61(1):37-49. |
3 |
Weiss JP, Everaert K. Management of Nocturia and Nocturnal Polyuria. Urology. 2019 Nov;133:24-33. |
4 |
Johnson TM, et al. Nocturia: Clinical Presentation, Evaluation, and Management in Adults. UpToDate. Literature review current through February 2022. Last updated January 2021. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Agent Names |
Strength |
Targeted MSC |
Available MSC |
Effective Date |
|
||||
NOCDURNA*desmopressin acetate sublingual tab |
27.7 MCG ; 55.3 MCG |
M ; N ; O ; Y |
N |
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Agent GPI |
Agent Names |
Strength |
QL Amount |
Dose Form |
Days Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Effective Date |
|
||||||||||
302010101007 |
NOCDURNA*desmopressin acetate sublingual tab |
27.7 MCG ; 55.3 MCG |
30.0 |
TABS |
30 |
Days |
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Agent Names |
Strength |
Client Formulary |
NOCDURNA*desmopressin acetate sublingual tab |
27.7 MCG ; 55.3 MCG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Agent Names |
Strength |
Client Formulary |
NOCDURNA*desmopressin acetate sublingual tab |
27.7 MCG ; 55.3 MCG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
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: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria
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 Limits for the Target Agent will be approved when ONE of the following is met:
Length of Approval: 12 months |
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
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.
BCBSAL _ PS _ Nocturia Prior Authorization with Quantity Limit _ProgSum_ 10/1/2022 _