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Hypoactive Sexual Desire Disorder (HSDD) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1118
This prior authorization applies Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
4/1/2023 |
1/1/2016 |
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Addyi® (flibanserin) Tablet |
Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
Limitations of Use:
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|
1 |
Vyleesi® (bremelanotide) Subcutaneous injection |
Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner. Limitations of Use:
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2 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Hypoactive Sexual Desire Disorder |
Hypoactive sexual desire disorder (HSDD) is the most common sexual dysfunction in women. It is associated with medical conditions, including depression, and negative emotional and psychological states. HSDD is defined as persistent and recurrent lack of motivation for sexual activity in women who report a loss of desire to initiate or participate in sexual activity with clinically significant personal distress for a minimum of 6 months. The International Society for the Study of Women’s Sexual Health recommends the use of the Decreased Sexual Desire Screener and/or a sexual history to accurately diagnosis and determine type of HSDD. Modifiable contributing factors (e.g. relationship dissatisfaction, stress, fatigue, problems related to arousal, pain, and orgasm) should also be evaluated.(3)
Although the underlying biological causes of HSDD remain unknown, generalized HSDD likely involves either a predisposition toward inhibitory processes or neuroadaptations that result in decreased excitation, increased inhibition, or a mixture of the two. Alterations in brain function and structure may be additionally modulated or reinforced by experience and behavior (experience-based neuroplasticity), further propagating the condition. This perspective is consistent with differential brain activity patterns and structural differences between women with and without HSDD.(3)
First line therapy for HSDD is education (including modification of any potentially contributing factors). This may include cognitive behavior therapy, couples counseling, and office-based counseling. Flibanserin is considered a second line option, according to the International Society for the Study of Women’s Sexual Health treatment algorithm.(3) |
Addyi-Efficacy(1) |
The efficacy of flibanserin for the treatment of HSDD in premenopausal women was established in three 24-week, randomized, double-blind, placebo-controlled trials (Studies 1, 2, and 3). The three trials included premenopausal women with acquired, generalized HSDD of at least 6 months duration. In the clinical trials, acquired HSDD was defined as HSDD that developed in patients who previously had no problems with sexual desire. Generalized HSDD was defined as HSDD that was not limited to certain types of stimulation, situations or partners. The patients were treated with ADDYI 100 mg once daily at bedtime (n equal to 1187) or placebo (n equal to 1188). The completion rate across these three trials was 69% and 78% for the ADDYI and placebo groups, respectively.
These trials each had two co-primary efficacy endpoints, one for satisfying sexual events (SSEs) and the other for sexual desire:
The three trials had a secondary endpoint that measured bother (a component of distress) related to sexual desire using Question 13 of the Female Sexual Distress Scale-Revised (FSDS-R). This question asks, “How often did you feel: Bothered by low sexual desire?” Patients assessed their sexual distress over a 7-day recall period and responded on a scale of 0 (never) to 4 (always). The desire domain of the Female Sexual Function Index (FSFI Desire) was also used as a secondary endpoint in Studies 1 and 2. In all three trials, ADDYI resulted in statistically significant improvement compared to placebo in the change from baseline in monthly SSEs at Week 24. In Study 1 and 2, there were no statistically significant differences between ADDYI and placebo for the eDiary sexual desire endpoint (change in baseline to Week 24). In contrast, in Study 3 there was statistically significant improvement in the change from baseline to Week 24 in sexual desire (using the FSFI Desire Domain) with ADDYI compared to placebo. The FSFI Desire Domain findings were consistent across all three trials as were the findings for the secondary endpoint that assessed distress using Question 13 of the FSDS-R. Additional analyses defined responders for each efficacy endpoint by anchoring change from baseline to end of treatment with the Patient's Global Impression of Improvement (PGI-I). The first analysis considered responders to be those who reported being “much improved” or “very much improved.” In this analysis, the absolute difference in the percentage of responders with ADDYI and the percentage of responders with placebo across the three trials was 8-9% for SSEs (29-39% for ADDYI; 21-31% for placebo), 10-13% for FSFI desire domain (43-48% for ADDYI; 31-38% for placebo), and 7-13% for FSDS-R Question 13 (21- 34% for ADDYI; 14-25% for placebo). The second analysis considered responders to be those who reported being at least minimally improved. The absolute difference in the percentage of responders with ADDYI and the percentage of responders with placebo across the three trials was 10-15% for SSEs (44-48% for ADDYI; 33-36% for placebo), 12-13% for FSFI desire domain (43-51% for ADDYI; 31-39% for placebo), and 9-12% for FSDS-R Question 13 (50-60% for ADDYI; 41-48% for placebo). |
Vylessi-Efficacy(2) |
The efficacy in premenopausal women was evaluated in two identical phase 3, randomized, double-blinded, placebo controlled trials. Both trials included premenopausal women with acquired, generalized HSDD of at least 6 months’ duration. A majority of patients (74% in Study 1 and 67% in Study 2) reported HSDD with concomitant decreased arousal. The trials consisted of two phases: a Core Study Phase (24-week placebo-controlled, double-blind treatment period) and an uncontrolled, 52-week Open-label Extension Study Phase. Study participants were randomized to subcutaneous injections of Vyleesi 1.75 mg (n= 635) or placebo (n= 632), self-administered by an autoinjector on an as-needed basis. Patients were instructed to administer the drug approximately 45 minutes prior to anticipated sexual activity. Patients were not to administer more than one dose within a 24-hour period and no more than twelve doses per month. The mean duration of HSDD was approximately 4 years. Across the two trials, the median number of Vyleesi injections was 10 in the 24-week double-blind treatment period and 12 during the uncontrolled open-label extension. Most patients used Vyleesi two to three times per month and no more than once a week. Study 1 and Study 2 had the following co-primary efficacy endpoints:
For patients who completed the double-blind treatment period, the EOS visit occurred at Week 24. In both studies, Vyleesi showed a statistically significant increase in the FSFI Desire Domain score and a statistically significant decrease in the FSDS-DAO Q13 score from baseline to the EOS visit compared to placebo. The magnitude of the treatment differences was similar in both studies. There was no significant difference between treatment groups in the change from baseline to end of study visit in the number of satisfying sexual events (SSEs), a secondary endpoint. |
Safety(1,2) |
Addyi carries the following boxed warning:
Addyi carries the following contraindications:
Vyleesi is contraindicated in patients:
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REFERENCES
Number |
Reference |
1 |
Addyi prescribing information. Sprout Pharmaceuticals Inc. September 2021. |
2 |
Vyleesi prescribing information. AMAG Pharmaceuticals, Inc. October 2020. |
3 |
Clayton, Anita H, et al. “The International Society for the Study of Women’s Sexual Health Process of Care for Management of Hypoactive Sexual Desire Disorder in Women.” Mayo Clinic Proceedings, vol. 93, no. 4, 12 Mar. 2018, pp. 467–487., doi: https://doi.org/10.1016/j.mayocp.2017.11.002. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
|
||||||
Addyi |
flibanserin tab |
100 MG |
M ; N ; O ; Y |
N |
|
|
Vyleesi |
bremelanotide acet subcutaneous soln auto-inj |
1.75 MG/0.3ML |
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 |
Days Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Effective Date |
|
||||||||||
Addyi |
flibanserin tab |
100 MG |
30.0 |
TABS |
30 |
Days |
|
|
|
|
Vyleesi |
bremelanotide acet subcutaneous soln auto-inj |
1.75 MG/0.3ML |
6.0 |
PENS |
30 |
Days |
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Addyi |
flibanserin tab |
100 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Vyleesi |
bremelanotide acet subcutaneous soln auto-inj |
1.75 MG/0.3ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Addyi |
flibanserin tab |
100 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Vyleesi |
bremelanotide acet subcutaneous soln auto-inj |
1.75 MG/0.3ML |
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: 8 weeks
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity Limits for the Target Agent(s) will be approved when the requested quantity (dose) does NOT exceed the program quantity limit Length of Approval: Initial: 8 weeks; 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.
Commercial _ PS _ Hypoactive Sexual Desire Disorder (HSDD) Prior Authorization with Quantity Limit _ProgSum_ 4/1/2023