Vyleesi (bremelanotide) prior authorization form coverage criteria
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This document is a prior authorization request form for Vyleesi (bremelanotide) for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal females; it governs information providers must supply to request initial or reauthorization of therapy from Highmark West Virginia.
No material clinical or coverage changes in this revision.
Coverage Criteria and Form Requirements
Form-based coverage considerations
Coverage consideration requires completion of and answers to the following fields on the form
All fields required on the form
If related, document on the form
Form asks these three items to support need for pharmacotherapy
Yes/No question on form
Requested Diagnosis and Codes
| Diagnosis/ICD-10 | Requested field for diagnosis and/or ICD-10 code(s) (no specific codes provided on form) |
Provider Actions, Submission, and Prior Authorization
Prior Authorization Required
Prior authorization is required. Complete the medication and clinical information sections confirming premenopausal status and diagnosis, and include all requested medication details and supporting clinical documentation when submitting the request.
- Complete ALL sections of the form, including member and provider information, medication name, strength, quantity, day supply, directions, and diagnosis/ICD-10 code(s).
- Confirm whether the member is a premenopausal female and whether the member has a diagnosis of HSDD.
- If HSDD is present, indicate whether the diagnosis is related to other medical/psychiatric conditions or medications, and complete the behavioral therapy assessment questions (candidate for behavioral therapy, enrollment status, and therapeutic failure).
- For reauthorization requests, provide information about clinical response (improved sexual desire from baseline while on therapy).
- Attach prior medication history and any other clinical documentation required to support medical necessity.
Behavioral Therapy Assessment
Assess and document the member's behavioral therapy status for HSDD. Indicate whether the member is a candidate for behavioral therapy, whether they are currently enrolled, and whether they have had therapeutic failure with behavioral therapy.
- Was the member a candidate for behavioral therapy for HSDD? (Yes/No)
- Is the member currently enrolled in behavioral therapy for HSDD? (Yes/No)
- Has the member experienced therapeutic failure with behavioral therapy for HSDD? (Yes/No)
Required Documentation and Submission
Submit the completed form with all required member and provider information, medication details, clinical responses, signature, and supporting documentation to the specified fax or mailing address. Follow the instructions for completing and submitting the form.
- Submit a separate form for each medication.
- Fax the completed form and all clinical documentation to 1-866-240-8123.
- Or mail the form to: 120 Fifth Avenue, SPECARE, Pittsburgh, PA 15222.
- Provide physician address (required for physician notification) and ensure legible printing in blue or black ink.
- The prescribing physician (PCP or Specialist) should, in most cases, complete the form.
Provider Actions — Payment and Eligibility
Payment is subject to member eligibility. An authorization, if granted, does not guarantee payment; final payment is determined at claim adjudication based on eligibility, benefits, and any applicable medical necessity review.
- The submitting provider certifies the information is true, accurate, and complete and that the requested services are medically indicated and necessary.
- Authorization does not guarantee payment; eligibility and benefits at the time of service will determine payment.
Background
This prior authorization request form is intended for premenopausal females with hypoactive sexual desire disorder (HSDD) who are being considered for treatment with Vyleesi (bremelanotide). The form collects necessary member and provider identifying information, specific medication details (drug name, strength, requested quantity and day supply, directions, and diagnosis/ICD-10), and targeted clinical information to confirm the member’s eligibility and clinical need for therapy.
Key clinical questions on the form require confirmation that the member is a premenopausal female and has a diagnosis of HSDD, assessment of whether HSDD is related to co-existing medical/psychiatric conditions, relationship problems, or medication/substance effects, and documentation regarding behavioral therapy (whether the member is a candidate for behavioral therapy, currently enrolled, or has experienced therapeutic failure).
For reauthorization requests the form specifically asks whether the member is experiencing improved sexual desire from baseline while on Vyleesi, which must be documented to support continuation of therapy. Providers must follow the form instructions for submission (fax to 1-866-240-8123 or mail to the SPECARE address) and complete all required fields to allow coverage consideration.
Definitions
Initial Therapy Requirements
Initial therapy requirements
Initial authorization requires clinical and medication details
See Medication Information and Medication History sections on the form
Answered via form clinical questions
If related, documentation should be provided
Behavioral therapy status is queried on the form and supports need for pharmacotherapy
Medication History section required; provider must certify accuracy
Reauthorization / Continuation Criteria
Reauthorization criteria
Reauthorization requests are approved when documentation shows clinical benefit while on therapy
Answered on the Reauthorization section of the form
Authorization does not guarantee payment; payment subject to member eligibility
Step Therapy and Behavioral Therapy Requirement
| Requirement | Form question / documentation | Coverage implication |
|---|---|---|
| Is the member a candidate for behavioral therapy for HSDD? (Yes/No) | ||
| Is the member currently enrolled in behavioral therapy for HSDD? (Yes/No) | ||
| Has the member experienced therapeutic failure in behavioral therapy for HSDD? (Yes/No) |
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