Genitourinary System

Tier-1 products are covered with no authorization necessary.

Tier-2 Approval Criteria:

• An FDA approved diagnosis; and
• A 4-week trial of 2 Tier-1 medications from different pharmacological classes within the past 90 days; or
• Documented adverse effect, drug interaction, or contraindication to all available Tier-1 medications.

Tier-3 Approval Criteria:

• An FDA approved diagnosis of Benign Prostatic Hyperplasia (BPH); and
• A 4-week trial of at least 2 Tier-1 medications from different pharmacological classes; and
• A 4-week trial of all Tier-2 medications within the past five months; or
• Documented adverse effect, drug interaction, contraindication, or lack of efficacy to all available Tier-1 and Tier-2 medications.
• Authorization for Cialis® (tadalafil) will be granted for the 5mg tablets only.

Entadfi® (Finasteride 5mg/Tadalafil 5mg) Approval Criteria:

• An FDA approved diagnosis of benign prostatic hyperplasia (BPH); and
• A patient-specific, clinically significant reason why all lower tiered medications are not appropriate for the member must be provided; and
• A patient-specific, clinically significant reason why the member cannot use the individual components (finasteride and tadalafil) must be provided; and
• A quantity limit of 30 capsules per 30 days will apply.
• Maximum treatment duration of 26 weeks will apply.

Tezruly™ (Terazosin Oral Solution) Approval Criteria:

• An FDA approved diagnosis of benign prostatic hyperplasia (BPH) or hypertension (HTN); and
• A patient specific, clinically significant reason why the member cannot use terazosin capsules must be provided; and
• For a diagnosis of BPH, a patient specific, clinically significant reason why the member cannot use Rapaflo^® (silodosin), which may be opened and sprinkled on applesauce for patients with difficulties swallowing, must be provided; and
• A quantity limit of 600mL per 30 days will apply.      

Filspari^® (Sparsentan) Approval Criteria [Immunoglobulin A Nephropathy (IgAN) Diagnosis]:

• An FDA approved indication to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression; and
• The diagnosis of primary IgAN must be confirmed by the following:
  • Kidney biopsy (can refer to a recent or historical biopsy); and
  • Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); and
• Member must be 18 years of age or older; and
• Must be prescribed by a nephrologist (or an advanced care practitioner with a supervising physician who is a nephrologist); and
• Member must be at risk of disease progression as demonstrated by proteinuria ≥0.5g/day (or equivalent); and
• Member must have previously tried and failed an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for at least 3 months, unless contraindicated or intolerant; and
• Prescriber must verify the member will not use other renin-angiotensin-aldosterone system (RAAS) inhibitors and endothelin receptor antagonists (ERAs) concurrently with Filspari^®; and
• Prescriber must evaluate the potential for drug interactions according to package labeling, prior to and during treatment with Filspari^®; and
• Females of reproductive potential must have a negative pregnancy test prior to initiation of therapy and must agree to use effective contraception during treatment and for 2 weeks after the last dose of Filspari^®; and
• Prescriber, pharmacy, and member must be enrolled in the Filspari^® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
• A quantity limit of 30 tablets per 30 days will apply.

Filspari^® (Sparsentan) Approval Criteria [Focal Segmental Glomerulosclerosis (FSGS) Diagnosis]:

• An FDA approved indication to reduce proteinuria in members with FSGS; and
• Member must be 8 years of age or older; and
• The diagnosis of FSGS must be confirmed by 1 of the following:
  • Kidney biopsy (can refer to a recent or historical biopsy); or
  • A genetic mutation known to cause FSGS (results of genetic testing must be submitted); and
• Member must not have nephrotic syndrome; and
• Must be prescribed by a nephrologist (or an advanced care practitioner with a supervising physician who is a nephrologist); and
• Member must have previously tried and failed an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for at least 3 months, unless contraindicated or intolerant; and
• Prescriber must verify the member will not use other renin-angiotensin-aldosterone system (RAAS) inhibitors and endothelin receptor antagonists (ERAs) concurrently with Filspari^®; and
• Prescriber must evaluate the potential for drug interactions according to package labeling, prior to and during treatment with Filspari^®; and
• Females of reproductive potential must have a negative pregnancy test prior to initiation of therapy and must agree to use effective contraception during treatment and for 2 weeks after the last dose of Filspari^®; and
• Prescriber, pharmacy, and member must be enrolled in the Filspari^® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
• Quantity limits will apply as follows:
  • 200mg tablets: A quantity limit of 30 tablets per 30 days will apply; and
  • 400mg tablets: A quantity limit of 60 tablets per 30 days will apply. 

Tarpeyo^® [Budesonide Delayed Release (DR) Capsule] Approval Criteria:

• An FDA approved indication to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression; and
• The diagnosis of primary IgAN must be confirmed by the following:
  • Kidney biopsy (can refer to a recent or historical biopsy); and
  • Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); and
• Member must be 18 years of age or older; and
• Must be prescribed by a nephrologist (or advanced care practitioner with a supervising physician who is a nephrologist); and
• Member must be at risk of disease progression as demonstrated by proteinuria ≥0.5g/day (or equivalent); and
• Approval duration will be for 9 months. The safety and efficacy of Tarpeyo^® have not been established beyond 9 months of treatment. For continued authorization consideration after 9 months of treatment, a patient-specific, clinically significant reason why a longer treatment duration is medically necessary for the member must be provided; and
• A quantity limit of 120 capsules per 30 days will apply.

Vanrafia™ (Atrasentan) Approval Criteria:

• An FDA approved indication to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression; and
• The diagnosis of primary IgAN must be confirmed by the following:
  • Kidney biopsy (can refer to a recent or historical biopsy); and
  • Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); and
• Member must be 18 years of age or older; and
• Must be prescribed by a nephrologist (or an advanced care practitioner with a supervising physician who is a nephrologist); and
• Member must be at risk of disease progression as demonstrated by proteinuria ≥0.5g/day (or equivalent); and
• Member must have previously tried and failed an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for at least 3 months alone, and member must agree to continue the use of an ACE or an ARB with Vanrafia™, unless contraindicated or intolerant; and
• Prescriber must evaluate the potential for drug interactions according to package labeling, prior to and during treatment with Vanrafia^®; and 
• Females of reproductive potential must have a negative pregnancy test prior to initiation of therapy and must agree to use effective contraception during treatment and for 2 weeks after the last dose of Vanrafia™; and
• Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.

Voyxact^® (Sibeprenlimab-szsi) Approval Criteria:

• An FDA approved indication to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression; and
• The diagnosis of primary IgAN must be confirmed by the following:
  • Kidney biopsy (can refer to a recent or historical biopsy); and
  • Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); and
• Member must be 18 years of age or older; and
• Must be prescribed by a nephrologist (or an advanced care practitioner with a supervising physician who is a nephrologist); and
• Member must be at risk of disease progression as demonstrated by proteinuria ≥0.5g/day (or equivalent); and
• For member self-administration or caregiver administration, the prescriber must verify the member or caregiver will be trained by a health care provider on proper administration and storage of Voyxact^®; and
• Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.