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:

• 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; 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), despite 3 months of maximal supportive care; and
• Member must be on a stable dose of a maximally tolerated 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 discontinue use of renin-angiotensin-aldosterone system (RAAS) inhibitors and endothelin receptor antagonists (ERAs) prior to initiating treatment with Filspari^®; and
• Member must not be taking strong CYP3A4 inhibitors (e.g., itraconazole) or strong CYP3A4 inducers (e.g., rifampin) concomitantly with Filspari^®; and
• Member must not be taking H2 receptor blockers or proton pump inhibitors (PPIs) concomitantly with Filspari^®; and
• If member is using antacids, they must agree to separate antacid and Filspari^® administration by 2 hours; 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.

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; 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
• Member must be on a stable dose of a maximally-tolerated angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB), unless contraindicated or intolerant; 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; 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), despite 3 months of maximal supportive care; and
• Member must be on a stable dose of a maximally tolerated angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for at least 3 months, unless contraindicated or intolerant; 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.