ENTADFI (finasteride and tadalafil)

ENTADFI (finasteride and tadalafil)

Self-Administration – oral

Diagnosis considered for coverage:

• Indicated to initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks
• Limitations of Use:
  • Entadfi is not recommended for more than 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit beyond 26 weeks is unknown

Coverage Criteria:

For diagnosis of BPH:

• Dose does not exceed finasteride 5 mg and tadalafil 5 mg once daily; AND
• Chart notes document a diagnosis of benign prostatic hyperplasia; AND
• Trial and failure, contraindication, or intolerance to an alpha-blocker (e.g., alfuzosin, doxazosin, tamsulosin, terazosin, silodosin); AND
• Trial and failure, contraindication, or intolerance to a 5 alpha-reductase inhibitor (e.g., finasteride, dutasteride); AND
• Medical records document a medical reason why the individual agents cannot be used

Coverage Duration: 

• Max treatment duration: 26 weeks

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

• Erectile dysfunction
• Alopecia

Additional Information: 

• Recommended dose: finasteride 5 mg and tadalafil 5 mg once daily for up to 26 weeks
• Contraindications
  • Concomitant use of any form of organic nitrate, either regularly and/or intermittently. Entadfi can potentiate the hypotensive effect of nitrates
  • Patients with known hypersensitivity to finasteride, tadalafil, or to any of the components of Entadfi. Hypersensitivity reactions have included Stevens-Johnson syndrome, exfoliative dermatitis, pruritis, urticaria, and angioedema
  • Pregnancy
  • Concomitant use with a guanylate cyclase (GC) stimulator. Entadfi may potentiate the hypotensive effects of GC stimulators

Policy Updates:

• 3/1/2023 – New policy approved by P&T

References:

• Entadfi Prescribing Information. Veru, Inc. Miami, FL. December 2021.