Does TRICARE Cover Finasteride? Coverage, Prior Auth, and Appeal Guide

At a glance

  • Drug class / 5-alpha reductase inhibitor that blocks conversion of testosterone to DHT [3]
  • 1 mg tablet / Propecia, NDA 020788, approved 12/19/1997; male pattern hair loss in men only [1][3]
  • 5 mg tablet / Proscar, NDA 020180, approved 06/19/1992; symptomatic BPH [2][4]
  • Generics / FDA-approved ANDAs for both strengths, with the same labeled risks
  • Other forms / Drugs@FDA entries list oral tablets; no FDA-approved topical or injectable finasteride [1][2]
  • Prescription status / Prescription-only [1][2]
  • TRICARE coverage / Not addressed in the FDA records or labels

Two tablets, two approvals, two indications

Finasteride is a competitive inhibitor of Type II 5-alpha-reductase, the enzyme that converts testosterone to dihydrotestosterone. It has no affinity for the androgen receptor [3].

In the United States it is sold as two distinct approved products with different indications. The 1 mg tablet is Propecia (NDA 020788), first approved 12/19/1997 and held by Organon [1]. It is indicated for male pattern hair loss in men only [3]. The 5 mg tablet is Proscar (NDA 020180), first approved 06/19/1992 and held by Organon [2]. It is indicated for symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate [4]. Both are prescription-only [1][2].

A 1 mg prescription and a 5 mg prescription name different products, different strengths and different labeled uses.

What the 1 mg tablet is labeled for

Propecia, the label for finasteride 1 mg, is indicated for male pattern hair loss (androgenetic alopecia), and efficacy in bitemporal recession has not been established [3]. The dose is one 1 mg tablet once daily, with or without meals. Daily use for three months or more is usually necessary before benefit is observed, and continued use is recommended to sustain benefit [3].

Pregnancy is a contraindication to finasteride, and contact with crushed or broken tablets can pose a risk to a male fetus [3].

In two 1-year trials of 1,553 men aged 18 to 41, hair count in a 1-inch (5.1 cm2) circle of balding vertex scalp rose 107 hairs above placebo at one year and 138 above placebo at two years, from a baseline of 876 hairs (P<0.001); the placebo group continued to lose hair [5].

What the 5 mg tablet is labeled for

Proscar is indicated to improve symptoms of BPH, reduce the risk of acute urinary retention, and reduce the risk of surgery including TURP and prostatectomy; with the alpha-blocker doxazosin it is indicated to reduce the risk of symptomatic BPH progression [4]. The label states a limitation of use: Proscar is not approved for the prevention of prostate cancer [4].

The dose is one 5 mg tablet once daily, with or without meals [4].

Generics and other forms

Generic finasteride 1 mg and 5 mg are FDA-approved under many ANDAs, and generics carry the same labeled risks as the brands. Drugs@FDA lists only oral tablets for finasteride, and no topical or injectable finasteride is FDA-approved [1][2].

Frequently asked questions

Which finasteride strength is approved for hair loss?
The 1 mg tablet (Propecia) is indicated for male pattern hair loss in men only, and efficacy in bitemporal recession has not been established [3].
Which finasteride strength is approved for BPH?
The 5 mg tablet (Proscar) is indicated for symptomatic BPH in men with an enlarged prostate, and it is not approved to prevent prostate cancer [4].
Is generic finasteride the same as the brand?
Generic finasteride 1 mg and 5 mg are FDA-approved under many ANDAs and carry the same labeled risks as the brand products.
Is topical finasteride FDA-approved?
No. Drugs@FDA lists only oral finasteride tablets, and no topical or injectable finasteride is FDA-approved [1][2].

References

  1. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. U.S. National Library of Medicine, DailyMed. Propecia (finasteride 1 mg) tablets, Organon prescribing information. Propecia (finasteride 1 mg) tablets, Organon label
  4. U.S. National Library of Medicine, DailyMed. Proscar (finasteride 5 mg) tablets, Organon prescribing information. Proscar (finasteride 5 mg) tablets, Organon label
  5. Kaufman KD, Olsen EA, Whiting D, Savin R, DeVillez R, Bergfeld W, et al. Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male Pattern Hair Loss Study Group. J Am Acad Dermatol. 1998;39(4 Pt 1):578-89. Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male Pattern Hair Loss Study Group
Evidence overview for Does TRICARE Cover Finasteride? Coverage, Prior Auth, and Appeal Guide