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Table 19: Benign Prostatic Hyperplasia (BPH) Agents


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


Drug Category: Men’s Health

Medication Class/Individual Agents: Alpha-1 Blockers, 5-Alpha-Reductase Inhibitors, & Phosphodiesterase Inhibitors

I. Prior-Authorization Requirements

 Benign Prostatic Hyperplasia (BPH) Agents – 5-Alpha-Reductase Inhibitors

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

dutasteride Avodart test   # , M90
finasteride Proscar test   # , M90

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

FDA-approved indications:

  • Hypertension: doxazosin, prazosin, terazosin
  • BPH: alfuzosin, doxazosin, silodosin, tadalafil, tamsulosin, terazosin

Dose and administration:

  • Doxazosin, prazosin, and terazosin: take first dose and subsequent first increased dose at bedtime to minimize lightheadedness and syncope.
  • Titrate to therapeutic maintenance doses to minimize dizziness and orthostatic hypotension.
  • If therapy is discontinued or interrupted for two or more days, reinstitute therapy cautiously.
 

 Benign Prostatic Hyperplasia (BPH) Agents – Alpha-1 Blockers

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

alfuzosin extended-release test   M90
doxazosin extended-release Cardura XL test  
doxazosin immediate-release Cardura test   # , M90
prazosin Minipress test   # , M90
silodosin Rapaflo PA   M90
tamsulosin Flomax test   # , M90
terazosin test   M90

 Benign Prostatic Hyperplasia (BPH) Agents – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

dutasteride / tamsulosin Jalyn PA   M90
finasteride / tadalafil Entadfi PA  

 Benign Prostatic Hyperplasia (BPH) Agents – Phosphodiesterase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

tadalafil tablet-Cialis Cialis PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
M90 Mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • BPH
  • status post-transurethral resection of the prostate (TURP) with persistent urinary symptoms

Non-FDA-approved, for example:

  • kidney stones

Note: The above lists may not include all FDA-approved and non-FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

  

dutasteride/tamsulosin

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: alfuzosin, doxazosin, tamsulosin, or terazosin; or
    • inadequate response (defined as ≥ 90 days of therapy), adverse reaction, or contraindication to finasteride; and
    • medical necessity for use of the combination product instead of the commercially available separate agents. 

      

Entadfi

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ one unit/day; and
    • medical necessity for use of the combination product instead of the commercially available separate agents; and
    • one of the following: 
      • requested duration of therapy is ≤ 26 weeks; or
      • medical necessity for use beyond 26 weeks of therapy.

      

silodosin

  • Documentation of the following is required for a diagnosis of BPH or TURP:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response, adverse reaction, or contraindication to both of the following: alfuzosin, tamsulosin; and
    • requested quantity is ≤ one unit/day.
  • Documentation of the following is required for a diagnosis of kidney stones:
    • appropriate diagnosis; and
    • prescriber is a urologist; and
    • inadequate response, adverse reaction, or contraindication to both of the following: a calcium channel blocker, tamsulosin; and
    • requested duration of therapy is ≤ 60 days.

SmartPA: Claims for silodosin at a quantity of ≤ one unit/day will usually process at the pharmacy without a PA request if the member is ≥ 18 years of age, has a history of MassHealth medical claims for BPH or status post TURP, and has a history of paid MassHealth pharmacy claims for alfuzosin and tamsulosin or a history of MassHealth medical claims for swallowing disorder.

 

tadalafil

  • Documentation of the following is required:
    • diagnosis of BPH; and
    • member is ≥ 18 years of age; and
    • requested strength is 5 mg daily; and
    • requested quantity is ≤ one unit/day.

 

 

Please Note: The MassHealth agency does not pay for any drug when used for the treatment of sexual dysfunction as described in 130 CMR 406.413(B) “Limitations on Coverage of Drugs – Drug Exclusions” (see link below).

 

 https://www.mass.gov/regulations/130-CMR-406000-pharmacy-services

 

 

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 04/2003

Last Revised Date: 03/2024


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Last updated 05/16/24

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