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Table 12: Antihistamines


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Drug Category: Cough/Cold/Allergy

Medication Class/Individual Agents: Antihistamines

I. Prior-Authorization Requirements

 First Generation (Nonselective) Antihistamines – Alkylamines

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

chlorpheniramine test   *, A90
dexchlorpheniramine solution PA   A90

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.

OTC

  • Some of the former prescription antihistamines are now available over-the-counter (OTC).

Combinations of antihistamines and decongestants (for example, chlorpheniramine/pseudoephedrine) may be payable under MassHealth, but may not be listed in the antihistamine table. Please refer to the OTC drug list.

 

 First Generation (Nonselective) Antihistamines – Ethanolamines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

carbinoxamine 4 mg/5 mL solution, 4 mg tablet test   A90
carbinoxamine 6 mg tablet PA   A90
carbinoxamine extended-release Karbinal ER PA  
clemastine tablet test   A90
dimenhydrinate injection test  
diphenhydramine Benadryl   test   # , *, A90

 First Generation (Nonselective) Antihistamines – Phenothiazine

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

promethazine test   A90

 First Generation (Nonselective) Antihistamines – Piperazines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

hydroxyzine hydrochloride test   A90
hydroxyzine pamoate Vistaril test   # , A90

 First Generation (Nonselective) Antihistamines – Piperidines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

cyproheptadine test   A90

 Second Generation (Peripherally Selective) Antihistamines – Nasal Preparations

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

azelastine 0.15% nasal spray PA   A90
azelastine 137 mcg nasal spray test   A90
olopatadine nasal spray Patanase PA   A90

 Second Generation (Peripherally Selective) Antihistamines – Piperazines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

cetirizine / pseudoephedrine test   *, A90
cetirizine syrup, tablet test   *, M90
levocetirizine solution PA   M90
levocetirizine tablet test   # , M90

 Second Generation (Peripherally Selective) Antihistamines – Piperidines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

desloratadine / pseudoephedrine Clarinex-D PA  
desloratadine orally disintegrating tablet PA   M90
desloratadine tablet Clarinex PA   M90
fexofenadine / pseudoephedrine test   *, A90
fexofenadine tablet test   *, M90
loratadine / pseudoephedrine test   *, A90
loratadine tablet, solution test   *, M90
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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without PA.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 
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:

  • perennial or seasonal allergic rhinitis: oral/intranasal antihistamines
  • chronic idiopathic urticaria: oral antihistamines only
  • vasomotor (i.e., non-allergic) rhinitis: oral/intranasal agents

Note: The above list may not include all 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.

 

azelastine 0.15% (generic Astepro) and olopatadine (generic Patanase) nasal sprays

  • Documentation of all of the following is required:  
    • appropriate diagnosis; and
    • inadequate response (defined as ≥ 14 days of therapy), or adverse reaction to one, or contraindication to all intranasal corticosteroid agents; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to azelastine 137 mcg nasal spray.
  • For quantities greater than one bottle/30 days, in addition to the above criteria, documentation must be provided regarding an inadequate clinical response at the manufacturer's recommended doses.

SmartPA: Claims for one bottle/30 days of azelastine 0.15% nasal spray and olopatadine nasal spray will usually process at the pharmacy without a PA request if the member has MassHealth medical claims for allergic rhinitis or non-allergic rhinitis and a history of paid pharmacy claims for ≥ 14 days out of the last 180 days of one intranasal corticosteroid and azelastine 137 mcg nasal spray.

 

carbinoxamine 6 mg tablet and Karbinal ER

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response (defined as ≥ 14 days of therapy), or adverse reaction to one, or contraindication to all intranasal corticosteroid agents; and 
    • inadequate response (defined as ≥ 14 days of therapy), or adverse reaction to two, or contraindication to all nonselective antihistamines available without prior authorization; and
    • for Karbinal ER, inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to carbinoxamine immediate-release solution; and
    • for carbinoxamine 6 mg tablet, inadequate response or adverse reaction to carbinoxamine 4 mg tablet. 

 

Clarinex-D

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response (defined as ≥ 14 days of therapy), or adverse reaction to one, or contraindication to all intranasal corticosteroid agents (if the diagnosis is chronic idiopathic urticaria, a trial with an intranasal corticosteroid is not required); and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to both of the following: loratadine/pseudoephedrine and cetirizine/pseudoephedrine.

 

SmartPA: Claims for Clarinex-D will usually process at the pharmacy without a PA request if the member has MassHealth medical claims for allergic rhinitis or chronic idiopathic urticaria and a history of paid pharmacy claims for ≥ 14 days out of the last 180 days of loratadine/pseudoephedrine, cetirizine/pseudoephedrine, and an intranasal corticosteroid.

 

desloratadine tablet

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to one or contraindication to all of the following: cetirizine, fexofenadine, levocetirizine, and loratadine.

SmartPA: Claims for desloratadine tablets will usually process at the pharmacy without a PA request if the member has MassHealth medical claims for allergic rhinitis or chronic idiopathic urticaria and a history of paid pharmacy claims for ≥ 14 days out of the last 180 days for one of the following: loratadine tablets or liquid, cetirizine tablets or liquid, fexofenadine tablet, or levocetirizine tablet. 

desloratadine ODT and levocetirizine solution

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for use of requested agent as noted by one of the following:
      • member utilizes tube feeding (G-tube, J tube); or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • member is < 13 years of age; and
    • inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to two or contraindication to all of the following: cetirizine, levocetirizine, and loratadine.

 

dexchlorpheniramine solution

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two antihistamine solutions available without prior authorization.

  

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: 06/2003

Last Revised Date: 03/2024


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Last updated 04/01/24

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