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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

chlorpheniramine * test  
dexchlorpheniramine solution PA  

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

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

 First Generation (Nonselective) Antihistamines – Phenothiazine

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

promethazine Phenergan # test  

 First Generation (Nonselective) Antihistamines – Piperazines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

hydroxyzine hydrochloride test  
hydroxyzine pamoate Vistaril # test  

 First Generation (Nonselective) Antihistamines – Piperidines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

cyproheptadine test  

 Second Generation (Peripherally Selective) Antihistamines – Alkylamines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

acrivastine / pseudoephedrine Semprex-D PA  

 Second Generation (Peripherally Selective) Antihistamines – Nasal Preparations

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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

 Second Generation (Peripherally Selective) Antihistamines – Piperazines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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

 Second Generation (Peripherally Selective) Antihistamines – Piperidines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

desloratadine / pseudoephedrine Clarinex-D PA  
desloratadine orally disintegrating tablet PA  
desloratadine syrup, tablet Clarinex # test  
ketotifen powder PA  
loratadine / pseudoephedrine * test  
loratadine tablet, solution * test  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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 prior authorization.
 

II. Therapeutic Uses

FDA-approved, for example:

  • perennial or seasonal allergic rhinitis
  • chronic idiopathic urticaria
  • vasomotor (i.e., non-allergic) rhinitis

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.
  • 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 requested medication (see below).

 

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

  • Documentation of all of the following is required:  
    • an appropriate diagnosis; and
    • an inadequate response (defined by 14 days of therapy), adverse reaction, or contraindication to one intranasal corticosteroid agent; and
    • an inadequate response (defined by 14 days of therapy), adverse reaction, or contraindication to azelastine 137 mcg nasal spray; and
    • an inadequate response (defined by 14 days of therapy), adverse reaction, or contraindication to two second-generation selective antihistamines.
  • For quantities greater than one inhaler/month, 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 inhaler/month 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 and a history of paid pharmacy claims for ≥ 14 days out of the last 180 days of one intranasal corticosteroid, azelastine 137 mcg nasal spray and two second-generation selective antihistamines.

  

azelastine 0.15% (generic Astepro) and olopatadine (generic Patanase) nasal sprays for non-allergic rhinitis

  • Documentation of all of the following is required:   
    • an appropriate diagnosis; and
    • an inadequate response (defined by 14 days of therapy), adverse reaction, or contraindication to one intranasal corticosteroid agent; and
    • an inadequate response (defined by 14 days of therapy), adverse reaction, or contraindication to azelastine 137 mcg nasal spray.
  • For quantities greater than one inhaler/month, 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 inhaler/month 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 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:
    • an appropriate diagnosis; and
    • an inadequate response (defined by 14 days of therapy), adverse reaction, or contraindication to one intranasal corticosteroid agent; and 
    • an inadequate response (defined by 14 days of therapy), adverse reaction, or contraindication to two generic nonselective antihistamines; and
    • if request is for Karbinal ER, an inadequate response (defined by 14 days of therapy) or adverse reaction to immediate-release carbinoxamine solution; and
    • if request is for carbinoxamine 6 mg tablet, clinical rationale for use instead of carbinoxamine 4 mg tablet and immediate-release carbinoxamine solution.

 

Combination antihistamine/decongestant agents (i.e. Clarinex-D, Semprex-D)

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

 

SmartPA: Claims for a combination antihistamine/decongestant agent listed above 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 ODT and levocetirizine solution

  • Documentation of all of the following is required:
    • an appropriate diagnosis; and
    • a swallowing disorder or a condition affecting swallowing ability; and
    • an inadequate response (defined by 14 days of therapy), adverse reaction, or contraindication to one intranasal corticosteroid; and
    • an inadequate response (defined by 14 days of therapy) or adverse reaction to two of the following, or contraindication to all of the following: cetirizine, desloratadine, levocetirizine, and loratadine.

 

dexchlorpheniramine solution

  • Documentation of all of the following is required:
    • an appropriate diagnosis; and
    • medical necessity for use of the requested agent over all other oral first- and second-generation antihistamines available in liquid formulation.

  

ketotifen powder

  • Documentation of all of the following is required:
    • an appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives cannot be used.

 

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: 10/2019


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Last updated 11/18/19