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Table 32: Serums, Toxoids, and Vaccines


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: Serums, Toxoids, and Vaccines

Medication Class/Individual Agents: Serums, Toxoids, and Vaccines

I. Prior-Authorization Requirements

 Serums, Toxoids, and Vaccines

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

adenovirus live vaccine delayed-release oral tablets test  
BCG live vaccine BCG Vaccine test  
BCG live, intravesical test   MB
chikungunya virus vaccine, live Ixchiq test  
cholera vaccine, live, oral Vaxchora test  
COVID EUA – October 3, 2023 for members ≥ 12 years of age Novavax COVID-19 vaccine, adjuvanted test  
COVID-19 Moderna vaccine, COVID EUA – September 11, 2023 for members ≥ 6 months of age Spikevax test  
COVID-19 Pfizer vaccine, COVID EUA – September 11, 2023 for members ≥ 6 months of age Comirnaty test  
dengue tetravalent vaccine, live Dengvaxia test  
diphtheria / tetanus / acellular pertussis / poliovirus inactivated / haemophilus B conjugate / hepatitis B vaccine Vaxelis test  
diphtheria / tetanus / acellular pertussis / poliovirus inactivated / haemophilus B conjugate vaccine Pentacel test   1
diphtheria / tetanus toxoids / acellular pertussis / hepatitis B, recombinant / poliovirus, inactivated vaccine Pediarix test   1
diphtheria / tetanus toxoids / acellular pertussis / poliovirus, inactivated vaccine Kinrix test   1
diphtheria / tetanus toxoids / acellular pertussis vaccine Daptacel test   1
diphtheria / tetanus toxoids / acellular pertussis vaccine Infanrix test   1
diphtheria / tetanus toxoids vaccine test   1
haemophilus B conjugate vaccine-Acthib Acthib test   1
haemophilus B conjugate vaccine-Hiberix Hiberix test   1
haemophilus B conjugate vaccine-Pedvaxhib Pedvaxhib test   1
hepatitis A vaccine, inactivated - Havrix Havrix test   1
hepatitis A vaccine, inactivated-Vaqta Vaqta test   1
hepatitis A, inactivated / hepatitis B recombinant Twinrix test   1
hepatitis B recombinant vaccine Engerix-B test   1
hepatitis B recombinant vaccine Prehevbrio test   1
hepatitis B recombinant vaccine Recombivax HB test   1
hepatitis B recombinant vaccine, adjuvanted Heplisav-B test   1
human papillomavirus 9-valent vaccine Gardasil 9 PA   - < 9 years and PA ≥ 46 years 1
influenza virus vaccine, adjuvanted Fluad PA   - < 65 years 1
influenza virus vaccine, high dose Fluzone PA   - < 65 years  1
influenza virus vaccine-Afluria Afluria test   1
influenza virus vaccine-Fluarix Fluarix test   1
influenza virus vaccine-Flublok Flublok test   1
influenza virus vaccine-Flucelvax Flucelvax test   1
influenza virus vaccine-Flulaval Flulaval test   1
influenza virus vaccine-Flumist Flumist test   1
influenza virus vaccine-Fluzone Fluzone test   1
japanese encephalitis vaccine Ixiaro test  
measles / mumps / rubella / varicella virus vaccine Proquad test   1
measles / mumps / rubella vaccine M-M-R II Vaccine test   1
measles / mumps / rubella vaccine Priorix test  
meningococcal group B vaccine-Bexsero Bexsero test   1
meningococcal group B vaccine-Trumenba Trumenba test   1
pentavalent meningococcal groups A, B, C, W and Y vaccine Penbraya test  
pneumococcal 13-valent conjugate vaccine Prevnar 13 test   1
pneumococcal 15-valent conjugate vaccine Vaxneuvance test  
pneumococcal 20-valent conjugate vaccine Prevnar 20 test  
pneumococcal 23-valent polysaccharide vaccine Pneumovax test   1
poliovirus vaccine, inactivated Ipol test   1
quadrivalent meningococcal conjugate vaccine-Menactra Menactra test   1
quadrivalent meningococcal conjugate vaccine-Menquadfi Menquadfi test   1
quadrivalent meningococcal conjugate vaccine-Menveo Menveo test   1
rabies virus vaccine-Imovax Rabies Imovax Rabies test  
rabies virus vaccine-Rabavert Rabavert test  
respiratory syncytial virus vaccine Abrysvo PA   - < 60 years
respiratory syncytial virus vaccine, adjuvanted Arexvy PA   - < 60 years
rotavirus vaccine, live, oral Rotarix test   1
rotavirus vaccine, live, oral, pentavalent Rotateq test   1
tetanus toxoid / diphtheria vaccine Tenivac test   1
tetanus toxoids / diphtheria / acellular pertussis / inactivated poliovirus vaccine Quadracel test  
tetanus toxoids / diphtheria / acellular pertussis vaccine Adacel test   1
tetanus toxoids / diphtheria / acellular pertussis vaccine Boostrix test   1
tick-borne encephalitis vaccine Ticovac test  
typhoid vaccine capsule Vivotif Berna test  
typhoid vaccine injection Typhim VI test  
varicella virus vaccine Varivax test   1
varicella zoster immune globulin, human Varizig test  
yellow fever vaccine YF-Vax test  
yellow fever vaccine, live Stamaril test  
zoster vaccine recombinant, adjuvanted Shingrix PA   - < 50 years

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.

 

Administrative Schedule:

  • PA requirements exist to ensure appropriate dosing of vaccines given in a series to adult members. The pharmacy may contact the MassHealth Drug Utilization Review program for review of the claim in the event that a dose is required that is not consistent with the current Advisory Council on Immunization Practices (ACIP) recommendations.
  • For vaccinations that require a series of doses, the time interval between each dose can be increased from the recommended schedule but should not be decreased. The immunization series does not need to be restarted, regardless of the length of time from the last dose (exception: oral typhoid).
  • If two live vaccines are administered separately, there should be an interval of at least 28 days in between
  • Multiple inactivated vaccines can be administered at any time in relation to another

Side Effects:

  • Usually minor (e.g., slight fever, rash, or soreness at the site of injection)
  • Serious reactions are extremely rare

Safety:

  • Thimerosal has been removed or reduced to trace amounts in almost all of the vaccines routinely recommended for children six years of age and younger
  • Current scientific evidence does not support the hypothesis that vaccines have a causal link to autism

Contraindications:

  • Serious allergic reaction to previous dose of vaccine or vaccine component

Not Contraindications:

  • Mild acute illness with or without fever
  • Current antimicrobial therapy
  • Mild to moderate local reaction (e.g., swelling, redness, soreness)
  • Low-grade or moderate fever after previous dose
  • Convalescent phase of illness
  • Premature birth

Precautions:

  • Moderate or severe acute illness with or without fever

Live Virus Vaccines (e.g., measles, mumps, rubella, varicella):

  • Avoid use in immunocompromised members
  • Administration should be deferred in the presence of active infections or inactive, untreated tuberculosis
  • Pregnancy should be avoided for three months following vaccination

Report unexpected events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS) at (800) 822-7967.

 
Table Footnotes
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
1 Product may be available through the Massachusetts Department of Public Health (DPH). Please check with DPH for availability. MassHealth does not pay for immunizing biologicals (i.e., vaccines) and tubercular (TB) drugs that are available free of charge through local boards of public health or through the Massachusetts Department of Public Health without PA (130 CMR 406.413(C)). In cases where free vaccines are available to providers for specific populations (e.g. children, high risk, etc.), MassHealth will reimburse the provider only for individuals not eligible for the free vaccines. Notwithstanding the above, MassHealth will pay pharmacies for seasonal flu vaccine serum without PA, if the vaccine is administered in the pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Maternal use for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through six months of age – Abrysvo
  • Prevention of diseases caused by human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 – Gardasil-9
  • Prevention of herpes zoster – Shingrix
  • Prevention of influenza – Fluad and Fluzone High-Dose 
  • Prevention of LRTD caused by RSV in individuals ≥ 60 years of age – Abrysvo, Arexvy

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.

 

Herpes zoster vaccine (Shingrix)

  • Documentation of the following is required:
    • appropriate indication; and
    • one of the following:
      • member ≥ 50 years of age; or
      • member is ≥ 18 years of age and is at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy.

 

SmartPA: Claims for Shingrix for ≤ two doses in all MassHealth pharmacy claims history 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 indicative of immunodeficiency or immunosuppression (including history of autologous hematopoietic stem cell transplant, hematologic malignancy, renal transplant, solid tumor receiving chemotherapy, HIV-infection).

   

Human papillomavirus 9-valent vaccine (Gardasil-9)

  • Documentation of the following is required:
    • appropriate indication; and
    • member is ≥ 9 and < 46 years of age; or
    • member is ≥ 46 years of age who has already begun the sequence while within the appropriate age range.

   

Inactivated influenza virus vaccine, high-dose (Fluzone High-Dose), and influenza virus vaccine, adjuvanted (Fluad) in members < 65 years of age

  • Documentation of the following is required:
    • appropriate indication; and
    • requested quantity of one dose/season; and
    • medical necessity for high-dose instead of standard formulation in members < 65 years of age.

 

Respiratory syncytial virus vaccine (Abrysvo) in members < 60 years of age

  • Documentation of the following is required for prevention of LRTD caused by RSV in adults < 60 years of age:
    • appropriate indication; and
    • medical necessity for the requested agent in member < 60 years of age.
  • Documentation of the following is required for maternal use for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through six months of age:
    • appropriate indication; and
    • vaccine will be administered between weeks 32 and 36 of pregnancy.

 

Respiratory syncytial virus vaccine, adjuvanted (Arexvy) in members < 60 years of age

  • Documentation of the following is required:
    • appropriate indication; and
    • medical necessity for the requested agent in member < 60 years of age.

 

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: 09/2003

Last Revised Date: 03/2024


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Last updated 05/16/24

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