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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
adenovirus live vaccine delayed-release oral tablets test  
BCG live vaccine BCG Vaccine test  
BCG live, intravesical Theracys test  
cholera vaccine, live, oral Vaxchora 1 test  
diphtheria / tetanus / acellular pertussis / poliovirus inactivated / haemophilus B conjugate vaccine Pentacel 1 test  
diphtheria / tetanus toxoid vaccine Tenivac 1 test  
diphtheria / tetanus toxoids / acellular pertussis / hepatitis B, recombinant / poliovirus, inactivated vaccine Pediarix 1 test  
diphtheria / tetanus toxoids / acellular pertussis / poliovirus, inactivated vaccine Kinrix 1 test  
diphtheria / tetanus toxoids / acellular pertussis vaccine Adacel 1 test  
diphtheria / tetanus toxoids / acellular pertussis vaccine Boostrix 1 test  
diphtheria / tetanus toxoids / acellular pertussis vaccine Daptacel 1 test  
diphtheria / tetanus toxoids / acellular pertussis vaccine Infanrix 1 test  
haemophilus B conjugate vaccine-Acthib Acthib 1 test  
haemophilus B conjugate vaccine-Hiberix Hiberix 1 test  
haemophilus B conjugate vaccine-Pedvaxhib Pedvaxhib 1 test  
hepatitis A vaccine, inactivated - Havrix Havrix 1 test  
hepatitis A vaccine, inactivated-Vaqta Vaqta 1 test  
hepatitis A, inactivated / hepatitis B recombinant Twinrix 1 test  
hepatitis B recombinant vaccine Engerix-B 1 test  
hepatitis B recombinant vaccine Recombivax HB 1 test  
hepatitis B recombinant vaccine, adjuvanted Heplisav-B test  
herpes zoster vaccine Zostavax PA   - < 50 years
human papillomavirus 9-valent vaccine Gardasil 9 1 PA   - < 9 years and PA ≥ 46 years
influenza virus vaccine, adjuvanted Fluad 1 PA   - < 65 years
influenza virus vaccine, high dose Fluzone 1 PA   - < 65 years 
influenza virus vaccine-Afluria Afluria 1 test  
influenza virus vaccine-Fluarix Fluarix 1 test  
influenza virus vaccine-Flublok Flublok 1 test  
influenza virus vaccine-Flucelvax Flucelvax 1 test  
influenza virus vaccine-Flulaval Flulaval 1 test  
influenza virus vaccine-Flumist Flumist 1 test  
influenza virus vaccine-Fluzone Fluzone 1 test  
japanese encephalitis vaccine Ixiaro test  
measles / mumps / rubella / varicella virus vaccine Proquad 1 test  
measles / mumps / rubella vaccine M-M-R II Vaccine 1 test  
meningococcal conjugate vaccine Menactra 1 test  
meningococcal group B vaccine-Bexsero Bexsero 1 test  
meningococcal group B vaccine-Trumenba Trumenba 1 test  
meningococcal quadrivalent vaccine Menveo A/C/Y/W-135 1 test  
pneumococcal 13-valent conjugate vaccine Prevnar 13 1 test  
pneumococcal vaccine Pneumovax test  
poliovirus vaccine, inactivated Ipol 1 test  
rabies virus vaccine-Imovax Rabies Imovax Rabies test  
rabies virus vaccine-Rabavert Rabavert test  
rotavirus vaccine, live, oral Rotarix 1 test  
rotavirus vaccine, live, oral, pentavalent Rotateq 1 test  
typhoid vaccine capsule Vivotif Berna test  
typhoid vaccine injection Typhim VI test  
varicella virus vaccine Varivax 1 test  
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 patients. 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 patients
  • 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
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 prior authorization (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 prior authorization, if the vaccine is administered in the pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Prevention of diseases caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58 – Gardasil-9
  • Prevention of herpes zoster – Shingrix and Zostavax
  • Prevention of influenza – Fluad and Fluzone High-Dose 

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).

 

Herpes zoster vaccine (Shingrix and Zostavax)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member ≥ 50 years of age.

Human papillomavirus 9-valent vaccine (Gardasil-9)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 9 and < 46 years of age; or
    • member is age ≥ 46 years 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:
    • an appropriate diagnosis; and
    • quantity of one dose per season; and
    • medical necessity for high dose over standard formulation in members < 65 years of age.

Original Effective Date: 09/2003

Last Revised Date: 11/2019

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Last updated 02/21/20