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 Generic Name

Drug Brand Name

PA
Status

adenovirus live vaccine DR oral tablets  
bcg vaccine-theracys TheraCys  
bcg vaccine-tice bcg TICE BCG  
diphtheria / tetanus toxoid vaccine Decavac 1  
diphtheria / tetanus toxoids / acellular pertussis / haemophilus influenza B conjugate vaccine TriHIBit  
diphtheria / tetanus toxoids / acellular pertussis / hepatitis B, recombinant / poliovirus, vaccine Pediarix  
diphtheria / tetanus toxoids / acellular pertussis / poliovirus, inactivated vaccine Kinrix 1  
diphtheria / tetanus toxoids / acellular pertussis vaccine Adacel 1  
diphtheria / tetanus toxoids / acellular pertussis vaccine Boostrix 1  
diphtheria / tetanus toxoids / acellular pertussis vaccine Daptacel 1  
diphtheria / tetanus toxoids / acellular pertussis vaccine Infanrix 1  
diphtheria / tetanus toxoids / acellular pertussis vaccine Tripedia 1  
diptheria / tetanus toxoids / acellular pertussis / poliovirus inactivated / haemophilus B conjugate vaccine Pentacel 1  
haemophilus b conjugate / hepatitis b vaccine Comvax  
haemophilus b conjugate vaccine-acthib ActHIB  
haemophilus b conjugate vaccine-pedvaxhib PedvaxHIB  
hepatitis A vaccine, inactivated - Havrix Havrix 1  
hepatitis A vaccine, inactivated - VAQTA VAQTA 1  
hepatitis A, inactivated / hepatitis B recombinant Twinrix  
hepatitis B recombinant vaccine Engerix-B 1  
hepatitis b, recombinant vaccine Recombivax HB  
herpes zoster vaccine Zostavax PA   - < 50 years
human papillomavirus bivalent vaccine Cervarix 1 2 PA   - < 9 years and PA ≥ 26 years 
human papillomavirus quadrivalent vaccine Gardasil 1 PA   - < 9 years and PA ≥ 27 years
influenza virus vaccine, high dose Fluzone HD 1 PA   - < 65 years 
influenza virus vaccine, intranasal FluMist PA   - >1 dose/season
influenza virus vaccine-Afluria Afluria 1  
influenza virus vaccine-Fluarix Fluarix 1  
influenza virus vaccine-Flublok Flublok 1  
influenza virus vaccine-Flucelvax Flucelvax 1  
influenza virus vaccine-FluLaval FluLaval 1  
influenza virus vaccine-FluLaval Quadrivalent FluLaval Quadrivalent 1  
influenza virus vaccine-Fluvirin Fluvirin 1  
influenza virus vaccine-Fluzone Fluzone 1  
influenza virus vaccine-Fluzone Intradermal Fluzone Intradermal 1  
japanese encephalitis vaccine Ixiaro  
japanese encephalitis vaccine Je-Vax  
measles / mumps / rubella / varicella virus vaccine ProQuad  
measles / mumps / rubella vaccine M-M-R II Vaccine 1  
meningococcal conjugate vaccine Menactra  
meningococcal groups C and Y and haemophilus b tetanus toxoid conjugate vaccine MENHIBRIX  
meningococcal polysaccharide vaccine Menomune-A/C/Y/W-135  
meningococcal quadravalent vaccine Menveo A/C/Y/W-135  
pneumococcal 13-valent conjugate vaccine Prevnar 13 1  
pneumococcal vaccine Pneumovax  
poliovirus vaccine, inactivated Ipol 1  
rabies virus vaccine-Imovax Rabies Imovax Rabies  
rabies virus vaccine-Rabavert RabAvert  
rotavirus vaccine, live, oral Rotarix  
rotavirus vaccine, live, oral, pentavalent Rotateq  
typhoid vaccine, capsule Vivotif Berna  
typhoid vaccine, injection Typhim VI  
varicella virus vaccine Varivax 1  
varicella zoster immune globulin, human VARIZIG  
yellow fever vaccine YF-Vax  

Please note: In the case where the prior authorization (PA) status column indicates PA for an FDA “A”-rated generic equivalent of a brand name drug, both brand and generic require PA.  Prior authorization requests submitted for a brand name drug must meet the criteria for the drug itself and the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective generic equivalent.

 

Administrative schedule:

  • Prior authorization 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 1-800-822-7967.

 
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.
 
2 Prior authorization status is gender specific.
 

II. Therapeutic Uses

FDA-approved, for example:

  • prevention of diseases caused by the human papillomavirus (HPV) types 6, 11, 16, and 18 – Gardasil
  • prevention of disease caused by HPV types 16 and 18 in female patients – Cervarix
  • prevention of herpes zoster – Zostavax
  • prevention of influenza disease caused by influenza virus subtypes A and B – Flumist

Note: The above list may not include all FDA-approved indications.

Back to top


III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA for an FDA “A”-rated generic equivalent of a brand name drug, both brand and generic require PA.  Prior authorization requests submitted for a brand name drug must meet the criteria for the drug itself and the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective generic equivalent.

  • All prior-authorization requests must include clinical diagnosis, drug name, dose, and frequency.
  • Additional criteria may apply, depending upon requested medication (see below).

 Herpes zoster vaccine (Zostavax)

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

Human papillomavirus bivalent vaccine (Cervarix)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is female; and
    • member is ≥ 9 and < 26 years of age; or
    • member is age ≥ 26 years who has already begun the sequence while within the appropriate age range.

Human papillomavirus quadrivalent vaccine (Gardasil)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 9 and < 27 years of age; or
    • member is a female or male age ≥ 27 years who has already begun the sequence while within the appropriate age range.

inactivated influenza virus vaccine (high dose), Fluzone HD 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.

Influenza virus vaccine, live, intranasal (FluMist) > 1 dose/season

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 2 and ≤ 8 years of age; and
    • documentation is provided that the member has not been previously vaccinated with either ≥ 1 dose of seasonal vaccine prior to the flu season or 2 doses of seasonal vaccine during the flu season.


Original Effective Date: 09/2003

Last Revised Date: 01/2014


Clinical Criteria Main Page | Back to topPrevious  |  Next

Last updated 03/10/14