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 |
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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:
Side Effects:
Safety:
Contraindications:
Not Contraindications:
Precautions:
Live Virus Vaccines (e.g., measles, mumps, rubella, varicella):
Report unexpected events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS) at (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. |
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.
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 11/25/19