National PBM Criteria for Use

Zoster / Shingles Vaccine (≥ 19,400 PFU / 0.65 ml)^†^

Revised June 2008

VHA Pharmacy Benefits Management Services and the Medical Advisory Panel

*The following recommendations are based on current medical evidence and
expert opinion from clinicians. The content of the document is dynamic
and will be revised as new Centers for Disease Control and Prevention
(CDC) recommendations and clinical data become available. The purpose of
this document is to assist practitioners in clinical decision-making, to
standardize and improve the quality of patient care, and to promote
cost-effective drug prescribing. The clinician should use and interpret
this guidance in the clinical context of the individual patient
situation.*

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| **Inclusion Criteria --- *Patients must meet all of the following     |
| criteria to receive zoster vaccine***                                 |
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| Age 60 years and older and immunocompetent at the time of             |
| vaccination, regardless of whether the patient reports a prior        |
| episode of chickenpox or herpes zoster (HZ). This includes persons    |
|                                                                       |
| -   with chronic medical conditions, unless those conditions are      |
|     contraindications or precautions;                                 |
|                                                                       |
| -   with a prior physician-diagnosed HZ rash (these persons can       |
|     frequently have recurrences even shortly after the initial        |
|     episode)^1^;                                                      |
|                                                                       |
| -   with leukemia in remission and not treated with chemotherapy      |
|     (e.g., alkylating drugs or antimetabolites) or radiation for at   |
|     least 3 months;                                                   |
|                                                                       |
| -   receiving low- to moderate-dose (less than 20 mg/d of prednisone  |
|     or equivalent) or short-term corticosteroid therapy (less than    |
|     14 days); intranasal, dermal, inhaled corticosteroids;            |
|     intra-articular, bursal, or tendon injections of corticosteroids; |
|     or long-term alternative-day treatment with low to moderate doses |
|     of short-acting systemic corticosteroids;                         |
|                                                                       |
| -   receiving low-dose methotrexate (0.4 mg/kg/wk or less),           |
|     azathioprine (3 mg/kg/d or less), or 6-mercaptopurine             |
|     (1.5 mg/kg/d or less) for treatment of rheumatoid arthritis,      |
|     psoriasis, polymyositis, sarcoidosis, inflammatory bowel disease, |
|     and other conditions;                                             |
|                                                                       |
| -   with impaired humoral immunity (e.g., hypogammaglobulinemia or    |
|     dysgammaglobulinemia)                                             |
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| Provider has discussed with patient the potential risks and benefits  |
| of vaccination, and the results of the Shingles Prevention Study^‡^   |
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| **Exclusion Criteria --- *Patients should not receive zoster vaccine  |
| if any of the following criteria are met***                           |
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| *Existing* evidence of non-immunity to chickenpox (e.g., negative     |
| antibody titers)---offer chickenpox vaccine instead (NB: *screening*  |
| and serologic testing for varicella immunity are not recommended)     |
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| Life-threatening disease likely to limit survival to less than 1 year |
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| History of anaphylactic / anaphylactoid reaction to gelatin,          |
| neomycin, or any other component of the vaccine                       |
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| History of primary or acquired immunodeficiency states including      |
| leukemia that is not in remission or that has been treated with       |
| chemotherapy or radiation within the previous 3 months; lymphomas of  |
| any type, or other malignant neoplasms affecting the bone marrow or   |
| lymphatic system; AIDS, other clinical manifestations of human        |
| immunodeficiency virus (HIV), and CD4+ count of ≤ 200 cells/µl or     |
| ≤ 15% total lymphocytes; or other unspecified cellular                |
| immunodeficiency based on clinical or laboratory evidence. For CD4+   |
| count \> 200 cells/µl, hematopoietic stem cell transplantation        |
| (HSCT), AND recombinant human immune mediators and modulators, see    |
| *Consider Benefits Versus Risks.*                                     |
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| Receiving immunosuppressive therapy, including high-dose              |
| corticosteroids (≥ 20 mg/d of prednisone or equivalent) lasting 2 or  |
| more weeks. This includes patients who have received organ            |
| transplants.                                                          |
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| Active untreated tuberculosis                                         |
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| Pregnant or may be pregnant                                           |
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| Acute febrile illness                                                 |
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| Receiving antiviral therapy that inhibits varicella zoster virus      |
| replication (e.g., acyclovir, valacyclovir, famciclovir, ganciclovir, |
| foscarnet, cidofovir, etc.), unless these medications can be          |
| temporarily discontinued (see under Dosing, Administration, and       |
| Storage).                                                             |
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| Intended use is to treat acute HZ or to prevent postherpetic          |
| neuralgia in persons with acute HZ                                    |
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  **Consider Benefits Versus Risks**

  AIDS / HIV infection with CD4+ count \> 200 cells/µl. Zoster vaccine is
  recommended for all indications except pregnancy, immunocompromising
  conditions, and HIV depending on CD4+ count. Zoster vaccine is
  specifically *contraindicated* if the CD4+ count is 200 cells/µl or
  less or total lymphocytes is 15% or less. There is no data on the use
  of zoster vaccine in HIV-infected individuals with CD4+ counts greater
  than 200 cells/uL.

  Hematopoietic stem cell transplantation (HSCT). Experience is limited.
  Assess patient's immune status and risk--benefits on a case-by-case
  basis. If vaccination is decided upon, administer zoster vaccine at
  least 24 months after transplantation.

  Receiving recombinant human immune mediators and immune modulators,
  especially the antitumor necrosis factor agents such as adalimumab,
  etanercept, and infliximab. The safety and efficacy of concurrent
  administration of these agents with zoster vaccine are unknown. If it
  is not possible to administer zoster vaccine before initiation of
  therapy, assess the patient's immune status and risk--benefits on a
  case-by-case basis. Otherwise, wait at least 1 month after
  discontinuing the immune mediator / modulator therapy before
  administering zoster vaccine.
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| **Dosing, Administration, and Storage**                               |
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| One dose (0.65 ml) by subcutaneous injection. *A booster dose is not  |
| FDA-approved.*                                                        |
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| Timing of administration in special situations:                       |
|                                                                       |
| *Persons anticipating immunosuppression.* Administer zoster vaccine   |
| at the first possible visit while immunity is still intact and at     |
| least 14--30 days before beginning immunosuppressive therapy, if      |
| delay is possible.                                                    |
|                                                                       |
| *Persons receiving antiviral therapy that inhibits varicella zoster   |
| virus replication (e.g., acyclovir, valacyclovir, famciclovir,        |
| ganciclovir, foscarnet, cidofovir, etc*. Temporarily discontinue      |
| these medications from at least 24 hours before administering zoster  |
| vaccine to at least 14 days after, if possible.                       |
|                                                                       |
| *Persons who recently discontinued high-dose corticosteroids.* Defer  |
| zoster vaccination for at least 1 month after discontinuation of      |
| high-dose corticosteroids (20 mg/d or greater of prednisone or        |
| equivalent for 2 or more weeks).                                      |
|                                                                       |
| *Persons undergoing hematopoietic stem cell transplantation.* If,     |
| after a case-by-case risk--benefit assessment, it is decided to       |
| administer zoster vaccine, defer zoster vaccination for at least      |
| 24 months after transplantation.                                      |
|                                                                       |
| *Persons receiving recombinant human immune mediators and immune      |
| modulators, especially the antitumor necrosis factor agents such as   |
| adalimumab, infliximab, and etanercept.* If, after a case-by-case     |
| risk--benefit assessment, it is decided to administer zoster vaccine, |
| defer vaccination for at least 1 month after discontinuation of the   |
| immune mediator/modulator therapy.                                    |
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| Zoster vaccine must be protected from light. It SHOULD BE STORED      |
| FROZEN at an average temperature of ‑15°C (+5°F) or colder until it   |
| is reconstituted for injection. Any freezer, including frost-free,    |
| that has a separate sealed freezer door and reliably maintains an     |
| average temperature of ‑15°C or colder is acceptable for storing      |
| zoster vaccine. For certain refrigerator/freezer models, it may be    |
| necessary to reduce the temperature to the coldest setting. Since     |
| doing so may affect the refrigerator temperature (and any vaccines or |
| drugs stored in the refrigerator), the temperature of both            |
| refrigerator and freezer should be checked at least twice a day. THE  |
| VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION TO    |
| MINIMIZE LOSS OF POTENCY. DISCARD RECONSTITUTED VACCINE IF IT IS NOT  |
| USED WITHIN 30 MINUTES. DO NOT FREEZE reconstituted vaccine.          |
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| **Simultaneous Administration with Other Vaccines for Adults Aged     |
| 60 Years and Older**                                                  |
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| ***Each vaccine must be administered in separate syringes at          |
| different body sites.***                                              |
|                                                                       |
| *Trivalent inactivated influenza vaccine.* Immunogenicity is not      |
| compromised; may administer simultaneously.                           |
|                                                                       |
| *Other inactivated vaccines (e.g., Td, Tdap, pneumococcal             |
| polysaccharide vaccines):* No data available; according to CDC        |
| recommendations,^1^ zoster vaccine can be given on the same day, any  |
| time before or after an inactivated vaccine.                          |
|                                                                       |
| *Live, attenuated vaccines:* No data available. CDC recommends        |
| administering zoster vaccine at least 4 weeks before or after another |
| live, attenuated vaccine.^1^                                          |
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|                                                                       |
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| ^†^ Varicella Virus Vaccine Live (Oka / Merck)                        |
|                                                                       |
| ^‡^ Shingles Prevention Study (Oxman MN, et al. N Engl J Med          |
| 2005;352:2271-84):                                                    |
| <http://content.nejm.org/cgi/reprint/352/22/2271.pdf>                 |
|                                                                       |
| 1 Prevention of Herpes Zoster. MMWR 2008. June 6; 57 (RR-5):1--30.    |
| Available at: <http://www.cdc.gov/mmwr/PDF/rr/rr5705.pdf>. Accessed   |
| 08 June 2008.                                                         |
|                                                                       |
| 2 MMWR Quick Guide, Recommended Adult Immunization Schedule ---       |
| United States, October 2007 --September 2008, available at:           |
| <http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm#print> |
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Prepared July 2008. Contact: Francine Goodman, PharmD, BCPS, Clinical
Pharmacy Specialist, PBM Services