Herpes Zoster Policy Number: PG0106 ADVANTAGE | ELITE | HMO Last Review: 01/09/2018

INDIVIDUAL MARKETPLACE | PROMEDICA MEDICARE PLAN | PPO

GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement.

SCOPE X Professional _ Facility

DESCRIPTION is a disease caused by the , the same virus that causes . After an attack of chicken pox, the virus lies dormant in certain nerve tissue. As people age, it is possible for the virus to reappear in the form of shingles. Shingles is characterized by clusters of blisters, which usually develop on one side of the body and can cause severe pain. The blisters can last two to four weeks, but the pain can last for weeks, months, or years after the virus reappears.

Zostavax (zoster vaccine) has shown to boost immunity against the varicella zoster virus, and is the first medical and only option for the prevention of shingles. It is different from other in that it helps to prevent a reactivation of a virus already present within the body. This vaccine is contraindicated in persons with a depressed immune system, or having a history of allergic reactions to any of the components within the vaccine. Zostavax is given as a single dose by an under the skin, preferably in the upper arm.

The Advisory Committee on Practices (ACIP) recommends Zostavax for people aged 60 years and older. The studies revealed the highest level of efficacy was for people 60-69 years of age. Since this is still a fairly new vaccine, there are still questions that have not been answered, such as concurrent vaccine administration and duration of protection. These risks and benefits need to be discussed between the member and their physician prior to the administration of the vaccine. It has been determined that even people who have had herpes zoster should receive the vaccine to help prevent future occurrences of the disease.

On October 20, 2017, the U.S. Food and Drug Administration (FDA) licensed Shingrix (zoster vaccine recombinant, adjuvanted; GlaxoSmithKline) for adults aged 50 years and older to prevent shingles (herpes zoster).

On October 25, 2017, the Advisory Committee on Immunization Practices (ACIP) voted that Shingrix is:  recommended for healthy adults aged 50 years and older to prevent shingles and related complications  recommended for adults who previously received the current shingles vaccine (Zostavax®) to prevent shingles and related complications  the preferred vaccine for preventing shingles and related complications

POLICY Shingrix (90750) (zoster vaccine) does not require a prior authorization for ages 50 and above.

Zostavax (90736) (zoster vaccine) does not require a prior authorization for ages 60 and above.

COVERAGE CRITERIA Paramount considers Shingrix & Zostavax (zoster vaccines) experimental and investigational for any indication

PG0106 – 12/14/2020 other than to reduce the risk of herpes zoster (e.g., autologous and allogeneic hematopoietic transplant recipients, individuals with chronic lymphocytic ) because its effectiveness for these indications have not been established.

Paramount allows members who previously received Zostavax to now receive Shingrix.

Shingrix is the preferred vaccine for preventing shingles and related complications.

Paramount considers repeat (booster) zoster as experimental and investigational.

Paramount considers Zostavax (zoster vaccine) not medically necessary for members with the following concomitant conditions:  Treatment of zoster or (PHN)  History of primary or acquired immunodeficiency states  On immunosuppressive therapy  Prevention of primary varicella (chickenpox)  History of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine

Paramount considers Shingrix (zoster vaccine) not medically necessary for members with the following concomitant conditions:  Prevention of primary varicella infection (chickenpox)  History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of Shingrix

HMO, PPO, Individual Marketplace, Advantage Shingrix (zoster vaccine) is considered a covered benefit to reduce the risk of herpes zoster (shingles) under the medical benefit based on the member’s individual coverage limitations, and policy coverage guidelines for members ages 50 and older.

Zostavax (zoster vaccine) is considered a covered benefit to reduce the risk of herpes zoster (shingles) under the medical benefit based on the member’s individual coverage limitations, and policy coverage guidelines for members ages 60 and older.

Elite/ProMedica Medicare Plan Shingrix (zoster vaccine) is only covered under the pharmacy benefit (Medicare Part D) to reduce the risk of herpes zoster (shingles) for members ages 50 and older, and is not reimbursed by Paramount as a medical service. This vaccine will be denied if it is billed by any provider as a medical claim.

Zostavax (zoster vaccine) is only covered under the pharmacy benefit (Medicare Part D) to reduce the risk of herpes zoster (shingles) for members ages 60 and older, and is not reimbursed by Paramount as a medical service. This vaccine will be denied if it is billed by any provider as a medical claim.

CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. CPT CODES 90736 Zoster (shingles) vaccine, live, for subcutaneous injection 90750 Zoster (shingles) vaccine (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection

REVISION HISTORY EXPLANATION ORIGINAL EFFECTIVE DATE: 10/15/2006 11/30/06: No change

PG0106 – 12/14/2020 01/01/08: No change 04/15/09: Updated references 02/01/11: Updated 05/18/12: Per medical policy review, coverage updated to include members ages 50-59 with prior authorization when medically indicated. 11/11/14: Zostavax® is now covered for 60 yrs + per ODM guidelines (04/01/2014). Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 03/14/17: Added code 90750 as non-covered pending FDA approval & ACIP recommendation. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 01/09/18: Shingrix (90750) is now covered without prior authorization for members ages 50 and older per FDA approval & ACIP recommendation. Title changed from Zostavax to Herpes Zoster Vaccine. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 12/14/2020: Medical policy placed on the new Paramount Medical policy format

REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services Industry Standard Review Hayes, Inc.

PG0106 – 12/14/2020