Clinical Policy Title: Zoster (shingles) vaccine

Transcription

1 Clinical Policy Title: Zoster (shingles) vaccine Clinical Policy Number: Effective Date: June 1, 2018 Initial Review Date: April 10, 2018 Most Recent Review Date: May 1, 2018 Next Review Date: May 2019 Policy contains: Varicella zoster virus. Herpes zoster virus. Postherpetic neuralgia. Related policies: None. ABOUT THIS POLICY: Prestige Health Choice has developed clinical policies to assist with making coverage determinations. Prestige Health Choice s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Prestige Health Choice when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Prestige Health Choice s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Prestige Health Choice s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Prestige Health Choice will update its clinical policies as necessary. Prestige Health Choice s clinical policies are not guarantees of payment. Coverage policy Prestige Health Choice considers the use of the shingles vaccine to be clinically proven and, therefore, medically necessary under the following circumstances (Centers for Disease Control and Prevention [CDC], 2018a; Cunningham, 2016; Dooling, 2018; Lal, 2015): The shingles vaccine zoster vaccine recombinant, adjuvanted, (Shingrix, or RZV, GlaxoSmithKline, Research Triangle Park, North Carolina) is recommended for all healthy persons ages 50 and older, with no upper age limit. Shingrix is preferred over zoster vaccine live (Zostavax, or ZVL, Merck and Co. Inc., Whitehouse Station, New Jersey). Shingrix should be administered in two doses, separated by two to six months. Shingrix is recommended for those who have had shingles, those who previously received zoster vaccine live, and for those who are not sure whether they have had a varicella (chicken pox) outbreak. 1

2 Shingrix is recommended for persons taking low-dose immunosuppressive therapy (e.g., <20 mg/day of prednisone or its equivalent, or using topical or inhaled steroids) and for persons anticipating immunosuppression or who have recovered from an immunocompromising illness. Limitations: Coverage determinations are subject to benefit limitations and exclusions as delineated by the state Medicaid authority. The Florida Medicaid website may be accessed at Shingrix should not be administered to persons meeting any of the following criteria (CDC, 2018a): A person who has ever had a life-threatening or severe allergic reaction to any component Shingrix or after a dose of Shingrix. A person who has a negative result on a test for immunity to varicella zoster. These persons should have a varicella vaccine. A person who currently has a shingles outbreak. A woman who is currently pregnant or breastfeeding. These women should wait to get Shingrix until they are no longer pregnant or breastfeeding. A minor acute illness, such as a cold, does not contraindicate vaccination. However, persons with a moderate or severe acute illness should generally wait to get the vaccine until they have recovered. Having a temperature of F or higher indicates that a person should wait to be vaccinated. Shingrix is licensed for all persons age 50 years. However, immunocompromised persons and persons receiving moderate to high doses of immunosuppressive therapy were excluded from the efficacy studies. Therefore, there is no recommendation regarding the use of Shingrix in these persons. It is anticipated that this will be discussed as additional data become available. Alternative covered services: None. Background Outbreaks of the herpes zoster virus, commonly known as shingles, or zoster, are a reactivation of the latent-stage varicella zoster virus (chicken pox), often decades after inoculation with varicella. Zoster is a localized condition, usually accompanied by painful skin lesions, along with viral syndrome symptoms such as headache and fatigue. In the United States, approximately 1 million cases occur annually. In immunocompetent populations, the incident rate overall is approximately 4.47 per 1,000 person-years, or 4.63 when adjusted for age and census data (Johnson, 2015). Incidence increases with age, such that the rate increases from 0.86 per 1,000 person-years among those under age 18, to per 1,000 2

3 person-years among those ages 80 and over. Incidence is higher among women and among immunosuppressed persons. Complications increase with age and include postherpetic neuralgia, a chronic neuropathic pain persisting three months or more after the zoster lesions have healed, affecting about 10 percent to 30 percent or more of those with zoster; disseminated zoster; and ocular, neurological, visceral, or vascular diseases, including stroke (Johnson, 2014; Kawai, 2014; Yawn, 2007). Zoster outbreaks may recur. While a person with zoster cannot transmit zoster, they can transmit varicella to a person who has not had varicella or who was not vaccinated against varicella. A live zoster vaccine, Zostavax, was approved by the U.S. Food and Drug Administration (FDA) in 2006 for inoculation of persons ages 60 and older (CDC, 2018b; Dooling, 2018). This vaccine is effective in reducing zoster outbreaks by about 50 percent. Since its release, Zostavax vaccination rates have slowly increased, such that about a third of adults over age 60 had been vaccinated by In October 2017, a two-dose subunit vaccine (zoster vaccine recombinant, adjuvanted, (Shingrix, manufactured by GlaxoSmithKline, Research Triangle Park, North Carolina) was approved by the FDA for prevention of zoster in adults ages 50 and older. Searches Prestige Health Choice searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on March 5, Search terms were: zoster, vaccine, postherpetic neuralgia, and Shingrix. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings A two-part, phase III, multicenter randomized clinical trial evaluated the performance of Shingrix. The total participant number was 30,000, half of whom received Shingrix and half of whom received saline 3

4 placebo. The two studies, Zoster Efficacy Study in Adults 50 Years of Age or Older (ZOE-50), and Zoster Efficacy Study in Adults 70 Years of Age or Older (ZOE-70), had median follow-up of 3.2 years and 3.7 years, respectively (Cunningham, 2016; Lal, 2015). The findings demonstrated that Shingrix is superior to Zostavax in preventing both shingles and postherpetic neuralgia. In adults 50 to 69 years old who got two doses, Shingrix was 97 percent effective in preventing shingles; among adults 70 years and older, Shingrix was 91 percent effective. In adults 50 to 69 years old who got two doses, Shingrix was 91 percent effective in preventing postherpetic neuralgia; among adults 70 years and older, Shingrix was 89 percent effective. The protective effect remained high in those ages 70 and older, measuring 85 percent at four-year follow-up. Policy updates: None. Summary of clinical evidence: Citation Lal (2015) Zoster efficacy study in adults 50 years of age or older (ZOE-50) Cunningham (2016) Content, Methods, Recommendations Key points: The efficacy for the prevention of herpes zoster was 96.6% (95% confidence interval [CI] = 89.6, 99.3) in persons ages years and 97.4% (CI 90.1, 99.7) in persons ages years. Key points: Zoster efficacy study in adults 70 years of age or older (ZOE-70) Using pooled data from both study arms, vaccine efficacy was 91.3% (CI 86.8, 94.5) in participants age 70 years. Vaccine efficacy in the first year after vaccination was 97.6% (CI 90.9, 99.8) and was 84.7% (CI 69.0, 93.4) or higher for the remaining three years of the study in persons age 70 years. Efficacy for prevention of postherpetic neuralgia was 91.2% (CI 75.9, 97.7) in adults age 50 years and 88.8% (CI = ) in those age 70 years. References Professional society guidelines/other: Centers for Disease Control and Prevention [CDC]. Vaccine information statements (VISs). Live shingles VIS. February 12, Accessed March 5, Dooling KL, Guo A, Patel M, et al. Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. MMWR Morb Mortal Wkly Rep. 2018;67(3): Updated February 26, Accessed March 5,

5 Peer-reviewed references: Cunningham AL, Lal H, Kovac M, et al. ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375: Johnson RW, Rice AS. Clinical practice postherpetic neuralgia. N Engl J Med. 2014;371(16): Johnson BH, Palmer L, Gatwood J, Lenhart G, Kawai K, Acosta CJ. Annual incidence rates of herpes zoster among an immunocompetent population in the United States. BMC Infect Dis. 2015;15:502. Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open 2014;4(6):e Kovac M, Lal H, Cunningham AL, et al. Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 2018;36(12): Lal H, Cunningham AL, Godeaux O, et al.; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372: Le P, Rothberg MB. Cost-effectiveness of the adjuvanted herpes zoster subunit vaccine in older adults. JAMA Intern Med 2018;7431. Leidner AJ. Overview of two economic models that assess the cost-effectiveness of herpes zoster vaccinations [slides]. Presentation to the Advisory Committee on Immunization Practices. Atlanta, Georgia. June 21, Accessed March 5, Yawn BP, Saddier P, Wollan PC, St Sauver JL, Kurland MJ, Sy LS. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc 2007;82: CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes 5

6 Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments Zoster (shingles) vaccine (HZV), live, for subcutaneous injection Zoster (shingles) vaccine (HZV), recombinant, subunit, adjuvanted, for intramuscular use ICD-10 Code Description Comments Z223 Encounter for immunization HCPCS Level II Code N/A Description Comments 6