H. pylori agents (VOQUENZA, HELIDAC)

H. pylori treatment agents (VOQUENZA, HELIDAC)

• Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin)
• Voquezna Dual Pak (vonoprazan, amoxicillin)
• Helidac (bismuth subsalicylate, metronidazole, tetracycline)

Self-Administration – oral

Diagnosis considered for coverage:

• Helicobacter pylori (H. pylori): Indicated for the treatment of Helicobacter pylori (H. pylori) in adults.

Coverage Criteria:

For diagnosis of H. pylori:

• Dose does not exceed 14 days of therapy per treatment course; AND
• Patient is 18 years of age or older; AND
• Trial and failure, contraindication, or intolerance to ONE of the following first line treatment regimens:
  • Clarithromycin based therapy (e.g., clarithromycin based triple therapy, clarithromycin based concomitant therapy)
  • Bismuth quadruple therapy (e.g., bismuth and metronidazole and tetracycline and proton pump inhibitor [PPI]).

Coverage Duration:

• 14 days.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• H. pylori is an infectious disease that is typically treated with combinations of 2–3 antibiotics along with a PPI, taken concomitantly or sequentially. Current guidelines recommend extended (10 to 14 days) treatment with all antibiotic regimens for H. pylori.
• H. pylori treatments without prior authorization include Omeclamox Pak, generic PrevPac (amoxicill-clarithro-lansopraz oral), Pylera, Talicia, or individual components prescribed separately.
  • Clarithromycin based therapy (e.g., clarithromycin based triple therapy, clarithromycin based concomitant therapy) include Omeclamox Pak, generic PrevPac, or individual components prescribed separately.
  • Bismuth quadruple therapy (e.g., bismuth and metronidazole and tetracycline and proton pump inhibitor [PPI]) include Pylera, Helidac, or individual components prescribed separately.
• The American College of Gastroenterology, (ACG) treatment guideline for first-line and salvage therapies was last updated in 2017. The 2017 ACG guideline outlines evidence-based, frontline treatment strategies for providers in North America. These include clarithromycin triple therapy, bismuth quadruple therapy, concomitant therapy, sequential therapy, hybrid therapy, levofloxacin triple therapy. Due to the complexity of treatment, hybrid therapy as first line treatment is limited. Sequential therapy is also complex, and it is not uniformly endorsed as first line treatment. Due to the rising rates of levofloxacin resistance, levofloxacin should not be used for treatment, unless the H. pylori strain is known to be sensitive to it or if levofloxacin resistance rates are known to be less than 15 %. Studies evaluating the efficacy of levofloxacin containing regimens in North America are lacking. In clinical practice, the initial course of eradication therapy, heretofore referred to as “first-line” therapy, generally offers the greatest likelihood of treatment success. Thus, careful attention to the selection of the most appropriate first-line eradication therapy for an individual patient is essential. The ACG guidelines for the treatment of H. pylori recommend several regimens for 1st line eradication therapy with no preference of 1 regimen over another. Therapy is individualized based on patient's previous antibiotic history and local resistance patterns.
• In the selection of the most appropriate empiric treatment regimen for H. pylori, previous antibiotic exposure, regional antibiotic-resistance patterns, and eradication rates should be taken into consideration because these factors can impact successful treatment. Successful treatment also relies on host factors such as allergies and adherence.

Policy Review History:

• 11/15/2022 – Initial Review. New utilization management program approved by P&T.
• 01/20/2023 - Remove prior authorization (PA) from the following H.Pylori drugs: Pylera, Omeclamox, Talicia.

References:

1. Chey WD, Leontiadis GI, Howden CW, et al. ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017; 112:212-238
2. Myran, L., Zarbock, S. Management of Helicobacter pylori Infection. Available at https://www.uspharmacist.com/article/management-of-helicobacter-pylori-infection. Accessed June 14, 2022.
3. Voquezna prescribing information. Phathom Pharmaceuticals, Inc. Buffalo Grove, IL. May 2022.