Addition of Talicia® by Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization is an important expansion of coverage for California patients and continues to increase Talicia’s overall unrestricted coverage
Coverage commenced for two million patients in MediCal’s FFS plan on October 1st, 2021
Talicia® is the first and only FDA-approved rifabutinbased therapy for H. pylori infection, designed as a first-line option to address the high resistance of H. pylori bacteria to standard-of-care therapies H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric cancer; H. pylori affects approximately 35% of the U.S. population
TEL-AVIV, Israel and RALEIGH, N.C., October 6, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that Medi-Cal – California’s Medicaid Health Care program covering two million patients – has added Talicia® (omeprazole magnesium, amoxicillin and rifabutin) to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required, effective October 1, 2021.
Coverage for Talicia commenced for two million patients in Medi-Cal’s California FFS plan on October 1, 2021.
“Medi-Cal’s addition of Talicia with no prior authorization required is an important step in Talicia’s continuing growth and we are pleased that it will be made available to Medi-Cal’s 2 million FFS lives,” said Rick Scruggs, RedHill’s Chief Commercial Officer. “There is growing recognition of the need to employ effective, first-line therapy against H. pylori infections that does not rely on clarithromycin and that patients can tolerate well and adhere to over 14 days of therapy. Talicia meets those criteria.”
Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to clarithromycin-based therapies. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the FDA and the World Health Organization (WHO) in recent years.
Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill’s pivotal Phase 3 study. Further, in
an analysis of data from this study, it was observed that subjects who were confirmed adherent[ii] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[iii].
Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
About H. pylori
H. pylori is a bacterial infection that affects approximately 35%[iv] of the U.S. population, with an estimated two million patients treated annually[v]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[vi] and a major risk factor for peptic ulcer disease[vii] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[viii]. More than 27,000 Americans are diagnosed with gastric cancer annually[ix]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics commonly used in standard combination therapies[x].
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[xi], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[xii], and Aemcolo® for the treatment of travelers’ diarrhea in adults[xiii]. RedHill’s key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2
selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation.
More information about the Company is available at: redhillbio.com
INDICATION AND USAGE
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy.
Talicia may reduce the efficacy of hormonal
contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Acute Interstitial Nephritis has been observed in patients taking PPIs and penicillins.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at:
1-833-ADRHILL (1-833-237-4455) or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch
Full prescribing information for Talicia is available at: Talicia.com
- Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults. For full prescribing information see: www.Talicia.com.
- Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
- The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
- Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
- IQVIA Custom Study for RedHill Biopharma, 2019
- Lamb A et al. Role of the Helicobacter pylori-Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
- NIH – Helicobacter pylori and Cancer, September 2013.
- Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
- National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
- Malfertheiner P. et al. Management of Helicobacter pylori infection – the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O’Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.
- Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
- Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia. com.
- Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.