California’s Medicaid Program Adds Talicia, Twirla to Drug List

Medi-Cal, California’s Medicaid program, has added two therapies to its formulary effective Oct. 1, 2021. RedHill BioPharma’s Talicia (omeprazole magnesium, amoxicillin and rifabutin) has been added to Medi-Cal’s fee-for-service contract drug list for Helicobacter pylori treatment, with no prior authorization required. Agile Therapeutics’ Twirla (levonorgestrel and ethinyl estradiol) has been added to Medi-Cal’s preferred drug formulary list.

Twirla transdermal system is a once-weekly combined hormonal contraceptive patch that contains the active ingredients levonorgestrel, a type of progestin, and ethinyl estradiol, and t is indicated for use as a method of contraception by women. It was added to Medi-Cal’s fee-for-service plans and related programs such as the Family Planning, Access, Care and Treatment Program, with the remainder of beneficiaries gaining access as of January 1, 2022.

Talicia is a fixed-dose, oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). The FDA approved Talicia in November 2019 to treat H. pylori infection in adults. In the pivotal phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat group vs. 58% in the active comparator arm. Patients who were confirmed adherent to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm.

Rick Scruggs

“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, Rick Scruggs, RedHill’s chief commercial officer, said in a statement.

H. pylori is a bacterial infection that can lead to stomach ulcers and is a risk factor for certain types of stomach cancer. The World Health Organization classifies H. pylori as a group 1 carcinogen.

Although the United States has a lower prevalence of H. pylori, studies show that half of the world’s population is infected.

Clarithromycin is an antimicrobial used to treat this infection, butH. pylori has become resistant to clarithromycin. In the United States, resistance to clarithromycin exceeds 20% prevalance.

In July, OptumRx, a part of UnitedHealth Group, added coverage of Talicia to its commercial formulary as an unrestricted brand.