OptumRx Excludes the Diabetes Biosimilar Semglee from Formulary

Semglee (insulin glargine-yfgn) will be excluded on OptumRx’s Premium Formulary and will be placed on Tier 3 with step therapy on OptumRx’s Select Formulary, according to an October 2021 update from the company.

OptumRx's current preferred long-acting insulin products are Lantus and Toujeo. These offer the lowest net cost long-acting insulin options and are Tier 2 on the OptumRx Premium and Select Formularies, according to OptumRx.

With the availability of an interchangeable biosimilar Semglee, OptumRx is evaluating potential strategies that may further reduce costs in the long-acting insulin category, according to the company.

Two other PBMs — Prime Therapeutics and Express Scripts — will remove Lantus from their formularies and include Semglee as the preferred therapy beginning January 2022.

Related: Prime Therapeutics and Express Scripts add Semglee to Formulary

The FDA approved Semglee, developed by Viatris and Biocon Biologics, in July 2021 to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. It is interchangeable with Lantus, a long-acting insulin analog. Semglee, offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily.

Viatris/Biocon recently launched Semglee both as a branded and nonbranded product. The currently marketed non-interchangeable Semglee will be phased out by the end of the 2021, according to a statement from the companies.

Viatris has established several programs to help to help with patient access, including a patient assistance program, a copay program that limits out-of-pocket expenses, and a program for Medicare Part D that limits out-of-pocket expenses to no more than $35 a month.

Related: Biocon Launches Biosimilar Semglee

OptumRx has also made decisions about other therapies approved this year, including:

• Exkivity (mobocertinib) and Tivdak (tisoteumab vedotin-tftv) have been included as tier 3 products on both the Premium and the Select formularies. Takeda’s Exkivity was approved by the FDA in September 2021. It is a targeted therapy to treat patients with nonsmall cell lung cancer who have epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Tivdak was developed by Seagen and Genmab and was approved in September 2021. It is antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer.
• Invega Hafyera (paliperidone palmitate) and Lybalvi (olanzapine and samidorphan) been excluded on the Premium formulary and included as a Tier 3 therapy on the Select formulary. Invega Hafyera, developed by Janssen, was approved by the FDA in September as a twice-yearly injection for schizophrenia. The FDA approved Lybalvia in June 2021 to treat adults with schizophrenia or bipolor 1 disorder. It was developed by Alkermes.
• Livmarli (maralixibat) has been included as a tier 3 product on both the Premium and the Select formularies. The FDA approved Livmarli in September 2021. Developed by Mirum Pharmaceuticals, Livmarli treats patients with a rare liver disorder.
• Loreev XR (lorazepam) capsule has been excluded on the Premium formulary and included as a Tier 3 therapy on the Select formulary. Loreev XR, developed by Almatica Pharma, is extended-release therapy for the treatment of patients with anxiety disorders. The FDA approved the product in August 2021.
• Roszet (ezetimibe-rosuvastatin)has been excluded on the Premium formulary and included as a Tier 3 therapy on the Select formulary with step and with quantity limits. The FDA approved Rozet in March 2021 to treat high cholesterol. It was developed by Althera.
• Trudhesa (dihydroergotamine mesylate) has been excluded on the Premium formulary and included as a Tier 3 therapy on the Select formulary. Developed by NeuroPharma, Trudhesa is a novel nasal spray treatment for migraine. It as approved by the FDA in September 2021.
• Opzelura (ruxolitinib) has been included as a tier 3 product on both the Premium and the Select formularies. The FDA approved Incyte’s Opzelura in September 2021 as the first topical formulation of a JAK inhibitor as a treatment of mild-to-moderate atopic dermatitis those 12 years of age or older.