Express Scripts Updates National Preferred Formulary

Express Scripts, a Cigna company, has added more than 60 products to its National Preferred Formulary, dated July 1, 2022 compared with the Jan. 1, 2022 list. About three quarters of the products have been added with some type of utilization management, including prior authorization, quantity limits or step therapy. (See table below for a list of the products that have been added and their utilization management strategies.)

Officials from Cigna say prior authorizations and other tools help health plans protect patient health and safety and improve affordability by reducing unnecessary costs.

“Tools like prior authorization help protect patient health and safety — ensuring that the right patient gets the right drug at right dose at the right time — and improve affordability by reducing unnecessary costs,” an Express Scripts spokesperson told Formulary Watch. “Most often, they apply with medicines that are unsafe when combined with other drugs, medicines that have lower-cost, equally effective alternatives, or medicines that are commonly misused.”

All formulary decisions are driven first by clinical consideration made by an independent committee of practicing physicians and pharmacists, and the final decision about a patient’s treatment rests with the individual and their doctor, the spokesperson said.

The updated preferred drug list includes 11 cancer therapies, and most — with the exception of Arranon, Novartis’ therapy for acute lymphoblastic leukemia, and Welireg, Merck’s therapy for von Hippel-Lindau disease — require prior authorization and/or have quantity limits.

Among those that Express Scripts requires both prior authorization and quantity limits is Takeda Oncology’s Exkivity (mobocertinib). Exkivity received an accelerated approval in September 2021. It treats non-small lung cancer in patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Eskivity has a wholesale acquisition cost of $25,000 for bottle of 120 capsules.

This is the second approval for this mutation and the first oral therapy. In May 2021, the FDA granted accelerated approval of Rybrevant (amivantamab-vmjw), a bispecific antibody directed against EGFR and MET receptors that is administered intravenously. Developed by Janssen, Rybrevant, however, has not been added to Express Scripts’ preferred list. Rybrevant has wholesale acquisition cost of $3,324, per vial.

EGFR exon 20 insertion NSCLC is an underserved cancer that doesn’t respond traditional EGFR tyrosine kinase inhibitors. These include Genentech’s Tarceva (erlotinib), AstraZeneca’s Iressa (gefitinib), and Boehringer Ingelheim’s Gilotrif (afatinib). Both Iressa and Gilotrif are included on Express Scripts’ preferred formulary but with prior authorization and with quantity limits.

EGFR mutations occur in about 30% of NSCLC and of these between 4% and 10% have EGFR 20 mutations.

Other cancer therapies added to Express Scripts’ preferred list that require both prior authorization and have quantity limits include:

• Lenvima. Developed by Eisai and Merck, Lenvima (lenvatinib) is approved for several cancers including inoperable liver cancer, differentiated thyroid cancer, advanced kidney cancer.
• Rydapt. Novartis’ Rydapt (midostaurin) is approved to treat acute myeloid leukemia.
• Venclexta. Developed by AbbVie and Genentech, Venclaxta (venetoclax) is approved for acute myeloid leukemia and chronic lymphocytic leukemia.
• Vistogard. Developed by Wellstat Therapeutics, Vistogard (uridine), is an emergency treatment of adults and children who received an overdose of the cancer drugs fluorouracil or capecitabine.
• Xospata. Astellas’ Xospata (gilteritinib) is used to treat acute myeloid leukemia.
• Zolinta. Merck’s Zolinta (vorinostat) is used to treat T-cell lymphoma.

A cancer therapy added to Express Scripts’ preferred drug list that requires prior authorization only is CTI BioPharma’s Vonjo (pacritinib), which was granted accelerated approval in February 2022. It is a JAK-inhibitor to treat patients with myelofibrosis, a bone marrow cancer. Another therapy added with a prior authorization requirement is Genentech’s Xeloda (capecitabine), which treats metastatic colorectal cancer and metastatic breast cancer.

Express Scripts has also added seven therapies that treat patients with central nervous system conditions, of which all — with the exception of the antiseizure medication dilantin — requires some form of utilization management. Corium’s Azstarys (serdexmethylphenidate and dexmethylphenidate) is among these. It is used to treat patients 6 years and older with attention deficit hyperactivity disorder (ADHD). Azstarys was approved in March 2021 and is classified as a Schedule II drug, although the company has indicated it has a low potential for abuse. As a prodrug, SDX is specifically designed to be pharmacologically inactive until reaching the lower gastrointestinal tract, where SDX is gradually converted to d-MPH throughout the day. Express Scripts requires step therapy for this medication.

Express Scripts has also added several newer migraine therapies to the preferred drug list: Qulipta (atogepant) and Trudhesa (dihydroergotamine) nasal spray. Both were approved in September 2021. For AbbVie’s Qulipta, Express Scripts requires a prior authorization. It is a once-daily oral to prevent episodic migraines in adults, and AbbVie in June 2022 submitted an application to the FDA for chronic migraine. For Trudhesa, the PBM requires step therapy. Developed by Impel NeuroPharma, it is a nasal spray for the acute treatment of migraine.

Several vaccines have been added to the preferred formulary without any prior authorization, including Flumist quad, the Pfizer COVID-19 vaccine (but not Moderna's vaccine), TicoVac syringe for tick-borne encephalitis and Vaxneuvance pneumococcal syringe. And although the Accu-Chek Lancets and Microlet lancets for diabetes care have been added without any utilization management, the Dexcom 6G receiver and transmitter has been include with prior authorization.

Only a few products have been removed, including the cream and gel forms of the acne medication Tazorac and the antidepressant sertraline.