Market access

CivicaScript Launches Initial Generic Drug, Plans Several More in Coming Years

CivicaScript last week began selling its initial generic drug, a 250 mg abiraterone acetate tablet. It’s the first of what the health insurer- and PBM-backed nonprofit company hopes are many medications that it will produce to help patients and payers lower their drug spending.

The product is currently only available through Intermountain Healthcare, a Utah-based integrated health plan and system that owns a specialty pharmacy, and Lumicera Health Services, a specialty pharmacy owned by Navitus Health Solutions. But CivicaScript President Gina Guinasso tells AIS Health, a division of MMIT, that she expects other pharmacies to offer the medication in the coming months.

0 Comments

Datapoint: Pfizer Scores Endometriosis Nod for Myfembree

The FDA last week approved Pfizer’s Myfembree for the treatment of moderate to severe endometriosis pain in pre-menopausal women. The once-daily pill was first approved for the treatment of uterine fibroids in May 2021. For this indication, the drug currently holds covered or better status for 80% of all insured lives, with 44.8% having preferred access to Myfembree.

0 Comments

Datapoint: FDA Approves Coherus Lucentis Copy

The FDA last week approved Coherus BioSciences, Inc.’s Lucentis biosimilar, Cimerli, across all five of its indications. The anti-VEGF therapy will be interchangeable with Lucentis, a blockbuster for manufacturer Roche, and hold interchangeability exclusivity for 12 months. The first Lucentis biosimilar, Byooviz, was approved in September 2021, but for just three of Lucentis’s indications, including wet age-related macular degeneration (AMD). For the treatment of AMD, Lucentis holds covered or better status for 86% of all insured lives under the medical benefit, to Byooviz’s 68%.

0 Comments

MMIT Reality Check on Kidney Cancer (August 2022)

A review of market access for kidney cancer treatments shows that under the pharmacy benefit, about 52% of the lives under commercial formularies are covered with utilization management restrictions. Around 25% of the lives under Medicare formularies are not covered for at least one of the drugs.

0 Comments

U.S. Sees First Ophthalmologic Biosimilar Launch in Crowded, High-Cost Space

The U.S. market recently welcomed the first ophthalmologic biosimilar onto the market: Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna), which references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). While the agent is entering what is becoming a fairly crowded space, it will offer a cost-effective option for payers, say industry sources.

On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). Under an agreement with Genentech, Samsung Bioepis and Biogen were not able to market the vascular endothelial growth factor (VEGF) inhibitor in the U.S. until June 2022. Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz, and the medication became commercially available on July 1. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.

0 Comments

MMIT Reality Check on Bipolar Disorder (July 2022)

A review of market access for bipolar disorder treatments shows that under the pharmacy benefit, about 24% of the lives under commercial formularies are covered with utilization management restrictions. Around 19% of the lives under Medicare formularies are not covered for at least one of the drugs.

0 Comments

Medication Abortion Faces Legal Uncertainty Post-Dobbs

With abortion banned or on the verge of a ban in a growing number of states following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, medication abortion has become more important than ever for women and pregnant people seeking abortion care. Abortifacients, the class of prescription drug used to terminate pregnancies, can be used more discreetly than surgical abortions: they don’t require an in-person consultation and, since the start of the pandemic, have been dispensed online without medical risk to patients.

However, experts say that the legal status of medication abortion is far from settled in states where abortion has been banned. Many patients haven’t heard that medication abortion is available, and women and pregnant people who do use abortifacients — or suffer a miscarriage — could face prosecution in states where abortion has been banned. It’s not clear what sort of criminal or civil risk providers, purchasers and carriers will bear if their patients and plan members use abortifacients prescribed across state lines.

0 Comments

MMIT Reality Check on Psoriatic Arthritis (July 2022)

A review of market access for psoriatic arthritis treatments shows that under the pharmacy benefit, about 73% of the lives under commercial formularies are covered with utilization management restrictions. Around 37% of the lives under Medicare formularies are not covered for at least one of the drugs.

0 Comments

Pharma Patent Practices Come Under Scrutiny From Congress, FDA, PTO

As Congress again proposes drug pricing efforts, many of its members, as well as a couple of government agencies, have pharma manufacturers in their crosshairs for a somewhat related reason: their patent processes. The FDA and the U.S. Patent and Trademark Office (USPTO) recently said they would be working together to scrutinize certain practices that could potentially lead to delays in competition from biosimilars and generics.

The move follows President Biden’s July 9, 2021, Executive Order on Promoting Competition in the American Economy in which he called for “a fair, open, and competitive marketplace” across numerous industries. “Too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.”

0 Comments

MMIT Reality Check on Acute Lymphoblastic Leukemia (July 2022)

A review of market access for acute lymphoblastic leukemia treatments shows that under the pharmacy benefit, about 37% of the lives under commercial formularies are covered with utilization management restrictions. Around 42% of the lives under Medicare formularies are not covered for at least one of the drugs.

0 Comments