Market access

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.

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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 (PTO) 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.”

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MMIT Reality Check on Hemophilia A or B With Inhibitors (July 2022)

A review of market access for hemophilia A or B with inhibitors treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions. Around 16% of the lives under health exchange formularies are not covered for at least one of the drugs.

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How Can Pharma Incorporate the Commercial Aspect Into Drug Development?

When pharma companies launch a successful product, the process leading up to that point contains many key decisions from various teams across a manufacturer, including commercial. And with science leading to more and more innovations and many drugs coming to market via an accelerated process, it’s critical now more than ever to understand when to bring in the commercial team and how it can help with the development of a drug and its ultimate success in the market.

During a recent webinar, which was part of the Fierce Leaders in Sciences Forum sponsored by Fierce Pharma, moderator Lisa Johnson Pratt, a board member for Assembly Biosciences, kicked off the discussion by asking what the biggest challenges are for companies that are trying to bring a strong commercial point of view and input into the product development process.

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As PBMs Are Under Microscope, New Suit Accuses CVS of Generics-Blocking Scheme

At a time when the federal government is clamping down on pharmacy benefit managers and seeking ways to lower prescription drug prices, a recently unsealed whistleblower complaint details how one of the three largest PBMs allegedly drove up costs for Medicare Part D beneficiaries and the federal government. In a lawsuit that CVS Health Corp. intends to fight, the False Claims Act complaint accuses the parent company of colluding with its “supposedly firewalled” entities — the SilverScript Part D subsidiary, PBM CVS Caremark and CVS pharmacies — of striking secret rebate agreements with the drug makers that required SilverScript to block substitution on its formularies of generic drugs in favor of costlier brand-name alternatives.

The U.S. Dept. of Justice chose not to intervene in the second amended complaint, which was filed in the U.S. District Court for the Eastern District of Pennsylvania in March and recently obtained by Stat. The suit was filed by relator Alexandra Miller, who worked for CVS Health for 19 years. According to Miller’s LinkedIn profile, she most recently served as senior director of Medicare Part D operations and is now senior director of member and provider experiences for Oscar Health.

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MMIT Reality Check on Type 2 Diabetes (SGLT2 and Combo) (2Q2022)

A review of market access for type 2 diabetes (SGLT2 and combo) treatments shows that under the pharmacy benefit, about 43% of the lives under commercial formularies are covered with utilization management restrictions. Around 20% of the lives under Medicare formularies are not covered for at least one of the drugs.

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MMIT Reality Check on Urothelial/Bladder Cancer (June 2022)

A review of market access for urothelial/bladder cancer shows that under the pharmacy benefit, about 46% of the lives under commercial formularies are covered with utilization management restrictions. Around 38% of the lives under Medicare formularies are not covered for at least one of the drugs.

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MMIT Reality Check on Chemotherapy-Induced Nausea and Vomiting (June 2022)

A review of market access for treatments of chemotherapy-induced nausea and vomiting shows that under the pharmacy benefit, about 27% of the lives under commercial formularies are covered with utilization management restrictions. Around 58% of the lives under Medicare formularies are not covered for at least one of the drugs.

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MMIT Reality Check on Hereditary Angioedema (June 2022)

A review of market access for hereditary angioedema treatments shows that under the pharmacy benefit, about 60% of the lives under commercial formularies are covered with utilization management restrictions. Around 29% of the lives under Medicare formularies are not covered for at least one of the drugs.

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News Briefs: Inflation Hasn’t Yet Affected Health Care Prices

Inflation has not yet impacted health care prices, according to new research from the Kaiser Family Foundation (KFF). The KFF study reports that in the 12 months ending in April 2022, “overall prices grew by 8.3% from the previous year, while prices for medical care increased by only 3.2%.” The authors added, “This is unusual, as health prices historically outpace prices in the rest of the economy. However, the relatively high rate of inflation seen in the rest of the economy may eventually translate to higher prices for medical care. This may lead to steeper premium increases in the coming years.” Generally speaking, according to the report, prices have grown faster for commercial insurance than public payers, a trend that held up in 2022. Though inflation is greater than it has been for a generation, its impact is likely delayed in health care because of contracting cycles. “Health prices are generally set in advance, administratively or via private insurance contracting, so there may be a delay in observable price increases,” the authors observe.

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