Biosimilars

News Briefs: Cancer Replaced Musculoskeletal Conditions as Biggest Driver of Large Companies’ Health Care Costs

Cancer replaced musculoskeletal conditions as the biggest driver of large companies’ health care costs, according to the Business Group on Health’s 2023 Large Employers’ Health Care Strategy and Plan Design Survey. The survey found that “13% of employers said they have seen more late-stage cancers and another 44% anticipate seeing such an increase in the future, likely due to pandemic-related delays in care.” Between May 31, 2022, and July 13, 2022, the organization polled 135 large employers in various sectors that cover more than 18 million people in the U.S. The survey also found that 99% of respondents said that they are concerned about prescription drug trend. Last year, prescription drugs were responsible for a median of 21% of the companies’ health care costs, and specialty drugs accounted for more than half of pharmacy spend.

Specialty Trend Rose in 2021, but Biosimilars Are Having Impact

Specialty drug trend in 2021 largely recovered from the hit it took from the COVID-19 pandemic in 2020, driven mainly by an increase in utilization. That’s according to the 2022 Artemetrx State of Specialty Spend and Trend Report from Pharmaceutical Strategies Group (PSG), an EPIC company.

Published in August, the report is sponsored by specialty pharmacy Reliance Rx. Findings are based on an Artemetrx analysis of 73.9 million medical claims and 55.1 million pharmacy claims from PSG’s book of business. It is the sixth annual version of the report.

Industry Expert Maintains That Specialty Pharmacy Market Has Reached ‘Inflection Point’

Multiple trends are occurring within the specialty pharmacy industry that could have a huge impact on the space, maintained longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. Those include greater competition among specialty products, a slowing of payer spending on specialty drugs and more vertical integration among both payers and providers. “We’re at kind of an inflection point in the specialty market,” he contended during the July 29 webinar, titled Specialty Drugs Update: Trends, Controversies, and Outlook.

New FDA Approvals: FDA Expands Patient Population for Diacomit

July 14: The FDA expanded the patient population of Biocodex, Inc.’s Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome in people between the ages of 6 months to 2 years and weighing at least 7 kg who are taking clobazam. The agency first approved the treatment on Aug. 20, 2018. The drug is available as a capsule and an oral suspension. Dosing is 50 mg/kg/day for both routes of administration. Drugs.com lists the price of 60 250 mg capsules and 60 250 mg powder for reconstitution as more than $1,589.

July 14: The FDA expanded the label of Pfizer Inc.’s Xalkori (crizotinib) to include the treatment of people at least 1 year old with unresectable, recurrent or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. The agency initially approved the kinase inhibitor on Aug. 26, 2011. The FDA gave the agent orphan drug designation and granted the application priority review; that review used the Assessment Aid, a voluntary submission from the applicant to assist the FDA in its analysis. Dosing for the newest indication of the capsule in adults is 250 mg twice daily. The recommended pediatric dosage is 280 mg.m2 twice daily based on body surface area. Drugs.com lists the price of 60 250 mg capsules as more than $20,657.

Industry Expert: Specialty Pharmacy Market Is at ‘Inflection Point’

Multiple trends are occurring within the specialty pharmacy industry that could have a huge impact on the space, maintained longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. Those include greater competition among specialty products, a slowing of payer spending on specialty drugs and more vertical integration among both payers and providers. “We’re at kind of an inflection point in the specialty market,” he contended during the July 29 webinar, titled Specialty Drugs Update: Trends, Controversies, and Outlook.

Among PBMs reporting their commercial plan sponsor clients’ spend, the average share of prescriptions by specialty drugs, both generic and brand, was 2% in 2021. The share of pharmacy revenues for specialty drugs was 38%, and the share of commercial payers’ net spending was 51%. “For the last few years, drug spending has been growing in the low-to-mid single digits, and that’s really the blend of traditional drugs” that have gone down in price due to generics, as well as the gross-to-net bubble — the growing difference between a drug’s gross sales at list price vs. its sales at net price, which includes rebates and other concessions. “Specialty drug spending has also been slowing down. It spiked quite a bit with the introduction of hepatitis C treatments and has been hovering in the 10% to 15% a year range,…but more recently, i.e., last year, it actually dropped.” He pointed out that CVS and Express Scripts reported that their specialty drug spending growth was only 5% to 6%.

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.

Democrats Make Another Attempt at Prescription Drug Pricing Reform

Democrats are once again seeking to pass drug pricing reform with a new proposal published earlier this month. While the bill is similar to previous ones, most notably with having Medicare conduct drug price negotiations, it also offers some changes from past efforts, including not basing those drug prices on an international reference model. Still, many pharma stakeholders expressed disappointment over aspects of the bill, and while its odds of passing have slightly improved more recently, industry experts are somewhat divided on the bill’s chance of approval.

The newest proposal was released on July 6 after negotiations with Sen. Joe Manchin (D-W.Va.), who squelched earlier administration attempts at drug pricing reform.

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.”

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.

Report Shows Evolution in Utilization Management for Specialty Drugs

While plan sponsors continue to use traditional utilization management (UM) tools for specialty drugs, some of these tactics have evolved over the years, as well as been joined by newer ones, such as new-to-market formulary blocks, according to a new report from Pharmaceutical Strategies Group (PSG), an EPIC company. And plans’ tracking of specialty spend under the medical benefit has improved, with 70% of respondents having this capability, up from 50% in 2019, according to the 2021 Trends in Specialty Drug Benefit Design Report.

The report, which is co-sponsored by Roche Group member Genentech USA, Inc., is the ninth annual version. It previously was published under the Pharmacy Benefit Management Institute (PBMI) brand.