Drug Approvals

Cardinal Health Predicts Biosimilar Boom in New Report

Pharmaceutical distribution and wholesaling giant Cardinal Health Inc. is optimistic that biosimilars will be broadly adopted and deliver big cost savings to the U.S. health care system in the next several years. The findings of a new white paper from the company run counter to more pessimistic predictions by other industry insiders, but Cardinal executives tell AIS Health, a division of MMIT, that even though some barriers to biosimilars remain, new approvals and regulatory changes have already accelerated adoption.

“I am deeply encouraged by the progress made in the U.S., especially this past year,” Sonia Oskouei, Cardinal Health’s vice president for biosimilars, wrote in the report. “Following the launch of the first biosimilar in 2015, we now have 33 FDA approved biosimilars with 21 available on the market as of January 2022. The U.S. biosimilars story that was initially described as sluggish and delayed has now transformed to one of progress and momentum. This past year, the promise of biosimilars has started to become a reality, as greater competition for some of the costliest biologic treatments on the market is beginning to drive meaningful cost savings.”

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News Briefs: New Drug to Break List Price Record

Ramona Sequeira has become the new chair of the Pharmaceutical Research and Manufacturers of America (PhRMA) board of directors. She is the first woman to hold that top leadership position at the industry’s chief lobbying group. Sequeira is the president of Takeda Pharmaceuticals’ U.S. business unit and head of global portfolio commercialization at the Japanese drugmaker, per a Feb. 3 press release.

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News Briefs: CMS Says It Found a Way to Cover Medicare Beneficiaries’ At-Home COVID Tests

CMS on Feb. 3 said it is working on an initiative to enable Medicare coverage of over-the-counter (OTC) COVID tests in early spring. The administration in January issued guidance requiring group and individual health plans to reimburse members for up to eight at-home COVID tests per month without cost sharing. Sen. Debbie Stabenow (D-Mich.) and 18 other senators on Jan. 24 wrote to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure urging them to extend the same access to Medicare enrollees. And in a bipartisan letter issued Jan. 20, House representatives made a similar request. Despite several issues that complicated CMS’s efforts to cover the tests, the agency said it has “identified a pathway that will expand access to free over-the-counter testing for Medicare beneficiaries.”

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News Briefs: US Drug Price Growth Offsets Falling Prices Elsewhere

The price of the average brand-name drug has increased by 18.3% annually on average over the last five years, according to research firm GlobalData. Floriane Reinaud, research and analysis director at GlobalData, said in a statement that this price growth is unique to the U.S. “While drug list prices have only been increasing in the US, major markets in the rest of the world are seeing declines. Japan, for example, saw drug prices decline by more than 9% while Germany declined by around 7.5%,” Reinaud said.

The business strength of “speculative grade” pharmaceutical companies varies considerably, mainly due to differences in their produce concentration and drug development pipelines, according to S&P Global Data. S&P analysts Patrick Bell and David A. Kaplan also wrote that “although speculative-grade companies are frequently more aggressive in pricing and life cycle management strategies, legislators and the media primarily focus criticism on well-known investment-grade peers and their more widely prescribed blockbuster drugs. Similarly, we believe pharmacy benefit managers place more attention on controlling spending on blockbuster drugs than those with narrower patient bases such as orphan drugs. Nevertheless, with a higher proportion of revenues generated in the U.S. and higher leverage, we believe drug price reform could hurt speculative-grade pharma companies disproportionately.”

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FDA Approves Cholesterol-Lowering Drug That Will Go Up Against PCSK9s

More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.

On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia who require additional lowering of low-density lipoprotein cholesterol.

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Notable 2021 Approvals Included Oncolytics, Interchangeables

Between the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER), the agency approved 60 new products in 2021, including biologics, cell and gene therapies, vaccines and blood products. As the COVID-19 pandemic continued for the second year, much of the pharma industry’s focus, understandably, was on vaccines and therapeutics for the coronavirus. As with prior years, oncology dominated the specialty drug space, but the FDA also approved novel treatments in other areas as manufacturers continued to pursue innovative new products. Moreover, the U.S. saw the first two interchangeable biosimilars gain approval. AIS Health, a division of MMIT, spoke with various industry experts about what they considered the most notable FDA approvals in 2021.

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Many Melanoma Therapies Exist, but Treatment Remains Challenging

Since 2011, the FDA has approved multiple therapies for advanced or late-stage melanoma. Recently, the agency granted an additional approval to one of those drugs for the earlier stage melanoma setting, filling an unmet need, industry experts note. However, the condition is complex to treat and may be challenging for health plans to manage.

On Dec. 3, the FDA approved Merck & Co., Inc.’s programmed death receptor-1 (PD-1) inhibitor Keytruda (pembrolizumab) for the adjuvant treatment of people at least 12 years old with stage IIB or IIC melanoma following complete resection. The agency also expanded the indication for the agent’s use as an adjuvant treatment of stage III melanoma following complete resection to include pediatric patients at least 12 years old.

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New FDA Approvals: FDA Approves Additional Indication for FoundationOne CDx | Jan. 13, 2022

Dec. 8: The FDA gave another approval to Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic for current and future BRAF inhibitors used to treat melanoma, including monotherapies targeting BRAF V600E and BRAF/MEK inhibitor combination therapies targeting BRAF V600E or V600K mutations. The agency first approved the test on Nov. 30, 2017.

Dec. 9: The FDA granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to help identify people with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 20-insertion mutations who may be candidates for treatment with Rybrevant (amivantamab-vmjw) from Janssen Biotech, Inc., a Johnson & Johnson company. The agency initially approved the test on June 22, 2017.

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Payer Groups Applaud CMS Coverage Decision on Aduhelm

CMS on Jan. 11 issued its long-awaited proposed National Coverage Determination (NCD) for Aduhelm (aducanumab), the Alzheimer’s drug that has been the subject of controversy since the FDA approved it last June. In what officials acknowledged was an unusual decision, CMS said Medicare will cover Aduhelm — and any other FDA-approved monoclonal antibodies that target amyloid plaques — only for people who are enrolled in qualifying clinical trials.

Health insurer trade groups praised the decision, which comes after Aduhelm manufacturer Biogen cut the price of the drug approximately in half in a bid to encourage both provider uptake and payer coverage.

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New Drugs for Asthma, Kidney Disease, HIV Are On the Horizon

A new biologic for severe asthma, a drug for anemia related to chronic kidney disease (CKD) and a long acting pre-exposure prophylaxis (PrEP) for HIV-1 are among the first-in-class therapies featured in OptumRx’s Q1 2022 Drug Pipeline Insights Report. In addition to these new drugs, the PBM also calls attention to the likelihood of more COVID-19 vaccines and treatments receiving full approval and additional uses in 2022.

Tezepelumab (brand name Tezspire) was approved by the FDA for maintenance treatment of severe asthma in December 2021. Many biologics for severe asthma are already on the market, but these drugs target asthma subtypes determined by baseline blood eosinophil counts, according to the OptumRx report. On the other hand, tezepelumab, developed by AstraZeneca and AmGen Inc., has been developed with a broader indication.

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