RADAR on Specialty Pharmacy
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Study Shows Only About One-Third of People With NSCLC Are Benefiting From Appropriate Care
The FDA has approved around 100 targeted therapies for different types of cancer, with many more in the pipeline. Current agents for non-small cell lung cancer (NSCLC), for example, target about 10 different biomarkers, and more than 70% of people with the condition have alterations in their tumors that are tied to available treatments. But a recent study found that due to practice gaps in the precision oncology pathway, just more than one-third of patients with biomarkers that could be treated with an FDA-approved therapy are actually benefiting from those drugs.
Lung cancer is one of the most common types of cancer, and NSCLC makes up the bulk of the cases. Many of the more than two dozen agents approved for NSCLC are targeted therapies that are indicated for specific subsets of the disease, and numerous tests are available to help providers determine the best treatment for a patient.
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New FDA Approvals: FDA Issues Emergency Use Authorization to Kineret
Nov. 9: The FDA issued an emergency use authorization to Amgen Inc.’s Kineret (anakinra) for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). The agency initially approved the interleukin-1 receptor antagonist (IL-1Ra) on Nov. 14, 2001. The recommended dosing for this latest use is 100 mg administered daily by subcutaneous injection for 10 days. Drugs.com lists the price of one 100 mg prefilled syringe as more than $1,265.
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News Briefs: Sen. Mike Lee Introduced Biosimilar Red Tape Elimination Act
Sen. Mike Lee (R-Utah) unveiled legislation aimed at boosting competition among biologics and reducing consumer costs for the agents. Introduced on Nov. 17, the Biosimilar Red Tape Elimination Act (S.6) would do away with the FDA requirement for switching studies for biosimilars seeking the interchangeability designation. “Eliminating this barrier would increase access to lower-cost biosimilars and save payers and consumers billions over the next five years,” according to a press release from Lee’s office. In contrast to the European Union, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) recently clarified that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars. Also quoted in the release was Sarfaraz Niazi, Ph.D., an adjunct professor of biopharmaceutical Sciences at the College of Pharmacy at the University of Illinois Chicago, who pointed out that “according to the FDA, ‘biosimilars have no clinically meaningful difference with their reference product,’ so if there is no difference, they should be interchangeable without the extensive and expensive switching and alternating studies in patients.”
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Biosimilars Are Picking Up Market Share, but Some Uncertainties Still Exist
Since the FDA’s approval of the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved almost 40 more agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). Although not all of those agents have launched yet, and almost all of the ones that have are all professionally administered, industry experts say they expect to see more competition in the space, depending on interchangeability status, provider uptake and the impact of the Inflation Reduction Act.
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PARP Inhibitors’ Data on Later Line Use in Ovarian Cancer Prompts Indication Withdrawals
Since June, manufacturers of the three FDA-approved poly (ADP-ribose) polymerase (PARP) inhibitors have withdrawn their indications in the later line treatment setting for ovarian cancer. Payers should be reviewing their utilization management criteria to make sure they are covering the drugs in the appropriate setting, advises one industry expert.
In a Form 8-K filed with the U.S. Securities and Exchange Commission on June 16, Clovis Oncology, Inc. said it was voluntarily withdrawing the FDA approval for Rubraca (rucaparib) for the treatment of BRCA-mutated ovarian cancer after at least two chemotherapies based on overall survival (OS) data from the ARIEL4 clinical trial. The company also disclosed that it had requested withdrawal of that indication in Europe. The drug’s indications for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and for the treatment of adults with a deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy, the latter of which has accelerated approval, remain on its label.
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