With New Data, Oncopeptides Rescinds Pepaxto Withdrawal

Three months after Oncopeptides AB said it was voluntarily withdrawing Pepaxto (melphalan flufenamide) from the U.S. market, the company is now taking back that withdrawal and has begun working with the FDA to review new data on the multiple myeloma therapy.

On Jan. 21, the company said that it had contacted the FDA to rescind its Oct. 22 letter requesting voluntary withdrawal of the agent’s New Drug Application (NDA). According to a company press release, “further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials have led the Company to reconsider its previous voluntary withdrawal request. Oncopeptides has discontinued the marketing of Pepaxto in the US and does not intend to market Pepaxto in the US at this time. The company has initiated a dialogue with the FDA to review the new data.”

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Drug Pricing Remains Hot Topic, but Legislation Addressing It Has Stalled

While drug prices continue to be an issue of concern to many Americans, whether it can get any legislative traction issue remains unclear. So what might happen on the issue in 2022?

Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth: Pharmaceutical drug pricing continues to be a contentious policy issue. Recent data has branded drug list prices growing annually by more than 9% over the last decade, which is much higher than gross domestic product (GDP) growth. However, a RAND study found that prices for unbranded generic drugs...are slightly lower in the United States than in most other nations. Additionally, patients’ out-of-pocket costs for specialty drugs have increased faster than GDP growth over the same period — 2.8% vs. 2.3%. Furthermore, the current White House administration and Congress have declared that reining in Medicare prescription drug costs to help older adults and people with disabilities is a top priority. This will put drug pricing in the crosshairs of elected officials, advocacy groups and patients.…

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ICER Draft Report Deems Four COVID Drugs Reasonably Priced

The manufacturers of four treatments aimed at easing the disease burden of mild-to-moderate COVID-19 received good news recently when the Institute for Clinical and Economic Review (ICER) determined in a draft report that their prices are “reasonably aligned with patient benefits.”

Each of the treatments — molnupiravir, Paxlovid and fluvoxamine, which are delivered orally, and the IV-administered sotrovimab — have been shown in clinical trials to greatly reduce the risk of hospitalization or death in comparison to placebo treatments, according to a draft evidence report released Feb. 3 by ICER.

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Aetna Could Face Class-Action Suit Over Proton Therapy Denials

Due to a Jan. 27 federal court order, CVS Health Corp.’s Aetna health insurance division could be the defendant in a class-action lawsuit regarding Aetna’s restrictive coverage decisions in breast and prostate cancer treatment. In a lawsuit filed in Florida district court, a federal judge found that Aetna improperly denied coverage of proton therapy to cancer patients who ultimately had to pay for the treatment out of pocket.

Proton beam radiation therapy (PBRT) is a type of cancer treatment “that uses high-powered energy to treat cancer and some noncancerous tumors,” according to the Mayo Clinic, which also notes that “studies have compared proton radiation and X-ray radiation, so it’s not clear whether proton therapy is more effective at prolonging lives.” The therapy isn’t widely available, although new proton therapy centers are being built in the U.S. and in other countries.

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Lower MA, Individual Enrollment Estimates Dim Cigna 4Q Earnings

Although Cigna Corp. ended 2021 with earnings that exceeded Wall Street expectations, the company also reported continued struggles with elevated medical costs last year. Further, the insurer disclosed that it expects less Medicare Advantage growth than it originally anticipated in 2022 and a decline in individual/family plan enrollment.

For the fourth quarter of 2021, Cigna reported adjusted earnings per share (EPS) of $4.77, beating the consensus estimate of $4.50. Cigna’s full-year adjusted EPS was $20.47, reflecting year-over-year growth of 11% that the company said was largely driven by the Evernorth health services segment.

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Mark Cuban’s Cash Pharmacy Launches Amid Strong Competition

Mark Cuban Cost Plus Drug Company (MCCPDC) launched its online, generic-dispensing pharmacy on Jan. 19, becoming the latest entrant into a burgeoning market of prescription drug retailers that operate independent of traditional pharmacy benefits. Health care insiders say that the amount of activity in the emerging segment is encouraging, but they add that no one player is likely to become dominant in the space.

MCCPDC, a discount prescription drug startup launched by venture capitalist and Dallas Mavericks owner Mark Cuban, now operates an online pharmacy that sells directly to consumers and does not accept insurance. MCCPDC CEO Alex Oshmyansky, M.D., Ph.D., told AIS Health, a division of MMIT, in October that the firm is registered as a pharmaceutical wholesaler with the FDA.

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Premiums, Deductibles Take Growing Portion of Workers’ Paychecks

People with employer-sponsored health plans spent 11.6% of their median household income on premiums and deductibles in 2020, up from 9.1% in 2010, according to an analysis published by The Commonwealth Fund. In 37 states, premiums and deductibles accounted for 10% or more of employees’ median income in 2020, with those in Mississippi and New Mexico facing the highest potential costs relative to income. The average premium for single coverage and family coverage reached $1,532 and $5,978 nationally.

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High Prices, Pandemic Strain Employer-Backed Insurance

Pandemic-driven macroeconomic uncertainty and rising prices remain the biggest challenges for employer-sponsored insurance plans, according to experts. The cost of health insurance premiums has made employer-backed health insurance unaffordable to the point of being useless for many families, while the pandemic has created a volatile environment for many employers, particularly small businesses.

During a Jan. 26 panel hosted by the Bipartisan Policy Center, a Washington, D.C. think tank, employer health insurance experts sounded off on the myriad difficulties facing plan sponsors and employee beneficiaries. Worries over cost and the pandemic took up most of the discussion.

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Anthem Reports Solid End to 2021, Offers Initial Look at 2022

Health insurer Anthem, Inc., reported solid fourth-quarter results on Jan. 26, with some numbers in line with expectations and others hitting above or below expectations. The company also indicated it’s bracing for medical costs to rise above normal levels this year amid the ongoing COVID-19 crisis — though perhaps not as much as in 2021.

Anthem reported $5.14 in adjusted earnings per share (EPS) for the quarter, beating the consensus of $5.11. “EPS appears to be aided by better-than-expected investment income to the tune of $0.42, which grew $23% [year over year],” Jefferies analyst David Windley wrote in a Jan. 26 note to investors.

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Premiums, Deductibles Take Growing Portion of Workers’ Paychecks

People with employer-sponsored health plans spent 11.6% of their median household income on premiums and deductibles in 2020, up from 9.1% in 2010, according to an analysis published by The Commonwealth Fund. In 37 states, premiums and deductibles accounted for 10% or more of employees’ median income in 2020, with those in Mississippi and New Mexico facing the highest potential costs relative to income. The average premium for single coverage and family coverage reached $1,532 and $5,978 nationally.

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