Radar on Specialty Pharmacy
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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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New FDA Approvals: FDA Grants Additional Indication to Rinvoq
Jan. 14: The FDA expanded the label of AbbVie Inc.’s Rinvoq (upadacitinib) to include the treatment of moderate-to-severe atopic dermatitis in people at least 12 years old whose disease did not respond to previous treatment and is not well controlled with other pills or injections or when those treatments are not recommended. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. Dosing of the tablet for people weighing at least 40 kg who are at least 12 years old and less than 65 is 15 mg once daily and can be increased to 30 mg once daily. For people at least 65, the recommended dose is 15 mg once daily. Website Drugs.com lists the price of 30 15 mg tablets as more than $5,500. -
News Briefs: Gilead Withdraws Two Zydelig Indications
Gilead Sciences, Inc. said on Jan. 14 that it is voluntarily withdrawing two indications for Zydelig (idelalisib): for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic leukemia (SLL), both of which had accelerated approval. “As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” said the company in a press release. Along with the FL and SLL approvals on July 23, 2014, the FDA granted traditional approval to the drug for the treatment of relapsed chronic lymphocytic leukemia. Zydelig will remain on the U.S. market for this indication. -
Medicare Plans to Cover Aduhelm but With Certain Restrictions
To say that the FDA’s approval of Biogen and Eisai, Co., Ltd.’s Alzheimer’s disease treatment Aduhelm (aducanumab-avwa) on June 7, 2021, garnered an immense amount of attention would seem to be an understatement. That said, the drug has somehow gathered even more notice over the past few months due to multiple developments, with CMS most recently issuing a proposed National Coverage Determination (NCD) on Aduhelm and other monoclonal antibodies that target beta amyloid plaque that will allow Medicare coverage for the therapies but only under certain circumstances. While commercial payers often follow CMS’s lead, it remains to be seen whether that decision — plus a dramatic price cut on Aduhelm — will prompt payers that have declined to cover the therapy to change course.
There is a 30-day public comment period on the proposed NCD, which was published Jan. 11. A final decision is expected on April 11.
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