Amgen and GSK Announce Refunds for 340B Overcharges

Enbrel autoinjector product tubes
Amgen is providing refunds for 340B overcharges for four NDCs of its top-selling drug Enbrel during 2016 and 2017.

Drug manufacturer Amgen is providing refunds for overcharges during varying periods over three years on some of its top selling drugs including Enbrel ($4.8 billion in U.S. sales in 2020), Neulasta ($2 billion), Kyprolis ($710 million), Aranesp ($629 million), Epogen

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Drug Industry-Funded Consumer Group Slams 340B on Conservative News Site

Screenshot of RealClear Health 340B Program story, "340B Program Isn't Working for Patients"
Industry-supported consumer protection group National Consumers League sharply criticized 340B hospitals and contract pharmacies in a recent opinion article for a conservative-leaning news site.

America’s oldest consumer protection group, shunned by some former allies in the labor movement for alleged favoritism toward its corporate donor Amazon, has slammed the 340B program in a commentary for the conservative-leaning news and opinion website RealClearHealth.

“Sadly, as

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AstraZeneca Stops Voluntary 340B Pricing on Orphan Drugs to Rural and Cancer Hospitals

AstraZeneca wordmark building-mounted sign
Effective June 1, AstraZeneca will stop offering voluntary 340B pricing on orphan drugs to critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals.

Drug manufacturer AstraZeneca effective June 1 will stop offering voluntary 340B pricing on its orphan drugs to critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals, the company said yesterday.

“AstraZeneca is making this change to

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Merck Adds 45-Day Time Limit on Replenishment Orders to its 340B Contract Pharmacy Policy

Merck and U.S. flags
Merck has imposed 45-day time limit on replenishment orders under its restrictions on 340B pricing when covered entities use contract pharmacies.

Merck is the latest drug company among the 16 that restrict 340B pricing when covered entities use contract pharmacies to impose a 45-day time limit on replenishment orders under its policy.

Merck disclosed the change last week in the same letter

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News Alert

Merck Extends its Conditions on 340B Pricing Involving Contract Pharmacies to Health Centers

Merck exterior building sign
Merck extended its restrictions on 340B pricing involving contract pharmacies to community health centers.

Drug manufacturer Merck today extended its restrictions on 340B pricing involving contract pharmacies to community health centers. The restrictions have applied only to hospital covered entities until now.

Other grantee covered entities remain exempt “at this time,” Merck said, adding

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340B Report Holding May 18 Webinar on Implementing Drug Makers’ New 340B Contract Pharmacy Rules

customers in line at a pharmacy
Multiple 340B covered entities and consultants say they have hit roadblocks trying to navigate drug manufacturers restrictions on 340B pricing when entities contract with outside pharmacies to dispense 340B drugs.

340B Report, an independent news organization covering the 340B drug pricing program, is holding its first event—a May 18 webinar about implementing drug manufacturers’ controversial new rules on 340B contract pharmacies. It is an exclusive and free

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Providers Alarmed About 45-Day Lookback Clauses in Drug Makers’ 340B Contract Pharmacy Policies

closeup of sand in an hourglass
Covered entities are concerned about 45-day time limits for claims submissions and replenishment orders in drug manufacturers' 340B contract pharmacy policies.

Drug manufacturer Sanofi drew attention this month when it added 45-day time limits for replenishment orders and claims submissions to its conditions on 340B pricing when covered entities use contract pharmacies.

Pfizer and Amgen also recently added similar 45-day lookback requirements

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Influential HIV/AIDS Group Asks Gilead to Exempt Ryan White Clinics from Company’s 340B Contract Pharmacy Restrictions

Gilead exterior office sign
Gilead Sciences will expand its data reporting requirements for 340B pricing on branded hepatitis C products to contract pharmacies wholly owned by covered entities.

Ryan White Clinics for 340B Access (RWC-340B) has asked drug manufacturer Gilead to exempt all Ryan White clinics from the company’s conditions on 340B pricing on its branded hepatitis C treatments when covered entities use contract pharmacies.

RWC-340B made the

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Six Groups Slam Drug Makers’ 340B Pricing Conditions on Hepatitis C Medicines

Six HIV/AIDS and viral hepatitis advocacy groups issued a joint statement criticizing AbbVie, Gilead, and Merck’s conditions on 340B pricing on hepatitis C medications.

UPDATE Thursday, April 21, 2022, 5:00 p.m. EDT—AbbVie issued this statement: AbbVie supports the 340B program and is committed to the program’s goal of improving access to medicines for uninsured and vulnerable patients. Our 340B initiative does not block access

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Sanofi Makes Two Big Changes to its 340B Contract Pharmacy Policy

Sanofi outdoor building sign
Changes to Sanofi's 340B drug pricing conditions may eliminate 340B discounts for health centers using multiple contract pharmacies within a chain.

Drug manufacturer Sanofi has made two major changes to its conditions on 340B pricing when health centers and certain hospitals and use contract pharmacies, a company spokesperson confirms. One is raising flags among 340B providers and the other appears to

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