AbbVie and AstraZeneca sued Kansas to block the state’s new contract pharmacy access law.

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Breaking News: AbbVie Becomes 11th Drug Maker to Restrict 340B Contract Pharmacy. Feds Appeal Rulings in Lilly, Novo Nordisk, and Sanofi Cases.

Biopharmaceutical company AbbVie—maker of the expensive and widely prescribed immunosuppressive medication Humira—today became the 11th drug manufacturer to announce conditions on 340B pricing when contract pharmacies dispense medicines to patients.

Starting Feb. 1, AbbVie will require hospitals to submit claims data on 340B contract pharmacy utilization to its vendor 340B ESP to be able to use bill to / ship to arrangements for AbbVie products with an unlimited number of contract pharmacies, the company said in a letter and FAQ today to covered entities. Grantee covered entities are exempt from the requirement. AbbVie will let hospitals that reject the requirement and that lack an in-house outpatient pharmacy designate a single contract pharmacy to receive and dispense orders of 340B-purchased AbbVie drugs.

AbbVie said its policy initially will apply to 24 products: Androgel, Creon, Depakote, Duopa, Gengraf, Humira, Kaletra, K-Tab, Lupron, Mavyret, Niaspan, Nimbex, Norvir, Oriahnn, Orilissa, Rinvoq, Synthroid, Skyrizi, Survanta, Tricor, Triplix, Ultane, Viekira Pak, and Zemplar. The company said it “will inform covered entities when additional products are added and of other changes to the product list.”

AbbVie said it will use hospitals’ 340B contract pharmacy claims data “to identify and resolve ineligible Medicaid, Medicare Part D, and commercial rebates and to determine eligibility for certain replenishment orders under the policy.”

The company said it was implementing the requirement “to address persistent abuses caused by the unwillingness of covered entities and their contract pharmacies to provide sufficient claims data to prevent prohibited and improper duplicate discounting on AbbVie products.”

“AbbVie supports the 340B program and is committed to the program’s goal of improving access to medicines for uninsured and vulnerable patients,” the company said in today’s letter to entities. “However, in recent years, the 340B program has increasingly suffered from abuses that undermine that goal and call into question whether patients benefit from 340B discounts.”

Hospital groups are expected to denounce AbbVie’s new policy and demand that the government declare it illegal.

DOJ Appealing Lilly, Novo Nordisk, and Sanofi Rulings

AbbVie’s announcement coincided with a flurry of federal government activity during the past 24 hours in multiple 340B contract pharmacy lawsuits.

Earlier today, we reported that the U.S. Justice Department (DOJ) yesterday filed notice that it is appealing a federal district judge’s Nov. 5 joint ruling in Novartis and United Therapeutics’ 340B contract pharmacy cases. DOJ yesterday also filed notices of appeal in Lilly, Novo Nordisk, and Sanofi’s contract pharmacy lawsuits.

340B stakeholders are still awaiting a federal district judge’s ruling in AstraZeneca’s 340B contract pharmacy lawsuit.

340B Provider Reaction to Decisions to Appeal

William von Oehsen, a principal at Powers Law who represents 340B covered entities including the advocacy group Ryan White Clinics for 340B Access (RWC-340B), said the decision to appeal the Novartis/UT decision was not unexpected because the judge was largely unpersuaded by DOJ’s arguments.

He added, “we are pleased that the government decided to appeal the Lilly and Sanofi/Novo decisions. Even though the courts in those two cases largely ruled in favor of the government, they nonetheless found that the 340B statute is ambiguous with respect to a manufacturer’s obligation to provide 340B discounts on drugs dispensed by contract pharmacies. DOJ is appealing the two decisions, we assume, on the grounds that manufacturers’ obligation to give 340B discounts on contract pharmacy drugs is unambiguous under the 340B statute. We agree with this analysis and are glad that the government continues to embrace what we consider to be the strongest defense of the 340B contract pharmacy program.” 

Hospital group 340B Health also praised the decisions to appeal.