December 9, 2011—Safety-net hospitals and free and charitable clinics say they are scrambling to replace formerly free bulk supplies of Sanofi U.S. medications, including the widely used anticoagulant Lovenox (enoxaparin), following the drug manufacturer’s mid-November notice that it is discontinuing its entire institutional patient assistance program (IPAP) at the end of December.
Sanofi began notifying its IPAP enrollees by mail last month that it is closing the program on Dec. 16, with final orders for bulk replenishment due by Dec. 28. A Sanofi spokesperson said the company was discontinuing its IPAP “because almost all of the products are readily accessible as generics.”
In its letter, the company instructed participating institutions that if a physician determined it was in an patient’s best interest to remain on a Sanofi product, the institution should “use its best efforts” to enroll the patient in Sanofi’s traditional PAP for individuals. According to the spokesperson, Sanofi products that have no generic versions “are still covered under the (traditional) PAP, which continues and covers more than 30 medicines.” (See related item.)
Focus on Lovenox
Lovenox, a standard of care to prevent and treat deep vein thrombosis, is one of the products for which there will be neither institutional nor traditional PAP coverage.
Outpatient pharmacy managers for two large metropolitan health systems estimated that the end of Lovenox bulk replenishment and individual patient assistance would cost them between $100,000 and $180,000 per year. The timing of the discontinuations, they said, makes the matter worse because their budgets for the year are already set.
It will be hard to replace Lovenox at low cost, they said, because the Food and Drug Administration (FDA) has approved only one generic substitute—Momenta Pharmaceuticals’ M-Enox. Sanofi began selling its own authorized generic version in October through its Winthrop subsidiary but withdrew it on Dec. 2, shortly after a federal district judge stopped a third drug manufacturer, Amphastar, from introducing its own generic version.
The hospital pharmacy managers added that although there are other anticoagulants in the market, none is FDA-approved for all of Lovenox’s most common indications.
According to Fern Paul-Aviles, pharmacy manager at Carolinas HealthCare System in Charlotte, N.C., the end of bulk replenishment of Lovenox and its unavailability through the traditional PAP creates a $100,000-plus shortfall in her just-approved budget for 2012. “We are still evaluating clinically acceptable alternatives, but I suspect we will just absorb the loss because it’s in the best interest of good patient care,” she said.
An outpatient pharmacy manager at large metropolitan health system who asked not to be named said she first became aware of a problem when the hospital did not receive a scheduled bulk replenishment shipment from Sanofi this autumn. It was only when she called to inquire that she was told the institutional PAP was ending.
“This is going to be devastating to my budget, probably close to $15,000 a month,” she said. “My budget was approved in July and it doesn’t include money to pay for this Lovenox that we now are going to have to buy. It’s available at a 340B price, but it doesn’t have much competition in the market so it’s pretty expensive even at that price.”
The pharmacy manager also noted that Sanofi gave its institutional PAP participants little time to complete the paperwork necessary to transfer diabetic patients who had been getting the company’s Lantus and Apidra insulins through the bulk replenishment program into the traditional PAP for those products. “This has the potential to cause patients harm,” she said.
“Huge Surprise to Us”
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Medications Available Through Sanofi’s
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Groups representing free and charitable clinics across the country sent a Nov. 22 letter to the drug company asking it to consider reinstituting limited bulk replenishment of Lantus and Apidra and giving them more time to transition patients from the bulk replenishment program to the traditional PAP. But according to Nicole Lamoureax, executive director of the National Association of Free Clinics (NAFC), they were told there would be no changes during a Dec. 6 call with company representatives.
Lamoureaux said the clinics are particularly concerned about losing access to free or reduced-cost Lovenox and Lantus for their patients because neither “has a $4 equivalent available.” The average monthly cost of Lovenox is $4,000 and the monthly cost of Lantus is $357, she said.
“At a minimum, there has been $5 million worth of Sanofi drugs per year administered to our patients through the IPAP,” Lamoureaux said. “This will have a huge impact on us financially.”
“The company’s sudden shift came as a huge surprise to us,” she continued. “We considered Sanofi a partner in providing access to medicine to the uninsured. This announcement and how it was handled was quite disappointing. It’s our hope that in the future we’ll be able to work with Sanofi in a timely fashion to get the medications our patients need and prevent a situation such as this from occurring again.”