February 6, 2012—In apparent response to urgent appeals by safety-net providers, drug manufacturer Sanofi U.S. has announced that it is reinstating patient assistance for its anti-coagulant Lovenox effective Feb. 15.
The company discontinued its patient assistance program (PAP) for the widely used drug in late December. It also ended its entire institutional patient assistance program (IPAP) at the same time.
[ms-protect-content id=”2799″]Lovenox is a standard of care to prevent and treat deep vein thrombosis. Hospital outpatient pharmacy managers said it would be hard to replace at low cost because the Food and Drug Administration (FDA) has approved only one generic substitute. Although there are other anti-coagulants in the market, none is FDA-approved for all of Lovenox’s most common indications.
Safety Net Hospitals for Pharmaceutical Access (SNHPA), which represents more than 800 340B hospitals, told Sanofi in a December letter that the end of bulk replenishment of Lovenox and its unavailability through the traditional PAP would create $100,000-plus shortfalls in some of its member hospitals’ already approved budgets for 2012. The National Association of Free and Charitable Clinics likewise told Sanofi that its decision would have “a huge impact” on its members.
Company Cites Market Changes
In a Feb. 1 fax to a hospital customer, Sanofi said that “due to recent changes in the market,” effective Feb. 15 the Sanofi Foundation for North America will reinstate Lovenox patient assistance “through the new Sanofi Patient Connection (SPC) program.”
Because the SPC program is entirely new, providers will have to reapply “to request access to Lovenox for your patients,” the fax continued.
“Any patient enrolled in the previous Lovenox reimbursement and patient assistance program must re-enroll using the new process,” Sanofi said. The application will be available on Feb. 15.
In addition to describing the application process and eligibility standards for individuals seeking assistance, Sanofi explained that “replacement product may be requested for past dates of service in the hospital outpatient setting only for dates of service beginning February 15, 2012 and moving forward.” Sanofi instructed recipients of the fax to “complete the Sanofi Patient Connection application and provide the requirement documentation … to be evaluated for product replacement.”
A Sanofi spokesperson could not be reached for comment on the call by safety-net providers for reinstatement of the bulk replenishment program.[/ms-protect-content]