Sanofi promises money back for discontinued blood disorder treatment – in some cases
Months after Pfizer launched its second drug warranty program, Sanofi is hopping on the trend.
The French pharma giant set up a warranty program for Cablivi, offering medical institutions a potential refund if inpatient treatment doesn’t work out. Patients must receive the drug in a hospital setting in order to qualify, and Sanofi will only cover the cost of up to six doses for patients who don’t respond, or up to 12 doses for those who worsen while on treatment.
In 2019, Cablivi became the first drug approved in the US for a rare but deadly blood disorder called acquired thrombotic thrombocytopenic purpura, or aTTP. Sanofi secured the drug, also known as caplacizumab, in its $4.8 billion Ablynx buyout and won a quick approval in Europe shortly after. Patients with aTTP suffer blood clots in the small arteries that can lead to strokes, brain damage or death.
Sanofi set the initial list price at $270,000 per course, raking in €164 million ($177 million) in 2021. Sales continued to rise through last quarter to €52 million ($56 million) in Q3, according to the company’s latest earnings results. Sanofi confirmed Friday that the current wholesale acquisition cost is $7,925 per vial.
To make that cost a bit more palatable, the company is now offering institutions a refund of up to the full wholesale acquisition cost (WAC) or actual acquisition cost, whichever is less. The drug must be administered according to the label and discontinued by a healthcare provider to qualify.
“Because aTTP is a life-threatening condition, Sanofi is, through this Program and other efforts, working to help remove as many barriers as possible for patients and the health care providers who support them,” Jeffrey Schaffnit, Sanofi’s general manager of US rare blood disorders, told Endpoints News in an email.
A patient is deemed to have no initial response if their platelet counts remain below 50 × 109/L after four days of combined treatment with plasma exchange (PEX) and immunosuppressive therapy. Sanofi considers patients who worsen as those who experience “a new drop in platelet count after initial platelet count normalization (>150 × 109/L), necessitating re-initiation of PEX after having ruled out any causes for the drop in platelet count other than aTTP pathophysiology,” according to the program’s website.
Pfizer similarly launched warranty programs for its drugs Xalkori and Panzyga, although those programs reimburse patients as opposed to hospitals.
Panzyga was approved in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It later bagged an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes.
Pfizer said it will refund certain CIPD patients for their out-of-pocket costs for the first four treatments if they must discontinue treatment for “clinical reasons,” up to a maximum of $16,500 per treatment or $50,000 total.
Under the program for its cancer drug Xalkori, eligible patients can get their out-of-pocket costs covered if they discontinue the drug before the fourth 30-day supply is administered.
Other companies are joining the wave. BioMarin has previously said it plans to offer an outcomes-based warranty for Roctavian, which would be “ready to implement with payers at launch” if the drug wins an approval in hemophilia A. And back in October 2021, Takeda inked a deal with insurance provider Point32Health that provides certain lung cancer patients access to Alunbrig through an “outcomes-based structure.”
“If a patient covered by Point32Health does not remain on the drug for at least three months due to effectiveness or tolerability, Takeda will refund a significant portion of the drug cost to Point32Health,” Takeda confirmed via email on Friday.
When asked whether Sanofi plans on expanding the warranty program to other drugs in its portfolio, Schaffnit said: “Currently, the Program is limited to the use of Cablivi in the inpatient setting. Depending on how the Program progresses it could be expanded.”