We commit to providing clear rationale for pricing at the time of launch of a new medicine.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers the following factors:
A holistic assessment of value, including: 1) Clinical value and outcomes, or the benefit the medicine delivers to patients, and how well it works compared to a standard of care; 2) Economic value, or how the medicine reduces the need—and therefore costs—of other healthcare interventions; and 3) Social value, or how the medicine contributes to quality of life, and productivity. Our assessments rely on a range of internal and external methodologies, including health technology assessment (HTA) and other analyses that help define or quantify value and include patient perspectives and priorities.
Similar treatment options available or anticipated at the time of launch, in order to understand the landscape within the disease areas in which the medicine may be used.
Affordability, including the steps we must take to promote access for patients and contribute to a more sustainable system for payors and healthcare systems.
Unique factors specific to the medicine at the time of launch. For example, we may need to support ongoing clinical trials to reinforce the value of the product (e.g., longer-term outcomes studies), implement important regulatory commitments, or develop sophisticated patient support tools that improve care management and help decrease the total cost of care.
Key 2019 Pricing Updates
Cablivi® (caplacizumab-yhdp): Cablivi was launched in March 2019. It is used in combination with plasma exchange and immunosuppression and was approved in the United States specifically for the treatment of adults with acquired thrombotic thrombocytopenic purpura or aTTP, a rare, life-threatening blood-clotting disorder that affects fewer than 2,000 people in the U.S. each year. The U.S. list price for treating a typical aTTP episode with Cablivi is $270,000.
In the case of Cablivi, our holistic assessment of value primarily considered the clinical data for the medicine, notably our Phase 3 HERCULES study. In the HERCULES study, treatment with Cablivi in combination with plasma exchange and immunosuppression resulted in a significantly shorter time to normalization of the platelet count, the study’s primary efficacy endpoint; in secondary endpoints, Cablivi showed a significant reduction on a composite endpoint of aTTP-related death, recurrence of aTTP, or a major thromboembolic event during study drug treatment (13% receiving Cablivi [9 people] vs 49% receiving placebo [36 people]); and a significantly lower number of aTTP recurrences in the overall study period (13% receiving Cablivi [9 people] vs 38% receiving placebo [28 people]). The most common side effects of Cablivi reported in clinical studies include nosebleed, headache, and bleeding gums.
Results of this study were published in the New England Journal of Medicine in January 2019. That publication also included data on reduction in use of hospital service. During the HERCULES study, patients receiving Cablivi experienced, on average, a 65% shorter duration of care in an intensive care unit (3.4 days vs. 9.7 days) and 5.8 days of plasma-exchange treatment as compared with 9.4 days of plasma-exchange treatment needed by patients in the placebo group. Data was collected prospectively. Descriptive statistics were run, but these data were not tested for significance. The clinical significance of these data is unknown.
We also considered similar treatment options and unique factors. In the case of aTTP, there was still an unmet need; it is estimated that up to 20% of patients die from aTTP episodes with plasma exchange and immunosuppression alone, with median time to death of nine days from diagnosis. aTTP is also a rare disease.
Finally, Sanofi is committed to ensuring those who are prescribed Cablivi have access to the medicine. For patients with aTTP who are prescribed Cablivi, Cablivi Patient Solutions provides support to eligible patients who require financial assistance, help in navigating insurance, benefits, and reimbursement, as well as other at-home support services.
What is CABLIVI?
CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
IMPORTANT SAFETY INFORMATION
Who should not take CABLIVI?
Do not take CABLIVI if you’ve had an allergic reaction to caplacizumab-yhdp or to any of the ingredients in CABLIVI.
What should I tell my healthcare team before starting CABLIVI?
Tell your doctor if you have a medical condition including if you have a bleeding disorder. Tell your doctor about any medicines you take.
Talk to your doctor before scheduling any surgery, medical or dental procedure.
What are the possible side effects of CABLIVI?
CABLIVI can cause severe bleeding. In clinical studies, severe bleeding adverse reactions of nosebleed, bleeding from the gums, bleeding in the stomach or intestines, and bleeding from the uterus were each reported in 1% of subjects. Contact your doctor immediately if excessive bleeding or bruising occur.
You may have a higher risk of bleeding if you have a bleeding disorder (i.e. hemophilia) or if you take other medicines that increase your risk of bleeding such as anti-coagulants.
CABLIVI should be stopped for 7 days before surgery or any medical or dental procedure. Talk to your doctor before you stop taking CABLIVI.
The most common side effects include nosebleed, headache and bleeding gums.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.
Click here for full Prescribing Information for CABLIVI.
Limited U.S. Price Increases
on our medicines over time
Continued Transparency in the U.S.
around our pricing decisions