Patient Access & Affordability
Patient Access and Affordability
- At Kaléo, the patient always comes first. We believe the most important price is the price to the patient.
- We believe that patients with life-threatening conditions deserve fair access to the latest medicines that offer technological innovations that address their medical needs.
- We believe that when a healthcare practitioner prescribes one of our products, patients should be able to fill their prescription without burdensome paperwork or high out-of-pocket costs.
- In this era of high deductible health plans, many patients find it harder than ever to afford their medications. Kaléo is committed to the belief that patients with commercial insurance, or those facing financial hardship, should be able to obtain our potentially lifesaving products for little to no out-of-pocket cost.
- Kaléo understands the importance of predictability in the healthcare community. Kaléo will limit potential list price increases to no more than a single digit percentage each year.
Patients facing financial hardships and who do not have insurance coverage for prescription medicines may be eligible for the Kaléo Patient Assistance Program.†
Eligible participants must have a prescription, be a legal US resident, have no government or commercial drug coverage, and have an annual household income of less than $100,000.
To learn more, call 502-213-7601
† Patients who are eligible for Medicaid coverage may be eligible for assistance to receive AUVI-Q at no cost.
- As a company founded by patients with life-threatening conditions, we take our commitment to the needs of patients, and their families, very seriously.
- Kaléo will continue to innovate so that we can bring future medical products to market that empower patients and families to take control in life-threatening emergencies. We are proud of more than 150 issued patents that our products have earned but more importantly, we are driven by the impact our products have on patients and families.
Access and Affordability Innovation
- We have seen firsthand, in this current healthcare system, the very real challenges patients are facing in being able to access and afford potentially life-saving medicines. Similar to our product innovation process, our access program has been built to help solve for these challenges and help focus on what matters most… access and affordability to patients.
- The current drug pricing and payer system is set up with a focus on stakeholders maximizing their economics over what should be the primary focus…what is best for the patient. It is our hope that other stakeholders join Kaléo in putting patients first again.
Expanded Access Policy
- Kaléo is dedicated to building innovative solutions for serious and life-threatening medical conditions. As such, we believe that the optimal way to gain an understanding of the safety and efficacy of a medical product in a specific population is by conducting investigational studies and clinical trials.
- We understand that there may be some circumstances where a patient with an immediately life-threatening condition or serious disease or condition seeks to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. This is called “compassionate use” or “Expanded Access.” Currently, an Expanded Access Program for Naloxone Auto-Injector 10 mg (NAI 10 mg) is not available.
- The posting of this policy by Kaléo shall not serve as a guarantee of access to any specific investigational drug by any individual patient. As authorized by, and in accordance with, the 21st Century Cures Act, Kaléo may revise this posted expanded access policy at any time.
- If you have additional questions regarding this policy, please contact firstname.lastname@example.org
Product Manufacturing and Quality
- Kaléo is committed to the highest standards of product and manufacturing quality. Final manufacturing and assembly of our products is conducted in the United States on a 100% automated robotic production line with more than 100 automated quality checks on each and every product.
- Patients can be confident in our approach to design quality into our products and incorporate quality into every aspect of the manufacturing process.
Our patients continue to inspire us. As a company founded by patients, we will always put patients’ interests first.