Kaléo Cares | kaléo

Kaléo Cares

Patient Assistance Program

We believe that it is important to not only make potentially life-saving medical products but to also ensure that the people who need those medicines are able to obtain them. Patients facing financial hardships who do not have insurance coverage for prescription medicines may be eligible for patient assistance support.

Healthy Communities

Kaléo is proud to be an engaged member of our community. We believe that it is important to collaborate with non-profit organizations that are dedicated to the growth of healthy communities. Kaléo team members volunteer their time with numerous organizations dedicated to working on behalf of people in need. We support our community through volunteerism, memberships and in leadership roles with various boards and commissions dedicated to philanthropic efforts.

Product Donation Grants

At kaléo, we are guided by our mission of empowering patients and caregivers to confidently take control in serious or potentially life-threatening situations. The kaléo Cares Product Donation Program provides our products at no cost to certain qualifying non-profit organizations and other groups demonstrating need. There are two product donation programs available to qualified applicants:

The EVZIO® (naloxone HCl injection) Product Donation Grant Program is intended for first responder organizations for use in the field or for qualifying non-profits, harm reduction groups and health departments who intend to distribute product to patients facing financial hardships who do not have insurance coverage for prescription medicines.

To apply for the EVZIO product donation grant please visit:
https://external-kaleo.idea-point.com/Submit.aspx?groupid=GRANTS

The "Q Your School" Product Donation Grant Program is intended to provide AUVI-Q® (epinephrine injection, USP) to elementary schools across the United States.

To apply for the "Q Your School" Product Donation Grant Program, please visit:
https://external-kaleo.idea-point.com/Submit.aspx?groupid=ACADEMIC

Questions can be sent via by email to donationrequest@kaleo.com.

Investigator Initiated Studies (IIS)

Kaléo aims to advance science and improve patient care by supporting high-quality research that is initiated, designed, implemented and sponsored by external investigators.

An investigator-initiated study is a research effort where the sponsor of the work is an investigator, healthcare institution, or some form of medical network, external to kaléo, that is seeking our support to conduct the work. This support can be in the form of product, funding, or a combination of both. The kaléo IIS Program is open to academic and community-based physicians and researchers in the United States who are interested in conducting their own research. This program consists of a committee of medical and scientific staff who meet regularly to review proposals. The decision to support a study proposal is based on the importance of the research objectives to medical science or patient care, the scientific rationale for the proposed methodology, and the ability of the study sponsor to deliver a high-quality, ethical study.

Kaléo does not support IIS in order to reward healthcare professionals for using, purchasing, recommending, or prescribing kaléo products or to persuade them to do so by supporting the proposed research.

Applications for product and/or funding are currently being accepted. Kaléo will consider requests for funding IIS in the following areas of interest:

  • Infant Anaphylaxis
    • Epidemiology (e.g., assessing the morbidity associated with infant anaphylaxis and characterizing age, gender, and identification of causation)
    • Diagnosis (e.g., assessments used and identification of anaphylaxis signs/symptoms)
    • Treatment (e.g., treatment(s) utilized and clinical course)
    • Outcome (e.g., disposition (ED observation, floor, PICU) after treatment)
  • Opioid Overdose
    • Impact of take-home naloxone and associated opioid safety education/opioid overdose emergency planning in patients being treated for chronic pain or opioid use disorder
      • Opioid utilization
      • Aberrant/risk-related behaviors
      • Opioid-related morbidity and mortality
  • Integration of take-home naloxone and opioid overdose emergency planning into clinical practice for patients being treated for chronic pain or opioid use disorder
  • Patient experience, satisfaction and preferences for various forms and routes of administration of take-home naloxone
  • Pharmacoeconomics of take-home naloxone auto-injectors

Submissions of IIS proposals including CVs and preliminary funding and/or product requests should be sent to: grants@kaleo.com. After review, the kaléo Grants Committee will communicate the decision to invite the study sponsor to submit a full protocol and budget detail (as applicable) for further review or decline the proposal. If invited to submit a full protocol, the Committee will review and communicate the decision to support or decline the protocol.

Submission of a proposal does not imply or guarantee approval. All proposals will be reviewed based on research merit criteria. Financial and/or product support is contingent upon full execution by both parties of the research agreement.

Independent Medical Education (IME)

Kaléo is committed to supporting Independent Medical Education that facilitates healthcare provider education, advances the quality of patient care, and aligns with kaléo’s therapeutic and clinical interests.  IME is professional education given by accredited medical education providers who design and implement programs completely independent of any kaléo influence.

Kaléo will consider requests for funding IME in the following therapeutic areas of interest:

  • Infant Anaphylaxis: epidemiology, diagnosis, treatment, and/or outcomes
  • Implementation of opioid guidelines
  • Outcomes associated with implementation of an Opioid Overdose Plan

Applications for IME funding may be submitted to support live presentations, written enduring materials, online courses and conference symposia as outlined below. Please note that submission does not imply or guarantee approval.

Program Requirements

The program must be accredited by a United States-based provider and fully compliant with the criteria and/or standards of commercial support for Accreditation Council for Continuing Medical Education (ACCME), guidelines, the Accreditation Council for Pharmacy Education (ACPE), the American Nurses Credentialing Center (ANCC) or other independent organizations. Furthermore, the program must be educational and non-promotional in nature, and planned, designed, and implemented in accordance with the U.S. Food and Drug Administration’s (FDA) Guidance on Industry-Supported Scientific and Educational Activities and PhRMA Code.

To align with FDA and ACCME Standards, kaléo requires that all IME programs:

  • Are conducted independently and without control or influence by kaléo, including planning, content development (including the selection of speakers or moderators), and execution
  • Is free of commercial bias for or against any product
  • Include disclosures of kaléo’s support of the program, any prior relationship between the organization and kaléo, and/or the relationship between kaléo and the program speaker(s)
  • kaléo not engage in, and the organization not permit any other sponsor to engage in, promotional activities in or near the program room or advertise its products in any materials disseminated as part of the program
  • Have established guardrails to ensure that any product discussions at the program are accurate, objective, balanced and scientifically rigorous with an inclusion of balanced discussion of each product and treatment alternatives, data limitations, identification of unapproved usage, and opportunities for questioning and debate

Kaléo requires that a fully-executed agreement, signed by the requesting IME provider and kaléo, be completed prior to the commencement of the IME program.

Submission Requirements

  • Requests must be submitted at least 60 days prior to the “decision needed by date;” i.e. the date a decision of the Kaléo Grants Committee is needed by in order to plan, confirm or proceed with the program
  • IME funding requests must include:
    1. A letter of request on official institutional letterhead which:
      1. Is addressed to kaléo
      2. Is signed and dated
      3. Includes the program title, date(s) and location as applicable
      4. Includes a description of the program including goals/objectives and delivery method
      5. Identifies the target audience and projected number of enrollees/participants/viewers
      6. Specifies the accrediting body and accredited provider, including type and number of medical education credits offered for the proposed activity
      7. Specifies if sole/multi support request from grantors
    2. Needs assessment (may be included in the letter of request)
    3. Draft agenda/brochure
    4. Detailed proposed budget (with line item costs) and requested amount
    5. W-9 that is dated and signed within 1 year of grant submission
  • Submissions with all associated documentation should be sent to: grants@kaleo.com 

Program Restrictions

Kaléo will not provide IME funding for:

  • Individuals
  • Requests for payments to individuals
  • Fellowships
  • Overhead expenses
  • General operating expenses
  • Entertainment expenses
  • Awards/travel awards
  • Cost of travel, lodging or other personal expenses of non-faculty individuals attending IME, either directly to the individuals participating in the event or indirectly to the event’s provider. Funding cannot be used to compensate participants for time spent at the IME event