Idorsia's goal is to discover, develop and bring more, innovative medicines to patients. We want to bring new perspectives to the development of innovative compounds, challenging accepted paradigms to answer the questions that matter most. Our key assets have the potential to transform treatment in the target indications.

Engaging with Patient Organizations

We engage with patient organizations and healthcare providers to better understand patients and their caregivers' needs. This includes working with and supporting patient groups, as well as discussing with healthcare professionals the broader range of disease challenges they and their patients face. Our ongoing aim is to ensure that all of our relationships with patient groups and other healthcare organizations continue to be based on transparency, trust and a shared objective to improve the lives of patients.

background image

Transfer of Value

Transfer of value to health care professionals, health care organizations, and patient organizations

Idorsia engages ethically with all providers and does so transparently and in compliance with country laws, regulations and trade association obligations.

Idorsia is committed to collaborating with health care professionals (HCPs), health care organizations (HCOs), patient organizations (POs), and other general members of the public to improve patient health across the globe. We support disclosure of these relationships wherever possible to increase visibility and ensure public trust and confidence and demonstrate the integrity of our relationships with HCPs, HCOs and POs.

Idorsia will publicly disclose transfers of value (ToVs) in the following jurisdictions, either where there is a legal requirement or where Idorsia is a member of the local trade association:

background image

Open Payments—Physician Payments Sunshine Act

Idorsia complies with requirements laid out in the Sunshine Act (also known as the Open Payments—Physician Payments Sunshine Act), enacted as federal law as part of the Affordable Care Act). The Act requires pharmaceutical and medical device manufacturers, such as Idorsia, to report certain financial transactions (e.g., clinical research payments, fee for service, food and beverage provided during a speaker program, grants and donations, etc.) paid to a defined set of HCPs and Teaching Hospitals on an annual basis to the Centers for Medicare and Medicaid Services (CMS). These payments are then made publicly available by CMS on the Open Payments Website.

State Reporting

Beyond the Sunshine Act, Idorsia discloses transfers of value in states that have additional reporting obligations given their broader definitions and policies for HCP and HCO interactions. Idorsia adheres to each of the following state disclosure requirements:

  • Nevada
  • Oregon
  • Vermont
  • Minnesota
  • Massachusetts
  • District of Columbia

In Europe, some countries have laws requiring pharmaceutical companies to report transfers of values with healthcare professionals, healthcare organizations, patient organizations, and other general members of the public . In other countries, transparency reporting is voluntary. Across the region, as SMEs of the EFPIA, we adhere to the disclosure code, where applicable. 

Please consult EFPIA's website for additional information on the HCP/HCO and Patient Organization Codes.

Belgium

Idorsia complies with the regulations laid out in the Belgian “Sunshine Act,” which became law in 2017. The Act requires life science companies to disclose “premiums and benefits granted to healthcare professionals, healthcare organizations and/or patient organizations.” Idorsia is required to make notifications to the Federal Agency for Medicines and Health Products (FAMHP) via Belgian Transparency Platform (beTransparent) on an annual basis.

France

Idorsia complies with the regulations laid out in Loi Bertrand (aka the French Sunshine Act), introduced by the French Public Health Code (PHC) in 2011. The law requires pharmaceutical companies operating in France or companies that manufacture or distribute products regulated under the Agence Nationale de Sécurité du Médicament (ANSM) to disclose the existence of any contract with HCPs and certain entities of the health sector, as well as any benefit in cash or in kind granted to the latter beyond a certain threshold. The ANSM maintains an online portal where the disclosed information is made available to the public. Reporting is done on a semi-annual basis (1 September for payments in the first half of the same year; 1 March for payments in the second half of the previous year).

Germany

Idorsia complies with the regulations laid out in the Code of Transparency of the Association of Voluntary Self-Control of the Pharmaceutical Industry (Verein Freiwillige Selbstkontrolle für die Arzneimittelindustrie – FSA) for interaction with Healthcare Professionals and Healthcare Organisations as well as Patient Organizations ("FSA Transparency Code"), which was adopted in 2013. As a member of the FSA, Idorsia will disclose transfers of value to covered recipients related to 1) research and development, 2) donations and other unilateral monetary or benefits in kind, 3) training events and other events, and 4) fees for service and consultancy.  Information is available on Verantwortung (idorsia.de).

Italy

Idorsia complies with the regulations laid out in the Farmindustria Code of Conduct, which requires pharmaceutical companies to report transfers of value made to covered recipients (“any Healthcare Professional or Organisation that carries out a profession or principle activity or that has the main domicile or legal head office in Europe”) related to events, consultancy services, donations / grants, and research & development. Information is available on Responsabilità (idorsia.it).

Spain

Idorsia voluntarily discloses Transfers of Value to HCPs and HCOs in accordance with its commitment to transparency, and in accordance with all applicable data protection laws and regulations in Spain. Information is available on Responsabilidades (idorsia.es).

United Kingdom (UK)

Idorsia complies with both the spirit and letter of the Code to the ABPI Code of Practice - administered by the Prescription Medicines Code of Practice Authority (PMCPA) - which covers the promotion of medicines for prescribing to health professionals and other relevant decision makers including administrative staff as well as the provision of information to the public about prescription only medicines in the UK. This information is published on the Disclosure UK website annually along with Idorsia’s methodological notes.

Historic payments

As of 2022, payments are disclosed via the platforms listed above. Previous to 2022, Idorsia’s payments to Healthcare Professionals or Healthcare Organizations in Switzerland amounted to CHF 330,002 in 2021, CHF 452,419 in 2020, and CHF 769,529 in 2019.

Compassionate Use

Kindly note that only qualified physicians may register patients for an Idorsia Discretionary Compassionate Use Program. A patient who is not eligible for or unable to participate in a respective clinical trial may be eligible for Idorsia’s Discretionary Compassionate Use Program subject to the following conditions:

  • The underlying disease or condition of the patient is seriously debilitating or life threatening.
  • There are no approved alternative therapies available to the patient.
  • The patient is not eligible for enrollment in any applicable, ongoing clinical trial for the relevant condition and the concerned investigational product.
  • The treating responsible physician reasonably expects that the patient will benefit from the treatment without undue safety risks.
  • It can be assured that providing the investigational drug will not interfere with the initiation, conduct or completion of clinical investigations that could support marketing approval or otherwise compromise the potential development of the investigational drug.
  • The treating physician will agree in writing to comply with Idorsia’s requirements in terms of medical criteria, safety reporting, drug supply/use, and protection of Idorsia proprietary information and/or intellectual property.
  • The request must be made by the patient’s treating physician, unsolicited by Idorsia or any other individual or organization.

In addition to these criteria, Idorsia will assess other factors to determine whether access to Idorsia’s Discretionary Compassionate Use Program can be provided to the patient, including available clinical data supporting an anticipated acceptable benefit–risk effect for the proposed use, any potential implications on the overall clinical development of the medicine, and the possible supply of the requested investigational drug.

Submission of a request:

Information about Idorsia’s active clinical trials is available on www.clinicaltrials.gov. Requests for access to an Idorsia investigational drug via its Discretionary Compassionate Use Program must be made by a qualified physician by sending a message via the contact form including the investigational treatment name and the patient’s disease or condition. To maintain the patient's privacy, no personally identifiable information must be included (no personal data of the patient such as e.g. patient's name, social security number, address, date of birth) in the request. The request will be acknowledged within 2 business days upon receipt.