March 16, 2018 Non-Medical Switching Principles and Guidelines

Non-medical switching forces a patient stabilized on one treatment to switch medicines for reasons such as cost rather than efficacy. In the interest of providing the best care for patients, BPC has developed the following non-medical switching principles and guidelines.

Principles

  • The physician-patient relationship must be protected to ensure the best patient outcomes. Protecting the physician-patient relationship is fundamental to achieving optimal patient care and outcomes. Non-medical switching undermines this important relationship. Non-medical switching can have a legitimate role in managing costs when it comes to traditional small molecule medicines and their generic equivalents. However, for patients with chronic illnesses who are treated and stable on large molecule biologic therapies, switching to another biologic therapy for cost reasons and without the physician’s consent may jeopardize patient health and safety. No two biologic therapies are identical and the immunogenic risks present with every biologic therapy may increase when patients are switched to another therapy.
  • Patients stabilized on a biologic therapy should not be forced to undergo a non-medical switch. Achieving patient stability is an important treatment goal for many chronic illnesses and forcing a switch undermines this goal. Further, switching medicines and/or switching to different means of administration can lead to instability and introduce unnecessary patient stress and anxiety, negatively impacting patient wellness.

Guidelines

  • To ensure patients can access the right therapy for their condition, streamlined authorization and appeal processes should exist when a patient is faced with a non-medical switch. Current appeals processes are time-consuming, onerous and include a different process for each insurer. Processes must be streamlined so that physicians and patients can more efficiently navigate the system and ultimately access the best therapy.
  • Robust scientific and clinical data must inform non-medical switching. Currently, there is inadequate literature on non-medical switching for biologic therapies. Clinical trials as well as studies assessing real-world scenarios, which evaluate multiple switches, are needed to best inform payor policies.
  • Vigorous pharmacovigilance must be in place to track adverse events related to non-medical switching. To better understand the potential impact of non-medical switching on patients, vigorous pharmacovigilance is necessary. FDA should mandate post-marketing surveillance when non-medical switching occurs between biologic therapies, including biosimilars. Collecting such data will provide the FDA with more information when approving a biosimilar for specific indications and provide physicians with important information to help guide treatment regimens.
  • A non-medical switch should not increase patients’ other medical expenses. There are recent data suggesting that patients across nine different chronic illnesses who switched to a less expensive treatment experienced higher non-drug related expenses than those who did not undergo a switch. [1]

Any decision to make a switch should lie with the physician and patient, after consultation, and should be an informed decision.

[1] Institute for Patient Access, Cost-Motivated Treatment Changes & Non-Medical Switching: Commercial Health Plans Analysis August 2017.