Access to investigational medicines

Our focus is on enrolling patients in clinical trials to obtain the data required to enable regulatory and reimbursement authorities to review and decide on whether these new medicines should be registered and reimbursed. Approval by regulatory authorities is the only way to make medicines broadly available to patients for use under the supervision of a qualified healthcare professional.

However, Roche recognizes that some patients with serious or life-threatening diseases or conditions may not be eligible for any clinical trials and may not have other treatment options available. Hence, under specific circumstances and in compliance with applicable laws and regulations, Roche may provide patients with Pre-Approval Access (PAA) to investigational medicines outside the clinical trials process, before they are approved by regulatory authorities. This could be for a group of patients through local PAA Programs such as an Expanded Access Program or for individual patients through Compassionate Use.

Further information on PAA can be found in our Roche Position Paper.

The following global compassionate use programs are currently available *:

  • Satralizumab
  • Risdiplam
  • Glofitamab
  • Mosunetuzumab
  • Entrectinib

(*open for requests by qualified healthcare professionals)

DISCLAIMER: An existing program does not guarantee availability in all countries. Various regulatory mechanisms exist in different countries to provide PAA to new medicines and as a result, country specific variations for PAA will occur. Any pre-approval access to medicines must always comply with the applicable country-specific laws and regulations, including medicine importation requirements (see below some examples**).

For further information about these Programs in your country please contact the medical information team in your country or submit your question using the Roche Medical Information site. A list of all the Roche affiliates can be found here.

** Examples of country specific regulations

  1. UK: https://www.gov.uk/government/collections/early-access-to-medicines-scheme-eams-scientific-opinions
  2. France: All cohort ATU programs are published on the website of the French Health Authority: http://ansm.sante.fr/.