Dear Healthcare Professional:
On March 26, 2020, REMS modifications to the Revlimid REMS®, Thalomid REMS® and Pomalyst REMS® programs were put in place to ensure appropriate patient access to REMS medications during the COVID-19 pandemic. These modifications are also applicable to the Lenalidomide REMS program. After careful consideration, Bristol Myers Squibb (BMS) has decided to continue the following REMS modifications; effective until further notice:
- Prescribers for patients who require routine pregnancy tests may use their discretion on how to verify negative pregnancy results. This includes the use of home (over the counter) pregnancy tests for patients that are sequestered in their homes; as long as the test has a sensitivity of at least 50 mIU/mL. Clinical urine or blood pregnancy tests are still recommended for patients who are able to complete tests in this manner. Current REMS required pregnancy testing frequency is still required and will not be waived.At-home pregnancy tests will be provided by BMS if recommended by the patient’s prescriber and cannot otherwise be obtained by patients.
- Prescribers will be able to enroll new patients in the REMS and remotely execute the Patient Physician Agreement Form (PPAF) on the patient’s behalf. If your patient is quarantined or you are unable to obtain a physical patient signature on the PPAF, the REMS Customer Care team will still enroll the patient provided the appropriate PPAF is submitted and an authorization letter is provided to Customer Care on the patient’s behalf after completing their counseling. Prescribers must still counsel patients, provide the applicable REMS patient materials to the patient and provide a copy of the PPAF to the patient for their records.In addition, REMS Customer Care will continue to accept electronic signatures from patients unable to physically sign the PPAF.
- Prescribers may verbally call in prescriptions to a REMS certified pharmacy. Prescribers must continue to provide the REMS authorization number and patient’s risk category to the pharmacy as part of the verbal prescription.
It is our hope that these REMS modifications will allow you to continue effectively and safely treat, educate, and enroll patients in the REMS. BMS will continue to update you as the pandemic evolves, and we make any additional changes to our REMS programs. Please feel free to contact Customer Care at 1-888-423-5436 if you have any questions.
Sincerely,
Faisal Mehmud, BSc MB BChir MRCP FFPM
VP, Global Head Risk Management