Portugal Confirms Patient Role in Treatment Decisions

The document addresses the use of biosimilars and any switching from a reference product to a biosimilar.  The issue was the subject of Guideline 5 in the commission’s February 2018 guidance of biosimilars, which elicited feedback from the country’s advocates and patient groups.

Affirming the importance of shared decision-making, the clarification document makes several points:

• The decision to treat a patient with a biological or biosimilar belongs to the prescribing physician, with the patient taking an “active part.” The commission calls this point “clear and unequivocal.”
• Switching stable patients from a reference product to a biosimilar should be the decision of the prescribing physician, who once again involves the patient. Pharmacies may not automatically substitute.
• Patients and physicians are not obligated to switch to a less expensive treatment. If they choose not to, however, they may need to justify their decision to the commission.
• A patient should be properly informed as he or she weighs treatment options. The commission provides an educational leaflet on biosimilars for patients’ consideration.

Patient advocates are heartened by the commission’s clarification.  Several groups had submitted comments on the issue since the commission released its initial guidance earlier this year.  Among those was the Portuguese League against Rheumatism, which weighed in on the issue following a policy discussion among patients and patient groups at a May 2018 webinar hosted by the Global Alliance for Patient Access.

Advocates remain hopeful that clarification from the National Commission for Pharmacy and Therapeutics will protect the physician-patient relationship, keep patients as active participants in a shared decision-making process about treatment, and ensure that stable patients have the right to continue with their medication.