Under the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85), the FDA has the authority to require manufacturers submitting drug approval applications to submit a proposed Risk Evaluation and Mitigation Strategy (REMS) program as part of the application.

There are varying degrees of a REMS program; it can be as simple as a medication guide included in each product package for patients and physicians, which outlines the risks and side effects of the medicine.  Since going into effect in 2007, a majority of all approved REMS programs fall into this category.

The other end of the spectrum is a REMS program which may require patients to be pre-screened/tested, enroll in a patient registry, and receive education before and during taking the medication.  Prescribers, pharmacies and physicians can also be required to enroll in a registry, receive detailed education and certification in order to administer or supply the medication.

An example of a REMS program falling into this category is Revlimid, a treatment for multiple myeloma.  In order to receive treatment, Celgene requires both patients and prescribers to enroll in the RevAssist REMS program. Once enrolled, patients are required to receive education, read and understand the medication guides and participate in a confidential survey.  After completing the survey, both patients and prescribers are required to read and sign an order form each time a prescriber writes the script.  Additionally, Celgene established a network of pharmacies where the product can be ordered from.  This enables Celgene to tightly control the distribution of Revlimid to patients meeting the strict requirements of RevAssist. 

From the perspective of an organization like Celgene, developing a REMS program is complex and requires significant resource and capital investment.  But, there is the potential to gain a competitive advantage from implementing this type of a REMS program.  For instance, life science companies have always struggled with making deep connections with patients directly and building brand loyalty.  Much of an organization’s marketing effort is spent on deploying legions of sales reps out to meet with physicians.  In recent years, in order to extend their influence on scripts, organizations have increased Direct to Consumer (DTC) advertising.  But results can be mixed and there is little opportunity for building brand loyalty or differentiation since most organizations actively promote to patients today. 

It’s conceivable that through a REMS program, organizations now have a new avenue to establish and foster connections directly with patients.  Imagine a situation where patients must enroll in a registry; organizations can begin to build brand loyalty with them by:

• Providing a portal for patients to receive additional education material
• Enabling patients to report side effects quicker than ever before
• Making it easier for patients to ask questions
  o FAQ’s
  o Ask a Doctor
  o Live chats
• Establishing forums, blogs or chat rooms for patients to connect with other patients
       
Additionally, these elements of the REMS program can be re-purposed for other key stakeholders including prescribers, physicians, hospitals, clinics and distributors.  The ultimate goal would be to build brand loyalty amongst all key stakeholders and make your medication the prescription of choice.  With the REMS landscape still in its infancy, organizations which can quickly adapt to the new rules can position themselves to benefit from these perceived regulatory hurdles. 

I would be very interested in knowing if your organization uses REMS as a competitive advantage? What benefits have you realized? 

Frank Gaibor

Tags: Business Strategy, Risk Management

This entry was posted on Monday, March 1, 2010 at 2:18 pm and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site, or  Forward