Comments Regarding Department of Public Health's Proposed Changes to the Regulations, List of Interchangeable Drug Products

The Massachusetts Medical Society appreciates the opportunity to provide comment to the Department of Public Health on the proposed changes to the regulations, List of Interchangeable Drug Products (105 CMR 720.000.)  The Medical Society remains committed to addressing the opioid use disorder epidemic in the state, and strongly supports thoughtful prescribing of opioids.  We support the promotion of opioids with abuse deterrent opioids, and hope many more will enter the market in the coming years.

The Medical Society applauds the work of the reconstituted Drug Formulary Commission.  The Commission has been given a tremendously difficult charge, and we commend the commitment to pursing the formulary that we comment on today, as well as other initiatives it has taken over the past year.  In fact, we made the Commission’s “List of Non-Opioid Drug Products for Pain Management” the headline of one of our newsletter emails that goes out to over 25,000 physicians, medical students, and other interested parties.  We think it provides an important contribution to the resources available to Massachusetts prescribers.

As we have reviewed the proposed regulations at the heart of this comment, and, specifically the detailed drug formulary as presented in the regulations, we have strong concern.  While the work of ensuring the formulary reflects clinically appropriate interchangeable drug alternatives appears sound, the Medical Society has significant concern about the failure to adequately consider the statutorily required factor of cost. Massachusetts General Laws Chapter 17, Section 13 clearly states, “In considering whether a drug is a chemically equivalent substitution the commission shall consider … whether the drug's substitute is cost prohibitive.” The Medical Society does not believe the current formulary properly reflects this explicit condition found in both the underlying statute as well the proposed regulations.

In particular, the automatic substitution of brand name Embeda for multiple generic opioid formulations including inexpensive generic MS Contin is inherently cost prohibitive. In conversations with several clinical pharmacists and physician administrators in the state, estimates project substantial increases, some projecting an 800% increase based upon this automatic substitution.  The Medical Society believes this increase should be considered cost prohibitive per the terms of the statute, and should thus be reevaluated by the Formulary Commission and the Department leadership.

A proper reevaluation with a particular eye towards cost is not only prudent given the underlying statutory requirement, but it provides consistency with the broader goals of the state of addressing the cost of overall healthcare in the state.  We strongly appreciate the balance between promoting good opioid prescribing to help combat the opioid epidemic with the broad considerations of cost containment.  There are important factors such as abuse deterrence that should outweigh cost in many clinical encounters.  But decisions about policies of automatic substitution that will affect thousands of prescriptions per year must properly balance all considerations.  We strongly urge reevaluation to ensure consistency with the underlying statutory requirement, and with the priorities of many leaders in the Commonwealth.

Additionally, as more physician organizations take on greater risk for total cost of care, including prescription drug expenses, the greater the impact of reducing the control that individual physicians and organizations have on the nature of specific prescription.   Automatic substitution fails to appreciate the nuances of the clinical presentation that allow for a more individualized assessment of abuse risk versus cost.

Lastly, the Medical Society notes that many important details about the implementation of this process are still unsettled. While we understand they may be outlined in a subregulatory guidance, we strongly urge input from a broad stakeholder group about the details of implementation before such a guidance is finalized.

The Medical Society strongly urges the Drug Formulary Commission to reevaluate the proposed formulary with an eye on ensuring compliance with the underlying statutory charge of ensuring that it is not cost prohibitive.



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