Interchangeables: Cheaper Biologics on Track for Michigan

Biologics took a big step toward affordability when HB 4812 had a second hearing before the MI Senate Health Policy Committee a few weeks ago. At issue was the prescribing process for interchangeables, the newer, cheaper versions of the expensive biologic drugs.

Capitol Building, Lansing, MI Fall, 2015 photo: Abigail Nobel

Capitol Building, Lansing, MI Fall, 2015 photo: Abigail Nobel

Patients who depend upon biologics for symptom control of diabetes, rheumatoid arthritis, and other disorders have waited a long time for more-affordable interchangeables to reach the market. Anticipating this event, manufacturers, pharmacies, disease-advocacy groups, and professional organizations have been lobbying state capitols for a variety of prescription rules. (More difficult rules “chill” the switch to new medications.) In short, competition has entered the legislative halls in search of market share, with lower prices as the forfeit.

Interchangeables: Testimony to Remove Red Tape

The original bill required pharmacies to notify prescribers of any substitution of interchangeables. This went beyond FDA guidelines. Citing patient safety concerns, manufacturers and disease advocacy groups pushed for the heavier requirements. Michigan pharmacies provided excellent testimony in support of lower-regulation, lower-cost patient access.

My goal is the greatest access possible for interchangeables through patient-centered, free market policy. For more background, plus my bill testimony before the House Health Policy Committee, see my October 5, 2015 blog post here.

When HB 4812 came to the Senate, my focus narrowed. I aimed my written submission to committee members toward one point: keeping prescriptions simple by removing HB 4812 notification requirements.

Section 17755 (5)

Why is the “simple” notification of sub-section 5 such a problem? Today’s clinicians are swamped in documentation requirements under Meaningful Use and other provisions of the ACA, Medicare, and other third party payers. Some studies indicate up to 70% of clinical time is spent meeting non-care tasks, and mindless documentation is one of the major factors listed in recent studies of medical depression and early retirement. Medical office busyness has a major downside for patients: visits take longer to schedule, and calls to clarify or correct prescription problems are delayed or even lost in the blizzard of data. Far more important than every biologic interchangeable medication having a back-check “just in case,” is that a patient with a real prescription problem can actually reach the doctor for resolution in a timely manner.

I ask the committee to reject any burden of time, documentation, or data-collection that is not absolutely required under current federal law. Notification requirements, by adding even more unnecessary data communication and filing to the pharmacy and prescriber roles, disrupt the flow of care by competing for valuable time. As such, I strongly oppose this provision and request that it be stricken. Let’s allow healthcare to get back to the point of it all: patient care.

Please take Section 5, the extra documentation mandate, out of HB 4812 before reporting this otherwise excellent bill to the floor of the Senate.

Abigail Nobel, BSN, RN, MA

My full submission can be seen on the formal record here.

Senate Health Policy Hearing

The MI Senate Health Policy Committee discusses HB 4812 starting at 35 minutes in this video.

Chairman Mike Shirkey (R, Clarklake) called for a roll call vote on adopting S-1, a substitute bill. This removed Sections 5, 6, and 7– every provision of the bill regarding special notification requirements. In their place, S-1 inserted one sentence requiring pharmacies to keep record of an interchangeable substitution for two years. The vote to accept the change was unanimous.

I was delighted with the deletion, but how burdensome was the replacement? I called my small local pharmacy to find out. They informed me that their current computer system stores prescription substitution records for ten years. The new interchangeables mandate should cause not even a ripple to their operations.

I’m good with that.

Next Hurdle: Full Senate Vote

With this vote, interchangeables are much closer to cost savings under an open market prescription policy in Michigan. The Senate Health Policy Committee voted unanimously to report S-1 to the full Senate with recommendation for passage. I applaud them for removing pharmacy notification in favor of a token record-keeping requirement. According to opposition testimony, if successful, Michigan would be the first state to pass a notification-free bill. Fiscal agency analysis showed significant savings for the state, meaning taxpayers benefit as well.

You can help Michigan set free market precedent by contacting your MI Senator today to request a no-amendment vote for HB 4812 on the senate floor.

The final challenge will be a concurrent House vote on the Senate amendment to the bill before it can proceed to signing by the governor.

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