Election May Determine Pace of Biosimilar Legislation

Ron Lanton III, Esq., has over 25 years of experience in government affairs at the municipal, state, and federal government levels, with 15 years dedicated to the healthcare sector. He is a regulatory attorney and government affairs professional who frequently consults Wall Street firms on financial issues related to the healthcare sector. Lanton is a featured industry speaker on issues such as pharmaceutical safety and healthcare cost containment, and he has authored numerous articles regarding pharmacy and healthcare law. He earned a BA from Miami University and a JD from The Ohio State University. He is also the chair of the Biologics Committee for the New York Bar Association.

March 07, 2020
By the end of 2019, 26 biosimilar products had been launched in the United States. As 2020 gets underway, there are several pending legislative proposals designed to encourage more commercialization of these cost-saving drugs.

House Legislation

HR 3: Elijah E. Cummings Lower Drug Costs Now Act
Many parts of this legislation could indirectly affect biosimilars. Two proposals of note would directly change drug costs for biosimilars if the law is passed.

The first proposal would require the HHS secretary to add a new set of measures to the 5-star rating system under Medicare in order to encourage increased access to biosimilar biological products. Specifically, the proposed legislation calls for determining whether a biosimilar is on formulary and whether and how utilization management tools are applied with respect to a biosimilar. The bill also calls for determination of the percentage of enrollees prescribed the biosimilar product when the reference biologic is also available.

The second proposal would temporarily increase the amount Medicare Part B pays for biosimilars for 5 years. This means that Medicare would pay the average sales price (ASP) plus 8% rather than plus 6%. The product would have to meet certain pricing criteria in order to qualify.

Both proposals may increase the utilization of biosimilars. The star rating system currently used does not make a distinction for biosimilars and allows payers to use the same policies for biosimilars and brands as they do for generics and brands. This can mean that a specialty pharmacy that dispenses under Part B does not get the same credit as a pharmacy that dispenses for Part D. Establishing new guidelines for the star rating system can help specialty pharmacy use more biosimilars and get credit toward its ratings with the payer.

An ASP increase of 2 percentage points could help cover additional costs for specialty pharmacy for educating consumers about biosimilar utilization.

This bill has passed the full House and has yet to be taken up by the Senate.

HR 4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act
This bill would eliminate a patient’s copay for a biosimilar under Medicare Part B. The bill would drive down medical costs by increasing access to lower-cost biosimilar drugs and give Americans more treatment options. This bill has been referred to the Subcommittee on Health in the House.

HR 2375: Preserve Access to Affordable Generics and Biosimilars Act
This would prohibit prescription drug companies from compensating other prescription drug companies to delay the market entry of a generic drug, biosimilar biological product, or interchangeable biological product. This would basically make “pay for delay” in patent settlements illegal. This legislation has cleared the Judiciary Committee and is pending in the House.

Senate Legislation

S 1416: Affordable Prescriptions for Patients Act of 2019
Originally, this legislation was aimed at allowing the Federal Trade Commission antitrust enforcement powers to sue manufacturers who use patent thickets to block generic and biosimilar products from launching. Since its introduction, the bill’s main sponsor, Sen John Cornyn, R-Texas, has stated that he is redesigning the bill to shift the enforcement power to the FDA instead of the FTC. As currently modified, the bill addresses anticompetitive practices involving manipulation of the availability of reference drugs. There is other patent thicket legislation proposed, which would be stricter than S 1416, but it is unknown when this would come to a vote in the Senate.

With the election season well underway, it remains to be seen whether any of these bills will advance before the year’s end.



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