Re: Revision of USP Medicare Model Guidelines v6.0 for Benefit Years 2015-2017
Dear Members of the Therapeutic Information and Formulary Support Expert Committee:
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the U.S. Pharmacopeial Convention (USP) Therapeutic Information and Formulary Support Expert Committee (the “Expert Committee”) in response to the Draft Medicare Model Guidelines Version 6.0 (the “Model Guidelines”) released October 1, 2013.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. Our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced health care expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.
BIO appreciates this opportunity to raise several concerns that could limit patient access to vital therapies if left unaddressed in the Version 6.0 Final Model Guidelines. Our comments, described in detail below, are structured in two parts based on the dual responsibilities of the Final Model Guidelines: as a comparator for Medicare Part D prescription drug plans, and as part of the minimum standard for the prescription drug benefit of health insurance plans subject to the Essential Health Benefits (EHB) for 2014 and 2015.
The Medicare Prescription Drug Improvement and Modernization Act of 2003 charged the Centers for Medicare and Medicaid Services (CMS) to cooperate with USP to develop a classification system to be used by Medicare Part D drug plans for formulary development. Updated every three years, the resulting Model Guidelines “utilize pharmacotherapeutic evidence within the context of FDA [Food and Drug Administration] approved indications to create categories and classes…which characterize the statutory requirement for Medicare Part D plan benefit design to include drugs from each category and class.” BIO appreciates the inclusion of several drugs and biologicals approved by the FDA since the last update to the Model Guidelines. However, we are concerned that this Version 6.0 update does not provide the sufficient granularity and comprehensiveness within and across the categories and classes that is necessary to ensure that the Model Guidelines include the spectrum of therapies needed by a Medicare population with diverse health needs. Similarly, BIO is concerned that the three-year update cycle allows a significant gap between when innovative therapies are available on the market and when the Model Guidelines reflect these innovations. To address these issues, BIO recommends that:
The USP categories and classes be more detailed to adequately represent the drugs needed by enrollees in Medicare Part D prescription drug plans; and,
The USP Model Guidelines be revised frequently to support timely access to new and innovative medications.
 Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation, 78 Fed. Reg. 12,834 (Feb. 25, 2013).
 Medicare Prescription Drug Improvement and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2085; Social Security Act § 1860D-4(b)(3)(C)(ii).
Full Comment Letter Available Here (PDF)