February 13, 2015
The Honorable Elizabeth McCann
Chair
Health, Insurance & Environment Committee
Colorado House of Representatives
200 East Colfax
Denver, CO 80203
RE: Senate Bill 15-071
Dear Representative McCann:
The Academy of Managed Care Pharmacy (AMCP) is opposed to Senate Bill 15-071, legislation that
would place an unnecessary burden on the substitution of drugs determined by the U.S. Food and Drug
Administration (FDA) under the Public Health Service Act to be interchangeable with reference biologic
products without the intervention of the health care provider who prescribed the reference product.
Despite opposition to this legislation in the Senate, it passed without amendment and is now under
consideration by your Committee. We would like to share with you the concerns that we raised when
the Senate considered this legislation.
AMCP is a national professional association of pharmacists and other health care practitioners, including
132 members in Colorado, who serve society by the application of sound medication management
principles and strategies to improve health care for all. The Academy’s nearly 7,000 members develop
and provide a diversified range of clinical, educational and business management services and strategies
on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit.
Biologic products are already playing an important role in today’s health care system, both in terms of
scientific improvements in the treatment of disease and in increased drug costs. The high costs of many
of these products threaten patient access to important therapies and place a strain on payers trying to
manage prescription drug spending. Since the introduction of biosimilars in 2006, the European Union
has experienced an average price reduction of 30 percent for products with competition from
biosimilars, and it is reasonable to expect a similar impact in the United States. Interchangeable
products are also expected to be less costly than the reference product.
Senate Bill 15-071 is problematic for four (4) reasons:

The definition of interchangeable added in Section 1 [12.42.5 102(16.5)(a)] refers to 42
U.S.C. Section 262(k)(4) of the federal Biologics Price Competition and Innovation Act
of 2009 (“BPCIA”). Section 262(k)(4) is actually the statutory provision that refers
to the safety standards used by the Secretary to determine interchangeability. We
recommend that that section should be amended to refer to the BPCIA definition of
the term interchangeable or interchangeability [42 U.S.C. Section 262(i)(b)(3)]: the
term ‘interchangeable’ or ‘interchangeability’ in reference to a biological product that
is shown to meet the standards described in subsection (k)(4), means that the
biological product may be substituted for the reference product without the
intervention of the health care provider who prescribed the reference product.

The reference in Section 1[12.42.5.102(16.5)(b)] refers to the “Orange Book” as the
FDA reference for biologic products. In September of 2014, the FDA released on its
website the Purple Book: Lists of Licensed Biological Products with Reference
Product Exclusivity and Biosimilarity or Interchangeability Evaluations. According
to the FDA, the Purple Book will also enable a user to see whether a biological
product licensed has been determined by the FDA to be biosimilar to or
interchangeable with a reference biological product (an already licensed FDA
biological product). The FDA also states that the Purple Book lists biosimilar and
interchangeable biological products under the reference product to which
biosimilarity or interchangeability was demonstrated. We recommend that the
reference to the “Orange Book” be replaced by reference to the “Purple Book.”

Section 2 amends 12-42.5-122 (b)(I) to provide that a pharmacist can only substitute
an interchangeable product if the FDA has determined the product is interchangeable
and if the practitioner has not indicated that the product cannot be substituted. We
recommend that this provision be deleted. The pharmacist will know if the FDA has
approved the product as interchangeable and the pharmacist already knows that by
Colorado law, a product cannot be substituted if the practitioner conveys that
information to the pharmacist.

Section 2 amends 12-42.5-122(b)(II) to add unnecessary and burdensome notification
requirements on the pharmacist in order to dispense an interchangeable product. The
prescriber has access to the Purple Book and will know prior to issuing the
prescription if she or he wants to give the pharmacist the option to substitute. This
requirement is supported by certain organizations as a means to slow the use of these
new drugs in the marketplace.
AMCP supported the approval of the BPICA as a needed incentive for the development of new
therapeutic products that hold the promise of preventing, treating or curing otherwise inevitable,
untreatable and incurable diseases. We support:



the FDA’s pathway as the mechanism to assure that safe drugs are permitted in the
marketplace;
the ability of practitioners to ensure that they are selecting the best medication for
their patients and, if they are unsure about a medication, to prohibit substitution;
the ability of a pharmacist to rely on the FDA’s determination of interchangeability;
and
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
the ability of employers, health plans, government payers and other payers to provide
cost savings to their members by making available FDA approved interchangeable
biologic drugs.
For these reasons, AMCP believes this legislation will discourage substitution, which only
benefits those entities offering more costly biologic drugs, conversely potentially increases
medication costs to patients and payers and, thereby, threatens patient access to more affordable
treatments. This legislation does not recognize the value that interchangeable products offer to
patients and payers by enhancing access to safe and lower cost medications.
We appreciate the opportunity to share our views on Senate Bill 15-071. We respectfully urge
you to vote against its passage. If you have any additional questions, you may contact AMCP’s
local advocacy leader, Ryan Haynes, RPh, MBA, at (720) 583-4689 or
ryanhaynes_2000@yahoo.com or AMCP’s Vice President of Government Affairs, Lauren
Fuller, at (703) 683-8416 or lfuller@amcp.org.
Sincerely,
Edith A. Rosato, R.Ph., IOM
Chief Executive Officer
cc: Members of the House Committee on Health, Insurance & Environment
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