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. Author manuscript; available in PMC: 2015 Oct 6.
Published in final edited form as: Health Aff (Millwood). 2014 Oct;33(10):1721–1727. doi: 10.1377/hlthaff.2014.0001

Exhibit 1.

Characteristics Of Forty-Seven Oral Oncologics Available In The US Market, First Quarter 2006 Through Third Quarter 2011

Category Oncologics
Number Percent
THERAPEUTIC CLASS

Alkylating agentsa 9 19
Topoisomerase inhibitorsb 2 4
Antimetabolitesc 5 11
Hormonal agentsd 12 26
Targeted agentse 14 32
Other 6 131

PATENT PROTECTION STATUS DURING STUDY PERIOD

Patent protected throughout 22 47
Lost patent protection 5 11
Generic throughout 20 43

FEE-FOR-SERVICE MEDICARE OUTPATIENT COVERAGE

Medical benefit (Part B) 9 19
Pharmacy benefit (Part D) 38 81

SOURCE Authors’ analysis of data from IMS Health’s National Sales Perspectives and the Food and Drug Administration’s approved drug labels.

a

Agents that cause the replacement of hydrogen by an alkyl group, especially in a biologically important molecule. These agents have mutagenic activity to inhibit cell division and growth.

b

Agents that block the ligation step of the cell cycle, generating single- and double-stranded breaks that harm the integrity of the genome. Introduction of these breaks leads to apoptosis and cell death.

c

Agents used to interfere with DNA production and therefore cell division and the growth of tumors. Because cancer cells spend more time dividing than other cells, inhibiting cell division harms cancer cells more than other cells.

d

Agents that manipulate the endocrine system by adding exogenous-specific hormones, particularly steroid hormones, or by inhibiting the production or activity of such hormones (hormone antagonists). Because steroid hormones are powerful drivers of gene expression in certain cancer cells, changing the levels or activity of certain hormones can cause certain cancers to cease growing or undergo cell death.

e

Includes agents that target specific genetic pathways, interrupting normal cell functioning such as cell division.