. Author manuscript; available in PMC: 2010 Mar 25.

Published in final edited form as: Nat Biotechnol. 2009 Dec;27(12):1082–1084. doi: 10.1038/nbt1209-1082

Table 1.

Formulary coverage, cost sharing, and utilization management for top-selling biologies in 2006, 2006 vs. 2009

Drug Class / Indication	Generic name	Brand name	Year of FDA approval^a	Black Box Warning in 2006^b	Average Monthly Cost^c	Formulary coverage^d (%)		Tier (modal value)^e 2006/ 2009	Type of cost-sharing as co-insurance^f (%)		Co-pay amount^g (modal value)		Prior authorization^h (%)		Quantity limitⁱ (%)
						2006	2009		2006	2009	2006	2009	2006	2009	2006	2009
Anemia						99.9^k
	darbepoetin alfa	ARANESP	2001	No	$1,098	92.9	91.7^*	4/4	65.0	89.0^*	$20	$35	90.8	97.4^*	13.3	41.3^*
	epoetin alfa	EPOGEN	1989	No	$576	65.8	74.9^*	4/4	72.4	86.9^*	$40	$59	89.1	96.7^*	12.8	69.0^*
	epoetin alfa	PROCRIT	1990	No	$901	95.4	98.7^*	4/4	65.3	72.5^*	$20	$35	77.1	97.6^*	9.9	66.4^*
Cancer						55.6^*
	Bevacizumab	AVASTIN	2004	Yes	$2,750	45.9	74.1^*	4/4	57.4	89.0^*	$30	$80	47.6	69.9^*	3.5	14.9^*
	Trastuzumab	HERCEPTIN	1998	Yes	$3,047	42.1	76.6^*	2/4	53.6	87.2^*	$30	$59	42.1	40.8	4.3	1.0^*
	Rituximab	RITUXAN	1997	Yes	$2,969	43.7	100^*	4/4	57.4	87.2^*	$20	$35	57.1	81.3^*	4.0	11.0^*
Diabetes						100%
	insulin lispro	HUMALOG	1996	No	$170	86.3	90.1^*	2/2	14.8	11.2^*	$30	$35	5.0	10.6^*	7.4	8.3
	insulin glargine	LANTUS	2000	No	$165	97.8	99.9^*	2/2	16.4	14.3^*	$30	$35	5.0	6.4^*	6.7	8.1^*
	insulin detemir	LEVEMIR	2005	No	$167	11.5	99.1^*	3/2	24.6	14.6^*	$60	$35	0.9	6.5^*	11.3	13.3
	insulin human regular	NOVOLIN	1982	No	$53	95.1	93.6^*	2/2	17.4	15.2^*	$30	$35	3.1	8.9^*	6.4	7.6
Hepatitis B&C	peginterferon alfa-2a	PEGASYS	2002	Yes	$1,908	78.8	100^*	4/4	62.2	92.3^*	$20	$35	77.4	91.2^*	27.9	38.7^*
Multiple sclerosis						99.9
	interferon beta-1a	AVONEX	1996	No	$1,672	96.3	93.8^*	4/4	66.8	95.9^*	$20	$59	61.6	71.1^*	15.4	40.6^*
	interferon beta-1b	BETASERON	1993	No	$1,898	99.5	100^*	4/4	72.3	96.1^*	$20	$29	64.7	71.8^*	17.8	38.4^*
	interferon beta-1a	REBIF	2002	No	$1,926	76.8	91.2^*	4/4	63.0	97.9^*	$50	$40	64.1	74.5^*	15.9	42.0^*
Neutropenia						99.3
	Pegfilgrastim	NEULASTA	2002	No	$3,348	70.6	90.1^*	4/4	63.5	92.9^*	$25	$59	40.2	80.8^*	10.2	33.8^*
	Filgrastim	NEUPOGEN	1991	No	$261	90.3	100^*	4/4	67.5	95.1^*	$20	$59	58.5	79.9^*	7.4	29.4^*
Rheumatoid arthritis						98.8
	Etanercept	ENBREL	1998	No	$755	99.6	99.6	4/4	67.5	96.0^*	$20	$59	86.1	86.1	22.3	39.4^*
	Adalimumab	HUMIRA	2002	Yes	$1,510	91.9	99.6^*	4/4	69.0	96.3^*	$20	$59	79.8	86.0^*	23.5	38.2^*
	Infliximab	REMICADE	1998	Yes	$671	98.5	99.4^*	4/4	71.8	97.4^*	$40	$40	80.7	87.9^*	2.0	0.8^*

Data sources:

Authors’ analysis of the Medicare Prescription Drug Plan Formulary Files, March 2006 and July 2009. N=3,075 prescription drug plans in 2006 (1,446 stand-alone prescription drug plans (PDP) and 1,629 Medicare Advantage prescription drug plans (MAPD)); N=4,207 prescription drug plans in 2009 (1,611 PDPs, and 2,596 MAPDs).

P<0.05, chi-square test (null hypothesis: the rate in 2006 equals to the rate in 2009). Four sets of tests were conducted: (1) the percentage of plans covering the drug in their formulary in 2006 vs. in 2009; (2) the percentage of plans requiring co-insurance for the drug in 2006 vs. in 2009; (3) the percentage of plans requiring prior authorization for the drug in 2006 vs. in 2009; (4) the percentage of plans requiring quantity limit for the drug in 2006 vs. in 2009.

Notes:

Data on the year of approval are from the FDA.

A black box warning is a labeling requirement imposed by the U.S. Food and Drug Administration (FDA) indicating that a drug may cause serious adverse effects. Data on the black box warning are from the FDA.

The monthly cost is based on the average wholesale price of commonly prescribed doses. Data on the average wholesale price are from the 2007 Redbook and data on the commonly prescribed doses are from the MICROMEDEX database. Average wholesale price is used to serve as benchmark pricing. The monthly costs based on average wholesale price presented here are likely to be overestimated.

Reports the percentage of the Medicare prescription drug plans that included the drug in their formulary coverage.

Reports the tier in which the drug was most frequently placed (the modal value) among the Medicare prescription drug plans. In tiered formularies, drugs are divided into “tiers,” with the first tier typically representing generics at the lowest level of patient cost sharing, and a higher tier requiring higher patient cost sharing.

Reports the percentage of the Medicare prescription drug plans that used co-insurance (vs. co-payment) as the type of cost-sharing for the drug.

Among plans that use co-payments, reports the co-payment amount that was most frequently used (the modal value) among the Medicare prescription drug plans.

Reports the percentage of the Medicare prescription drug plans that required prior authorization for the drug.

ⁱ

Reports the percentage of the Medicare prescription drug plans that required quantity limit for the drug.

j: Reports the percentage of the Medicare prescription drug plans that required step therapy for the drug

Coverage for drug class is defined as the coverage of at least one of these drugs within the class.