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insulin. In the late 1990s, Novo intro-

ever, A1C reductions greater than those

duced pen devices for insulin injection in the United States. Lilly introduced a pen device for the administration of lispro and, eventually, its other insulin products with the exception of regular insulin. In the past year, Novo has introduced sever- al additional pen injection devices.

from regular insulin have not been rou- tinely demonstrated. Still, the literature does provide fairly convincing evidence that these insulin analogs are associated with a moderately lower risk of hypo- glycemia, particularly nocturnal hypo- glycemia, than are equivalent human insulins.

Documentation of Efficacy The justification for the cost of these newer insulin products, based on their demonstrated clinical efficacy, remains to be completely confirmed. In each case, whether for insulin analog or the pen-injection device, there are no large- scale multicenter studies documenting that the new products yield clinically meaningful improvements in hemoglo- bin A1c (A1C) compared to standard, comparable products.6

Substantiation of the notion that pen injection of insulin leads to improved glycemic control is also unavailable.10 Pen-injection may be helpful in certain clinical circumstances, such as with patients who follow hectic daily sched- ules.11 Studies have not been carried out on the features of pen-injection that could be beneficial, such as its potential for reducing the time required to initiate insulin therapy or the numbers of patient errors in insulin administration.

For example, detailed kinetic stud- ies of insulin glargine (Lantus) versus NPH or ultralente insulin have demon- strated a less variable pattern of insulin action over time.7 However, no study yet available has shown clearly that glargine reduces A1C results more than does NPH or ultralente insulin. Similar- ly, the rapid-acting insulin analogs lispro8 and insulin aspart (Novalog)9 have been shown to have positive effects in acute studies on patterns of postprandial glucose fluctuations. How-

The Pricing of Insulin Innovation has come with increasing cost. The retail prices of analog or pen- injected insulins are significantly higher than those of conventional insulin prepa- rations (Table 2). In most cases, the cost of equivalent amounts of insulin, in terms of units of insulin, is at least 50% higher and more often more than 200% higher for the new insulin products and devices than for conventional prepara- tions in vials.

Table 2. Retail price comparison of different forms of injected insulin

The Innolet disposable pen devices recently marketed by Novo have the smallest price differential versus human insulin in vials, but they only deliver tra- ditional human insulin products. At least for now, the long-acting insulin analogs are sold at a lower premium than the short-acting insulin analogs. The highest cost for these new insulin products applies to disposable pen injectors of insulin analogs.

Growth of the Insulin Market The market for insulin in the United States is currently growing at more than 10% per year.12 Between May 2000 and May 2001, it grew at 11% to $1.4 bil- lion. Growth is projected to continue at that rate or more at least until 2020, when insulin sales are projected to exceed $7.5 billion.13 Much of this growth will be fueled by the introduc- tion of more and more insulin analogs. The data do not account for the potential impact of inhaled insulin, if and when it is released for commercial use.

Insulin is also an important part of the product portfolio for its established manufacturers. During the last fiscal year, insulin and other diabetes-related products represented the second-largest product line for Lilly (>$1.2 billion in annual worldwide sales)14 and the largest product group for Novo (>$1.9 billion in

Analog, long-acting

10

U100

Vial

1,000

$43.95

$0.044

Analog, rapid-acting

5 1.5

U100

Cartridge

750

$41.54

$0.055

Analog, rapid-acting

53

U100

Cartridge

1,500

$89.92

$0.060

Analog, rapid-acting

53

U100

Pen

1,500

$94.53

$0.063

Analog, rapid-acting

10

U100

Vial

1,000

$48.40

$0.048

Human

53

U100

Cartridge

1,500

$67.25

$0.045

Human

5 1.5

U100

Cartridge

750

$34.00

$0.045

Human

5 1.5

U100

Pen

750

$35.40

$0.047

Human

53

U100

Pen

1,500

$136.85

$0.091

Human

53

U100

Innolet

1,500

$60.00

$0.040

Human

20

U500

Vial

10,000

$160.58

$0.016

$200.00

$0.020

Human

10

U100

Vial

1,000

$25.00

$0.025

$29.00

$0.029

$31.00

$0.031

Product

$100.00

$0.067

$106.00

$0.071

$60.00

$0.060

$65.00

$0.065

$75.00

$0.050

$72.00

$0.048

$49.00

$0.049

$50.00

$0.005

$57.00

$0.076

$42.50

$0.057

Size (ml) Concentration Container

Online Pharmacy 2

Local Pharmacy

Price Cost/unit

(Georgia) Price Cost/unit

Online Pharmacy 1

Units

Price

Cost/unit

CLINICAL DIABETES Volume 21, Number 1, 2003

41

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