Approval, ownership, market structure, and placement on WHO EML for 100 new cancer NMEs on NCI alpha list

KEI research associate Paul Miano has written the following paper: Cancer: Approval, ownership, market structure, and placement on WHO Model Essential Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of cancer drugs and vaccines. KEI Research Note 2011:1,

A full copy of the paper is available in PDF format here.

The following is from the introduction (sans footnotes, which are in the PDF version):

Introduction and Summary

This research note presents data on the approval, ownership, market structure and placement on the WHO Model Lists of Essential Medicines new molecular entities (NMEs) approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer. The examined products, which include both drugs and vaccines, are those included in the U.S. National Cancer Institute (NCI) “alpha list” of cancer drugs. The July 2011 version of the alpha list includes 100 unique molecular entities, as well as a number of new formulations or combinations and chemotherapeutic regimens. Our analysis focuses on the 100 unique molecular entities.

Each of the products was approved by the FDA through one of two mechanisms. For pharmaceutical drugs, products are registered under a New Drug Application (NDA). For biologic products, registration is through a Biologic License Application (BLA).

Among our findings are the following:

1. The role of biologic products has increased

• 1.1 Of the 100 drugs and vaccines, 79 were registered under New Drug Applications (NDA) and 21 were registered under Biologic License Applications (BLA).
• 1.2 From January 1, 2000 to July 2011, 15 of 52 products were biologics, or 29 percent of the total.
• 1.3 For the 48 products registered before 2000, 6 of 48 were biologic, or 12.5 percent of the total.

2. Registrations have increased, and most cancer drugs are relatively new

• 2.1 Despite an overall decline in the registration of NME products in recent years, there has been a sharp rate of increase in the registration of NME products for the treatment of cancer.
• 2.2 In the 38 years from 1952 to 1989, there were only 21 NME on the NCI list, an average of .55 per year.
• 2.3 In the ten year period of 1990 to 1999, the list contains 27 NME cancer products – an average of 2.7 per year.
• 2.4 In the ten year period of 2000 to 2009, 45 NME cancer products were registered – an average of 4.5 per year.
• 2.5 For 2010 through the July of 2011, 7 NME products were registered, an average of 4.4 per year.
• 2.6 More than half (52 of 100) of all cancer NME products were first registered after January 1, 2000.

3. Most drugs are only available from a single supplier

• 3.1 66 of the 100 products are only available to one FDA approved supplier or a joint venture managing the same brand name, suggesting strong barriers to entry due to intellectual property rights and other factors.
• 3.2 45 of 79 pharmaceutical drugs (57 percent) do not have competitive suppliers.
• 3.3 21 of 21 biologic products (100 percent) do not have competitive suppliers.
• 3.4 For products registered between January 1 2000, and July 2011, 51 of 52 products (98 percent) do not have competitive suppliers.

4. Ownership is concentrated in six countries, and among thirteen companies

• 4.1 28 companies own or control the sale of the 66 drugs that do not have competitive suppliers.
• 4.2 13 companies control more than one cancer monopoly, including:
• GlaxoSmithKline (9), Amgen (5), Novartis (5)
• 4 each for Sanofi, Bristol Myers Squibb, Celgene and Roche
• 3 each for Eisai, Merck, Astrazeneca and Eli Lilly, and
• 2 each for Pfizer and Cephalon
• 4.3 In terms of nationality, just six countries host the companies that own and control cancer products sold as a monopoly.
• 4.4 One half (33 of the 66) monopoly products are controlled by firms located in the United States.
• 4.5 Of the remaining 33 monopoly products 12 are controlled by UK firms, 11 by firms in Switzerland, 5 by firms in Japan, 4 by firms in France and 1 by a firm in Germany.

5. The WHO Model Essential Medicines List excludes all new cancer drugs

• 5.1 The March 2011, 17th Edition of the WHO Model Essential Medicines List (EML) includes zero products from the NCI alpha list of cancer drugs on its “core” list of the minimum medicine needs for a basic health care-system.
• 5.2 The 17th Edition of the WHO Model EML includes 20 products from the NCI alpha list on its “complementary” list of “essential medicines for priority diseases.”
• 5.3 For the 2011 WHO Model EML complementary list, the newest product that is also on the NCI alpha list was registered 15 years ago, in 1996.
• 5.4 The newest cancer product on the 2002 version of the complementary WHO Model EML was first registered 19 years earlier, in 1983.

Note: These are the 100 “alpha list” drugs and vaccines included the paper: