Prices for Abbott's Norvir (generic name Ritonavir) as a Standalone Product in 2010, KEI Research Note 2010:4

KEI Research Note 2010:4
August 12, 2010
Anne Mira Guha

Prices for Abbott's Norvir (generic name Ritonavir) as a Standalone Product in 2010

1. Introduction

Ritonavir is a protease inhibitor (PI) used to treat the HIV infection. In a number of countries, ritonavir is patented and exclusively marketed by Abbott Labs under the trade name Norvir. While ritonavir was originally introduced as a "third drug" in a triple anti-retroviral (ARV) therapy regime for HIV/AIDS, it is now used to as an agent to enhance the effectiveness of other protease inhibitors. It is available in 100mg tablets, 100mg capsules, and as an oral solution. Most commonly prescribed are the pill forms (caps/tabs). The tablets, a relatively new presentation, are heat-resistant. The soft-gel capsules, an older presentation but still the most commonly available, require refrigeration. The oral solution, which comes in peppermint and caramel flavored vehicles, is often used for pediatric treatment.

For adults, the most common use is in doses of 100 to 200 mg per day, either as the standalone product Norvir, or co-formulated with lopinavir, a protease inhibitor combination treatment marketed by Abbott under the trade name Kaletra. In late 2003, Abbott "re-priced" Norvir in the United States, introducing a 400 percent increase when it is used as a standalone product. The price increase did not apply to countries outside the US, nor to the Abbott combination product Kaletra.

2. Recent Prices in High Income Countries

The following are prices from higher income countries where the ritonavir patent is in effect. (Prices are effective August 2010, unless otherwise noted.)

Table 1: Prices for 100 mg tablet or soft-gel capsule in high income countries

Country Prices, August 2010 Price in USD [1]
(per pill)
Annual Cost in USD
(at 2 pills a day)
United States;
Average Retail Price
$320.95 per 30 (same for caps & tabs) [2] $10.70 $7,811.00
Denmark 60,15 eur per 30 (caps) [3] $2.63 $1,919.90
Norway 384,60 kr per 30 (tabs) [4]
(includes VAT)
$2.15 $1,569.50
Austria Gross Retail Price: 133.04 euro for 84 (caps) [5] $2.04 $1,489.20
Norway 1014 kr per 84 (caps)
(includes VAT)
$1.96 $1,430.80
Sweden SEK 1063 per 84 (caps) [6] $1.80 $1,314.00
Italy 104.91 eur per 84 (caps) [7] $1.65 $1,204.50
France PPTTC: 37,48 Euro per 30 (film-coated tablets) [8]
(PPTTC: price for the public with all taxes incl.)
$1.61 $1,175.30
Canada (Ontario) 1.4671 CAD each (caps) [9] $1.42 $1,036.60
Australia 965.09 AUD per 720 (caps) [10] $1.42 $1,036.60
Netherlands € 1,07 each (same for tabs & caps) [11] $1.41 $1,029.30
Australia 103.82 AUD per 672 (tabs) $1.29 $941.70
United States; Federal Supply Schedule [12] $35.90 per 30 (same for caps & tabs) $1.20 $876.00
New Zealand $121.27 per 84 (caps) [13] $1.04 $759.20

The following are prices for the oral solution of Norvir in high income countries.

Table 2: Prices for oral solution in high income countries

Country Exchg Rt Domestic Price ml mg/ml Price in USD for 100mg
United States;
Average Retail Price
-- 1,797,37 USD 240 80 $9.36
Italy (1.28) 449.58 Euro 450 80 $1.60
Sweden (.135432) 4110 SEK 450 80 $1.55
Canada
(Ontario)
(.954472) 1.1839 CAD 1 80 $1.41
Australia (0.89489) 986.12 AUD 900 80 $1.41
United States; Federal Supply Schedule -- 196.49 USD 240 80 $1.02

3. Prices in Developing Countries

The following are prices for Norvir in developing countries taken from the MSF periodic surveys of ARV prices.

Table 3: Selected prices of tabs, capsules and oral solution in developing countries [14]

Manuf. Presentation $/100mg
(i.e. 1 pill)
Annual Cost
(200mg/day)
Abbott RTV 100mg
soft-gel capsule
$0.114 $83
Abbott RTV 100mg
heat-stable capsule
$0.114 $83
Abbott RTV 80mg/ml
oral solution
$0.116
(0.093/ml)
$85
Cipla RTV 100mg
soft-gel capsule
$0.442 $323
Strides RTV 100mg
soft-gel capsule
$0.300 $219

4. Comparison of U.S. to Foreign Prices

As demonstrated above, in August 2010, prices for Norvir were four to ten times higher in the United States than in other high income countries. The following graph shows the comparative annual costs of Norvir, calculated for a dose of two 100mg soft-gel capsules per day.

Figure 1, August 2010 annual cost of twice daily dose of 100 mg soft-gel capsules (in high income countries)
ritonavir_prices_554x528.png

Recall from above that in developing countries a 100 mg dose of ritonavir is available for approximately $.11 to $.40 to national AIDS programs, resulting in an annual treatment price of $83-323.

5. U.S. Government Support for Development of Ritonavir

Ritonavir was invented by Abbott with Government support under contract number AI27220 awarded by the National Institute of Allergy and Infectious Diseases (NIAID).

An August 11, 2010 search of the NIH RePORT database using the search term "ritonavir" identifed 1,230 NIH grants. The RePORT database identifies 58 patents that have cited support from these grants.

An August 11, 2010 search of the USPTO database using the search terms "ritonavir" and "government" identifies 370 patents.

An August 11, 2010 search of ClinicalTrials.Gov identifies 130 trials that were funded by the NIH or other U.S. federal agencies. 181 trials were identified as funded by a university or other non-profit entity. 289 trials were identified as having received funding from industry. These results include 77 cases where trials were jointly funded. The total number of trials identified was 523.

Following the 400 percent price increase in the United States, in 2004, Essential Inventions asked the NIH to grant an open license for use of ritonavir in the United States, in a case concerning the March-In rights of the Bayh-Dole Act. The NIH rejected this request in August 2004.

6. Notes

[1] currency conversions done at http://www.xe.com/ucc
[2] http://www.drugstore.com/pharmacy/drugindex/rxsearch.asp?search=norvir
[3] http://www.medicinpriser.dk/Default.aspx?id=15&vnr=036290
[4] http://www.felleskatalogen.no/
[5] http://cedd.oep.hu/
[6] http://www.fass.se/LIF/produktfakta/artikel_produkt.jsp?NplID=1996082600...
[7] http://farmaco.agenziafarmaco.it/index.php
[8] http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000022389700
[9] https://www.healthinfo.moh.gov.on.ca/formulary/SearchServlet
[10] http://www.pbs.gov.au/html/home
[11] http://www.medicijnkosten.nl/
[12] See http://www.pbm.va.gov/DrugPharmaceuticalPrices.aspx, which provides the following explanation:

The FSS (Federal Supply Schedule) is a multiple award, multi-year federal contract that is available for use by any Federal Government agency. It satisfies all Federal contract laws and regulations. Pricing is negotiated based on how vendors do business with their commercial customers.

The FSS program also provides additional opportunities for savings to the customers with negotiated quantity and tier discounts.

For those products covered under Public Law 102-585, Veterans Health Care Act of 1992, pricing is either negotiated based on vendor’s most favored commercial customer pricing or statutorily-required pricing calculations. Vendors have an opportunity to establish FSS Big 4 prices and FSS dual prices. Big 4 prices are only available to VA, Department of Defense, Public Health Service (Indian Health Service), and U.S. Coast Guard customers and are based on pricing calculations outlined under the Public Law. Dual prices are negotiated for Other Government Agencies (OGAs) that comprise the remaining authorized users of the FSS program. Dual prices are based on most favored commercial customer pricing negotiations held with the vendors.

[13] http://www.pharmac.govt.nz/Schedule?q=norvir
[14] Untangling the Web of Antiretroviral Price Reductions: 13th (July 2010) and 12th editions (January 2010); http://www.msfaccess.org/resources/key-publications/

Response by Abbott

Abbott was given an opportunity to review and comment on this research note. On September 3, 2010, Abbott indicated it would not provide a comment on the report, via an email from Elizabeth Hoff, Senior Manager of Pharmaceutical and Public Affairs for Abbott.