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Controversies in Using Lapatinib at Reduced Dosage With Food

Azienda Ospedaliera-Universitaria Careggi, Firenze, Italy

To the Editor:

Ratain and Cohen¹ advocate the daily use of two 250-mg tablets of lapatinib with food (as opposed to the standard dosage of five 250-mg tablets under fasting conditions) because the savings resulting from the reduced-dosage strategy are substantial. They also observe that a 500-mg formulation for once-daily dosing with food could hopefully be registered by GlaxoSmithKline (GSK) in the upcoming months.

Unfortunately, the authors do not point out that, according to the regulation of most countries, giving lapatinib at reduced dosages with food is an off-label treatment, and this has negative medicolegal implications.

Another point of controversy is that, on the basis of the so-called value-for-money approach for drug pricing,^2-5 spending US $2,900 per month in lapatinib (or about US $100 per day) does not purchase the 1,250 daily milligrams of the drug, but purchases the progression-free months gained by the patients as a result of the drug's efficacy. Hence, if GSK decides to register the once-daily 500-mg formulation to be dosed with food (and shows that this new formulation is equally effective and/or biologically equivalent), the value-for-money unit price that GSK could legitimately claim is around US $100; in this framework, there would be no saving at all for the health care systems or third payers.

On the other hand, if the purpose of the manufacturer is to sell at a lower price the survival gain produced by lapatinib, halving the price of the current TYKERB formulation (GSK, Research Triangle Park, NC) could be a much simpler solution.

AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

REFERENCES

1. Ratain MJ, Cohen EE: The value meal: How to save $1,700 per month or more on lapatinib. J Clin Oncol 25:3397-3398, 2007[Free Full Text]

2. Pearson SD, Rawlins MD: Quality, innovation, and value for money: NICE and the British National Health Service. JAMA 294:2618-2622, 2005[Abstract/Free Full Text]

3. Minhas R, Moon JC: The Office of Fair Trading report: A prescription for value-based drug pricing. J R Soc Med 100:216-218, 2007[Free Full Text]

4. Henry DA, Hill SR, Harris A: Drug prices and value for money: The Australian Pharmaceutical Benefits Scheme. JAMA 294:2630-2632, 2005[Free Full Text]

5. International Trade Administration: Pharmaceutical price controls in OECD countries: Implications for US consumers, pricing, research and development, and innovation. US Department of Commerce, Washington, DC, 2004, pp 1-111

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