Abbott raises price of ritonavir in the US by over 400%
Simon Collins, HIV i-Base
On 3 December 2003, Abbott Pharmaceuticals increased the US price of ritonavir by over 400%. This prompted an immediate response from both community and medical organisations that included withdrawing co-operation with Abbott projects and returning previous funding grants.
The increase is seen as an attempt to regain a higher percentage of the limited budget available for HIV drugs in the US and may be one of the largest price increases announced for any medication in recent years. A spokesperson for Abbott could not say whether the company had recently increased the price of any of its other drugs so substantially in the last few years.
Ritonavir now is widely used as a pharmacokinetic booster for other protease inhibitors. It helps produce more stable, constant and sustained drug levels and reduces inter-patient variability. Protease inhibitors boosted by ritonavir include lopinavir, indinavir, saquinavir, fosamprenavir and atazanavir and the pipeline compounds tipranavir and TMC-114. Although lopinavir is co-formulated with ritonavir in Abbott’s protease inhibitor the price oeÀÎaletra has not been increased.
These combinations are particularly important for treatment-experienced and salvage patients with few or no treatment options left. Although in the US a company can set its own price for a drug, legal advice is being sought on how the increase, which gives Kaletra an immediate cost advantage over other boosted protease combinations, can be challenged.
One community editorial said: ‘What Abbott has done is unforgivable and will go into the history of the AIDS epidemic as a repugnant commercial manipulation that unnecessarily burdens people living with HIV/AIDS, especially those with fewer treatment options who can truly benefit from boosted protease-inhibitor therapy. Physicians, researchers, government officials, and patients should be outraged by these events and should take heed of such gross opportunism tainting the very nature and purpose of healthcare“.
In a letter to Abbott, the AIDS Treatment Activist Coalition stated: “Instead of being grateful that Norvir still has therapeutic application and will enjoy continued sales, Abbott has apparently made an ultimatum that therapeutic options for salvage patients or even those who just need more potent therapy (arguably any patient with HIV) will cost, and cost dearly.”
The letter continues: “Abbott has just changed the landscape of HIV/AIDS for the worse – is this what it wants to be known for? ATAC urges Abbott to reconsider its recent actions and to rejoin the battle against HIV/AIDS by advancing research and therapeutics until this scourge against humanity is conquered. Further, we challenge you to roll back the price of Norvir. Abbott has obviously regained its development costs many times over with this drug, which received full approval on the basis of a minimal development package and without an Expanded Access Program.”
Also highlighted is the potential impact for next generation drugs that are being developed as boosted agents. Many patients have been hoping that tipranavir, a drug with activity against many protease-resistant viruses that is currently in Phase 3 studies, would become an important component of their treatment. The increased costs for the boosting component of these pipeline regimens (tipranavir, capravirine, TMC114) could jeopardize both clinical development and access post-approval.
In a comment to the Wall Street Journal, Abbott says that the sharp price increase is a long-overdue adjustment after years of being priced below other protease inhibitors, and that it invested a substantial amount in reformulating the drug. Abbott is developing another formulation of ritonavir that will not require refrigeration.
The website of AIDS Treatment Activists Coalition (ATAC) provides further details of the community response, including HIV Medical Association and ATAC press releases:
There appears to be no justification whatsover for this price hike. It looks like a cynical and cruel manipulation of the marketplace to give Kaletra a cost benefit over any other PK enhanced PI.
Pharmaceutical companies are able to set their own prices for drugs in the US but it is not possible to comment on claims for research and development costs as independently audited breakdowns for these costs are never publicly available.
It certainly seems like Abbott wants to block the coadministration of once-daily saquinavir/r (see below) by this move to protect Kaletra, and this would explain the unchanged price for Kaletra. This seems logical because the US are their home market and boosting PIs is today a much wider used strategy in Europe compared to the US. A secondary effect may be to additionally boost its revenues by increasing the price of RTV 100 mg BID to a range usually matched by PIs dosed as true antivirals. Finally, it is a clear signal that the Meltrex formulation will be far more expensive compared to ritonavir at current European prices.
Abbott say that there are no plans to change the price for ritonavir in the UK which will be held stable in Europe until a new formulation of ritonavir is developed. They could not comment on the expected price for the non-refridgerated Meltrex formulation which may be available by 2005. If it is priced close to the new US price, this would be likely to increase the cost of tipranavir-boosted combinations to more than T-20.