US activists 'applaud' darunavir (Prezista, TMC114) pricing

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Community treatment advocates from the United States have "applauded" Tibotec's pricing of its newly-approved next-generation protease inhibitor, darunavir (Prezista, formerly known as TMC114). The company announced last week that the drug will cost less than tipranavir (Aptivus) and is priced virtually the same as atazanavir (Reyataz), representing a major reversal in the pricing of new antiretrovirals in the US.

"This is the first time we can remember an HIV drug company pricing a new drug lower than the last FDA approved anti-HIV medication," said Rey Candelaria, Steering Committee Chair of the AIDS Treatment Activist Coalition (ATAC), one of the many patient advocate groups involved in discussions with Tibotec over pricing prior to last week's announcement as part of the Fair Pricing Coalition.

Martin Delaney of Project Inform, another member of the Coalition, added that "we are pleased that Tibotec Therapeutics has reversed a years-long trend toward ever higher prices by the pharmaceutical industry. The last three drugs approved for HIV each set new and dramatically higher pricing thresholds, making it more and more difficult for public and private payers to keep up with the demands for care. After lengthy discussions, Tibotec finally priced their drug within pennies of the cost of the least expensive of the other new drugs and far below the most expensive. It has finally reversed the juggernaut of higher pricing and acted as a responsible corporate citizen."

Glossary

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

trend

In everyday language, a general movement upwards or downwards (e.g. every year there are more HIV infections). When discussing statistics, a trend often describes an apparent difference between results that is not statistically significant. 

treatment-experienced

A person who has previously taken treatment for a condition. Treatment-experienced people may have taken several different regimens before and may have a strain of HIV that is resistant to multiple drug classes.

fusion inhibitor

Anti-HIV drug targeting the point where HIV locks on to an immune cell.

boosting agent

Booster drugs are used to ‘boost’ the effects of protease inhibitors and some other antiretrovirals. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective.

"This successful outcome proves that it is worth making our needs known to pharmaceutical companies," commented Lynda Dee, a member of the ATAC Drug Development Committee. "Had we not made the effort and gotten so many people involved and speaking out, I don't doubt we'd be seeing another jump in prices today. Instead, we're celebrating what we hope will be the end of an era of escalating prices."

However, she added that "ATAC would still prefer even lower drug prices, as the price point achieved here [$25.00 per day] is still far from inexpensive."

Tibotec's announcement – and the community's reaction – comes in stark contrast to three years ago, when Roche announced the US pricing of their fusion inhibitor, enfuvirtide (Fuzeon, T-20), which currently stands at around $61 per day, and which needs to be taken alongside a ritonavir (Norvir) boosted protease inhibitor regimen for optimum potency.

The spiralling cost of new drugs was compounded by Abbott's 400% price increase of ritonavir, also in 2003.

"Tibotec's decision to do the right thing is a good first step that must be copied by other drug companies," noted Dee. "Price escalation had to stop somewhere. We've drawn a line in the sand and there's no turning back."

Darunavir received accelerated approval for treatment-experienced patients from the US Food and Drug Administration (FDA) last week.