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Abbott & New Kaletra Tablets Pricing
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Commentary by Jules Levin, NATAP
The FDA approved on Friday October 28th the new tablet formulation of Kaletra. The new tablets are replacing the Kaletra capsules and the new tablets have certain benefits for patients: (1) there's no food requirement, so you can eat or not eat when taking Kaletra,; (2) the new tablets do not have to be refrigerated; (3) the tablets have a reduced pill count: 4 per day. These improvements will be particularly welcome in developing countries as well as in the USA. The capsules did not provide these benefits. Abbott announced the tablets will be available in pharmacies across the country within a few weeks. They are planning for a full conversion from capsules to tablets to avoid the potential for confusion for patients & pharmacists between the two formulation by March 2006.
The New Kaletra Tablets Pricing Process: Give Abbott Credit
The prices for Kaletra and the other currently available HIV protease inhibitors is reported below. It has taken 7 years to develop and manufacture the new Kaletra tablets. Abbott is still in the process of developing the new tablet formulation for Norvir. Abbott increased the price by 7.9% for the new Kaletra tablets. The yearly price of Kaletra went from $7,183 to $7,749. Abbott has agreed to an ADAP price freeze for Kaletra tablets through the end of 2007. Take a look at the list of prices for HIV protease inhibitors at the end of this article & you'll see that relative to other protease inhibitors, Kaletra is reasonably priced. In fact it is less expensive than all protease inhibitors except nelfinavir.
Last year there was quite a lot of contention between Abbott and affected communities-activists & doctors - regarding the price increase Abbott took for Norvir. There was quite a bit of anger directed at Abbott by the communities because they were unhappy about the price increase. As a result Abbott became an outcast and disliked. Before taking the Norvir price increase, Abbott did not consult with the activist community, the patient community, or doctors. I think Abbott learned a few lessons. This time before the Kaletra tablets were approved, this Fall, Abbott met with the patient and activist communities to discuss the price for Kaletra tablets. As well, Abbott discussed the issue with medical providers. Apparently, there was consensus that 10% increase would be reasonable.
Relationships between drug companies and the activist and patient communities has at times been torture and very strained over pricing. The most difficult experience was the Norvir situation last year. It appears to me that this time around with Kaletra tablets Abbott has made attempts to work with the affected communities and improve relations. The development of Kaletra tablets has taken a number of years, the new Kaletra tablets provide clear benefits for patients, and development of the tablets has a certain cost involved. Kaletra still is priced significantly below other popular protease inhibitors. So, I give Abbott credit for the way they handled this situation.
Abbott has been anxious about their relations with doctors and patients due to the major battles and bad press Abbott received that occurred last year over the Norvir pricing. It's time to work with Abbott again just as we do with the other drug companies developing HIV drugs. You know there are only a handful of major pharma companies active in HIV. It appears that Abbott does want to stay in HIV and develop new drugs for both HIV and for hepatitis C, which is killing more people with HIV and AIDS is. We all realize that new drug development is laborious and costly. One of the incentives for drug development is the profit motive. Although HIV drug development is more scrutinized, nonetheless HIV drug development is still in part motivated by hopes for profit. And that is a 'good thing'. It's this incentive that keeps the development process going for new drugs for all diseases. However, we hope for a fair price process. In this instance, Abbott has kept within the boundaries of pricing fair play. We want Abbott and the other HIV and hepatitis C drug developers to make a fair profit and remain dedicated to developing more and better drugs.
PK Study of Tablets in Healthy Volunteers
At the Intl AIDS Conference in Rio held during the Summer 2005, Abbott reported the results from a PK study in healthy volunteers. Following a single dose of LPV/r 400/100, the tablet provides similar exposure lopinavir and ritonavir exposures to the soft-gelatin capsule (SGC) under moderate fat meal conditions. The tablet met bioequivalence criteria with respect to lopinavir (LPV) and ritonavir (RTV) relative to the SGC at a dose of 400/100 under the moderate-fat meal conditions. The tablet lacks significant food effect for LPV & RTV. The tablet provides similar exposure under fasting and non-fasting conditions. The tablet provides consistent exposure to LPV and RTV regardless of meal conditions and the tablet has reduced pharmacokinetic (PK) variability compared to the SGC under any meal condition. 138 healthy adults received the tablet formulation, and the vast majority of adverse events were mild. No subject discontinued due to a drug related adverse event.
They reported that in healthy volunteers the tablet formulation was safe and well tolerated and appeared to result in lower incidence of GI effects compared to the SGC in healthy subjects receiving single doses. They reported: "138 healthy adults received the tablet formulation. The vast majority of adverse events were mild in severity. The tablet formulation was safe and well tolerated. No subject discontinued due to a drug-related adverse event." The frequency of moderate or severe diarrhea after a single dose administration (400/100mg) was 0.3% for the tablet and 1.1% for the soft-gel capsules. They also reported-- any moderate or severe adverse event: 0.7% for the tablets and 1.1% for the capsules. They said multiple dose administration of the tablet was similarly safe and well tolerated. Additional studies in HIV+ individuals are expected so that we can more clearly understand the side effects, safety, and tolerability of the tablets.
Kaletra Price
Abbott increased the price of the new tablets by 7.9% over the price of the Kaletra capsules. Here is a review of pricing for currently approved HIV protease inhibitors:
(WAC Pricing)
Unboosted Reyataz:
$8691 per year
$23.81
Boosted Reyataz:
$11,822 (current norvir price).
$32.39
Old norvir price: $9,319
Kaletra tablets $7,749
7.9% Increase over Kaletra capsules
$19.68/day (with price increase)
Kaletra capsules $7,183.
Nelfinavir: $7,363
$20.18/day
Unboosted Lexiva: $12,830
Lexiva/rtv $12,673
$34.72/day
Tipranavir: $10,877 per year without Norvir; with rtv $12,670
Norvir is available for free from Abbott Patient Assistance Program.
$29.80/day
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