Abbott stands firm in ritonavir price increase

500% increase for patients taking 100 mg a day

Abbott Laboratories is not backing down from its decision to increase the price of ritonavir (Norvir) by 500% monthly for patients who take 100 mg a day. Ritonavir is used in almost all protease inhibitor combinations for treating HIV infection.

Ritonavir is unusual because it was approved as an HIV protease inhibitor but it is actually being used as an inhibitor of the cytochrome P450 system, says Daniel Kuritzkes, MD, director of AIDS research at Brigham and Women’s Hospital in Boston, and director of the Program in Retroviral Therapeutics at Harvard Medical School. Ritonavir is the most potent of the cytochrome P450 inhibitors, and it has now become a component of protease inhibitor-based regimens.

The HIV Medicine Association (HIVMA) in Alexandria, VA, had called on Abbott to rescind the price hike, which took effect Dec. 4. In the letter, Paul Volberding, MD, and Kuritzkes, who are chairman and vice chairman, respectively, of the HIVMA board of directors, tell Abbott that, "While we recognize the value of ritonavir, we are alarmed by your decision to raise the cost of protease inhibitor regimens to the point where many people who need these life-saving drug combinations will struggle to pay for them or won’t have access to them at all. In addition to our particular concern about the price increase for ritonavir, we are generally concerned about continuing upward pressure on prices as each new HIV drug is approved."

HIVMA outlines its case

The letter acknowledges the role Abbott played in developing the drug regimens, but asks the drug manufacturer to consider these harmful effects of the price hike:

  • The decision increases the average wholesale price of ritonavir to $8.55 for 100 mg, which equates to a monthly total of $260 for patients who take 100 mg daily as part of an ATV/RTV regimen. Previously, the monthly price was $45.
  • The higher cost will likely raise insurance premiums and increase the amount of ritonavir copayments to a level that most people with HIV/AIDS cannot afford.
  • The dramatic increase in price could cause payers to impose restrictions on available HIV/AIDS therapies.
  • AIDS Drug Assistance Programs (ADAPs) may have to pay more. The price increase will result in higher profits to the pharmacy and wholesaler, which will translate into higher costs to ADAPs, if the reimbursement rate used for pharmacies is indexed to the average wholesale price.
  • The price hike may create budget problems for ADAPs, since the lag time between payments to pharmacies and receipt of debates from the manufacturer can be as long as six months.

Abbott explains why

Even though Abbott has had a number of discussions with physicians around the country who are concerned about the impact of the price increase, according to Kuritzkes, the drug manufacturer didn’t budge.

In a Dec. 23 letter to HIVMA, Abbott says it did not make the price decision easily. The higher price was necessary to support Abbott’s ability to continue research to bring a next-generation HIV medication to market, to develop improved formulations of its existing products, and to continue its commitment to the developing world, wrote John Leonard, MD, vice president of global pharmaceutical development. He says Abbott currently is investing in new HIV and hepatitis C compounds as well as another new formulation of ritonavir and a new formulation of lopinavir/ ritonavir (Kaletra).

The new price also reflects ritonavir’s changing role and value, Leonard says in the letter. "In 1996, Norvir was prescribed as a stand-alone protease inhibitor at a recommended daily dose of 1,200 mg and a daily price of $20.52. Today, Norvir is primarily used at low doses of 100 mg to 200 mg in combination with other protease inhibitors, with 100 mg being the most common-ly prescribed daily dose. At the new price of $8.57 per 100 mg, Norvir is most often the low- est cost component of a protease inhibitor-based regimen."

Patient access assured

What impact the pricing change will have depends on what ADAPs and other payers do, Kuritzkes says. Abbott says it was taking steps to assure that patients overall were not adversely affected by the decision. First, the company expanded its Patient Assistance Program (PAP) for Norvir to "ensure that all patients without drug coverage can receive this drug for free from Abbott, regardless of their financial status."

Leonard says Abbott has met with ADAP directors and has issued a Memo of Commitment honoring the former price for all ADAPs through June 2005. In addition, the company has told state Medicaid programs that the cost of the drug for them would not change from the former price.

The top private insurance providers contacted by Abbott do not plan to increase copays or premiums based on the pricing action, Leonard says. "[Less] than 10% of privately insured patients pay a percentage of the prescription cost vs. a flat copay. It is expected that these patients are protected and will not pay more annually due to out of pocket maximums."