December 14, 2007
DRUG PRICE DRAMA
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Full price? Discount? Who gets what when? |
Several dozen representatives from patient advocacy groups and pharmaceutical companies gathered at the Latino Commission on AIDS (LCOA) office last Friday for a healthy buffet lunch, "informal networking" and a presentation and discussion by Gary Puckrein, president and CEO of the National Minority Quality Forum (NMQF).
The presentation on "Investment & Innovation: Health Care Winners & Losers" was funded by Pfizer Inc. as part of a nationwide effort to unite different patient-advocacy groups in support of the launch of the newly formed Patient-Centered Quality Alliance (PCQA). The project is explicitly designed to add weight to efforts to limit drug price negotiations by federal and state governments. The main NMQF/PCQA argument: That government negotiation over drug prices hurts minorities.
The proposition is certainly debatable. Price-negotiation tools like Preferred Drug Lists (PDLs) have actually protected minorities and low-income Americans from the harmful health impact of high-profit/questionable-value Big Pharma drugs like Vioxx, which studies showed tripled or quadrupled the risk of heart attack and stroke among users, or Avandia, which is suspected of causing cardiovascular problems for people with diabetes. Medicaid PDLs often steered doctors towards proven, lower-cost alternatives where appropriate, thus sparing beneficiaries of the public health care programs (disproportionately people of color) from health problems suffered by those who could get coverage or pay for the higher-cost alternatives.
Even more problematic is the concern that NMQF and PCQA—which receive the majority of their funding from pharmaceutical companies—are merely a platform for pharmaceutical companies to maximize profits.
Although NMQF literature states its primary goal is "to assist health-care providers, professionals, administrators, researchers, policy makers, and community and faith-based organizations in delivering appropriate health care to minority communities" their presentation at LCOA was more specifically aimed at alerting the audience to the dangers of government "drug rationing," including generic substitution for brand-name drugs and cost-based formularies like Preferred Drug Lists or Preferred Drug Programs.
"We're going through the system as onesies and twosies, but we need to coalesce and not elect anyone with drug rationing," Puckrein told the group. According to Puckrein, in order to control costs the U.S. and state governments are imposing drug rationing measures and "one-size-fits-all-medicine"—where the government decides which drugs can be prescribed for Medicaid and Medicare —particularly hurting racial minorities, women and the elderly, who are often excluded from drug trial studies that help guide prescribing preferences. Puckrein said the wave of the future is personalized medications tailored to individuals, and that it is important that the government not "stand in the way of innovation."
One type of so-called "rationing " Puckrein and his group opposes are preferred drug lists (PDLs). Medicaid programs use PDLs to obtain cost discounts from drug companies; doctors and other providers don't need special approval to prescribe on-list drugs for their patients, but may need to seek approval for off-list drugs. The list of preferred drugs for particular conditions is usually developed in consultation with health experts, with a focus on health outcomes, proven effectiveness, safety, and value. States have implemented PDLs in wildly differing fashion, widening or narrowing consumer access to medication and obtaining varying levels of cost savings for state health care budgets.
New York spends more money on medications on Medicaid beneficiaries than any other state in the country, and prior to 2005 lacked "even the most basic controls that dozens of other states and private health insurers have used," according to New York Times. That year the State Legislature approved and Governor George Pataki signed legislation for New York's first-ever Preferred Drug Program. All medically-necessary drugs covered by Medicaid remain available under the PDP, though doctors have to receive approval from a toll-free phone number to prescribe non-preferred drugs. And New York included the strongest PDL consumer protections in the nation, with prescribing providers allowed the final say on all prescriptions: the state can't deny authority to prescribe a medication the doctor says the patient needs.
Because of these protections, Housing Works and other advocacy groups, including AARP, Statewide Senior Action, the Center for Medical Consumers and Citizen Action backed the plan as a reasonable effort at reducing New York's high drug expenses. The PDL was opposed by several leading AIDS groups, including LCOA and Gay Men's Health Crisis. GMHC's position paper on the topic in 2005 stated, "GMHC does not support the creation of a Preferred Drug Program (PDP) in Medicaid. Should one be established in New York State, GMHC asks that HIV Medicaid beneficiaries be exempt from the Medicaid PDP. ARV drug class exemption is an insufficient consumer protection for HIV positive Medicaid beneficiaries. According to HHS guidelines, drugs that are commonly considered interchangeable for most healthy individuals, such as cholesterol lowering drugs Lipitor and Zocor, have unique interactions with ARVs that can affect the potency of both the HIV and non-HIV drugs, and therefore impact the health of a person with HIV if paired incorrectly."
Currently, the only drug classes exempt from the PDL are for atypical anti-psychotics, anti-depressants, anti-rejection drugs used for the treatment of organ and tissue transplants and antiretrovirals for HIV/AIDS. There have been discussions in the legislature and among state health officials regarding the inclusion of antiretrovirals and other HIV/AIDS medications to the Preferred Drug Program, with the prospect of reinvestment of cost savings into HIV prevention and support services for people with HIV/AIDS.
Dennis deLeon, the (HIV-positive) president of LCOA, said the New York State PDL could compromise care. "I trust my doctor, because he has kept me healthy and I haven't had an AIDS diagnosis in a long time. And I don't want the government getting involved in this process."But others say that as long as there are safeguards for patient care, a preferred drug program for HIV/AIDS drugs could be an acceptable cost-saving initiative. "The doctor has the final say in New York, and that's what makes our PDL work right. If we can get folks the drugs they need and save money, I'd rather see the savings go towards AIDS care for poor people than into the pockets of pharmaceutical companies," said Michael Kink, Legislative Counsel for Housing Works.
While preferred drug lists may allow doctors the option of applying for different medications, Puckrein said, "the process can be tedious and a lot of doctors just give up." Puckrein also alerted the group about U.S. laws that allow generic drugs to include just 80 percent of the chemicals in brand-name drugs they replace. People living with HIV/AIDS, epilepsy, and other conditions could be hurt by the differences between generic and name-brand drugs, according to the NMQF presentation.
Friday's forum included a fair amount of doctor-bashing in the room, particularly from Dr. Hector Castro, the Medical Director of the Beth Israel Latino Health Institute. "Our med schools are in crisis because doctors aren't learning how to treat patients. They're learning how to problem-solve." But Castro said that despite these flaws, doctors need to be the ones prescribing medications—not pharmacists, HMOs or the government.