Health Coalition Wants Government Less Involved in Drug Decisions

As various groups urge changes to the regulation and coverage of medications in Medicare's Part D prescription drug benefit, an umbrella organization representing about 100 million Americans with chronic conditions and disabilities cautioned Congress to make access to all needed medications a priority.

The National Health Council (NHC), a collective of more than 50 patient advocacy groups, including the National Mental Health Association, told congressional staff at a September briefing that patients prefer that they and their physicians, rather than government regulators, be allowed to decide a drug's relative risk for them.

“The burden of living with chronic disease often far outweighs drug risks,” said Margaret Kirk, CEO of the Y-ME National Breast Cancer Organization.

The patient-advocacy push on this issue comes after several years of mounting criticism that the federal government provides insufficient safety monitoring of approved medications. In response, federal regulators have mandated black-box warnings for some drugs, including antidepressants, over concerns about potentially dangerous side effects, and some drugs were voluntarily pulled by their manufacturers due to such concerns.

Pressure to improve drug safety has led one pharmaceutical company, for example, to withhold an antiseizure drug from the market after research indicated it could result in blindness, according to Eric Hargis, president and CEO of the Epilepsy Foundation.

“The important thing is that we always look at it from a risk-benefit perspective,” Hargis said. “This was a drug for children with up to 100 seizures a day.”

An Institute of Medicine (IOM) report issued in late September also made recommendations to improve drug safety, including a requirement that the Food and Drug Administration (FDA) “reevaluate the safety and effectiveness of new prescription drugs within five years of approval” (see Original article: page 1).

Myrl Weinberg, president of NHC, told Psychiatric News that she applauded the IOM report for requesting more FDA resources and postmarket surveillance but cautioned that any improvements in safety required “an appropriate balance” with patient access.

Patient-Driven Care Is Key

An NHC report released at the congressional briefing noted that better patient access to health care information has allowed an increasing number of patients to work as a team with their physicians and other health care professionals in making treatment decisions. The report cautioned physicians that patient-driven health care is limited by patients' inclination to make inferences beyond the information provided to them, so clinicians “must actively participate in the patient's information processing and decision making.”

Better evidence-based information on medications is needed, said the NHC report, so patients can better prepare questions for their physicians about medications, and physicians can better explain risk-benefit information to their patients.

Among the steps Congress was urged to take to improve patient access to medications was removing the legislative exclusion from Medicare coverage of medications such as benzodiazepines and barbiturates prescribed for disorders such as epilepsy, Alzheimer's disease, depression, and bipolar disorder.

The coverage exclusion has fueled concern by psychiatrists and other physicians about the medication choices available to their patients under Part D formularies.

“Denied access to these drugs has resulted in breakthrough seizures and increased hospitalization,” said Hargis, of the Epilepsy Foundation.

The patient advocates also urged Congress to continue “all or substantially all” Part D policies protecting the availability of several classes of medicines, including anti-depressant and antipsychotic medications.

Concern About Dual Eligibles Expressed

Although the advocates said Medicare's prescription program has been a success overall, they found indications that drug access has worsened for so-called dual eligibles, those who qualify for both Medicare and Medicaid.

Few data have been collected on how Part D has served these patients, who often have low incomes and chronic health conditions. Advocates said they were concerned that many dual eligibles do not use their Part D benefits because of higher deductibles and copays than they had under Medicaid. Hargis and other advocates said that they have heard many individual cases of low-income beneficiaries stopping needed medications after relatively small fee increases.

The advocates urged changes to the program to ensure access to medications through gap coverage that includes both branded and generic choices, offering the “lowest tiering payments” for drugs that do not have a generic equivalent, and eliminating copayments for dual eligibles.

“We don't think Congress intended for people to have to make choices between food and their needed medications,” Hargis said.

Other steps that could improve patients' access to needed medications, the NHC report noted, are reauthorization of the Prescription Drug Fee User Act and increased funding for the FDA's drug-approval process to provide“ safe and effective medicines as quickly as possible for people living with chronic conditions.”

Congress also could help those with chronic illness through more funding and expanded FDA use of the Critical Path Initiative, which aims to foster innovation in the drug-approval process.

Further information on the NHC reports and recommendations is posted at<www.nhcouncil.org/newsroom/20060926_NR_congressional.pdf>.▪