WASHINGTON — New rules proposed by the Obama administration to limit the array of antidepressants and other prescription drugs currently available to millions of seniors have set off an intense round of lobbying by patient advocates clamoring to preserve access and by pharmaceutical companies eager to preserve profits.
Under the proposed guidelines for Medicare prescription drug benefits, seniors who currently have access to about 57 antidepressants and anti-
psychotics could see their choices dwindle to 15, according to a pharmaceutical industry-backed group.
Federal officials have said the policy change would save $720 million over five years, between 2015 and 2019. By proposing the change, the Centers for Medicare & Medicaid Services said it also aims to rein in over-prescribing of some expensive drugs.
“This rule would severely limit the choice physicians have to work with their patients to figure out which medications work best for them,” said Andrew Sperling, chief lobbyist for the National Alliance on Mental Illness, a Washington-based mental health advocacy organization that is heavily funded by pharmaceutical companies. “It troubles me that CMS would move forward with something like this without any scientific basis, just to save a dime.”
The changes, made in accordance with the Affordable Care Act, underscore the numerous decisions still to be made that will have profound effects on drug companies and the public as Obama’s health insurance law plays out.
Medicare granted special protection to six classes of drugs, including antidepressants and antipsychotics, starting in 2006, guaranteeing that they be covered. The idea was to make sure that low-income, medically fragile individuals had access to those drugs through Medicare.
Now that preferential treatment is likely to change beginning in 2015. Pharmaceutical companies with antidepressants and antipsychotics still under patent, including Marlborough, Mass.-based Sunovion Pharmaceuticals, have the most to lose.
Sunovion manufactures Latuda, a drug used to treat schizophrenia and bipolar disorder that costs in the range of $5,000 a year. Another drug used to treat schizophrenia and bipolar disorder, a generic, costs about $1,800 a year. While the comparison highlights the dramatic cost savings available with generics, some psychiatrists caution that one antipsychotic cannot necessarily replace another because there is enormous variation in how patients respond to different drugs.
Sunovion would not divulge how much money it stands to lose, but said in a statement that the Medicare prescription drug benefit was established to ensure that the most vulnerable beneficiaries have access to the medications that work best for them.
“The proposed rule would eliminate existing patient protections and may make it more difficult for those with serious mental illness to achieve recovery by limiting choice and access to treatment,” said Tricia Moriarty, a Sunovion spokeswoman.
Medicare is rolling out its plan in two stages, with the limits on antipsychotics delayed until 2016.
The Centers for Medicare & Medicaid Services said the rules change could also curb what it says is an overprescription of antipsychotics driven by profits. Because nearly all “protected” drugs, no matter how expensive, must be covered under the current rules, the industry spends billions each year marketing directly to doctors and patients. If the proposed changes go into effect, manufacturers of branded drugs will be pressured to lower prices in order to be covered by a plan, the agency said.
The agency also believes the new rules would limit the misuse or abuse of drugs that are not medically necessary.
“We are concerned that requiring essentially open coverage of certain categories and classes of drugs presents both financial disadvantages and patient welfare concerns,” the agency wrote in its proposed rules published Jan. 10 in the Federal Register.
The agency pointed to several studies, including reports by the Department of Health and Human Services’ Office of the Inspector General as well as the National Bureau of Economic Research, that showed prescription insurance plans spend significantly more on drugs that have protected status than ones that do not.
Some psychiatrists and other medical researchers are also skeptical that most new drugs for mental illness work any better than the older, cheaper generics already on the market.
“There really is very little evidence that within each of these classes any one of these drugs is dramatically better than others,” said Dr. Jerry Avorn, a Harvard Medical School professor of pharmacoepidemiology and pharmacoeconomics at Brigham & Women’s Hospital. “The issues of switching from one psych med to another are not as terrifying as the drug industry claims.”
Many of the newer drugs are simply minor tweaks to drugs whose patents have expired, prompting pharmaceutical companies to come up with a slightly different product to maintain patent protection — and resulting profit, said Dr. Sandra Steingard, a psychiatry professor at the University of Vermont College of Medicine in Burlington.
“I’m in favor of there being a pretty high bar to get these branded drugs,” said Steingard, who almost exclusively prescribes generics.
In addition to antidepressants and antipsychotics, immunosuppressants used to prevent organ transplant rejection would also lose their protected status starting in 2015. Immunosuppressants are already dominated by generics, so drug manufacturers would feel less of an impact with that change. Drugs used to treat HIV/AIDS, cancer, and epilepsy would continue to be protected.
The new policy hews closer to practices in the commercial insurance market, where drug coverage varies greatly depending on the price consumers pay for their prescription benefits. Neither expanded Medicaid coverage under the Affordable Care Act nor any plan sold in the new health insurance marketplaces extends coverage to all drugs in any particular class.
Spurred by the federal health law, the Obama administration specified new criteria for identifying when drugs can fall under a protected class: if a patient will die, be hospitalized, or otherwise be disabled without access to the drug within seven days, and if the patient needs access to multiple drugs within a category to treat a particular disease.
Matthew Bennett, senior vice president at Pharmaceutical Research and Manufacturers of America, which lobbies for pharmaceutical and biotechnology companies in Washington, said in a statement that the proposed changes would “shake the foundation” of Medicare’s prescription drug benefits, and are a “damaging reversal of policy that is neither necessary nor warranted and jeopardizes the health of vulnerable patients.”
Consumer advocates also fear that the changes could result in seniors and other Medicare beneficiaries not receiving the specific drugs that they need.
Brenda Sulick, senior policy adviser at the National Committee to Preserve Social Security & Medicare, said seniors with severe mental illness may need to try different drugs before finding one that works best for their condition.
“The generic may not work for you,” Sulick said. “Without access to these drugs, it could lead to other medical issues that could end up costing more.”
Despite protests from patient advocates and the pharmaceutical industry, health economists say the changes make fiscal sense.
Jonathan Gruber, an MIT economics professor and director of the health care program at the National Bureau of Economic Research, said the decision comes down to weighing the benefits of allowing insurers to more competitively choose the lowest-cost drug options with making sure patients have the options that work for their individual cases.
“We have to start restraining our spending on health care. It’s the single most important long-run fiscal issue facing our nation,” Gruber said. “At the end of the day, the government cannot provide all things to all people.”
Representative Richard Neal, the dean of the Massachusetts all-Democrat delegation, said he has concerns about the proposal and its potential impact on the state because biotechnology companies pump billions of dollars into the Massachusetts economy each year.
“What are the immediate consequences to this critically important regional industry? These are some of the concerns I intend to raise with the administration at the earliest opportunity,” said Neal, who sits on the Ways and Means Committee, which has jurisdiction over Medicare.
Representative Tim Murphy, a Pennsylvania Republican and chairman of the House Energy and Commerce Oversight Subcommittee, met with Marilyn Tavenner, Centers for Medicare & Medicaid Services administrator, last week to discuss his concerns about the rule change.
Murphy, a clinical psychologist, has sponsored a mental health bill that would, in part, ensure that patients continue to have full access to all antidepressant and antipsychotic medication, and plans to seek cosponsors among Massachusetts Democrats.
The public will have until March 7 to submit comments to the Medicare agency; the rules are expected to be finalized by May.