It’s not unusual for medical and patient advocacy groups to make their opposition known to government proposals they fear will hurt doctors and patients. But in the case of the Trump administration’s latest proposal aimed at tackling high prescription drug costs, they are taking their case directly to the public.
A coalition that includes the American Medical Association, American Society of Clinical Oncology (ASCO) and American Society of Consultant Pharmacists has launched a major ad campaign urging the public to speak out in opposition to proposed changes to Medicare Part D’s six “protected classes” of drugs.
The ad is slated to run in major national newspapers starting today with a bold headline that says in capital letters: “When you limit drug therapies, you threaten lives.”
The ad is being led and paid for by the American Cancer Society Cancer Action Network, the group’s advocacy arm. Some 57 organizations, from the American Heart Association to the National Alliance on Mental Illness, signed on in support.
ASCO joined the ad campaign out of its concerns that the proposed rule would reduce the number of prescription drugs available to Medicare Part D beneficiaries with chronic, potentially life-threatening illnesses, including cancer, said CEO Clifford A. Hudis, M.D., in a statement to Fierce Healthcare.
“While ASCO supports efforts to control drug prices, the fact that nearly 60 patient and provider groups are working together publicly to halt this proposal, strengthens the important message that for seriously ill patients, including people with cancer, optimal care requires patient access to the most medically appropriate treatment, at the most opportune time, based on the highest quality evidence,” Hudis said.
The ad says the proposal could “interfere with what doctors think is the best course of treatment for their patients and if finalized, could delay patients’ access to lifesaving innovative therapies. It’s wrong and it will put patients’ lives at risk,” it states.
The ad asks people to tell HHS Secretary Alex Azar and members of Congress to protect patients’ lives and stop the changes included in a proposed rule (PDF) published in November that would allow Medicare Part D plans to negotiate better prices in “protected classes.” Comments on the proposal are due next Friday, Jan. 25.
In the ad, the medical and patient groups said the change could delay access to medicines for patients in six protected classes: those living with cancer, organ transplants, epilepsy, HIV/AIDS or mental illness.
In announcing the plan, CMS Administrator Seema Verma said the proposals would create certain exceptions to current constraints on protected drugs, allowing Part D sponsors broader use of prior authorization and step therapy—a flashpoint between insurers and providers. It would also allow plans to exclude from their formularies protected class drugs that have price increases that are greater than the rate of inflation or certain drug formulations that are not a significant innovation over the original product.
Hudis said ASCO is particularly concerned about the provisions that allow use of step therapy and other potentially restrictive utilization management strategies. “Such policies may unnecessarily impede patient access to needed cancer care and lead to irreversible disease progression and other significant health risks,” he said.
“Every patient is different. A drug therapy that works for one may not work for another,” the coalition ad said, saying the policy has been in place for more than a decade for Medicare beneficiaries, giving them access to cutting-edge, FDA-approved therapies. “Our patients know this policy works and it saves lives.”
Among the drugs that could get more restricted are antirejection drugs for patients who have received transplants, antiretrovirals for patients with HIV and anticonvulsants for patients with epilepsy.
But Verma said the "protected class" of drugs under Medicare Part D has grown 63% since the policy was first created. Because those drugs have to be covered, it thwarts competition from suitable and cheaper alternatives. "As a result, beneficiaries taking these drugs have not seen these discounts that beneficiaries taking other drugs experience. This is not fair," Verma said.
Hudis argued that the proposal is not the answer. “We look forward to continuing our work with the administration, Congress, and our fellow advocacy groups on solutions to high prescription drug costs that will not compromise access to high-quality care for Americans with cancer,” he said.