(Editor's note: Comments from the American Medical Association were added to the original story.)
Physician and patient advocacy groups are not happy with the latest effort by the Trump administration to lower drug costs, saying it takes decisions out of doctors’ hands and will limit patients' treatment options.
The administration’s change to the way Part D plans construct drug formularies, offering more flexibility for sponsors to add or exclude drugs based on a particular indication, will take decisions out of the hands of doctors and put insurance companies in control of patient treatment plans, said the American College of Rheumatology (ACR) in a statement.
Ted Okon, executive director of the Community Oncology Alliance (COA), urged the administration to put the brakes on its efforts to lower drug costs and consider the consequences, which he said will be a “nightmare” for older cancer patients.
“COA is extremely concerned by the administration’s frantic push to do anything to bring down drug prices, which need to come down—especially in cancer treatment,” Okon said, in an email to Fierce Healthcare. “However, the recent moves to empower corporate middlemen with step therapy, and now formulary control, will be a nightmare for senior cancer patients.”
The Arthritis Foundation, a patient advocacy group, also issued a statement (PDF) calling the policy a step backward in ensuring patients with chronic diseases such as arthritis have access to innovative therapies.
The American Medical Association, the country's largest doctors' group, also opposed the change. “Rather than benefiting patients, the CMS proposal actually introduces unfair complexity to Medicare patients and further cements the role that insurance companies play in deciding treatment plans. This is not a recipe for good health," said Barbara L. McAneny, M.D., president of the AMA, in an email.
The Centers for Medicare & Medicaid Services (CMS) announced Wednesday it will allow “indication-based formulary design” among Part D plans as a tool to lower drug costs, a change that will take place Jan. 1, 2020. Officials said the change adds a significant negotiating tool for Part D plan sponsors to lower the cost of drugs.
RELATED: CMS allows Medicare Advantage plans to negotiate Part B drug prices, implement step therapy
ACR, a global medical society that represents rheumatology physicians and other health professionals, reacted quickly. “These changes are a departure from current policy, which requires plans to cover each on-formulary drug for all indications that are approved by the FDA. It takes clinical decision making out of the hands of providers and puts insurance companies in control of patient treatment plans," it said.
The group said the guidance will allow plan sponsors to implement indication-based formulary designs that allow them to select drugs for their formularies based on the disease indications they want to use.
Wednesday’s news comes on the heels of the announcement earlier this month that CMS will allow Medicare Advantage plans to negotiate Part B drug prices and implement “step therapy.” Step therapy is a form of prior authorization that requires patients to try a "preferred" drug—that is, a less-expensive biosimilar— before the plan will cover a different, more expensive one. CMS says this will reduce costs for plans and beneficiaries alike.
Okon said he worries the changes will be bad for cancer patients. “On the commercial side, oncologists and staff deal daily with PBMs [pharmacy benefit managers], insurers, and specialty pharmacy—increasingly part of the same corporation—in fighting through prior authorizations, step therapy and formularies that stop cancer patients from getting the right medication, in the right dosage, and on time,” he said.
ACR concurred it will have a negative impact on patients. “The proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy. Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together,” the group said, urging the Trump administration to scrap the plan or at least clarify the process for allowing exemptions for patients for whom a specific therapy is medically necessary.
“This process should be straightforward and not place an undue burden on the physician or patient in gaining access to needed medications,” the group said. ACR said it also concerned what the change would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.
The Arthritis Foundation urged the Trump administration to rescind the guidance.
“Over the last fifteen years, the Medicare prescription drug benefit has provided beneficiaries with chronic diseases like arthritis a pathway to access innovative therapies that were previously out of reach. Yesterday’s guidance from CMS to permit indication-based drug coverage in Medicare Part D represents a step backward from the program’s promise to these beneficiaries,” the group said.
Allowing plans to limit formulary coverage of a drug only for the specific indication for which it is most effective will further restrict the already narrow treatment options available to patients with inflammatory forms of arthritis, the group said.
CMS' change will create a more complicated scenario for both patients and doctors, said the AMA's McAneny. Patients, who may not be sophisticated in how formularies work, will face the challenge of navigating health plans to make sure their needed drug is on their selected formula. That can change based on their health conditions and patients with several chronic diseases are unlikely to find a formulary that covers all their needs, she said.