- The Department of Health & Human Services’ drug pricing blueprint presents numerous opportunities to lower drug prices, but the agency should be wary of changes that would restrict patient access to care, the American Cancer Society and American Academy of Family Physicians both said in separate comments on the proposed rules.
Specifically, HHS should not make any changes to the “six protected classes” of drugs. These drug formularies ensure patients can access the very specific medications they need to manage a certain illness. Any changes to these formularies could hinder a patient’s ability to access that drug in the future, AAFP board chair John Meigs, MD, wrote in the organization’s comment letter.
“We recognize there may be noteworthy proposals under consideration that may result in lower costs but urge the administration to prioritize patient access to these essential drugs,” Meigs said.
The drug pricing blueprint, which was published in May 2018, also lacks certain measures needed to improve access to generic, and therefore less costly, drugs. While there are some positive steps supporting generic drug development, HHS needs to go further to protect this type of medication.
For example, HHS should create regulations that prevent a drug company from delaying manufacture of generics in exchange for settlement payments. The agency should likewise consider limiting practices where a drug company makes very minor variations in a drug to extend the drug’s patent. These practices could cap the expedient development and therefore access to a medication.
Furthermore, HHS should place greater emphasis on patient access to preventive services. Specifically, the agency should make preventive vaccines available to all patients regardless of ability to pay.
There are some high points in the blue print, however. Calls for improving drug price transparency could empower patients and providers to shop for the best value medication.
“Transparency policies do not directly lower drug costs but may provide more data that could help federal agencies and policymakers increase accountability and would allow physicians and patients to make more informed treatment choices,” Meigs explained. “The AAFP urges HHS to require pricing transparency, including for off-patent and generic drugs.”
Ultimately, AAFP’s priorities lay with patients and their ability to easily access affordable medications.
“The number and complexity of conditions, complaints and diseases seen in family medicine is far greater than those seen by any other physician specialty,” Meigs wrote. “Ensuring access to medications is an integral part of a physician's role as an advocate for their patients. Unfortunately, and too frequently, family physicians encounter patients who cannot afford their medications or adhere to treatment recommendations.”
ACS Cancer Access Network (ACS CAN) also issued a public comment on the HHS drug pricing blueprint, echoing many of the sentiments AAFP shared. For example, ACS CAN likewise cautioned against disrupting the six protected classes.
The current formulary setup helps preserve patient access to cancer medications regardless of other factors.
“This policy is intended to ensure the most vulnerable Medicare enrollees, including cancer patients, are able to access the drugs required to treat their disease,” ACS CAN wrote in its own letter. “If these classes are changed or eliminated, Part D plans could exclude or restrict access to certain drugs as a means to reduce costs. Prescription drug indications vary widely and increasingly in cancer – with the development of precision medicine – drugs target specific mutations. Restricting formularies would leave out many unique drugs that have no alternative to treat distinct cancers.”
The group also opposed shifting some Medicare Part B drugs to Part D formularies, explaining that such a change could increase out-of-pocket patient costs. Currently, additional insurance programs such as Medigap will cover extra expenses for Part B drugs, but not for Part D drugs. Shifting a drug from Part B to Part D would get rid of that supplemental payment many cancer patients rely on to pay for their medications.
There are some positive parts of the drug pricing blueprint, ACS CAN said. For example, putting caps on Medicare Part D out-of-pocket patient costs will promote health equity among different age groups.
Younger cancer patients who are more likely to have employer-sponsored coverage largely already enjoy the benefits of spending caps. The Part D proposal will drive health equity for cancer patients over age 65 who have Medicaid and have previously not seen these spending caps.
“Other proposals that could help patients include allowing Medicare enrollees to use co-pay discount cards when generics or biosimilar drugs are unavailable, allowing pharmacists to tell patients when they could buy a drug for less without using their insurance, and eliminating cost sharing for generic drugs for certain low-income Medicare beneficiaries,” ACS CAN summarized.
ACS CAN has placed high priority on helping cancer patients access their medications. Treatment access is integral with a serious condition like cancer. Removing barriers will help patients get in contact with the specific drugs targeting at treating a certain kind of cancer.
“Drug therapies play an integral role in cancer treatment,” ACS CAN concluded. “Providing access to affordable prescription drug therapies to all Americans, including those on Medicare, will be key to improving cancer outcomes and decreasing death and suffering from this disease.”