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From Patient Advocates to Pharma, Groups Weigh in on Trump Blueprint for Drug Costs

Mary Caffrey
Interest groups representing drug companies, patients, providers, and health plans all submitted comments to a Request for Information on the Trump administration blueprint for controlling drug prices and out-of-pocket costs. 
Giving patients relief at the pharmacy counter is essential, but it won’t be simple, based on responses from advocacy groups and stakeholders who weighed in after HHS asked for comments on President Donald Trump’s blueprint for reining in what consumers pay for prescription drugs.

Monday was the deadline to respond to the Request for Information (RFI) on American Patients First, which offered policy ideas for controlling drug prices and out-of-pocket (OOP) costs for patients.

An umbrella of 53 patient advocacy groups, led by the Patient Access Network (PAN) Foundation, called for smoothing out the seasonal bumps in OOP costs that result from benefit design, including the triggers for catastrophic coverage in Medicare. The groups’ letter highlighted the direct relationship between making drugs affordable and getting patients to stick with their regimens.

“When patients cannot afford their therapies, they cannot be adherent to their treatment plans, which can increase the total cost of care for these patients over time,” the letter states. “Such an outcome hurts patients, their families, and taxpayers—all who bear the burden of the higher cost of care.”

The patient advocacy groups said (1) OOP costs should not be a barrier to therapy, (2) information for patients could be better, and information should be “meaningful, easy to understand, and actionable,” and (3) patients should not bear too much responsibility for managing costs, and “shifting complicated decision-making onto beneficiaries cannot be a substitute for oversight.”

Policy changes should not occur “without evidence-based research,” the groups said.

Comments and recommendations included:
  • A call for a cap on OOP costs in the Medicare catastrophic phase, which would do the most good for patients who spend the most on drugs. The advocates identified patients whose income is not high but also not low enough to receive the Medicare Part D low-income subsidy. These patients “should not have to make impossible choices between purchasing the prescription drugs they need to get well and stay healthy or pay for everyday living expenses.”
  • The groups worry that pricing drugs by indication—or charging more for off-label use—would cause some patients to be “discriminated against through higher cost-sharing.”
  • Patients need access to a range of therapeutic options, including drugs in the Medicare Part D protected classes. Annual price ceilings in Part D would help patients budget for the year.
  • The group supported several policies to improve access to information, including improvements to the Medicare dashboard, ending pharmacy gag clauses, and putting lower-cost alternatives on the Explanation of Benefits sent to patients.
The groups said the idea to move some Medicare Part B drugs to Part D could have unintended consequences, including “significant OOP implications for patients,” because of different cost-sharing requirements between the 2 programs. The letter warned about changes that would leave providers unable to account for the chain of custody of therapies that need special storage or handling. No changes should occur without a model or pilot program to avoid harming patients, the letter said.

Advocates also called for allowing patients to keep using coupons, discount cards, and patient assistance programs without penalty, saying these programs are not responsible for driving up prices. Maintaining the “safety net” is critical for those with serious illnesses who do not qualify for government subsidies. They note that Medicare beneficiaries cannot use coupons from pharmaceutical companies.

Community oncologists. Other groups who submitted comments to the RFI included the Community Oncology Alliance (COA), which said its response reflects “longstanding commitment to oncology payment and system reform,” including data collection and sharing. COA called on the administration to address “the true drivers of healthcare spending,” and avoid steps that would unintentionally harm patients. Despite the administration’s call to rein in the power of pharmacy benefit managers (PBMs), COA fears some parts of the blueprint will strengthen their hand, including the shift of cancer drugs from Medicare Part B to Part D.

“We commend the Trump Administration for taking on the tremendous challenge of reducing drug costs in America. Continuously increasing drug prices and cancer care costs are unsustainable and unacceptable, and we must act together to do something about it. No one knows this better than the men and women of community oncology who are on the frontlines of America’s cancer care system,” said Jeff Vacirca, MD, FACP, president of COA and CEO of NY Cancer Specialists.

Health insurers. In a 35-page letter, America’s Health Insurance Plans (AHIP) said members “unequivocally support lower list prices for prescription drugs,” and that they will work with any drug manufacturer who wants to lower prices. Among blueprint elements that AHIP supports are calls to boost manufacturing of generics, promotion of biosimilars, and “enhancing benefit flexibility,” especially in Medicare Part D.

AHIP supports the administration’s call for increasing plans’ negotiating clout in Medicare Part D, particularly for drugs in protected classes and those that lack competitors. But the insurers also listed “areas of concern,” and rejected the presumption that health plans want drugs with high list prices to secure larger rebates. Lower list prices with smaller rebates are welcomed, their letter said, but rebates should not be removed entirely as a tool. The letter goes on to say that the attention to rebates distracts “from the fundamental threat of high drug prices.”

Particularly when a drug lacks a competitor, “The reality is deceivingly simple—drug companies set high prices and increase them because they can.”

AHIP also called on HHS to limit new levels of regulation, to not interfere with value-based contracting, and to not take steps that would result in higher premiums. But AHIP said there are places where “the system must make concrete steps toward creating a commonly accepted definition of value.” Specifically, the group called for empowering a third-party entity, such as the Institute for Clinical and Economic Review, to objectively define value, and HHS should protect all involved by requiring drug companies to share data with payers to ensure negotiations are fair.

Pharmaceutical companies. The Pharmaceutical Research and Manufacturers of America (PhRMA) said in a statement that its comments include a “bold new policy position,” which calls for severing the link between the level of compensation and the amount of the rebate. Instead, the drug makers say, compensation for PBMs and others in the supply chain should be “a fee based on the value of their services.”

“Delinking supply chain payments from the list price will be disruptive and requires our companies and others to adapt, but it is necessary to improve patient affordability,” said Stephen J. Ubl, president and chief executive officer of PhRMA. We hope realigning these incentives will result in a greater shift toward value and lower costs for patients.”

In an executive summary, PhRMA called for:
  • Empowering payers and making sure that patients directly benefit from rebates
  • Lowering OOP costs for seniors in Medicare Part D
  • Maintaining policies that payers must cover protected classes and offer 2 drugs per class
  • Continue treatment of coverage gap discounts when calculating true OOP costs
  • Reform the 340B program, including patient eligibility standards
  • Remove regulatory barriers to value-based contracts
PhRMA differed from the blueprint in some key areas, including a call to not move drugs from Medicare Part B to Part D and a rejection of the idea that drug list prices should be featured in advertising aimed at consumers. The drug industry also rejected a competitive acquisition program, except those that are voluntary. But drug makers supported the blueprint’s criticism of “global free riding,” in which price controls abroad drive up drug prices in the United States, where the FDA does not regulate drug prices. Trade policy tools that could aid this effort include regional and bilateral negotiations, and enforcement of existing trade agreements, including those with South Korea and Australia.

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