Reducing the high cost of prescription drugs continues to be a priority focus for both the U.S. Congress and Trump administration, and ONS is closely monitoring and providing input on how key proposals could affect patient access to oncology care.
Drug Reform’s Current Environment
The Senate Finance Committee began holding a series of hearings early in the 116th Congress to address increasing drug costs and the adverse impact on patients. Committee Chair Chuck Grassley (R-IA) called for more pricing transparency during a January 2019 hearing and shared his belief that manufacturers need to disclose prices in advertisements.
The House Committee on Oversight and Government Reform initiated similar hearings, and Chair Elijah Cummings (D-MD) referred to drug pricing reform as a strong bipartisan issue on which Congress must act. During a House Ways and Means Committee hearing, committee members highlighted stories from constituents unable to afford their medications. Although several members expressed desire to work in a bipartisan manner, Republicans made it clear they oppose government price controls that could potentially harm drug innovation. Some policy changes that received bipartisan support included incenting use and developing lower-cost generic drugs, reforming drug patent evergreening to allow earlier competition, and replacing the current Medicare Part B provider reimbursement formula.
Patients often confide in nurses about inability to pay for cancer drugs, and nurses want to make sure patients adhere to medication treatment regimens to minimize side effects and optimize their health outcomes. For these reasons, ONS closely monitors drug reform issues and advocates for greater access and affordability for patients with cancer.
Drug Rebate Proposals
Although the pharmaceutical industry strongly opposes many recent U.S. Department of Health and Human Services (HHS) drug reform proposals, it supports the HHS Office of the Inspector General’s proposal to reform the drug rebate process and pass on more drug discounts directly to patients. The impact on beneficiaries and federal spending is difficult to predict accurately, but HHS said that “total beneficiary cost sharing would decrease and premiums would increase, the decrease in total beneficiary cost-sharing would offset the total increase in premiums across all beneficiaries, and out-of-pocket impacts are likely to vary by individual and the greatest benefit of these transfers accrues to sicker beneficiaries (e.g., those with more drug spending and/or those using high-cost drugs).”
Currently, the antikickback statute broadly prohibits the exchange of remuneration for business reimbursable under any federal healthcare program. However, given the law’s broad reach, certain discounts have safe harbors, including rebates manufacturers pay to pharmacy benefit managers (PBMs).
The drug rebate proposal would eliminate the antikickback safe harbor for pharmaceutical rebates paid to insurers and PBMs and create two new safe harbors instead: one for discounts given at the point of sale and another for the fees manufacturers pay to PBMs. Banning the rebates would remove the incentive for providers to select drugs with higher list prices rather than lower-cost brand or generic drugs or biosimilars. Patients pay higher cost-sharing amounts for higher-rebated drugs compared to less costly alternatives.
Pharma Industry Opposition
Also proposed is an International Price Index model, which would base reimbursement for Medicare Part B drugs on a formula tied to drug prices in 14 foreign countries. Although HHS Secretary Alex Azar argued that the model will “secure for the American people a share of the price concessions that drug makers voluntarily give to other countries” (HHS, 2018), pharmaceutical companies strongly oppose it as government interference that would stymy drug innovation. ONS is monitoring the proposal to ensure investment in lifesaving cancer drug development.
The pharmaceutical industry also strongly opposes CMS’s proposal to allow health plans to increase utilization management, including use of step therapy (that requires a patient to try and fail first on a less expensive drug before accessing the brand-name drug) for products in Medicare Part D’s six protected classes: antineoplastics, as well as antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and immunosuppressants. Except in limited circumstances, Part D plans are currently required to include all drugs in those categories on formulary.
If the proposal is approved, nurses who handle prior authorization paperwork could potentially see increased workload and reduced access for patients. In response, ONS cosigned a January 2019 letter from the American Cancer Society Cancer Action Network that urged Azar to proceed cautiously with changes to the protected classes that could “harm beneficiary access to medically appropriate therapies” or harm patients with comorbidities.
As part of its legislative agenda, ONS represents the interests of patients with cancer and advocates where necessary for more guardrails and patient protections to ensure access and affordability.