On Friday, President Donald Trump proposed a “blueprint” of widespread changes designed to reduce prescription drug costs, drawing a lot of attention from oncology groups and patient advocates across the nation. The proposal, a 44-page plan titled, <em>American Patients First,</em> promises to make generic drugs and biosimilars more accessible. Incentives keeping drug prices high will also be removed.
On Friday, President Donald Trump proposed a “blueprint” of widespread changes designed to reduce prescription drug costs, drawing a lot of attention from oncology groups and patient advocates across the nation. The proposal, a 44-page plan titled,American Patients First,promises to make generic drugs and biosimilars more accessible. Incentives keeping drug prices high will also be removed.
Trump's proposal includes an FDA evaluation to consider whether drug manufacturers should share prices in their advertising moving forward. Long-term efforts will also focus on balancing what consumers pay for drugs developed in the United States versus what foreign consumers pay in their own countries. Drug prices are often substantially lower outside of the United States.
Activating programs that allow CMS to stimulate drug price negotiation among Medicare Part D plan sponsors has been included in this proposal, as well as efforts to improve the value of drug purchasing programs.
“We will have tougher negotiation, more competition, and much lower prices at the pharmacy counter,” Trump said in his speech.
According to Alex Azar II, the United States Health and Human Services Secretary, the proposal includes 50 different actions. This plan is based on 4 crucial strategies including increasing competition, encouraging drug cost negotiation, creating incentives to reduce list prices, and decreasing costs from patients.
Azar said that efforts are also being made to increase the availability and awareness of biosimilars, according to Azar, because they are similar, yet cheaper than their brand-name counterparts. Biosimilars are defined as biological products that are interchangeable with FDA-licensed biological products.
“We need a vital and vibrant generic industry and generic drug market,” he said. “We need to foster and nurture a new, competitive biosimilar drug market."
Only a small number of biosimilars are currently approved by the FDA for cancer treatment. ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin) from manufacturers Amgen and Allergan, became the first biosimilar approved by the FDA for treatment of patients with cancer in September 2017, specifically approved for treatment of adult patients with colorectal, lung, brain, kidney, and cervical cancers. Soon after, MYL-1401O (Ogivri; trastuzumab-dkst), a trastuzumab (Herceptin) biosimilar developed by Mylan Pharmaceuticals, was approved for metastatic breast cancer and metastatic gastric cancer by the FDA as well in December 2017.
Trump's proposal is designed to halt anticompetitive practices by drugmakers. Azar, a former Eli Lilly executive, said that drugmakers could be punished for blocking the development of generics and biosimilars.
“We also have to get after pharma companies that engage in anticompetitive practices and try to block the entry of generics or biosimilar products to market,” Azar said.
The plan aims to remove "gag" rules placed on pharmacists that stop them from advising patients on drugs that could cost less if the patient pays out of pocket instead of going through their insurance.
Trump vowed to stop the “abuse” leading to higher drug prices and attacked pharmaceutical companies, payers, and pharmacy benefit managers. He said that “the middle man” has become rich on the backs of patients.
The FDA followed Trump’s speech with their own statement, declaring that they will improve the overall generic drug review process and reduce cycles of review required for generic drugs. The FDA is already in the midst of streamlining the submission process for generic drug applicants and hopes to prioritize the review of certain generics.
A proposal allowing Medicare to directly negotiate drug prices was not included in the blueprint, however, which was a promise Trump had campaigned on in 2016. Instead, the administration plans to move high-cost drugs into the Medicare Part D program. Plan sponsors will also gain more power to negotiate with the manufacturers of the drugs.
The administration is also considering rules that would institute site neutrality. This has the potential to reduce facility fees charged for drugs used at hospitals and hospital-owned clinics. Additionally, site neutrality rules can eliminate differences in inpatient and outpatient Medicare payment policies.
According to an ASCO spokesperson, the organization is reviewing the administration’s plan and has declined to make a statement. The American Cancer Society also stated that the group was reviewing the plan and could not comment on specifics at this time.
Chris Hansen, President of the American Cancer Society Action Network (ACS CAN), said in a statement saying that prescription drug prices are only 1 cost factor in a complex healthcare system.
“Keeping health care affordable for cancer patients and other Americans requires a comprehensive examination of all cost drivers,” Hansen said. “ACS CAN will continue its advocacy efforts to ensure patients have access to quality, affordable health care coverage for all their needs, including prescription drugs.”
The Community Oncology Alliance (COA) disclosed that it “strongly supports” these efforts in reducing drug prices. However, COA criticized the administration for leaving a 2% sequester cut to Medicare reimbursement for cancer drugs in 2013.
“Today, President Trump has proposed several important initiatives to lower drug prices that align perfectly with COA’s ongoing work to advance meaningful, patient-centered solutions aimed at making cancer care less costly and more effective,” Ted Okon, the executive director of COA, said in a statement. “However, it is really disturbing that the blueprint released today does not address the Medicare sequester cut to drug payments that is fueling higher costs and cancer drug prices. All the sequester cut to Medicare drug payments for cancer drugs has produced is less access to cancer treatment, higher costs for patients and Medicare, and increased drug prices. It has to be stopped now.”
The FDA has adopted these policies “to reduce gaming of statutory and regulatory requirements to help ensure that drug companies don’t use anticompetitive strategies to delay development and approval of important generic drugs.”