President Donald Trump signed an executive order on the costs of prescribed medications on Tuesday, which includes a potential change in the Medicare medication price negotiation program that will probably make some pharmaceutical companies happy.
The negotiation program was introduced by the Biden administration through the inflation reduction law. It allows the Federal Government to negotiate the prices of some of the most expensive medicines in the D of Medicare directly with the pharmaceutical companies. The first 10 medications selected for negotiation were announced in August 2023, and negotiated prices will enter into force in 2026. 15 additional medications were added in January in the last days of the Biden Administration, and these negotiated prices will enter into force in 2027.
Currently, medications can only be selected for negotiation if they are brand medications to carry or biological products without generic or biosimilar equivalents. Small molecule medications must be seven years old to their FDA approach or on the license date, while biologicals must be 11 years old for this date, according to KFF. Small molecule medications generally come in the form of pills or tablets and are generally cheaper and easier to manufacture than biological products.
However, the Trump Administration is directing Robert F. Kennedy Jr., the Secretary of the Department of Health and Human Services of the United States, to work with Congress to modify the program to “align the treatment of medications prescribed with small molecules with products with products”, biological products “, biological products,” biological products “” biological products “”
In other words, the executive order could give to small molecule a four -year extra extra before they are eligible to be selected for the negotiation program. Therefore, both small molecule medications and biological products would be eligible for selection after 11 years in the market.
Pharmaceutical companies have referred to the shortest time frame of small molecules drugs for selection as a “penalty of pills”, arguing that it could reduce incentives to invest in their development. So extending the timeline would be a victory for pharmaceutical companies. In fact, a PHRMA spokesman, a commercial group of pharmaceutical companies, applauded the executive order.
“We are encouraged to grow support to fix the [Inflation Reduction Act’s] The pill fine that has already led to a 70% reduction in investment in small molecule medications that are more convenient and affordable for patients, “said Alex Schriver, senior vice president of public affairs in PHRMA, in an email.
However, the movement could be a blow to patients.
“Changing the law to further delay the selection of small molecules medications for Medicare pricing negotiation would be a cost for Medicare and the beneficiaries when giving the pharmaceutical companies 4 additional years to establish their own prices, the priority that is obtained eligible that it is obtained eligible to be eligible that it is eligible. -The geegsalge gee be eligible to obtain eligible that the gym is obtained by obtaining gimidity obtaining the gym that is won on Wednesday.
What this means for drugs already selected for negotiation is not yet clear, but it does not seem likely that the government changes the drugs already chosen, according to Juliette Cubanski, deputy director of the Medicare program. The current list of medications was selected based on specific criteria in existing law and regulations, so medications should be final.
However, if this provision had a leg when current drugs had bone chosen for negotiation, then more than half of the drugs would not have eligible bone, according to KFF. This includes five of the 10 drugs selected for the first round of negotiations and eight of the 15 drugs selected for the second round of negotiations. The examples are eliquis in advance, the medication to lose weight Ozempic and Ibrance of breast cancer drugs.
Patients for affordable medications, a patient’s defense organization, qualified the arrangement in the “deeply harmful” negotiation program.
“Delaying Medicare negotiation for small molecules medications, the most used medications, is a clear raffle to Big Pharma. I would deliver to the pharmaceutical companies four additional years to patients at the price of price price, one of whom cannot pay their medications prescribed today,” said Merith Basey, executive director of the organization, in a statement. “This change is not about supporting innovation as the industry states, it is about protecting exorbitant profits.”
Basey noticed that patients will be encouraged by other steps tasks in this executive order, including efforts to increase competition by generic and biosimilar, reduce insulin costs and improve the responsibility of pharmacy benefits administrators. With the last provision, the Administration aims to improve the dissemination of rates that pbms pay runners for directing employers to their services.
The National Community Pharmaceutical Association, a defense organization for community pharmacists, said it is optimistic about administration’s efforts to take energetic measures against PBM.
“President Trump has spoken several times about the need to control them, and we are pleased to be looking to do it,” the organization said in a statement. “Independent community pharmacies compete against a deck that is stacked against them by PBMs that wish to trample their competence through anti -competitive tactics such as paying the pharmacy below its cost in time audits. Costs and reducing access to consumers.”
That said, the “demon will be in details and implementation,” NCPA said.
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