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The Biden administration working for the people

Not one family member making money off the deal, like Jared and Ivanka.

“There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma’s pockets,” Biden said in a statement issued by the White House, reflecting his intention to use the issue as a feature of his campaign for reelection.

The Biden administration Tuesday identified 10 expensive prescription drugs that will be included in price negotiations with pharmaceutical manufacturers as the government seeks to ease the financial burden on older and disabled Americans, an unprecedented step in a long political war over the nation’s exorbitant drug costs.

Half of these first drugs chosen for price negotiations are medications used to prevent blood clots and treat diabetes and were taken by millions of people on Medicare in the past year, according to a list released by federal health officials who oversee Medicare, the vast public health insurance system. Others are used to treat heart trouble, autoimmune disease and cancer. Consumers will not see benefits swiftly, with the lower, negotiated prices due to become available in early 2026.

The top three of the 10 drugs on the widely anticipated list include Eliquis, a blood thinner; Jardiance, which treats diabetes and heart failure; and Xarelto, another blood thinner. They cost Medicare $16 billion, $7 billion and $6 billion respectively in the past year.

Medications could be targeted for price negotiation if they are available under Medicare drug benefits, lack certain competition to push down their prices and have been sold for at least several years to give drugmakers time to help recoup the expense of developing them.

Tuesday’s step toward reducing Medicare drug prices was a significant element in last year’s Inflation Reduction Act, a law that President Biden and his aides herald as a policy victory, even though the number of medications and the timing of the first price reductions — 2026 — are less ambitious than some Democrats had sought for many years. And the fate of the entire negotiation plan rests with the courts because six drug manufacturers, the Chamber of Commerce and the pharmaceutical industry’s main trade group have lodged separate lawsuits around the country trying to block it.

Still, the Biden administration, Democratic allies in Congress and consumer health-care advocates portrayed this initial list of 10 drugs as a milestone to shore up the financial stability of the Medicare system and ease the burden on its beneficiaries. Medicare is a federal insurance system for people who are at least 65, along with younger adults who have disabilities. When last year’s law passed, the Congressional Budget Office predicted the negotiations would save the program slightly more than $100 billion during the following decade.

More than 60 percent of the 65 million people on Medicare take prescription medication, and 25 percent take at least four prescriptions, according to a survey this summer by KFF, a health-care policy organization.

The rest of the list consists of Januvia, Farxiga and NovoLog, which treat diabetes among other conditions; Enbrel and Stelara, for arthritis and psoriasis; and Entresto, for heart failure; and Imbruvica, for cancers of the blood.

Wall Street analysts widely expected that most of the 10 drugs selected for price negotiations would appear on the list, based on Medicare expenditures and their sales in the United States, among other criteria. For seniors enrolled in Medicare, their average, annual out-of-pocket costs ranged from $121 for diabetes drug NovoLog to $5,247 for cancer-drug Imbruvica, including those with financial assistance. All told, HHS estimates that about 9 million seniors enrolled in Medicare’s prescription drug program used one or more of the 10 drugs in 2022, and paid a total of $3.4 billion out of pocket.

The 10 drugs identified Tuesday represent the first wave of medicines destined for price negotiation, with the roster expanding in future years. For this initial batch, manufacturers have until the start of October to agree to price negotiation with the Centers for Medicare and Medicaid Services. If they do, the companies will quickly need to disclose an array of data to CMS for each selected drug regarding revenue and what the manufacturer spent to research, develop and produce it.

If a manufacturer refuses to negotiate or won’t agree to what federal rules call a “maximum fair price,” the company will face a substantial tax or must withdraw from Medicare and Medicaid, the nation’s largest public health insurance program designed for people with low incomes.

To be considered for the price negotiation, a drug must have no competition from a less expensive generic competitor, and a biologic — a category of drugs made from living organisms — must not compete with any cheaper version known as biosimilars. The number of drugs involved will expand slightly during the next two years, with a total of 15 each of the next two years and 20 drugs in following years. This year and next, the drugs are part of Medicare’s Part D, the program’s drug insurance created two decades ago. After that, the drugs can come from Part D or from Part B, such as cancer therapies, which are administered by doctors.

Senior health administration officials, briefing reporters early Tuesday and speaking on the condition of anonymity before a speech by the president, said CMS started with nearly 7,500 prescription drugs that are covered through Part D. They then whittled the possibilities to 50 that don’t have much competition and that result in the highest costs to Medicare, including drugs that were approved by the Food and Drug Administration at least seven years ago and biologics approved at least 11 years ago. A few other criteria were used, too. From there, CMS ranked the 50, choosing the 10 with the highest costs to the program.

Limited though it is, the arrival of Medicare drug price negotiation is a sharp break from Medicare’s history. When the program was created in the 1960s, it covered drugs that were administered in a doctor’s office — Part B — but excluded medications that patients took on their own. Despite efforts over the decades to add outpatient drug benefits, they were woven into larger health-reform proposals that failed, and the broader drug benefits did not become part of the program until a set of Medicare changes adopted by Congress in 2003. To win Republican support, that statute included language that prohibited any role for the government to negotiate medication prices. The 2022 Inflation Reduction Act — known as IRA — rescinded the prohibition.

Since the outpatient drug benefits embedded in the 2003 law began three years later, Medicare beneficiaries have been able to get that coverage by buying a separate drug plan — through Part D — or as part of managed-care plans, known as Medicare Advantage. Either way, beneficiaries still pay some of the cost of getting the medicines, and the government has not influenced the prices that pharmaceutical companies set.

The push for price negotiation faced intense opposition from pharmaceutical companies, which contend that capping potential earning erodes their ability to invest in further research and development. After a rare loss on Capitol Hill, the industry and its business allies have turned to the courts, with the eight cases that could take years to resolve and could land before the Supreme Court.

If the negotiation process stands, industry analysts predict it will have profound ripple effect. Prices negotiated and made public by Medicare could affect negotiations between commercial insurers and drugmakers. In turn, pharmaceutical companies could focus on developing larger-molecule drugs — such as vaccines and gene therapies — that are exempted from potential Medicare price negotiations for a longer period than prescription pills.

The ultimate impacts of the law are hard to predict. Even companies critical of it acknowledge they could benefit from provisions that make their medications more affordable to patients.

“The IRA law is not all gloom and doom for biopharma, since it will reduce seniors’ out-of-pocket” costs, motivating patients to stay on them longer, according to analysts at Leerink Partners, a health care-focused investment bank. And some drugs designated for negotiation at first might not remain on the list for long, because they are scheduled to lose their patent protection soon after the lower prices take effect, meaning they would have competition and no longer be eligible for the negotiated prices.

For the Biden administration, the Inflation Reduction Act provision is a centerpiece of a battle to curb drug prices that it is waging on several fronts.

Under the law, Medicare beneficiaries pay a limit of $35 a month for insulin. Biden issued an executive order last year directing the Department of Health and Human Services to study new models to lower drug costs for Medicare and Medicaid beneficiaries. In May, HHS proposed a rule that would give the department and states more leverage to negotiate payment for the most expensive drugs covered by Medicaid. And the Federal Trade Commission has taken a more aggressive approach to pharmaceutical mergers, citing concerns about price increases when it filed suit in May to block Amgen from acquiring Horizon Therapeutics — even though the two companies don’t directly compete.

Because the impact of the Medicare drug price provision will unfold over years, the negotiated prices may have a minimal effect on some drugs, including Eliquis, a blood-thinning medication that cost Medicare $6.2 billion in 2021, by far the most of any drug. Eliquis, made by Bristol Myers Squibb and Pfizer, is set to lose patent protection in 2026, the year that Medicare’s negotiated prices first takes effect.

“Whatever the impact is will not be long lasting on our portfolio,” Angela Hwang, Pfizer’s chief commercial officer, said of Eliquis in a call with financial analysts this month, according to a transcript compiled by S&P Global Market Intelligence.

Johnson & Johnson — with three drugs on the list, the most of any drugmaker — was less conciliatory. “The IRA’s policies put an artificial deadline on innovation, threatening intellectual property protections and shortening the timeframe to deepen our understanding of patients’ unmet medical needs,” the company said in a statement Tuesday.

Bristol-Myers Squibb said in a statement Tuesday that Eliquis “was targeted for this program due to the sheer number of Medicare patients who benefit from the medicine, not its price.”