Category: Pharmacy

Alternative Headline: Vaccine Access in Jeopardy

[MM Curator Summary]: Pediatricians warn that changes under RFK Jr.’s leadership at HHS could threaten vaccine access for millions of children, especially those on Medicaid.

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For two decades, Washington, D.C., pediatrician Lanre Falusi has counseled parents about vaccine safety, side effects, and timing. But this year, she said, the conversations have changed.

“For the first time, I’m having parents of newborns ask me if their baby will still be able to get vaccines,” Falusi said.

Throughout the country, pediatricians say anxious parents are concerned about access to routine childhood immunizations, especially those with children on Medicaid, the government insurance program for low-income families and people with disabilities. Medicaid covers 4 in 10 children in the U.S.

“It really became an issue when RFK Jr. stepped into the role of HHS secretary,” said Deborah Greenhouse, a pediatrician in South Carolina.

The concern accelerated after the shake-up of a key Centers for Disease Control and Prevention vaccine advisory body in June, raising fears that millions of American families could soon have to pay out-of-pocket for shots now covered by their health insurance.

Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, removed all 17 members of the CDC’s Advisory Committee on Immunization Practices, the panel responsible for recommending which shots are included in the nation’s adult and childhood immunization schedules.

Kennedy replaced the panelists with new members aligned with his views, prompting alarm among medical professionals and public health experts.

“People should be worried about what’s going to happen to the availability of vaccines for children,” said Jennifer Tolbert, deputy director of the Program on Medicaid and the Uninsured at KFF, a national health information nonprofit that includes KFF Health News.

Under the Affordable Care Act, health insurers are required to cover all ACIP-recommended vaccines. States and other jurisdictions use the childhood vaccine schedule to set immunization requirements for schoolchildren. ACIP’s recommendations also determine which vaccines get covered by the Vaccines for Children Program, a CDC-funded initiative that provides free immunizations to low-income and uninsured children. Half of children in the U.S. are eligible for the VFC program.

If the new ACIP members withdraw support for a particular vaccine and the CDC director agrees, Tolbert said, the consequences would be immediate. “It would automatically affect what is covered and therefore which vaccines are available to children on Medicaid,” she said.

Health insurance companies have not yet said how they would alter coverage, but Tolbert said such a move would open the door for private insurers to refuse to cover the vaccine.

Pediatricians worry about a future where parents might have to choose — pay hundreds of dollars out-of-pocket for shots or leave their kids unprotected.

The health insurance industry group AHIP said that health plans “continue to follow federal requirements related to coverage of ACIP-recommended vaccines and will continue to support broad access to critical preventive services, including immunizations.”

Pediatricians say news about President Donald Trump’s new budget law, which is expected to reduce Medicaid spending by about $1 trillion over the next decade, also prompted questions from parents.

While parents may be worried about losing their Medicaid, the law doesn’t mention vaccines or change eligibility or benefits for children’s Medicaid, Tolbert said. But less federal funding means states will have to make decisions about who is covered and which services are offered.

To raise the revenue needed to pay for Medicaid, states could raise taxes; move money earmarked for other spending, such as education or corrections; or, more likely, reduce Medicaid spending.

“And they may do that by cutting eligibility for optional populations or by cutting services that are optional, or by reducing payments to providers in the form of provider rates,” Tolbert said. “It’s unclear how this will play out, and it will likely look different across all states.”

In May, Kennedy announced in a post on X that the CDC is no longer recommending the covid-19 vaccine for healthy children and pregnant women. The move prompted a lawsuit by the American Academy of Pediatrics and other physician groups that seeks to freeze Kennedy’s directive.

In June, the new ACIP members appointed by Kennedy voted to recommend that adults and children no longer receive flu vaccines with thimerosal, a preservative rarely used in some flu vaccines. Anti-vaccine activists, including Kennedy, have rallied against thimerosal for decades, alleging links to autism despite no evidence of any association.

“There is no cause for concern,” Department of Health and Human Services spokesperson Emily Hilliard said in a statement. “As Secretary Kennedy has stated, no one will be denied access to a licensed vaccine if they choose to receive one.”

“When the ACIP committee met last month, they reaffirmed that flu vaccines will remain accessible and covered, and they emphasized safety by ensuring these vaccines are mercury-free,” Hilliard wrote. “The Vaccines for Children (VFC) program continues to provide COVID-19 vaccines at no cost for eligible children when the parent, provider, and patient decide vaccination is appropriate. Medicaid will continue to reimburse the administration fee.”

But the possibility that a vaccine could be restricted or no longer covered by insurance is already changing how parents approach immunization. In Falusi’s practice, parents are scheduling appointments to coincide precisely with their child’s eligibility, sometimes making appointments the same week as their birthdays.

Melissa Mason, a pediatrician in Albuquerque, New Mexico, has evaluated some patients who contracted measles during the multistate outbreak that started in neighboring Texas.

She’s concerned that any new limitations on access or reimbursement for childhood vaccines could lead to even more preventable illnesses and deaths.

Nationally, there have been more than 1,300 measles cases since January, including three deaths, according to the CDC. “We’re seeing this outbreak because vaccination rates are too low and it allows measles to spread in the community,” Mason said.

Children and teens account for 66% of national measles cases. Mason has begun offering the measles vaccine to infants as young as 6 months old, a full six months earlier than standard practice, though still within federal guidelines.

Last year, overall kindergartenvaccination rates fell in the U.S. At the same time, the number of children with a school vaccination exemption continued to rise.

Pertussis, or whooping cough — another disease that can be deadly to young children — is spreading. As of July 5, more than 15,100 cases had been identified in U.S. residents this year, according to the CDC.

Mason said pertussis is especially dangerous to babies too young to receive the vaccine.

For now, pediatricians are trying to maintain a sense of urgency without inciting panic.

In Columbia, South Carolina, Greenhouse used to offer families a flexible age range for routine vaccinations.

“I’m not saying that anymore,” the pediatrician said.

She now urges parents to get their children vaccinated as soon as they are eligible.

She described anxious parents asking whether the HPV vaccine, which helps prevent cervical cancer, can be administered to children younger than the recommended age of 9.

“I actually had two parents today ask if their 7- or 8-year-olds could get the HPV shot,” Greenhouse said. “I had to tell them it’s not allowed.”

With the vaccine requiring multiple doses months apart, Greenhouse fears time may run out for families to get the series covered by insurance. If they have to pay out-of-pocket, she’s afraid some families may choose not to get the second dose. A second dose could cost about $300 if no longer covered by insurance.

“I cannot be 100% sure what the future looks like for some of these vaccines,” Greenhouse said. “I can tell you it’s a very scary place to be.”

Kennedy’s newly appointed vaccine advisory committee is expected to hold its next public meeting as soon as August.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

https://amp.cnn.com/cnn/2025/07/28/health/medicaid-vaccines-kff-health-news

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Alternative Headline: Trump Floats 250% Tariffs

[MM Curator Summary]: Trump floated tariffs up to 250% while pharmaceutical firms boost U.S. production to avoid disruptions.

Trump Suggests Tariffs Could Reach 250 Percent as Pharmaceutical Industry Boosts US Production

Former President Donald Trump stated that tariffs on certain goods could potentially reach as high as 250%, according to remarks made during a recent address. The comments come amid ongoing discussions about trade policies and their implications for various industries, including pharmaceuticals.

In response to shifting policy landscapes, pharmaceutical manufacturers are reportedly increasing their investments in U.S.-based production facilities. Industry sources indicate that these efforts aim to bolster supply chain resilience and mitigate potential disruptions caused by evolving trade regulations. This trend reflects broader adjustments across sectors as companies adapt to the possibility of heightened tariffs and other economic measures.

https://www.geneonline.com/trump-suggests-tariffs-could-reach-250-percent-as-pharmaceutical-industry-boosts-us-production/

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Alternative Headline: CMS Eyes Weight Loss Drug Pilot

[MM Curator Summary]: CMS may launch a pilot for Medicaid and Medicare Part D coverage of popular weight loss drugs, while the Trump administration slows efforts to mandate IVF coverage.

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The Center for Medicare and Medicaid Innovation may introduce a five-year pilot model to expand access to weight loss drugs, while the Trump administration appears to be backing away from a campaign trail promise to mandate coverage of in vitro fertilization (IVF), reports The Washington Post.

State Medicaid programs and Medicare Part D plans could choose to cover GLP-1 drugs like Ozempic, Mounjaro, Wegovy and Zepbound through the pilot model, documents obtained by the Post show. The model would start in April in Medicaid and in January 2027 for Part D plans.

GLP-1 users and advocates say the drugs’ ability to improve health outcomes is unparalleled. However, due to the drugs’ popularity, there has been concern over the impact on state and federal budgets from high levels of utilization.

The Centers for Medicare & Medicaid Services (CMS) proposed a rule requiring Part D and Medicaid to cover anti-obesity medications in November. But the final rule, released under the new administration, omitted this policy.

GLP-1 drugs Ozempic, Wegovy and Rybelsus were included, however, in the second annual list of drug price negotiations under the Inflation Reduction Act. An official under the Biden administration told the press all dosage forms and strengths of the drug would be included in negotiations.

Trump issued an executive order in an attempt to modify the program and issued new draft guidance to potentially include Part B drugs for the third cycle of negotiations.

But the administration may not require health insurers to cover IVF services, potentially severing a campaign promise by Trump, two people with knowledge of internal discussions told the Post. Proposals to expand coverage to people on the Affordable Care Act (ACA) exchanges have reportedly been halted.

It’s expected broader coverage would increase premiums. Lawmakers are also discussing whether to extend the ACA enhanced premium subsidies, which expire at the end of the year.

Trump previously dubbed himself the “fertilization president,” even as a new-look Department of Health and Human Services shuttered an office of reproductive technology surveillance within the Centers for Disease Control and Prevention.

The report suggests a path to coverage includes Congress passing legislation allowing IVF to be classified as an essential health benefit, but the White House has not yet demanded lawmakers address this priority. A White House spokesperson said the administration is still focused on the issue.

Trump signed an executive order in February aimed at expanding access to IVF, directing the Domestic Policy Council to explore ways to reduce the cost of treatment.

https://www.fiercehealthcare.com/payers/cmmi-considers-weight-loss-drug-coverage-pilot-trump-ivf-pledge-slips-reports

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Alternative Headline: Medicare/Medicaid May Cover Weight-Loss Drugs

[MM Curator Summary]: The Trump administration is exploring a five-year pilot to allow Medicare and Medicaid to cover costly weight-loss drugs.

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 The Trump administration is considering a five-year pilot program to cover weight-loss drugs under Medicare and Medicaid, the Washington Post reported on Friday, citing documents from the Centers for Medicare and Medicaid Services.

The documents outline plans that would allow the government insurance programs to cover Novo Nordisk’s Wegovy and Ozempic, and Eli Lilly’s Zepbound and Mounjaro for weight loss, the newspaper reported.

The drugs, which have been shown to reduce body weight by 15% to 20% in trials, can cost $5,000 to $7,000 per year, that raises questions about the long-term affordability for states and the federal government.

The move would be a shift in federal policy after the administration earlier this year rejected a Biden-era proposal to cover weight loss drugs.

"It does feel like a big shift in view, at least on the Medicare side," said Ryan MacDonald, analyst at Needham, noting that previous government efforts had prioritized cost containment and limited coverage.

According to the Washington Post, 13 states currently cover the drugs for Medicaid patients, while Medicare prohibits coverage of the drugs used solely for weight loss, but allows for treating indications they are approved for like sleep apnea and heart disease.

The proposed CMS initiative would expand the coverage efforts, with a Medicaid pilot beginning in April 2026 and a Medicare pilot in January 2027.

A Novo spokesperson declined to comment on the pilot but said "comprehensive coverage through government and commercial insurance plans is critical to affordable healthcare and treatment options."

The Centers for Medicare & Medicaid Services, however, said it does not comment on potential models or coverage.

More than 70 million people are covered by Medicaid, the state and federal government program for low-income people, and about 65 million people are enrolled in the government’s Medicare program, which covers people aged 65 and older or who have disabilities.

A spokesperson for Lilly said it is committed to working with payers and policymakers to expand coverage and improve care. "Lilly is dedicated to ensuring that all patients, regardless of their insurance provider, can access evidence-based obesity care."

Shares of Lilly, one of the key players in the market, were up over 2%, while U.S.-listed Novo shares were up 1.2%.

Bernstein analyst Courtney Breen viewed the development as a positive for Lilly, and expects the company to benefit significantly once its experimental oral weight-loss drug is launched in the market. The Washington Post reported that the drug, if approved by regulators, would be included in the pilot.

In contrast, telehealth platform Hims & Hers Health was down 6%. Analysts said broader public coverage of branded GLP-1 drugs could reduce demand for compounded alternatives offered by the company.

https://www.reuters.com/business/healthcare-pharmaceuticals/us-plans-test-medicare-medicaid-coverage-weight-loss-drugs-washington-post-2025-08-01/

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Alternative Headline: Siklos Gains Medicaid Access

[MM Curator Summary]: Siklos®, a sickle cell disease treatment, is now reimbursed under Medicaid in 37 states, broadening access for patients.

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, /PRNewswire/ – Medunik USA, a specialty pharmaceutical company dedicated to providing rare disease patients with access to orphan drugs and part of Duchesnay Pharmaceutical Group (DPG), winner of the 2024 Life Sciences Innovation Award by ADRIQ, is pleased to announce that public reimbursement for Siklos® (hydroxyurea) under Medicaid Programs is now available in 37 states, with 13 states including it on their Preferred Drug List, while 24 states offer it with limited, or no, restrictions. This important milestone for Medunik USA allows broader access to this essential medicine, benefiting patients suffering from sickle cell disease (SCD).

Siklos® has been used worldwide to treat SCD for over 15 years and was approved by the FDA for use in the USA in 2017. This medicine is the only hydroxyurea (HU)-based therapeutic option that offers both flexible dosing and administration, giving patients and caregivers more control over managing their care and shaping a treatment routine that works for them. Patients can choose the best way to take Siklos®, whether by swallowing it whole or split based on the dose, or dissolving it in a small amount of water.

Siklos® is the only FDA-approved dissolvable formulation of hydroxyurea that reduces painful crises and blood transfusions for sickle cell patients aged 2 years and older.   Siklos® has a BOXED WARNING regarding Low Blood Cell Count and Cancer. The most common side effects of Siklos® in children include: infections and low white blood cells, and in adults include: infections, headache, and dry skin.

"We are proud to see increased coverage for this important therapy, which represents a significant step forward in the standard of care for patients with sickle cell disease. Siklos® provides patients with options on how to best take their HU treatment," said Tanya Carro, Executive Vice President, U.S. Entities. "With fewer SCD treatment options currently available, it is even more important to empower patients to stay on therapy in a way that fits their lives. That’s what drives long-term adherence and meaningful health outcomes."

Sickle cell anemia is the most common inherited blood disorder, resulting in the production of abnormal hemoglobin, known as hemoglobin-S, responsible for the sickling of red blood cells. This disease affects nearly 100,000 Americans, decreases life expectancy by 25 to 30 years, induces significant morbidity and, may therefore, reduce quality of life1,2. Most of those affected are of African ancestry; a minority are of Hispanic or southern European, Middle Eastern or Asian Indian descent3.

Committed to improving the lives of people living with rare disorders, Medunik USA strives to remove the logistical barriers and to broaden reimbursement pathways to empower patients with SCD and their caregivers. Medunik USA supports patient access by offering a robust assistance program that includes educational resources and savings programs. For more information please visit: https://medunikusa.com/products .

INDICATION AND IMPORTANT SAFETY INFORMATION

SIKLOS is a prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in adults and children, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. It is not known if SIKLOS is safe and effective in children less than 2 years of age.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: LOW BLOOD CELL COUNT and CANCER

See Full Prescribing Information for complete Boxed Warning.

Low blood cell counts are common with SIKLOS, including low red blood cells, white blood cells, and platelets, and can be severe and life threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and every 2 weeks during treatment with SIKLOS. Your healthcare provider may change your dose or tell you to stop taking SIKLOS if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever or chills; shortness of breath; body aches; unusual headache; feeling very tired; bleeding or unexplained bruising.

Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking SIKLOS for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing.

WHAT IS THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT SIKLOS?

• SIKLOS can harm your unborn baby.
• For females taking SIKLOS who can become pregnant:

• You should talk with your healthcare provider about the risks of SIKLOS to your unborn baby.
• You should use effective birth control during treatment with SIKLOS and for at least 6 months after treatment with SIKLOS.
• Your healthcare provider will perform a pregnancy test before you start treatment with SIKLOS. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.

• For males taking SIKLOS:  SIKLOS can affect your sperm. If you have a female sexual partner who can become pregnant, you should use effective birth control during treatment with SIKLOS and for at least 6 months after treatment.
• SIKLOS may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.

WHO SHOULD NOT TAKE SIKLOS
Do not take SIKLOS if you are allergic to hydroxyurea or any of the ingredients in SIKLOS. See the Medication Guide for a list of the ingredients in SIKLOS.

WHAT SHOULD YOU TELL YOUR HEALTH CARE PROVIDER BEFORE TAKING SIKLOS?
Tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems or are receiving hemodialysis
• have liver problems
• have human immunodeficiency virus (HIV) or take HIV medicines. Taking SIKLOS with certain HIV medicines can cause serious reactions and may lead to death.
• have increased levels of uric acid in your blood (hyperuricemia)
• have a history of receiving interferon therapy or are currently receiving interferon therapy
• have leg wounds or ulcers
• plan to receive any vaccinations. You should not receive "live vaccines" during treatment with SIKLOS.
• are pregnant or plan to become pregnant. See "What is the most important information I should know about SIKLOS?"
• are breastfeeding or plan to breastfeed. It is not known if SIKLOS can pass into your breast milk. Do not breastfeed during treatment with SIKLOS.
• are using a continuous glucose monitor (CGM) to test your blood glucose. Talk to the healthcare provider that prescribed your CGM about whether it is safe to use while you are taking SIKLOS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF SIKLOS?
SIKLOS may cause serious side effects, including: 
See "What is the most important information I should know about SIKLOS?"

• Skin ulcers, including leg ulcers, and death of skin tissue (gangrene) have happened in people who take SIKLOS. This has happened most often in people who receive interferon therapy or have a history of interferon therapy. Your healthcare provider will decrease your dose or stop treatment with SIKLOS if you develop any skin ulcers.
• Enlarged red blood cells (macrocytosis). Macrocytosis is common in people who take SIKLOS and can make it difficult to detect a decrease of folic acid. Your healthcare provider may prescribe a folic acid supplement for you.
• Hemolytic Anemia, the fast breakdown of red blood cells, has happened in people who take SIKLOS. Tell your healthcare provider I you develop yellowing of your skin (jaundice) or blood in your urine. Your healthcare provider may do blood tests if you have persistent or worsening anemia not related to sickle cell anemia.

The most common side effects of SIKLOS in children include: infections and low white blood cells.

The most common side effects of SIKLOS in adults include: infections, headache, and dry skin.

These are not all the possible side effects of SIKLOS.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch, or 1-800-FDA-1088.

Please read the Full Prescribing Information, including Boxed Warning, Medication Guide and Instructions for Use, at www.SIKLOSusa.com.

ABOUT MEDUNIK USA

Based in Princeton, New Jersey, Medunik USA is part of Duchesnay Pharmaceutical Group and works to improve the health and quality of life of Americans living with rare diseases by making orphan drug therapies available in the United States. Through its strategic partnerships, Medunik USA develops and provides Americans suffering from rare disease with access to orphan drugs that are not currently available in the U.S. Medunik USA makes critical medications to treat rare diseases available to American patients who might not otherwise have access to these medications.

For more information about Medunik USA, please visit www.medunikusa.com.

Follow us on LinkedIn.

ABOUT DUCHESNAY PHARMACEUTICAL GROUP

Duchesnay Pharmaceutical Group (DPG), with its affiliated companies, is headquartered in Blainville, Quebec. The Group consists of six pharmaceutical companies to meet the needs of patients in Canada, the U.S. and abroad. The companies are Duchesnay (Canada) and Duchesnay USA, both dedicated to women’s health; Medunik Canada and Medunik USA, which provide treatments for rare and debilitating diseases; and Analog Pharma Canada and Analog Pharma, specializing in orphan generic medications. From its state-of-the-art manufacturing plant, DPG exports its innovative treatments to more than 50 countries.

DPG is one of the eight companies across the country chosen to participate in the Government of Canada’s Global Hypergrowth Project. This appointment offers exclusive and personalized support for at least two years, in order to accelerate its growth to become an anchor firm in the Canadian economy.

DPG is the winner of the 2024 Life Sciences Innovation Award by ADRIQ, the Association for the Development of Research and Innovation of Quebec, which recognizes DPG’s healthy workplace culture and commitment to pharmaceutical innovation, while DPG president Éric Gervais is the recipient of the 2024 Bernard-Landry Award by ADRIQ which acknowledges his impactful leadership on Quebec’s research and innovation ecosystem.

DPG, through its proprietary research and development, and through exclusive partnerships, offers innovative treatments for a variety of medical conditions in women’s health, urology, oncology and for rare diseases, plus lower-cost generic medications. DPG recognizes the dedication and professionalism of its employees and promotes a positive culture and flexible work environment. It is deeply committed to environmental responsibility and to giving back to the community through the support of various charitable organizations.

For more information, please visit https://duchesnaypharmaceuticalgroup.com/en.

Follow us on LinkedIn.

For inquiries or corrections to Press Releases, please reach out to Cision.

https://www.wjbf.com/business/press-releases/cision/20250722MO34407/medunik-usa-expands-siklos-hydroxyurea-coverage-under-medicaid-programs-to-37-states/

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Alternative Headline: Budget Bill’s Pharma Impact

[MM Curator Summary]: The budget bill offers partial pharma wins with IRA reforms and PBM restrictions but leaves out key industry asks, such as a fix to the IRA’s "pill penalty." 

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The budget bill currently under consideration in Congress is big — and it’s complicated. The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry.

The legislation, which was narrowly approved in the House last month and is now in the hands of the Senate, includes reforms to pharmacy benefit managers and the Inflation Reduction Act.

But the bill’s path forward is uncertain. Senate Republicans need a 51-vote majority to pass the mammoth legislation through the budget reconciliation process, but divides among GOP members are making a self-imposed July 4 deadline murky, according to recent reports. Namely, Senators are split over spending cuts, including billions from Medicaid and Medicare, and the bill’s potential to add trillions to the national deficit. 

Meanwhile, pharma needs to be aware of key reforms in the bill, which contains both wins and losses for the industry. 

IRA reforms

Industry advocates have pushed for reforms to the IRA since it passed during the Biden administration, with the focus squarely on the Medicare drug price negotiation program.

Currently, the program exempts orphan drugs from price negotiations if they only have one indication for rare disease. The law made it less likely for pharma companies to pursue more rare disease indications, according to industry groups such as the National Pharmaceutical Council. A brief by the council found that the percentage of orphan drugs that received a second indication dropped 48% after passage of the IRA.

The budget bill proposes adjusting this rule to extend the exemption to orphan drugs that treat “one or more rare diseases or conditions.” 

Another sought-after reform is notably absent from the budget bill, even after significant industry lobbying efforts over the past few years. Known as the pill penalty, the IRA currently makes small molecule drugs eligible for price negotiations after nine years, while biologics are granted 13 years. Lobbyists argue the law has had an impact on R&D and investments by disincentivizing small molecule drugs, including the discontinuation of 51 research programs and 26 drugs, according to Incubate, a coalition for venture capitalists that tracks investment impacts of the IRA.

Expectations were high that the reform would be included in Republicans’ budget agenda. President Donald Trump even included the fix in an April executive order that aimed to lower drug prices.

Congress could pass a pill penalty fix on its own — a standalone bill called the Ensuring Pathways to Innovative Cures (EPIC) Act was introduced in Congress earlier this year, but it has yet to be approved.

“While the current draft of the budget reconciliation package does not include a fix for the pill penalty, we remain encouraged that there are still viable legislative vehicles to address this issue in the near term,” John Stanford, founder and executive director of Incubate, told PharmaVoice. “We urge the Senate to find a way to address the pill penalty in reconciliation. If that doesn’t happen, the next step would be passing the EPIC Act to restore parity for small molecule drugs and biologics — and send a clear signal that small molecule innovation is a national priority.”

PBM changes

The budget bill also includes another win from pharma’s lobbying agenda that takes aim at pharmacy benefit managers, which the industry has long blamed for drug prices in the U.S. PBMs are also a target for Trump in his “most favored nation” policy that would “totally cut out the famous middleman” and allow direct pharmaceutical sales to Americans at the same prices paid by other countries.

While the budget bill doesn’t include all the PBM reforms that have been considered in the past few years, there are some “modest” changes related to federal health programs, Bloomberg stated. 

The bill prohibits spread pricing, which is a practice where PBMs charge health plans, in this case Medicaid, higher prices than what they reimburse pharmacies for the same drugs. PBMs would no longer be able to pocket the difference as profit if the bill passes. Plus, the package would require all rebates or discounts received by PBMs to be passed on to a Medicare Part D plan sponsor, according to a recent brief by Mintz. PBMs would also be limited to collecting only service fees as compensation, and would have to follow new reporting requirements about the drugs they cover, their average acquisition costs, rebates and more. 

Other PBM reforms may be on Congress’ agenda outside of the budget bill later this year, and the Senate could still amend the proposed budget bill to get it across the finish line. For example, the Senate was close to passing a comprehensive PBM reform package at the end of 2024 that also included the prohibition of spread pricing, but Republicans nixed the bill, targeting inclusion in their budget package instead, according to Mintz, which expects that at least some PBM reforms will be passed this year.

https://www.pharmavoice.com/news/pharmas-wins-losses-budget-ira-pill-penalty-trump/750369/

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Alternative Headline: AI-Driven Maternal Health Pilot

[MM Curator Summary]: Drive Health, Google, and Illinois launched an AI-powered maternal health program to reduce disparities in prenatal care for over 56,000 underserved mothers.

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Drive Health and Google Public Sector have partnered with the State of Illinois to launch Healthy Baby, a pilot program providing AI-powered maternal health support to underserved populations in rural Cook County.

The multi-year initiative will engage more than 56,000 participants, providing Google Pixel phones and Fitbit devices to expectant mothers to access Drive Health’s AI assistant called Nurse Avery. The program aims to reduce maternal mortality, improve birth weights, and increase full-term pregnancies while reducing healthcare costs.

“Our mission has always been to create technology that breaks down barriers and democratizes healthcare access,” said Kevin Longoria, CEO of Drive Health. “Partnering with Google, the State of Illinois, and former Senator James Clayborne to launch Healthy Baby represents a critical milestone in our commitment to supporting the most vulnerable populations.”

The initiative addresses significant healthcare disparities, with only a quarter of high-risk mothers on Medicaid receiving consistent prenatal care. According to the announcement, behavioral health conditions go undiagnosed or untreated in up to 40% of pregnant women in Medicaid populations. In Illinois, a third of counties are considered maternal care deserts.

“The Healthy Baby pilot represents a critical step in maternal healthcare, showing how AI can help deliver personalized, proactive health support directly to underserved mothers,” said Chris Hein, Field Chief Technology Officer at Google Public Sector. “Using the AI agent, Nurse Avery, and delivering it through Google Pixel phones and Fitbit devices, the program provides real-time support – managing appointments, monitoring vitals, and offering health guidance directly.”

The program serves women in Cook County who are considering family planning, expectant mothers, and mothers with children under three years old. Participants receive a Google Pixel 8a phone to communicate with Nurse Avery and a Fitbit Inspire 3 device to track physical activity, heart health, and sleep data.

Nurse Avery provides various services including nutritional support and folic acid coordination, vaccination updates, chronic disease management, mental health resources, and genetic risk assessment. The platform includes voice-command options for accessibility and operates within HIPAA-compliant infrastructure.

According to the Centers for Disease Control and Prevention, more than 80% of maternal deaths are preventable, and babies of mothers who do not receive prenatal care are five times more likely to die, according to the Office on Women’s Health.

The platform is built on Google Cloud’s infrastructure and adheres to state and federal data security and privacy guidelines to protect patient information while providing personalized care recommendations.

https://femtechinsider.com/drive-health-and-google-partner-with-illinois-on-ai-powered-maternal-health-program/

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Alternative Headline: Trump Drug Plan Needs Congress

[MM Curator Summary]: Trump’s MFN executive order would lower U.S. drug prices by benchmarking them to other nations — but it can’t be enforced without new legislation that many Republicans still oppose. 

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One of the drug industry’s biggest guardrails against President Trump’s "most favored nation" drug pricing plan is the fact that it’s less enforceable without the involvement of Congress.

Why it matters: Enshrining such a policy in law would be proof of GOP evolution on drug prices — or at least the party’s willingness to break with its traditional aversion to government price-setting.

• It would also likely enable policy changes resulting in deeper reductions in what Americans pay for drugs, potentially slashing manufacturers’ revenue and creating global disruption.
• But for now, Trump isn’t asking much from the GOP on drug prices while lawmakers deal with a sweeping overhaul of Medicaid and government spending battles.

State of play: Trump issued an executive order this month calling for the U.S. to pay less for drugs than other comparable countries. Last week, Health and Human Services outlined targets manufacturers are expected to hit based on the lowest price in Organization for Economic Cooperation and Development nations with a GDP per capita of at least 60% of the U.S. GDP per capita.

• Analysts have noted it isn’t apparent how the plan would overcome legal hurdles.
• The EO "lacks a clear legal mechanism for implementation, a positive for the industry," Capstone analysts wrote. "Ultimately, any substantive price-setting beyond the Inflation Reduction Act’s Medicare negotiation will be tested in litigation."
• "To disrupt reimbursement within Medicaid, Medicare Part D, or outside government insurance programs, Capstone believes that the administration would be unable to implement policy without Congress," they added.
• "Notably, we expect the implementation of MFN to require legislation with Trump citing a roll up into an official bill where we believe the industry has more avenues to oppose and with noted internal GOP opposition," wrote a UBS Investment Bank analyst.

Flashback: Trump tried to enact a similar most favored nation policy during his first term, but it was halted by the courts after the drug industry sued. The idea was eventually abandoned by the Biden administration.

• The courts blocked Trump’s plan based on how it was implemented, not on the merits itself — "something the administration could relatively easily fix," said Washington University law professor Rachel Sachs.
• But there were also legal challenges to the underlying policy, and there almost certainly would be again should the executive order ever translate into actual regulation. Going through Congress instead could help avoid at least some such pitfalls, as well as confront some of regulation’s operational challenges, Sachs said.
• "Congress has more authority to legislate for the benefit of a much broader set of Americans, but there are also more veto points in place, including political realities, that would limit Congress’ ability to do that," she added.

The intrigue: While testifying on the Hill earlier this month, HHS Secretary Robert F. Kennedy Jr. told Sen. Bernie Sanders (I-Vt.) that he "absolutely" would work with him on legislation to lower U.S. drug prices so they’re better aligned with what other countries pay, Axios Pro reported.

• Sanders said Trump’s executive order is likely to be thrown out in court, necessitating legislation for lower prices. He and other Democrats recently introduced such legislation.
• A similar bill was introduced earlier this month — but this one by a bipartisan duo, including GOP Sen. Josh Hawley of Missouri.

Reality check: Hawley is the exception among congressional Republicans, not the rule. Though many of pharma’s fiercest defenders have retired from Congress, the GOP is still generally hardwired to avoid anything that could be considered price-setting within health care.

• Recent chatter about including an MFN-for-Medicaid policy in the GOP’s reconciliation bill ended up going nowhere.
• And the Trump administration itself has already passed on the chance to include some kind of MFN-like policy within Medicare drug price negotiation guidance, which also came out last week (but to much less fanfare).
• The guidance doesn’t include any kind of international reference pricing component for negotiated prices that will take effect in 2028.

What we’re watching: Yes, there’s a very strong case for why MFN is going nowhere on the Hill. And yet, stranger things have already happened during Trump’s tenure, as the GOP’s populist streak overtakes traditional free-market conservatism.

• "Before the end of this Congress, I feel pretty confident betting that MFN will end up as the law of the land. And as a human consumer of pharma, do I think that’s a disaster? Yes," said one former senior GOP Senate aide. "But politically it’s a no-brainer."

https://www.axios.com/2025/05/27/trump-drug-pricing-congress-most-favored-nation

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Alternative Headline: Trump Drug Plan Shakes Markets

[MM Curator Summary]: ​Trump’s plan to slash drug prices triggered a global selloff in pharmaceutical stocks amid fears of revenue hits and renewed legal battles.

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Shares of pharmaceutical companies fell across the world after US President Donald Trump said he planned to order a cut in US prescription drug costs to bring them in line with other countries, prompting concern that profits will take a hit.

European drugmakers including Novo Nordisk A/S, AstraZeneca Plc and Roche Holding AG slid, missing out on a broader rally, while in Asia, the pharmaceuticals subgroup in Japan’s Topix Index posted its biggest one-day loss since August. Shares in US drugmakers were also weaker, with Eli Lilly & Co., Pfizer Inc., Bristol-Myers Squibb Co. and Merck & Co. Inc. all down in premarket trading in New York.

The declines come after Trump said on social media he intends to sign an executive order lowering the price of prescription medicines at 9 a.m. on Monday in Washington, after reports emerged of the plan last week. His social media post didn’t detail how the order would work, or any limits that may apply.

“This has the potential to be very negative for the industry,” Bank Vontobel analyst Stefan Schneider said in a note, adding that the plan will probably be directed at Medicare, Medicaid and some hospitals. “Such a move will likely face lawsuits by the industry,” Schneider said.

Americans pay the most in the world for medicines, fueling innovation and driving the growth of the industry. The US government already negotiates prices for some of the highest-cost medicines used in Medicare under the Inflation Reduction Act, which was passed in 2022 under former President Joe Biden, with more slated to be added every year.

Firms that depend on the US for a large chunk of sales, including Japan’s Takeda Pharmaceutical Co., Astellas Pharma Inc. and Otsuka Holdings Co., are especially vulnerable, Hidemaru Yamaguchi, a health-care sector analyst at Citigroup Global Markets Japan Inc., wrote in a note.

For the European pharmaceuticals sector, companies such as Novo Nordisk, AstraZeneca, Roche, Novartis AG, GSK Plc and Sanofi SA generate between roughly 40% and 60% of their revenues in the US, according to data compiled by Bloomberg.

Novo Nordisk shares, which fell as much as 8.6% in early trading, were also weighed down after a head-to-head study showed Eli Lilly’s obesity drug Zepbound helped people trim about two inches more off their waists than Novo’s Wegovy.

It’s not the first time Trump has targeted high drug costs. His current plan seems similar to one proposed during his first term aimed at capping Medicare drug prices, Stephen Barker, an equities analyst at Jefferies Japan Ltd., wrote in a note. The effort was struck down in federal court after drug companies challenged it, claiming the administration hadn’t properly carried out the rule-making process.

Still, a renewed push to lower drug prices may have an “enormous” impact on the sector’s revenues, Barker said. That’s because Medicare, a government-funded program that offers health insurance for people aged 65 or older, and Medicaid, which covers low-income citizens, may collectively account for about 40% of all drug sales in the US, he said.

Trump’s plan likely only affects the drugs up for price negotiations under the IRA, said Evan Seigerman, head of health-care research at BMO Capital Markets. “Importantly, the government has no power to set prices in the commercial market,” and potentially faces resistance from House Republicans to implementing legislation beyond what can be done via the executive order, Seigerman said.

https://www.advisorhub.com/pharmaceutical-stocks-tumble-on-trump-plan-to-cut-us-drug-prices/

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Alternative Headline: Trump Taps Oz for Drug Price Cuts

[MM Curator Summary]: As customs enforcement tightens on declaring values and legal uncertainty grows, Trump has appointed CMS Administrator Mehmet Oz to lead drug price negotiations under the Most Favored Nation policy — aiming for rapid cost reductions in branded drugs. 

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The Trump administration’s “Most Favored Nation” drug pricing policy is starting to take shape, with the president on Friday signaling  that he wants Mehmet Oz, recently confirmed as administrator of the Centers for Medicare and Medicaid Services, to lead the negotiations.

Speaking at a Make America Healthy Again Commission event, President Donald Trump called Oz a “very tough hombre,” and charged him with leading the effort to bring down drug costs. “You’re going to have to get in and you’re going to fight,” Trump said. “If you do it, you can have, within a period of weeks, you’re going to have drug costs that drop like a rock.”

Meanwhile, the U.S. Customs and Border Protection (CBP) last Thursday reminded pharmaceutical companies to ensure that their imports and exports are properly declared. “Declaring incorrect value on import or export documentation submitted to the CBP is considered trade evasion,” the agency warned, “and CBP will pursue any violations to the fullest extent possible.”

While the CBP’s release on Thursday explicitly named Trump’s Most Favored Nation policy and the administration’s “strategy to lower health care costs in the United States,” it appears that the warning may have more to do with a recently emerged trade loophole that pharma companies could exploit to soften the blow of tariffs.

The first-sale rule is an obscure clause in U.S. customs law that allows companies to base their import duty calculations on the initial factory price of their product, rather than the final retail price, which is often inflated, as per CNBC. This move could allow importers to cut out costs associated with the profits of the middlemen.

These developments come as Trump tries one tack after another in an attempt to lower drug prices and boost domestic manufacturing in the pharma industry. At the center of this effort is the Most Favored Nation executive order, which he signed earlier this month, seeking to bring drug prices down in line with other similarly developed countries where these medicines are cheaper.

There remains substantial uncertainty regarding this policy. Earlier this month, the Department of Health and Human Services clarified that it will specifically be focusing on branded drugs and that it wants drugmakers to match medication prices in countries with a GDP at least 60% of the U.S.’s. The HHS has yet to release a list of drugmakers and drugs that the policy will affect.

In an opinion piece for BioSpace last week, Robert Albarano, partner at the international management consulting firm Arthur D. Little, said that Trump’s executive order is “legally vulnerable and politically fragile.” The executive order has no statutory authority to enact such price controls, according to Albarano, and potentially conflicts with certain Medicare and Medicaid statutes.

“Without enabling legislation, MFN remains vulnerable to legal challenge, repeal or administrative inaction,” he wrote.

Trump attempted to bring in MFN pricing during his first term, but the policy was ultimately overturned by the courts.

https://www.biospace.com/policy/trump-taps-oz-to-lead-drug-pricing-negotiations-as-customs-warns-against-import-violations

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