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PHARMA – Cipher Pharmaceuticals’ Natroba granted Medicaid preferred status in Illinois

PHARMA – Cipher Pharmaceuticals’ Natroba granted Medicaid preferred status in Illinois


Alternative Headline: Illinois Backs Natroba Treatment

[MM Curator Summary]: Illinois has designated Cipher’s Natroba as the preferred Medicaid treatment for scabies and lice, replacing Permethrin 5%.

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Cipher Pharmaceuticals’ Natroba granted Medicaid preferred status in Illinois

・Cipher Pharmaceuticals (TSX:CPH), a profitable specialty pharma company, reports that its Natroba treatment for scabies and head lice has been upgraded to preferred status by the state of Illinois

・Concurrently, the state has downgraded Natroba’s main competitor, Permethrin 5%, to non-preferred status

・Cipher is a specialty pharmaceutical company with a diversified portfolio of commercial and early to late-stage products, mainly in dermatology

・Cipher Pharmaceuticals stock has added 50.23 per cent year-over-year and 1,322.22 per cent since 2020

Cipher Pharmaceuticals (TSX:CPH), a profitable specialty pharma company, reports that its Natroba treatment for scabies and head lice has been upgraded to preferred status by the state of Illinois. Concurrently, the state has downgraded Natroba’s main competitor, Permethrin 5%, to non-preferred status.

According to Tuesday’s news release, the changes mean that “all Medicaid treatments for scabies and Permethrin 5% prescriptions in the state must first step through Natroba being the preferred treatment in Illinois.”

The company believes that recent studies showing parasitic resistance to Permethrin played a determining factor in the updated preferred drug listing. See work by Rinaldi and Simonart for further reference.


Cipher has delivered positive net income over the past five fiscal years, with a high of US$26.64 million in 2022, and grew revenue by 58 per cent in 2024 thanks to increasing market share and the acquisition of Natroba. Investors have collected an over 1,300 per cent return since 2020.

Leadership insights

“The medical decision made by the state of Illinois is just another example of the effectiveness of Natroba (Spinosad) and what clear growth potential for the product remains ahead of us,” Craig Mull, Cipher Pharmaceuticals’ interim chief executive officer, said in a statement. “We believe it is only a matter of time until more state pharmacy directors require step-through of Natroba representing the standard of care in the treatment of scabies and head lice. We are in active discussions with other U.S. states to build upon this recent success, and we continue to believe there is significant potential outside the U.S. to out-license Natroba whereby lice resistance to Permethrin-based products is a pervasive worldwide issue and whereby Natroba fills an unmet need.”


https://www.msn.com/en-ca/money/general/cipher-pharmaceuticals-natroba-granted-medicaid-preferred-status-in-illinois/ar-AA1DQP14



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PHARMA – Informa Connect’s Medicaid Drug Rebate Program Summit

PHARMA – Informa Connect’s Medicaid Drug Rebate Program Summit


Alternative Headline: MDRP Summit Returns This Fall

[MM Curator Summary]: The 2025 MDRP Summit in Chicago will offer critical insights and compliance training for pharma professionals navigating Medicaid and government pricing programs.

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The Medicaid Drug Rebate Program Summit returns to Chicago this September! Join 700 annual attendees and nearly 100 expert speakers to master complex regulatory guidelines to deliver compliant government pricing and reporting programs.

The 2025 event features:

  • Workshops covering Government Pricing and Reporting 101Tactical Calculations and StrategyCommercialization for Emerging PharmaSPTR, and 340B Boot Camp.
  • Tracked Programming, where you’ll build your own agenda with options such as 340B Evolution, State Level Trends, The IRA Rollercoaster, and The New Administration.
  • Town Hall Style Learning where you’ll review best practices and policy ideas.
  • State Dispute Resolution Meetings where you’ll participate in targeted discussions between manufacturers and states to resolve rebates, reporting, and compliance questions.
  • Opportunity to attend a Closed-Door Executive Strategy Summit, where senior executives will participate in interactive discussions bridging policy with business strategy.
  • Fireside Chats where an expert panel of attorneys discuss the most pressing issues facing MDRP and Government Pricing.
  • OIG Address reviewing recent investigations, audit findings, and enforcement actions related to government pricing programs, and a focus on upcoming enforcement priorities.
  • Deep Dive General Sessions led by nearly 100 industry experts!
  • Opportunities to network and build valuable connections with more than 700 annual attendees.
  • PLUS–Don’t miss a Keynote from CMS.

Previous attendees praise the event as "An excellent forum to meet industry professionals and gain insight into best practices, current and future, of what’s to come regarding manufacturers and government regulations."

The MDRP Summit remains essential for anyone navigating the complex intersection of pharmaceutical economics, compliance, and government programs. With expert speakers, targeted sessions, and valuable networking opportunities, this event delivers actionable insights you can implement immediately.

https://www.drugchannels.net/2025/07/informa-connects-medicaid-drug-rebate.html


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PHARMA – FDA Appoints Pharmaceutical Industry Veteran as New CDER Director Amid Medicaid Policy Debates

PHARMA – FDA Appoints Pharmaceutical Industry Veteran as New CDER Director Amid Medicaid Policy Debates


Alternative Headline: FDA Taps Industry Expert for CDER

[MM Curator Summary]: The FDA has appointed a pharmaceutical expert as CDER director while Medicaid policy changes stir national concern.

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The Food and Drug Administration (FDA) has appointed a new leader for its Center for Drug Evaluation and Research (CDER), selecting an individual with extensive experience in the pharmaceutical industry. The announcement marks a significant development within the agency, which oversees the approval and regulation of medications in the United States. The appointment comes amid ongoing discussions about health policy changes, including Medicaid cuts that could impact access to care.

The newly named CDER director is expected to bring industry expertise to the role, which involves guiding drug evaluation processes and ensuring safety standards are met. This decision aligns with broader efforts by the FDA to balance regulatory oversight with innovation in drug development. Meanwhile, policymakers continue to debate potential rescissions tied to Medicaid funding, raising concerns about how such measures might affect vulnerable populations. These developments highlight key intersections between regulatory leadership and health policy shifts currently unfolding at both federal and state levels.

https://www.geneonline.com/fda-appoints-pharmaceutical-industry-veteran-as-new-cder-director-amid-medicaid-policy-debates/


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PHARMA – Trump Won’t Force Medicaid To Cover GLP-1s for Obesity. A Few States Are Doing It Anyway.

PHARMA – Trump Won’t Force Medicaid To Cover GLP-1s for Obesity. A Few States Are Doing It Anyway.


Alternative Headline: Few Qualify for Costly Wegovy

[MM Curator Summary]:  South Carolina Medicaid has become to 14th state to approve GLP-1 drugs for obesity treatment, but strict requirements mean few will qualify, despite widespread obesity.

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CHARLESTON, S.C. — When Page Campbell’s doctor recommended she try an injectable prescription drug called Wegovy to lose weight before scheduling bariatric surgery, she readily agreed.

“I’ve struggled with my weight for so long,” said Campbell, 40, a single mother of two. “I’m not opposed to trying anything.”

In early April, about four weeks after she’d started taking Wegovy, Campbell said she hadn’t experienced any side effects, such as nausea or bowel irritation. But she doesn’t use a scale at home, she said, so she didn’t know whether she’d lost any weight since her most recent medical appointment earlier this year, when she weighed 314 pounds. Still, she was confident about achieving weight loss.

“It’s going to work because I’m putting in the work. I’m changing my eating habits. I’m exercising,” said Campbell, a shipping manager at a Michaels store. “I’m not going to second-guess myself.”

Wegovy belongs to a pricey class of drugs called GLP-1s (short for glucagon-like peptide-1 agonists) that have upended the treatment of obesity in recent years, offering hope to patients who have tried and failed to lose weight in myriad other ways.

Campbell gained access to Wegovy through South Carolina Medicaid’s decision in late 2024 to cover these weight loss drugs. But the medications remain out of reach for millions of patients across the country who could benefit from them, because many public and private health insurers have deemed the drugs too expensive.

report published in November by KFF, a health information nonprofit that includes KFF Health News, found only 13 states were covering GLP-1s for the treatment of obesity for Medicaid beneficiaries as of August. South Carolina became the 14th in November.

Liz Williams, one of the report’s authors and a senior policy manager for the Program on Medicaid and the Uninsured at KFF, said she was not aware of any other state Medicaid programs joining the list since then. Looking ahead, the remaining states may be reluctant to add a new, expensive drug benefit while they brace for potential federal cuts coming from Congress, she said.

“As the budget debate, federally, is developing, that may impact how states are thinking about this,” Williams said.

The federal government won’t be helping anytime soon, either. Medicare covers GLP-1s to treat diabetes and some other health conditions, including obstructive sleep apnea and cardiovascular disease, but not obesity. In early April, the Trump administration announced it will not finalize a rule proposed by the Biden administration that would have allowed an estimated 7.4 million people covered by Medicare and Medicaid to access GLP-1s for weight loss. Meanwhile, the FDA is poised to force less expensive, compounded versions of these drugs off the market.

And the barrier to entry remains high, even for Medicaid patients in those few states that have agreed to cover the drugs without a federal mandate.

Case in point: In South Carolina, where more than one-third of all adults, and nearly half of the African American population, qualify as obese, the state Medicaid agency estimates only 1,300 beneficiaries will meet the stringent prerequisites for GLP-1 coverage.

Under one of those requirements, Medicaid beneficiaries who wish to access these drugs to lose weight must attest to “increased exercise activity,” said Jeff Leieritz, a spokesperson for the South Carolina Department of Health and Human Services.

Campbell, who is insured by Medicaid, was granted coverage for Wegovy based on her body mass index. First, though, she was required to submit six months’ worth of documentation proving that she’d tried and failed to lose weight after receiving nutrition counseling and going on a 1,200-calorie-a day diet, said Kenneth Mitchell, one of Campbell’s doctors and the medical director for bariatric surgery and obesity medicine at Roper St. Francis Healthcare.

Campbell’s Wegovy prescription was approved for six months, Mitchell said. When that authorization expires, Campbell and her health care team will need to submit more documentation, including proof that she has lost at least 5% of her body weight and has kept up with nutrition counseling.

“It’s not just, ‘Send a prescription in and they cover it.’ It’s rather arduous,” Mitchell said. “Not a lot of folks are going to do this.”

Mitchell said South Carolina Medicaid’s decision to cover these drugs was met with excitement among those working in his medical specialty. But he wasn’t surprised that the state anticipates relatively few people will access this benefit annually, since the approval process is so rigorous and the cost high. “The problem is the medicines are so expensive,” Mitchell said.

Novo Nordisk, which manufactures Wegovy, announced in March that it was cutting the monthly price for the drug from $650 to $499 for cash-paying customers. The price that health insurance plans and beneficiaries pay for these drugs varies, but some GLP-1s cost more than $1,000 per patient per month, Mitchell said, and many people will need to take them for the rest of their lives to maintain weight loss.

“That is a tremendous price tag that someone has to foot the bill for,” Mitchell said.

That’s the reason California Gov. Gavin Newsom on May 14 proposed eliminating Medicaid coverage of GLP-1s for weight loss starting Jan. 1, to save an estimated $680 million a year by 2028.

And the North Carolina State Health Plan Board of Trustees voted last year to end coverage of GLP-1s for state employees, after then-North Carolina Treasurer Dale Folwell’s office estimated in 2023 that the drugs were projected to cost the State Health Plan $1 billion over the next six years. The decision came only a few months after a separate North Carolina agency announced it would start covering these drugs for Medicaid beneficiaries. North Carolina Medicaid has estimated it will spend $16 million a year on GLP-1s.

South Carolina Medicaid, which insures fewer than half the number of people enrolled in North Carolina Medicaid, anticipates spending less. Leieritz estimated GLP-1s and nutrition counseling offered to Medicaid beneficiaries in South Carolina will cost $10 million a year. State funding will cover $3.3 million of the expense; the remainder will be paid for by matching Medicaid funds from the federal government.

In a recent interview, Health and Human Services Secretary Robert F. Kennedy Jr. didn’t rule out the possibility that Medicare and Medicaid might cover GLP-1s for obesity treatment in the future as costs come down.

They’re “extraordinary drugs” and “we’re going to reduce the cost,” Kennedy told CBS News in early April. He said he would like GLP-1s to eventually be made available to Medicare and Medicaid patients who are seeking obesity treatment after they have tried other ways to lose weight. “That is the framework that we’re now debating.”

Meanwhile, public health experts have applauded South Carolina Medicaid’s decision to cover GLP-1s. Yet the new benefit won’t help the vast majority of the 1.5 million adults in South Carolina who are classified as obese, according to data published by the South Carolina Department of Public Health.

“We still have some work to do,” acknowledged Brannon Traxler, the public health department’s chief medical officer.

But the state’s new “Action Plan for Healthy Eating and Active Living,” written by a coalition of groups in South Carolina, including the Department of Public Health, makes no mention of GLP-1s or the role they might play in lowering obesity rates in the state.

The action plan, underwritten by a $1.5 million federal grant, isn’t meant to lay out an overarching approach for lowering obesity in South Carolina, Traxler said. Instead, it promotes physical activity in schools, nutrition, and the expansion of outdoor walking trails, among other strategies. A more comprehensive obesity plan might address the benefits of surgical intervention and GLP-1s, but those also carry risk, expense, and side effects, Traxler said.

“Certainly, I think, there is a need to bring it all together,” she said.

Campbell, for one, is taking the comprehensive approach. On top of injecting Wegovy once weekly, she said, she is prioritizing protein intake and moving her body. She also underwent weight loss surgery in late April.

“Weight loss is my biggest goal,” said Campbell, who expressed appreciation for Medicaid’s coverage of Wegovy. “It’s one more thing that’s going to help me get to my goal.”

https://capitalbnews.org/medicaid-obesity-wegovy-south-carolina/



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PHARMA – Merck, Astellas Pharma, and Gilead Sciences Face Revenue Challenges Under New Drug Pricing Bill – GeneOnline News

PHARMA – Merck, Astellas Pharma, and Gilead Sciences Face Revenue Challenges Under New Drug Pricing Bill – GeneOnline News


Alternative Headline: Drug Giants Face Pricing Squeeze

[MM Curator Summary]: New drug pricing legislation — aiming to lower Medicaid drug reimbursements and government spending — threatens to significantly reduce revenues for Merck, Astellas Pharma, and Gilead Sciences.

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Merck, Astellas Pharma, and Gilead Sciences Face Revenue Challenges Under New Drug Pricing Bill

A recent analysis highlights the pharmaceutical companies that may face significant financial impacts from a new legislative measure referred to as the “One Big Beautiful Bill.” The legislation, which introduces substantial changes to drug pricing and Medicaid reimbursement policies, is expected to affect several major drugmakers, including Merck, Astellas Pharma, and Gilead Sciences. Industry experts are closely examining how these changes could reshape the financial landscape for these companies.

The bill reportedly targets high-cost medications and aims to reduce government spending on prescription drugs through revised Medicaid payment structures. Among the affected products are treatments for chronic conditions such as HIV prevention therapies. Companies like Gilead Sciences, known for its leadership in HIV treatment and prevention drugs, may see reduced revenue streams due to lower reimbursement rates under Medicaid. Similarly, Merck and Astellas Pharma could experience financial strain as their portfolios include medications that fall under the bill’s cost-reduction measures. Analysts suggest that these changes could lead to broader implications for drug pricing strategies across the industry.

Further details about the legislation’s impact on specific drugs and markets remain under review by stakeholders.

https://www.geneonline.com/merck-astellas-pharma-and-gilead-sciences-face-revenue-challenges-under-new-drug-pricing-bill/


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PHARMA – Pharma’s hoped-for tweak to US drug pricing controls excluded from Senate bill

PHARMA – Pharma’s hoped-for tweak to US drug pricing controls excluded from Senate bill


Alternative Headline: Orphan Drug Price Talks in Limbo

[MM Curator Summary]: The ORPHAN Cures Act, intended to shield multi-indication orphan drugs from IRA pricing talks, faces likely failure after exclusion from the Senate budget.

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The US Centers for Medicare & Medicaid Services’ power to negotiate certain drug prices under the Inflation Reduction Act (IRA) has been criticised by the pharmaceutical industry for myriad reasons. While drugmakers’ attempts to overturn the programme as a whole have been repeatedly rejected, a legislative fix was in the works to alleviate a specific pain point concerning orphan drugs — but the bill’s chances of making it into law are now looking slim.

Under the IRA, drugs that have been on the market for seven years — or 11 for biologics — are eligible for pricing negotiations. While therapeutics approved by the FDA for a single orphan indication were exempt, if the treatment was later cleared for a second rare disease, or a non-orphan indication, it could then be subject to pricing talks — with its on-market period calculated from its first orphan approval.

The ORPHAN Cures Act, introduced by Congressmen Don Davis and John Joyce into the US House of Representatives in February, aimed to expand the orphan drug exclusion so that therapeutics approved for multiple rare diseases would not be eligible for negotiations. Additionally, if an orphan drug subsequently was greenlit for a non-orphan indication, the timeline to determine its eligibility for pricing talks would be based on that second, non-rare disease approval. 

The Biotechnology Innovation Organization (BIO) trade group threw its support behind the ORPHAN Cures Act, saying that it would "ensure the continuation of essential research and development of new medicines for patients with rare diseases." BIO criticised the IRA’s current orphan drug provisions, claiming they "disincentivize companies to test whether existing treatments for rare diseases also benefit other rare diseases."

The ORPHAN Cures Act seemed to be making positive headway after it was included in the House’s 2025 budget, which was approved in May. However, it appears to have been excluded from the Senate’s version of the bill, per reconciliation text released by the finance committee this week. 

While the future of the ORPHAN Cures Act is uncertain, another piece of the IRA that has been widely criticised by industry — the so-called "pill penalty" discrepancy between when drugs and biologics are eligible for pricing negotiations — is looking more likely to be fixed. President Donald Trump signed an

executive order

in April directing Congress "to align the treatment of small molecule prescription drugs with that of biological products, ending the distortion that undermines relative investment in small molecule prescription drugs."

https://firstwordpharma.com/story/5973650



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PHARMA – Medicaid Denials and Nursing Shortages Force Parents to Provide Hospital-Level Care at Home – GeneOnline News

PHARMA – Medicaid Denials and Nursing Shortages Force Parents to Provide Hospital-Level Care at Home – GeneOnline News


Alternative Headline: Parents Fill Care Gap

[MM Curator Summary]: Families with medically complex children are forced to deliver hospital-level care at home due to Medicaid coverage gaps and nursing shortages.

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Medicaid Denials and Nursing Shortages Force Parents to Provide Hospital-Level Care at Home

Parents of children with complex medical needs are increasingly taking on hospital-level care at home due to gaps in Medicaid coverage and limited access to essential resources. Families report that Medicaid often denies or delays approval for necessary medical equipment, while shortages of trained nursing staff leave parents to manage intensive care responsibilities on their own.

Many parents describe significant challenges in obtaining durable medical equipment (DME) through Medicaid, citing frequent denials, lengthy approval processes, and difficulties working with suppliers. Additionally, families face a lack of qualified in-home nursing support, forcing some caregivers to take on round-the-clock duties themselves. One parent shared that they eventually stopped sleeping altogether to ensure their child received the required care. These issues highlight systemic barriers that leave families struggling to meet the complex healthcare needs of their children within the constraints of current policies and resources.

Newsflash | Powered by GeneOnline AI

https://www.geneonline.com/medicaid-denials-and-nursing-shortages-force-parents-to-provide-hospital-level-care-at-home/


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