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Severe asthma patients in New Mexico could face additional health care hurdles

Severe asthma patients in New Mexico could face additional health care hurdles

Yahoo30-04-2025

A recent insurance policy change in five states may mean patients with severe asthma could face additional delays, including in New Mexico. (Getty Images)
A recent policy change by the largest private insurer in New Mexico could result in patients with severe asthma facing additional delays for care.
So says Dr. Michelle Harkins, a pulmonary critical care doctor at the University of New Mexico Hospital, in response to a new policy rolled out earlier this month by Blue Cross Blue Shield that mandates asthma patients on a class of injectable drugs self-administer those drugs at home unless their doctors receive prior approval from the insurance company.
'Delaying care by constantly doing prior authorizations is always concerning, not just for asthma, but for the many other specialty medications,' Harkins said. 'We want to be able to provide the appropriate care to the right patient in a timely fashion to improve their quality of life.'
The change — which was effective immediately — applied only to patients in New Mexico, Texas, Illinois, Oklahoma and Montana, where Health Care Service Corporation operates Blue Cross Blue Shield, and excludes patients on Medicare, the public health insurance for people 65 and older or Medicaid, which insures low-income people and families, the company said.
The company's officials declined an interview with Source NM.
'Health Care Service Corporation is committed to expanding access to quality, cost-effective physical and behavioral health care. We updated medical policies for some medications that are FDA-approved for self-administration,' Business Manager Amanda Douglas said in a written statement. 'Our policy revision was made with the interests of our members in mind — promoting access to treatment that is convenient and effective.'
Douglas further wrote that patients can contact the company with questions using the number on their member ID or log in to the website Blue Access.
The policy change applies to four medications all in a class of complex drugs called biologics that are expensive to produce and in high demand for treatments for rheumatoid arthritis, asthma and other inflammatory conditions. A year of treatment can cost tens of thousands of dollars for monthly or semi-monthly injections.
Asthma, a chronic lung disease characterized by inflammation and hyper-reactive airways that can cause shortness of breath, coughs, wheezing and chest tightness, affects about 25 million adults and children nationwide.
New Mexico's asthma rate is about equal to national levels, according to Deyonne Sandoval, a coordinator and evaluator for the state Department of Health's Environmental Public Health Tracking program.
'Asthma is a complex, highly prevalent costly health condition that affects people in New Mexico statewide,' Sandoval told Source, noting that in 2023, 9.7% of New Mexico adults — about 162,000 people — reported having asthma, and an estimated 1 in 13 children is diagnosed with asthma in the state.
Numbers aren't broken down by severity, Sandoval said.
A variety of factors can cause asthma, including: genetics, allergies and exposure to certain types of chemicals or other elements that can prompt asthma over time at home or in workplaces.
'In New Mexico, adults and children living in households making less than $25,000 tend to have a high prevalence and poorly controlled asthma,' Sandoval said. National health research attributes high prevalence of asthma to lower-quality housing, which can harbor more triggers, such as mold, poor ventilation and various allergens.
The New Mexico Department of Health recommends anyone diagnosed with asthma to immediately work with a doctor to explore medications, reduce potential triggers and create an asthma management plan.
The insurance changes target medications for patients with very severe asthma, Harkins said.
Patients manage asthma with a variety of medications, depending on the severity, with some medicine used as-needed, daily medication or other long-acting medications to open up airways. But even then, that may not be enough.
'Typically, when a patient is on full therapy and they're still having problems — needing the rescue inhaler several times a day, or they're waking up at night or their asthma is not well-controlled — then I may start to look at using a biologic,' Harkins said.
Harkins established UNMH's severe adult asthma clinic; has assisted the state with its health study on the rate of disease in adults and children; and currently treats patients with asthma.
Has the recent Blue Cross Blue Shield change on biologics affected you? Email reporter Danielle Prokop, or call or text (505) 226-2663.
She said these drugs can be 'a game-changer' for people with severe asthma. Biologics already requires insurance companies permission to prescribe, so the new requirement adds additional red tape.
Harkins said she and her office staff have to spend a significant amount of time justifying the use of biologics in current patients: printing out notices, submitting for review, potentially appealing a denial.
'Sometimes it'll take three or four times before the use of a drug is approved,' she said.
Biologics not only require permission for initial prescription, they require renewal every year.
Harkins said she understands these are expensive treatments, and that insurance companies want to ensure patients actually need them.
'But then to ask for yet another prior authorization on top of the prior authorization for medications is always a concern, because so much of our time in the clinic is spent justifying why this patient deserves this medication, why we think it's the best,' Harkins said.
Side effects from biologics are often minor: rashes, dry eyes, joint pains or irritation at the injection site. But very rarely, this class of drugs can cause anaphylaxis, a life-threatening tightening of the airways that can lead to cardiovascular collapse.
This rare, severe reaction usually happens at the beginning of treatments, so Harkins said she always starts new biologics patients on injections in the office. Since the treatments can last years, some patients subsequently opt to take them at home.
'For those patients that take their biologics at home, I have prescribed them an EpiPen, something to treat anaphylaxis, in case anything happens, they can self-administer,' she said.
Harkins said the changes have not caused an impact for her yet, but she's had several patients undergoing the prior authorization process just to access the medication. She worries they'll face further delays in receiving care.
'These kinds of decisions take the decision-making between the doctor and the patient away,' she said.
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Medera and Novoheart Presented Breakthroughs in Human mini-Heart Platforms and Gene Therapy at ISSCR 2025
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Medera and Novoheart Presented Breakthroughs in Human mini-Heart Platforms and Gene Therapy at ISSCR 2025

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Featured Oral Presentation 'Gene Therapy Clinical Trial for Heart Failure with Preserved Ejection Fraction (MUSIC-HFpEF) Informed by In Vitro Screening with Stem Cell-Based Bioengineered Mini-Hearts' (Abstract #2036995)Track: Clinical ApplicationsPresenter: Dr. Kevin Costa, co-founder of NovoheartThis presentation showcased how data generated from Novoheart's human mini-Heart platform informed both the FDA's Investigational New Drug (IND) approval and Fast Track Designation of the MUSIC-HFpEF gene therapy trial (NCT06061549). The trial is investigating SRD-002, a one-time gene therapy treatment delivered through proprietary minimally invasive intracoronary infusion methodology. The FDA's recognition of these in vitro human cardiac models reflects a broader regulatory embrace of non-animal technologies to advance safer and more targeted therapies, in line with new federal policy. 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Missouri should establish a commission on boys and men
Missouri should establish a commission on boys and men

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Missouri should establish a commission on boys and men

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BioRestorative Reports Compelling Preliminary Data for FDA-Fast-Tracked BRTX-100 – an Autologous Stem Cell Therapy to Treat Chronic Lumbar Disc Disease
BioRestorative Reports Compelling Preliminary Data for FDA-Fast-Tracked BRTX-100 – an Autologous Stem Cell Therapy to Treat Chronic Lumbar Disc Disease

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BioRestorative Reports Compelling Preliminary Data for FDA-Fast-Tracked BRTX-100 – an Autologous Stem Cell Therapy to Treat Chronic Lumbar Disc Disease

– The International Society for Stem Cell Research ('ISSCR') 2025 Annual Meeting is the world's foremost gathering of stem cell and regenerative medicine leaders – – Updated data presented at ISSCR 2025 demonstrates >50% improvement in pain and function in a significant portion of cLDD subjects – – Number of evaluated subjects increases by more than two-fold since last update –– MELVILLE, N.Y., June 13, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ('BioRestorative,' 'BRTX' or the 'Company') (NASDAQ: BRTX), a clinical-stage regenerative medicine company developing stem cell-based therapies for serious musculoskeletal conditions, today announced the presentation of promising preliminary blinded data from the first 36 subjects in its ongoing Phase 2 clinical trial of BRTX-100, an autologous stem cell therapy for chronic lumbar disc disease (cLDD). 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Compelling Clinical Signals: Over 74% of subjects showed >50% improvement in function (ODI) by 52 weeks; Over 72% of subjects reported >50% reduction in pain (VAS) by 52 weeks; Combined >50% improvement in both ODI and VAS measures was achieved by a meaningful portion of subjects across all timepoints. Excellent Safety Profile: No serious adverse events (SAEs) or dose-limiting toxicities reported between 26 and 104 weeks at the target dose (40 million cells). Strengthening Data: Each new data analysis has outperformed prior releases, highlighting an upward trend in efficacy markers. The following is a detailed breakdown of the subjects that had greater than 50% improvement in function, as measured by ODI, greater than 50% decrease in pain, as measured by VAS, and greater than 50% improvement in both ODI and VAS: Week Percentage of Subjects With >50% Average Improvement in ODI Percentage of Subjects With >50% Average Improvement in VAS Number of Subjects With >50% Average Improvement in Both ODI and VAS Baseline 0.00 % 0.00 % 0/36 12 67.57 % 73.82 % 5/25 26 74.04 % 76.94 % 6/15 52 74.63 % 72.35 % 8/10 104 75.13 % 68.54 % 2/4 'With every new analysis, our confidence grows that BRTX-100 is positioned to meet and potentially exceed the FDA's functional and pain reduction thresholds,' said Lance Alstodt, Chief Executive Officer of BioRestorative. 'We are excited by the trajectory of this material milestone and its potential to address a massive unmet need in chronic lower back pain — one of the largest global healthcare burdens. 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As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we also operate a commercial BioCosmeceutical platform: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person's own) cultured mesenchymal stem cells collected from the patient's bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient's bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient's damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained U.S. Food and Drug Administration ('FDA') Investigational New Drug ('IND') clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain. • Metabolic Program (ThermoStem®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells ('BADSC') to generate brown adipose tissue ('BAT'), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss. • BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging BioCosmeceuticals space. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements. CONTACT: Stephen KilmerInvestor RelationsDirect: (646) 274-3580 Email: skilmer@

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