US allows increased production of Takeda’s ADHD drug to address shortage

US allows increased production of Takeda’s ADHD drug to address shortage

https://www.reuters.com/business/healthcare-pharmaceuticals/us-allows-increased-production-takedas-adhd-drug-address-shortage-2024-09-04/

The U.S. Drug Enforcement Administration (DEA) has increased the production limit for Takeda Pharmaceutical’s (4502.T)

ADHD drug Vyvanse and its generic versions by about 24% to address the medicine’s ongoing shortage in the United States.
The raised production limit follows the Food and Drug Administration’s request in July, the DEA said in a notice on Tuesday.
Attention deficit hyperactivity disorder (ADHD) drugs have been in short supply for years. The FDA warned of a shortage of Israel-based drugmaker Teva Pharmaceutical Industries’ (TEVA.TA)
Adderall in October 2022, troubled by manufacturing delays.
That led to a spike in demand and subsequent shortage of Takeda’s Vyvanse.
Vyvanse, also known as lisdexamfetamine, is classified by the DEA as a schedule II controlled substance, which is applied to drugs considered to have a high likelihood of being abused, and additional prescribing safeguards are put in place.
The production limit for lisdexamfetamine was increased by 6,236 kilograms (kg), which includes 1,558 kg to address increased domestic demand and 4,678 kg for increased foreign demand for finished dosage medications, according to the DEA.
“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” DEA said.
US FDA approved generic versions of Vyvanse from 11 drugmakers, including U.S.-based drugmakers Mallinckrodt and Viatris (VTRS.O)

UK-based Hikma Pharmaceuticals (HIK.L) and Indian drugmaker Sun Pharmaceutical Industries (SUN.NS)

last year after Takeda lost exclusivity over the drug.

September is Chronic Pain & Suicide Awareness month


National Suicide Prevention Awareness Month - Volunteers ...

OMG he is US!

I just want to say the following sucks 1. My Retirement. Ok really this time! #1 Goverment #2 Healthcare #3 with my sick kids again! #4 I have No Snacks! #5 And of course life now and again

Donald Trump Opens Up to Dr. Phil in Latest Interview | Dr. Phil Primetime

Pain Identified as Dominant Symptom in Long COVID

Pain Identified as Dominant Symptom in Long COVID

https://reachmd.com/news/pain-identified-as-dominant-symptom-in-long-covid/2467986/

Pain may be the most prevalent and severe symptom reported by individuals with long Covid, according to a new study led by UCL (University College London) researchers.

The study, published in JRSM Open, analysed data from over 1,000 people in England and Wales who logged their symptoms on an app between November 2020 and March 2022.

Pain, including headache, joint pain and stomach pain, was the most common symptom, reported by 26.5% of participants.

The other most common symptoms were neuropsychological issues such as anxiety and depression (18.4%), fatigue (14.3%), and dyspnoea (shortness of breath) (7.4%). The analysis found that the intensity of symptoms, particularly pain, increased by 3.3% on average each month since initial registration.

The study also examined the impact of demographic factors on the severity of symptoms, revealing significant disparities among different groups. Older individuals were found to experience much higher symptom intensity, with those aged 68-77 reporting 32.8% more severe symptoms, and those aged 78-87 experiencing an 86% increase in symptom intensity compared to the 18-27 age group.

Gender differences were also pronounced, with women reporting 9.2% more intense symptoms, including pain, than men. Ethnicity further influenced symptom severity, as non-white individuals with long Covid reported 23.5% more intense symptoms, including pain, compared to white individuals.

The study also explored the relationship between education levels and symptom severity. Individuals with higher education qualifications (NVQ level 3, 4, and 5 — equivalent to A-levels or higher education) experienced significantly less severe symptoms, including pain, with reductions of 27.7%, 62.8%, and 44.7% for NVQ levels 3, 4 and 5 respectively, compared to those with lower education levels (NVQ level 1-2 — equivalent to GCSEs).

Socioeconomic status, as measured by the Index of Multiple Deprivation (IMD), also influenced symptom intensity. Participants from less deprived areas reported less intense symptoms than those from the most deprived areas. However, the number of symptoms did not significantly vary with socioeconomic status, suggesting that while deprivation may exacerbate symptom intensity, it does not necessarily lead to a broader range of symptoms.

Lead author Dr David Sunkersing (UCL Institute of Health Informatics) said: “Our study highlights pain as a predominant self-reported symptom in long Covid, but it also shows how demographic factors appear to play a significant role in symptom severity.

“With ongoing occurrences of Covid-19 (e.g., LB.1, or D-FLiRT variants), the potential for more long Covid cases remains a pressing concern. Our findings can help shape targeted interventions and support strategies for those most at risk.”

In the paper, the researchers called for sustained support for long Covid clinics and the development of treatment strategies that prioritise pain management, alongside other prevalent symptoms like neuropsychological issues and fatigue.

Given the significant impact of demographic factors on symptom severity, the study underscored the need for healthcare policies that addressed these disparities, ensuring equitable care for all individuals affected by long Covid, the researchers said.

Study limitations included a lack of information on other health conditions participants may have had and a lack of information about health history. The researchers cautioned that the study may have excluded individuals with very severe Covid and those facing technological or socioeconomic barriers in accessing a smartphone app.

The study was led by the UCL Institute of Health Informatics and the Department of Primary Care and Population Health at UCL in collaboration with the software developer, Living With Ltd.

Oversight Chair Knocks PBM Execs for July Testimony Under Oath

Oversight Chair Knocks PBM Execs for July Testimony Under Oath

https://ncpa.org/newsroom/news-releases/2024/08/28/oversight-chair-knocks-pbm-execs-july-testimony-under-oath

Calls on them to provide any necessary corrections to the record within three weeks

Isn’t lying under oath called perjury? According to this article, three top execs of the 3 largest PBMs LIED under oath to the  House Committee on Oversight and Accountability

Chairman James Comer (R-Ky.) called on executives from Express Scripts, CVS Caremark, and OptumRx to correct the record for statements.

What kind of political BS is this, the law says a fine or FIVE YEARS IN PRISON. Those corporations will pay just about any fine that would be imposed. Each of those companies are worth hundreds of millions each.  Throw those 3 exec’s ass in JAIL FOR 5 YEARS and watch all those PBMs rapidly start changing their processes.  Repeal the   https://en.wikipedia.org/wiki/ McCarran%E2%80%93Ferguson_Act McCarran–Ferguson Act  gives the insurance industry an exemption to the Sherman Antitrust Act and then let the FTC have their way with the monopolistic practices of our insurance industry.

ALEXANDRIA, Va. (Aug. 28, 2024) – The National Community Pharmacists Association released the following statement from CEO B. Douglas Hoey, pharmacist, MBA, after House Committee on Oversight and Accountability

Chairman James Comer (R-Ky.) called on executives from Express Scripts, CVS Caremark, and OptumRx to correct the record for statements they made under oath during their appearance before the committee in July:

“PBM-insurers’ days of reckoning are continuing. Congress and the FTC aren’t falling for their nonsense, and the heat on them has never been higher. PBM-insurers exert so much influence on which drugs patients have access to and how much they cost that calling out their mistruths and working to hold them accountable is critical, and we applaud Chairman Comer for doing so. We also need to emphasize that Congress must absolutely pass PBM reforms this year. The time for waiting is over because PBM-insurers showed they will fudge the truth wherever they can and they’ll only change their ways if they are forced.”

In a statement released after the July hearing, Hoey called out

the excuses and at times downright lies the PBM executives were attempting to feed members of the committee about the roles their organizations play in increasing prescription costs and decreasing patient access to health care.  

Making sure to note that under the law,

those who are untruthful in committee testimony under oath run the risk of a fine or five years of imprisonment,

Comer’s letters to the PBM executives specifically highlight their statements that contradict the committee’s and the Federal Trade Commission’s findings about the PBMs’ self-benefitting practices that jeopardize patient care, undermine local pharmacies, and raise prescription drug prices; claims that they do not steer patients to PBM-owned pharmacies; and claims contradicting the committee’s and FTC’s findings regarding contract negotiations, contract opt-outs, and payments to pharmacies. The committee is asking the big three PBMs to provide their corrections to the record by Sept. 11, 2024.

Dr. Mark Ibsen describes his experience being targeted for treating pain

A teachable moment

I have been wanting to post about this but waited till there was some progress. Back the end of Jan 2024 Barb ended up having lumbar surgery. Her pain had reached a level that even upping her doses of opioids over several months could not suppress her increased pain.

She debated on having the surgery for several months before relenting to having it done. The Surgeon what we chose, was recommended by the surgeon that had done my partial knee replacement in mid-2023.

This surgeon is an employee of a very large and very well known and respected ortho surgeon group that has been around for maybe 5+ decades, and the practice is owned by one of the three major hospital system in a city that is the largest city in the state and there is also a nearby medical school.

Barb went back for a 6 weeks follow up. The surgeon seem to start off with THE INCISION IS INFECTED!  After we expanded our pharmacy into providing home medical equipment and then we started dealing with pts who were bed or wheelchair confined and experiencing “bed sores” and/or “decubitus ulcers“. Barb got the opportunity to get certified as a tissue therapist. So she could help pts and their caregivers try to prevent those decubitus ulcers and/or help them to heal those if they already had them. She knew the outwards signs if a broken skin, bedsore, surgical incision was infected, and I learned them via osmosis being married to her.  I knew from clinical standpoint what lab tests would suggest that the pt had an infected decubitus.  A infected decubitus typically had necrotic (dead) tissue around the perimeter, had a bad odor, their blood work should show elevated white blood cell count and pts would have at least a low grade elevated temp.

Barb’s labs nor her surgical incision showed any indication that it was infected, but the surgeon was insistent that he had to debride Barb’s incision STAT.. sent her directly from his office to the hospital and had her admitted. Two days later she was in surgery again. While Barb “survived” the surgery. The overall care that Barb received was no where ideal nor close to best practices and standard of care.

https://www.cms.gov/medicare/quality/quality-improvement-organizations

The above organization QIO, followups on complaints from Medicare pts and the pt’s care in a hospital environment.  I filed a complaint with this organization around the end of April 2024 and just got a return phone call from one of their representatives, as a follow up. This representative was basically quoting from the physician reviewer report/summary. First of all the ortho surgeon NEVER provided any of Barb’s medical records from his practice. The representative said that, my complaints would be forward on to CMS (Center for Medicare/Medicaid Services) to deal with the ortho surgeon’s lack of response of providing medical records.

Most of what I heard, was the reviewer could not document most of my complaints from the medical records from the various providers, starting with the hospital itself down to several vendors who provided Barb’s home services.

When all was said and done, the representative told me that I could have a second reviewer to look over my complaints and also said that I could add any more information.  I had provided them with 7-8 pages of  typed (word processor) detailed complaints and I told the representative that I felts that my complaint was VERY DETAILED!

There was a pause in the conversation and then the representative said “that is a good description”. I asked the representative that if I asked for another reviewer to look at my complaint that if I could ask that the reviewer focus on the what appeared to be that most of the medical documentation – IMO – did not come close to what I understand as what should be a standard of care and best practice.   The representative stated that she would state that and highlight it on my request for a second reviewer to evaluate the quality of medical records that were provided.

Apparently the jury is still out!

 

 

Don’t expect a medicare insurance broker to recommend Centene Medicare Part D prgm

Centene to end Part D broker payments

https://www.beckerspayer.com/payer/centene-ends-part-d-broker-payments.html

Centene will no longer pay commission to insurance brokers enrolling or renewing members in its Medicare Part D plans. 

In a message sent to brokers, published Aug. 25 on Pinnacle Financial Services, Centene said it will continue paying compensation to brokers enrolling members in its Wellcare Medicare Advantage plans. 

In its message, Centene said the Inflation Reduction Act has resulted in “significant changes” to Part D. 

“To continue providing access to high-quality healthcare and Part D coverage that helps families and individuals, we have made a difficult decision — effective Jan. 1, 2025 — to cease new and renewal commissions for PDP beginning with the 2025 plan year,” Centene wrote to brokers. 

In 2024, provisions of the Inflation Reduction Act that eliminate copays for Part D beneficiaries who enter the catastrophic phase of coverage took effect. In 2025, a $2,000 out-of-pocket spending cap will apply to Part D members. 

Medicare Advantage and Part D plans pay brokers compensation for new enrollments and renewals in their plans. 

Jessica Brooks-Woods, CEO of the National Association of Benefits and Insurance Professionals, said in an Aug. 27 statement the decision to cut commissions “threaten not only the livelihoods of Medicare agents but also the communities they serve and the seniors who rely on their expert guidance.” 

The association has reached out to Centene leaders, Ms. Brooks-Woods said, as the decision sets a precedent. 

“We invite the leaders to talk about how these decisions will affect Medicare beneficiaries and their families,” Ms. Brooks-Woods said. “We are asking important questions and looking at all possible options to make sure our seniors and their trusted partners are protected.” 

Centene was the fourth largest Medicare Part D plan sponsor in 2023, according to KFF. The company had 6.6 million Part D members as of June. 

The insurer will also exit six Medicare Advantage markets next year. Centene will no longer offer its Wellcare MA plans in Alabama, Massachusetts, New Hampshire, New Mexico, Rhode Island and Vermont, but will continue to offer prescription drug plans in those states.

Becker’s has reached out to Centene for comment and will update this article if more information becomes available.