TMJ 'dysfunction' - Health implications

Alemtuzumab,Ofatumumab

The cost of the drug is £7045 per vial, this equates to £35,225 for the 5-day course in year 1 and £21,135 for the second and subsequent courses. About 65% of alemmtuzumab-treated MSers will need just 2 courses over 5-years, 25% 3 courses, 10% 4 courses and very few 5 courses. In addition to the cost of the drug there are all the costs associated with infusions, treatment of infusion reactions, monthly blood monitoring, annual MRI scans and the treatment of the autoimmune complications.

AND the benefit?
Unknown!

April 19, 2021
And the newest drug to be introduced:
Kesimpta (ofatumumab) has been approved in the U.K. as the first self-administered, at-home, B-cell-targeting therapy for people with relapsing forms of multiple sclerosis (MS) and active disease.

More specifically, the approval includes patients with either clinically isolated syndrome, relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS), who have been experiencing relapses or showing new lesions on MRI scans.

This approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) follows similar decisions in the E.U., the U.S., Canada, Switzerland, Singapore, Australia, Japan, Argentina, the United Arab Emirates, Albania, and India.

The U.K.’s National Institute for Health Care and Excellence (NICE) and the Scottish Medicines Consortium now will decide whether to add Kesimpta to their respective National Health Service (NHS), which would allow patients to access treatments at low or no cost. NICE’s decision is expected in the coming weeks, and a determination for Scotland will be issued later this year.

“We are very pleased that ofatumumab has been granted a UK licence,” David Martin, CEO of the MS Trust, said in an organization press release. “Ofatumumab is an effective treatment which people take at home once a month and will be a useful alternative to other disease modifying drugs which require treatment in hospital clinics.”

Kesimpta, developed by Novartis, is an antibody therapy that binds the CD20 receptor on the surface of immune B-cells — a type of immune cell involved in the abnormal immune responses that drive MS — promoting their death.

While its mechanism of action is similar to that of Ocrevus (ocrelizumab) and other B-cell targeted therapies, Kesimpta is the first treatment of its kind that can be self-administered at home, using the Sensor ready autoinjector pen. This gives patients a more convenient method of taking the medication.

The three initial doses of Kesimpta are administered once a week, and treatment is given once a month thereafter. The first injection must be performed under the guidance of a healthcare professional.

The wholesale acquisition price of Kesimpta has been announced as $83,000 per year.

And the benefit?
Remains to be seen!

However, in the USA the costs are:

The cost for Kesimpta subcutaneous solution (20 mg/0.4 mL) is around $7,819 for a supply of 0.4 millilitres, depending on the pharmacy you visit. This amounts to $109,466 per year! Prices are for cash paying customers only!

Latest info on Kesimpta:
Cost: The cost of Kesimpta varies significantly based on insurance, discounts, and where it's being bought from. Generally, it can cost anywhere from $6500 to $8500 for one dose, but without insurance, it could cost up to $26,000 to $39,000 per year.

Proof of Benefit: Kesimpta (ocrelizumab) has been shown in multiple clinical trials to be an effective treatment for Multiple Sclerosis (MS). A study published in The New England Journal of Medicine showed that it reduced annual relapse rates by almost 50%, decreased disability progression, and reduced new or enlarging brain lesions in people with relapsing forms of MS. Another study published in The Lancet showed similar results for people with primary progressive MS.

Adverse Reactions: Some common adverse reactions of Kesimpta include upper respiratory tract infections, infusion-related reactions (like fever, headache, rash, and nausea), skin infections, and lower respiratory tract infections. Rare but serious adverse reactions can include hepatitis B reactivation and progressive multifocal leukoencephalopathy (MLN), a rare brain infection that can lead to severe disability or death. Kesimpta may also increase the risk of cancers like breast cancer and skin cancer.

Note: While Kesimpta does offer a potentially effective treatment for people with MS, it is also accompanied by a risk of significant side effects. Patients should thoroughly discuss these risks with their healthcare providers. Also, I believe the information I provided regarding Kesimpta might be confused with Ocrevus. Kesimpta (ofatumumab) and Ocrevus (ocrelizumab) are both medications used to treat multiple sclerosis (MS), but they are different medications. So, the prices and findings of clinical trials of one medication can't be accurately attributed to the other one.

COMMENT: The purported benefits are no better than a joke, as are the names of the drugs. MS symptoms are almost entirely related to a dysfunctional jaw and effortlessly managed. A proper controlled study can prove this every time.

I came across another article already sited elsewhere on this forum:[/b]

http://www.alternet.org/story/153332/se ... age=entire

"Supply-driven marketing, also known as "Have Drug, Need Disease and Patients” not only turns the nation into pill-popping hypochondriacs, it distracts from Pharma's drought of real drugs for real medical problems. Of course, not all diseases are Wall Street pleasers. To be a true blockbuster disease, a condition must:

(1) Really exist but have "huge diagnostic wiggle room" and no clear-cut test.
(2) Be potentially serious with "silent symptoms" said to "only get worse" if untreated,
(3) Be "under recognised", "underreported" with "barriers" to treatment,
(4) Explain hitherto vague health problems a patient has had,
(5) Have a catchy name like ED, ADHD, RLS, Low T or IBS and instant medical identity, and
(6) Need an expensive new drug that has no generic equivalent."

My experience shows that perhaps ME/CFS, FM, MS, RA and so on should also be added to these "incurable" diseases that need expensive permanent medication till death do us part!