Monday, January 23, 2023

Why Is There A Shortage Of Bcg For Bladder Cancer

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Q: Why Is There A Shortage Of Bcg

Management of BCG Unresponsive Cystectomy Ineligible Bladder Cancer Patients Pembrolizumab

A. Merck & Co., Inc. is the sole maker and supplier of BCG to the United States. They are also the only source of BCG to many other countries around the world.

Although Merck has boosted its production of BCG by more than 100 percent and is producing the drug to the fullest extent of their manufacturing capacity, they are not able to sustain the increasing global demand of this product. This has led to supply constraints and a BCG shortage.

Bladder Cancer And Its Symptoms

Bladder cancer is an invasive type of cancer that develops within the bladder. It affects the cells in the bladder and progresses slowly. When the cancerous cells spread to other parts of the body, it is referred to as metastasized bladder cancer.

The symptoms of bladder cancer are often vague or non-existent and so it can be hard to detect or diagnose. The symptoms depend on where the cancer is in the bladder i.e., whether it is contained only in the bladder or it has spread to other parts of the body.

The signs you should look out for include frequent urination, blood in the urine, pressure in your bladder and pain when urinating.

When cancer spreads out of the bladder, it is called metastasis. The most common place for metastasis of bladder cancer is in the bones, lymph nodes, liver and lungs. The symptoms of bladder cancer from its initial stage to the advanced stage include dizziness, difficulty in breathing, rashes, joint pain and in rare cases fever.

Persistent Bcg Shortages Lead To Hard Choices In Bladder Cancer

Andrew D. SmithOncologyLive

The Tice strain of BCG has emerged as a go-to drug for treating primary and recurrent bladder cancer, but in the United States and some other countries, a constellation of marketplace dynamics has reduced manufacturers of this agent to a sole producer that is unable to keep up with demand. Available supplies are being rationed, and sufficient expansion of supply could be years away.

Edward Messing, MD

Over the years, the Tice strain of bacillus CalmetteGuérin has emerged as a go-to drug for treating primary and recurrent bladder cancer, but in the United States and some other countries, a constellation of marketplace dynamics has reduced manufacturers of this agent to a sole producer that is unable to keep up with demand. Available supplies are being rationed, and sufficient expansion of supply could be years away.

BCG is indicated for the treatment and prophylaxis of carcinoma in situ of the urinary bladder and for the prevention of primary or recurrent stage Ta or T1 papillary tumors following transurethral resection. Multiple strains of BCG are produced worldwide, but just Merck produces BCG Ticecurrently the predominant, if not only, strain available in the US market.

Studies have not quantified the damage done by prior shortages, so its hard to estimate the likely impact of this shortage or the shortages that experts expect to occur periodically during future years. However, each shortage of BCG has common elements .

Origins of BCG

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After Your Bcg Treatment

If thecatheter was left in the bladder during your treatment, the BCG will be drainedback into a bag before the catheter is removed.

If you wouldlike something to drink you can now do so.

Sex youshould abstain from intercourse/oral sex for 2-3 days after each treatment. Theuse of condoms thereafter is advised and should continue to be used for severalweeks after your treatment has been completed.

Pregnancy -the effects on pregnancy are unknown. If you are planning to have children youshould discuss this with your doctor as female patients of child bearing ageare advised to use birth control during treatments and to wait at least 2 yearsbefore conceiving, longer if on maintenance treatment.

Breastfeeding is not advised when having BCG treatment

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Q: How Is Merck Determining How Much Bcg Each Physician Office In The United States Will Receive During This Shortage

BCG vaccine is priced too low  now, shortage for bladder cancer

A. As the sole supplier of BCG to the United States, Merck is allocating the quantity of available supply across states based on historical demand.

To minimize disruption to patient care, in January, Merck announced an immediate change to their BCG distribution model, and began allocating BCG exclusively to wholesalers and distributors based on product supply and historical purchasing patterns of physicians and hospitals. Wholesalers and distributors in turn, began utilizing the same allocation model to fulfill physician and hospital orders directly.

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Supply Chain Challenges: Lessons From Bcg

Experts say that shortages of Bacillus Calmette-Guérin , the treatment of choice for treating high-risk nonmuscle invasive bladder cancer , will not be ending any time soon, meaning clinicians need to understand and adhere to new guidelines that direct the drug to patients most in need.

Shortages have been an on-again, off-again problem for years. For a long time, two large companies, Merck and Sanofi Pasteur, were making it in the U.S., but since 2017, only one of them has been supplying it, explained Sam Chang, M.D., Patricia and Rodes Hart Professor of Urologic Surgery at Vanderbilt University Medical Center. Chang chaired development of the most recent national guidelines for bladder cancer which seek to risk-stratify NMIBC patients and improve BCG utilization.

Supply Still Limited In Us

Approached by Medscape Medical News for comment, Alexander Kutikov, MD, chief of urologic oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, confirmed that for many centers in the United States, the supply of BCG is still limited.

At his own center, which is a high-volume facility, “the supply is being delivered to us preferentially, so we’ve been able to keep our heads above water and continue to treat our own patients as well as referrals from other practices that are out of BCG right now,” he noted.

However, the supply of BCG is not infinite anywhere in the United States, “so we’re doing dose reduction routinely as well,” he added.

The main difference Kutikov sees between Brazil and the United States regarding recommendations for use of BCG during periods of shortage is what he describes as the “luxury” that countries such as Brazil have in being able to import strains of BCG other than the ones produced in their own country.

“The US is locked out of everything but the Tice strain, so Tice is the only FDA-approved strain in the US, but in Brazil, this is one of the ways they are suggesting to try and augment their own supply,” Kutikov explained.

Kutikov also felt that it was interesting that Brazilian researchers appear to be advocating use of intravesical gemcitabine as a good alternative to BCG.

“Usually, BCG has been tested against mitomycin,” he explained.

“In this space, gemcitabine appears to have similar efficacy to mitomycin,” Kutikov noted.

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What Can I Expect Following Treatment

You may be advised to drink plenty of fluid to flush the rest of the medication from your bladder.

For six hours after each treatment, youll have to be very careful when you urinate to avoid transmitting BCG to others. Men should urinate while seated to avoid splashing.

Disinfect the urine by adding 2 cups of bleach into the toilet. Let it stand for about 20 minutes before flushing. You should also wash your genital area very carefully after you urinate, so your skin doesnt become irritated from the BCG. Wash your hands thoroughly, too.

Men can pass BCG to their partner during sex. For that reason, you should avoid sex for 48 hours after each treatment. Use a condom between treatments and for six weeks following your final treatment.

Women should avoid getting pregnant or breastfeeding while on BCG therapy.

Treatment is usually given every week for six weeks. After that, you might need to do it once a month for six months to a year.

One benefit of BCG is that while it affects the cells in your bladder, it doesnt have a major effect on any other part of your body. But there can be a few side effects such as:

When comparing BCG to other bladder cancer treatments, its important to remember that treatment isnt the same for everybody. Some of the factors that determine your options are:

  • type of bladder cancer

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A Brief History Of The Problem

BCG dosing for bladder cancer: Standard frequency schedule correct

BCG supplies have been dwindling. In 2011, the FDA temporarily stopped production at Sanofi Pasteurs Toronto BCG plant because of quality issues. An inspection had revealed mold in the production area, the result of natural flooding. In 2017, Sanofi Pasteur chose to cease the drugs production permanently.

Its not easy to make BCG, Chang said. Its a bacteria that grows slowly, and it has to be kept sterile. Its like a generic drug theres no patent on it and little profit in its production and sale.

BCG was first used to successfully treat bladder tumors in 1976, and quickly became the gold standard therapy to avoid recurrence and progression.

The authors of a recent systematic review published in Cancer Medicine noted that BCG is considered the most effective therapy for bladder cancer they stated that in 68.1percent of patients treated with BCG, a complete initial response rate is achieved and that 46.7 percent of BCG-treated patients remained free of disease upon follow-up at a median of 3.6 years.

Its not easy to make BCG its a bacteria that grows slowly, and it has to be kept sterile. Theres no patent on it and little profit in its production and sale.

Different strains of BCG are used clinically in different parts of the world. In the U.S., currently only the Tice BCG substrain has FDA approval. There are no good alternative drugs to replace BCG, Chang says.

Also Check: How To Detect Bladder Cancer Early

Figure 2 Randomized Phase Iii Trial Of Bcg Tokyo Versus Tice15

BCG studies conducted since then have reported wildly different efficacy rates, ranging from 0% to 80%. This is attributed to genetic variability among the many BCG strains produced around the world. A meta-analysis published in 1994 concluded that, on average, the vaccine reduces TB risk by about 50%.4 This mediocre efficacy explains why TB remains a major disease and why, in low-risk countries such as the United States, health authorities only recommend BCG vaccine for small populations with elevated TB risks. BCG studies conducted in the 1950s made the surprising discovery that vaccinated animals contracted cancer less frequently than their unvaccinated counterparts. The first practical application for this finding came in 1976, when Morales et al published a landmark study on BCG in 9 patients with recurrent superficial bladder tumors that found that the vaccine favorably altered recurrence patterns.5 Results of larger trials confirmed the finding, and BCG has been a significant therapy for non-muscle invasive bladder cancer ever since.

At the University of Rochester Medical Center, for example, doctors are giving full induction courses of BCGboth in terms of total bladder instillations and dosage per instillationbut they are not giving patients any maintenance therapy with the vaccine. Patients who see recurrences or progression receive chemotherapy or undergo surgeries to remove part or all of their bladders.

New Strain Of Bcg Could End Drug Shortage In Canada

Bladder cancer patients across Canada welcome the news of a new strain of Bacillus Calmette-Guerin on the Canadian market.

BCG is the most common type of immunotherapy inserted directly into the bladder for treating early-stage bladder cancer. Its used to help stop cancer from growing and prevent it from coming back. Originally developed as a vaccine for tuberculosis, BCG is a weakened form of the tuberculosis bacterium which stimulates immune responses within the bladder to destroy the cancer cells.

Fortunately, 75% of bladder cancer diagnoses are identified as non-muscle-invasive which means that BCG is an effective treatment to preserve the patients bladder and their quality of life.

BCG is the most common intravesical immunotherapy for treating early-stage bladder cancer. Its used to help stop cancer from growing and prevent it from coming back. Originally developed as a vaccine for tuberculosis, BCG is a weakened form of the tuberculosis mycobacterium which stimulates immune responses within the bladder to destroy the cancer cells.

Fortunately, 75% of bladder cancer diagnoses are identified as non-muscle-invasive which means that BCG is an effective treatment to preserve the patients bladder and their quality of life.

No patient dealing with a bladder cancer diagnosis should also have to worry that their BCG treatments will be delayed or if they are only receiving a partial does due to limited quantities in Canada.

Also Check: How To Stop A Weak Bladder

Brief Q& a On The Bcg Shortage By The International Bladder Cancer Group And Treatment Options In The Bcg Failing Population

Urology News and Education Resource
Saturday, 24 September 2022
Brief Q& A for Patients by the International Bladder Cancer Group on the BCG Shortage In this Question and Answer presentation by Ashish M. Kamat and colleagues from the International Bladder Cancer Group the authors provide a patient resource on BCG treatment answering questions including: What is BCG, Who and how is it made, If there is a shortage of BCG what are my options?, Is a reduced dose of BCG as effective as a full dose?, and are there any ongoing trials involving new therapies?
Setting the Stage for the BCG Unresponsive Population – Interview with Ashish Kamat Ashish M. Kamat, MDAshish Kamat and Alicia Morgans discuss non-muscle invasive bladder cancer, where the field stands particularly for BCG refractory patients and the definition of the BCG unresponsive patient. Ashish overviews the efforts of the SUO-CTC Bladder Committee and important updates and trials in this disease state.
High Grade Non-Muscle Invasive Bladder Cancer and BCG Refractory Patient Joshua J Meeks, MD, Ph.DAlicia Morgans and Josh Meeks highlight ongoing trials in non-muscle invasive bladder cancer. Review SWOG 1602 and 1605, and highlight the great work being done in the search for treatment options for patients with this disease with the ultimate hope for patients to retain their bladder and potentially be cancer-free.

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Bcg Shortage Affects Bladder Cancer Treatment

BCG vaccine is priced too low  now, shortage for bladder cancer
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Another shortage of Bacillus Calmette-Guérin expected in 2019 has people with non-muscle invasive bladder cancer and their physicians concerned about treatment. Global utilization and manufacturing issues associated with live BCG in recent years has resulted in product supply shortages.1 These shortages have slowed the overall usage of BCG and some physicians have rationed the product to those with the highest-risk during times of limited access.1

Bladder cancer is the ninth most commonly occurring cancer in the world, with the highest incidence in Northern America and Europe.2

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So Why The Shortage Of The Bcg Vaccine

In an article in the Washington Post, it appears that there is a nationwide shortage of the vaccine. As a result, many bladder cancer patients are facing the disease without one of the best treatments available.

According to the article,

Because of the BCG shortage, some patients are being undertreated, and some are going to have to undergo radical surgery and lose their bladders, said Bernard Bochner, a urologist at Memorial Sloan Kettering Cancer Center. Those patients will have to wear a urine-collection bag or undergo difficult surgery to make a new bladder out of their intestines life-altering changes, he said.

Fearful of such an outcome, patients are calling hospitals and clinics and scouring chat rooms looking for help. We are hearing from more and more desperate patients every day, said Stephanie Chisolm, director of education and research at the Bladder Cancer Advocacy Network, a patient group.

The shortage results from the relatively low price for the vaccine about $150 per dose, which is probably one of the least expensive cancer treatments on the market . The low price disincentivizes the sole manufacturer in the USA, Merck, from producing sufficient doses.

Here are some of the issues that are constraining the supply:

  • All new manufacturing will take years to design, build, and get approval from the FDA . From a finance perspective, Merck would have to invest possibly $2 billion without any income for 5-7 years.
  • Aua : What To Do During Bcg Shortage For High

    In a plenary session at the American Urologic Association Virtual Annual Meeting, Dr. Seth Lerner moderated a session designed to answer the question of What to do During BCG Shortage for High-Risk NMIBC Patients?. Along with panelists Drs. Steve Boorjian, Ashish Kamat, James McKiernan, Chad Ritch, and Dr. Lerner explored a number of treatment options.

    To begin, Dr. Lerner provided context, highlighting the current status of the Bacille Calmette-Guérin shortage as well as risk stratification and guideline recommendations. With respect to the BCG shortage, Dr. Lerner reviewed the situation highlighting that the Connaught strain has been off-line since 2012 with confirmed permanent closure as of 2017. As a result, the sole source is the Merck manufactured Tice strain which is produced in a single plant for distribution to 70 countries.

    Based on personal communication, Dr. Lerner conveyed that Merck considers the production of BCG at maximal capacity to be a priority. In the meantime, he highlighted that BCG dose reduction may actually provide benefit as an appropriate cytokine response may be observed with very low disease, as little as 1/100th of a standard treatment dose. Further, the AUA split dosing policy supports the use of the same vial for more than one patient to avoid wastage.

    Dr. Kamat then discussed how to prioritize the utilization of limited BCG supplies. He highlighted the IBCG risk stratification approach for patients with intermediate-risk disease.

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