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Cristina Mitchell

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Cristina Mitchell

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THERE IS no way to avoid it, everywhere around us is covered in germs. Bacteria and viruses are all around us in the air and on most surfaces, and these include germs such as bacteria, viruses, and fungi, and toxins; chemicals made by microbes. So...

View the full post Service disruption at main office of Ministry of Health on NOW Grenada.

PAHO and CAF to work together to strengthen health systems in Latin America and the Caribbean

Cristina Mitchell

19 Sep 2023

The Barbados National NCD Commission unreservedly supports the urgent call for the introduction of the Octagonal “high-in” front-of-package warning labels to be placed on pre-packaged food and beverage products. The octagonal warning label (OWL) is the best label for Barbados and the Caribbean.

Global and regional scientific evidence, conducted by researchers free from conflicts of interest, supports the OWL as the best option to empower consumers to correctly, quickly and easily identify foods high in sugars, sodium and fats. The OWL has consistently outperformed other front-of-package nutrition labels such as the magnifying glass, the traffic lights and the facts upfront. Research just released shows that the OWL has the potential to avert 16 per cent of the deaths caused by diet-related non-communicable diseases (NCDs). 

The support of the Barbados National NCD Commission comes against a backdrop of an epidemic of obesity and NCDs across our region and in Barbados.

80% of deaths in Barbados are caused by NCDs and 76% of premature deaths are caused by this group of diseases.

31% of our children are overweight or obese.

66% of adults are overweight and 33% are obese.

1 in 5 adult Barbadians has diabetes.

We can no longer afford to ignore these dangerous trends affecting the health and well-being of the citizens of this country. We must become more conscious of ensuring the health and wellness of every one of us is taken seriously.

An unhealthy diet dominated by ultra-processed products high in sugars, sodium and fats is the single greatest risk factor for overweight, obesity and NCDs. Overconsumption of these foods drastically increases the risk of developing hypertension, obesity, type 2 diabetes, heart disease and some types of cancer. 

Consumers make purchasing decisions in a matter of seconds, and it takes far too much time to understand the nutrition facts panel on the back of packaged products. Especially now, we need octagonal warning labels on the front of our food packages to easily identify food that has excess levels of key nutrients – especially for people who are living with NCDs such as diabetes, hypertension and cancer.

As the labels are now, it is very unlikely that most shoppers read food labels as they are often confusing and misleading. Having the octagonal “high-in” front-of-package labelling prominently displayed and easily readable will allow the consumer to make informed choices. This type of labelling is hard to ignore.

The health implications and the costs to fight NCDs and other diseases far outweigh the costs to manufacturers in implementing changes to their labels. We have over the years heard the cries from Ministries of Health across the region of the burgeoning costs of healthcare and the billions spent annually dealing with increasing cases of NCDs among our vulnerable population. The introduction of policies such as OWL can save the Government in excess of a billion Barbados dollars as predicted by the aforementioned study.

The octagonal warning label, recommended by PAHO/WHO and CARPHA, is a foundational and enabling policy which forms part of a comprehensive package of evidence-based policy actions aimed at creating healthy food environments in which healthy food is accessible, affordable, attractive, and widely available to all citizens regardless of socio-economic status. The OWL complements the recently introduced Barbados National School Nutrition Policy by providing the information needed to allow school administrators to readily identify foods which should be permitted in school settings.

Right now, CARICOM countries including Barbados, are voting on whether or not to approve a regional standard for the labelling of prepackaged foods which contains the octagonal warning label. Our Commission commends the Barbados Government as one of the governments in our region to vote yes for the Front-of-Package Warning Labels Octagonal System in 2021. As CARICOM continues to review this process, we want our collective voices to be heard and to resonate across the Caribbean in support of front-of-package warning labels.

Silence is no longer an option. Inaction cannot be the solution.

There is a clear and present danger to the health and well-being of our citizens from the onslaught of unhealthy foods and beverages.

Suleiman Bulbulia STE JP 

Chairman 

The post NCD Commission supports front-of-package warning labels appeared first on Barbados Today.

Abelacimab is a novel, highly selective, fully human monoclonal antibody with dual inhibitory activity against factor XI and its active form, factor XIa.

The AZALEA-TIMI 71 trial stopped early due to an unprecedented bleeding benefit for adults with AF. The company noted that abelacimab is also the first and only factor XI inhibitor to demonstrate an unprecedented reduction in major bleeding compared with a DOAC (direct oral anticoagulant). 

"The study was stopped by the data monitoring committee after it met its primary endpoint, a composite of major and clinically relevant nonmajor bleeding, in participants taking abelacimab versus patients taking rivaroxaban (Xarelto, Janssen/Bayer), a factor X inhibitor and a leading standard-of-care DOAC," Anthos stated in a press release.

“The AZALEA-TIMI 71 study is the largest and longest head-to-head study of a factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to the standard-of-care anticoagulant,” Marc S. Sabatine, MD, MPH, the Lewis Dexter, MD, Distinguished Chair in Cardiovascular Medicine, Brigham and Women’s Hospital, professor at Harvard Medical School and chairman of the TIMI Study Group, said in the release.

“With a median of 21 months of follow-up, spanning more than 2,000 patient-years, AZALEA-TIMI 71 represents a landmark study confirming the promise of factor XI inhibition as causing substantially less bleeding than a current standard-of-care.”

The trial enrolled 1,287 patients from 95 centres in Asia, Europe, and North America and had a median of 21 months of follow-up before being stopped. Patients were randomized to receive either 20 mg oral daily rivaroxaban or 150 mg or 90 mg subcutaneous abelacimab every month.

According to Anthos Therapeutics, the full findings of the AZALEA-TIMI 71 will be presented at an upcoming scientific congress.

Just recently, the company announced that abelacimab had received a fast-track designation from the US FDA for the prevention of systemic embolism and stroke in AF patients. The fast-track designation is granted to therapies with the potential to fill the unmet needs of patients with serious medical conditions.

The investigational drug is a highly selective, fully human monoclonal antibody with dual inhibition against factor XI and factor XIa. It is not currently approved for any indication in any country.

Reference:

Verhamme P, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2105872.

But it isn’t here yet. Makers of biosimilars must still work within a health care system in which basic economics rarely seems to hold sway.

For real competition to take hold, the big pharmacy benefit managers, or PBMs, the companies that negotiate prices and set the prescription drug menu for 80% of insured patients in the United States, would have to position the new drugs favorably in health plans.

They haven’t, though the logic for doing so seems plain.

Humira has enjoyed high-priced U.S. exclusivity for 20 years. Its challengers could save the health care system $9 billion and herald savings from the whole class of drugs called biosimilars — a windfall akin to the hundreds of billions saved each year through the purchase of generic drugs.

The biosimilars work the same way as Humira, an injectable treatment for rheumatoid arthritis and other autoimmune diseases. And countries such as the United Kingdom, Denmark, and Poland have moved more than 90% of their Humira patients to the rival drugs since they launched in Europe in 2018. Kaiser Permanente, which oversees medical care for 12 million people in eight U.S. states, switched most of its patients to a biosimilar in February and expects to save $300 million this year alone.

Biologics — both the brand-name drugs and their imitators, or biosimilars — are made with living cells, such as yeast or bacteria. With dozens of biologics nearing the end of their patent protection in the next two decades, biosimilars could generate much higher savings than generics, said Paul Holmes, a partner at Williams Barber Morel who works with self-insured health plans. That’s because biologics are much more expensive than pills and other formulations made through simpler chemical processes.

For example, after the first generics for the blockbuster anti-reflux drug Nexium hit the market in 2015, they cost around $10 a month, compared with Nexium’s $100 price tag. Coherus BioSciences launched its Humira biosimilar, Yusimry, in July at $995 per two-syringe carton, compared with Humira’s $6,600 list price for a nearly identical product.

“The percentage savings might be similar, but the total dollar savings are much bigger,” Holmes said, “as long as the plan sponsors, the employers, realize the opportunity.”

That’s a big if.

While a manufacturer may need to spend a few million dollars to get a generic pill ready to market, makers of biosimilars say their development can require up to eight years and $200 million. The business won’t work unless they gain significant market share, they say.

The biggest hitch seems to be the PBMs. Express Scripts and Optum Rx, two of the three giant PBMs, have put biosimilars on their formularies, but at the same price as Humira. That gives doctors and patients little incentive to switch. So Humira remains dominant for now.

“We’re not seeing a lot of takeup of the biosimilar,” said Keith Athow, pharmacy director for Tennessee’s group insurance program, which covers 292,000 state and local employees and their dependents.

The ongoing saga of Humira — its peculiar appeal to drug middlemen and insurers, the patients who’ve benefited, the patients who’ve suffered as its list price jumped sixfold since 2003 — exemplifies the convoluted U.S. health care system, whose prescription drug coverage can be spotty and expenditures far more unequal than in other advanced economies.

Biologics like Humira occupy a growing share of U.S. health care spending, with their costs increasing 12.5% annually over the past five years. The drugs are increasingly important in treating cancers and autoimmune diseases, such as rheumatoid arthritis and inflammatory bowel disease, that afflict about 1 in 10 Americans.

Humira’s $200 billion in global sales make it the best-selling drug in history. Its manufacturer, AbbVie, has aggressively defended the drug, filing more than 240 patents and deploying legal threats and tweaks to the product to keep patent protections and competitors at bay.

The company’s fight for Humira didn’t stop when the biosimilars finally appeared. The drugmaker has told investors it doesn’t expect to lose much market share through 2024. “We are competing very effectively with the various biosimilar offerings,” AbbVie CEO Richard Gonzalez said during an earnings call.

How AbbVie Maintains Market Share

One of AbbVie’s strategies was to warn health plans that if they recommended biosimilars over Humira they would lose rebates on purchases of Skyrizi and Rinvoq, two drugs with no generic imitators that are each listed at about $120,000 a year, according to PBM officials. In other words, dropping one AbbVie drug would lead to higher costs for others.

Industry sources also say the PBMs persuaded AbbVie to increase its Humira rebates — the end-of-the-year payments, based on total use of the drug, which are mostly passed along by the PBMs to the health plan sponsors. Although rebate numbers are kept secret and vary widely, some reportedly jumped this year by 40% to 60% of the drug’s list price.

The leading PBMs — Express Scripts, Optum, and CVS Caremark — are powerful players, each part of a giant health conglomerate that includes a leading insurer, specialty pharmacies, doctors’ offices, and other businesses, some of them based overseas for tax advantages.

Yet challenges to PBM practices are mounting. The Federal Trade Commission began a major probe of the companies last year. Kroger canceled its pharmacy contract with Express Scripts last fall, saying it had no bargaining power in the arrangement, and, on Aug. 17, the insurer Blue Shield of California announced it was severing most of its business with CVS Caremark for similar reasons.

Critics of the top PBMs see the Humira biosimilars as a potential turning point for the secretive business processes that have contributed to stunningly high drug prices.

Although list prices for Humira are many times higher than those of the new biosimilars, discounts and rebates offered by AbbVie make its drug more competitive. But even if health plans were paying only, say, half of the net amount they pay for Humira now — and if several biosimilar makers charged as little as a sixth of the gross price — the costs could fall by around $30,000 a year per patient, said Greg Baker, CEO of AffirmedRx, a smaller PBM that is challenging the big companies.

Multiplied by the 313,000 patients currently prescribed Humira, that comes to about $9 billion in annual savings — a not inconsequential 1.4% of total national spending on pharmaceuticals in 2022.

The launch of the biosimilar Yusimry, which is being sold through Mark Cuban’s Cost Plus Drugs pharmacy and elsewhere, “should send off alarms to the employers,” said Juliana Reed, executive director of the Biosimilars Forum, an industry group. “They are going to ask, ‘Time out, why are you charging me 85% more, Mr. PBM, than what Mark Cuban is offering? What is going on in this system?’”

Cheaper drugs could make it easier for patients to pay for their drugs and presumably make them healthier. A KFF survey in 2022 found that nearly a fifth of adults reported not filling a prescription because of the cost. Reports of Humira patients quitting the drug for its cost are rife.

Convenience, Inertia, and Fear

When Sue Lee of suburban Louisville, Kentucky, retired as an insurance claims reviewer and went on Medicare in 2017, she learned that her monthly copay for Humira, which she took to treat painful plaque psoriasis, was rising from $60 to $8,000 a year.

It was a particularly bitter experience for Lee, now 81, because AbbVie had paid her for the previous three years to proselytize for the drug by chatting up dermatology nurses at fancy AbbVie-sponsored dinners. Casting about for a way to stay on the drug, Lee asked the company for help, but her income at the time was too high to qualify her for its assistance program.

“They were done with me,” she said. Lee went off the drug, and within a few weeks the psoriasis came back with a vengeance. Sores covered her calves, torso, and even the tips of her ears. Months later she got relief by entering a clinical trial for another drug.

Health plans are motivated to keep Humira as a preferred choice out of convenience, inertia, and fear. While such data is secret, one Midwestern firm with 2,500 employees told KFF Health News that AbbVie had effectively lowered Humira’s net cost to the company by 40% after July 1, the day most of the biosimilars launched.

One of the top three PBMs, CVS Caremark, announced in August that it was creating a partnership with drugmaker Sandoz to market its own cut-rate version of Humira, called Hyrimoz, in 2024. But Caremark didn’t appear to be fully embracing even its own biosimilar. Officials from the PBM notified customers that Hyrimoz will be on the same tier as Humira to “maximize rebates” from AbbVie, Tennessee’s Athow said.

Most of the rebates are passed along to health plans, the PBMs say. But if the state of Tennessee received a check for, say, $20 million at the end of last year, it was merely getting back some of the $48 million it already spent.

“It’s a devil’s bargain,” said Michael Thompson, president and CEO of the National Alliance of Healthcare Purchaser Coalitions. “The happiest day of a benefit executive’s year is walking into the CFO’s office with a several-million-dollar check and saying, ‘Look what I got you!’”

Executives from the leading PBMs have said their clients prefer high-priced, high-rebate drugs, but that’s not the whole story. Some of the fees and other payments that PBMs, distributors, consultants, and wholesalers earn are calculated based on a drug’s price, which gives them equally misplaced incentives, said Antonio Ciaccia, CEO of 46Brooklyn, a nonprofit that researches the drug supply chain.

“The large intermediaries are wedded to inflated sticker prices,” said Ciaccia.

AbbVie has warned some PBMs that if Humira isn’t offered on the same tier as biosimilars it will stop paying rebates for the drug, according to Alex Jung, a forensic accountant who consults with the Midwest Business Group on Health.

AbbVie did not respond to requests for comment.

One of the low-cost Humira biosimilars, Organon’s Hadlima, has made it onto several formularies, the ranked lists of drugs that health plans offer patients, since launching in February, but “access alone does not guarantee success” and doesn’t mean patients will get the product, Kevin Ali, Organon’s CEO, said in an earnings call in August.

If the biosimilars are priced no lower than Humira on health plan formularies, rheumatologists will lack an incentive to prescribe them. When PBMs put drugs on the same “tier” on a formulary, the patient’s copay is generally the same.

In an emailed statement, Optum Rx said that by adding several biosimilars to its formularies at the same price as Humira, “we are fostering competition while ensuring the broadest possible choice and access for those we serve.”

Switching a patient involves administrative costs for the patient, health plan, pharmacy, and doctor, said Marcus Snow, chair of the American College of Rheumatology’s Committee on Rheumatologic Care.

Doctors’ Inertia Is Powerful

Doctors seem reluctant to move patients off Humira. After years of struggling with insurance, the biggest concern of the patient and the rheumatologist, Snow said, is “forced switching by the insurer. If the patient is doing well, any change is concerning to them.” Still, the American College of Rheumatology recently distributed a video informing patients of the availability of biosimilars, and “the data is there that there’s virtually no difference,” Snow said. “We know the cost of health care is exploding. But at the same time, my job is to make my patient better. That trumps everything.”

“All things being equal, I like to keep the patient on the same drug,” said Madelaine Feldman, a New Orleans rheumatologist.

Gastrointestinal specialists, who often prescribe Humira for inflammatory bowel disease, seem similarly conflicted. American Gastroenterological Association spokesperson Rachel Shubert said the group’s policy guidance “opposes nonmedical switching” by an insurer, unless the decision is shared by provider and patient. But Siddharth Singh, chair of the group’s clinical guidelines committee, said he would not hesitate to switch a new patient to a biosimilar, although “these decisions are largely insurance-driven.”

HealthTrust, a company that procures drugs for about 2 million people, has had only five patients switch from Humira this year, said Cora Opsahl, director of the Service Employees International Union’s 32BJ Health Fund, a New York state plan that procures drugs through HealthTrust.

But the biosimilar companies hope to slowly gain market footholds. Companies like Coherus will have a niche and “they might be on the front end of a wave,” said Ciaccia, given employers’ growing demands for change in the system.

The $2,000 out-of-pocket cap on Medicare drug spending that goes into effect in 2025 under the Inflation Reduction Act could spur more interest in biosimilars. With insurers on the hook for more of a drug’s cost, they should be looking for cheaper options.

For Kaiser Permanente, the move to biosimilars was obvious once the company determined they were safe and effective, said Mary Beth Lang, KP’s chief pharmacy officer. The first Humira biosimilar, Amjevita, was 55% cheaper than the original drug, and she indicated that KP was paying even less since more drastically discounted biosimilars launched. Switched patients pay less for their medication than before, she said, and very few have tried to get back on Humira.

Prescryptive, a small PBM that promises transparent policies, switched 100% of its patients after most of the other biosimilars entered the market July 1 “with absolutely no interruption of therapy, no complaints, and no changes,” said Rich Lieblich, the company’s vice president for clinical services and industry relations.

AbbVie declined to respond to him with a competitive price, he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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