In 2022, the US Congress passed the Inflation Reduction Act (IRA) to address high drug costs and limited drug accessibility. IRA’s passage followed a 2019-2021 investigation by the House of Representatives Committee on Oversight and Reform into pharmaceutical pricing that reviewed previously sealed communications and documents from manufacturers of blockbuster drugs. The Congress concluded that pricing and market protection practices by manufacturers resulted in high costs. One investigated drug was lenalidomide, a treatment for multiple myeloma. Lenalidomide is an example of a drug whose financial success resulted from price increases and anticompetitive market strategies. We review tactics that led lenalidomide to become the third largest revenue-producing pharmaceutical product worldwide, with $12.2 US dollars (USD) billion sales in 2020, focusing on impact on patients and Medicare and developing policy recommendations …

High costs of drugs are not tightly correlated with value, and pricing decisions by many manufacturers are responsible for high costs, patient burden, and unsustainable pharmaceutical markets.

Read the full article at: https://ascopubs.org/doi/10.1200/OP.23.00579

VIVIO CEO, Pramod John, speaks with UK-based Consilium Scientific.

The paradox: Why can’t we reject high costs and subpar drug quality? Delve into healthcare inefficiencies driving this disparity and explore a pragmatic path to enhance outcomes and cut costs! Why can’t we say ‘No’ to high prices and low drug quality? The United States, which accounts for only 4% of the world’s population, spends as much on drugs as the rest of the world combined. Despite this, health outcomes in the US are often worse than those in developing countries. Economic inefficiencies of the healthcare system are the main drivers of these poor results. By focusing on outcomes and taking a commonsense approach, significant cost savings can be achieved.

Humira biosimilars have given employers and policy makers a false sense of security about impending cost relief, but all that’s happened is the health industry has once again succeeded in making us lose sight of the real problem. The unanswered question is how and why Humira became the biggest selling drug in history. If we don’t reflect on the root cause of our drug problem, we’re going to have the same hand wringing conversation five or 10 years from now, with a different set of drug names.

The root cause: an anti-competitive PBM model

In a free and fair market, the drug with the best outcomes data for each patient at the best price would win. Humira has been on the market for so long that its patents have expired and biosimilars have been available to 96% of the world’s population outside of the U.S. for years.  Humira is not the best at anything; it is just one of many inflammatory drugs with average clinical data. As proven in clinical trials, different drugs work for different people. For instance, in rheumatoid arthritis (RA) trials, only 10% of those taking Humira achieved a great response (ACR 70 score), while 76% achieved a mediocre to no response.  Fewer than 25% of patients receive a good response from the best-selling drug of all time.

Read the full article at: https://www.benefitspro.com/2023/05/04/why-biosimilars-will-fail-and-what-we-can-do-about-it/

“It’s the law unintended consequences,” Pramod John, Ph.D., chief executive officer of Vivio Health. “The ACA’s intent was not that providers now can charge whatever they wanted for service, whether a drug manufacturer or hospital. It was trying to protect a member could have a million dollar out of pocket costs in a year. This is when we started to see expansion of drug pricing because now with out-of-pockets limits, it doesn’t matter whether a drug costs $6,000 or $600,000.”

Pharmaceutical manufacturers, John said, started offering copay cards after high-deductible plans were launched. “Now a drug manufacturer can arbitrarily raise the price of a drug or remove all pricing sensitivity for the cost of the drug by paying patients’ copays and deductibles.”

Ultimately, it’s a steering mechanism, he said. “Copay cards set up economic incentives that favor the wrong behavior,” John said. “We’ve removed pricing sensitivity for patients and incentivized providers to be able to jack up the price of goods and services.”

Read the full article at: https://www.formularywatch.com/view/patients-often-lose-in-the-battle-between-pharma-and-pbms

San Leandro, CA – VIVIO, the leading drug outcomes company, proudly announces third-party validation of specialty drug savings delivered for VIVIO customers. Validation Institute independently certified a self-funded employer with 27,000 covered lives that spent 39% less in their first year with VIVIO than they did in the previous year with a Big-3 PBM.

The analysis compared an employer’s specialty drug costs in 2021 with a traditional PBM to that same employer’s specialty drug costs in 2022 managed by VIVIO.

This chart summarizes the Per Member Per Month (“PMPM”) costs for the employer before VIVIO and the following year with VIVIO. VIVIO’s PMPM costs were 39% lower than under the prior plan.

While PBM models focus on formularies that exclude drugs and limit drug access, VIVIO takes the opposite approach of personalizing drug therapies for each patient without formulary restrictions.

“As an independent, objective third-party organization, Validation Institute provides unbiased, data-driven insights on healthcare programs. The goal is to put more purchasing power into buyers’ hands,” said Benny DiCecca, Validation Institute CEO & President. “Our team found that the VIVIO program significantly reduces specialty drug costs.”

“We are delighted to have received independent third-party validation of the VIVIO program,” said Chris Crawford, VIVIO’s Chief Growth Officer. “We have taken a different approach than the traditional PBM model, which is proven to deliver better health outcomes for the members we serve and lower costs for our employer customers.”

About VIVIO
We prioritize health outcomes by fixing the following system problems: identifying expensive drug therapies that don’t work even though they have FDA approval; not knowing if a member is responding adequately to the therapy; doctors not reading the clinical trials themselves; the arbitrary line between pharmacy and medical benefit; and, egregious supply chain waste. VIVIO uses clinical trial, patient, and financial data to drive better health outcomes while eliminating wasted spending. VIVIO Precision Care™ plugs into an employer’s current carriers and PBMs. In 2021, VIVIO customers spent 67% less on specialty drugs than the national benchmark.

About Validation Institute
Validation Institute is a professional community that advocates for organizations and approaches that deliver better health value and stronger health outcomes at lower cost. We connect, train, and certify health care purchasers, and we validate and connect providers delivering superior results. Founded in 2014, the mission of the organization has consistently been to help provide transparency to buyers of health care. To learn more about Validation Institute, visit validationinstitute.com

Media contact:
T. J. Tedesco
[email protected]

For PDF of this news release, click here.

San Leandro, CA – VIVIO, a public benefit corporation reinventing the use of drug trial data in care delivery, announces a relationship with Mark Cuban Cost Plus Drug Company (Cost Plus Drugs) to acquire specialty drugs for less. Since Cost Plus Drugs and VIVIO are Public Benefit Corporations (PBCs), improving public health by lowering the cost of healthcare is as important as the bottom line.

America spends $500 Billion a year on prescription drugs. Less than 2% of prescriptions are written for ‘specialty’ drugs, but these account for $250 Billion, half of America’s total drug spend. Clinical trials and real-world evidence demonstrate that suboptimal drugs are being prescribed frequently. This means we pay for drugs that often don’t work because no one is asking the question, what do these drugs do? VIVIO’s team of clinicians and researchers match drug trial evidence to individual patient data, which improves outcomes, reduces side effects, and lowers member, employer, and health plan drug costs. 

“The event that led to finalizing the collaboration between VIVIO and Cost Plus Drugs is as horrific as it is incredibly uplifting,” said Mark Cuban. “Last week I was contacted by a friend from Indiana University who mentioned that a mutual friend was in a dire situation. The mutual friend was quoted a price of $3,000 per month for a generic specialty drug called droxidopa. He asked if Cost Plus Drugs could find an affordable source of the medication.”

The Cost Plus Drugs team went to work immediately, says Cuban. Within a week, Cost Plus Drugs had sourced the same medication at a price of $75 for a three-month supply, less than 1% of the cost Cuban’s friend was paying. “I mentioned this in an interview with Trevor Noah on The Daily Show and this caught the attention of Pramod John, the CEO of VIVIO. As it turns out, VIVIO also has patients taking droxidopa. I am excited to say our relationship was finalized in a matter of days,” said Cuban. “Now VIVIO patients will have access to pay far less for droxidopa and many other medications when using Cost Plus Drugs. I am so looking forward to us working together to benefit patients everywhere!”

“As a Public Benefit Corporation, the interests of VIVIO, our patients, and our employer and health plan customers must be aligned. They want better outcomes and lower costs, and so do we. Unlike PBMs, we don’t have a formulary or own any pharmacies or provider services. Instead, our sole business is to use data to ensure drugs are working for each patient and are acquired at the lowest cost,” says Pramod John, VIVIO CEO. “We seek to partner with other like-minded innovators to drive meaningful change to an industry that desperately needs it but doesn’t want it. Our relationship with Cost Plus Drugs allows our customers to stop overpaying for drugs, and that’s an important part of our mission.”

“A foundational principle for Cost Plus Drugs and VIVIO is fairness and transparency,” says Alex Oshmyansky, CEO of Cost Plus Drugs. “It is never fair to pay $3K for a drug that’s available for $21 or to pay for a drug without the data supporting its use. This causes inflation, premium increases, and a bloated, inefficient $4.2 Trillion health system.”

About VIVIO Health, a Public Benefit Corporation
VIVIO Precision Care™ uses data to fix the big unsolved problem of paying for expensive drug therapies that don’t work for members while causing side effects. VIVIO helps self-insured employers and health plans ensure their members are on the right drugs while not overpaying for them. In 2021, VIVIO customers’ specialty drug spend was 65% lower than national benchmarks.

About Mark Cuban Cost Plus Drug Company, a Public Benefit Corporation
Cost Plus Drugs aims to change the way the pharmaceutical industry operates. As a public-benefit corporation, its social mission of improving public health is just as important as the bottom line. Cost Plus Drugs transparently charges a standard markup on every drug it sells. The costplusdrugs.com online pharmacy launched in January 2022 now carries nearly 1,000 prescription products, delivered by mail to thousands of happy customers every day. Cost Plus Drugs works with health plans, managed-care organizations, pharmacy benefits managers (PBMs), and self-insured employers to bring these same savings to employer-sponsored benefit plans nationwide.

For more information, contact Chris Crawford at [email protected]

The original press release can be found at: http://www.prweb.com/releases/2022/10/prweb18961234.htm

Advancing principles for value in addressing inflammatory bowel disease As the Center for Medicare and Medicaid Innovation (CMMI) continues to advance value-based payment (VBP) models to address quality and total cost of care in primary care and large-scale populations, many stakeholders are grappling with how to build VBP models for chronic specialty and subspecialty conditions for smaller populations, such as inflammatory bowel disease (IBD).1 Some believe that VBP models have the potential to improve patient and cost related outcomes in IBD, and while some commercial payers and practice partners are experimenting with such models, most of these efforts remain nascent.

Beginning in 2021, Tapestry Networks engaged a diverse group of stakeholders—including payers, self-insured employers, gastroenterologists and clinical specialists, patient advocacy organizations, industry representatives, and others—in its IBD Shared Value Initiative to address the challenges and opportunities surrounding value-based care (VBC)2 and VBP models in IBD. The initiative culminated in the May 2021 Progress Summit. 3 Following the summit, many stakeholders noted that establishing consensus-based principles for value in IBD could help guide those looking to pilot new approaches. Therefore, throughout 2021 and early 2022, Tapestry continued discussions with key stakeholders to consider what those principles might be. From this broader group, a small subset of payers and providers, chosen for their roles and leadership in care delivery and contracting, collaborated to draft a publication on the topic. In June 2022, the draft framework publication was presented to the larger stakeholder group for further insights. Meeting participants also discussed considerations for practical implementation of the framework, including the incentives and resources necessary to advance the principles proposed in the draft. The meeting also provided a forum for candid discussion among stakeholders for continuous learning, and more such meetings may be convened in the future.

For more information, contact T. J. Tedesco at [email protected]

The original PDF can be found at: https://viviohealth.com/inflammatory-bowel-disease-shared-value-initiative/

Apparently the often-low standards for the FDA aren’t low enough. Now we just move trials to poor countries and use control arms that we wouldn’t approve here. VIVIO team member Bishal Gyawali writes about this in the Lancet. Look at the data yourselves and stop listening to the ‘experts’ who are paid to say ‘yes.’

VIVIO clinical team member, Bishal Gyawali, MD, PhD, is part of the team that develops the WHO Essential Medicines List (EML) identifies priority medicines that are most important to public health. Over time, the EML has included an increasing number of cancer medicines. See the details of their ground breaking work.

Mary Catherine Person and Jim Pursley have joined VIVIO as the company sees unprecedented demand for its specialty drug PBM carve-out services.

Mary Catherine is the former President of HealthSCOPE Benefits, a leading national Third-Party Administrator (TPA), which was sold to UnitedHealthcare in 2019. Ms. Person provided the following thoughts: “As a health plan sponsor, I had firsthand experience with a few specialty drugs accounting for more than 25% of our combined medical and pharmacy plan spend. As a Third-Party Administrator, we saw our customers constantly looking for answers to similar challenges. VIVIO offers plan sponsors the solution to solve the problem of high-cost specialty drugs and I couldn’t be more excited to help expand the mission.”

Jim was the Chief Commercial Officer for Livongo Health, which went public in 2019 before being acquired by Teledoc Health for $18.5B in 2020. Jim now serves as the President of Hinge Health, the leading Digital Musculoskeletal (MSK) Clinic for health plans and employers. Per Mr. Pursley: “Everywhere I go, I hear stories of employers and payors struggling with the rising cost of specialty drugs. Complex markets like this need innovative, transparent solutions that use data to drive personalized care. VIVIO’s next generation Specialty Drug management model efficiently removes waste from the system and improves outcomes for members. They are making significant progress and I am excited to support the VIVIO team.”

Pramod John, Founder and CEO of VIVIO, said “I know that Mary Catherine and Jim will provide unique perspectives as we continue to scale our operations to serve more and more customers. Our Specialty Drug Carve-Out solution works across pharmacy and medical benefits, and nobody understands benefit administration better than Mary Catherine. Jim has focused his career on employee benefit cost containment and improving health outcomes for members; that experience of listening to customers and improving the member experience will be crucial as we grow.”

About VIVIO: VIVIO Precision Care™ fixes the following system problems: identifying expensive drug therapies that don’t work even though they have FDA approval; not knowing if a member is responding adequately to the therapy; doctors not reading the clinical trials themselves; the arbitrary line between pharmacy and medical benefit; and, egregious supply chain waste. VIVIO uses clinical trial, patient, and financial data to drive better patient outcomes while eliminating wasted spend. The company’s carve-out program plugs into an employer’s current carriers and PBMs. 2020 net savings for VIVIO customers was 37%, while both outcomes and member experience significantly improved. In 2020, on average, VIVIO customers experienced a 7.5X ROI on program fees.

VIVIO Adds Industry Leaders to Advisory Board as Demand Increases for Transparent and Innovative Specialty Drug Management (prweb.com)