Month: November 2022

One of the few 2022 specialty pharmacy acquisitions was announced recently.  Elevance Health will acquire long running BioPlus as it seeks to expand its specialty pharmacy services.  (BioPlus is one of the few mature Specialty Pharmacies that have not been acquired and taken out of the independent Specialty Pharmacy column.) Elevance is an insurer that was formerly known as Anthem Health…. BioPlus will be integrated into Elevance’s PBM, IngenioRx.

Elevance is continuing a trend of insurers scooping up SPs.  The deal was cut with Nautic Partners / CarepathRx which had invested in BioPlus some time ago. 

Looking back a bunch of years we found that there has been scant press about BioPlus (save a little faux pas related to a HIPAA violation earlier this year.) Also, BioPlus did not make the 2021, Top 15 Largest SP list….. so we don’t have any solid idea about revenues.

Why are insurers keen on integrating SPs into their portfolios?  

In a word, money….. and leverage (that’s two words). A well-run SP…. with enough volume will be profitable. Elevance can steer plan members into their PBM, IngenioRx, and thereby to there specialty pharmacy. That supercharges profit opportunity. And, PBMs love leverage over manufacturers. Being able to put large specialty purchases on the table goes a long way in negotiations for rebates, etc.

Financial terms of the deal were not disclosed.

———————————————————————

Elevance Health to Acquire BioPlus

Acquisition deepens Elevance Health’s capabilities in specialty pharmacy

November 09, 2022 

INDIANAPOLIS–(BUSINESS WIRE)–Elevance Health (NYSE: ELV) today announced that it has entered into an agreement with CarepathRx, a portfolio company of Nautic Partners, to acquire BioPlus, a comprehensive specialty pharmacy. BioPlus provides a complete range of specialty pharmacy services for patients living with complex and chronic conditions, such as cancer, multiple sclerosis, hepatitis C, autoimmune diseases, and rheumatology. This acquisition will help Elevance Health meet the specialty drug needs of its clients and customers with a whole-health approach, supported by integrated programs across Elevance Health and Carelon, Elevance Health’s healthcare services brand.

“In making BioPlus part of the Elevance Health family, we are committed to leveraging our resources to scale and broaden the reach of BioPlus’ best-in-class specialty pharmacy capabilities, delivering greater affordability and access to critical medications.”

Tweet this

“As a trusted, lifetime health partner, the acquisition of BioPlus helps us deliver on our whole-health strategy that gives our consumers improved access and reliability to their prescriptions when they need it most,” said Pete Haytaian, Executive Vice President, Elevance Health and President, Carelon. “In making BioPlus part of the Elevance Health family, we are committed to leveraging our resources to scale and broaden the reach of BioPlus’ best-in-class specialty pharmacy capabilities, delivering greater affordability and access to critical medications.”

The company will look to expand BioPlus’ speed and service models across more complex disease treatment areas to provide timely access to medication, deliver leading support services for both providers and patients, and ensure individuals receive distinctive clinical expertise and service at all levels of care.

BioPlus currently offers Centers of Excellence (CoEs), which address therapeutic areas such as oncology and multiple sclerosis, and Elevance Health will look to build out additional CoEs for therapeutic areas to serve consumers. CoEs include teams of specialized pharmacists and clinicians knowledgeable in therapeutics areas who partner with patients throughout their treatment journey. These services help ensure medication access, adherence, and high-quality health outcomes.

After the acquisition closes, the specialty pharmacy will operate as part of IngenioRx, Elevance Health’s pharmacy benefit manager within Carelon, Elevance Health’s healthcare services brand. BioPlus’ offerings will complement IngenioRx capabilities and will increase Elevance Health’s ability to provide end-to-end pharmacy services, act as a patient advocate for integrated services, and promote affordability.

After BioPlus is integrated into Elevance Health, consumers who receive both medical and pharmacy benefits from Elevance Health’s subsidiaries will benefit from the company’s ability to leverage medical and pharmacy data to deliver proactive, whole-health insights. Carelon will connect its businesses through its digital platform, so in situations where BioPlus’ pharmacy team identifies a patient who may need behavioral health support or in-home care services, that team will be able to seamlessly connect that patient to services to address their whole health needs.

The acquisition is subject to customary closing conditions and is expected to close in the first half of 2023. BioPlus is not expected to have a material impact on adjusted earnings per share in 2023.

About Elevance Health, Inc.

Elevance Health is a lifetime, trusted health partner fueled by its purpose to improve the health of humanity. The company supports consumers, families, and communities across the entire care journey – connecting them to the care, support, and resources they need to lead healthier lives. Elevance Health’s companies serve more than 119 million people through a diverse portfolio of industry-leading medical, digital, pharmacy, behavioral, clinical, and complex care solutions. For more information, please visit www.elevancehealth.com or follow us @ElevanceHealth on Twitter and Elevance Health on LinkedIn.

About CarepathRx

CarepathRx seeks to transform pharmacy care delivery for health systems and hospitals by delivering improved patient outcomes that drive clinical, quality, and financial results. Through an industry leading, comprehensive, end-to-end hospital pharmacy care delivery model, CarepathRx works to turn hospital pharmacy into an active care management strategy and revenue generator while providing support across the patient’s complete healthcare journey. The company takes an enterprise approach, providing a powerful combination of technology, market-leading clinical pharmacy services, and wrap-around services that aim to optimize pharmacy performance for fully integrated pharmacy operations, expanded healthcare services, improved ambulatory access, minimized clinical variation, and new health system revenue streams. Today, CarepathRx serves more than 20 health systems and 600 hospitals, with more than 2,000 employees nationwide. For more information about CarepathRx, visit www.carepathrxllc.com.

About Nautic

Nautic Partners, LLC (“Nautic”) is a middle-market private equity firm that focuses on three industries: healthcare, industrials, and services. Nautic has completed over 150 platform transactions throughout its 35-plus year history. Nautic’s strategy is to partner with management teams to accelerate the growth trajectory of its portfolio companies via add-on acquisitions, targeted operating initiatives, and increased management team depth. For more information, please visit www.nautic.com.

There is a general understanding that Big Pharma spent a lot of effort and $$$s to counter-detail legislation to allow price negotiations in Medicare. They viewed any move in that direction as a red line thinking that any crack in the dam would evolve to potentially include all federal drug purchases. 

The article below offers a good look back of those efforts. It lays out the depths to which Big Pharma went to defend their long-held strangle hold on prices. Few know that PhRMA spent over $100 million this year to unleash a massive army of 1,500 lobbyists on Capitol Hill.

Pharma’s battle cry went for the heartstrings of Americans….. federal price negotiations will “immediately halt private funding of drug discovery and development”…. a “tragic loss for patients.” That’s a voter attention getter.

What Pharma hoped would get lost in the noise is that the Congressional Budget Office estimated Medicare would realize savings of $102 billion over 10 years. To get past the finish line, the legislation was watered down to start in 2026 with only 10 drugs. 

Price negotiation will face ongoing withering attacks and Pharma will not rest. A new congress will be lobbied starting on day one to stall or even reverse the modest progress to date. 

——————————————————————————————–

Big pharma went all in to kill drug pricing negotiations

For decades, the drug industry has yelled bloody murder each time Congress considered a regulatory measure that threatened its profits. But the hyperbole reached a new pitch in [2022] to adopt modest drug pricing negotiation measures in the Inflation Reduction Act.

The bill “could propel us light-years back into the dark ages of biomedical research,” Dr. Michelle McMurry-Heath, president of the Biotechnology Innovation Organization, said last month. Venture capitalists and other opponents of the bill said that it “immediately will halt private funding of drug discovery and development.”

Steve Ubl, leader of the ubiquitous Pharmaceutical Research and Manufacturers of America, or PhRMA, called the bill’s Senate passage a “tragic loss for patients.” He threatened in an interview with Politico to make politicians suffer if they voted for the measure, adding that “few associations have all the tools of modern political advocacy at their disposal in the way that PhRMA does.”

In the past 12 months, PhRMA and closely allied groups spent at least $57 million — $19 million of it since July — on TV, cable, radio, and social media ads opposing price negotiations, according to monitoring by the advocacy group Patients for Affordable Drugs. PhRMA spent over $100 million this year to unleash a massive team of 1,500 lobbyists on Capitol Hill.

The final bill is weaker than earlier versions, which would have extended negotiations to more drugs and included private insurance plans. The bill would enable only Medicare to negotiate prices beginning in 2026, initially for just 10 drugs.

It would save the Centers for Medicare & Medicaid Services about $102 billion over a decade, the Congressional Budget Office estimates. In 2021 alone, the top U.S. pharmaceutical companies booked tens of billions of dollars in revenue: Johnson & Johnson ($94 billion), Pfizer ($81 billion), AbbVie ($56 billion), Merck & Co. ($49 billion), and Bristol Myers Squibb ($46 billion).

The bill authorizes hundreds of millions of dollars for CMS to create a drug negotiation program, setting in motion a system of cost-benefit evaluations like those used in Europe to guide price negotiations with the industry. Americans pay, on average, four times what many Europeans do — and sometimes far, far more — for the same drugs.

The bill does not affect the list prices companies charge for new drugs, which increased from a median price of $2,115 in 2008 to a staggering $180,007 in 2021, according to recent research.

The bill’s champions say that PhRMA’s gloomy prophecies are overblown, and that history is on their side.

“It’s complete bullshit and a scare tactic,” Andy Slavitt told KHN. As a leading federal health official in 2016, he tried to change part of a Medicare program that pays doctors a fixed 6% of the cost of a drug each time they administer it, creating an incentive to use the most expensive infusion drugs. PhRMA funded most of the loud campaign that defeated his efforts, Slavitt said.

Another scare tactic: The drug industry warns that any price negotiation will kill innovation. Such warnings “constitute the pharma response in literally every instance since 1906,” the year the first drug regulation agency was created, said Dr. Aaron Kesselheim, who leads the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital in Boston. And yet, he said, regulatory changes rarely choked out investment in new drugs.

For example, the drug industry bemoaned a bill to boost generic drugs sponsored by Rep. Henry Waxman (D-Calif.) in 1984. Yet while 50% of prescribed drugs were generics in 2000 — up from 15% in 1980 — approvals of important new drugs also soared during the period, Kesselheim noted. The threat of losing market share to generics, he said, may have induced manufacturers to invest in innovation.

In 1993, Thomas Copmann, then a PhRMA vice president, charged that President Bill Clinton’s Vaccines for Children program, which funded vaccinations for any kid whose parents couldn’t afford them, “would just kill innovation because the government would control the market.” Over the next 16 years, childhood vaccination rates climbed — from 72% to around 93% for polio vaccine, for example. Over the same period, new vaccines against hepatitis A and B, pneumonia, chickenpox, human papillomavirus, and rotavirus were added to the schedule.

The drug industry’s attacks on regulation have a rich and florid history. In the early 1900s, the Proprietary Association of America warned newspapers that their advertising revenue would dry up if the industry had to list its ingredients (mostly alcohol). The law passed in 1906, but newspapers — and the drug industry — survived it.

Sometimes the industry’s breast-beating is a negotiating tactic, one that has led to concessions from Congress and the federal government.

In the 1990s, when discussions began about requiring drug companies to pay user fees to have their drugs reviewed, the industry described the fees as a “tax on innovation.” Eventually, it agreed to pay the fees if the FDA set deadlines for the reviews. The resulting boost in FDA staffing levels ushered in an increase in drug approvals over the ensuing five years.

Yet “killing innovation” remains a go-to trope. Drug imports, efforts to rein in “pay-for-delay” agreements between brand and generic companies, investigations of price gouging by drugmakers — all, according to conservatives and pharmaceutical executives, “kill innovation.” Former House Speaker Newt Gingrich in 2009 said the same about the Affordable Care Act. A golden decade for new drugs followed, with FDA approvals increasing from 21 in 2010 to 50 in 2021.

Critics of the bill argued that history and economic research show that drug investment will lag when markets shrink, which they say will be the case if price controls lead corporations to earn less money on their blockbuster drugs.

If Medicare negotiations cut into the profits of the biggest earners, investors in risky biotech companies, whose drugs rarely strike it rich, will shift some of their portfolios from pharmaceuticals into other sectors, said Craig Garthwaite, director of health care at Northwestern University’s Kellogg School of Management. “There’s a fair argument as to how much,” he said.

He noted that after Medicare’s drug program was created in 2003 — the drug industry initially opposed it — an increase in federal spending on medicines inspired pharmaceutical companies to spend more on drugs aimed at older people. “Once you invest in clinical trials, that money never comes back unless it’s in revenue for products sold,” he said.

The moribund antibiotics industry demonstrates how shrinking markets — hospitals and doctors intentionally limit the use of new drugs to reduce microbial resistance — lead to lower investment, Garthwaite said.

Yet some experts argue that Medicare drug pricing negotiations could hasten innovation if they steer companies away from drugs that modestly improve outcomes but can earn massive amounts of cash in the current system of unchecked prices.

In the cancer field, most investment is in drugs that provide incremental benefits at a high price, said Dr. Vincent Rajkumar, a Mayo Clinic oncologist. He was a principal investigator on two large trials testing Ninlaro (ixazomib), a pill for multiple myeloma that is very similar to the injected drug Velcade (bortezomib). While more convenient, Ninlaro is no more effective, he said, and it costs about eight times as much as generic bortezomib. A newer multiple myeloma drug, Xpovio (selinexor), keeps patients progression-free for about four additional months; it costs $22,000 a month.

Most new cancer drugs extend life for only a short time, said Rajkumar, who helped organize a 2015 letter signed by 118 oncologists that called for giving Medicare the power to bargain. If forced to negotiate, “maybe the companies would spend their research and development funds on something more meaningful,” he said.

In other high-income countries, drug price negotiations are the norm. “Right now, we are the odd man out,” Rajkumar said. “Are we really that brainy that we are right and everyone else is wrong? Are we really looking out for our public better than everyone else?”

Large patient groups such as the American Cancer Society, American Heart Association, and American Diabetes Association, all of which have significant drug industry support, stayed on the sidelines of the debate over the language in the drug price negotiation bill.

Some other patient groups, fearful that the industry will lose interest in drugs for smaller populations should prices decline, opposed the bill — and successfully won exceptions that would prevent Medicare from negotiating prices on drugs for rare diseases.

David Mitchell, a multiple myeloma patient who founded Patients for Affordable Drugs in 2017, said he’s sure the bill won’t discourage innovation — and his life may depend on it. The 68-year-old said he’s on a four-drug regimen but “cancer is very clever and finds a way to get around drugs.”

“The idea that taking a small bite out of pharma revenue is going to stop them from creating new drugs is bullshit,” he said.

Kaiser Health News: This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Reviewed by Emily Henderson, B.Sc.

CLICK HERE to access this article

We’ve often written about companies that work with hospitals to develop owned-and-operated specialty pharmacies. Those pharmacies boast that they that are significantly better than independent specialty pharmacies and they deserve to keep the prescriptions that their doctors write. Such companies include Shields Health (which acquired competitor ExceleraRx now part of Walgreens) as well as TrellisRx (acquired by CPS Solutions).

The valuation of these acquired companies were astronomical and that kind of $opportunity$ attracts even more competition. Some weeks ago, Cornerstone Health Solutions, which builds ‘specialty pharmacy accelerator programs’ for hospitals and health systems, announced that they are going head-to-head with Shields and CPS. They rebranded the company Clearway Health.  Name aside, it portends more competition for independent specialty pharmacies as health systems rush to open their own specialty pharmacies.

It is noteworthy that the genesis of Clearway Health is Bahston Medical Center Health Systems….. oops, Boston. It is unique that a hospital system has started a dedicated business targeting the creation of specialty pharmacies for other hospitals . Their press release said, “Clearway Health joins with hospitals and health systems to improve access to care and manage the complex medication needs of patient populations – strengthening the patient experience and driving revenue for clients.”

Time will tell if Clearway Health will be a better mousetrap.

CLICK HERE for more information

Walgreens….. its been good to know ya!

That’s not saying that Walgreens is going away. To the contrary, it is the dawn of a new day for Walgreens, a day when Walgreens fully emerges from the chrysalis of pharmacy leader to a gosh darn, dyed in the wool, integrated health care provider butterfly.

We see the tipping point as the recent full acquisition of CareCentrix for $392million….. oh, that’s on top of the initial investment of $330million earlier in 2022. As you may recall, CareCentrix coordinates home care for health plans, patients, and medical providers which represents 19 million patients in the home setting and approx. 7,400 provider locations.

Other acquisitions over the past year+ are integral to fast-tracking its transition….. in particular, specialty pharmacy developer / manager Shields Health Solutions for a $billion (see our report Oct 13, 2022) and primary care network VillageMD majority share for $5.2 billion. Both are highly complementary to the CareCentrix market. [NOTE: Walgreens-backed VillageMD is exploring a merger with medical practice Summit Health, the parent company of CityMD, according to a Bloomberg report on October 31^st. The combined Summit company could be valued between $5 billion and $10 billion, also according to Bloomberg.]

Not to be outdone, CVS announced it was acquiring home care company Signify Health for $8 billion seemingly mirroring Walgreens’ integrated health care provider strategy. And, not to be a wall flower, Amazon acquired One Medical for $3.9 billion earlier this year.

The FDA recently approved a new first-in-class tyrosine kinase 2 (Tyk2) inhibitor, ORAL therapy, Sotyktu (deucravacitinib) from Bristol Myers Squibb, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval included a favorable safety profile.

Sotyktu joins a robust multi-$- billion plaque psoriasis market with analysts suggesting that it will rapidly break $4 billion at peak. By reference, Amgen’s Otelza, clipped in with $2.3 billion in 2021 and is also an oral….. but with twice daily dosing. Trial results demonstrated a significant uptick in patient response with Sotyktu vs. Otezla. Competing injectable drugs include Cosentyx (secukinumab) and Skyrizi (risankizumab). There are an estimated eight million people diagnosed with plaque psoriasis in the US. 

BMS confirmed that Sotyktu will launch at a price of $6,164 for a 30-day supply (approx. 40% higher than Otezla.

BMS did not announce plans for distribution. Given the relatively large patient population and relatively low therapy management requirements there is little justification for BMS to launch Sotyktu in limited distribution. However, BMS has gone the LD route for other oral specialty therapies in the past….. and….. Otezla launched through LD. So, SPs must wait to see if Sotyktu will be one of the few newly approved drugs that they can add to their toolbox.

CLICK HERE for full prescribing information

The FDA recently approved a new infused therapy, Xenpozyme (olipudase-alfa) from Genzyme , for pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death.  Xenpozyme is the first approved medication to treat symptoms that are not related to the central nervous system in patients with ASMD. 

ASMD is caused by the lack of an enzyme needed to break down a complex lipid, called sphingomyelin, that accumulates in the liver, spleen, lung, and brain. Patients with ASMD have enlarged abdomens that can cause pain, vomiting, feeding difficulties, and falls. They also have abnormal liver and blood tests. The most severely affected patients have profound neurologic symptoms and rarely survive beyond two to three years of age. Other patients may survive into adulthood but die prematurely from respiratory failure.

The U.S. list price of Xenpozyme is $7,142.00 per vial.  Xenpozyme comes with a complicated, weight-based dose escalation schedule – biweekly for the first 14 weeks and then bi-weekly thereafter upon sustaining the recommended full dose (see prescribing information). 

Xenpozyme is supplied in a 20 mg vial and one may guesstimate that 26 vials (biweekly) will be utilized during a year resulting in an annual cost of approx. $185,000.

No details were announced relating to distribution. Given its cost and the need to monitor patient response it may be likely that this ‘rare’ therapy will launch through specialty pharmacy distribution.

CLICK HERE for full prescribing information