As pharmacies get deeper into chronic care treatment, what will it mean for both pharmacy and the world of managed care?
National health expenditures are expected to grow 5.5% annually between 2018 and 2027 according to the most recent report from CMS. The overall healthcare tab will increase from $3.8 trillion in 2019 to $5.9 trillion in 2027.
A major component that increase in healthcare spending is money spent on chronic diseases, which provide both challenges and opportunities for healthcare organizations-even those that traditionally have not been heavily involved in that arena. To help fill gaps in the system-and to stay competitive in the ever-shifting healthcare landscape- retail pharmacies CVS and Walgreens are looking to diversify their business model and are remodeling hundreds of stores into medical-service centers targeted at customers with chronic conditions.
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“As predominantly brick-and-mortar pharmacies, Walgreens and CVS are looking for new ways to stay competitive against online operations, such as Amazon, which threaten to eat into their market share,” says Jose Rivero, CEO of HealthComp, a health benefits administrator serving the needs of employers, plan members, and brokers. “This means coming up with new ways to bring customers into their stores. Today, there are many healthcare services that still require a local, hands-on approach.”
Rivero cites current offerings like flu shots and health screenings as examples of this approach becoming more and more common. But using those same offering to help people with chronic conditions like diabetes or high blood pressure, Rivero says, could help to address a “significant health challenge”-and also to bring many more patients through their doors.
Here’s what other experts say about the pharmacies’ move toward chronic care:
Peter A. L. Bonis, MD, chief medical officer, clinical effectiveness, at Wolters Kluwer, Health:
“A lot will have to go right. Retail pharmacies can legitimately claim a right to participate more directly in healthcare delivery. They are ubiquitous in the community and thus provide easy access to care. They also can potentially deliver certain services less expensively than traditional healthcare settings. Both aspects play well with rising consumerism in healthcare where cost-shifting has intensified price sensitivity and where the widespread availability of new technology (such as a video, texting, and other forms of communication) makes interactions within traditional care delivery models seem frustratingly primitive.
“At the same time, those who finance healthcare recognize that the current cost structure is unsustainable and new care delivery models must evolve potentially leading them to embrace alternative care settings.
“However, integrating chronic care into alternative care settings is easier said than done. Patients currently receive care through their health systems (hospitals and clinics) which are also embarking on new care delivery models that are both cost-effective and consumer-friendly. Retail pharmacies will need to insert themselves into an existing care-delivery system, making transitions and communications across care settings safe and effective.
“One way to drive change is to align payment with preferred care settings. Thus, the alliance between CVS and Aetna, for example, has the potential to create insurance products and other incentives that help catalyze the change. Still, the swim lanes are currently murky.
“Healthcare is complex and bubbling with innovation. But it is also notoriously slow to change. A shift in how and where patients with chronic illness are cared for will not be immune to this cadence.”
David Pittard, managing principal at OneDigital:
“As CVS references, brick and mortar retail stores are losing market-share for convenience consumer goods; thus, their physical locations must evolve to remain relevant beyond episodic medication fill. This reality coupled with a desire to capitalize on the acquired insured population with Aetna is the genesis of why CVS is taking this step. The feeling is more that there are assets that need to be reinvented than CVS is modernizing healthcare delivery.
“An interesting consideration for health plan sponsors, especially those with Aetna, is will CVS capture more drug fills within its retail stores as a result of engagements with the HealthHUB concierges? If so, this could increase drug pricing for the plans as CVS has historically been one of the higher cost retail providers; and, the HealthHUB model could deter members from considering lower cost pharmacy options, such as Walmart, Costco, or Amazon.
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“If CVS demonstrates success in patient capture rates through the HealthHUB models, plan sponsors may be less likely to change from Aetna insurance, since there could be greater disruption for their membership. This approach will cause all stakeholders to reconsider if their approach to consumer engagement is vulnerable. As more plan sponsors look to carve-out their PBM services, will CVS/Aetna’s combined offering encourage the market to gravitate to a definitive carved-in model?
“There is no doubt that the mergers of insurance carriers, PBMs, and retail pharmacies is a major transformation in the healthcare market that the remaining PBMs will need to figure out how to respond to, as the major stakeholders work to change the rules of engagement. Historically, comprehensive solutions provided by insurance carriers have proven ineffective; however, the new approaches are adding consumer convenience. If independent PBMs want to retain and grow their market share, they will have to demonstrate quantifiable decision points that will keep the insurers from forcibly capturing the remaining market. With the four major insurers controlling the majority of the provider networks, we now have the dominant players in the PBM space, and we expect to see more market consolidation of boutique and mid-sized PBMs as they seek to capitalize on the businesses they have built if they fear they will not be competitive in the future.”
Rivero:
“Healthcare executives are always looking for effective ways to help patients manage chronic conditions. If done right, this model has the potential to provide a convenient, low-cost, and effective solution. To enable plan members to try new approaches and to leverage the solutions that work for them, health plans should consider building flexibility into their plans, such as flexible spending accounts, that would allow their plan members to give it a try.
“There are a lot of potential impacts this could have on healthcare, which executives should consider. One is it could give patients access to one-on-one, ongoing coaching to keep their conditions in check. Many patients with chronic conditions know what they should be doing, whether it’s eating right, lowering stress levels or getting regular exercise, but they’re missing that convenient, low-cost way to stay accountable in taking those actions. Second, as these programs develop, healthcare executives need to think about giving members access to those services through their plans, and third, they need to proactively think of ways to collect and share information with such programs to monitor outcomes.”
Laurie Groven, VP strategic marketing and business development at Smart Meter LLC:
“With retail pharmacies now having access to millions of patients all over the country, it is clear that they are well-positioned to take action and be go-to treatment centers for managing chronic illnesses. However, with the adoption of remote patient monitoring (RPM) growing rapidly as evidenced by healthcare reimbursement through new 2019 CMS CPT codes, clinicians are recognizing that there are cost-effective ways of managing chronic disease patients remotely if they can get a complete and reliable picture of a patient’s health status. With cellular technology, that is now possible. Patients easily share their blood glucose testing results and a healthcare provider can effectively monitor them between visits. The race for the chronic care patient’s loyalty and their associated revenue dollars has begun. With cellular technology, many different providers within the patient’s healthcare team can implement an effective remote patient monitoring program that will engage them.
“To remain competitive, healthcare hospital/health system executives and providers are implementing RPM programs to improve patient interaction, track medication adherence, and monitor test results.”
“With such extreme numbers surrounding the scale and importance of managing chronic disease, payers, employers, healthcare organizations, and retail pharmacies are taking more and more steps to keep their patient population healthy and blood glucose levels on track. There is also a growing understanding that costs can be reduced by all of these contributors of the patient’s circle of care through more effective management of diabetic patients by utilizing population health strategies like RPM. The news of CVS Walgreens remodeling hundreds of stores into health-based centers, focused on providing services to treat patients with diabetes, heart disease, and hypertension, is just an example of the value being put on RPM and connected health technology.
“Second, we may start to see more and more strategic partnerships between hospital systems and retail pharmacy. It is well known that hospitals and emergency departments are overwhelmed with patients that suffer from chronic disease. Retail clinics may be the best way for patients to easily access affordable and trusted care. At the same time, the hospital systems and the provider will still want to play a vital role in their patient’s care. With tools like cellular diabetes management solutions, many in the patient Circle of Care can monitor their care and stay engaged.
“Finally, key to any connected health strategy is the patient’s participation. As an example, with a cellular diabetes solution, all a patient does is test. There are no extra steps asked of them to share their data. We’ve moved past the days of depending on the patient to download data or work with apps to get their results to their healthcare team. RPM has to be effortless for the patient yet provide information a healthcare team can trust. Choosing the right technology makes all the difference in an effective RPM program.”
Shital Mars, CEO of Progressive Care Inc. Progressive Care Inc. a personalized healthcare services and technology company based in South Florida
“With Amazon entering the healthcare space, we will begin to see more companies look to close the healthcare loops. This can be a good thing and a bad thing. A closed loop means shared systems, more communication, and integration which the healthcare space badly needs. However, this could also lead to abuse of monopolization through decreased competition and choice. CVS and Aetna may no longer have to work hard to provide great healthcare and service, because the patient has no other choice but to use them. Other companies will see this as an opportunity to close their loops and do the same, with all major healthcare players choosing teams and leaving smaller providers behind.
“Integration of medical and pharmacy data is a must to lower healthcare costs and other execs can look for ways to do this in their own networks. It is true that monitoring medication adherence can greatly reduce medical spending. But that number has yet to be fully quantified because holders of medical data and pharmacy data do not talk to each other, each party being very possessive of its information. But if these two things were to unify, we could determine best pharmaceutical practices and best treatment regimens that lead to lower costs and best outcomes.
“Health care execs must find a way to keep personal engagement with their patients, or otherwise risk losing them to the influence of other healthcare players. Walgreens and CVS both intend to use patient data to increase engagement, increase adherence, and increase system use. If healthcare execs want to have influence over their patients’ choices, they can either buy into the Walgreens/CVS model and team up or they can send out their own messaging and control that messaging. If you want your company to be the go to for healthcare, you are going to have to step and compete on a higher level for patient attention.”
Researchers to Medicare: Mark Cuban Prices Could Have Saved You $3.6 Billion
June 25, 2022
Harvard researchers calculated that buying 77 generic drugs at prices being charged by Mark Cuban’s online pharmacy prices would have lowered Medicare spending on those drugs from $9.6 billion to $6 billion.
Mark Cuban said he has come up with a way of making drugs more affordable when he launched his namesake online pharmacy in January 2022.
Harvard researchers lent some credence to Cuban’s claims some when they reported calculations that that Medicare program could have saved $3.6 billion in 2020 it had bought 77 generic drugs at Cuban’s prices.
The findings were reported in this week’s Annals of Internal Medicine.
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Cuban’s online pharmacy says it sets its generic drug prices based on the cost of the ingredients and manufacturing plus a 15% margin, $3 dispensing fee, and $5 shipping fee.
Hussain S. Lalani, M.D., M.P.H., and his colleagues at the Program on Regulation, Therapeutics and Law at the Brigham and Women’s Hospital in Boston and Harvard Medical School, came up with their estimate by identifying the Cuban’s price for 109 generic drugs on Feb.8 of this year. They recorded the price for a 30-day supply and a 90-day one. Then they identified Medicare Part D spending on 89 of those drugs in 2020, excluding 20 drugs with multiple dosage forms because the Cuban prices and the Medicare information didn’t match up for those drugs.
Their estimate of the savings involved the fairly straightforward math of taking the difference in the unit price between the Cuban online pharmacy and price that Medicare paid, multiplied by the number of units dispensed. The adjusted Medicare to reflect costs as of Feb. 8.
Their results showed $3.6 billion in savings on 77 of the 89 drugs had they been purchased at Cuban prices in 90-day-supply amounts. That works out to a 37% savings.
The savings were less in the the 30-day-supply amounts: $1.7 billion on 42 of the 89 drugs.
The drugs that would have generated the highest savings at Cuban prices were esomeprazole (as brand-name drug sold as Nexium) $293 million; rosuvastatin (as a brand-name drug sold as Crestor), $241 million; and aripiprazole (as a brand-name drug sold as Abilify), $233 million.
Other research has also suggested Medicare overpayment. Lalani and his colleagues referenced a study that showed Medicare overspent relative to Costco member prices.
“Our findings suggest that Medicare is overpaying for many generic drugs,” they concluded. They cited a previous research that has shown that the various entities in the drug supply chain retain 64% of every dollar spent on generic drugs
FTC Has Put PBMs, PBM Rebates in its Hot Seat
June 17, 2022
A week after announcing a study of the PBM industry, the Federal Trade Commission announced yesterday that it was stepping up possible enforcement actions targeting the industry’s rebate practices. Rebates to exclude lower costs from formularies may constitute commercial bribery under the Robinson-Patman Act, the commission said.
On the heels of an announcement last week that it was going to conduct a thorough study of the pharmaceutical benefits management (PBM) industry, the Federal Trade Commission announced yesterday that it was ramping up possible enforcement action against PBMs, zeroing on rebate practice that, in the commission’s view, may constitute commercial bribes and restraint of trade.
The commission voted 5-0 to issue the six-page policy statement. The chair, Lina Kan, and three of the other commissioners, issued their own statements.
JC Scott, president and CEO of the Pharmaceutical Care Management Association, the trade association for PBM industry, issued a statement that said that the rebates had been studied multiple and the “the same conclusion reached – rebates lower prescription drug costs for consumers.” Scott’s statement said that PBM negotiations with drugmakers reduce consumer drug costs by nearly $1,000 per consumer each year, and that PBMs are expected to save health plans and consumers more than $1 trillion over the next 10 years.
Yesterday’s announcement came after the commission announced on June 7 that it was launching a study of the PBM industry. The commission has subpoena-like power to conduct such studies. As part of this one, commission is requiring the six largest PBMs to provide answers to a list of 38 questions about their businesses and business practices. Six PBMs receiving the questions that must answer are CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics. and MedImpact Healthcare Systems.
The possible connection between high list prices for insulin and rebates practices was mentioned in the overall policy statement and in the individual statements by the commissioners.
“…some have suggested that high rebates and fees to PBMs and other intermediaries may incentivize higher list prices for insulin and discourage coverage of the lowest-cost insulin products,” said the overall policy statement.
In her statement, Commissioner Rebecca Kelley Slaughter discussed the disproportionate burden of diabetes on Black and Hispanic people and that Black and Hispanic people are also make up a disproportionate percentage of people in the U.S. who don’t have health insurance or whose coverage exposes them to the burden of high list prices. “Exorbitant insulin pricing is even more disturbing from a racial and health equity standpoint,” wrote Slaughter.
Commissioner Alavro Martin Bedoya said in this statement that the focus on PBMs shouldn’t be taken as removing drug manufacturers for possible blame for high insulin prices: “Today’s statement may appear to focus on pharmacy middlemen — PBMs — but the statement very much focuses on both PBMs and manufacturers.”
In her individual statement, Kan said that that the wholesale price of insulin nearly tripled between 2009 and 2017. Without mentioning insulin specifically, Kan said that PBMs and other middlemen may exclude the lower-cost generics and biosimilar drugs from formularies to maximize rebates and fees.
“Such practices,” she said in her individual statement, “may violate the fundamental bargain at the center of the American prescription drug system, which is that brand drugs are given a period of patent exclusivity that is then followed by free and fair competition from generic or biosimilar alternatives at dramatically lower prices.”
The policy statement asserts that the commission has the power to take possible enforcement action against PBM rebates practices under the 1890 Sherman Act, the foundational antitrust law that prohibited monopolies and other anticompetitive business practices; the 1914 Clayton Act, which prohibits anticompetitive mergers and pricing; and 1936 Robinson-Patman Act, which prohibits discriminatory pricing and commercial bribery.
The press release about the commission’s overall policy statement says that “paying or accepting rebates in exchange for excluding lower cost drugs may constitute commercial bribery” under the Robinson-Patman Act.
“If buyers (say, an insurer and their insured customers) use an agent (say, a PBM) to negotiate on their behalf, and that agent takes payment from the seller (say, a drug manufacturer) this may create a conflict of interest,” Bedoya wrote in his statement. “It may also be a commercial bribery violating Robinson-Patman.”
Aduhelm: Great Expectations Fizzle
June 17, 2022
MHE Publication,
Dogged by controversy, the new Alzheimer’s drug has not fared well since its approval by the FDA a year ago.
Before its approval on June 7, 2021, Aduhelm (aducanumab) was seen as possibly being one of the most important drugs launched in decades. It was heralded as the first new agent to treat Alzheimer’s disease in almost two decades. Moreover, data suggested it worked by reducing beta amyloid plaques in the brain, which many experts believe causes the disease.
At the time of its approval, some analysts projected that annual sales of Aduhelm could be between $8.2 billion and $10 billion. But now, a year after the FDA gave the drug an accelerated approval, those heady projections look like so many popped balloons. In 2021, Aduhelm generated just $3 million in sales, and in the first quarter of 2022, just $2.8 million. Biogen’s stock is trading at less than half the price it was in the days after the approval. The company is reducing its “commercial infrastructure” that supported Aduhelm and taking other cost-reduction measures, including inventory write-offs. One analyst told Bloomberg that the Cambridge, Massachusetts, company was “essentially throwing in the towel on Aduhelm.” In early May, Biogen announced that CEO Michel Vounatsos was stepping down.
Aduhelm’s apparent fizzle might have been foretold by all the controversy it kicked up. The late-stage development program for the drug consisted of two phase 3 clinical trials: one met the primary end point, showing a reduction in clinical measures of the effects of Alzheimer’s on cognition, but the other did not. The FDA approved the therapy even after an advisory committee voted against it, saying the data created uncertainties about the drug’s clinical benefit. Several committee members resigned in protest.
Biogen’s pricing strategy added fuel to the fire. The initial price tag for a year’s supply was $56,000. The Alzheimer’s Association, an important advocacy group to which Biogen has donated, called that price “simply unacceptable.” In December 2021, Biogen slashed the price in half. Still, the Institute for Clinical and Economic Review (ICER), an independent cost-effectiveness assessment organization in Boston, said Aduhelm would have to be priced far lower — between $3,000 and $8,000 — to meet typical cost-effectiveness thresholds.
Aduhelm got a cold reception payers. Almost immediately after its approval, several Blue plans and the Department of Veterans Affairs indicated they wouldn’t cover the drug because they considered it experimental and not medically necessary. Health systems such as Cleveland Clinic and Mount Sinai said they would not administer Aduhelm. In early April 2022, CMS issued its final coverage decision for Aduhelm, limiting Medicare coverage to prescriptions for people who are enrolled in clinical trials. UnitedHealthcare, which had been waiting for the CMS decision, said it would not cover the therapy either.
The CMS decision is likely to have a big impact, notes Supriya Munshaw, Ph.D., a senior lecturer at the Johns Hopkins Carey Business School. “A lot of private payers were waiting to see what CMS was going to say. This will affect other decisions to cover the drug as well.”
“Biogen was expecting a lot more adoption” Munshaw continues. “A $20,000 drug that is not going to be reimbursed will certainly affect how many patients will be able to use it, because not many patients can afford this out of pocket.”
Biomarker controversy
Munshaw says Aduhelm’s woes can be traced to data from the two pivotal studies showing only a marginal effect on a biomarker, which not everyone agrees is a good indicator of the drug having a positive effect on the cognitive difficulties caused by Alzheimer’s.
“Biogen ran two trials for this drug, and only one of them showed marginal differences in the populations between the control and the treatment arm based on a particular marker and not necessarily the disease outcome,” she said. “There is some controversy surrounding the use of that marker to predict Alzheimer’s disease. If the experts in the biology are not even consistent on whether or not this marker is important in Alzheimer’s, the fact that (the drug) got approved based on this marginal improvement of this marker is pretty controversial.” That marker is the accumulation of beta amyloid protein in the brain. Some evidence points to beta amyloid deposits, often called plaques, as having a causative role. Animal studies have shown this connection, but the results from human studies are mixed results.
Aduhelm had excited researchers when early data showed that not only could it block the production of beta amyloid plaques but it also could clear some existing ones. Biogen’s two studies were designed to assess the impact of Aduhelm on cognitive function using the Clinical Dementia Rating Scale Sum of Boxes score, an integrated scale that assesses function and cognition. Other outcomes that assessed behavior and biomarker end points were also used. But both studies were stopped when they were at their halfway point of enrollment. A pooled analysis showed only one study had met its end point.
Biogen has recently begun enrolling patients for a phase 4 confirmatory trial of Aduhelm. Researchers eventually will enroll 1,500 patients with early Alzheimer’s disease in the study, with a primary clinical end point at 18 months after treatment initiation. Biogen expects the study to be completed in about four years. It will use the same end point scale as the previous studies and will also include a trial extension to collect longer-term treatment data for up to 48 months. Biogen also indicated that about 18% of participants enrolled will be Black/African American and Latino.
ICER scrutiny
Aduhlem’s downward arc may make the findings somewhat anticlimactic, but ICER is planning to do a cost-effectiveness evaluation of Aduhelm compared with two as yet unapproved Alzheimer’s therapies, Eli Lilly’s donanemab and Eisai’s lecanemab. Originally, ICER planned to discuss the findings of its report during a meeting scheduled for July 2022, but it has been moved to the first quarter of 2023.
Eisai, a Japanese company and a partner of Biogen, completed a rolling submission in May 2022 for an accelerated approval of lecanemab, a monoclonal antibody that targets beta amyloid, to treat patients with early Alzheimer’s disease. Eisai has requested a priority review. The company’s application is based on data from a phase 2b trial in patients with confirmed presence of beta amyloid plaques in the brain, an open-label extension study, and a confirmatory phase 3 trial.
Results from a simulation model conducted by Eisai, published in April 2022 in Neurology and Therapy, found that lecanemab can potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of Alzheimer’s disease. In this projection, the mean time to advancing to mild, moderate and severe Alzheimer’s dementia was longer for patients in the lecanemab group than for patients in the standard of care group by two and half years.
Eisai is continuing with a confirmatory phase 3 study of lecanemab with results expected in the fall of this year. The FDA has agreed that this trial could be used to verify clinical benefit.
Eli Lilly announced separately in fall 2021 that it had begun a rolling submission to the FDA for donanemab, which also acts on beta amyloid, for accelerated approval. The company intends to complete its submission in the second quarter of 2022, which could result in an FDA decision in early 2023. Lilly also plans to conduct a phase 3, head-to-head clinical trial comparing donanemab with Aduhelm. This open-label study will enroll 200 patients and will assess plaque clearance of the two therapies based on positron emission tomography scans
FTC Launches Inquiry Into PBM Industry
June 8, 2022
The Federal Trade Commission says its inquiry “will shed light on” clawbacks, potentially unfair audits, rebates and other business practices of the pharmacy benefits management (PBM) industry. Today’s announcement says the commission will be requiring information from the six largest PBMs.
The Federal Trade Commission (FTC) announced an inquiry into the pharmacy benefits management (PBM) industry today that will require the six largest PBMs to provide information and records regarding their business practices.
The commission said that the companies it is targeted with compulsory orders under its investigative powers are CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics and MedImpact Healthcare Systems.
“Although many people have never heard of pharmacy benefit managers, these powerful middlemen have enormous influence over the U.S. prescription drug system,” said FTC Chair Lina M. Khan, a Biden appointee, said in a prepared statement posted on the commission’s website. “This study will shine a light on these companies’ practices and their impact on pharmacies, payers, doctors, and patients.”
The FTC announcement triggered reactions from the industry and its critics.
JC Scott, the president and CEO of the Pharmaceutical Care Management Association, the trade and lobbying group for the industry, issued a statement that the group was confident that any investigation will show that the “PBMs are the only member of the prescription drug supply and payment working to lower costs.”
Meanwhile, B. Douglas Hoey, the CEO of the National Community Pharmacists Association, a trade group for independent pharmacists that is critical of the industry, said in a prepared statement that PBMs have “escaped serious scrutiny for far too long but this study will bring their dirty laundry out into the open.”
The 5-0 vote for the inquiry came after the commission deadlocked on whether to investigate the industry in February. This time, Trump appointees Noah Joshua Phillips and Christine Wilson voted for going ahead with the inquiry, although they issued a separate statement in which they defended their opposition in February and explained why they switched to being supportive. The current study, they wrote, was prepared with input from PBM experts at the commission and will look at the “competitive impact of PBM practices including — critically — how those practices might impact the out-of-pocket costs for consumer.”
The commission statement announcing the vote and the launching of the inquiry listed seven practices that it will “shed light on”:
- Fees and clawbacks charged to unaffiliated pharmacies
- Methods to steer patients towards pharmacy benefit manager-owned pharmacies
- Potentially unfair audits of independent pharmacies
- Complicated and opaque methods to determine pharmacy reimbursement
- The prevalence of prior authorizations and other administrative restrictions
- The use of specialty drug lists and surrounding specialty drug policies
- The impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients
The inquiry that the commission is launching is referred to as a 6(b) inquiry in reference to the section of FTC Act that authorizes such studies. According to a synopsis on the commission’s website, the 6(b) section authorizes the commission to require answers in writing to specific questions about an entity’s “organization, business, conduct, practices, management, and relation to other corporations, partnerships, and individuals.” As with a subpoena, the entity receiving the request can file a petition to limit or quash the 6 (b) order.
The commission website says the 6(b) authority “enables it to conduct wide-ranging studies that do not have a specific law enforcement purpose.” A different section of the FTC law authorizes the commission to “make public from time to time” portions of the information that it obtains, where disclosure would serve the public interest.
In her statement about the 6(b) study, FTC Commissioner Rebecca Kelly Slaughter said the information that the FTC uncovers in an 6(b) inquiry “can — and should — be presented to the public in a final report” and that a “public-facing work product” can inform policy makers and other government agencies But she also said the commission should pursue enforcement actions where it finds violations of law.
Pfizer, Sidekick Health Launch Digital Therapeutic Aimed at Atopic Dermatitis Market
June 1, 2022
The launch is one of several digital therapeutics partnerships Pfizer has announced in recent months.
Pfizer and Sidekick Health have teamed up to launch a new digital therapeutics solution for patients with atopic dermatitis (AD).
The new platform is designed to boost treatment adherence among patients with AD. The partnership between the Icelandic startup and the international pharmaceutical giant is the latest in a string of digital therapeutics investments by Pfizer.
“At Pfizer, we recognize patient care goes beyond medical advances and we are proud to be working with Sidekick to put their technology in the hands of the people who need it most,” said Ana Paula Carvalho, Pfizer’s regional president of international developed markets for inflammation and immunology, in a press release.
Sidekick’s platform uses gamification, behavioral economics, and artificial intelligence to track and reward patients who adhere to their treatment plans. Under the terms of the agreement, the smartphone application will first be made available to patients in the United Kingdom, followed later this year by Belgium, Norway, the Netherlands, Sweden, France, Ireland, and Japan.
By 2024, patients in a total of 24 markets will have access to the product, Sidekick Health said. The launch is part of a partnership first announced two years ago.
The AD market is large and growing. According to a 2020 study, as many as 14% of adults worldwide have the skin condition. In its moderate and severe forms, the disease can lead to stress, anxiety, and sleep loss, the companies noted.
Treatments range from over-the-counter topical ointments to new systemic therapies, such as Pfizer’s oral once-daily Janus kinase 1 inhibitor, Cibinqo (abrocitinib), which received Food and Drug Administration approval in January to treat adults with recurrent moderate-to-severe AD.
Sidekick said its digital patient support program can make a meaningful impact on people with AD, by reducing stress, improving sleep quality, and improving overall quality of life. They said a recent feasibility study of their platform found that it increased patient medication adherence in 83% of patients who used the app to manage their chronic illness.
“At Sidekick, it’s always been our ambition to help as many people as possible to make long-lasting improvements to lifestyle behaviors and improve their quality of life,” said Tryggvi Thorgeirsson, MD, Sidekick’s co-founder and chief executive. “Our work with Pfizer better enables us to reach our goal of bringing digital therapeutics into the homes of people around the world.”
The launch of the Sidekick platform follows other partnerships between Pfizer and digital therapeutics makers.
In January, Pfizer announced a strategic partnership with the Swedish software-maker Alex Therapeutics to create digital therapeutics targeting smoking cessation.
Then in April, Pfizer announced an agreement to acquire the Australian firm ResApp Health, which makes digital therapeutics focused on respiratory health indications. Among ResApp’s products is SleepCheck, an app designed to assess sleep apnea risk.
Last year, Pfizer made a deal with the Malaysian firm Doctor on Call to launch a digital therapeutics platform aimed at three therapeutic areas: smoking cessation, vaccination, and cardiovascular health.
Carvalho said Pfizer’s digital therapeutics investments represent the company’s broader approach to patient health.
“A holistic approach to treating the individual, not just the disease, is essential in order to advance the standard of care for patients and to empower them to live their best lives,” she said, in the press release.
The CMS Spend on Accelerated Approval Drugs. Is It Time To Tap the Brakes?
May 27, 2022
Two studies published this week documented the billions that Medicare and Medicaid spend on drugs that have been granted accelerated approval by the FDA based on surrogate end points. A study reported today in JAMA Health Forum found that only 6 of the 22 confirmatory trials used clinical outcomes.
Two studies published this week documented the billions Medicare and Medicaid spend on drugs that have been granted accelerated approval by the FDA based on surrogate end points. A study reported today in JAMA Health Forum found that only 6 of the 22 confirmatory trials used clinical outcomes.
The FDA’s accelerated drug approval process is coming under some heightened scrutiny, partly because of the agency’s controversial decision last year to approve Aduhelm (aducanumab). Congress is considering several proposals that would tighten up the rules for the confirmatory trials that drugmakers are supposed to conduct after their products get accelerated approval. Proposals to put some limits on Medicaid and Medicare coverage have also been discussed.
Just how much Medicare and Medicaid spend on drugs that have received accelerated has been the subject of recently reported studies.
On Tuesday, a team of Johns Hopkins researchers reported findings in the Annals of Internal Medicine that showed that traditional Medicare program spent $1.2 billion on 36 accelerated approval drugs in 2019, with oncology drugs accounting for 72% of the spending. After extrapolating the findings to Medicare Advantage, Jeromie Ballreich, Ph.D., M.H.S., and his colleagues calculated that Medicare spending on the accelerated approval drugs climbed another $600 million and totaled $1.8 billion.
Today findings from a similar but broader study of accelerated approval drugs were reported in JAMA Health Forum, the JAMA journal devoted to health policy.
Joshua Skydel, M.D., of the Dartmouth-Hitchcock Medical Center, and his colleagues found that CMS spent $67.9 billion on 37 drugs granted accelerated approval from 2012 to 2017.
Medicare Part D spending on accounted for $34.4 billion of that amount, or slightly more than half (51%) and Part B spending, $25.4 billion (37%,) and Medicaid spending, $8.1 billion.
Based on confirmatory trials, the FDA can convert an accelerated approval to a full-fledge one. Skydel has his colleagues reported that the approval of 22 of the drugs in their study were converted and that $62.1 billion (91%) of the CMS’ $67.9 billion tab was for converted drugs and, furthermore, most of the spending on converted drugs occurred after were reclassified as fully approved drugs ($11.1 billion [18%] before conversion compared with $51 billion [82%] afterward). Nearly all (97%) of the money spent on the drugs with converted approval was for cancer treatment drugs, a group that includes Keytruda (pembrolizumab), Ibrance (palbociclib) and Opdivo (nivolumab).
The flip side to the spending drugs that ultimately gained full approval is that CMS spent $5.8 billion on drugs that did not convert to full approval, according to this research.
One of main issues with accelerated approval is the use of surrogate end points, such as changes in various lab values or, in the case of cancer drugs, tumor size, that are supposed to correlated with “clinical benefits,” such as symptom relief or living longer. Skydel and his colleagues note that confirmatory trials are supposed to have clinical benefits as end points as a way of confirming that initial accelerated approval based on surrogate end points was warranted. But they found that only 6 (27%) of the 22 conversions from accelerated to full approval were based on confirmatory trials that used clinical benefit end points. That means, they said, that CMS spent $40.3 billion on drugs supported only by surrogate end point data.
“The accelerated approval pathway was developed to facilitate earlier access to drugs that address the unmet needs of patients with serious conditions with the expectation that clinical benefit would be confirmed by postapproval trials,” the researchers wrote in the discussion section of the study. “However, use of surrogate end points in both preapproval and postapproval trials supporting accelerated approval has been common.”
They mention several proposals to curb CMS spending on accelerated approval drugs including the exclusion of drugs without full approval from coverage mandates and linking rebates to evidence of clinical benefits.
Specialty Pharmacy Controls Limit Patient Access, Fein and Long Explain: 2022 Asembia Specialty Pharmacy Summit
May 4, 2022
Conferences | Asembia’s 2022 Specialty Pharmacy Summit
In their general session, Adam J. Fein, PhD of Drug Channels Institute, and Doug Long of IQVIA reviewed the current specialty pharmacy space, ongoing trends and future expectations.
Pharmacy benefit managers (PBMs) continue to dominate the specialty dispensing and payer control is challenging patient access, explained Adam J. Fein, PhD, CEO, Drug Channels Institute, and Doug Long, vice president, industry relations, IQVIA, during their session at Asembia’s Specialty Pharmacy Summit, held May 2-5 in Las Vegas, Nevada.
The top three specialty pharmacies by revenue in 2021, explained Fein, were PBMs: CVS Health, Express Scripts, OptumRx. And payers are not only limiting where patients can go, but they are often sending patients to the specialty pharmacy owned by their PBM.
Another big driver in specialty pharmacy has been 340B. The top three specialty pharmacies are also among the five companies—CVS Health, Walgreens, Walmart, Express Scripts and OptumRx—holding the majority (73%) of 340B relationships. However, the 340B program recently faced a massive change when 16 manufacturers have pulled back from 340B pricing from contract pharmacy networks.
This decision by the manufacturers resulted in a drop in the growth rate of new purchases in 2021 after years of positive growth, Fein explained. For instance, the growth of 340B purchases for mail pharmacies had averaged more than 50% annually for four years, but the growth of new purchases in 2021 was –20%.
Another trend in the market that is important to note is vertical integration, said Fein. The practice of hospitals buying up physician practices “accelerated more than you might think.” The integration has happened particularly in areas with 340B pricing, and hospitals and health systems have started to utilize the same tactics they’ve seen plans and PBMs do: steer patients to their own specialty pharmacies.
Health systems with larger specialty pharmacies were more likely to steer patients to them. According to Fein, 70% of health systems with fewer than 15,000 annual specialty prescriptions either preferred the specialty pharmacy in the health system’s plan or had an exclusive specialty pharmacy for the health system’s plan compared with 86% of health systems with 15,000 to 45,000 prescriptions and 95% of health systems with more than 45,000 prescriptions.
Long continued the presentation by reminding the audience of the market share specialty medicines has. In February 2022, specialty accounted for 49.9% of sales, and the only reason traditional medicines still had a majority was because of COVID-19 vaccines, which are considered traditional medicines. Long noted that he expected specialty medicines to take the majority when the March or April numbers were considered.
Reviewing one- and five-year growth, Long pointed out that generics and biosimilars have helped to slow spending growth in certain therapeutic areas, such as multiple sclerosis and HIV. In addition, oncology showed slowing growth, which was largely due to biosimilars. Another reason for the slowed growth for oncology was that there were fewer tests and screenings for cancers during the pandemic, and patient visits have not yet returned to normal.
Long also explained that payer control was challenging patient access to specialty medicines. Compared with 2013, specialty patients are 20% more likely to not fill a prescription today, and OptumRx, Caremark and Express Scripts have placed controls on more than 75% of specialty medicines. In addition, 79% of specialty patients have a National Drug Code block and 60% have a step edit that they are not able to overcome within 30 days.
In 2021, 81 million prescriptions were abandoned at pharmacies by patients starting a new therapy, and has costs rise, so does the frequency of abandonment. Six percent of prescriptions costing $0 were abandoned, which increased to 20% for costs between $40 and $49.99. When medicines cost between $125 and $249.99, 46% were abandoned, and when they cost $250 and more, 61% were abandoned.
Only 1 in 4 new to brand patients who attempted to fill a launch brand were successful due to payer controls, Long said. Plus, as many as 70% of patients on newly launched drugs are supported by patient assistance programs, which cost the manufacturer. As a result of these and other factors, launch success is becoming more difficult and the time to positive investment is delayed, Long explained.
Nancy Lurker of EyePoint Pharmaceuticals Addresses Innovations in Eye Care, How to Grow in the C-Suite and What it Takes to Run a Biopharma Company
April 28, 2022
Briana Contreras, editor of Managed Healthcare Executive, spoke with Nancy Lurker, CEO and president of EyePoint Pharmaceuticals. Nancy shared a bit about EyePoint and how the organization’s innovative therapies are addressing patient needs through eye care, and most importantly, she addressed C-Suite positions like the CEO role. Nancy shared advice for those seeking to reach the CEO level, especially toward women in healthcare and other roles, and what it takes to run a biopharma company.
https://embeds.audioboom.com/posts/8073997/embed/v4
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Pharma: Striding Towards the Digital-only Reality with AI
November 21, 2021
As industries across the board move towards a digital-only world, pharma companies must account for the different technologies that are transforming the R&D process.
Pharma companies have long been playing a critical role in our lives, albeit being in the background. However, COVID-19 has pushed the pharma industry firmly to the foreground. Governments and societies are pinning their hopes on the industry to help prevent the next epidemic while they continue to find cures to known health conditions and diseases.
Navigating a Complex & Fast-changing Landscape
In the wake of the pandemic, pharma companies face a growing number of challenges, especially in relation to Research and Development (R&D). Costs have spiraled over the last decade. In 2020, R&D spending in the pharma industry totaled about $200 billion globally. The journey from pre-clinical research to marketing can take anywhere between 12 to 18 years, pushing any kind of Return on Investment (ROI) into the distant future and increasing the risk to company finances and, in particular, liquidity. On the contrary, COVID-19 has set a precedent and expectation for the speedy development of essential vaccines.
The growth of generics is eating away at market share and regulations have become more complex. Pharma companies that fall foul of the rules can expect not just fines, but greater reputational damage than ever. Developing drugs to combat new and sometimes little understood conditions is particularly time consuming and costly. On the other hand, developing treatments that offer really significant improvements over existing products is also challenging. Meanwhile, the US Food and Drug Administration (FDA) has signaled its desire to bring more competition to the pharma market in an attempt to reduce the cost of medicines.
To remain competitive, drug companies need to invest in their R&D systems to speed up the discovery process. As industries across the board move towards a digital-only world, pharma companies must account for the different technologies that are transforming the R&D process. Digital adoption is the future of the pharma industry, and it is essential that pharma companies understand which technologies can deliver faster, more effective R&D.
Tapping into the Immense Potential of AI
Artificial Intelligence (AI) offers forward-thinking pharma companies the opportunity to revolutionize their drug discovery and development processes. Insilico Medicine, based in Hong Kong, for instance, has used AI and deep learning to design, synthesize and validate a novel drug candidate in 46 days – 15 times faster than what was previously thought possible.
As the Insilico Medicine case study demonstrates, it is already clear that AI, guided by humans, has the potential to manage the vast number of compound permutations needed for drug design. This fast-evolving technology enables the aggregation, harmonization and analysis of multiple data sources needed for discovery, design and clinical trials, thereby shortening the drug development process.
AI can increase novel drug discovery, minimize potential drug interactions, enhance the understanding of disease mechanisms, speed drug design, identify biomarkers, run pre-clinical experiments, design clinical trials, and provide deep insights more efficiently. It can be leveraged to predict the medicines that will ultimately work and the ones that will not, thus helping to reduce the investment in candidates unlikely to make it to market.
By becoming fully digital, pharma companies can gain real-time competitor insights and be vigilant to change in drug regulations across regions. With the use of AI and data analytics, they can streamline knowledge collation via available public and commercial data sources. This instantly provides R&D teams with insights needed on their competition as well as intelligence on local regulations, emerging conditions in a particular regime and the release of new drugs into the market.
AI and data analytics can process vast amounts of data, some of which is unstructured, in a fraction of the time taken by human beings. AI can “learn” what trends and developments to look out for in the data and only alert human beings to what is relevant.
Advancing CI with AI & Cloud at the Core
Cloud-based platforms allow pharma companies to become more agile, as they provide an immediate, interactive, and customizable way of storing Competitor Intelligence (CI) data. With a cloud-based platform, users can access insights across devices such as tablets, smartphones or desktops – through highly secure and seamless authentication. This is particularly important for sales representatives or attendees of conferences and meetings, as vital information can be shared quickly among all relevant parties within the organization.
Pharma groups can integrate their cloud solutions across company systems in a way that combines both Business Intelligence (BI) tools and commercial data. These platforms are customizable so that they can display in-house and external news, competitor profiles, and sales and pricing information via easily accessible dashboards and layouts. Combining valuable data analytics insights, AI and cloud-based platforms makes retrieving market insights streamlined for R&D teams.
Insights from CI have always enabled pharma companies to identify their core strengths in relation to their competitors. As well as transforming drug development, AI can enhance CI to cope with rapidly evolving markets and greater disruption. The more detailed, accurate and timely CI can help companies target unmet needs to transform not just their offerings, but entire business models. The analysis of the competitive environment can also guide their own R&D focus. This helps benchmark performance, identify strengths, and highlight priority areas. Superimposing results from business and CI helps pharma companies identify new avenues to differentiate their brand and fulfill market needs as they emerge.
Cloud computing can be used to complement AI-powered tools as they harvest data from millions of website pages to draw out valuable insights by tracking a competitor’s entire digital footprint, both on and off their site. Together, technologies can measure everything – from changes in the price of competitors’ products to new appointments. Natural Language Processing (NLP) can analyze the sentiment that competitors’ brands are experiencing on social media, and read customer reviews on a wide variety of platforms and convert it into usable data and actionable information.
Cloud computing enables companies to effortlessly increase or reduce their storage requirements for CI data. The insights that they develop can also be easily shared across all departments, from R&D to finance, on a variety of devices using intuitive interfaces such as dashboards.
Factoring in the Obvious Challenges
As small and large pharma companies rush to adopt these new technologies, they are bound to run into obstacles. Currently, for instance, patent laws largely do not acknowledge AI as an ‘Inventor.’ Hence, AI inventions cannot enjoy the same protection as traditional innovations. With the variety and scale of data used increasing, including genetic code, security risks are evolving too, necessitating new governance measures. AI will be limited by processing speeds, requiring pharma companies to adopt new technologies in their endeavor of maximizing AI impact.
As competitors possibly compress years of product research, development and launch efforts into mere months, companies will need to ensure that their CI can keep pace.
Even the largest pharma companies need to look for trusted technology partners to help them benefit fully from AI. As they focus on their core competencies, they can work alongside these partners, with their specialist knowledge and capabilities, to draw up a road map for the adoption of AI. Their partner organization should be able to identify the right solutions and then enable to scale them up rapidly in a controlled environment.
CI platforms such as PRECIZON from WNS have built-in readiness for the rapid acceleration of R&D enabled by AI. The pace of the market will increasingly demand Machine Learning (ML) intelligence for real-time user recommendations and content classification. Delivered on the cloud, such technologies can be integrated into other core systems with personalized content available through all devices. As AI increases pipeline pace, such scalable enterprise tools are becoming vital to ensure insights from robust automated systems that enable collaboration.
Ranking is a ML technique for recommendation systems such as intelligent CI. In what are known as “clustered approaches,” information about user behavior can be utilized to recommend items. These recommendations are generated with user-user or item-item similarity. Based on these similarity measures, the resulting suggestions are provided to the user. By predicting these user preferences, the portal delivers effortless user engagement.
The Time for Accelerated Innovation is Now
Interestingly, these new, innovative technologies feed off each other. As the growth of AI and automation drives various facets of pharma operations to becoming digital-only, enterprises will increasingly find themselves storing data on cloud-based platforms. They need to start now by integrating these new technologies into their everyday workflows to stay relevant and ahead of the competition.
Innovation has always been at the heart of the pharma industry. However, the urgency for new drugs is greater than ever, even as risks and uncertainties continue to mount. Implemented correctly, AI and other technologies will enable agile, forward-thinking companies to manage these risks, exploit new opportunities, and deliver for their employees, shareholders and patients around the world.
Akhilesh Ayer is the Head of Research & Analytics Practice and Mark Halford is the SVP- Client Services, Life Sciences and Healthcare Practice at WNS, a leading provider of global Business Process Management (BPM) services.