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CVS Legal Woes Continue

It’s been a rocky road for CVS of late. In July, CVS was assessed a multi-million $ fine in an arbitration case filed by a small specialty pharmacy (see our report on 7/14/2022) and now, CVS is facing a major anti-trust suit by the State if New York relating to how it self-directed prescriptions for Part D members.

Here’s the skinny…..

On July 28, 2022, the Attorney General of the State of New York (NYOAG) brought an antitrust suit against CVS Health in Manhattan state court. The NYOAG accused CVS of violating the Donnelly Act, New York’s state antitrust law, by illegally tying access to contract pharmacy services at CVS retail and specialty pharmacies to the use of a third-party administrator (TPA) called Wellpartner, a company CVS acquired in 2017. The business segment in question is the CVS Silverscripts Part D membership and also the the role played by CVS Caremark, its PBM.

The NYOAG requests civil monetary penalties and to enjoin CVS’s anticompetitive conduct and require CVS to notify New York 340B hospitals that exclusive use of Wellpartner is no longer required. More surprisingly, the NYOAG also seeks “equitable relief which could include an injunction and an order of divestiture” of the Wellpartner business.”

Oh what a tangled web…….


Whistleblower suit: CVS prevented Part D members from accessing generics

A lawsuit against CVS Health comes as policymakers are turning up the heat on pharmacy benefit managers. 

A newly unsealed whistleblower suit claims that multiple CVS Health subsidiaries coordinated to prevent members from accessing generic drugs in a bid to boost the bottom line.

The suit was filed by Alexandra Miller, who worked at CVS for nearly two decades before leaving the company three years ago. When she reported the behavior to a superior, she was told that the company had decided the benefits of the alleged scheme outweighed the likelihood of being caught.

Miller claims that CVS’ SilverScripts Part D subsidiary as well as its Caremark pharmacy benefit manager and retail pharmacies worked together to prevent access to generics, which allowed it to pocket higher rebates because members were pushed to buy branded medications rather than lower-cost options.

Members were also often kept in the dark about potential authorized generic medications or identical drugs that are produced by the same manufacturer but offered at a lower cost.

The company violated Medicare regulations by…………. 

CLICK HERE to read the full article


What’s Your Value Based Contracting Knowledge Level?

We’ve written numerous times about value-based contracting (VBC)….. including earlier this week. When it emerged a few years ago there was much hope that VBC would offer some remedy to the acceptance of ultra-high cost therapies that have been the predominant source of new specialty FDA approvals for the last few years. However, relatively few VBCs have been implemented due to their complexity. 

Value methodologies have begun to morph. In fact, the term ‘value-based contracting’ is now a bit too high level. Are you familiar with the nuanced differences between value-based pricing (VBP), value-based insurance design (VBID), long-term financing (LTF), and outcomes-based contracts (OBCs)? If not, the time may be neigh to get up to speed.

We ran across an abstract (below) that does a very nice job of taking our understanding of VBC to the next level. It summarizes the views of 22 health plans with multiple lines of business collectively covering more than 34 million beneficiaries. These plans are large enough to have dipped their toes into the VBC pond and/or thought long on the inherent challenges.

The initiative identified four business objectives including access to new therapies, their rising costs, spending variability across the patient spectrum, and the incidence of reduced levels of clinical evidence. Additionally, the initiative selected five operational strategies including developing new UM controls, the need for increased patient engagement, including providers in the risk sharing methodologies, expansion of data analytics unique to each contract, and the need to staff more pharmacists, statisticians, and data scientists to be experts in the unique aspects of managing each contract.

The contracting world is less and less satisfied with rebates and is looking for something else to fuel the specialty pharmacy engine. VBC is a no brainer IF design and implementation can be refined. So, if you want to keep abreast of that trend, consider the lessons offered. 


Value-Based Management of Specialty Drugs:

Practical Considerations and Implications for Pharmacy

May 13, 2021 — Policy makers and health plans seek value-based management of specialty drugs. This study examines real-world factors that favor some approaches over others and their potential impact.


Objectives: Concerns about high and rising drug prices have prompted a call to manage prescription drugs according to their value. Although not all proposals referred to as “value based” are well suited to advance this mission, health plans must select among them under the influence of competing demands and constraints of their market and nonmarket environments. To understand the implications for health policy, we sought to explore how health plans might select among and implement these approaches for specialty pharmacy (SP) under the incentives and barriers that these conditions create.

CLICK HERE to access the full abstract.


Delaware Medicaid Pens Value-Based Contracts

Value Based Contracting….. the great hope for fixing many of the disparities in access and payment for pharmaceuticals, especially those that cost a boat load of bucks!

Our curiosity was piqued by the article below detailing a major value-based contracting initiative by Delaware Medicaid. The program will target a quarter million lives in the state. It will include three payor organizations – . AmeriHealth Caritas, Highmark Health Options and Centene Corp.’s Delaware First Health.  Selection was based on each payor’s willingness to implement reforms to migrate the system away from traditional fee-for-service (FFS)/volume-based care to a system that focuses on rewarding and incentivizing improved outcomes, quality improvement and reduced expenditures.

Unfortunately no detailed terms of the VBC terms were disclosed. What is noteworthy, however, is the fact that a major account like Delaware Medicaid has made the leap to try a VBC program. Hopefully some proofs of concept will be forthcoming over the first year of implementation. 

Specialty pharmacies may want to follow VBC development as they can play a key role in the administration of these contracts….. something that we’ve said many times over the past couple of years.


Centene Will Join Delaware in Value-Based Medicaid Revamp

With a focus on value-based care, health equity and social determinants of health, Delaware recently selected three managed care organizations to serve some 280,000 Medicaid and CHIP recipients through the statewide Diamond State Health Plan and DSHP Plus managed care programs. Incumbents AmeriHealth Caritas and Highmark Health Options Blue Cross Blue Shield were both chosen for the new pacts, while Centene Corp.’s Delaware First Health will round out the trio of plans. 

New contracts mark state’s shift to value-based care 

•            Delaware’s Medicaid managed care program is currently operating under the authority of a Section 1115 demonstration waiver that was most recently extended through Dec. 31, 2023. It provides integrated physical health, behavioral health and long-term services and supports (LTSS) to eligible Medicaid and CHIP enrollees. 

• According to AIS’s Directory of Health Plans, Highmark Health has the largest share of lives (55.6%) with 156,267 enrollees. AmeriHealth Caritas serves 84,144 lives, while the remaining 40,395 Medicaid/CHIP beneficiaries are in fee-for-service Medicaid. The new five-year pacts will be effective Jan. 1, 2023, with three optional one-year extensions. 

• In its December request for proposals, the Delaware Dept. of Health and Social Services’ Division of Medicaid and Medical Assistance asked bidders to describe how they plan to implement a value-based purchasing model in the first year of the contract. The state in its RFP said it intends to “accelerate the implementation of reforms and innovation within Delaware’s health care delivery system to migrate the system away from traditional fee-for-service (FFS)/volume-based care to a system that focuses on rewarding and incentivizing improved outcomes, quality improvement and reduced expenditures.” 

Win supports Centene’s growth story 

• The award will mark the 30th state where Centene has Medicaid plans; its Ambetter Affordable Care Act exchange product is available in 25 of its current 29 Medicaid states. 

• Assuming Centene will serve one-third of the total population, the new contracts will contribute approximately 2 cents to Centene’s earnings per share and add more than $700 million to the company’s revenues, estimated Oppenheimer & Co., Inc. 

•  “Although the contribution is modest, we believe this represents incremental growth and reflects favorably on the positioning of the business,” wrote securities analyst Michael Wiederhorn in a July 12 note to investors. “Overall, we continue to believe Centene is deploying the correct strategy with its value creation plan by focusing on its core strengths.” The firm maintained an outperform rating for Centene. 

•  The state plans to hold an open-enrollment period for the new program starting on Oct. 1. For individuals who are required to enroll in a DSHP or DSHP Plus MCO and fail to voluntarily choose one, they will be automatically assigned to an MCO and be informed of their auto-assignment, according to the RFP. 

by Lauren Flynn Kelly, AIS Health


Report Says Biosimilars Are Saving $$s – Sort of

Several recent reports have touched on biosimilars and today we’ll offer up some new data that shows how pricing is being impacted.

A new university study drills down into the pricing trends of two well-established follow on biosimilars, Fulphila and Udenyca, as well as Neulasta, their reference product.

Here’s what’s interesting…..
The use of pegfilgrastim biosimilars was associated with lower patient OOP costs….. but the biosims did not generate the lowest health plan costs! As noted below, out-of-pocket costs were 47% to 59% lower for patients overall, but, payer costs were actually lower for Neulasta vs. the biosimilars. Go figure! Bottom line, the researchers found no significant differences in febrile neutropenia treatment and management costs between biosimilars and the brand product.

So, we can see two things in this analysis.
First, the list price of Neulasta has dropped significantly since competition appeared on the scene.
Second, rebates further mask how patient out of pocket costs are assessed while payer costs are still likely to be even lower than the study was able to document.

Oh what a tangled web….. even with data.

No Significant Cost Savings From Neulasta Biosimilars for Payers

A study of Neulasta (pegfilgrastim) compared with its biosimilars in the prevention of febrile neutropenia has shown savings for patients but not for payers.

Use of Neulasta and other white blood cell growth stimulators is recommended as prophylaxis to lower the risk of infection following myelosuppressive chemotherapy. However, real-world studies of the savings have been lacking, according to lead author Ching-Yu Wang, M.S., of the Department of Pharmaceutical Outcomes and Policy at University of Florida in Gainesville, and his co-authors.

Wang and his co-authors acknowledged that competition from Neulasta biosimilars, five of which have been approved by the FDA since 2018, has succeeded in pushing down the price of Neulasta. By the second quarter of 2021, Neulasta’s average sales price had dropped 41%, according to its maker, Amgen.

But if appearances are to be believed, Neulasta, despite being the reference brand, is not selling at a premium to its biosimilars. Wang and his co-investigators said that during the 2019, one-year period they selected for retrospective analysis of commercial payer data, there was no significant difference in payer costs for febrile neutropenia management between Neulasta and two of its biosimilars, Fulphila (pegfilgrastim-jmdb) and Udenyca (pegfilgrastim-cbqv). They reported their findings in the July 2022 issue of the Journal of Managed Care and Specialty Pharmacy.

One major limitation of that finding, though, was that information was not available on discounts and rebates manufacturers gave to payers to incentivize preference of Neulasta or the biosimilars.

“For managed care pharmacies interested in adopting pegfilgrastim biosimilars, prices offered by manufacturers after considering all discounts and rebates is a determining factor,” Wang and his co-authors wrote.

The study looked at costs of primary prophylaxis use of the reference product and its biosimilars for patients receiving chemotherapy in the first cycle. Patients were predominantly treated for breast cancer (> 64%), lung cancer, and non-Hodgkin lymphoma.

Data show that out-of-pocket (OOP) costs were 47% to 59% lower for patients who received biosimilars as primary prophylaxis for febrile neutropenia. Again, there were limitations attached to this finding. One was that 67% to 83% of patients paid nothing for treatment in the first cycle, possibly because of manufacturer patient support programs or possibly because patients had maxed out their deductibles and co-pay requirements by the time Neulasta and the biosimilars were prescribed, the researchers noted.

In the study (N = 1,930), 46% of patients used Neulasta; 22%, Fulphila; and 32%, Udenyca. The respective per-patient, per-cycle reference drug or biosimilar OOP costs were $299, $182, and $159, Wang and his co-authors wrote.

Payer costs for the biologic drugs were clustered in a narrow range: Neulasta, $5,618; Fulphila, $5,783; and Udenyca, $5,845.

When it came to per patient, per cycle febrile neutropenia treatment and management costs, health plan costs, and total costs overall, there were no significant differences for patients who received either the reference product or its biosimilars, study authors said. OOP treatment costs for patients were $192 for Neulasta, $197 for Fulphila, and $240 for Udenyca. The respective FN treatment costs for health plans were $2,804, $2,970, and $2,745.

Although savings studies of Neulasta vs biosimilars are rare, use of Neulasta biosimilars could produce savings that enable expanded access to treatment for patients with non-Hodgkin lymphoma, according to a recent simulation study led by Ali McBride, Pharm.D., M.S., BCOP, former clinical coordinator of hematology/oncology at the University of Arizona Cancer Center and currently director of health economics and outcomes research for Bristol Myers Squibb.

McBride was also lead author on another recent simulation study that suggested significant cost efficiencies are possible by switching patients from the Neulasta on-body injector to standard Fulphila injections. Those potential savings were based on on-body injector failures and related FN hospitalization costs.

Tony Hagen, Managed Healthcare Executive


FDA Approves New Sub-q Tx for Asthma – Tezspire

The FDA recently approved a new subcutaneously administered therapy, Tezspire (tezepelumab-ekko) from AstraZeneca AB and Amgen, as an add-on maintenance treatment used to improve severe asthma symptoms when used with a patient’s current asthma medicine. Tezspire is approved for adults and children aged 12 years and older with severe asthma not controlled by their current asthma medicine.

Tezspire is a monoclonal antibody and the only biologic to date to significantly reduce exacerbations across a broad spectrum of severe asthma patients. This group accounts for roughly 10% of the world’s 339 million asthma sufferers.

The cost for Tezspire subcutaneous solution (210 mg/1.91 mL) is around $3,835 per vial which is the prescribed volume for the once monthly injection.

The companies did not release distribution details. It will be interesting to see if this therapy goes into limited distribution given the somewhat large patient population and ‘relatively’ low cost. If so, it may be the first specialty therapy approved in quite some time that has not gone LD. However, both Amgen and Astra Zeneca have long histories showing their preference for LD.


FDA approves maintenance treatment for severe asthma


FDA has approved Tezspire (tezepelumab-ekko) injection as an add-on maintenance treatment used to improve severe asthma symptoms when used with a patient’s current asthma medicine. Tezspire is approved for adults and children aged 12 years and older with severe asthma not controlled by their current asthma medicine. Tezspire is the first asthma treatment targeting thymic stromal lymphopoietin, a molecule involved in airway inflammation. Tezspire is also the first treatment for severe asthma that is not limited to a specific type of severe asthma.

Tezspire is administered once every four weeks by a health care professional through a subcutaneous (under the skin) injection.

Disease or Condition:

Asthma is a long-term inflammatory disease that causes the airways of the lungs to become swollen or inflamed and can be triggered by several factors, including allergen or irritant exposure and viral infections. An asthma attack (exacerbation) can include wheezing, cough, chest tightness, and make it hard to breathe.

Severe asthma attacks can be intense, last for long periods of time, and impact daily activities. Severe asthma symptoms usually do not get better with use of short-term treatments. Approximately 5-10 percent of Americans with asthma have severe asthma.


Safety and effectiveness of Tezspire were demonstrated in two clinical trials (NCT02054130 and NCT03347279), where participants with severe asthma received Tezspire 210 mg or placebo subcutaneously once every four weeks for 52 weeks.

Participants receiving Tezspire had significant reductions in the annualized rate of asthma attacks compared to placebo. Additionally, there were fewer asthma attacks requiring emergency room visits and/or hospitalization among participants treated with Tezspire compared to placebo. The benefits of Tezspire seen in participants weren’t limited by specific severe asthma type.

Safety Information:

Tezspire should not be used to treat short-term asthma symptoms or short-term asthma attacks. Patients should not discontinue systemic or inhaled corticosteroid treatments abruptly after starting therapy with Tezspire. Reductions in corticosteroid treatment dose, if appropriate, should be gradual and performed under the direct supervision of a health care professional. Patients with pre-existing helminth infections should be treated for the helminth infection before starting therapy with Tezspire for asthma. Patients with a serious hypersensitivity reaction to Tezspire must not take Tezspire. Live vaccines should be avoided in patients receiving Tezspire.


Tezspire received breakthrough designation for the treatment of severe asthma.

CLICK HERE: See the prescribing information for additional information 


Has Biosimilar Fever Arrived?

The answer to whether biosimilar fever has arrived is ….. ‘almost’….. if one believes the comments from CIGNA in the article below. 

CIGNA is bullish on biosimilars and is willing to put its money behind its prognostications of realizing billions of dollars in savings. 

  • “Under the new Shared Savings Program, members will be offered a one-time $500 debit card for healthcare services or medications if they make the decision to switch to a biosimilar.”

To get the bonus, members on Remicade therapy would need to switch to either Avsola or Inflectra, biosims approved in April 2016 and December 2019 respectively. (Of note, two other approved infliximab biosimilars, Renflexis and Ixifi, were not included in the bonus program.)

CIGNA goes on to say that they are looking closely at promoting biosimilar use of other approved and commercially available biosimilars. The potential for huge savings ramps up significantly in 2023 when already approved biosims for Humira and Enbrel are finally released for marketing.


Cigna to offer $500 incentive for members who switch to a biosimilar drug

Cigna is launching a new program that aims to encourage eligible members to switch to biosimilar drugs. 

Under the new Shared Savings Program, members will be offered a one-time $500 debit card for healthcare services or medications if they………

CLICK HERE to read the full article


Two Associations Duel Over White Bagging

Today we offer a review of a recent report issued by the American Hospital Association (AHA) wherein the association excoriates payer practices that ‘force’ the use of the onerous practices like white bagging and prior-authorizations….. “practices that delay patient care and raise administrative costs.”

Let’s look at white bagging since everyone is up to date on this model after reading our report on the practice earlier this week. 

The AHA says “white bagging  prohibits providers from using their own medication inventory.” What the AHA is really saying is that hospitals want to use the product they have purchased so they can bill for it at their usually exorbitant, marked up rates.

AHA goes on to claim that “white bagging compromises patient safety and adds significant complexity to the healthcare system and tremendous administrative burden to providers who are trying to manage these policies on behalf of their patients. There are several safety issues that come with white bagging including delaying care when medications are not delivered on time and preventing providers from validating that specialty medications were managed appropriately when being delivered. These medications often have temperature and handling requirements.”

A response from American Health Insurance Plans (payors) disputes these claims. AHIP states that “specialty pharmacies have to meet extra safety requirements for specialty drugs that are imposed by the drug manufacturers as well as by state and federal legal and regulatory requirements.” 

Very few therapies are needed on a ‘stat’ / life threatening basis. Even-hospital owned therapies would be on the shelf waiting for payor prior-authorizations, so the delays, which can often run days or even weeks, are shared regardless. And, specialty pharmacies can reliably ship a therapy the same day as a prior authorization is approved for delivery next day. As we know, specialty pharmacies have excellent performance records relating to safely shipping medications within rigid temperature and handling requirements. 

As the article concludes….. the “report is evidence of the longstanding rift between providers and payers.”  Some things are never likely to change.


American Hospital Association Turns Up the Heat On Commercial Insurers In Scathing Report

However, insurers’ practices, such as white bagging, are needed to reduce costs for patients says America’s Health Insurance Plans

Commercial health plans use practices that delay patient care and raise administrative costs, a recent report by the American Hospital Association charged.

The report listed several practices that it says burdens providers and harms patient care. This includes prior authorization, the process that determines if a payer will cover a service; fail-first policies, in which patients try and fail certain treatments before insurers authorize more costly treatments; white bagging, which prohibits providers from using their own medication inventory; and several others.

“Some commercial health insurers have implemented policies that add billions of dollars in added unnecessary administrative costs to the healthcare system while compromising patient care,” AHA states. “Commercial health plan abuses must be addressed to protect patients’ health and ensure that medical professionals, not the insurance industry, are making the key decisions in patient care.”

Some of these practices are needed to reduce expenses for patients, countered Kristine Grow, senior vice president of communications at America’s Health Insurance Plans. But the two topics in the report Grow particularly pushed back against were prior authorization and white bagging, also known as specialty pharmacies.

Article continues……..

CLICK HERE to read the full article

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