Month: August 2022

We’ve written frequently on two of the biggest trends in channel access, the shift away from buy-and-bill to other, less costly, sites of service as well as payer policies that have shifted reimbursement away from physician / hospital purchased drugs to specialty pharmacies. An article we want to review today is from Drug Channels. It is a great read and includes some fresh data to document these trends.

That article, an excerpt from a larger market report available for purchase from the company, first refreshes our understanding of the types of patient access now being employed. By now we are all familiar with White Bagging and Brown Bagging (if not, read the article). A term that is beginning to catch on is Clear Bagging in which the hospital-owned specialty pharmacy does the fulfillment.

What the data shows is that there has been a significant increase in White Bagging over the past two years with a 20% increase at physician practices and a 25% increase at hospital outpatient departments. Brown Bagging has virtually disappeared in these settings. Strangely, buy-and-bill at Home Infusion companies increased by a whopping 41% in the same time period and Brown Bagging more than doubled. Go figure! The data is based on a very large ‘n’ of payers nationally.

There are several points for further consideration.

• First, the list of impacted drugs goes beyond Oncology….. and is growing.
• Secondly, a number of specialty pharmacies have been designated by manufacturers as limited distribution (LD) partners (often exclusive) for certain drugs….. even bypassing traditional wholesalers. Since virtually all of these SPs are now also licensed distributors they can sell direct for professional use as a buy-and-bill drug….. under the medical benefit. (Not popular with hospitals and many providers.)
• Next, Payer and PBM policies have ramped in the past year+ to push these transactions over to the pharmacy benefit (even less popular) through rewriting the patient benefit plan…. including introducing patient OOP if billed as a medical benefit.
• Concurrently, PBMs and Payers have been able to co-opt these dynamics to further their cost management efforts on other, non-LD drugs. The data does not separately break out these LD drugs which further muddies up the total White Bagging picture.
• And finally, we can more easily understand why hospitals are increasingly desperate to redirect fills internally to owned specialty pharmacies to recapture lost buy-and-bill revenue.

White Bagging Update: PBMs’ Specialty Pharmacies Keep Gaining on Buy-and-Bill Oncology Channels Drug Channels

Another $2.8 million gene therapy was approved this month. So, we need to ask….. Are we looking forward to the day when specialty pharmacies as we know them will go the way of the buggy whip? Inevitably, the answer is yes. Maybe not soon….. but its ‘a comin!

When a leading PBM like Optum raises a red flag about something one should pay attention. They make the point in the article below that gene therapies are here and that more are in development. The specter of a hoard of budget busting drugs would make all payors quake in their boots.

So far, gene therapies have targeted ultra-rare diseases and conditions, and they currently account for nearly half of FDA approvals in recent years. The technologies being used to develop these ‘one shot and cured’ therapies are advancing at a rapid pace. One only needs to ask when the technology will enable researchers to develop gene cures for other more common diseases like hemophilia….. oh wait, that’s already happening!

Specialty pharmacies might want to imagine a time not so far in the future when gene therapies will be one shot and cured solutions for ALL of the disease states that they support. It would only be a matter of time before there aren’t any more patients in need of long-term therapy. It might look a lot like the last days of the buggy whip business model. Just sayin’

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The gene therapy pipeline may be at a ‘tipping point’. 

Optum says payers need to take notice

Should they be approved, the drugs highlighted in this quarter’s report would double the number of gene therapies on the market to four, and it’s a trend payers should be keeping a close—and early—eye on. (UnitedHealth Group)

The response to COVID-19 likely slowed the development of pricey gene therapy drugs, but those products are now making their way back into the approval pipeline, according to a new report from Optum Rx.

The pharmacy benefit manager released its quarterly look at the drug development pipeline. The latest analysis spotlights two gene therapy products headed to the Food and Drug Administration’s approval table this fall: elivaldogene autotemcel, under the brand Skysona, and betibeglogene autotemcel, as Zynteglo.

Both therapies are for rare conditions, with Skysona targeting cerebral adrenoleukodystrophy (CALD) in young boys and Zynteglo treating beta thalassemia patients who depend on blood transfusions.

Orphan drugs currently account for nearly half of FDA approvals, and gene therapies like Skysona and Zynteglo carry particularly high price tags. Should they be approved, these drugs would double the number of gene therapies on the market to four, and it’s a trend payers should be keeping a close—and early—eye on, said Bill Dreitlein, senior director of pipeline and drug surveillance at Optum Rx, in an interview.

“COVID has had somewhat of an impact, delaying the development of some of those products but now I think we’re starting to see a small wave of those products coming to market,” he said.

He said if the wave of gene therapies swells, it could signal a “tipping point” for these drugs.

Both Zynteglo and Skysona are developed by bluebird bio. Analysts forecast that a single dose of Zynteglo could cost $2.1 million, and there are an estimated 3,000 people in the U.S. with beta thalassemia, with about half dependent on regular transfusions.

The report doesn’t list a potential price for Skysona but notes that Zolgensma, a gene therapy currently on the market for the ultra-rare condition spinal muscular atrophy, costs $2.125 million per dose. There are about 40 people in the U.S. with CALD annually, according to the report.

And because these drugs treat conditions that are so rare, the data on long-term efficacy is limited, but that information would be another consideration for payers weighing coverage. For both drugs, there is data available from seven years of follow-up.

Insurers and PBMs “only know as much as the data available to us,” which makes tracking these products key, Dreitlein said.

“Now is a good time to get back into monitoring the gene therapy pipeline,” he added.

Click Here to access the article on the web

Last week, the FDA approved yet another one-and-done gene therapy, Zynteglo (betibeglogene-autotemcel) from Bluebird Bio, for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee unanimously recommended approval in June.

Beta-thalassemia causes a significant reduction of hemoglobin or the absence of hemoglobin altogether, owing to mutations in the beta-globin gene. Patients typically require transfusions every 2–5 weeks. The median age of death is 37 years.

Zynteglo, a one-time gene therapy, represents a potential cure in which functional copies of the mutated gene are inserted into patients’ hematopoietic stem cells via a replication-defective lentivirus. The therapy is administered as a single dose. Each dose of Zynteglo is a customized treatment created using the patient’s own cells (bone marrow stem cells) that are genetically modified to produce functional beta-globin (a hemoglobin component).

In trials, 89% of 41 patients aged 4 to 34 years maintained normal or near-normal hemoglobin levels and didn’t need transfusions for at least a year.

The gene therapy had been approved in Europe with a $1.8 million price tag. However, in 2021, Bluebird discontinued operations there due to failing “negotiations with European payers and challenges to achieving appropriate value recognition and market access.”

Zynteglo is expected to launch in the US at a whopping $2.1 million. Experts that specialize in medical cost-effectiveness analyses have stated that, given the annual costs of standard care, Zynteglo meets commonly accepted value thresholds at an anticipated price of $2.1 million.” Bluebird has also offered to pay back 80% of the cost if patients require a second transfusion within 5 years.

Bluebird did not announce plans for distribution at this time.

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FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with beta-thalassemia Who Require Regular Blood Transfusions

August 17, 2022 — The U.S. Food and Drug Administration has approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions.

“Today’s approval is an important advance in the treatment of beta-thalassemia, particularly in individuals who require ongoing red blood cell transfusions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Given the potential health complications associated with this serious disease, this action highlights the FDA’s continued commitment to supporting development of innovative therapies for patients who have limited treatment options.”

Beta-thalassemia is a type of inherited blood disorder that causes a reduction of normal hemoglobin and red blood cells in the blood, through mutations in the beta-globin subunit, leading to insufficient delivery of oxygen in the body. The reduced levels of red blood cells can lead to a number of health issues including dizziness, weakness, fatigue, bone abnormalities and more serious complications. Transfusion-dependent beta-thalassemia, the most severe form of the condition, generally requires life-long red blood cell transfusions as the standard course of treatment. These regular transfusions can be associated with multiple health complications of their own, including problems in the heart, liver and other organs due to an excessive build-up of iron in the body.

The safety and effectiveness of Zynteglo were established in two multicenter clinical studies that included adult and pediatric patients with beta-thalassemia requiring regular transfusions. Effectiveness was established based on achievement of transfusion independence, which is attained when the patient maintains a pre-determined level of hemoglobin without needing any red blood cell transfusions for at least 12 months. Of 41 patients receiving Zynteglo, 89% achieved transfusion independence.

The most common adverse reactions associated with Zynteglo included reduced platelet and other blood cell levels, as well as mucositis, febrile neutropenia, vomiting, pyrexia (fever), alopecia (hair loss), epistaxis (nosebleed), abdominal pain, musculoskeletal pain, cough, headache, diarrhea, rash, constipation, nausea, decreased appetite, pigmentation disorder and pruritus (itch).

There is a potential risk of blood cancer associated with this treatment; however, no cases have been seen in studies of Zynteglo. Patients who receive Zynteglo should have their blood monitored for at least 15 years for any evidence of cancer. Patients should also be monitored for hypersensitivity reactions during Zynteglo administration and should be monitored for thrombocytopenia and bleeding.

This application was granted a rare pediatric disease voucher, in addition to receiving Priority Review, Fast Track, Breakthrough Therapy, and Orphan designations.

The FDA granted approval of Zynteglo to Bluebird Bio, Inc.

Earlier this year CVS published a sponsored article in Fierce Healthcare that raised a red flag around the concept of a specialty pharmacy carve-out. 

Before we start, there may be some confusion as to what exactly is a “carve-out”. Our definition of a carve-out is to take a coverage category and treat it as a health benefit to manage on a stand-alone basis. Examples of clinical carve-outs that have delivered positive results both clinically and financially include mental health, radiology, dental, vision care…. but these benefits remain as part of the total package offered to a member.

But, some health plans have already turned to “alternate funding programs (AFPs) wherein the specialty drugs are removed from the plan R_x formulary. This essentially provides no coveragefor the specialty drugs. The payer will select a third-party company to support these now “uninsured” members and will apply for manufacturers’ patient assistance (PAP) funds to cover the cost of the prescriptions. The manufacturer ends up paying the full cost of the prescription and the pharmacy services. According to published reports, about 8% of payers have already taken this action and 30%+ are evaluating what appears to be a scam. 

But let’s take a closer look at what CVS has to say.

CVS states that payers are asking themselves whether they should carve out specialty pharmacy services from the integrated pharmacy benefit management model and spotlight some of the consequences.  It is unclear whether they mean ‘my’ definition of a carve-out or the APF model.

CVS says that payors are concerned with “ensuring member access to important treatments.” With so many specialty therapies launching through limited distribution one could say that a clean carve-out program (not an AFP) might be even better positioned to provide broader access.

CVS also says, “Many niche vendors (AFP vendors??) make bold claims about the results they can deliver with specialty carve-out including that it will lead to dramatic savings and enhance clinical care. Such claims are simply myths…..” But, CVS goes on to say, “In fact, our unique approach to specialty cost management can enable up to 49 percent savings on gross specialty spend.” Are such huge savings are possible without shifting a big chunk of members to uninsured status for SP??? We can’t find clarity on this claim.)

CVS says that a carve-out “involves hidden costs in the form of rebate losses and multiple vendor fees.”  If anything, a unified carve-out could be better positioned to negotiate rebates. One also has to ask….. What vendor fees unless there are AFP vendors in the middle?

So, we are left with more questions than answers at this point.

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Multiple Specialty Vendors Mean More Headaches

Breaking down the myths about specialty carve-out — Sponsored by CVS Health

Specialty medications continue to be the biggest cost management challenge for payers, driving 54 percent of overall drug spending in 2021. The trend shows no signs of slowing and has employers and health plans looking for solutions to regain control of rising specialty pharmacy costs while ensuring member access to important treatments.

This has led to some payers asking themselves whether they should carve out specialty pharmacy services from an integrated pharmacy benefit management approach.

The question they should be asking is, “Are specialty carve-out savings too good to be true?” Many niche vendors make bold claims about the results they can deliver with specialty carve-out including that it will lead to dramatic savings and enhance clinical care. Such claims are simply myths they are perpetuating to support carving out specialty management. The reality is starkly different.

Financial Risks Outweigh the Perceived Benefits

Payers seeking tighter management of specialty drugs and greater specialty savings won’t find them by carving out. A careful analysis shows there’s no credible evidence that carve-out strategies by these niche vendors reduce net cost. Instead, two studies published in the Journal of Managed Care & Specialty Pharmacy find integrating pharmacy benefits resulted in lower medical costs and fewer hospitalizations.1,2

So, what really happens with a carved-out approach? It leads to exaggerated savings estimates that don’t take into account that treatment denials not rooted firmly in clinically rigorous decision making are likely to be overturned in the appeals process. It also involves hidden costs in the form of rebate losses and multiple vendor fees. In fact, in most cases much of the perceived “savings” are simply shifting costs from the pharmacy benefit – which has much tighter controls – to the medical benefit setting, which does not, and is often more expensive.

The Impact on Patient Care and Support

While a carved-out approach may seem like a cost-saving solution, it enables a fragmented, siloed system that jeopardizes member care – resulting in poor health outcomes and experience.

Members lose the ability to obtain needed medications easily and efficiently to effectively manage their condition. This can lead to disruption, challenge care management, and jeopardize continuity of care, and therefore worse outcomes and increased potential for adverse events.

It’s confusing and complicated for members when different vendors handle different components of the specialty pharmacy benefit. And the potential for breaks in service, therapy delays and inconsistent care grows at every step of the therapy journey. Members in plans with carved-out pharmacy benefits could lose access to connected digital tools that support their overall health and medication adherence. With so much at stake, it’s important for payers to use strategies that keep members at the center while creating cost savings.

Better Value with an Integrated Approach

A connected specialty pharmacy can deliver the consistent, personalized support that specialty patients need to stay on track. CVS Health takes an integrated approach to specialty cost management, which targets every step across the member journey, and all the components work together to deliver the most savings for payers. In fact, our unique approach to specialty cost management can enable up to 49 percent savings on gross specialty spend.

We use proven strategies and targeted solutions to deliver significant savings along with a better, cohesive member experience. We believe there’s a clear benefit to the member journey in our integrated model, which:

Helps ensure members start and stay on the most appropriate therapy

Offers the ability to better manage all prescriptions, including non-specialty medications

Engages members and their providers throughout the duration of therapy to help reduce costly, adverse events

Supports the whole patient, including comorbidities for better health outcomes

When considering which specialty management approach to adopt, the key consideration is simply whether payers want a siloed, fragmented approach or one that’s connected, and manages spend across the duration of treatment in a seamless, integrated fashion. Working with an integrated pharmacy benefit manager that supports all specialty management needs not only results in better care but also creates maximum value.

To learn more about our connected resources, and how we can help tackle your management challenges, please visit us at: https://payorsolutions.cvshealth.com/insights/power-integration.

A recent DoJ press release (below) is a stark reminder for specialty pharmacies that they need to ensure strict compliance with federal and state laws and regulations or risk getting a severe spanking in their bank accounts….. and, heavens forbid, possibly even jail time.

The short story below is that a whistleblower at a manufacturer let the cat ‘outta de bag regarding the filing of fraudulent Medicare claims.  Much of the ‘fraud’ was related to the waiving copays without proof of financial hardship way back in 2017-18. But, the hanky-panky also extended to fraudulent handling of prior-authorizations and even patient clinical information.

So, the stroll down this path cost Solera Specialty Pharmacy a cool $1.3 million. Ouch!

All specialty pharmacies should spend a fraction of that amount to implement oversight protocols to spot any deviations from claim submission standards (usually through frequent audits). 

Remember…….there may be a whistleblower looking over your shoulder even now 👀

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Solera Specialty Pharmacy Agrees to Enter into Deferred Prosecution Agreement

Company and CEO to Pay $1.31 Million for Submitting False Claims for Anti-Overdose Drug

Wednesday, July 13, 2022 — Florida-based Solera Specialty Pharmacy has entered into a deferred prosecution agreement and agreed to pay a $1.31 million civil settlement to resolve allegations that it submitted fraudulent claims to Medicare for Evzio, a high-priced drug used in rapid reversal of opioid overdoses.

According to Solera’s admissions in the criminal and civil agreements, the pharmacy dispensed Evzio from January 2017 to May 2018. During that time, Evzio was the highest-priced version of naloxone on the market and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio. Solera completed Evzio prior authorizations forms in place of the prescribing physicians, including instances in which Solera staff signed the forms without the physician’s authorization and listed Solera’s contact information as if it were the physician’s information. In addition, Solera submitted Evzio prior authorization requests that contained false clinical information to secure approval for the expensive drug. Finally, Solera waived Medicare beneficiary co-payment obligations for Evzio on numerous occasions without analyzing whether the patient had a genuine financial hardship.

“Pharmacies, like all Medicare providers, must submit accurate claims,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “This settlement demonstrates…………………….

CLICK HERE to read the full Department of Justice press release

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are several LD deals that have been recently publicly confirmed subsequent to the approvals.

Amber Specialty Pharmacy Added to Pfizer’s Limited Distribution Network for Oncology Portfolio

August 03, 2022  — OMAHA, Neb.–(BUSINESS WIRE)–Amber Specialty Pharmacy announced that they will begin dispensing 13 Pfizer oncology products. The pharmacy’s comprehensive service model will support patients, caregivers, and oncology specialists throughout the country. 

The Pfizer portfolio of oncology products now supported by Amber Specialty Pharmacy includes:

• Besponsa® (inotuzumab ozogamicin)
• Bosulif® (bosutinib)
• Braftovi® (encorafenib)
• Daurismo® (glasdegib)
• Ibrance® (palbociclib)
• Inlyta® (axitinib)
• Lorbrena® (lorlatinib)
• Mektovi® (binimetinib)
• Mylotarg® (gemtuzumab ozogamicin)
• Sutent® (sunitinib malate)
• Talzenna® (talazoparib)
• Vizimpro® (dacomitinib)
• Xalkori® (crizotinib)

Biologics by McKesson is now the Exclusive Specialty Pharmacy Provider of XERMELO

CARY, N.C., July 25, 2022 -Biologics by McKesson has been selected by TerSera Therapeutics LLC, as the exclusive specialty pharmacy provider for XERMELO (telotristat ethyl), effective Sept. 1, 2022. XERMELO is used for the treatment of Carcinoid Syndrome Diarrhea in adults who are not adequately controlled by somatostatin analog (SSA) therapy. XERMELO was approved by the FDA in 2017, as an orally administered, tryptophan hydroxylase inhibitor indicated for use in combination with SSA therapy for the treatment of Carcinoid Syndrome Diarrhea in patients with metastatic neuroendocrine tumors. 

ORSINI SPECIALTY PHARMACY SELECTED AS LIMITED DISTRIBUTION PARTNER FOR AMVUTTRA

ELK GROVE VILLAGE, Ill., July 20, 2022 /PRNewswire/ — Orsini Specialty Pharmacy was chosen by Alnylam Pharmaceuticals as a specialty pharmacy partner for AMVUTTRATM (vutrisiran). AMVUTTRA is indicated to treat the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.  A rare, rapidly progressive, and often fatal disease, hATTR amyloidosis affects approximately 50,000 patients worldwide. 

ORSINI SPECIALTY PHARMACY SELECTED AS THE EXCLUSIVE SPECIALTY PARTNER FOR ZTALMY

ELK GROVE VILLAGE, Ill., July 28, 2022 /PRNewswire/ — Orsini Specialty Pharmacy announced that Marinus Pharmaceuticals, Inc. has selected it as the exclusive specialty pharmacy for ZTALMY(ganaxolone). ZTALMY is the first and only treatment approved specifically for seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older.  CDKL5 deficiency disorder (CDD) is a serious and rare genetic disorder caused by a cyclin-dependent kinase-like 5 (CDKL5) gene mutation. 

PANTHERx Rare Announces Partnership with Biocodex for the Distribution of DIACOMIT (stiripentol)

PITTSBURGH, June 27, 2022 /PRNewswire/ — PANTHERx Rare announces that it has been selected by Biocodex as their new exclusive U.S. pharmacy distribution partner for DIACOMIT® (stiripentol). DIACOMIT is a new molecular entity approved by the FDA in 2018 for the adjunctive treatment of seizures associated with Dravet syndrome in those 2 years of age and older taking clobazam. An orally administered antiseizure, DIACOMIT is given as either a capsule or powder for suspension. Dravet syndrome, also known as Severe Myoclonic Epilepsy Infancy (SMEI), is a rare epileptic disorder typically diagnosed in infancy occurring in 1 in 15,700 individuals in the United States.

Soleo Health Named as Limited Drug Distribution Partner for Administration of LEQVIO

July 26, 2022  — FRISCO, Texas–(BUSINESS WIRE)–Soleo Health announced that it has been selected as a limited distribution partner for cardiovascular drug LEQVIO, manufactured by Novartis. LEQVIO subcutaneous injection is indicated as an adjunct to diet and statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).  Soleo Health will administer to patients in their homes or at one of the Company’s Ambulatory Infusion Centers (AICs) nationwide.

Soleo Health Selected As a Specialty Pharmacyto provide Cuvitru

Administered subcutaneously, Cuvitru is manufactured by Takeda Pharmaceutical Company Ltd. Cuvitru replaces antibodies not working correctly or are missing from one’s body to help protect it against infection. CUVITRU is for treating primary immunodeficiency (PI) in adults and children two years of age and older.

The FDA just approved another biosimilar!

That’s always big news that often starts a panic in the healthcare industry…. said no one ever.

However, this new biosimilar is different as it was awarded the coveted interchangeable designation! Only two other biosims have been so lucky. For a new entrant to a very finite market….. with a well-entrenched brand….. that designation is a HUGE differentiator. 

Ok….here’s  the details.

The new biosim is called Cimerli  (ranibizumab-eqrn) from Coherus and is an interchangeable biosimilar product to Lucentis (ranibizumab injection) for all five the brand’s indications.

• Neovascular (wet) Age-Related Macular Degeneration (AMD)
• Macular Edema following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR), and 
• Myopic Choroidal Neovascularization (mCNV) 

Cimerli isn’t the first biosimilar of Lucentis to be given the green light as the FDA approved Samsung Bioepis’ Byooviz in September of 2021.

Cimerli is administered by ophthalmic intravitreal injection only. It belongs to the successful anti-VEGF therapy class of biologics which generates billions in annual sales. Standard physician administered dosing is once monthly.

Commercial availability of Cimerli, in both 0.3 mg and 0.5 mg dosages, is planned for early October 2022.

Coherus hasn’t yet released pricing for Cimerli. By way of reference, Byooviz launched on July 1^st at a 40% discount to Lucentis, a list price of $1,130 per single-use vial.

CLICK HERE for full prescribing information

CVS recently released its a Drug Trend Report for 2021. Caremark found that 35.9% of its clients saw negative specialty trend in 2021. In addition, 65.3% saw specialty trend under 10%, according to the report.

Both stats would normally be considered stellar performance for specialty.

But, peel back the onion to see how some savings were really extracted. 

CVS points to two areas, 1) the increased use of generics and 2) by taking advantage of manufacturer copay cards. But, there are still precious few generics in specialty that can make big impacts on specialty trend and, the push to use manufacturer co-pay cards is now a questionable business practice and is under the regulatory spotlight at both the federal and state levels.

CVS’ web site states that their copay card program, PrudentRx, was introduced in 2020 and adopted by a number of clients for 2021. Those that signed on with the program saw 12.5% decrease in their specialty drug spend on average, while those who were not enrolled in the program saw costs increase by 7.4% on average.

It goes on to say, “Members pay $0 out-of-pocket for any specialty therapy prescription on the client’s exclusive specialty drug list (translate as exclusions…. often generics!) as long as they remain enrolled in the program. The PrudentRx program works with clients’ plan designs and formulary & utilization management, to help continue to drive to the lowest net cost therapies.” (Guess how the savings get distributed!)

Now here is the real kicker….. “Because the program is combined with our True Accumulation offering, the portion of drug cost paid for by the copay card does not apply to the member’s deductible or annual out-of-pocket limit, helping prevent a negative impact on payors and plan premiums. By doing so we can help members benefit from drug copay cards without raising costs for the plan. (Members increasingly dispute that this program is meant to ‘help’ them!)

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How CVS Caremark kept specialty drug trend to an industry low in 2021

CVS Caremark kept overall drug trend for clients to 2.4% over the first three quarters of 2021, marking multiple years of single-digit trend in drug price growth.

The pharmacy benefit management arm of CVS Health also kept its specialty drug trend to single digits through the third quarter, at an industry-low 5.8%, according to the company’s annual Drug Trend Report released Thursday. Caremark found that 35.9% of its clients saw negative specialty trend in 2021. In addition, 65.3% saw specialty trend under 10%, according to the report.

Alan Lotvin, M.D., president of Caremark and executive vice president of CVS Health, told Fierce Healthcare that while a coming wave of biosimilars holds the greatest promise to address growing specialty drug costs, there are steps that can be taken now to mitigate those expenses effectively.

For one, there is a growing selection of generic options in specialty that can offer a lower-cost alternative, he said. In addition, PBMs can track whether patients are using the appropriate dose or medication regimen, which can mitigate costs. If a patient is taking a drug that doesn’t benefit them or inadvertently stockpiling doses, that can drive up expenses, he said.

Plans that can consistently drive down cost also have their arms around waste and take advantage of programs that can capture lower costs, such as by taking advantage of manufacturer copay cards.

“Some of it, I would say, is good pharmacy benefit management hygiene,” Lotvin said. “Highly managed plans can get control over their drug spend.”

CVS’ copay card program, PrudentRx, was introduced in 2020 and adopted by a number of clients for 2021. Those that signed on with the program saw 12.5% decrease in their specialty drug spend on average, while those who were not enrolled in the program saw costs increase by 7.4% on average.

The program aims to prevent drug companies’ copay card programs from circumventing the insurance plan, according to the report.

Digital intervention and communication have also proved critical in managing drug costs, according to the report. Most members, about 92%, are actively enrolled in digital communications with CVS, which allows the PBM to track adherence, answer questions and act proactively about their treatment plan.

In addition, Caremark is connected directly to 75% of members’ electronic health records, according to the report.

These digital channels have led to savings of about $3,000 per effective clinical intervention and $2,300 for each patient that was targeted by interventions to manage excess supply.

While these successes have been noted, the true promise in managing growing costs is in the coming wave of biosimilars products to challenge costly, popular therapeutics. While the industry awaits true challengers to industry leaders like Humira, there are already examples of biosmilars driving down costs.

Biosimilar drugs for Remicade, an immunosuppressive drug, hit the market about five years ago. Since then, they’ve driven down the therapy’s price by nearly half.

“That deflationary pressure on drug cost from the biosimilars will be substantial,” Lotvin said.

CLICK HERE to read the full article

CLICK HERE to visit the CVS web site for statements on PrudentRx

Walgreens continues to morph into a diverse health services company.

The headline of the article below isn’t the real news. Rather, the article below lists a number of cross-organizational moves that Walgreens is taking to change the face of what was once considered a pure play pharmacy.

For example, Walgreens has struck a host of deals with hospitals over the past few years to provide integrated pharmacy solutions (retail and specialty) for health systems that prefer to partner vs. build their own specialty pharmacies. The article suggests a doubling of such deals in the next year.

Walgreens Health ponied up $5.2 billion to expand its value-based medical network VillageMD and another $330 million in its home care provider CareCentrix. Additionally, Walgreens dropped a cool $979 million to acquire Shields Health Solutions (hospital based specialty Rx). These moves markedly expand way beyond the walk-in health clinic concept. And while we are at it…. Walgreens has also reaffirmed its desire to pursue risk-based contracts and a clinical trial management division.

This ain’t your grandfather’s pharmacy any longer!

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Walgreens Health Corners network swells with new Buckeye partnership in Ohio

Walgreens has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer.
Buckeye is the third payer to launch Walgreens Health Corner locations, community clinics meant to supplement care received from primary care and specialty physicians.

About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100.

Through the Buckeye partnership, the new Health Corners will offer eligible Ohio Medicaid members access to integrated care led by Health Advisors, who are pharmacists or registered nurses.

Services revolve around preventive care, wellness checks and assistance with managing chronic conditions, including health screenings like blood pressure checks, scheduling mammography appointments or answering general health questions or concerns about medications.

In northeast Ohio, the services will be available for free for Buckeye members, Walgreens said. The company will share patient services and outcomes with Buckeye and patients’ other providers.

The new partnership follows a Walgreens Pharmacy pilot program with Buckeye in 2021 centered on asthma and COPD patients, where Buckeye reimbursed Walgreens pharmacists for counseling patients on how to use their inhalers, identifying and providing outreach to nonadherent patients and more.

The retail pharmacy company launched Walgreens Health, a division for its healthcare assets including value-based medical network VillageMD and home care provider CareCentrix, in October. The goal of Walgreens Health is to develop consumer-focused and tech-enabled healthcare products.

Walgreens has been investing in building out the division.
Late last year, the company doubled its ownership stake in VillageMD with an additional investment of $5.2 billion. It also invested $330 million in home care provider CareCentrix and funneled another $970 million into specialty pharmacy company Shields Health Solutions.

In an October call with investors, management said they plan to expand their health and wellness services and are willing to take on risk-based contracts.

The co-branded Walgreens and VillageMD clinics, along with the Health Corner concept, are central to this effort, as Walgreens — like its retail pharmacy rivals CVS Health and Walmart — looks to capture a greater slice of the care continuum and the corresponding revenue.

Walgreens announced the launch of a clinical trials business. Ramita Tandon, the chief clinical trials officer, said in a statement that the new division is “yet another way we are building our next growth engine of consumer-centric healthcare solutions.”