…………..catching up on recent FDA approvals

The FDA recently approved a new ORAL therapy, Velsipity (etrasimod) from Pfizer, for adults with moderately to severely active ulcerative colitis (UC).  Velsipity is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5.

UC is a chronic, debilitating condition affecting about 1.25 million people in the United States. Symptoms often include chronic diarrhea with blood and mucus, abdominal pain, and urgency.  The therapy provides patients the opportunity to achieve steroid-free remission.

Velsipity has launched with a wholesale acquisition cost is $6,164 for 30-day supply or ~$75,000 annually. Pfizer did not disclose distribution details although, given its cost, it is highly likely to be dispensed only through specialty pharmacy limited distribution.

CLICK HERE to read prescribing information

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U.S. FDA Approves Pfizer’s Velsipity for Adults with Moderately to Severely Active Ulcerative Colitis

CLICK HERE to read the full press release

There has been scant news about any big moves by large national specialty pharmacies this year. Today, however, we read about a move by CarelonRx, the specialty pharmacy operated by Elevance Health.

Many of you may be scratching your heads trying to figure out the story behind these entities. We are happy to provide some relief.

In late 2022 Elevance Health acquired long-running BioPlus Specialty Pharmacy as it sought to expand its specialty pharmacy services. (BioPlus was one of the few mature SPs that had not been acquired and taken out of the independent SP column.) More significantly, Elevance is the insurer formerly known as Anthem Health….BioPlus was then integrated into Elevance’s – then branded – PBM, IngenioRx. 

We continue to ask….. Why are insurers keen on integrating SPs into their portfolios?

In a word, money….. and leverage (guess that’s two words). A well-run SP with a solid revenue stream is very profitable. Elevance appears poised to supercharge its market presence both ‘digitally’ and geographically which enables greater steerage of plan members into their specialty pharmacy and supercharge profit opportunity.  And…… PBMs love leverage over manufacturers. Being able to put large specialty purchases on the table goes a long way in manufacturer negotiations.

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Elevance Health’s CarelonRx rolling out new digital pharmacy

Dec 5, 2023

The CarelonRx Pharmacy launch is one of several steps that the company is taking to improve the experience for members.

Elevance Health’s pharmacy benefit manager is launching a new digital pharmacy that aims to make it easier for members to track their prescriptions.

CarelonRx Pharmacy will launch on Jan. 1, and members will be able to connect with pharmacists via text, chat or phone around the clock. The platform will also allow them to check the price of medications for comparison and track their prescriptions throughout the order process, similar to how a customer may follow a pizza order.

……………………………….article continues

CLICK HERE to access the full article

………..catching up on recent FDA approvals

The FDA recently approved a new infused therapy, Pombiliti (cipaglucosidase alfa-atga) from Amicus Therapeutics, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy. 

Pombiliti is approved only in combination with Opfolda (miglustat), an oral drug that is to be administered approximately 1 hour before the infusion of Pombiliti. 

Pombiliti is a recombinant human GAA enzyme (rhGAA). Opfolda is an enzyme stabilizer designed to stabilize the enzyme in the blood. Pombiliti / Opfolda will be distributed in tandem. 

About 5,000 to 10,000 people have been diagnosed globally with Pompe. The majority of patients on current standard of care decline after about two years. The previous standard of care has been Sanofi’s Lumizyme. 

The combo therapy launched at an annual price of $650,000 for a patient weighing about 70 kg.

Pombiliti will be distributed by Orsini Specialty Pharmacy according to a recent press release.

Pombiliti was approved with a black box warning.

CLICK HERE to access prescribing information

In the wacky world of specialty pharmacy, the therapies that get the most attention and press coverage over the past couple of years are the big ticket items. At the tippity top of that list are the new gene and cell therapies that have smashed the multi-million-dollar per patient cost barriers. And, at the very top of that auspicious list, are the new FDA approved therapies for hemophilia with price tags that range from about $3 million to $3.5 million….. yes, the most expensive therapy approved so far.

The article being offered for your reading pleasure today won’t offer any surprises for those of you that regularly support the hemophilia patient community. However, those working  within the specialty pharmacy sphere would benefit from a better understanding of why the gene therapies for hemophilia are actually easier to cost justify than most other gene therapies. 

First, their efficacies are readily measurable vs. traditional blood factor products…. a more apples to apples comparison.

Secondly, gene therapies for other rare conditions are essentially ‘cures’….. where, before hand, there were mostly only therapies that managed symptoms….. a more apples to oranges comparison.

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Why Are Hemophilia Gene Therapies So Expensive?

Biomarin and CSL Behring’s haemophilia gene therapies have boosted innovation in the field, but assessing their cost effectiveness is less than straightforward.

he treatment landscape for haemophilia has undergone significant advancements following two pathbreaking FDA approvals of gene therapies for the inherited blood disorder. However, the cost and the value they provide to patients and society continue to receive scrutiny.

………………………….article continues

CLICK HERE to read the full article

Catching up on recent FDA approvals

The FDA approved a specialty therapy…. with a difference….. it is a topical ointment. The approval for the new therapy, Ycanth (cantharidin) from Verrica Pharmaceuticals, is indicated for Molluscum Contagiosum in adult and pediatric patients 2 years of age and older.  Molluscum Contagiosum is a viral skin infection that cause itchy skin reactions in almost any area of the body. The virus is transmitted by skin-to-skin contact and is most common among children under 10.

Since it is a topical, the first assumption was that specialty pharmacies would be able to dispense this new therapy, however, that’s not the case. It must be administered only by health care providers every 3 weeks as needed. That may be related to one of the serious side effects for Ycanth….. loss of the outer layer of skin at the application site.

The label also includes an unusual patient instruction….. Ycanth is flammable, even after drying. Patients should avoid fire, flame, or smoking near lesion(s) during treatment and after application until removed. 

Cost of Ycanth will depend on the number of lesions. 

A single carton of 12 applicators is priced at $8500 according to GoodRx.

CLICK HERE to read the full FDA press release

CLICK HERE to read the Ycanth prescribing information

Continuing our deep dive into biosimilars

It may well take the wisdom of Solomon to fully appreciate the logic of the recently released guidance (or non-guidance?) on communicating biosimilar interchangeability. 

The guidance treads a fine line. It says that (many??) prescribers are already picking a biosimilar because it was approved as being the same as the reference product and, therefore, can be ‘considered’ interchangeable…. even if the FDA did not pin the official interchangeable designation medal on its chest.

Only four biosimilars have been Olympic interchangeable medal winners to date. The press release below touches on the fact that this designation is important since many state pharmacy laws / regulations require pharmacist substitution. However, qualifying for FDA interchangeable eligibility requires jumping through several more hoops….. and that translates into time and money. None the less, some biosim manufacturers are pursuing the designation post-launch.

So, the FDA is soft peddling the way interchangeability is communicated. They essentially say that it should not be mentioned in the package insert / prescribing information since the prescriber is free to refer to the Purple Book for that information. That is a good example of the definition of the word ‘befuddling’.

In short, this conundrum is likely to continue for some time.

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ARE YOU NOT INTERCHANGED? 

FDA’S RECENT BIOSIMILAR LABELING GUIDANCE CHIPS AWAY AT INTERCHANGEABLE PRODUCT ADVANTAGES

Key Takeaways:

• Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance.
• FDA justified its reversal on including the interchangeability disclosure in labeling by inferring that prescribers pay little heed to interchangeability information in labeling when considering biosimilars for patients.
• This labeling policy eliminates an important advantage of interchangeability designations and hints at a broader agency trend to minimize the designation’s significance.

The Food and Drug Administration (FDA) released a new Draft Guidance document…..

……….. press release continues

CLICK HERE to read the full press release

Continuing our focus on Biosimilars

The FDA recently approved a new infused biosimilar, Tofidence (tocilizumab-bavi) from Biogen, for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. Tofidence is a biosim to reference product Actemra, a first competitor for that brand (although at least there is one additional biosim candidate inching its way towards approval).

The approval of this biosimilar is noteworthy if only for the fact that yet another unchallenged brand has fallen to a biosimilar competitor. As more are approved, biosimilars will be challenging a much larger group of brand name products….. further eroding their near monopoly in many disease categories.

Tofidence was approved without an ‘interchangeable’ designation….. which many still feel is the jewel of biosimdom (yes, new word). It was also approved with a Black Box Warning.

CLICK HERE to view prescribing information

Biogen did not release pricing for Tofidence at time of approval. 

Now, weeks later, pricing info is still not to be found.

Biogen did not release details on distribution.

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FDA Approves Biogen’s Tofidence, a Biosimilar Referencing ACTEMRA

Tofidence becomes the first tocilizumab biosimilar to gain FDA approval in the United States

CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The Tofidence intravenous formulation is approved for the treatment of ………………………….. press release continues

CLICK HERE to read the full press release

Continuing Biosimilar Week

Recently the FDA approved a new biosimilar, Tyruko (natalizumab-sztn) from Sandoz Inc., with indications for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and adults with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s therapies and tumor necrosis factor (TNF) inhibitors.

Tyruko is the first biosimilar to reference product Tysabri.

What was noteworthy about this approval is that it introduced a totally new disease to the relatively short list of supported diseases targeted by other biosimilars. Nearly half of all biosimilars approved to date were for only three drugs….. Humira, Avastin and Neulasta!

The pipeline for biosimilars is where the market now has a laser focus. The amount of investment in developing new biosimilars is beyond significant….. and big returns on investment are expected.  However, the first obstacle to jump start biosimilar uptake (we addressed that in our last REPORT). But, that is changing with approvals including FDA ‘interchangeable’ designations and increasing payor receptivity.

The last remaining challenge is pricing. Tyruko came to market at about a 20% discount to Tysabri which is ‘expected’ and isn’t considered a ‘Blue Light Special’ deal. Much has been written about the pricing strategies that take place behind the scene in which brand manufacturers cut deals with PBMS and payors to offer rebates that negate the benefit of the lower wholesale prices of the biosimilar. None the less, biosimilars are elbowing their ways onto preferred payor formularies.

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FDA Approves First Biosimilar to Treat Multiple Sclerosis

The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis,” said Paul R. Lee, M.D., Ph.D., director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.” 

Tyruko is approved to treat the following relapsing forms of MS:……………….  article continues

CLICK HERE to read the full FDA press release

We are going to hear a lot more about biosimilars in coming days. The leader board now shows that 44 biosimilars have been approved to date…. even including a handful of interchangeable products. After initial slow uptake, biosimilar demand is really starting to percolate as these products elbow their ways onto payor formularies.

One of the biggest drags on biosimilar adoption has been confidence. 

Patients… and even providers…. have been reticent to try a biosimilar….. especially when the reference product could be obtained for the same out-of-pocket cost through a payor.   The trend towards increasing coinsurance (generally based on wholesale price) is a factor that is contributing towards patients and providers looking kindlier at biosimilars.  

But, is out-of-pocket cost enough to move the needle…. pun intended? NO

What is really needed is proof of concept. For many new products confidence can be determined in quick order…. even minutes. Medicines, however, need long timelines to prove their mettle…. even years. Well, the years are passing and, finally, biostatisticians are now cobbling data together to show long term biosimilar efficacy. 

The article below is one of many that we should be seeing as post marketing outcomes data for biosimilars are published. The article below details the efficacy of several Oncology biosimilars…. arguably the most challenging category in which to shine. Strong data will go a long way to bolster that confidence factor we mentioned above.

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Oncological Biosimilars Shown to Be as Safe as Their Reference Products

Study finds patients with cancer feel reassured that biosimilars provide a safe, adequate, and cost-effective alternative to the pricier reference drug.

Biosimilars are commonly used in numerous clinical fields, including oncology. These drugs are different from the generic form of chemical products because it is impossible to develop molecules identical to their reference products due to natural variation and their heterogenic product process. Biosimilars are comparable to the reference product regarding structure, biological activity, efficacy, safety, and immunogenicity; however, there is some skepticism surrounding the safety and efficacy of these products among physicians and patients.

In a study published in Cancers, researchers analyzed post-marketing pharmacovigilance data of biosimilar monoclonal antibodies used in oncology compared with their respective reference products. The study authors evaluated the distribution of medicine-reaction pairs related to biosimilars of 3 antitumor biological products—bevacizumab, rituximab, and trastuzumab—as well as their respective corresponding biosimilar drugs—Avastin, MabThera, and Herceptin. ….. article continues

CLICK HERE to read the full article

Ok….. here’s something innovative in the wacky world of specialty pharmacy!

CVS has launched a new subsidiary called Cordavis. The new entity “will work directly with manufacturers to commercialize and/or co-produce biosimilar products”.  The most noteworthy thing in that line is the word ‘co-produce’. They don’t really explain exactly the extent of CVS’ involvement in co-producing….. but that is where the innovation really pops up. 

The focus of the initiative will target biosimilars. 

The article cites that “…. Cordavis to [will] launch biosimilar Hyrimoz with Sandoz beginning in 2024 at more than 80% lower list price than Humira.” This ‘out of the gate’ move is extra noteworthy.

We’ve seen a huge spike in activity around biosimilars in recent months….. and we expect it to continue with new biosims being approved for more and more reference products beyond the many that have already been approved for the early brand targets.

Our Reports over the next two weeks will be dedicated to even more noteworthy biosimilar developments. 

Yes, we’ve used the word ‘noteworthy’ now 4 times in this Report…. which itself says something noteworthy…. Ok, now its 5 times.

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CVS Health Launches Cordavis

New business will bring high quality biosimilar products to market with goal of reducing drug spend and ensuring access to affordable medications

CLICK HERE to read the full article