Month: August 2024

We’ve written about Value-Based Contracting (VBC) numerous times. 

The logic of VBC is self-evident. 

However, the feasibility and implementation of VBC is a totally different matter….. it is simply not easy. 

Great ideas often pop up but fade away because they are too hard to manage. 

VBC may soon be the exception to the rule.

VBC requires a team effort. As we know, forming a team in most organizations can be a nightmare and healthcare is a poster child for poorly formed team efforts.  None the less, VBC has not withered and is striving to blossom in rocky soil.

The article below is some proof of the prospects for VBC. Key members in VBC are health plan providers who have been skeptical of the entanglements that VBC portends. As you are likely familiar, health plans have a long-standing national association, AHIP (America’s Health Insurance Plans), and, based on their comments, the organization seems to be warming up to VBC. 

There is already proof of concept that VBC works for health plans.  The prospect that manufacturers will be accountable (usually financially) is a lever that clearly can work in health plans’ favor. 

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Providers are Key to Success of Value-Based Specialty Programs | AHIP 2024

CLICK HERE to read the full article

The FDA recently approved a new infused therapy, Rytelo (imetelstat) from Geron Corporation, for the treatment of adult patients with low – to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

Rytelo is an oligonucleotide telomerase inhibitor and is the first and only telomerase inhibitor approved by the FDA. It is indicated to be administered as an intravenous infusion over two hours every four weeks.

Rytelo is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In MDS, abnormal bone marrow cells often express an enzyme, telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. 

The company has priced a single dose (47 mg) of Rytelo at $2,471. 

Actual dosage is determined by patient weight.

Distribution will be supported by specialty pharmacies.  

Onco360 has confirmed that it was named as a distribution partner.

CLICK HERE for prescribing information

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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

CLICK HERE to read the full article

In the third century BCE a wonder of the world, the Colossus of Rhodes, stood as testament to ever lasting power and strength. As history tells, even a colossus will eventually fall. Now, in the 21^stcentury, a colossus in the pharmaceutical industry is rapidly falling away…. and is a harbinger of the demise of other, perhaps smaller, colossi. 

Ok…. We are talking about the colossus called Humira.

Yes, this pharmacy powerhouse therapy has held the #1 position on the US leader board for the past two decades. However, even PBMs are now throwing in the towel and are starting to embrace less costly biosimilars to dethrone the king.

By example, PBM colossi CVS and Accredo / Evernorth are now demoting Humira and adding biosimilars in preferred positions on their formularies.  With that ice broken….. and payers and patients and government pushing for cost relief….. the tea leaves now confirm that biosimilars have finally found their footing in the marketplace…… THE BARBARIANS ARE AT THE GATE!

The article below is the closest thing to a eulogy we have heard in quite a while…. and it cites some sober statistics.

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PBMs Start to Embrace Biosimilars

CLICK HERE to access the full article

………….. catching up on FDA Approvals

The FDA recently approved a biosimilar….. meh news…… huh?

But wait….. on the same day the FDA approved two biosimilars….. big news?

The more interesting news is that the approval was for two different biosimilars….. and….. both have the same indication!…. perhaps that’s the biggest news.

The approvals included….. Yesafili (aflibercept-jbvf) from Biocon Biologics and Opuviz (aflibercept-yszy) from Biogen, Samsung Bioepis with an indication for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD); macular edema following retinal vein occlusion (RVO), diabetic macular edema, and diabetic retinopathy.

Both therapies  are the first interchangeable biosimilars to reference product Eylea (aflibercept) from Regeneron.  Yesafili and Opuviz are both vascular endothelial growth factor (VEGF) inhibitors and each is administered by intravitreal injection every 4 weeks for the first 5 injections, followed by 2 mg (0.05 mL of 40 mg/mL solution) once every 8 weeks.

Regeneron recorded U.S. sales of $5.72 billion from Eylea in 2023. Regeneron’s reference product, Eylea (intravitreal solution (40 mg/mL), is around $2,000. 

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FDA Approves First Biosimilars to Eylea

CLICK HERE to read the article

…….. catching up on FDA approvals

The FDA recently approved a new infused therapy, Imdelltra (tarlatamab-dlle) from Amgen, indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Imdelltra is the first bispecific delta-like ligand 3 (DLL3)-directed CD3 Tcell.  

Amgen said that it has been decades of no real treatment advances for this type of lung cancer. With small cell lung cancer, the disease has typically spread beyond the lung by the time it is diagnosed and most patients live just eight to 13 months after their diagnosis, despite having chemotherapy and immunotherapy.

Imdelltra was approved with a Black Box Warning for cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome.

Amgen said the U.S. price for Imdelltra is $31,500 for the first cycle, and $30,000 for subsequent cycles. The company said trial patients were on the treatment for a median of over five months, which would equate to a commercial price of about $166,500.

CLICK HERE to access prescribing information

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FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer

CLICK HERE to read the FDA press release

The FDA recently approved a trastuzumab biosimilar, Hercessi (trastuzumab-strf; HLX02) from Accord BioPharma, to reference product Herceptin, for the treatment of several forms of HER2-positive breast and gastric cancers. Hercessi is supplied in powder form for reconstitution prior to infusion.

Hercessi is the sixth trastuzumab biosimilar approval overall. 

Hercessi was granted interchangeable designation.

Prior biosimilars to trastuzumab are as follows—-

• Ogivri (trastuzumab-dkst)          December 2017
• Herzuma (trastuzumab-pkrb)    December 2018
• Ontruzant (trastuzumab-dttb)   January 2019
• Trazimera (trastuzumab-qyyp)   March 2019
• Kanjinti (trastuzumab-anns)       June 2019

HER2-positive, is an aggressive form of cancer in which cancer cells grow rapidly. However, HER2-positive breast cancer generally responds well to treatment.

Breast cancer is the most common cancer in women in the U.S., and HER2-positive breast cancer accounts for about 20 percent of all breast cancer diagnoses (in 2023, that’s 297,790 women and 2,800 men who will be diagnosed).

Pricing for Hercessi has not been confirmed. 

The company has not disclosed plans for distribution.

CLICK HERE to access prescribing information

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FDA Approves Hercessi, the Sixth Trastuzumab Biosimilar

CLICK HERE to read the full article