Oncology products continue to be the top products driving the pharma marketplace. They are among the most expensive and complex due to the numerous iterations of the disease. As such, the market access challenges are, and will continue to be, extraordinary.

Today’s highlighted article delves into the intricate strategies required for achieving commercial success. It emphasizes that the high-stakes environment of cancer care, combined with rapid advancements in science and growing payer and regulatory pressures, necessitates a specialized approach that goes beyond traditional market access strategies. Seamlessly integrating market access, patient services, and medical affairs is essential to developing impactful and customized solutions.

Key topics include:
The Unique Complexity of Oncology Market Access
Three Pillars of Product Market Access for Oncology
The Impact of Oncology Pathways on Product Access
Building Trust with Healthcare Ecosystem Stakeholders
Financial Value Proposition and Payment Model Considerations
Key Financial Considerations
The Path Forward: Deep Oncology Expertise as a Necessity

This insightful article offers valuable perspectives that can be broadly applied across the pharmaceutical industry, particularly in scenarios where establishing effective market access is crucial.

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Oncology Brands Face Uniquely Complex Market Access Challenges: A Specialized Approach for Commercial Success

CLICK HERE to access the article

The FDA recently approved a therapy originally approved in 1983, Vykat XR (diazoxide choline) from Soleno Therapeutics, based on a breakthrough indication for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). It is an oral medication in extended-release tablet form. Vykat XR is the first drug approved to treat hyperphagia.

Prader-Willi syndrome is a rare disease which leaves patients with low muscle tone, short stature and intellectual and developmental problems.

The Prader-Willi Syndrome Association USA estimates that the disorder occurs in 1 in every 15,000 live births, with more than 300,000 people worldwide affected. Soleno says that claims data show there are 10,000 PWS patients in the U.S

The company announced that, based on the average weight of patients in its clinical trials, Soleno will charge $466,200 per year for Vykat XR. The company expects it to launch in Q2. Panther Rare Rx has announced that it has been selected by Soleno to distribute Vykat XR

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Soleno breaks through with FDA nod for Prader-Willi syndrome treatment Vykat XR

CLICK HERE to read the full article

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

Here are six LD deals that have been publicly confirmed subsequent to their approvals.

PANTHERx Rare to Distribute Vigafyde

PANTHERx Rare was selected by Upsher-Smith for the distribution of Vigafyde (vigabatrin), a ready-to-use, concentrated oral solution approved for the treatment of infantile spasms in pediatric patients one month to two years old.

PANTHERx Rare to Distribute Vykat

PANTHERx Rare was selected by Soleno Therapeutics to distribute Vykat XR (diazoxide choline extended-release tablets), for the treatment of hyperphagia in individuals four years of age and older with Prader-Willi syndrome (PWS).

Orsini to Distribute Encelto

Orsini Specialty Pharmacy has been selected by Neurotech Pharmaceuticals, Inc., as the exclusive specialty pharmacy partner for Encelto (revakinagene taroretcel-lwey), an FDA-approved encapsulated cell therapy implant for the treatment of Macular Telangiectasia type 2 (MacTel).

CareMed to Distribute Vanrafia

CareMed has been selected by Novartis Pharmaceuticals to join the Limited Distribution Network for Vanrafia (atrasentan), indicated for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) and are at risk of rapid disease progression.

(CareMed is an independent Specialty Pharmacy that is an affiliate of Onco360 Specialty Pharmacy)

Soleo Health to Distribute Qfitlia

Soleo Health has been named the exclusive in-network specialty pharmacy for Qfitlia (fitusiran) by Sanofi. Qfitlia is the first antithrombin-lowering therapy for hemophilia. Qfitlia was approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors.

Onco360 to Distribute Avmapki – Fakzynja CO-PACK

Onco360 has been selected as a national pharmacy partner by Verastem Oncology for Avmapki – Fakzynja CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. 

The past year has brought rough financial seas to Walgreens. As recently as this January we reported on Walgreens plans to possibly go private after closing underperforming retail stores and whole divisions such as VillageMD. 

We said then that Walgreens (WAGS) is facing a serious reversal of fortunes to the tune of $billions$ of dollars. The numbers are jaw dropping….. about 10 years ago Walgreens’ market cap was more than $100 billion. They ended the year with a valuation of only $8 billion.

Earlier this month WAGS had yet another major problem to resolve…. a federal anti-kickback charge by the US government. In this case they were able to settle for $50 million.

This story is less about Walgreens and more about the fact that the government is still vigilant about anti-kickback schemes such as that conducted by WAGS. While the financial penalty my only sting, the impact to the company reputation and ability to qualify for other government programs can be impacted. Remember, under the federal False Claims Act, whistleblowers are entitled to a portion of whatever money the government is able to recover.

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Walgreens to pay $50M in anti-kickback case

• Company gave illegal discounts, government says
• Walgreens marketed a savings plan without checking if people were covered by Medicare or Medicaid, officials said. 

CLICK HERE to read the full article

Today’s Report spotlights a relatively insignificant event in therapy distribution. We are talking about COSTCO, yes the warehouse retailer. What they did is simply add a new drug to their pharmacy inventory, a little therapy called Steqeyma. In doing so, however, it reinforced a major shift in the specialty pharmacy industry.

Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), has been added to the Costco Member Prescription Program. Still not impressed? Read on….

Adding a biosmilar to a prescription drug discount card program is not hugely surprising.

What is surprising is that COSTCO has been discreetly adding other specialty pharmacy therapies for several years. In fact, they are affirming that there are now “COSTCO Specialty Pharmacies.”

To be fair, a host of other retailers have been playing in the specialty pharmacy sand box for years. That COSTCO appears to be fully committed to be a player says a lot about the SP market and the shifting competitive landscape. 

The company said that the formulary including the specialty products is currently available for self-funded employer plans and Costco members who are uninsured and want to pay cash for their Steqeyma prescription or who have been denied coverage by their insurers.

FYI…. Steqeyma is available in both subcutaneous injection and intravenous infusion and is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn’s disease (CD) and ulcerative colitis (UC) in adult patients.

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Celltrion’s Steqeyma (ustekinumab-stba), now added to the Costco Member Prescription Program

CLICK HERE to read the full article

The FDA recently approved one… no wait, two… no wait, is it really one times two denosumab biosimilars…..?? The/these approval/s include Ospomyv (denosumab-dssb) and Xbryk (denosumab-dssb)… it/they are from Samsung Bioepis.

NO WAIT… the FDA approved yet another pair of denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) from Celltrion.

And if that’s not enough, Wyost and Jubbonti were approved as Prolia and Xgeva biosims in 2024.

All of these biosims were approved as interchangeable with the reference products, Prolia and Xgeva from Amgen.

You should be familiar with the big differences between these ‘twin’ injectables. But, one has a twice yearly administration schedule… the other has a much more frequent dosing schedule. While both products are included in the same FDA approved prescribing information document you need to scroll way down (e.g., page 96) to read the details for the ‘twin’s’ therapy detail and the dosing information for completely different indications. 

CLICK HERE to access prescribing information for Ospomyv and Xbryk

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FDA, EMA Approve Second Pair of Denosumab Biosimilars

CLICK HERE to read the full article 

The FDA recently approved a new ORAL therapy, Romvimza (vimseltinib) from Deciphera Pharmaceuticals, LLC, indicated for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

Tenosynovial giant cell tumor (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is primarily treated through surgical resection. Treatment with TGCT typically involves direct removal of the tumor nodule. Treatment for diffused-type TGCT (DTGCT) with larger tumors affecting major joints, includes total synovectomy, joint replacement, or, in extremely rare cases, or amputation.

The highest prevalence of TGCT accounts for approximately 45% of total cases. Giant cell tumors can occur in the knee, ankle, hip, and other areas. The article cites that diffuse TGCT was most frequently observed in the knee, with an estimated 30,000 cases in the US in 2023.

Pricing details for Romvimza have not yet been announced.

Distribution details have not yet been announced by the company.

CLIC HERE to access prescribing information

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FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor

CLICK HERE to read the full press release

How do you validate value? 

How do you demonstrate the ability to ‘walk the talk’?

The National Association of Specialty Pharmacy (NASP) has taken its years of specialty pharmacy knowledge and suggests it has a model that answers those questions. The validation points include improved patient outcomes, reduced costs, better medication adherence, cutting waste and increased patient safety.

If you think all this sounds familiar, it should. It has been the mantra for the SP industry for decades. What is different is the degree of proactive intervention that should push the standard of care past the performance ‘red line’.

NASP is still at work adding detail to the framework to facilitate implementation. For example, the framework will include a variety of new metrics such as affordability, supply chain impact, and tracking not only the number of interventions as well as the type such as patient, physician, care team, financial, etc., etc. to paint a very broad picture and understanding of each patient’s journey.

The current standard of care is already expensive. And, the expanded vision suggested by the framework would logically be even more costly. Perhaps AI may provide the secret sauce need to make the framework a reality.

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NASP’s 5-Step Procedure Tracks Patient Intervention Effectiveness

CLICK HERE to read the full article

Following what seems to be a new trend, the FDA has approved yet another 20+ year old therapy based on a major remodel… this one was originally approved in 2004. 

The therapy in question is Onapgo (apomorphine hydrochloride) injection from Supernus Pharmaceuticals, now available for subcutaneous use indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. 

Onapgo is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.  Onapgo is a wearable subcutaneous infusion device that provides continuous treatment during the waking day for more consistent control of ‘OFF’ time. Onapgo is the second under-the-skin infusion-based therapy approved by the FDA this year for Parkinson’s, the first being Vyalev which delivers a continuous infusion of levodopa and carbidopa. Onapgo is a dopamine agonist that acts like dopamine, the brain chemical that affects movement and decreases in people with Parkinson’s. By dosing continuously sub-q, Onapgo bypasses the gastrointestinal (GI) tract allowing improved dosing direct to the brain.

Supernus expects to launch Onapgo in Q2-2025. As noted in an article, one analyst expects pricing to be in line with Vyalev and launch with a WAC of ~$119,000 for a year of therapy. 

The company did not release any details related to distribution.

CLICK HERE to access prescribing information

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Second Under-the-Skin Infusion for Parkinson’s Earns FDA Approval

CLICK HERE to access the full article

The FDA recently approved a new therapy originally approved in 2006, Susvimo (ranibizumab) from Genentech, an ocular implant providing customized therapy for diabetic macular edema (DME). This therapy has been granted a new indication and approved an updated delivery system.

Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time. 

Susvimo is the first and only FDA-approved treatment shown to maintain vision for patients with DME. Susvimo is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.

DME is the leading cause of vision loss for patients with diabetes affecting 12% of type 1 and 28% of type 2 diabetic patients. The lifetime risk of developing DME for people with diabetes is about 10%.

Genentech originally confirmed pricing for the implant and Susvimo at $16,950 the first year, and two refills every six months in year two are priced at $16,000.

Genentech did not announce details for distribution.

CLICK HERE to access prescribing information

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FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness

• Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)
• With as few as two treatments per year, Susvimo may help people with DME maintain their vision
• Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD)

CLICK HERE to read the full press release