Month: November 2024

The FDA recently approved an ORAL therapy, Livdelzi (seladelpar) from Gilead Sciences, Inc., for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

PBC is a rare, chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans, primarily women, and is known to cause liver damage and, ultimately, liver failure if untreated. The disease currently has no cure.

Common symptoms include incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night.

Gilead confirmed a list price of $12,606 for 30 tablets (10-mg) which works out to $151,272 per year.

Gilead also confirmed that oral Livdelzi will be distributed through specialty pharmacy.

CLICK HERE to access prescribing information

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Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA

First and Only Treatment to Demonstrate Statistically Significant Reductions Across Key Biomarkers, ALP Normalization and Pruritus Versus Placebo –

CLICK HERE to read the full Gilead press release

PBMs are increasingly under the gun to remedy a variety of practices that are not considered consumer and provider network friendly. It is not surprising, therefore, that a PBM might want to tout some of the things that they have done to move the collective patient journey in a positive direction. But, it is in the short list of things that they are promising in the future that we find of greater interest. 

A short video interview with a senior leader at one PBM, OptumRx, recaps some of their successes over recent years but also opens the window on some noteworthy strategies in development.

The pipeline includes a more aggressive approach to cost containment especially through value-based strategies that go beyond pharmacy, in short, a ‘whole of government approach’….. ummm, a ‘whole of medicine approach’. This means embracing a big tent model of all providers that support specialty patients with complex needs…. often with multiple diagnoses. The evolving model must also develop a true cross-benefits model — Medical and Pharmacy to eliminate existing disparities. There’s more……

If you have 10 minutes, the video interview will add detail and other morsels of concepts upon which to chew. (link below)

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Optum Rx’s Vision for the Future of Specialty Care

OptumRx Healthcare Costs Value-Based Care Patient experience

Rising costs, technological advancements, the growing complexity of patient needs – these are all factors transforming the specialty pharma landscape at present.

CLICK HERE to access the video

…………catching up on FDA approvals

The FDA has approved a new therapy, Imuldosa (ustekinumab-srlf) from Accord BioPharma Inc., as a biosimilar to Janssen Biotech’s Stelara. Imuldosa is available in a subcutaneous form as well as an infusible.  

The approval of Imuldosa marks the fifth ustekinumab approval for the US. 

Imuldosa is slated to launch in May 2025 according to sources.

Imuldosa is indicated for—– 

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.
• Pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis.

It is noted that prescribing information specifies subcutaneous dosing and administration for Psoriasis and Psoriatic Arthritis while specifying intravenous dosing instructions for Crohn’s Disease and Ulcerative Colitis.

CLICK HERE for prescribing information

While Imuldosa did not receive a Black Box warning there are a number of warnings and precautions consistent with the other previously approved Stelara biosimilars.

Pricing and distribution plans were not announced.

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FDA Approves Imuldosa, a Biosimilar to Stelara

CLICK HERE to read the 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 five LD deals that have been publicly confirmed subsequent to their approvals.

DirectRx to Distribute Ohtuvayre

DirectRx is now part of the U.S. pharmacy network distributing Ohtuvayre (ensifentrine), a newly approved therapy for chronic obstructive pulmonary disease (COPD). The Verona Pharma therapy was cleared by the U.S. Food and Drug Administration as an inhaled maintenance therapy for adults with COPD.

Amber Specialty Pharmacy to Distribute Ohtuvayre

Amber Specialty Pharmacy has announced that it has been named by Galderma to distribute Nemluvio (nemolizumab-ilto) for the treatment of Prurigo Nodularis in adults. The condition is a chronic, debilitating skin condition.

Orsini Specialty Pharmacy Exclusive Distributor for Miplyffa

Orsini Specialty Pharmacy has been chosen as the exclusive provider for Miplyffa (arimoclomol), the First FDA-Approved Treatment for Niemann-Pick Disease Type C, an ultra-rare and progressive neurodegenerative disease. MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older.

Biologics by McKesson to Distribute Voranigo

Biologics by McKesson has been selected by Servier Pharmaceutical as a specialty pharmacy partner for Voranigo (vorasidenib). Voranigo is approved for the treatment of adults and pediatric patients 12 years of age and older with grade 2 astrocytoma or oligodendroglioma and a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection.

ONCO360 to Distribute Voranigo

Onco360 has also been selected by Servier Pharmaceutical as a specialty pharmacy partner for Voranigo (vorasidenib).