Month: December 2024

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

The FDA recently approved a new therapy, Hympavzi (marstacimab-hncq) from Pfizer Inc., indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors.

This approval is yet another, cutting edge development in the hemophilia category in the past of year+. Hympavzi is the first of its kind and works by targeting a protein in the blood clotting process.

For decades, clotting factor products merely replaced clotting factor. Hympavzi works by reducing the amount of tissue factor pathway inhibitor, a naturally occurring anticoagulation protein. As such, it increases the amount of thrombin, an enzyme that is critical in blood clotting. Ultimately this is approach is expected to reduce the frequency of bleeding episodes.  

Hympavzi is a once-weekly subcutaneous injection and is supplied in pre-filled auto-injector pens.

CLICK HERE to access prescribing information

Pfizer set a wholesale acquisition cost (WAC) at $795,600 for Hympavzi. 

By comparison to other recent hemophilia breakthrough therapies, Pfizer charges $3.5 million for its Beqvez product and matches the price for Hemgenix , a hemophilia B gene therapy.

The company announced that Hympavzi would launch through Orsini Specialty Pharmacy limited distribution.

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FDA Approves New Treatment for Hemophilia A or B

Product is First Non-Factor and Once-Weekly Treatment for Hemophilia B

CLICK HERE to access the press release 

If you work in specialty pharmacy it is a safe bet that you are familiar with pharmacy accreditation. If you are familiar with accreditation you understand that accreditation is a comprehensive approach to measure specialty pharmacy performance against specific standards. And, if you are that familiar with accreditation, you almost assuredly are familiar with URAC, one of the leading independent accrediting organizations in the US.

URAC recently released a report that summarizes performance among its numerous participating specialty pharmacies with a five year lookback. The report focuses on key metrics that are valuable for specialty pharmacies to gauge their own performance against competing specialty pharmacies in the marketplace. Payers and even patients are increasingly attuned to such performance metrics when seeking to do business with an organization that has the health, safety, and financial fortunes in their hands.

Some of the leading metrics cited in the new report include;

• Quality monitoring enhancement
• Fostering industry standards
• Improvement in call center performance
• Dispensing accuracy enhancements
• Challenges in distribution accuracy
• Turnaround time trends
• ….. and more.

The report, therefore, should be mandatory reading for every specialty pharmacy.

CLICK HERE to access the URAC Five-Year Specialty Pharmacy Report: Making a Difference With Measurement

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URAC Releases Specialty Pharmacy Report

• Over the five-year period, URAC-accredited pharmacies responded to patient calls within 30 seconds 75% of the time, improving to 86% by 2023.

CLICK HERE to read the article

…………………………catching up on FDA approvals

The FDA recently approved an ORAL therapy, Itovebi (inavolisib) from Genentech, Inc. Itovebi is indicated in combination with palbociclib and fulvestrant for the treatment locally advanced or metastatic breast cancer in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

Itovebi is a type of targeted therapy medicine called a PI3K inhibitor. Previously, Piqray (alpelisib) was the only PI3K inhibitor approved to treat breast cancer with a PIK3CA mutation.  Approximately 70% of all breast cancers are hormone-receptor positive, HER2-negative.  PIK3CA is the most commonly mutated gene in hormone-receptor positive, HER2-negative breast cancer, with approximately 40% of patients harboring this mutation. 

Genentech said that Itovebi will launch at a price of $22,867 for a 28-day cycle.

Distribution details were not announced. Although it comes with a relatively high cost, Good Rx shows current availability at a large number of retail pharmacies including CVS, Walgreens, Walmart, etc. 

CLICK HERE to access prescribing information

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FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

CLICK HERE to read the full press release

Quiz me this……………

Would you prefer to have your medication administered intravenously or in pill form?

Did it take more than a nano second to answer that question?

Probably not.

The article below may have some good news for the vast number of patients that deal with the burdens of an infused course of therapy.  As the article below points out, infusions are inconvenient or even inaccessible to patients….. and, complications often arise not from the active drug, but the infusion itself. “Turning these drugs into pills could be transformative.”

But is it doable?  

Researchers say ‘YES’. They are actively working to solve a big hurdle….. ‘bioavailability’….. or how to make oral medications more readily dissolvable in the bloodstream with maximum absorption. (Ever try to mix a vinegrette dressing? Ya got to make the oil combine with the vinegar or water.) The article explains how new technology is being developed to achieve exactly that….. think routinely breaking the oil vs. water barrier.

Are you familiar with the term ‘sol-moiety’? Existing drugs are now being tested in the lab to achieve bioavailability using this technique….. and results have been spectacular with bioavailability increases from nearly zero to 100% being observed. Proof-of-concept is no longer a hurdle.

Read the full article for more details and perhaps a glimpse of the future.

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New strategy could turn intravenous medicines into pills

CLICK HERE to access the full article