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What Might Be Impact of First Interchangeable Biosimilar?

August 4, 2021

More than 10 years after the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Affordable Care Act, the FDA finally has approved the first interchangeable biosimilar. But while many in the industry are hailing the move, at least one expert wonders whether interchangeables will hamstring use of biosimilars that do not have that designation.

On July 28, the FDA approved Viatris Inc. and Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Semglee (insulin glargine-yfgn) to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. It is a biosimilar to and interchangeable with its reference product, Sanofi Aventis’ Lantus (insulin glargine), a long-acting insulin analog. The product will be available in 10 mL vials and 3 mL prefilled pens and is administered subcutaneously once daily. It also has 12 months of exclusivity under section 351(k)(6) of the Public Health Service (PHS) Act during which the FDA cannot approve another biosimilar that is interchangeable with Lantus.

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FDA Approval Gives Third Option to Treat Rare, Deadly Disease

August 4, 2021

The FDA recently approved a third agent to treat paroxysmal nocturnal hemoglobinuria (PNH). With some conditions, that number of treatments may prompt payer preferencing, but that is unlikely to happen with this ultra-rare, potentially fatal disease, observe industry experts.

On May 14, the FDA approved Apellis Pharmaceuticals, Inc.’s Empaveli (pegcetacoplan) as the first and only targeted C3 therapy for the treatment of adults with PNH. It is approved for both treatment-naïve people, as well as ones switching from any C5 inhibitor. The FDA has approved two of those drugs: Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz), both from Alexion Pharmaceuticals, Inc., which was just acquired by AstraZeneca in July.

PNH is an acquired, life-threatening blood disorder that causes the destruction of red blood cells, formation of blood clots and impairment of bone marrow function. It is an ultra-rare disease, impacting about 1 to 1.5 people per million, according to Johns Hopkins’ Sidney Kimmel Comprehensive Cancer Center. The median age of diagnosis is between 35 and 40 years old, with a 10-year median survival after diagnosis, although some people may live for decades with minor symptoms. Blood tests that can confirm the diagnosis are available.

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MedPAC Suggests Biosimilars Are Helping Bring Down ASPs

Chart: Trends in Medicare Part B Payment Rates for Originator Biologics and Their Biosimilar Products

August 4, 2021

While total Medicare spending on all Part B drugs continued to rise from 2018 to 2019, a Medicare Payment Advisory Commission (MedPAC) report found that average sales prices (ASPs) for some traditionally costly drugs actually decreased, a trend that may be due to biosimilar competition, posits the recent report.

The report, titled Health Care Spending and the Medicare Program, was published in July 2021. In 2018, total Part B drug spending was just shy of $35 billion, an amount that rose to more than $39 billion the following year. Among the top 10 drugs, 2018 total spend was almost $15 billion, increasing to more than $16 billion in 2019 — or about 41% of all Part B spending for the year.

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BioMatrix Continues to Expand Its Capabilities Via Deals

August 4, 2021

While specialty pharmacy merger and acquisition activity has certainly slowed, one independent specialty pharmacy continues to snap up other complementary organizations — and, as a result, may find the M&A focus on itself.

BioMatrix Specialty Pharmacy revealed in early July that it had acquired InfuCare LTD, an infusion-focused specialty pharmacy. Located in Tyler, Texas, InfuCare provides BioMatrix with a physical location in what the latter calls a “key geographic area,” providing “access to additional covered lives in one of the nation’s largest states,” according to a company press release. It also brings expertise in chronic, complex conditions that require home infusion with therapies such as intravenous immune globulin (IVIG) and parenteral nutrition.

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What Do Employers Need to
Know About Specialty Drugs?

August 4, 2021

Employers have long been concerned about costs for specialty therapies, but some may have been hesitant about putting too many restrictions on them. However, as these drugs continue to come onto the market with higher and higher price tags, employers should become more familiar with these therapies in order to properly manage them, industry experts suggest.

Over the past three years, specialty drugs have made up almost two-thirds of all new drug approvals, points out Katie Asch, Pharm.D., senior director and U.S. consulting pharmacy practice lead at Willis Towers Watson. And as these drugs make up the bulk of the pharma pipeline, employers should expect their utilization to continue to rise, she says. “Furthermore, specialty drugs are becoming more widely used in disease states like asthma or eczema that have historically been treated with less expensive inhalers or topical creams,” which also will result in increased utilization.

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New FDA Specialty Approvals

August 4, 2021

July 9: The FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have received at least one line of therapy. The agency also converted the Nectin-4-directed antibody and microtubule inhibitor conjugate’s accelerated approval, granted Dec. 18, 2019, to regular approval for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic urothelial cancer setting. Dosing for both indications is 1.25 mg/kg via a 30-minute intravenous infusion on days one, eight and 15 of a 28-day cycle. Website Drugs.com lists the price of a 20 mg lyophilized powder as more than $2,380.00.

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