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.

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.

The FDA also issued three fact sheets to help improve understanding of biosimilars and interchangeable biosimilars.

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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.

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,

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.

Top Part B Drugs Are All Biologics

All of the top Part B drugs have been biologics since 2016. In 2019, the top 10 drugs included ones for cancer or supportive oncology care, ocular conditions such as age-related macular degeneration and inflammatory conditions such as rheumatoid arthritis. Regeneron Pharmaceuticals, Inc.’s ocular drug Eylea (aflibercept) ranked No. 1, with total Part B spending of more than $2.9 billion.

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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.

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.

The companies did not disclose financial details.

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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.

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.

A variety of steps may be taken to ensure that employers truly understand these drugs and their value proposition. While much of their focus, understandably, is around the products’ increasing spend and trend, it’s important for employers “to understand that many patients with specialty conditions also incur significant direct and indirect medical costs related to their conditions,” declares Erin Lopata, Pharm.D., MPH, senior director of the access experience team at PRECISIONvalue. “Direct costs can include symptomatic treatments, procedures, hospitalizations and use of durable medical equipment. Indirect costs may include impacts to the employee’s productivity as they manage their own condition or serve as a caregiver to a dependent. Understanding the complete picture of disease burden and cost will be critical to effectively implementing models that minimize risk and improve predictability, while providing access to the appropriate patients. This is particularly important for value-based contracts, which also serve to describe the long-term value these treatments may bring.”

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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.

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.

July 12: The FDA granted another indication to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least one line of therapy, including lenalidomide and a proteasome inhibitor. The agency initially approved the anti-CD38 monoclonal antibody on May 1, 2020. The recommended dosage is 1,800 mg/30,000 units subcutaneously into the abdomen over approximately three to five minutes weekly for weeks one to eight, every two weeks from weeks nine to 24 and then every four weeks. Drugs.com lists the price of an 1,800 mg/30,000 per 15 mL vial as more than $8,290.

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News Briefs

August 4, 2021

Bristol Myers Squibb will voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib. The move follows an April meeting of the agency’s Oncologic Drugs Advisory Committee to discuss whether to keep certain indications for a handful of checkpoint inhibitors that target programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) and received accelerated approval but had not met post-marketing requirements demonstrating confirmatory benefit. Opdivo received a negative vote for this indication, as did Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with disease progression on or after at least two lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2/neu-targeted therapy. Merck said recently that it would voluntarily withdraw that indication in the U.S.

Bristol Myers Squibb will voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib. The move follows an April meeting of the agency’s Oncologic Drugs Advisory Committee to discuss whether to keep certain indications for a handful of checkpoint inhibitors that target programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) and received accelerated approval but had not met post-marketing requirements demonstrating confirmatory benefit. Opdivo received a negative vote for this indication, as did Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with disease progression on or after at least two lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2/neu-targeted therapy. Merck said recently that it would voluntarily withdraw that indication in the U.S.

Bristol Myers Squibb also will withdraw the indication for Istodax (romidepsin) as monotherapy for the treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy. The FDA initially gave the drug from Celgene Corp., now a Bristol Myers Squibb subsidiary, accelerated approval. A confirmatory Phase III trial did not meet the primary efficacy endpoint of progression free survival.

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Datapoint: GSK Scores Nasal Polyps Approval for Nucala

August 4, 2021

The FDA on July 29 approved GlaxoSmithKline’s Nucala for the treatment of chronic rhinosinusitis with nasal polyps, making it the first IL-5 inhibitor in its class. The biologic will have to face off against Sanofi and Regeneron’s Dupixent, which was approved for nasal polyps in 2019. Under the pharmacy benefit, Dupixent holds preferred status (with utilization management restrictions applied in most cases) for 38% of all covered lives. Overall, it holds covered or better status for 73% of lives.

The FDA on July 29 approved GlaxoSmithKline’s Nucala for the treatment of chronic rhinosinusitis with nasal polyps, making it the first IL-5 inhibitor in its class. The biologic will have to face off against Sanofi and Regeneron’s Dupixent, which was approved for nasal polyps in 2019. Under the pharmacy benefit, Dupixent holds preferred status (with utilization management restrictions applied in most cases) for 38% of all covered lives. Overall, it holds covered or better status for 73% of lives.

SOURCE: MMIT Analytics, as of 8/2/21

Datapoint: AstraZeneca’s Saphnelo Cleared to Treat Lupus

August 3, 2021

The FDA on Monday approved AstraZeneca’s Saphnelo for the treatment of moderate to severe systemic lupus erythematosus (SLE), the most common form of the disease. The type I interferon receptor antagonist is the first approval for SLE since 2011, when GlaxoSmithKline’s Benlysta entered the market. While Saphnelo could pose a threat, Benlysta is highly advantaged in the SLE market basket. Its intravenous form holds covered or better status for 94% of all insured lives under the medical benefit vs. 65% of lives under the pharmacy benefit.

The FDA on Monday approved AstraZeneca’s Saphnelo for the treatment of moderate to severe systemic lupus erythematosus (SLE), the most common form of the disease. The type I interferon receptor antagonist is the first approval for SLE since 2011, when GlaxoSmithKline’s Benlysta entered the market. While Saphnelo could pose a threat, Benlysta is highly advantaged in the SLE market basket. Its intravenous form holds covered or better status for 94% of all insured lives under the medical benefit vs. 65% of lives under the pharmacy benefit.

SOURCE: MMIT Analytics, as of 8/2/21

Datapoint: Pfizer, J&J Settle Remicade-Inflectra Legal Battle

August 2, 2021

Pfizer and Johnson & Johnson have settled their legal battle over anticompetitive practices marketing their two immunology drugs, J&J’s blockbuster Remicade and Pfizer’s biosimilar Inflectra, according to a report from the American Journal of Managed Care’s Center for Biosimilars. While terms of the settlement were not disclosed, Pfizer will continue to market Inflectra. For the treatment of ulcerative colitis, Remicade remains advantaged over Inflectra, holding covered or better status for 59% of all insured lives under the pharmacy benefit and 91% under the medical benefit. Meanwhile, Inflectra is covered or better for 50% of lives under the pharmacy benefit and 90% under the medical benefit.

Pfizer and Johnson & Johnson have settled their legal battle over anticompetitive practices marketing their two immunology drugs, J&J’s blockbuster Remicade and Pfizer’s biosimilar Inflectra, according to a report from the American Journal of Managed Care’s Center for Biosimilars. While terms of the settlement were not disclosed, Pfizer will continue to market Inflectra. For the treatment of ulcerative colitis, Remicade remains advantaged over Inflectra, holding covered or better status for 59% of all insured lives under the pharmacy benefit and 91% under the medical benefit. Meanwhile, Inflectra is covered or better for 50% of lives under the pharmacy benefit and 90% under the medical benefit.

SOURCE: MMIT Analytics, as of 7/28/21