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FDA Approval of Biosimilar, Proposed Change in US Drug Prices, and 2018 ASCO Presscast

Gina Columbus
Published: Friday, May 18, 2018



Today-

An FDA approval for a biosimilar, a proposed change to drug prices by President Donald Trump, and highlights from a presscast held ahead of the 2018 ASCO Annual Meeting.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has approved epoetin alfa-epbx, known by the trade name Retacrit, for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.

The biosimilar is also indicated for use prior to and following surgery to reduce the likelihood that patients will need a red blood cell transfusion caused by blood loss from surgery.

The FDA’s Oncologic Drugs Advisory Committee voted 14 to 1 recommending approval of a biologics license application for epoetin alfa-epbx in May 2017.

Hospira, the manufacturer of the biosimilar, submitted the application based on results from 2 single-center, randomized, open-label studies, EPOE-12-02 and EPOE-14-01.

The first trial was aimed to establish the pharmacokinetics and pharmacodynamics of epoetin alfa-epbx following a single subcutaneous dose in 81 healthy patients. EPOE-14-01 was designed to determine the drug’s PK and PD following multiple doses of subcutaneous epoetin alfa-epbx 3 times weekly for 4 weeks in 129 patients. Epoetin alfa-epbx was compared with epoetin alfa in both trials.

Results of both studies showed that epoetin alfa-epbx met the prespecified acceptance criteria for similarity.

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President Donald Trump announced a sweeping blueprint to lower prescription drug costs, promising to expand access to generic drugs and biosimilars and remove incentives that keep drug prices high.

The plan comprises an FDA evaluation of whether drug manufacturers should be required to list prices in their advertising, as well as longer-term efforts to change the imbalance between what US consumers pay for drugs developed in the United States versus what foreigners pay in their own countries, where drug prices are often significantly lower.

The 44-page plan, which is titled American Patients First, includes 50 different actions and proposals based on 4 key strategies: increase competition, encourage drug price negotiation, create incentives to lower list prices, and lower out-of-pocket costs.

The FDA issued a statement following Trump’s speech that the agency is promising to improve the overall generic drug review process and reduce the cycles of review required for generic drugs. The FDA said it has taken steps to streamline the submission process for generic drug applicants and prioritize the review of certain generics.

*********************************

ASCO held a presscast ahead of the 2018 Annual Meeting this week, highlighting research on cancer screening, treatment, and symptom management.

Results of the randomized phase III PERSEPHONE trial showed that a shorter 6-month course of adjuvant trastuzumab was found to be noninferior for disease-free survival versus the standard 12-month course for patients with HER2-positive early breast cancer.

Five-year follow-up showed that the 4-year DFS rate was 89.8% with 12 months of trastuzumab versus 89.4% with the 6-month course, which met the criteria for noninferiority. In addition to improvements in DFS, the number of patients stopping treatment due to cardiac toxicity was cut in half with the shorter duration of trastuzumab. Overall, 8% of those enrolled in the 12-month group discontinued treatment with trastuzumab due to cardiotoxicity compared with just 4% in the 6-month group.

The PERSEPHONE study, which began enrolling in 2007, will continue to follow patients to determine whether there is a benefit for overall survival.

*****************************************

In metastatic lung cancer, another study released during the presscast showed that next-generation sequencing, or NGS, can save Center for Medicare and Medicaid Services payers $1.4 to $2.1 million. Additionally, NGS was found to save commercial insurance providers more than $250,000.

The economic impact of NGS was compared against sequential, exclusionary, and panel testing strategies. For NGS and panel, the estimated time to receive results was 2 weeks, which is 2.7 and 2.8 weeks faster than exclusionary and sequential, respectively.

For hypothetical 1 million-member health plans, investigators suggested that 2066 tests would be paid for by CMS and 156 would be paid for by commercial insurers. This is based on the age and number of people in the United States with metastatic non–small cell lung cancer. Using CMS reimbursement, NGS represented savings of $1,393,678 versus exclusionary, $1,530,869 versus sequential, and $2,140,795 versus panel, investigators noted.

Moreover, NGS was the least expensive testing modality by $3,809 versus exclusionary, $127,402 versus sequential, and $250,842 versus panel.

************************************

A third study discussed during the presscast revealed that 1.9% of more than 7.6 million current and former heavy smokers in the United States underwent lung cancer screening in 2016, suggesting that it remains inadequate despite recommendations from the United States Preventive Services Task Force. The USPSTF calls for annual low-dose CT scans in patients ages 55 to 80 years who are current or former heavy smokers.

Overall, results showed that while a total 1796 screening centers could have screened 7,612,975 current and former heavy smokers, only 141,260 people underwent low-dose CT scans, leading to a 1.9% national screening rate.

Data showed that the Northeast had the highest screening rate at 3.5% followed by the Midwest at 1.9%. Moreover, the South region had 663 accredited screening sites, the largest of the 4 regions, and the highest number of smokers eligible for screening at 3,072,095. However, the screening rate here was 1.6% determined to be the second-lowest screening rate in the country. In the West, findings showed that this region had the lowest number of accredited screening sites and the lowest screening rate at 1.0%.

Additionally, 85% of the current smokers who did have low-dose CT scans were offered smoking cessation resources.

*****************************************

This week, we sat down with Dr Matthew S. Davids, of Dana-Farber Cancer Institute, to discuss approaching therapy for patients with relapsed/refractory CLL.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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Today-

An FDA approval for a biosimilar, a proposed change to drug prices by President Donald Trump, and highlights from a presscast held ahead of the 2018 ASCO Annual Meeting.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has approved epoetin alfa-epbx, known by the trade name Retacrit, for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.

The biosimilar is also indicated for use prior to and following surgery to reduce the likelihood that patients will need a red blood cell transfusion caused by blood loss from surgery.

The FDA’s Oncologic Drugs Advisory Committee voted 14 to 1 recommending approval of a biologics license application for epoetin alfa-epbx in May 2017.

Hospira, the manufacturer of the biosimilar, submitted the application based on results from 2 single-center, randomized, open-label studies, EPOE-12-02 and EPOE-14-01.

The first trial was aimed to establish the pharmacokinetics and pharmacodynamics of epoetin alfa-epbx following a single subcutaneous dose in 81 healthy patients. EPOE-14-01 was designed to determine the drug’s PK and PD following multiple doses of subcutaneous epoetin alfa-epbx 3 times weekly for 4 weeks in 129 patients. Epoetin alfa-epbx was compared with epoetin alfa in both trials.

Results of both studies showed that epoetin alfa-epbx met the prespecified acceptance criteria for similarity.

*********************************

President Donald Trump announced a sweeping blueprint to lower prescription drug costs, promising to expand access to generic drugs and biosimilars and remove incentives that keep drug prices high.

The plan comprises an FDA evaluation of whether drug manufacturers should be required to list prices in their advertising, as well as longer-term efforts to change the imbalance between what US consumers pay for drugs developed in the United States versus what foreigners pay in their own countries, where drug prices are often significantly lower.

The 44-page plan, which is titled American Patients First, includes 50 different actions and proposals based on 4 key strategies: increase competition, encourage drug price negotiation, create incentives to lower list prices, and lower out-of-pocket costs.

The FDA issued a statement following Trump’s speech that the agency is promising to improve the overall generic drug review process and reduce the cycles of review required for generic drugs. The FDA said it has taken steps to streamline the submission process for generic drug applicants and prioritize the review of certain generics.

*********************************

ASCO held a presscast ahead of the 2018 Annual Meeting this week, highlighting research on cancer screening, treatment, and symptom management.

Results of the randomized phase III PERSEPHONE trial showed that a shorter 6-month course of adjuvant trastuzumab was found to be noninferior for disease-free survival versus the standard 12-month course for patients with HER2-positive early breast cancer.

Five-year follow-up showed that the 4-year DFS rate was 89.8% with 12 months of trastuzumab versus 89.4% with the 6-month course, which met the criteria for noninferiority. In addition to improvements in DFS, the number of patients stopping treatment due to cardiac toxicity was cut in half with the shorter duration of trastuzumab. Overall, 8% of those enrolled in the 12-month group discontinued treatment with trastuzumab due to cardiotoxicity compared with just 4% in the 6-month group.

The PERSEPHONE study, which began enrolling in 2007, will continue to follow patients to determine whether there is a benefit for overall survival.

*****************************************

In metastatic lung cancer, another study released during the presscast showed that next-generation sequencing, or NGS, can save Center for Medicare and Medicaid Services payers $1.4 to $2.1 million. Additionally, NGS was found to save commercial insurance providers more than $250,000.

The economic impact of NGS was compared against sequential, exclusionary, and panel testing strategies. For NGS and panel, the estimated time to receive results was 2 weeks, which is 2.7 and 2.8 weeks faster than exclusionary and sequential, respectively.

For hypothetical 1 million-member health plans, investigators suggested that 2066 tests would be paid for by CMS and 156 would be paid for by commercial insurers. This is based on the age and number of people in the United States with metastatic non–small cell lung cancer. Using CMS reimbursement, NGS represented savings of $1,393,678 versus exclusionary, $1,530,869 versus sequential, and $2,140,795 versus panel, investigators noted.

Moreover, NGS was the least expensive testing modality by $3,809 versus exclusionary, $127,402 versus sequential, and $250,842 versus panel.

************************************

A third study discussed during the presscast revealed that 1.9% of more than 7.6 million current and former heavy smokers in the United States underwent lung cancer screening in 2016, suggesting that it remains inadequate despite recommendations from the United States Preventive Services Task Force. The USPSTF calls for annual low-dose CT scans in patients ages 55 to 80 years who are current or former heavy smokers.

Overall, results showed that while a total 1796 screening centers could have screened 7,612,975 current and former heavy smokers, only 141,260 people underwent low-dose CT scans, leading to a 1.9% national screening rate.

Data showed that the Northeast had the highest screening rate at 3.5% followed by the Midwest at 1.9%. Moreover, the South region had 663 accredited screening sites, the largest of the 4 regions, and the highest number of smokers eligible for screening at 3,072,095. However, the screening rate here was 1.6% determined to be the second-lowest screening rate in the country. In the West, findings showed that this region had the lowest number of accredited screening sites and the lowest screening rate at 1.0%.

Additionally, 85% of the current smokers who did have low-dose CT scans were offered smoking cessation resources.

*****************************************

This week, we sat down with Dr Matthew S. Davids, of Dana-Farber Cancer Institute, to discuss approaching therapy for patients with relapsed/refractory CLL.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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