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August 15, 2023
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Generic Baraclude, Viread for chronic HBV saved Medicare nearly $300M in 2020

Fact checked byHeather Biele
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Key takeaways:

  • Medicare spending for Baraclude and Viread dropped considerably with the introduction of generic versions in 2014 and 2017, respectively.
  • The number of beneficiaries for generic versions increased.

Researchers estimated that the introduction of generic medications for chronic hepatitis B virus infection could save Medicare Part D nearly $300 million annually from the cost of medication alone, according to data in Gastroenterology.

“One of the biggest concerns in the U.S. health care system is its ever-increasing spending, which accounts for almost 20% of our national gross domestic product,” Arun B. Jesudian, MD, associate professor of clinical medicine and director of liver quality at Weill Cornell Medicine, told Healio. “Almost 10% of that spending is on prescription medications.

Arun B. Jesudian, MD

“Given our interest in liver disease, we set out to better understand the cost of hepatitis B medications for Medicare Part D and to see how the introduction of generic medications impacted drug pricing and utilization.”

In a cross-sectional study, Jesudian and colleagues analyzed Medicare Part D data from 2013 to 2020 to determine the number of beneficiaries receiving drugs for chronic HBV, the total number of 30-day refills and total annual spending on these drugs. They included five oral medications in the analysis: brand names Viread (tenofovir disoproxil fumarate, Gilead Sciences), Baraclude (entecavir, Bristol Myers Squibb) and Vemlidy (tenofovir alafenamide, Gilead Sciences), as well as generic tenofovir DF and entecavir.

Results demonstrated a total of $1.8 billion in Medicare spending from 2013 to 2020, most of which was for Viread (48%) followed by generic entecavir (19%), Vemlidy (18%), Baraclude (11.2%) and generic tenofovir DF (4.6%).

During this time, researchers also reported increases in the total number of beneficiaries from 28,446 to 43,924 (annual percent change [APC] = 6.4; 95% CI, 4.1-8.7) and the total number of 30-day refills from 245,483 to 411,918 (APC [2013-2018] = 6.7; 95% CI, 5.7-7.7; APC [2018-2020] = 9.6; 95% CI, 4.9-14.5).

“Physicians have generally been very good about prescribing generic medications if they are available,” Jesudian said. “In our study, we found that approximately 70% of patients were taking generic versions of entecavir, approved in 2014, and tenofovir disoproxil fumarate, approved in 2017, 1 year after their approval.”

Researchers noted that after approval of these generic versions, Medicare spending for Baraclude dropped from $74 million in 2014 to $24 million in 2015 and $3.8 million in 2020 (APC = –37.4; 95% CI, –45.2 to –28.4), as did the total number of beneficiaries from 8,474 in 2014 to 320 in 2020. Conversely, the number of beneficiaries for generic entecavir increased from 4,736 to 17,896 during this time, with an estimated cost savings of $180 million in 2020 and $580 million between 2014 and 2020.

Researchers reported a similar trend with Viread, with total Medicare spending dropping from $167 million in 2017 to $6.4 million in 2020 (APC = –68.9; 95% CI, –82 to –46.4), as well as a reduction in beneficiaries from 20,353 to 734 (APC = –67.8; 95% CI, –70.9 to –64.3). Beneficiaries for generic tenofovir DF increased from 512 to 14,344 (APC = 173.3; 95% CI, –78.3 to 3,342.4) during this time, with an estimated cost savings of $140 million in 2020 and $325 million between 2017 and 2020.

“We estimate that the approval of these two generics has saved Medicare Part D approximately $300 million in 2020 alone,” Jesudian told Healio. “As physicians, we need to be mindful of our health care utilization while still providing the best care for our patients. As we found in our study, a majority of patients were switched to generic versions a year after their approvals.”

He continued: “That is encouraging in that it shows that we are staying up to date with drug approvals and are mindful of how our prescribing behaviors impact our patients and society at large.”