Drug Benefits

Datapoint: Amarin Loses Vascepa Patent Appeal

September 10, 2020

A U.S. appeals court last week upheld a lower court ruling that definitively invalidates Amarin’s fish oil derivative drug Vascepa’s patents, meaning generic challengers can move forward. Amarin had blockbuster hopes for the heart drug, which the FDA approved in December 2019. Vascepa currently holds preferred status for 21% of all covered lives under the pharmacy benefit, growing to 44% with utilization management restrictions.

A U.S. appeals court last week upheld a lower court ruling that definitively invalidates Amarin’s fish oil derivative drug Vascepa’s patents, meaning generic challengers can move forward. Amarin had blockbuster hopes for the heart drug, which the FDA approved in December 2019. Vascepa currently holds preferred status for 21% of all covered lives under the pharmacy benefit, growing to 44% with utilization management restrictions.

SOURCE: MMIT Analytics, as of 9/9/20

Part D Base Beneficiary Premium Will Grow Slightly in 2021

September 4, 2020

The monthly Medicare Part D base beneficiary premium for 2021 will be $33.06, up from $32.74 in 2020, according to recent CMS projections. Meanwhile, the Part D national average monthly bid amount dropped slightly, from $47.59 in 2020 to $43.07 in 2021. While regional low-income premium subsidy amounts fluctuated over the past six years, 46 states are projected to see an increase in 2021. Hawaii is projected to see the biggest growth, with its average subsidy amount going up from $25.21 in 2020 to $31.12 in 2021.

by Jinghong Chen

The monthly Medicare Part D base beneficiary premium for 2021 will be $33.06, up from $32.74 in 2020, according to recent CMS projections. Meanwhile, the Part D national average monthly bid amount dropped slightly, from $47.59 in 2020 to $43.07 in 2021. While regional low-income premium subsidy amounts fluctuated over the past six years, 46 states are projected to see an increase in 2021. Hawaii is projected to see the biggest growth, with its average subsidy amount going up from $25.21 in 2020 to $31.12 in 2021.

SOURCE: CMS. Visit https://go.cms.gov/3hwGZ4P. Infographic compiled by AIS Health.

USPS Delivery Slowdown Is Unlikely to Cause Major Rx Fill Disruption

August 31, 2020

The recent, sudden disruption of U.S. Postal Service (USPS) deliveries has caused concern about people receiving their medications later than they normally would. While news reports and statements by lawmakers indicate that many Americans have lost prescriptions in the mail or received them late, drug benefit and supply chain experts say the disruption to the most vulnerable patients served by specialty and mail order pharmacies should be minimal.

An Aug. 24 Axios-Ipsos poll shows that one in five Americans received medication through the mail during the preceding week. One in four of that group, or 5% of Americans overall, didn’t receive their medication or got it late.

By Peter Johnson

The recent, sudden disruption of U.S. Postal Service (USPS) deliveries has caused concern about people receiving their medications later than they normally would. While news reports and statements by lawmakers indicate that many Americans have lost prescriptions in the mail or received them late, drug benefit and supply chain experts say the disruption to the most vulnerable patients served by specialty and mail order pharmacies should be minimal.

An Aug. 24 Axios-Ipsos poll shows that one in five Americans received medication through the mail during the preceding week. One in four of that group, or 5% of Americans overall, didn’t receive their medication or got it late.

In addition, PBMs have not reported significant disruption to their supply chains.

“Most of the drugs shipped from a mail order pharmacy — a non-specialty pharmacy — you worry about them being perishable, but they tend to be pretty stable. They’re oral pills, things like that,” says Mike Schneider, a principal at Avalere Health.

Schneider also suggests that mail order pharmacies’ longer fills, which typically keep shipping costs down by filling for 90 days or more, should insulate patients from major disruptions. He adds that most mail order medication businesses also build logistical complications into their shipping schedules.

Omar Hafez, a principal at Avalere and a former supply chain executive at specialty pharmacy McKesson Specialty Health, says that time- and temperature-sensitive therapies have very specific delivery windows that are mandated by law. He says the strict requirements mean that the bulk of the supply chain for temperature-sensitive specialty drugs is managed by specialized logistics firms, not the USPS.

Schneider says the pharmacy supply chain as a whole has proved remarkably resilient over the course of 2020 — despite the tumult caused by the pandemic and the USPS brouhaha.

“I think a lot of supply chain issues never really materialized, at least not to my knowledge,” Schneider says. “There are a certain drugs that have shortages, but nothing that seemed like it was a national emergency. I think part of the reduced supply might have been everybody was going and filling their prescriptions as the virus was hitting, and everybody was getting some longer-term fills.”

Datapoint: With Truvada Generic Imminent, UnitedHealthcare Stops Covering Descovy

August 26, 2020

UnitedHealthcare, the largest insurer in the U.S., notified members that it will no longer cover Gilead Sciences’ HIV PrEP option Descovy as of September 1. In its stead, generic Truvada will be available at no out-of-pocket cost to members once it launches at the end of September. Descovy currently holds preferred status under the pharmacy benefit for 55% of all covered lives.

UnitedHealthcare, the largest insurer in the U.S., notified members that it will no longer cover Gilead Sciences’ HIV PrEP option Descovy as of September 1. In its stead, generic Truvada will be available at no out-of-pocket cost to members once it launches at the end of September. Descovy currently holds preferred status under the pharmacy benefit for 55% of all covered lives.

SOURCE: MMIT Analytics, as of 8/24/20

Current Market Access to Shingrix

August 21, 2020

Sales of GlaxoSmithKline plc.’s vaccine Shingrix plummeted in 2020, as few people ventured out for vaccination amid the coronavirus pandemic. For the shingles vaccine, more than 75% of covered lives are under the preferred tier/preferred with prior authorization or step therapy and covered tier/covered with PA/ST under the pharmacy benefit across all formularies. Over the last year, the market saw significant shifts in access to Shingrix, with more people getting coverage under commercial and health exchange formularies. The graphics below show how the vaccine is covered among commercial health plans, health exchange programs and Medicare and Medicaid programs, and their utilization management restrictions.

by Jinghong Chen

Sales of GlaxoSmithKline plc.’s vaccine Shingrix plummeted in 2020, as few people ventured out for vaccination amid the coronavirus pandemic. For the shingles vaccine, more than 75% of covered lives are under the preferred tier/preferred with prior authorization or step therapy and covered tier/covered with PA/ST under the pharmacy benefit across all formularies. Over the last year, the market saw significant shifts in access to Shingrix, with more people getting coverage under commercial and health exchange formularies. The graphics below show how the vaccine is covered among commercial health plans, health exchange programs and Medicare and Medicaid programs, and their utilization management restrictions.

NOTES: Under the pharmacy benefit, the covered lives under commercial, health exchange, Medicare and Medicaid formularies are 171.2 million, 10.5 million, 46.7 million and 63.9 million, respectively. Under the medical benefit, the covered lives under commercial, health exchange, Medicare and Medicaid formularies are 169.3 million, 10.5 million, 48.5 million and 63.9 million, respectively.

SOURCE: Managed Markets Insight & Technology, LLC database as of August 2019 and 2020.

Datapoint: Roche Scores NMOSD Nod for Enspryng

August 19, 2020

The FDA last week approved Roche’s Enspryng for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Enspryng will be the third available treatment for the disorder, and will compete with Alexion’s Soliris and Viela Bio’s Uplinza. For the treatment of NMOSD under the pharmacy benefit, Soliris is currently the most advantaged therapy, holding preferred status for 3% of covered lives, growing to 17% with utilization management restrictions.

The FDA last week approved Roche’s Enspryng for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Enspryng will be the third available treatment for the disorder, and will compete with Alexion’s Soliris and Viela Bio’s Uplinza. For the treatment of NMOSD under the pharmacy benefit, Soliris is currently the most advantaged therapy, holding preferred status for 3% of covered lives, growing to 17% with utilization management restrictions.

SOURCE: MMIT Analytics, as of 8/17/20