UnitedHealthcare gives biosimilars preferred formulary status.

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Aug. 23, 2019

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Editor’s Note: The policy world has entered the dog days of summer (no offense to dogs.) We will not be publishing Health Policy Weekly for 2 weeks, which only guarantees there will be nonstop action starting Monday. Enjoy the last days of cookouts and time at the pool—see you after Labor Day.

 
FEATURED STORY
 

The Price Is Right: UHC Adds 2 Biosimilars as Preferred Formulary Products

 
 

This week, UnitedHealthcare (UHC) announced that its commercial and community plans are giving preferred formulary status to 2 new biosimilars. Starting October 1, use of Amgen’s MVASI (bevacizumab awwb) and KANJINTI (trastuzumab-anns) will be preferred over their reference products (Genentech’s AVASTIN [bevacizumab] and HERCEPTIN [trastuzumab], respectively).

However, this policy is limited to those specific biosimilars, as UHC indicated the other 5 Food and Drug Administration (FDA)-approved AVASTIN and HERCEPTIN biosimilars, not yet on the market, will not be preferred products. Both MVASI and KANJINTI launched mid-July at a 15% lower price point compared to the original branded products.

UHC also kept ZARXIO (filgrastim) as a preferred option over GRANIX (tbo-filgrastim), NEUPOGEN (filgrastim), and NIVESTYM (filgrastim-aafi). As more biosimilar products come to the market, contracting will become increasingly important. Using biosimilars as preferred products will likely push utilization up and make prescribers more familiar (and comfortable) with biosimilars, thus shaping adoption for future biosimilars.

 
 

Ensuring Access to Meds Remains a Moving Target

 
 

Learn what Health Policy Weekly’s Editor-in-Chief Jennifer Snow had to share with Pharmacy Practice News about the added pressure on patient assistance foundations and patient representatives to help patients cover their medications.

Read article >

 

 

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LEGISLATIVE UPDATE
 

Congress on Recess

 
 

Congress is on recess and will reconvene after Labor Day (unless Senate or House leadership calls back their chambers).

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THE VALUE CORNER
 

VAF and FDA: Games of Big Bucks and Hopefully No Whammies

 
 

Last week, the Institute for Clinical and Economic Review (ICER) announced the publication of its Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and value of 3 treatments for Duchenne muscular dystrophy (DMD): 2 exon-skipping therapies—EXONDYS 51 (eteplirsen) and golodirsen—as well as the corticosteroid EMFLAZA (deflazacort). The report was not kind to any of the treatments. A few days later, the manufacturer of both exon-skipping therapies, Sarepta, announced it received a “surprising” Complete Response Letter from the FDA denying the approval of golodirsen over concerns about the risk of infections and kidney toxicity seen in early clinical trials. Sarepta is expected to meet with the FDA to discuss these issues and possibly negotiate a black box warning.

Additionally, ICER announced the release of proposed changes to its 2020 Value Assessment Framework (VAF) on Wednesday. Stay tuned for the next Value Corner article with details outlining the recommendations. In the meantime, registration is open for patient organizations and the general public to attend a webinar on September 4. The full timeline for this initiative is available on ICER’s website.

This week, the Journal of Clinical Pathways published several commentaries related to VAFs, 2 of which discussed the importance of transparency and inclusion of the patient voice. In particular, Dr. Surabhi Dangi-Garimella’s viewpoint suggests that the Innovation and Value Initiative (IVI) addresses these concerns through its Open-Source Value Platform (OSVP) by incorporating patient-level simulation. In a counterpoint, Drs. Tom Valuck and Matthew Castner argue that although IVI’s work in open-source development is promising, the approach may be problematic as there is no established consensus on the definition of value. Nevertheless, the authors agree that a commitment to transparent, patient-centered processes is especially important to consider as these VAFs evolve.

As always, if you need assistance with all things ICER or value-related, please contact Kristen.Migliaccio@xcenda.com.

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REGULATORY UPDATES
 

Who Wants To Be a Millionaire? CMS Saves $7 Million in Part B

 
 

The Office of Inspector General (OIG) recently released an annual report showing that Medicare and its beneficiaries saved $7 million over 1 year by substituting average manufacturer price (AMP)-based drug payments for average sales price (ASP)-based drug payments for 14 drugs based on 2017 comparison data. The report also made recommendations for achieving additional savings for Medicare Part B drugs.

Medicare generally pays for Part B drugs at 106% of ASP. Most manufacturers report both ASP and AMP quarterly to the Centers for Medicare & Medicaid Services (CMS). The Social Security Act mandates the OIG make quarterly ASP-to-AMP comparisons and then directs the Secretary of Health and Human Services (HHS) to pay for a drug based on the lower AMP calculated rate (103% of AMP) if the ASP for the drug exceeds the AMP by 5%.

Through regulation, CMS currently implements this substitution only if the ASP for a drug exceeds the AMP by 5% in the 2 previous quarters or 3 of the previous 4 quarters. Instances when CMS does not make price substitutions include when: 1) partial AMP data are submitted; 2) the AMP-based payment amount is greater than the ASP-based payment amount on their respective effective dates; or 3) the FDA has identified a drug as being in short supply. The price substitutions that CMS does make are implemented in the quarter after the OIG shares the results of its most recent ASP-AMP pricing comparison and remain in effect for 1 quarter.

The OIG identified an additional potential savings of $2.9 million from 18 drugs with complete AMP data if CMS were to expand its price-substitution criteria to include drugs that exceeded the 5% threshold in a single quarter. The OIG also suggested CMS could exclude substitution when the AMP-based payment was below provider acquisition costs to maintain drug access. CMS will consider future changes as it gains experience with the price-substitution policy. For now, CMS believes its policy continues to safeguard access to most drugs while not overpaying for those that meet the criteria. However, one can question the value of such a practice, along with the expenses of reporting on it.

 

Information Buffet (AKA, Other Stuff That Caught Our Attention)

 
 

We kept running into stories we wanted to bring to your attention, so here’s a quick hit list of other news we thought you should know:



 

Live Webinar: Achieve Better Patient Outcomes With Clinically Supported, Tech-Enabled Adherence Programs

 
 

Thursday, August 29 | 11:00 AM ET / 8:00 AM PT

At Lash Group, we believe keeping the patient at the center of a support program is essential to improving adherence.

Join Lash Group leadership—Michael A. Craig, Vice President, Market Development and Strategy, and Dale Hanna, Product Director, Adherence Services—to discuss why clinical expertise and teams trained in empathy are critical components of tech-enabled support solutions—and how this combination can transform outcomes.

Register today >

 

 
 
HEARD ON THE STREET
 

“Of course it would be. How are you going to get it passed? I think that we should focus on improving Obamacare. We can do that—without bringing something that would be much harder to sell. Improving Obamacare: People understand that. They would appreciate that. It locks in many important things.”

– Former Senate Majority Leader Harry Reid’s (D-NV) response when asked if he thought supporting Medicare for All would be problematic in the 2020 general election

Source: “EXCLUSIVE: Harry Reid: ‘Of Course’ Medicare for All and Decriminalizing Border Crossings Are Bad Ideas,” VICE News, August 20

 
POLICY BY NUMBERS
 

37% vs 66%

 

The overall number of pre-emptive kidney transplants covered by Medicaid has increased by 37% in states that did not expand Medicaid and by 66% in states that did expand Medicaid.

Source: “Kidney Transplants Covered by Medicaid Increased in States After Medicaid Expansion,” Journal of General Internal Medicine, August 20

 
UPCOMING MEETINGS & CONFERENCES
 

Live Webinar: Achieve Better Patient Outcomes With Clinically Supported, Tech-Enabled Adherence Programs

Thursday, August 29 | 11:00 AM–12:00 PM ET
Join Lash Group leadership—Michael A. Craig, Vice President, Market Development and Strategy, and Dale Hanna, Product Director, Adherence Services—to discuss why clinical expertise and teams trained in empathy are critical components of tech-enabled support solutions—and how this combination can transform outcomes. Register today

 

AMCP Nexus 2019

October 29November 1 | National Harbor, MD
Xcenda and Dymaxium are proud to join managed care colleagues in National Harbor, MD for 4 days that spotlight the innovative practices currently impacting the managed care and healthcare community. Join us a booths #311 and #313. Learn more

 
 
 

Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.

 
 
 
 
 
FEATURED CONTRIBUTORS
 

EDITOR-IN-CHIEF:
Jennifer Snow
Vice President,
Reimbursement and
Policy Insights,
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Doug Cook
President | Commercialization Services & Animal Health

Kristine Flemister, PharmD
President | Xcenda

Tommy Bramley, PhD, RPh
President | Lash Group

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

Rita Norton
Senior Vice President | Government and Public Policy | AmerisourceBergen Corporation

Ana Stojanovska
Vice President | Commercial Consulting | Xcenda

CONTRIBUTING AUTHORS:

Milda Kaitz | Isabell Kang | Anne Loos | Scott Shields

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Aug. 23, 2019

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