Coverage from the Academy of Managed Care Pharmacy Nexus 2021 meeting, held in Denver, Colorado.
During her October 20 presentation at the Academy of Managed Care Pharmacy Nexus 2021 meeting, Aimee Tharaldson, PharmD, senior clinical pharmacist of emerging therapeutics at Express Scripts, highlighted the most anticipated specialty pharmacy drugs awaiting FDA approval, which include several treatments for cancer and rare diseases as well as gene therapies.
Tharaldson identified the specialty medications that are expected to receive FDA approval or new indications in the next 12 months and reported on the likely effect that new specialty medications will have in the managed
At the time of Tharaldson’s presentation, 31 specialty drugs had been
approved in 2021, with 8 more expected to be approved by the end of the year. If this schedule holds, it will rival the 39 approvals that were given in 2020. Biosimilars A big topic of discussion was the potential for biosimilars, which represents a $61-billion opportunity for manufacturers. By 2025, 98 patent expirations are anticipated, including those for Humira (adalimumab), Stelara (ustekinumab), Eylea (etanercept), and Prolia (denosumab).
Tharaldson mentioned 13 biosimilars that are pending approval, including
some referencing Humira, Avastin (bevacizumab), Neupogen (filgrastim),
Novolog (insulin aspart), Neulasta (pegfilgrastim), and Lucentis (ranibizumab).
Tharaldson discussed how approximately 17 million Americans have a history
of cancer and nearly 2 million new cases of cancer are diagnosed each year. In 2020, 19 cancer drugs were approved, which was a new record in approvals. So far, in 2021, 15 have been approved, with 2 more expected to receive approval by the end of November 2021.
Tharaldson mentioned that 6 new cancer drugs are expected to be approved
during the first quarter of 2022 to treat neuroendocrine tumors, uveal melanoma, chronic myeloid leukemia, melanoma, chronic lymphocytic leukemia, and non–small cell lung cancer.
As of October 2021, 9 of the drugs approved during the year were indicated for orphan conditions. Among all drugs currently in the specialty drug pipeline, 47% are indicated for orphan conditions, compared with 31% for oncology and 22% for other conditions.
Gene therapies involve the modification of a person’s genes to treat or cure a disease. Tharaldson said that about 400 gene and cell therapies are in the pipeline and that the market is expected to generate $25 billion per year by 2034. Nine gene therapies have been approved between 2010 and 2021, and 9 more are expected to receive approval by 2022, including Janssen’s ciltacabtagene autoleucel, which was on schedule to receive approval in late November 2021.
The inflammatory pipeline currently contains 8 drugs, 4 of which have already been approved but are expected to get new indications forpsoriatic arthritis, ankylosing spondylitis, Crohn disease, and alopecia areata. Additionally, the approval for the psoriasis medication bimekizumab, which was anticipated in 2021, was deferred due to the manufacturer, UCB, receiving a complete response letter from the FDA requiring them to do additional testing.
Tharaldson explained that the atopic dermatitis pipeline through 2023 has 7 drugs pending approval, 4 of which will be administered orally and 3 subcutaneously.
Through 2025, the multiple sclerosisspace is expected to have approvals for
5 new medications, 4 of which are orally delivered Bruton tyrosine kinase
inhibitors. The outlier, ublituximab, is expected to be approved in 2022 and is
the only anti-CD20 monoclonal antibody currently in the pipeline.
Tharaldson said that 95% adherence is needed to maintain viral suppression
of HIV, which is why the most frequently used medications rely on daily intake.
However, ViiV Healthcare is looking to get an updated approval for its cabotegravir/rilpivrine combination to be administered every 2 months instead of every 1 month, which is expected in December 2021.
Of the 5 products awaiting approval, all are for injectable formulations, with
the exception of islatravir by Merck, which is delivered orally and is expected to be approved in 2022.
Nonalcoholic steatohepatitis (NASH)
NASH is estimated to impact between 6 and 19 million Americans, according
to Tharaldson, and treatment options are limited. The treatment space is
expected to grow substantially in the coming years, with 13 products awaiting approval between 2023 and 2024. Eventually, the NASH therapeutic market is expected to generate $20 billion per year as the treatment space grows.
The Alzheimer disease pipeline currently has 5 drugs awaiting approval, with
3 anti–amyloid-beta antibodies expected to be approved in 2022 or 2023 and 2 anti-tau antibodies expected to be approved in 2024, stated Tharaldson.
Alzheimer disease is estimated to affect 6.2 million Americans. Although Aduhelm (aducanumab-avwa) was approved in June 2021, the approval has drawn a large amount of controversy; data have revealed the
possibility that the drug does not work as well as previously disclosed.
Tharaldson highlighted 9 drugs that are expected to receive FDA approval
between 2022 and 2023: 5 are indicated for just hemophilia A, 2 for just
hemophilia B, and 2 for both hemophilia types A and B. The 2 drugs indicated for both hemophilia A and B are delivered through subcutaneous injection; the others all are administered through intravenous infusion. Hemophilia A is the most common type of hemophilia, estimated to account for about 80% of hemophilia cases.
Payers were found to be more accepting of biosimilars than expected,
according to survey results presented during a panel discussion at the Academy of Managed Care Pharmacy’s 2021 Nexus meeting.
The panel discussed the current trajectory of biosimilar adoption, barriers
to adoption, and how coverage of biosimilars is anticipated to evolve in
the coming years.
Tasmina Hydery, PharmD, MBA, BCGP, assistant director of integrated
delivery solutions at AmerisourceBergen/Xcenda, talked about the anticipation surrounding the launches of the 6 FDA-approved adalimumab biosimilars, which are scheduled to enter the US market in 2023, and the interchangeable formulation of Semglee (insulin glargine), the first interchangeable biosimilar to be approved in the United States.
Hydery mentioned that reactions to the potential for interchangeable
biosimilars have been positive; however, states have enacted their own laws,
which has caused confusion among payers, patients, and providers on whether interchangeability designations will have an impact.
“Some FDA leaders have noted that there’s potential for cost savings, there’s
more competition in the marketplace, and now there’s potentially more access to affordable products. But others are speculating whether this will actually translate into uptake and how important it is to educate pharmacists about the different state laws and how pharmacies will actually operationalize the availability of the interchangeable biosimilars,” said Hydery.
Another challenge for biosimilar uptake concerns patent thickets, which Congress is working to address, according to Hydery. She said that by limiting the number of continuation and divisional patents that can be filed for a single patent and capping the number of patents that could be asserted against a biosimilar product, Congress could prevent future patent thickets.
Cate Lockhart, PhD, PharmD, MS, executive director of the Biologics and
Biosimilars Collective Intelligence Consortium, delved into the existing
research on coverage, adoption, and utilization patterns of biosimilars, saying that survey results show that among 17 of the largest commercial health plans in the United States, only 14% cover biosimilars as preferred products.
Lockhart also explained how the filgrastim biosimilar Zaxio (filgrastim-sndz) is listed as a preferred product on coverage plans 51% of the time, a figure much higher than those for infliximab-abda and infliximab-dyyb (0% and 5%,
respectively). Additionally, she said that although biosimilar uptake has been slow, regression models estimate that the market share of reference products would decline by about 0.38% to 0.46% for each month a biosimilar is available.
However, despite uptake being on the rise, only 35% of payers are continuing to cover all biosimilars, according to Jennifer Snow, MPH, vice president of reimbursement policy insights at AmerisourceBergen/Xcenda. Health plans (48%) and pharmacy benefit managers (22%) were most likely to cover all biosimilars whereas 100% of integrated delivery networks surveyed said they cover only some biosimilars.
Overall, Snow said that 59% of payers agreed that biosimilars have provided their organization with meaningful cost savings. Most surveyed payers said that they contract with biosimilar manufacturers for select biosimilars and that they would cover the biosimilar for the same indications as the reference product (75% and 55% respectively), regardless of whether the indications were approved by the FDA.
Snow proclaimed that the statistics that surprised her most were that
96% of the surveyed payers agreed that biosimilars are safe and effective for
treatment-naive patients and that 92% agreed that switching to a biosimilar
from a reference product was safe and effective. Cost savings were also cited as the most important factor driving the adoption of biosimilars; 65% of payers ranked it as their top influencing factor, followed by 27% who chose interchangeability status as their top influencing factor.
Lockhart noted Kaiser Permanente’s success in achieving substantial
biosimilar uptake, achieving a 95% utilization rate for filgrastim-sndz and 80% rate for infliximab-dyyb, both much higher than the national average (32% and 3%, respectively). Lockhart said they were able to achieve such numbers by adopting the biosimilars shortly after they received FDA approval.
Finally, Lockhart explained that despite biosimilar adoption having a slow
start, the United States is starting to see increased utilization, with shorter lag
times between approval and launch. Additionally, many managed care settings are seeing success by implementing strategies to encourage biosimilar use; they anticipate biosimilars covered by pharmacy benefits and are identifying potential formulary strategies.
“There’s a lot of hope and a lot of people who I think are really invested in doing this, because we want patients to get access to the medications they need at a cost they can afford. And we’ve seen some successes with that,” said Lockhart.