First in class, biosimilars, oncology drugs and even some generics have been added to Optum Rx’s list of exclusions for 2024.
Optum Rx has added more than 50 products — including both branded and generics — to the exclusion list for the 2024 Premium Formulary. Several of these are therapies that have been approved over the last few year and Optum Rx does not provide alternatives.
While the company would not comment on specific products that have been removed from the formulary, a spokesperson said Optum Rx designs formularies to optimize lowest cost of care with use of generic or therapeutic equivalent products, use of biosimilars, and medications that do not have a significant safety concern or minimal therapeutic benefit.
“Optum Rx promotes high-quality, cost-effective formulary design and management by basing formulary decisions on clinical quality, choice, and lowest cost of care,” the spokesperson said. “Our pharmacy and therapeutics Committee comprised of practicing physicians and pharmacists provides unbiased, evidence-based review and appraisal of new drugs, existing drugs and their place in therapy, also reviews utilization management programs and oversees clinical programs.”
Among those excluded are new products that are first-in-class therapies — Rebyota to prevent Clostridioides difficile (C. diff) infections, Tzield for diabetes and Camzyos for hypertrophic cardiomyopathy. Optum Rx does not provide an alternative option for these treatments. (Editor's note: Since the formulary list was released, Optum Rx has made changes, including no longer excluding Reybota, according to a company spokesperson.)
Rebyota (fecal microbiota, live – jslm) is the first microbiota product to prevent the recurrence of C. diffinfection. Launched in February 2023, Rebyota is indicated for use in people 18 years of age and older. It was developed by Rebiotix, a Ferring Pharmaceuticals company, and is administered rectally as a single dose. The list price is about $9,487 for a supply of 150 milliliters, according to Drugs.com.
Rebyota was found to be cost-effective compared with standard of care in preventing recurrent C. diff., according to an analysis published in Advances in Therapy. This study found that Rebyota improved quality of life, decreased healthcare resource utilization, and lower medical costs and had an incremental cost-effectiveness ratio of $18,727 per quality-adjusted life year (QALY) gained, well below the cost-effectiveness threshold of $100,000 per QALY gained.
Another newer innovative drug is Tzield (teplizumab-mzwv) that Optum Rx has excluded. It was approved by the FDA in November 2022 and it is the first immunotherapy for type 1 diabetes that delays the need for insulin. It is indicated for adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. Tzield is anti-CD3-directed antibody and was developed by Provention Bio, which was acquired by Sanofi in April 2023. Tzield launched with wholesale acquisition cost of $13,850 per vial for 14-day treatment course list price of $193,900.
Another first-in-class therapy excluded from Optum Rx’s formulary is Camzyos (mavacamten), which was approved in April 2022 to treat adults with obstructive hypertrophic cardiomyopathy (HCM), a condition that causes thickening of the heart muscle. There is no cure for hypertrophic cardiomyopathy.
Developed by Bristol Myers Squibb, Camzyos addresses the excessive contraction of the heart that leads to severe disease where the blood flow is obstructed. At the time of launch, the wholesale acquisition cost was about $89,500 a year.
Additionally, beginning in January 2024, Optum Rx has also excluded from coverage an older cancer drug that is considered the therapy of choice for non-small cell lung cancer: Xalkori (crizotinib), which was first approved in 2011, treats several cancers with specific mutations. Developed by Pfizer, Xalkori is approved to treat ALK- or ROS1-positive non-small cell lung cancer and ALK-positive large cell lymphoma in children and young adults. It was also approved in 2022 to treat patients with ALK-positive myofibroblastic tumors, a rare cancer of the immune cells.
Additionally, Optum Rx excluded certain dosages of generics, such as metformin 625 mg for diabetes and venlafaxine ER 112.5 mg for depression. Based on the dosages the formulary suggests as alternatives, it would be difficult to reach metformin 625 mg and venlafaxine ER 112.5 mg without splitting pills.
In terms of biosimilar coverage, Optum Rx favors the biosimilar Cimerli and compounded bevacizumab over Lucentis or Byooviz, another biosimilar, for macular degeneration. The FDA approved Cimerli (ranibizumab-eqrn) in August 2022 as a biosimilar product interchangeable with Genentech’s Lucentis (ranibizumab). Developed by Coherus BioSciences, Cimerli is available in both 0.3 mg and 0.5 mg dosages and will be interchangeable for all of Lucentis’s indications, including neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
Cimerli launched with a list price of $1,360 for the 0.5 mg dose single-use vial and $816 for the 0.3 mg dose vial. Byooviz, another Lucentis interchangeable biosimilar Byooviz launched in June 2022 with a list price of $1,130 per 0.05 mg single use vial to be administered by injection to the back of the eye. Avastin is a therapy that has been approved to treat patients with several cancers, but it is used off-label to treat eye diseases.
In terms of coverage for the autoimmune therapy Humira (adalimumab), Optum Rx has excluded several biosimilars, including: Adalimumab-fkjp, Hadlima, Hulio, Idacio, Yuflyma and Yusimry. In June 2023, Optum Rx had indicated that it would offer access to three biosimilars of the blockbuster It treats patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. The three that will be offered include:
* Sandoz’s Hyrimoz and adalimumab-adaz, both high concentration treatments, their high-list and low-list products, respectively.
* Boehringer Ingelheim’s Cyltezo, the first interchangeable biosimilar, and its low-list price version, adalimumab-adbmn.
* Amgen’s Amjevita, both high-list and low-list versions, which were added earlier this year.
Optum Rx will include these biosimilars on the standard formulary on parity with Humira. All four products will be on Tier 2 of standard formularies with prior authorization required and quantity limits upon launch, an Optum Rx spokesperson had said previously.
Separately, Optum Rx announced it will shift eight insulin products to tier one, or preferred status on standard formularies. Three manufacturers will have products added to tier one, including Eli Lilly, Novo Nordisk and Sanofi. Today more than 70% of people who use Optum Rx already pay less than $35 per month on insulin. Effective Jan. 1, 2024, 98% of all Optum Rx consumers will have access to insulin for $35 or less per month.
In total, 170 medications are part of the Optum Rx Critical Drug Affordability program that includes a recommended cost share of $35 or less for consumers.