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Key takeaways:
Current biosimilar market dynamics may be confusing and seem to put biosimilars at a perceived disadvantage against their originator biologics. The first biosimilars to enter the market were covered by medical benefit plans, but recently approved biosimilars are covered by pharmacy benefit plans. This has created additional pricing complexities, formulary decisions and contracting challenges, which may result in pharmacy benefit managers (PBMs) not preferring them.
Issues with getting access to formularies are considered one of the largest obstacles to biosimilar adoption in the U.S.2 Some payers may only include a few biosimilars on their formularies. Originator manufacturers who are looking to keep their high market share may offer PBMs list price discounts that deter entry by lower-priced drugs and block patient access to these competitors.3
For biosimilars and, more importantly, patients to benefit, payers must promote access. Increased competition will drive sales prices down and deliver savings to the broader system.1 When biosimilars are listed at parity with the brand biologic on formularies, patients and the healthcare system cannot realize the potential benefits.
Payers should evaluate the incorporation of biosimilars into formularies based on numerous factors, including product characteristics and evidence, manufacturer supply, dosage-form suitability for the covered population, and the economic impact on payers and patients.1,4
Lack of payer support or limiting access to biosimilars will create slower uptake and could have an impact on the development of future biosimilars.
Learn more about the key considerations for biosimilars with each of the following groups.
To learn more about the promise of biosimilars, the impact they can create, and our work in this space, visit the following pages:
1. Rifkin; Peck. Biosimilars: Implications for clinical practice. J Oncol Pract 2017;13(9_suppl):24s-31s.
2. Joszt L. Employers face barriers with adopting biosimilars. Formulary Watch. March 1, 2022. https://www.formularywatch.com/view/employers-face-barriers-with-adopting-biosimilars.
3. Arad N, Staton E, Hamilton-Lopez M, et al. Realizing the benefits of biosimilars: Overcoming rebate walls. Margolis Center for Health Policy. March 9, 2022. https://healthpolicy.duke.edu/publications/realizing-benefits-biosimilars-overcoming-rebate-walls.
4. Singh SC, Bagnato KM. The economic implications of biosimilars. Am J Manag Care. 2015;21(16 suppl):S331–S340.
Do not use CAMCEVI® in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI as anaphylactic reactions to these drugs have been reported in the medical literature.
CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. As with other GnRH agonists, cases of ureteral obstruction and spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications.
Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy.
Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice.
Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients should be monitored for cardiovascular disease and be managed according to current clinical practice.
Androgen deprivation therapy may prolong the QT/QTc interval. Consider periodic monitoring of electrocardiograms and electrolytes.
Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Patients experiencing convulsions should be managed according to the current clinical practice.
Monitor serum levels of testosterone following injection of CAMCEVI.
Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women.
The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
Click here for full Prescribing Information.
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