MVASI Bevacizumab Header Web Silicone free Syringe3


Unit-Dose Repackaged MVASITM Bevacizumab Syringes

 

MVASI™ (bevacizumab-awwb) is now available in the United States. It is an Avastin® biosimilar. Compliance and convenience are now possible with Edge Pharma's unit dose repackaged MVASI™ Bevacizumab in silicone-free syringes.

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MVASI™ Bevacizumab Ophthalmic Injection 

Concentration = 1.25 mg / 0.05 mL
Fill = 0.13 mL
Supplied dosage = 3.25 mg / 0.13mL
Compliant silicone-free syringe

 

Repackaged MVASI™ Bevacizumab Features and Benefits

  • No vial drop-shipping required. Simply log in and order.
  • No contracts required and no minimum orders.
  • Volume discounts and contracted pricing available. Call or email to inquire.
  • Compliant silicone-free syringe.
  • Meet new FDA requirements for subvisible particle testing.
  • Every batch of compounded MVASI™ from Edge Pharma undergoes rigorous sterility, potency, endotoxin, visual inspection, and subvisible particle analysis before release.

 

References

 

1.  Horizontal Blue Cross Blue Shield of New Jersey website: “Medical Policy Updates: Drug Step Therapy for Medicare Advantage Members.”

“Effective January 1, 2021, Horizon BCBSNJ will change the way we process and reimburse claims for certain drugs for patients enrolled in our Medicare Advantage plans based on the following medical policies:

  • Vascular Endothelial Growth Factor Inhibitor and Human Epidermal Growth Factor Receptor Inhibitor”

“Beginning January 1,2021, patients enrolled in our Medicare Advantage plans who are newly prescribed certain brand name drugs (listed below column 2) will, in some cases, be required to first try a Preferred alternative agent (listed below in column 3) to treat his or her medical condition before we will cover another drug for that condition.”

Requested Product Preferred Alternative Agent(s)

Avastin®

Mvasi™, Zirabev®

 

 

 

https://www.horizonblue.com/providers/news/

2. AmeriHealth Website: 

“Effective January 1, 2020, Avastin® and its biosimilars (i.e., Mvasi™, Zirabev™) will be the preferred intravitreal vascular endothelial growth factor (VEGF) products for AmeriHealth members.* We will continue to cover the other intravitreal VEGF products, but they will be approved only for members who have demonstrated failure, contraindication, or intolerance to Avastin or an Avastin biosimilar.”

“Updates to VEGF precertification requirements for ophthalmologic indications

  • Requests for intravitreal Avastin or its biosimilars do not require precertification approval from AmeriHealth.”

https://provcomm.amerihealth.com/

3. UnitedHealthcare Network Bulletin August 2019: Oncology Medication Clinical Coverage

"Policy update Oct. 1, 2019. The policy will be updated to include preferred product coverage criteria for Avastin® (bevacizumab) and Herceptin® (trastuzumab). Preferred product language will be added as follows:"

  • "Use of Mvasi (bevacizumab-awwb) prior to the use of Avastin and other bevacizumab biosimilar products."

https://www.uhcprovider.com/ 

4. According to the Blue Cross Blue Shield of Western New York website: "Drug Therapy Guidelines: Bevacizumab (Avastin® [bevacizumab], Mvasi® [bevacizumab-awwb])"

"Coverage of Avastin or Mvasi is also available for the following ophthalmic indications:"

  • "Neovascular (wet) Age-related macular degeneration (AMD)"
  • "Diabetic Macular Edema (DME)"

https://www.bcbswny.com/ 

5. According to the American Academy of Ophthalmology:

"Avastin® is a drug used to treat wet age-related macular degeneration (AMD). It is also used to treat diabetic eye disease and other problems of the retina. It is injected into the eye to help slow vision loss from these diseases.

Avastin® is the brand name for the drug, which is called bevacizumab. It blocks the growth of abnormal blood vessels in the back of the eye. Those blood vessels can leak and affect vision, causing vision loss from wet AMD and diabetic eye disease.

Avastin® is one of several anti-VEGF treatments that are injected into the eye.

Avastin® was first approved by the Food and Drug Administration (FDA) to treat different types of cancer. Its use to treat eye disease is considered an “off-label” use. The FDA allows “off label” drug use if doctors are well informed about the product and studies prove the drug is helpful."

From www.aao.org/eye-health/drugs/avastin

"Bevacizumab (Avastin) is widely used off-label for treating neovascular ophthalmic diseases. Approval of the biosimilar [MVASI™], which will carry the generic name bevacizumab-awwb, was based on evidence from 2 comparative clinical trials as well as extensive structural and functional characterization."

https://www.aao.org/

6. Specialty Guideline Management -- AVASTIN (bevacizumab), MVASI (bevacizumab-awwb)

"The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy."

Section B.7.b: "Neovascular (wet) age-related macular degeneration (AMD)""

https://provider.carefirst.com/ 

7. Clinical Policy: Bevacizumab (Avastin, Mvasi)

"It is the policy of health plans affiliated with Centene Corporation® that Avastin and Mvasi are medically necessary when the following criteria are met."

Section I.C.1.a: "Neovascular (wet) age-related macular degeneration"

https://www.superiorhealthplan.com/

 

 

Literature Reviews

 

Avastin® Biosimilars

Biological products – used to diagnose, prevent, treat, and cure diseases and other medical conditions – are the fastest growing class of therapeutic products in the U.S., according to the Food and Drug Administration.(1) Biologics include vaccines and medications for a wide range of medical conditions including rheumatoid arthritis, multiple sclerosis, diabetes, infertility, cancers, and age-related macular degeneration.

Biosimilars are drugs that are highly similar to a biologic. The FDA recognizes biosimilars and stipulates that biosimilars must be expected to produce the same clinical result as the original biologic, which is referred to as the reference product. Biosimilars must be able to be alternated with the reference product without increasing risk to the patient.(1) Increasingly, some health insurance companies are informing providers and patients of their preference for biosimilars.(2,3,4)

For age-related macular degeneration, the biologic Avastin® is used off label to block the growth of abnormal blood vessels in the back of the eye. The leaking of these bloods vessels leads to vision loss, according to the American Academy of Ophthalmology.(5) At this point, there is generally health insurance coverage for the use of Avastin® in intravitreal injections, but the momentum to move to biosimilars across all uses is evident.(2,3,4)

There are now two FDA-approved biosimilars for Avastin®, Zirabev® (bevacizumab-bvzr) and Mvasi™ (bevacizumab-awwb). Edge Pharma offers repackaged Mvasi™ 1.25mg/0.05mL concentration with 0.13mL fill in a pre-filled silicone free syringe. Edge does not require drop-shipping of bevacizumab vials.


(1) U.S. Food and Drug Administration, Biosimilars, https://www.fda.gov/drugs/
(2) Quartz Health Solutions, New Policies for Biologics with Biosimilars, https://quartzbenefits.com/
(3) UnitedHealthcare Network Bulletin, August 2019: Oncology Medication Clinical Coverage, https://www.uhcprovider.com/
(4) Blue Cross Blue Shield, Western New York, Drug Therapy Guidelines: Bevacizumab (Avastin® [bevacizumab], Mvasi® [bevacizumab-awwb] https://www.bcbswny.com/
(5) Turbert, D., Vemulakonda, G. M.D. (reviewer) American Academy of Ophthalmology, What is Avastin, https://www.aao.org/eye-health/drugs/avastin

 

Age-Related Macular Degeneration

Age-related macular degeneration is the leading cause of vision loss and blindness for Americans over the age of 65, according to the Centers for Disease Control.(1) There are two forms of age-related macular degeneration, “dry” and “wet.” Wet age-related macular degeneration is the more advanced and serious form of macular degeneration. It is often treated with anti-VEGF drugs that are injected into the eye, which stops bleeding and leaking from blood vessels into the back of the eye.(2)

Avastin® (bevacizumab) is often used to manage wet age-related macular degeneration. It is used off-label for this purpose.(3) “In 2016, the American Society of Retina Specialists reported presumed silicone oil droplets associated with intravitreal bevacizumab injected using insulin syringes.”(3) The medicine does not contain the silicone, rather the silicone oil is a lubricant in the syringe.(4)

A study published in a major medical journal examined 6632 intravitreal bevacizumab injections. The syringe used for all injections was an insulin syringe with a 31-gauge Ultra-Fine Short Needle, manufactured by Becton Dickinson. There were 60 cases of silicone droplets identified in patients. Of those cases, symptoms included “floaters with spots of light.” The study concluded, “Physicians should counsel their patients on the risk of floaters with intravitreal bevacizumab preloaded in insulin syringes. Using syringes that do not contain silicone oil for lubrication may minimize this complication.”(3)

In 2018, Becton Dickinson, the world’s largest manufacturer of syringes, sent a letter to the attention of “Compounders, including 503B Outsourcing Facilities and Pharmacies, the American Academy of Ophthalmology, and the American Society of Retina Specialists.” The letter stated, “BD has become aware that its insulin syringes are being used for intraocular injections. Adverse events associated with ‘floaters’ have been reported when insulin syringes are used for intraocular injections. BD Insulin syringes are intended for subcutaneous injection of insulin and have only been tested and validated for this intended use.”(5) 


(1) Centers for Disease Control, Learn About Age-Related Macular Degeneration, https://www.cdc.gov/
(2) National Eye Institute, Age-Related Macular Degeneration, https://www.nei.nih.gov/
(3) Khurana, R. M.D., Change, L. M.D., PhD, Porco, T. PhD, Journal of the American Medical Association/Ophthalmology, Incidence of Presume Silicone Oil Droplets in the Vitreous Cavity After Intravitreal Bevacizumab Injection with Insulin Syringes, https://jamanetwork.com/
(4) Kinker, B. M.D., JD, Tewari, A. M.D., Tosi, J., JOJ Ophthalmology, Intravitreal Silicone Oil Droplets after Multiple Avastin Injections, https://juniperpublishers.com/
(5) Letter from Becton Dickinson, Important Product Information BD Insulin Syringes, http://www.ncbop.org

 

White Paper

Review of Published Clinical Studies Investigating the Use of Bevacizumab Biosimilars in Ophthalmology:

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