Mandatory Drug Wastage Program

Description:
This policy provides information around establishing a procedure for therapeutically appropriate, and cost-effective dose optimization of certain weight-based or body surface area (BSA) based infused medications. It requires dose rounding (i.e. reduction) for infused drug products to the nearest next lowest vial size if within +/- 10% of the original prescribed dose. This effort seeks to reduce the potential for errors in drug administration and decrease drug wastage across all drug products noted below.

This medical policy will apply to the following drugs:

• • Nab-paclitaxel (Abraxane)
  • Tocilizumab (Actemra)
  • Crizanlizumab (Adakveo)
  • Brentuximab vedotin (Adcetris)
  • Pemetrexed (Alimta)
  • Bevacizumab (Avastin)
  • Infliximab-axxq (Avsola)
  • Belimumab (Benlysta)
  • Inotuzumab ozogamicin (Besponsa)
  • Imiglucerase (Cerezyme)
  • Daratumumab (Darzalex)
  • Fam-trastuzumab deruxtecan (Enhertu)
  • Cetuximab (Erbitux)
  • Givosiran (Givlaari)
  • Trastuzumab (Herceptin)
  • Infliximab-dyyb (Inflectra)
  • Gemcitabine (Infugem)
  • Cabazitaxel (Jevtana)
  • Ado-trastuzumab emtansine (Kadcyla)
  • Alglucosidase (Lumizyme)
  • Bevacizumab awwb (Mvasi)
  • Gemtuzumab ozogamicin (Mylotarg)
  • Irinotecan liposomal (Onivyde)
  • Patisiran (Onpattro)
  • Trastuzumab-dttb (Ontruzant)
  • Enfortumab vedotin (Padcev)
  • Polatuzumab (Polivy)
  • Luspatercept (Rebloyzl)
  • Infliximab (Remicade)
  • Infliximab-abda (Renflexis)
  • Rituximab (Rituxan)
  • Rituximab-pvvr (Ruxience)
  • Isatuximab-irfc (Sarclisa)
  • Golimumab (Simponi ARIA)
  • Teprotumumab-trbw (Tepezza)
  • Sacituzumab govitecan (Trodelvy)
  • Rituximab-abbs (Truxima)
  • Panitumumab (Vectibix)
  • Elosulfase (Vimizim)
  • Ipilimumab (Yervoy)
  • Ziv-aflibercept (Zaltrap)
  • Bevacizumab-bvzr (Zirabev)

Policy:

I. Dose rounding for infused drug products to the nearest next lowest vial size if within +/- 10% of the original prescribed dose will be required unless the following medical necessity criteria are met:

• Provider indicates recommended dose may result in suboptimal outcome due to one of the following:
  • Member’s age is less than 18 years of age
  • Member is partially responsive to the exact prescribed dose
  • Member previously demonstrated a suboptimal response to a lower rounded down dose
  • Member has a history of rapidly fluctuating body weight (i.e., weight gain of at least 10% body weight in a one month time period within the past 6 months)
  • Member is clinically unstable and at high risk for hospitalization if the requested mediation produced a suboptimal response
  • Member is being treated for an oncology indication with a curative goal (i.e., adjuvant, neoadjuvant)
  • Laboratory values indicate that a dose reduction will result in a suboptimal response

II. All other reasons not referenced in this policy are not considered medically necessary.

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References:
1. Fahrenbruch R, Kintzel P, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. American Society of Clinical Oncology. March 2018. Volume 14, Issue 3. Jop.ascopubs.org

2. Park JJ, Boutillier L, et al. Effect of Standardized Infliximab Dose Rounding on an Outpatient Infusion Center. Journal of Managed Care & Specialty Pharmacy. October 2018. Vol. 24, No. 10. www.jmcp.org.

3. IPD Analytics. RxBrief: Oncology. Oncology Management: Dose Rounding and Weight-Based Dosing. September 2020.

4. Vandyke TH, Athmann PW, Ballmer CM, Kintzel PE. Cost avoidance from dose rounding biologic and cytotoxic antineoplastics. J Oncol Pharm Pract. 2017 Jul;23(5):379-383. doi: 10.1177/1078155216639756. Epub 2016 Mar 21. PMID: 27000279.

5. Dooley MJ, et al. Implications of dose rounding of chemotherapy to the nearest vial size. Support Care Cancer. 2004 Sep;12(9):653-6. doi: 10.1007/s00520-004-0606-5

6. Buckley, B. Dose Rounding A Hedge Against High Cancer Cost. Clinical Oncology News. September 9, 2020. https://www.clinicaloncology.com/Current-Practice/Article/05-20/Dose-Rounding-A-Hedge-Against-High-Cancer-Cost/59426

7. Canadian Agency for Drugs and Technologies in Health. CADTH technology review: optimal use 360 report: dosing and timing of immuno-oncology drugs. Published online November 2019. Accessed September 23, 2020. https://www.cadth.ca/sites/default/files/ou-tr/ho0008-dosing-timing-immuno-oncology-drugs.pdf

8. Bennett, C. Drug Costs: Putting Oncologists in the Driver’s Seat. OBR Journal. July 2019, Vol. 11, Issue 7. https://obroncology.com/article/drug-costs-putting-oncologists-in-the-drivers-seat/

9. Smith SM. Targeting Oncology Medications for Dose Rounding. Pharmacy Purchasing & Products Magazine. November 2019, Vol 16, No 11. Page 26. https://www.pppmag.com/article/2474

10. Francis SM, Heyliger A, Miyares MA, Viera M. Potential cost savings associated with dose rounding antineoplastic monoclonal agents. Journal of Oncology Pharmacy Practice. 2015;21(4):280-284. doi:10.1177/1078155214533369

11. Ibrahim N (2018) Global Initiative to Establish and Implement Dose Rounding Policy for Expensive Cancer Therapy . J Pharma Care. Health Sys 5: e147. doi:10.4172/2376-0419.1000e147. https://www.longdom.org/open-access/global-initiative-to-establish-and-implement-dose-rounding-policy-forexpensive-cancer-therapy-2376-0419-1000e147.pdf

 
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS

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