Payment Policy

Policy Num:       PP.001.001
Policy Name:     Dose Rounding of Drug Covered Under The Medical Benefit
Policy ID:          [PP.001.001] 

Last Review:      May 10, 2024
Next Review:      May 20, 2025
 

Dose Rounding of Drug Covered Under The Medical Benefit

Purpose

The purpose of this policy is to establish guidance about dose rounding of drugs covered under the Medical Benefit. Dose rounding of biologic, cytotoxic and chemotherapy agents, among others, is a recognized method for reducing drug waste, and professional organizations have published position statements recommending dose rounding when feasible.

Policy Statements

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

a.       Provider indicates Recommended Dose may result in a suboptimal outcome due to one of the following:

                                        i.      Member’s age is less than 18 years of age

                                        ii.     Member previously demonstrated a suboptimal response to a lower rounded down dose

                                        iii.     Member is clinically unstable and at high risk for hospitalization if the requested medication produces a suboptimal response

                                        iv.     Member's laboratory values indicate that a dose reduction resulted in a suboptimal response

                                        v.      Patients with relevant enzyme deficiencies, or genetic polymorphisms may not be good candidates for dose rounding

   b. All other reasons not mentioned in this policy are not considered medically necessary.

Background

The Hematology/Oncology Pharmacy Association (HOPA) establishes that rounding of biologic and cytotoxic agents within 10% of the ordered dose is designated as acceptable for routine clinical care¹. Dose changes ≤ 10% are not expected to reduce the safety or effectiveness of therapy¹. The rounding amount 10% is rational in the context of standard dose adjustments for patient tolerance and tumor response, and the influence of interpatient pharmacokinetic variability¹. HOPA supports the use of the same threshold for dose rounding of anticancer drugs as that used for palliative and curative therapy¹. HOPA recommends each institution to develop its own policy that addresses biologic and cytotoxic agents’ dose rounding¹.

Dosage Rounding Calculation

If a drug is available as a 500mg vial size, and the recommended dose is 20mg/kg for an 80kg member, this is equal to a 1,600mg dose. For this member, the dose is rounded to 1,500mg (three 500mg vials), which is equivalent to only a 6% dose reduction. This dose rounding is in accordance with the statement provided in this policy.

Benefit applicatioN

This payment policy applies to Commecial and Medicare Advantage LOB. For Medicaid LOB Leuprolideis coverred under pharmacy benefit according to ASES normative letter 18-0813

References

1.       Fahrenbruch R, Kintzel P, Bott AM, Gilmore S, Markham R. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. Journal of oncology practice. 2018;14(3):e130-e136. doi:10.1200/JOP.2017.025411

2.       Horizon Healthcare of New Jersey, Inc. Drug Wastage Program. September 2022.

Policy History