Hypokalemia (low potassium level in the blood)

Hypokalemia is a condition that can be caused from diarrhea, increased urination (from diuretic medications), or low dietary potassium intake. Symptoms of hypokalemia include fatigue, muscle cramps, and weakness. Potassium chloride is commonly used to correct hypokalemia. It is available in many formulations including capsules, tablets, and oral solutions.

Definitions

Diuretic is a type of drug that increases urination (such as hydrochlorothiazide and furosemide).

Effervescent tablets are medications that can be dissolved in water and produce tiny bubbles similarly to soda water. This makes it easier to take the medication than tablets or capsules.

Medical Necessity Criteria for Initial Authorization

1. The requested medication is being used for the treatment or prevention of hypokalemia (potassium deficiency); AND
2. The member is unable to use or has tried and failed ONE (1) of the following Potassium Chloride alternative formulation:
   • Potassium Chloride Effervescent tablet; or
   • Potassium Chloride Extended-Release Tablet; or
   • Potassium Chloride Extended-Release Capsule; AND
3. Chart documentation and supporting lab work are provided for review to substantiate the above listed requirements.

If the above prior authorization criteria are met, potassium chloride oral solution will be approved for 12 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if BOTH of the following are met:

1. the member still meets the applicable initial criteria; AND
2. recent chart documentation (within the last 12 months) shows the member has experienced a clinical benefit (e.g., prevention or treatment of life-threatening manifestations or complications of hypokalemia, replacement of potassium deficit).

Experimental or Investigational / Not Medically Necessary

Potassium chloride oral solution for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. Guenter P, Boullata JI, Ayers P, et al; Parenteral Nutrition Safety Task Force, American Society for Parenteral and Enteral Nutrition (ASPEN). Standardized competencies for parenteral nutrition prescribing: the American Society for Parenteral and Enteral Nutrition model. Nutr Clin Pract. 2015;30(4):570-576. doi:10.1177/0884533615591167
2. K-Tab (potassium chloride) [prescribing information]. North Chicago, IL: AbbVie Inc; April 2018.
3. Klor-Con (potassium chloride) [prescribing information]. Maple Grove, MN: Upsher-Smith Laboratories LLC; August 2019.
4. Klor-Con extended-release tablet (potassium chloride) [prescribing information]. Maple Grove, MN: Upsher-Smith Laboratories LLC; October 2018.
5. Klor-Con M extended-release tablet (potassium chloride) [prescribing information]. Maple Grove, MN: Upsher-Smith Laboratories LLC; October 2020.
6. Klor-Con M tablet (potassium chloride) [prescribing information]. Princeton, NJ: Sandoz Inc; October 2020.
7. Klor-Con Powder (potassium chloride) [prescribing information]. Maple Grove, MN: Upsher- Smith Laboratories LLC; March 2020.
8. Klor-Con Sprinkle (potassium chloride) [prescribing information]. Maple Grove, MN: Upsher- Smith Labs; September 2017.
9. Nilsson E, Gasparini A, Xu H, et al. Incidence and determinants of hyperkalemia and hypokalemia in a large healthcare system. Int J Cardiol. 15 Oct 2017. 245:277-284.
10. Potassium chloride extended-release capsule [prescribing information]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; March 2018.
11. Potassium chloride extended-release capsule [prescribing information]. Parsippany, NJ: Actavis Pharma, Inc; May 2018.
12. Potassium chloride extended-release tablet [prescribing information]. Piscataway, NJ: Camber Pharmaceuticals, Inc; March 2021.
13. Potassium chloride oral solution [prescribing information]. Hauppauge, NY: Saptalis Pharmaceuticals LLC; March 2021.
14. Potassium chloride oral solution [prescribing information]. Livonia, MI: Major Pharmaceuticals; December 2020.
15. Zacchia M, Abategiovanni ML, Stratigis S, Capasso G. Potassium: From Physiology to Clinical Implications. Kidney Dis (Basel). 2 June 2016. 2(2):72-9.

Clinical Guideline Revision / History Information

Original Date: 11/05/2020

Reviewed/Revised: 10/14/2021, 12/01/2021, 9/15/2022, 9/21/2023