Pharmacy Medical Necessity Guidelines:
Sodium-Glucose Co-Transporter 2 Inhibitors
Effective: June 1, 2017
Prior Authorization Required
√
Type of Review – Care Management
Not Covered
Type of Review – Clinical Review
√
Pharmacy (RX) or Medical (MED) Benefit
RX Department to Review
RXUM
This pharmacy medical necessity guideline applies to the following:
Fax Numbers:
Tufts Health Plan Commercial Plans
Tufts Health Plan Commercial Plans – large group plans
Tufts Health Plan Commercial Plans – small group and individual plans
Tufts Health Public Plans
RXUM:
617.673.0988
Tufts Health Direct – Health Connector
Tufts Health Together – A MassHealth Plan
Tufts Health RITogether – A RIte Care + Rhody Health Partners Plan
Tufts Health Freedom Plan products
Tufts Health Freedom Plan - large group plans
Tufts Health Freedom Plan - small group plans
OVERVIEW
FDA-APPROVED INDICATIONS
The sodium-glucose co-transporter 2 inhibitors (SGLT2s) are indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Tufts Health RITogether Preferred Drug List status:
Generic Name
Brand Name
PDL Status
Quantity Limitation
Canagliflozin*
Invokana tablets
ST
1 tablet/day
Canagliflozin-Metformin*
Canagliflozin-Metformin
Extended Release*
Invokamet tablets
ST
2 tablets/day
Invokamet XR tablets
ST
2 tablets/day
Dapagliflozin
Farxiga tablets
PA
1 tablet/day
Dapagliflozin-Metformin
Xigduo XR tablets
PA
n/a
*Invokana (canagliflozin), Invokamet (canagliflozin/metformin), and Invokamet XR (canagliflozin/metformin
extended-release) are the preferred SGLT2s for RITogether members and may process as a step therapy
medication at the point-of-sale if the Member has previous prescription claims for a 30-day supply of metformin
and at least two alternative antidiabetic agents within the last six months.
SGLT2 Inhibitors not included in the PDL or within the SGLT2 medical necessity guideline are considered noncovered.
COVERAGE GUIDELINES
The plan may authorize coverage of a sodium-glucose co-transporter 2 inhibitor for Members when
the criteria are met and limitations do not apply:
For Invokana, Invokamet, or Invokamet XR
1. The member is stable on the requested medication
OR
2. The member tried and failed therapy, or the provider indicates clinical inappropriateness of
therapy with metformin and with at least two other antihyperglycemic agents
For Farxiga or Xigduo XR
1. The member is stable on the requested medication
OR
2. The member tried and failed therapy, or the provider indicates clinical inappropriateness of
therapy with metformin and with at least two other antihyperglycemic agents, one of which must
be a canagliflozin-containing product
LIMITATIONS
1. The coverage of Invokana is limited to two tablets per day of the 100 mg strength, and one tablet
per day of the 300 mg strength.
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Pharmacy Medical Necessity Guidelines:
Sodium-Glucose Co-Transporter 2 Inhibitors
2. The coverage of Invokamet and Invokamet XR is limited to two tablets per day.
3. The coverage of Farxiga is limited to one tablet per day.
4. The coverage of Farxiga is limited to one tablet per day.
CODES
None
REFERENCES
1. American Association of Clinical Endocrinologists Comprehensive Diabetes Management Algorithm.
Endocr Pract. 2013; 19(2):327-36. URL: http://aace.metapress.com/content/a38267720403k242/
. Accessed 2014 Jan 30.
2. American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care. 2014;
37(Suppl 1):S14-S80.
3. Australian Government Department of Health and Aging. Pharmaceutical Benefits Scheme. URL:
http://www.pbs.gov.au/html/consumer.home. Available from Internet. Accessed 2014 Feb 5.
4. Bailey C, Gross J, et al. Effect of dapagliflozin in patients with type 2 diabetes who have
inadequate glycaemic control with metformin: a randomized, double-blind, placebo controlled trial.
Lancet. 2010 June. 375: 2223-2233.
5. Center for Disease Control. National Diabetes Fact Sheet, 2011.
6. URL: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdff. Available from the Internet.
Accessed 2014 Jan 30
7. Farxiga prescribing information. Princeton, NJ: Bristol Myers Squibb Company., 2014 January.
8. Invokana™ (canagliflozin) [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March
2013.
9. Invokana™ (canagliflozin) AMCP Formulary Dossier. Titusville, NJ: Janssen Scientific Affairs, LLC;
April 2013.
10. Food and Drug Administration. Drugs@FDA. URL:
http://www.accessdata.fda.gov/scripts/CDER/drugsatfda. Available from Internet. Accessed 2014
Jan 30.
11. Ferrannini E, Tang W, et al. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate
Glycemic control by diet and exercise. Dabetes Care. 2010 October. 33(10):2217-2224.
12. Henry R, Murray A, Marmolejo M, et al. Dapagliflozin, metformin XR, or both: initial
pharmacotherapy for type 2 diabetes, a randomized controlled trial. The International Journal of
Clinical Practice. 2012 May. 66(5):446-456.
13. Jabbour S, Hardy E, et al. Dapagliflozin is effective as add on therapy to sitagliptin with or without
metformin: A 24 week multicenter, randomized, double blind, placebo controlled study. Diabetes
Care. 2013 October. 10:1-11.
14. Kohan D, Fioretto P, et al. Long term study of patients with type 2 diabetes and moderate renal
impairment shows that dapagliflozin reduces weight and blood pressure but does not improve
glycemic control. Kidney International. 2013 September. 10: 1-9.
15. National Institute for Health and Clinical Excellence. Diabetes (type 2) - canagliflozin. In progress.
URL: http://guidance.nice.org.uk/TA/WaveR/160. Available from Internet. Accessed 2014 Feb 5.
16. National Institute for Health and Clinical Excellence. Diabetes (type 2) - dapagliflozin. URL:
http://publications.nice.org.uk/dapagliflozin-in-combination-therapy-for-treating-type-2-diabetesta288/guidance. Available from Internet. Accessed 2014 Feb 5 .
17. Nauck M, Rohwedder K, et al. Dapagliflozin vs. glipizide as Add-on therapy in patients with type 2
diabetes who have inadequate glycemic control with metformin. Diabetes Care. 2011 September.
34: 2015-2022.
18. Rosenstock J, Salsali A, et al. Effects of dapagliflozin, an SGLT2 inhibtor, on HBA1C, body weight,
and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone
monotherapy. Diabetes Care. 2012 July. 35:1473-1478.
19. Strojek K, Yoon K, et al. Effect of dapagliflozin in patients with type 2 diabetes who have
inadequate glycaemic control with Glimepiride: a randomized, 24-week, double blind, placebo
controlled trial. Diabetes, Obesity and Metabolism. 2011 June. 13:928-938.
20. Wilding J, Woo V, et al. Long term efficacy of dapagliflozin in patients with type2 diabetes mellitus
receiving high doses of insulin. Annals of Internal medicine. 2012 September. 156:405-415.
APPROVAL HISTORY
December 12, 2013: Reviewed by Pharmacy & Therapeutics Committee.
Subsequent endorsement date(s) and changes made:

June 12, 2014: No changes.

March 10, 2015: Xigduo XR added; approval duration limited to one year.
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Pharmacy Medical Necessity Guidelines:
Sodium-Glucose Co-Transporter 2 Inhibitors
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September 16, 2015: Approval duration approved for life of plan.
January 1, 2016: Administrative change to rebranded template.
January 12, 2016: No changes.
January 10, 2017: Added criteria and quantity limit for Invokamet XR.
April 11, 2017: Administrative update. Effective 6/1/2017, Medical Necessity Guideline applies to
Tufts Health RITogether.
BACKGROUND, PRODUCT AND DISCLAIMER INFORMATION
Pharmacy Medical Necessity Guidelines have been developed for determining coverage for plan
benefits and are published to provide a better understanding of the basis upon which coverage
decisions are made. They are used in conjunction with a member’s benefit document and in
coordination with the member’s physician(s). The plan makes coverage decisions on a case-by-case
basis considering the individual member's health care needs. Pharmacy Medical Necessity Guidelines
are developed for selected therapeutic classes or drugs found to be safe, but proven to be effective in
a limited, defined population of patients or clinical circumstances. They include concise clinical
coverage criteria based on current literature review, consultation with practicing physicians in the
service area who are medical experts in the particular field, FDA and other government agency
policies, and standards adopted by national accreditation organizations. The plan revises and updates
Pharmacy Medical Necessity Guidelines annually, or more frequently if new evidence becomes
available that suggests needed revisions.
This Pharmacy Medical Necessity Guideline does not apply to Uniformed Services Family Health Plan
members or to certain delegated service arrangements. Unless otherwise noted in the member’s
benefit document or applicable Pharmacy Medical Necessity Guideline, Pharmacy Medical Necessity
Guidelines do not apply to CareLinkSM members. For self-insured plans, drug coverage may vary
depending on the terms of the benefit document. If a discrepancy exists between a coverage guideline
and a self-insured member’s benefit document, the provisions of the benefit document will govern.
Applicable state or federal mandates will take precedence.
For Tufts Health Plan Medicare Preferred, please refer to Tufts Health Plan Medicare Preferred Prior
Authorization Criteria.
Treating providers are solely responsible for the medical advice and treatment of members. The use of
this policy is not a guarantee of payment or a final prediction of how specific claim(s) will be
adjudicated. Claims payment is subject to member eligibility and benefits on the date of service,
coordination of benefits, referral/authorization and utilization management guidelines when applicable,
and adherence to plan policies and procedures and claims editing logic.
Provider Services
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Pharmacy Medical Necessity Guidelines:
Sodium-Glucose Co-Transporter 2 Inhibitors