063 Form

1

Pharmacy Medical Policy Heart Failure, Chronic Kidney Disease and Hypertrophic Cardiomyopathy (HCM) Policy Table of Contents Authorization Information
Summary
Step Therapy Requirements
Prior Authorization Requirements
Policy History
References
Policy Number: 063 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply and can be found in Medical Policy #621B • Diabetes Step Therapy Medical Policy #041

Prior Authorization Information

Policy ☒ Prior Authorization ☒ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 1/15/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or

2

that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.
See Appendix for additional information.

Summary This is a comprehensive policy covering step therapy, prior authorization and quantity limit requirements for medications used to treat Heart Failure, Chronic Kidney Disease and Hypertrophic Cardiomyopathy (HCM). Due to only modest improvements in glycemic control and a lack of long-term safety data on the effects of prolonged glycosuria, SGLT2 inhibitors are not considered as first line therapy for most patients with diabetes. However, in patients with comorbid cardiovascular and/or kidney disease, some SGLT2 inhibitors have shown some benefit in cardiovascular and kidney outcomes.
The following policy applies only when below medications are used for the treatment of heart failure and/or hypertrophic cardiomyopathy. For coverage criteria of other FDA-approved indications (i.e. Type 2 Diabetes) Please see section above on related medical polices.
Step Therapy Requirements The step therapy requirements for covered formulary medications used in the management of heart failure and hypertrophic cardiomyopathy is as follows:
Heart Failure Step Therapy Table
Drug Formulary Status (BCBSMA Commercial Plan) Step Requirement Step 1 Beta-Blockers (e.g. sotalol, atenolol, metoprolol, nadolol) Preferred

Covered with no requirements Angiotensin-converting Enzyme (ACE) Inhibitors (e.g. lisinopril, benazepril, enalapril, ramipril)
Preferred Angiotensin Receptor Blockers (ARBs) (e.g. candesartan, irbesartan, losartan, valsartan) Preferred
Step 2 Farxiga (dapagliflozin) ST, QCD Requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication in this table within the previous 130 days.
Jardiance (empagliflozin) ST, QCD Kerendia (finerenone)
ST, QCD Verquvo (vericiguat) ST, QCD Step 3 Inpefa ™ (sotagliflozin) ST, QCD Requires prior use of TWO step 2 medications OR if on the formulary history of prior use of any step 3 medication within the previous 130 days dapagliflozin NFNC, QCD QCD - Quality Care Dosing (quantity limits policy #621B); ST – Step Therapy; NFNC – Non-formulary, Non-Covered Approval Length: 24 months, unless otherwise specified in Clinical Guideline Coverage Criteria

3

Chronic Kidney Disease and Risk Factor Step Therapy Table
Drug Formulary Status (BCBSMA Commercial Plan) Step Requirement Step 1 loop diuretics (e.g. furosemide, bumetanide, torsemide) Preferred

Covered with no requirements phosphate binders (e.g. calcium acetate, lanthanum, sevelamer, Fosrenol, Renvela)
Preferred statins (e.g. atorvastatin, fluvastatin, pitavastatin, simvastatin) Preferred, QCD Step 2 Farxiga ® (dapagliflozin) ST, QCD Requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication within the previous 130 days. See below for prior use criteria. Jardiance ® (empagliflozin) ST, QCD Kerendia (finerenone)
ST, QCD Step 3 dapagliflozin NFNC, QCD Requires prior use of TWO step 2 medications OR if on the formulary history of prior use of any step 3 medication within the previous 130 days Approval Length: 24 months, unless otherwise specified in Clinical Guideline Coverage Criteria Prior Use Criteria The plan uses prescription claim records to support criteria for prior use within previous 130 days or the trial and failure of formulary alternatives when available. Additional documentation will be required from the provider when historic prescription claim data is either not available or the medication fill history fails to establish criteria for prior use or trial and failure of formulary alternatives. Documentation will also be required to support any clinical reasons preventing the trial and failure of formulary alternatives. Please see the section on documentation requirements for more information.

4

Prior Authorization Requirements

Drug Formulary Status (BCBSMA Commercial Plan) Requirement

Camzyos (mavacamten) PA, QCD Covered if PA criteria below are met Lodoco (colchicine) PA QCD - Quality Care Dosing (quantity limits policy #621B); PA – Prior Authorization
Approval Length: 12 months, unless otherwise specified in Clinical Guideline Coverage Criteria

Clinical Coverage Criteria: Camzyos Camzyos (mavacamten) may be covered when ALL of the following criteria are met:

1. Diagnosis of obstructive hypertrophic cardiomyopathy (OHCM) consistent with current ACC/AHA and ESC guidelines (unexplained LV hypertrophy with maximal LV wall thickness of ≥15 mm OR ≥13 mm with family history of HCM; LVOT gradient ≥50 mm Hg) AND
2. Age 18 years or older AND
3. Documented LVEF ≥55% AND
4. NYHA class II or III AND
5. Member has had prior therapy with, or a contraindication or intolerance to, beta blockers (e.g. metoprolol, propranolol, atenolol) and/or calcium channel blockers (e.g. verapamil, diltiazem) AND

6. The drug is prescribed by a board-certified or board eligible Cardiologist

   Clinical Coverage Criteria: Lodoco
   Lodoco (colchicine) may be covered when ALL of the following criteria are met:

7. Diagnosis of atherosclerotic disease OR the member has documented multiple risk factors for cardiovascular disease AND
8. Age 18 years or older AND
9. Being used for a reduction of the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death.

5

Appendix Formulary Status For non-covered medications, in addition to the prior authorization criteria or step therapy required, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient. Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Criteria Documentation Provider must submit supporting documentation (e.g., chart notes, lab results or other clinical information) to show that the member has met all approval criteria. Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434 Individual Consideration (for Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines

Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043

6

Phone: 1-800-366-7778 Fax: 1-800-583-6289 Samples Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review.

Policy History

Date Action 1/15/2026 Added expanded indication for Kerendia to the policy. Updated references. 1/2026 Removed Entresto from policy. Updated formatting. 4/2024 Updated to add a new step table for Kidney and other risk factors. 3/2024 Updated to add dapagliflozin to Step 3 and Non-covered. 1/2024 Updated to add Lodoco ® to the policy. 9/2023 Reformatted policy. Updated IC to align with 118E MGL § 51A. 8/2023 Updated to add Inpefa ™ to the policy.
7/2023 Reformatted Policy. 8/2022 Updated to include Camzyos ™ and updated Policy Name. 7/2022 Clarified Step requirements. 10/2021 Updated to add Farxiga and Jardiance to the policy. 4/2021 Updated to add Verquvo to the policy at step 2 and changed Policy name to Heart Failure Step Therapy. 1/1/2020 Implement new Step therapy policy

References

1. Camzyos [package insert]. Brisbane, CA: Myokardia, Inc.: 4/2022.
2. Farxiga [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP: 5/2021.
3. Inpefa [package insert]. The Woodlands, TX: Lexicon Pharmaceuticals, Inc.: 6/2023.
4. Jardiance [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.: 8/2021.
5. Kerendia [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, LLC.: 8/2025.
6. Lodoco [package insert]. Parsippany, NJ: AGEPHA Pharma USA, LLC.: 8/2023.
7. Verquvo [package insert]. Whitehouse Station, NJ: MERCK & CO., INC.: 1/2021.