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Combination NSAID Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1212

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.            

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

07-01-2024            

01-01-2024

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Consensi®

(amlodipine/celecoxib)

Tablet

Indicated in adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate.

Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal CV events, primarily strokes and myocardial infarctions.

Celecoxib is indicated for the management of the signs and symptoms of osteoarthritis.

6

Duexis®

(ibuprofen/ famotidine)

Tablet*

Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications

* Generic available

4

Vimovo®

(naproxen/ esomeprazole)

Tablet*

Indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen associated gastric ulcers.

The naproxen component of Vimovo is indicated for relief of signs and symptoms of:

  • osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults
  • juvenile idiopathic arthritis (JIA) in adolescent patients

The esomeprazole magnesium component of Vimovo is indicated to decrease the risk of developing naproxen-associated gastric ulcers.

* Generic available

1

Yosprala®, Aspirin/ Omeprazole

Tablet

Indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.

The aspirin component of Yosprala is indicated for:

  • Reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli
  • Reducing the combined risk of death and nonfatal myocardial infarction (MI) in patients with previous MI or unstable angina pectoris
  • Reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris
  • Use in patients who have undergone revascularization procedures [coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA)] when there is a pre-existing condition for which aspirin is already indicated

The omeprazole component of Yosprala is indicated for decreasing the risk of developing aspirin associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (greater than or equal to 55) or documented history of gastric ulcers.

 

 

5

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Clinical Rationale

Nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, cause considerable morbidity and mortality related to gastric and duodenal mucosal injury. Thus, prevention of NSAID-induced gastrointestinal (GI) toxicity is an important issue. Strategies for gastroprotection during NSAID therapy include supplementation with a synthetic prostaglandin analog (misoprostol), gastric acid suppression (proton pump inhibitors), or the selective use of those NSAIDs least likely to inhibit gastric prostaglandins.(2,3,8) Per the American College of Gastroenterology (ACG) 2009 practice guidelines on prevention of NSAID-related ulcers, the following are risk factors for developing an NSAID-induced GI ulcer(3):

  • Age greater than or equal to 65 years
  • Prior history of peptic, gastric, or duodenal ulcer
  • History of NSAID-related ulcer
  • History of clinically significant GI bleeding
  • Untreated or active H. pylori gastritis
  • Concurrent use of oral corticosteroids
  • Concurrent use of anticoagulants
  • Concurrent use of antiplatelets

Many hypertensive patients require chronic analgesic therapy with NSAIDs in order to treat chronic pain (e.g., due to osteoarthritis). With the possible exception of calcium channel blockers (CCBs), NSAIDs can inhibit the effectiveness of most antihypertensive drugs. Thus, use of the CCB amlodipine, which is acceptable first-line therapy in the treatment of hypertension, may simplify management of such patients.(7) Consensi, a single-pill combination of amlodipine and celecoxib, has shown similar blood pressure reduction to an equal dose of amlodipine.(6,7)

Efficacy

Although Vimovo, Duexis, and Yosprala showed statistically significant efficacy over placebo or single NSAID agents, no clinical trials were conducted comparing these combination agents against taking both active ingredients separately but at the same time.(1,4,5)

Safety

Consensi is contraindicated in the following:(6)

  • Known hypersensitivity to amlodipine, celecoxib, or any inactive ingredients of Consensi
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
  • In the setting of coronary artery bypass graft (CABG) surgery
  • History of allergic-type reactions to sulfonamides

Consensi also carries the following boxed warnings:(6)

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
  • Consensi is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Duexis is contraindicated in the following:(4)

  • History of asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs
  • In the setting of coronary artery bypass graft (CABG) surgery
  • Known hypersensitivity to ibuprofen or famotidine or any components of Duexis
  • Known hypersensitivity to other H2-receptor antagonists

Duexis also carries the following boxed warnings:(4)

  • Ibuprofen, a component of Duexis, may increase the risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • Duexis is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
  • NSAIDs, including ibuprofen, a component of Duexis, increase the risk of serious gastrointestinal (GI) adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk.

Vimovo is contraindicated in the following:(1)

  • Known hypersensitivity to naproxen, esompraole, magnesium, substituted benzimidazoles or to any components of the drug product including omeprazole
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
  • In the setting of coronary artery bypass graft (CABG) surgery
  • Patients receiving rilpivirine-containing products

Vimovo also carries the following boxed warning:(1)

  • Naproxen, a component of Vimovo, may cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • Vimovo is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
  • NSAIDs, including naproxen, a component of Vimovo, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patient with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious gastrointestinal (GI) events.

Yosprala carries the following contraindications:(5)

  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
  • In pediatric patients with suspected viral infections, with or without fever, because of the risk of Reye's Syndrome
  • Known hypersensitivity to aspirin, omeprazole, substituted benzimidazoles, or to any of the excipients of Yosprala
  • Patients receiving rilpivirine-containing products

REFERENCES                                                                                                                                                                           

Number

Reference

1

Vimovo prescribing information. Horizon Medicines, LLC. June 2023.

2

Bhatt DL, Scheiman JM, Abraham NS, et al. ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. J Am Coll Cardiol. 2008;52(18):1502-1519.

3

Lanza FL, Chan FKL, Quigley EMM, et al. American College of Gastroenterology (ACG) Practice Guidelines: Guidelines for Prevention of NSAID-Related Ulcer Complications. Am J Gastroenterol. 2009;104:728–738.

4

Duexis prescribing information. Horizon Medicines, LLC. April 2021.

5

Yosprala prescribing information. Pharmaceutika LTD. January 2020.

6

Consensi prescribing information. Burke Therapeutics, LLC. April 2021.

7

Townsend RR, et al. NSAIDs and Acetaminophen: Effects on Blood Pressure and Hypertension. UpToDate. Last updated March 2022. Literature review current through October 2022.

8

Feldman M, Das S, et al. NSAIDs (Including Aspirin): Primary Prevention of Gastroduodenal Toxicity. UpToDate. Last updated May 2021. Literature review current through November 2022.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Consensi

amlodipine besylate-celecoxib tab

10-200 MG ; 2.5-200 MG ; 5-200 MG

M ; N ; O ; Y

N

Yosprala

aspirin-omeprazole tab delayed release

325-40 MG ; 81-40 MG

M ; N ; O ; Y

M ; N

Duexis

ibuprofen-famotidine tab

800-26.6 MG

M ; N ; O ; Y

O ; Y

Vimovo

naproxen-esomeprazole magnesium tab dr

375-20 MG ; 500-20 MG

M ; N ; O ; Y

O ; Y

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Consensi

amlodipine besylate-celecoxib tab

10-200 MG ; 2.5-200 MG ; 5-200 MG

30

Tablets

30

DAYS

Duexis

ibuprofen-famotidine tab

800-26.6 MG

90

Tablets

30

DAYS

Vimovo

naproxen-esomeprazole magnesium tab dr

375-20 MG ; 500-20 MG

60

Tablets

30

DAYS

Yosprala

aspirin-omeprazole tab delayed release

325-40 MG ; 81-40 MG

30

Tablets

30

DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Consensi

amlodipine besylate-celecoxib tab

10-200 MG ; 2.5-200 MG ; 5-200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Duexis

ibuprofen-famotidine tab

800-26.6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Vimovo

naproxen-esomeprazole magnesium tab dr

375-20 MG ; 500-20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Yosprala

aspirin-omeprazole tab delayed release

325-40 MG ; 81-40 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Consensi

amlodipine besylate-celecoxib tab

10-200 MG ; 2.5-200 MG ; 5-200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Duexis

ibuprofen-famotidine tab

800-26.6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Vimovo

naproxen-esomeprazole magnesium tab dr

375-20 MG ; 500-20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Yosprala

aspirin-omeprazole tab delayed release

325-40 MG ; 81-40 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. For Consensi, BOTH of the following:
      1. The patient has a diagnosis of hypertension AND
      2. The patient has a diagnosis of osteoarthritis OR
    2. BOTH of the following:
      1. ONE of the following:
        1. For Duexis or ibuprofen/famotidine requests, the patient has a diagnosis of at least ONE of the following:
          1. Rheumatoid arthritis OR
          2. Osteoarthritis OR
        2. For Vimovo or naproxen/esomeprazole requests, the patient has a diagnosis of at least ONE of the following:
          1. Osteoarthritis in adults OR
          2. Rheumatoid arthritis in adults OR
          3. Ankylosing spondylitis in adults OR
          4. Juvenile idiopathic arthritis (JIA) in adolescents weighing greater than or equal to 38 kg AND
      2. The patient has at least ONE of the following risk factors for developing NSAID-induced gastrointestinal (GI) ulcers:
        1. Age greater than or equal to 65 years
        2. Prior history of peptic, gastric, or duodenal ulcer
        3. History of NSAID-related ulcer
        4. History of clinically significant GI bleeding
        5. Untreated or active H. pylori gastritis
        6. Concurrent use of oral corticosteroids
        7. Concurrent use of anticoagulants
        8. Concurrent use of antiplatelets OR
    3. For Yosprala or aspirin/omeprazole requests, BOTH of the following:
      1. The patient has an indication of use of at least ONE of the following:
        1. Reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli OR
        2. Reducing the combined risk of death and nonfatal myocardial infarction (MI) in patients with previous MI or unstable angina pectoris OR
        3. Reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris OR
        4. Use in patients who have undergone revascularization procedures (coronary artery bypass graft [CABG] or percutaneous transluminal coronary angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated AND
      2. The patient has at least ONE of the following risk factors for developing NSAID-induced gastrointestinal (GI) ulcers:
        1. Age greater than or equal to 55 years
        2. Prior history of peptic, gastric, or duodenal ulcer
        3. History of NSAID–related ulcer
        4. History of clinically significant GI bleeding
        5. Untreated or active H. pylori gastritis
        6. Concurrent use of oral corticosteroids
        7. Concurrent use of anticoagulants
        8. Concurrent use of antiplatelets AND
  2. If the patient has an FDA labeled indication, then ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. There is support for using the requested agent for the patient’s age for the requested indication AND
  3. There is support for the use of the individual ingredients within the target combination agent, as separate dosage forms, is not clinically appropriate for the patient AND
  4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

QL with PA

Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
  3. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
    3. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

 Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

 

Commercial _ PS _ Combination_NSAID_PAQL _ProgSum_ 07-01-2024