Esbriet- Ofev - NC Standard Criteria

Restricted Product(s):

Restriction applies to brand and generic products

• ESBRIET® (pirfenidone)
• OFEV® (nintedanib esylate)

FDA Approved Use:

• For the treatment of idiopathic pulmonary fibrosis (IPF)
• For the treatment of systemic sclerosis-associated interstitial lung disease to slow the rate of decline in pulmonary function.
• For the treatment of chronic fibrosing interstitial lung disease with a progressive phenotype.

Criteria for Approval of Restricted Product(s):

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of idiopathic pulmonary fibrosis (medical record documentation required); AND
   1. Other known causes of interstitial lung disease are excluded (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity); AND
   2. The diagnosis was confirmed by the presence of usual interstitial pneumonia pattern on high-resolution computed tomography (HRCT) in patients not subjected to surgical lung biopsy; OR
   3. The diagnosis was confirmed by a combination of HRCT and surgical lung biopsy pattern in patients subjected to surgical lung biopsy; OR
3. The patient has a diagnosis of systemic sclerosis-associated interstitial lung disease (medical record documentation required); AND
   1. The requested medication is Ofev; AND
   2. The patient has had inadequate control, is intolerant to, or has contraindications to mycophenolate or cyclophosphamide; AND
   3. The patient will not be taking concurrently with Esbriet; OR
4. The patient has a diagnosis of chronic fibrosing interstitial lung disease (ILD) (medical record documentation required); AND
   1. The requested medication is Ofev; AND
   2. The patient has relevant fibrosis (greater than 10% fibrotic features) on HRCT; AND
   3. The patient has clinical signs of progression defined as ONE of the following:
      1. FVC decline ≥10%
      2. FVC decline ≥5% and < 10% with worsening symptoms or imaging
      3. Worsening symptoms and worsening imaging all in the 24 months prior to screening; AND
   4. The patient has an FVC ≥ 45% of predicted; AND
   5. The patient has progressed despite appropriate management for ILD (corticosteroids, immunosuppressants, etc.); AND
   6. The patient will not be taking concurrently with Esbriet; AND
5. Members requesting branded generic pirfenidone 534 mg will achieve this dose through usage of generic pirfenidone 267 mg tablet strength and formulation; OR
   1. The patient has a documented medical reason to support the use of a different strength or formulation (medical record documentation required); AND
6. If the request is for brand Esbriet or branded generic pirfenidone 534 mg tablet,
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic pirfenidone (medical record documentation required); AND
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:

365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Tashkin DP, Elashoff R, Clements PJ, Goldin J, Roth MD, Furst DE, et al. Cyclophosphamide versus placebo in scleroderma lung disease. N Engl J Med. 2006;354:2655.

Policy Implementation/Update Information:

January 2023: Criteria update: New generic pirfenidone 267 mg capsules available. Continue to prefer tablet formulation.

August 2022: Criteria change: Formatting updates. Added medical record documentation required for diagnosis. Created preference of 267 mg tablets over 534 mg tablets.

May 2022: Criteria update: Require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication.

March 2020: Criteria update: Ofev in chronic fibrosing interstitial lung disease with a progressive phenotype added to policy

September 2019: Criteria update: Ofev in systemic sclerosis-associated interstitial lung disease added.

October 2017: Formatting change: clarification added that diagnostics are required prior to the initiation of therapy.

April 2017: Formatting change: no change to criteria

October 2014: Original utilization management policy issued.