PHARMACY POLICY 5.01.555

Pharmacologic Treatment of Idiopathic Pulmonary Fibrosis

Effective Date: Feb. 1, 2018

Last Revised: Jan. 30, 2018

Replaces: N/A

RELATED MEDICAL POLICIES:

5.01.522 Treatment of Pulmonary Hypertension

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POLICY CRITERIA | CODING | RELATED INFORMATION

EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

Idiopathic means unknown cause. Idiopathic pulmonary fibrosis (IPF) is a lung (pulmonary)

condition in which the lungs become scarred (fibrosis). Usually only one person in a family

develops IPF. In a very small number of cases, IPF can develop in family members. When this

happens, its called familial pulmonary fibrosis.

Because of the scar tissue, the lungs are not able to move oxygen into the bloodstream very

well. The usual symptoms are a shortness of breath and a dry cough. Its a progressive condition,

meaning it gets worse over time. IPF usually affects people between 50 and 70 years old. There

is no cure for IPF but certain drugs can slow the progression to help maintain breathing

capacity. This policy describes when medications for IPF may be considered medically necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

Policy Coverage Criteria

https://www.lifewiseor.com/medicalpolicies/5.01.522.pdf

Page | 2 of 10

Drug Medical Necessity Ofev (nintedanib)or

Esbriet (pirfenidone)

Ofev (nintedanib) or Esbriet (Pirfenidone) may be

considered medically necessary for the treatment of idiopathic

pulmonary fibrosis (IPF)* when ALL the following conditions

are met:

IPF was diagnosed within the last five years, in accordance with

the 2000 ATS/ERS criteria (see table below)

AND

Forced vital capacity (FVC) 50% of the predicted value

AND

DLCO between 30-79% of the predicted value

AND

HRCT performed within the last 12 months

*Note: Patients must have a confirmed diagnosis of IPF.

ATS/ERS/JRS/ALAT Criteria for the Diagnosis of Idiopathic Pulmonary Fibrosis 1. IPF is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of

unknown cause, occurring primarily in older adults, limited to the lungs, and associated with

the histopathologic and/or radiologic pattern of UIP (Usual Interstitial Pneumonia)

2. The diagnosis of IPF requires:

a. Exclusion of other known causes of interstitial lung disease (ILD) (eg, domestic and

occupational environmental exposures, connective tissue disease, and drug toxicity)

b. The presence of a UIP pattern on high-resolution computed tomography (HRCT) in patients

not subjected to surgical lung biopsy (Biopsy may not be feasible in certain patients due to

their risk for the procedure)

c. Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to

surgical lung biopsy

3. The accuracy of the diagnosis of IPF increases with multidisciplinary discussion between

pulmonologists, radiologists, and pathologists experienced in the diagnosis of ILD

(Published in Am J Respir Crit Care Med 201l;183:788824. Available without membership or subscription at

http://www.thoracic.org/statements/insterstitial-lung-disease.php Accessed January 2018.)

http://www.thoracic.org/statements/insterstitial-lung-disease.php

Page | 3 of 10

Drugs Investigational Ofev (nintedanib) and

Esbriet (pirfenidone)

Combination therapy with Ofev (nintedanib) plus Esbriet

(pirfenidone) is considered investigational.

Use of these agents for any indication other than the above is

considered investigational.

Approval Criteria Initial authorization Ofev (nintedanib) and Esbriet (pirfenidone) can be approved

for 1 year.

Re-authorization criteria Future re-authorization would depend on clinical benefit/response

shown at the time of re-authorization where:

Chart notes documenting decrease in FVC not greater than

10% from previous year22

Coding

N/A

Related Information

Benefit Application

This policy is managed by the Pharmacy benefit.

Evidence Review

Page | 4 of 10

Comparison of Treatment Recommendations in the 2015 and 2011

ATS/ERS/JRS/ALAT Idiopathic Pulmonary Fibrosis Guidelines

Treatment 2015 Guideline 2011 Guideline

New and Revised Recommendations

Multi-target tyrosine kinase inhibitor

[nintedanib (OFEV) ]

Conditional recommendation for

use*

Not addressed

Antifibrotic agent [pirfenidone

(ESBRIET)]

Conditional recommendation for

use*

Conditional recommendation against

use

Anticoagulation [warfarin

(COUMADIN)]

Strong recommendation against use* Conditional recommendation against

use

Combination corticosteroid

(prednisone) + azathioprine + N-

acetylcysteine

Strong recommendation against use Conditional recommendation against

use

Selective endothelin receptor

antagonist [ambrisentan (LETAIRIS)]

Strong recommendation against use Not addressed

Single-target tyrosine kinase

inhibitor [Imatinib (GLEEVEC)]

Strong recommendation against use* Not addressed

Dual endothelin receptor antagonists

[macitentan (OPSUMIT), bosentan

(TRACLEER)]

Conditional recommendation against

use

Strong recommendation against use*

Phosphodiesterase-5 inhibitor

[sildenafil (REVATIO)]

Conditional recommendation against

use*

Not addressed

Unchanged Recommendations

Anti-acid therapy Conditional recommendation for

use

Conditional recommendation for

use

N-acetylcysteine monotherapy Conditional recommendation against

use

Conditional recommendation against

use

Antipulmonary hypertension therapy Recommendation deferred Conditional recommendation against

use

Single vs. bilateral lung

transplantation

Recommendation deferred Not addressed

* Moderate confidence in effect estimates

Low confidence in effect estimates

Very low confidence in effect estimates

Page | 5 of 10

Ofev (nintedanib)

Ofev (nintedanib) is a tyrosine kinase receptor inhibitor (TKI) indicated for the treatment of

idiopathic pulmonary fibrosis (IPF). A recent Phase III replicate trial (INPULSIS-1 and INPULSIS-2)

demonstrated the efficacy of nintedanib verses placebo in patients with idiopathic pulmonary

fibrosis. The trial was conducted for 52 weeks and enrolled 1066 patients who were diagnosed

with IPF within the previous five years. Criteria for eligibility included having a forced vital

capacity (FVC) greater than 50% of the predicted value, a diffusion capacity of the lung for

carbon monoxide (DLCO) between 30 79% of the predicted value, and a chest high resolution

computed tomography (HRCT) within the last twelve months. The primary outcome for both

trials was the annual rate of decline in FVC (milliliters/year). Secondary outcomes were the time

to the first acute exacerbation and change from baseline score on the St. Georges Respiratory

Questionnaire (SGRQ) - a subjective measuring tool for quality of life.

Patients receiving nintedanib 150mg BID as monotherapy achieved a significant decrease in

annual FVC decline when compared to placebo at a reduction of 125.5ml/year (95% CI, 77.7-

172.8, p< 0.001) in INPULSIS- 1 and 93.7ml/year (95% CI, 44.8- 142.7, p< 0.001) in INPULSIS- 2.

While IMPULSIS- 1 did not show significant reduction in the time until first exacerbation,

IMPULSIS -2 did demonstrate some significant decrease with a hazard ratio of 0.38 (95%Ci,

0.19- 0.77, p= 0.005). When comparing changes in SGRQ scores from baseline, there were

decreases in both trials indicating an improvement in quality of life (QOL). However, once again

only IMPULSIS- 2 demonstrated significance at -2.69 (95% CI, -4.95 to -0.43; p= 0.02).

The TOMORROW Phase II trial was similar in design and primary outcomes. As opposed to the

phase III trials that did demonstrate efficacy, the phase II trial did not show significance in

regards to decreased annual FVC decline when compared to placebo. However, it was noted

that with nintedanib 150mg twice daily, there was a trend towards a general reduction in annual

FVC decline at 68.4% (p= 0.06). This prompted the current therapeutic dose recommended

today of 150mg BID with a lower dose of 100mg showing some efficacy with less potential for

adverse events. Secondary outcomes of this trial were incidences of acute exacerbations per 100

patient-years and difference in the mean SGRQ score from baseline. The number of acute

exacerbations was significantly lower in the nintedanib group compared to placebo with a

relative risk of 0.16 (95% CI, 0.03- 0.70; p= 0.02). Similar to phase III trials, there was a significant

decrease in the SGRQ score from baseline of 0.66 (p= 0.007).

The most common adverse events noted in the registrational clinical trials were gastrointestinal

(GI) in nature. In the phase II trials, patients receiving nintedanib 150mg BID experienced at least

one episode of diarrhea (55%), nausea (23%), and vomiting (13%) during the duration of the

study and these events were responsible for most of the discontinuations in the treatment

Page | 6 of 10

group. Patients participating in IMPULSIS- 1 and -2 had similar adverse events, with diarrhea

(61.5% and 63%) and nausea (23% and 26%) being the most prominent, and discontinuations of

4.5% and 4.3% in each trial, respectively.

Nintedanib has also been associated with elevated liver enzymes in both phase II and III trials.

Some patients experienced clinically significant increase (three times the upper limit of normal)

in aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Because nintedanib is

metabolized partially by the liver, its use should be monitored for mild liver impairment and

avoided in those with moderate to severe impairment. Liver enzymes should be monitored at

baseline, prior to initiating nintedanib therapy and monitored periodically afterwards. Dose

reduction and/or discontinuation of nintedanib resulted in a normalization of liver enzymes with

no chronic liver impairment.

Nintedanib has not been studied in patients with severe renal and moderate to severe hepatic

impairment (Child Pugh score B or C). Currently there are no guidelines for the treatment of

patients with severe renal impairment, but mild to moderate renal insufficiencies do not require

any dose adjustments as less than 1% of the starting dose is excreted by the kidneys. Nintedanib

should not be recommended for patients with moderate to severe hepatic impairment.

Esbriet (pirfenidone)

Esbriet (pirfenidone) is a novel antifibrotic agent that has been recently approved for the

treatment of idiopathic pulmonary fibrosis (IPF) after being previously removed from the market

a few years ago due to the lack of efficacy data. Since its removal, three more phase III trials

were conducted: CAPACITY 004 & 006 and ASCEND. These were double blinded, randomized,

placebo controlled, international and multi-center trials. Treatment consisted of pirfenidone

2403mg/daily compared to placebo. In the CAPACITY 004 trial, a lower 1197mg/day dose was

used to examine any dose response relationship. Pirfenidone has shown mixed results in its

efficacy, which is defined as a decrease in disease progression. The usual measurement is the

change in forced vital capacity (FVC) over time. In the three studies, treatment duration either

lasted between 52 and 72 weeks. Enrolled patients had either a clinical or radiographic diagnosis

of IPF with other causes ruled out. Baseline characteristics were generally balanced amongst all

groups. The population age was between 40 80 years old with the mean age of 67 years. A

majority of the patients were white males with some form of smoking history. The mean

baseline FVC was 72% across all treatment groups.

Both CAPACITY 004 and ASCEND showed significant results in regards to percent predicted FVC

after the trial period from baseline. CAPACITY 004 had an absolute mean FVC difference of 4.4%

Page | 7 of 10

between pirfenidone 2403mg daily versus placebo after 72 weeks. ASCEND demonstrated an

absolute mean FVC difference of 4.8% between pirfenidone 2403mg daily and placebo after 72

weeks. The impact of the 0.4% difference between the two trials is not known. CAPACITY 006

was the only trial out of the three that did not met its primary endpoint. There was no

association between differences in predicted FVC and certain secondary outcomes. These

include but are not limited to the University of California at San Diego Shortness of Breath

Questionnaire (SOBQ) for dyspnea, World Health Organization Quality of Life score, and

mortality. Secondary outcomes in all three trials were noted to be exploratory and not make a

claim for efficacy in the prescribing information.

The most common adverse effects noticed in all three trials were nausea (36%) and rash (30%).

The mean exposure time to pirfenidone across all three trials was 62 weeks with the maximum

duration being 118 weeks. Longer term safety risks have yet to be established. At the daily

recommended dose of 2403mg, there were slightly higher discontinuations in treatment due to

adverse effects than compared with placebo (15% vs. 10%).1, 2

In three of the Phase III trials, there were higher incidences of photosensitivity reactions usually

within the first 6 months of initiating treatment.

Elevated liver enzymes have also been associated with pirfenidone. Across the three phase III

trials, there were higher incidences of alanine aminotransferase (ALT) or aspartate

aminotransferase (AST) elevations (3 times the upper limit of normal [ULN]) in pirfenidone

treatment versus placebo (3.7% vs. 0.8%). These effects were reversible with dose reduction or

discontinuation of the treatment. No further complications or liver failure were noted.

In a trial comparing the pharmacokinetics of pirfenidone in patients with normal renal function

to either mild, moderate, or severe renal impairment, there was an increase in overall systemic

exposure of 1.4, 1.5, and 1.2 fold, respectively. Pirfenidone should be used with caution in

patients that have mild, moderate, or severe renal impairment, and adverse effects should be

monitored closely with therapeutic adjustments, if needed.

Phase III data has shown that while the side effect profile of pirfenidone can vary to be

gastrointestinal (GI) or dermatologic in nature, the symptoms can be treated with supportive

therapy or avoidance of prolonged sun exposure and other concomitant photosensitive drugs.

Page | 8 of 10

2015 Update

A primary literature search from 1/1/14 to 10/31/15 did not identify any new evidence requiring

changes to this policy. This policy was reviewed by the Pharmacy and Therapeutics Committee

November 19, 2015.

2016 Update

Addition of new and revised recommendations, as well as annual policy maintenance. This policy

was reviewed by the Pharmacy and Therapeutics Committee February 25, 2016.

2017 Update

Recent data do not indicate a need for change to the above medical necessity criteria.

2018 Update

Primary literature search from 1/1/16 to 1/20/18 was conducted. Added initial approval duration

and re-authorization criteria taken from a recent review article found. No other references were

found that would impact this policy.

References

1. Noble P, Albera C, Bradford W, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised

trials. Lancet. 2011; 377: 1760- 69.

2. King TE, Bradford W, Castro-Bernardini S, et al. A Phase 3 Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The

New England Journal of Medicine. 2014; 370 (22): 2083- 92.

3. Esbriet (pirfenidone) prescribing information. InterMune, Inc.; Brisbane, CA. October 2014.

4. Archibald C, Guidotti T. Degree of objectively measured impairment and perceived shortness of breath with activities of daily

living in patients with chronic obstructive pulmonary disease. Can J Rehab. 1987; 1: 45-54.

5. The University of California, San Diego Shortness of Breath Questionnaire (SOBQ). American Thoracic Society. Web.

http://www.thoracic.org/assemblies/srn/questionaires/sobq.php Accessed January 2018.

http://www.thoracic.org/assemblies/srn/questionaires/sobq.php

Page | 9 of 10

6. Selman M, King TE, Pardo A et al. Idiopathic pulmonary fibrosis: prevailing and evolving hypotheses about its pathogenesis and

implications for therapy. Annals of Internal Medicine. 2001; 134 (2):136-51.

7. King TE, Schwartz M, Brown K, et al. Idiopathic pulmonary fibrosis: relationship between histopathologic features and mortality.

American Journal of Respiratory and Critical Care Medicine. 2001; 164(6): 1025-1032.

8. Ley B, Collard H. Epidemiology of idiopathic pulmonary fibrosis. Clinical Epidemiology. 2013; 5: 483-492.

9. Yu T, Wu N, Chuang C, et al. Burden of hospital admissions and exacerbations among patients newly diagnosed with idiopathic

pulmonary fibrosis. American Thoracic Society International Conference; May 16-21, 2014; San Diego, CA.

10. Collard H, Ward A, Lanes S, et al. Burden of illness in idiopathic pulmonary fibrosis. J Med Econ. 2012; 15(5): 829-835.

11. Raghu G, Collard H, Egan J, et al. An Official ATs/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based

Guidelines for Diagnosis and Management. American Journal of Respiratory and Critical Care Medicine. 2011; 183: 788-824.

12. Cerri S, Spagnolo P, Luppi F, et al. Management of idiopathic pulmonary fibrosis. Clin Chest Med. 2012; 33(1): 85-94.

13. Dimitroulis I. Nintedanib: A Novel Therapeutic Approach for Idiopathic Pulmonary Fibrosis. Respir Care. 2014. doi:

10.4187/respcare.03023.

14. Shi S, Wu J, Chen H, et al. Single- and Multiple- Dose Pharmacokinetics of Pirfenidone, an Antifibrotic Agent, in Healthy Chinese

Volunteers. J Clin Pharmacol. 2007; 47: 1268- 1276.

15. Richeldi L, du Bois R, Raghu G, et al. Efficacy and safety of Nintedanib in Idiopathic Pulmonary Fibrosis. The New England

Journal of Medicine. 2014; 370 (22): 2071- 82.

16. Richeldi L, Costabel U, Selman M, et al. Efficacy of a Tyrosine Kinase Inhibitor in Idiopathic Pulmonary Fibrosis. The New England

Journal of Medicine. 2011; 365 (12): 1079- 87.

17. OFEV (nintedanib) prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT. October 2014.

18. Paul W. Jones, Frances H. Quirk, Chlo M. Baveystock, and Peter Littlejohns "A Self-complete Measure of Health Status for

Chronic Airflow Limitation: The St. George's Respiratory Questionnaire", American Review of Respiratory Disease, Vol. 145, No. 6

(1992), pp. 1321-1327.

19. St. Georges Respiratory Questionnaire. American Thoracic Society. Web.

http://www.thoracic.org/assemblies/srn/questionaires/sgrq.php Accessed January 2018.

20. Dimitroulis I. Nintedanib: A Novel Therapeutic Approach for Idiopathic Pulmonary Fibrosis. Respir Care. 2014. doi:

10.4187/respcare.03023.

21. Wells AU, Kokosi M, Karagiannis K. Treatment Strategies for Interstitial Pneumonias. Curr Opin Pulm Med 2014;20(5):442-448

22. Shaw J, Marshall T, Morris H, et al. Idiopathic Pulmonary Fibrosis: A Holistic Approach to Disease Management in the

Antifibrotic Age. Journal of Thoracic Disease. 2018; 9(11):4700-4707.

History

Date Comments 12/08/14 New policy, add to the Prescription Drug section. Considered medically necessary

when criteria are met.

12/08/15 Annual Review. Policy updated with literature review; no change in policy statements.

http://www.thoracic.org/assemblies/srn/questionaires/sgrq.php

Page | 10 of 10

Date Comments 04/01/16 Annual Review, approved March 8, 2016. Policy updated with new and revised

recommendations.

07/07/17 Policy moved into new format, no changes to policy statement.

09/01/17 Annual Review, approved August 22, 2017. A literature search was conducted from

4/2/16 to 8/18/17. No new studies were found that would require changes to this

policy.

02/01/18 Annual Review, approved January 30, 2018. Primary literature search from 1/1/16 to

1/20/18. Added initial approval duration and re-authorization criteria per new

referenced found.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply.

CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). 2018 Premera

All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

the limits and conditions of the member benefit plan. Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

037405 (07-2016)

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