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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
Select a hyperlink below to be directed to that section.
POLICY CRITERIA | CODING | RELATED INFORMATION
EVIDENCE REVIEW | REFERENCES | HISTORY
Clicking this icon returns you to the hyperlinks menu above.
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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