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Hereditary Angioedema - Commercial and Healthcare Reform
Number: J-0424 Category: Prior Authorization
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial:

Prior Authorization (1.):

  1. Miscellaneous Specialty Drugs Injectable = Yes w/ Prior Authorization

Healthcare Reform: Not Applicable
Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • Berinert [C1 Esterase Inhibitor (Human)]
  • Cinryze [C1 Esterase Inhibitor (Human)]
  • Firazyr (icatibant)
  • Haegarda [C1 Esterase Inhibitor (Human)]
  • Ruconest [C1 Esterase Inhibitor (Recombinant)]
  • Takhzyro (lanadelumab-flyo)
FDA-Approved Indications:
  • Berinert: Treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients.
  • Cinryze: Routine prophylaxis against angioedema attacks in adults, adolescents and pediatric patients (6 years of age and older) with Hereditary Angioedema (HAE).
  • Firazyr: Treatment of acute attacks of hereditary angioedema in adults 18 years of age or older.
  • Haegarda: Indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.
  • Ruconest: Treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
  • Takhzyro (lanadelumab-flyo): Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.


Background:
  • Hereditary angioedema (HAE) is a disease that presents with episodes of non-allergic angioedema. Patients experience swelling episodes that resolve within 2 to 5 days without treatment; however laryngeal swelling can be fatal. The swelling occurs without hives or itching. Bradykinin is a vasodilator that results in the swelling that is associated with angioedema. Since the angioedema is non-allergic, histamines are not involved and antihistamines are not effective. HAE can also occur because of a deficiency or malfunction of the C1 inhibitor in the body which regulates the coagulation pathway. There are three types of HAE. HAE type I is caused by a deficiency in C1 inhibitor, HAE type II is caused by a dysfunction of C1 inhibitor, HAE type III also known as Hereditary with Normal C1 inhibitor is a type not caused by C1 inhibitor deficiency.
  • Berinert is indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema in adult and pediatric patients. Berinert was tested in 124 adult patients in a placebo-controlled double blind trial with the primary objective of shortening the time to onset of relief of symptoms. Patients who received Berinert were shown to have a reduction in time to onset of relief with a median of 48 minutes for the Berinert group compared to 4 hours in the placebo group.
  • Cinryze is a medication indicated for routine prophylaxis against angioedema attacks. The efficacy of Cinryze was evaluated in a placebo controlled trial. 24 patients were randomized to receive Cinryze for 12 weeks followed by placebo for 12 weeks or to receive placebo for 12 weeks followed by Cinryze for 12 weeks. The average number of attacks was 6.1 while patients were receiving Cinryze compared to 12.7 while patients were on placebo.
  • Firazyr was studied in a randomized, placebo-controlled, double-blind clinical trial with 98 adult patients. The median time to reduction in symptoms was significantly lower in the Firazyr group compared to 19.8 hours in the placebo group.
  • Haegarda is indicated for routine prophylaxis to prevent angioedema attacks in adolescents and adults. The clinical efficacy was demonstrated in a multicenter, randomized, double-blind, placebo-controlled, crossover study. The primary efficacy endpoint was the difference in the time-normalized number of HAE attacks (the rate of attacks) relative to placebo. Patients were randomized to receive either 60 IU/kg or 40 IU/kg of C1-INH [Human] (Haegarda) for 16 weeks and placebo in the other 16 week treatment period. Patients who were in the Haegarda 60 IU/kg demonstrated a reduction of 3.5 attacks per month.
  • Ruconest is indicated for the treatment of acute attacks in patients with hereditary angioedema. Ruconest was studied in a placebo-controlled, double-blind, randomized study with the primary outcome of looking at the time to relief of symptoms. The median time to relief of symptoms was significantly lower in the Ruconest group than in the placebo group. Note, the effectiveness of Ruconest was not established in HAE patients with laryngeal attacks.
  • Takhzyro (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. The primary endpoint was the number of investigator-confirmed HAE attacks over the entire 26-week study duration. The trial demonstrated a mean monthly reduction of number of attacks in all treatment groups. In the pivotal study, patients taking Takhzyro 300 mg every 2 weeks had an 87% reduction in mean monthly attacks vs. placebo
  • Prescribing considerations:
    • The effectiveness of Ruconest in laryngeal attacks has not been established.


Approval Criteria

I.      Initial Authorization

A.    Berinert [C1 Esterase Inhibitor (Human)]

HAE Type I & II

When a benefit, coverage of Berinert may be approved when all of the following criteria are met (1. through 6.):

1.     Berinert is being used for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in patients greater than or equal to five (5) years of age.

2.     A low C4 level less than or equal to 14mg/dL or a C4 below the lower limit of the laboratory’s reference range and one of the following criteria (a. or b.):

a.     C1 inhibitor (C1INH) antigenic level less than or equal to 19 mg/dL (normal range:19 to 37 mg/dL) or below the lower limit of the laboratory’s reference range.

b.    A normal C1INH antigenic level (C1INH greater than or equal to 19 mg/dL) and a low C1INH functional level (functional C1INH less than 50 % or below the laboratory’s reference range).

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

6.     Documentation of the member’s weight has been provided.

HAE Type III

When a benefit, coverage of Berinert may be approved when all of the following criteria are met (1. through 7.):

1.     Berinert is being used for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in patients ≥ 5 years of age.

2.     Clinical laboratory performance of the following (a., b., or c.):

a.     C4 within normal limits (normal range:14 to 40 mg/dL) OR C4 within normal limits of the laboratory's normal reference range 

b.    C1INH antigen within normal limits (normal range:19 to 37 mg/dL) OR C1INH antigenic level within normal limits of the laboratory's normal reference range

c.     C1INH functional within normal limits of the laboratory's normal reference range

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

6.     Documentation of the member’s weight has been provided.

7.     Members have experienced therapeutic failure, contraindication, or intolerance to antihistamines.

 

B.    Cinryze [C1 Esterase Inhibitor (Human)]

HAE Type I & II

When a benefit, coverage of Cinryze may be approved when all of the following criteria are met (1. through 5.):

1.     Cinryze is being used for routine prophylaxis management against angioedema attacks in adult, adolescent, and pediatric patients (≥ 6 years of age) with hereditary angioedema (HAE).

2.     A low C4 level less than or equal to 14mg/dL or a C4 below the lower limit of the laboratory’s reference range and one of the following criteria (a. or b.):

a.     C1 inhibitor (C1INH) antigenic level less than or equal to 19 mg/dL (normal range:19 to 37 mg/dL) or below the lower limit of the laboratory’s reference range.

b.    A normal C1INH antigenic level (C1INH greater than or equal to 19 mg/dL) and a low C1INH functional level (functional C1INH less than 50 % or below the laboratory’s reference range).

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

 

HAE Type III

When a benefit, coverage of Cinryze may be approved when all of the following criteria are met (1. through 6.):

1.     Cinryze is being used for routine prophylaxis management against angioedema attacks in adult, adolescent, and pediatric patients (≥ 6 years of age) with hereditary angioedema (HAE).

2.     Clinical laboratory performance of the following (a., b., or c.):

a.     C4 within normal limits (normal range: 14 to 40 mg/dL) OR C4 within normal limits of the laboratory's normal reference range. 

b.    C1INH antigen within normal limits (normal range: 19 to 37 mg/dL) OR C1INH antigenic level within normal limits of the laboratory's normal reference range.

c.     C1INH functional within normal limits of the laboratory's normal reference range.

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

6.     Members have experienced therapeutic failure, contraindication, or intolerance to antihistamines.

 

C.    Firazyr (icatibant)

HAE Type I & II

When a benefit, coverage of Firazyr may be approved when all of the following criteria are met (1. through 5.):

1.     Firazyr is being used for treatment of acute attacks of hereditary angioedema (HAE) in adults (≥ 18 years of age).

2.     A low C4 level less than or equal to 14mg/dL or a C4 below the lower limit of the laboratory’s reference range and one of the following criteria (a. or b.):

a.     C1 inhibitor (C1INH) antigenic level less than or equal to 19 mg/dL (normal range:19 to 37 mg/dL) or below the lower limit of the laboratory’s reference range.

b.    A normal C1INH antigenic level (C1INH greater than or equal to 19 mg/dL) and a low C1INH functional level (functional C1INH less than 50 % or below the laboratory’s reference range).

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

 

HAE Type III

When a benefit, coverage of Firazyr may be approved when all of the following criteria are met (1. through 6.):

1.     Firazyr is being used for treatment of acute attacks of hereditary angioedema (HAE) in adults (≥ 18 years of age).

2.     Clinical laboratory performance of the following (a., b., or c.):

a.     C4 within normal limits (normal range: 14 to 40 mg/dL) OR C4 within normal limits of the laboratory's normal reference range 

b.    C1INH antigen within normal limits (normal range: 19 to 37 mg/dL) OR C1INH antigenic level within normal limits of the laboratory's normal reference range

c.     C1INH functional within normal limits of the laboratory's normal reference range

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

6.     Members have experienced therapeutic failure, contraindication, or intolerance to antihistamines.

 

D.    Haegarda [C1 Esterase Inhibitor (Human)]

HAE Type I & II

When a benefit, coverage of Haegarda may be approved when all of the following criteria are met (1. through 6.):

1.     Haegarda is being used for prophylaxis management against angioedema attacks in patients ≥ 12 years of age with hereditary angioedema (HAE).

2.     A low C4 level less than or equal to 14mg/dL or a C4 below the lower limit of the laboratory’s reference range and one of the following criteria (a. or b.):

a.     C1 inhibitor (C1INH) antigenic level less than or equal to 19 mg/dL (normal range:19 to 37 mg/dL) or below the lower limit of the laboratory’s reference range.

b.    A normal C1INH antigenic level (C1INH greater than or equal to 19 mg/dL) and a low C1INH functional level (functional C1INH less than 50 % or below the laboratory’s reference range).

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

6.     Documentation of the member’s weight has been provided.

 

HAE Type III

When a benefit, coverage of Haegarda may be approved when all of the following criteria are met (1. through 7.):

1.     Haegarda is being used for prophylaxis management against angioedema attacks in patients ≥ 12 years of age with hereditary angioedema (HAE).

2.     Clinical laboratory performance of the following (a., b., or c.):

a.     C4 within normal limits (normal range:14 to 40 mg/dL) OR C4 within normal limits of the laboratory's normal reference range 

b.    C1INH antigen within normal limits (normal range:19 to 37 mg/dL) OR C1INH antigenic level within normal limits of the laboratory's normal reference range

c.     C1INH functional within normal limits of the laboratory's normal reference range

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

6.     Documentation of the member’s weight has been provided.

7.     Members have experienced therapeutic failure, contraindication, or intolerance to antihistamines.

 

E.    Ruconest [C1 Esterase Inhibitor (Recombinant)]

HAE Type I & II

When a benefit, coverage of Ruconest may be approved when all of the following criteria are met (1. through 6.):

1.     Ruconest is being used for treatment of acute hereditary angioedema (HAE) attacks in patients ≥ 13 years of age.

2.     A low C4 level less than or equal to 14mg/dL or a C4 below the lower limit of the laboratory’s reference range and one of the following criteria (a. or b.):

a.     C1 inhibitor (C1INH) antigenic level less than or equal to 19 mg/dL (normal range:19 to 37 mg/dL) or below the lower limit of the laboratory’s reference range.

b.    A normal C1INH antigenic level (C1INH greater than or equal to 19 mg/dL) and a low C1INH functional level (functional C1INH less than 50 % or below the laboratory’s reference range).

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

6.     Documentation of the member’s weight has been provided.

 

HAE Type III

When a benefit, coverage of Ruconest may be approved when all of the following criteria are met (1. through 7.):

1.     Ruconest is being used for treatment of acute hereditary angioedema (HAE) attacks in patients ≥ 13 years of age.

2.     Clinical laboratory performance of the following (a., b., or c.):

a.     C4 within normal limits (normal range:14 to 40 mg/dL) OR C4 within normal limits of the laboratory's normal reference range 

b.    C1INH antigen within normal limits (normal range:19 to 37 mg/dL) OR C1INH antigenic level within normal limits of the laboratory's normal reference range

c.     C1INH functional within normal limits of the laboratory's normal reference range

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

6.     Documentation of the member’s weight has been provided.

7.     Members have experienced therapeutic failure, contraindication, or intolerance to antihistamines.

 

F.    Takhzyro (lanadelumab-flyo)

HAE Type I & II

When a benefit, coverage of Takhzyro may be approved when all of the following criteria are met (1. through 5.):

1.     Takhzyro is being used for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

2.     A low C4 level less than or equal to 14mg/dL or a C4 below the lower limit of the laboratory’s reference range and one of the following criteria (a. or b.):

a.     C1 inhibitor (C1INH) antigenic level less than or equal to 19 mg/dL (normal range:19 to 37 mg/dL) or below the lower limit of the laboratory’s reference range.

b.    A normal C1INH antigenic level (C1INH greater than or equal to 19 mg/dL) and a low C1INH functional level (functional C1INH less than 50 % or below the laboratory’s reference range).

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

 

HAE Type III

When a benefit, coverage of Takhzyro may be approved when all of the following criteria are met (1. through 6.):

1.     Takhzyro is being used for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

2.     Clinical laboratory performance of the following (a., b., or c.):

a.     C4 within normal limits (normal range:14 to 40 mg/dL) OR C4 within normal limits of the laboratory's normal reference range 

b.    C1INH antigen within normal limits (normal range:19 to 37 mg/dL) OR C1INH antigenic level within normal limits of the laboratory's normal reference range

c.     C1INH functional within normal limits of the laboratory's normal reference range

3.     Past medical history of at least one (1) symptom of moderate or severe angioedema attack (e.g. airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) in absence of concomitant hives or use of medication to cause angioedema.

4.     Medications known to cause angioedema (i.e. ACE-inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.

5.     Members should not be on two claims for acute therapy processed on the same day.

6.     Members have experienced therapeutic failure, contraindication, or intolerance to antihistamines.

 

II.    Reauthorization

A.    When a benefit, coverage of products for HAE may be approved when the following criteria are met (1. and 2.):

1.     The member requires additional therapy for HAE.

2.     Members should not be on two claims for acute therapy processed on the same day.

 

For Commercial and HCR members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made based on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.


Limitations of Coverage

I.      Coverage of Berinert, Cinryze, Firazyr, Haegarda, Ruconest and Takhzyro for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

II.    For Commercial or HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.


Authorization Duration
  • Commercial and HCR Plans: If approved, up to a 12 month authorization may be granted.


Automatic Approval Criteria

None


Version: J-0424-006
Effective Date Begin: 07/01/2019
Effective End Begin: 12/31/2019
Original Date: 03/04/2015
Review Date: 05/01/2019


References:

  1. Cinryze [package insert]. Shire ViroPharma, Inc. Lexington, MA. 2008. Revised June 2018.
  2. Cinryze. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics: 2015. Last Modified: February 26, 2015.
  3. Cinryze. Clinical Pharmacology. Tampa, FL: Gold Standard Multimedia; 2015. Last Modified: July 1, 2015.
  4. Berinert [package insert]. CSL Behring, Kankakee, IL: 2009. Revised February 2014.
  5. Berinert. Clinical Pharmacology. Tampa, FL. Gold Standard Multimedia; 2015. Last Modified: July 1, 2015.
  6. Berinert. DRUGDEX System (Micromedex 2.0) Greenwood Village, CO: Truven Health Analytics: 2015. Last Modified: February 26, 2015.
  7. Ruconest [package insert]. Santaris. Raleigh, NC. 2014. Revised February 2015.
  8. Ruconest. Clinical Pharmacology. Tampa, FL. Gold Standard Multimedia; 2015. Last Modified: July 31, 2014.
  9. Ruconest. DRUGDEX System (Micromedex 2.0) Greenwood Village, CO: Truven Health Analytics: 2015.  Last Modified: May 06, 2015.
  10. Haegarda [prescriber information].Kankakee, IL: CSL Behring, LLC; June 2017.
  11. McEvoy GK,ed. AHFS: Drug Information. Bethesda, MD: American Society of Health-System Pharmacists: 2015.
  12. Firazyr [prescriber information]. Lexington, MA: Shire Orphan Therapies, LLC; November 2015.
  13. Takhzyro [package insert]. Lexington, MA: Shire LLC; August 2018.
  14. Banerji A. Lanadelumab for prevention of attacks in hereditary angioedema: results from the phase 3 HELP study. American College of Allergy, Asthma and Immunology Meeting. 2017, 74: 1-18
  15. Banerji et al. Inhibiting plasma kallikrein for hereditary angioedema prophylaxis. N Engl J Med. 2017; 376(8):717-728.
  16. Craig T, Pursun A, Bork K, et al. WAO guideline for the management of hereditary angioedema. Available at: Accessed January 25, 2016.
  17. Zuraw BL, Banerji A, Bernstein JA, Busse PJ, et al. US Hereditary Angioedema Association Medical Advisory Board 2013 Recommendations for the Management of Hereditary Angioedema Due to C1 Inhibitor Deficiency. J Allergy Clin Immunol.2013;1:458-67.
  18. Gainer JV, Morrow JD, Loveland A, et al. Effect of Bradykinin-Receptor Blockade on the Response To Angiotensin-Converting-Enzyme Inhibitor In Normotensive And Hypertensive Subjects. NEJM. 1998; 339(18): 1285-1291.
  19. Zuraw BL, Bork K, Binkley KE, et al. Hereditary angioedema with normal C1 inhibitor function: Consensus of an international expert panel. Allergy Asthma Proc. 2012;33 Suppl 1:S145-S156.
  20. Bowen T, Cicardi M, Farkas H, et al. 2010. International consensus algorithm for the diagnosis, therapy and management of hereditary angioedema. Allergy Asthma Clin Immunol 2010;6:24.

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Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.


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