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TO:                 PHYSICIANS, OSTEOPATHS, DENTISTS, MID-LEVEL PRACTITIONERS, PHARMACISTS

 

FROM:           PAUL SWATSENBARG, Deputy Administrator

                        Division of Medicaid  

 

Effective May 20, 2002, the following three (3) groups of medications will require prior-authorization:

 

·        Non-sedating antihistamines;

·        COX-2 NSAID inhibitors;

·        Proton pump inhibitors.

 

Enclosed with this information release is a letter from our Medical Director, Dr. Thomas Young, drug class specific prior authorization forms, and prior authorization criteria for these groups of medications.  Please make additional copies of the prior authorization forms for future use.

 

If you have any questions regarding this program change, you may call the Medicaid Pharmacy Section at 208-364-1829. 

 

 

PS/pm

 

Attachments

______________________________________________________________________________

April 17, 2002

 

 

 

 

 

Dear Doctor or Health Care Provider:

 

I am writing to you at this time to discuss the Medicaid Program and inform you of some changes.  As you know, the Medicaid Program is funded by a combination of Federal and State appropriations.  Thus, the program is completely funded by our tax dollars.  Costs to the State of Idaho have been rising dramatically in many areas.  As you might expect, pharmaceutical costs are one of the top rising costs with an increase of 38 percent in the past two years.  In attempting to control these spiraling costs, strategies used by private payers, such as co-pay and formularies, are restricted under Federal policies.  Given this environment, we must look to alternate cost saving measures.  In this regard, the Division of Medicaid is expanding the Prior Authorization process.

 

With our pharmacy prior authorization programs, we are attempting to work with you to reduce escalating costs. As you know, there are specific medications and types of medications that currently require prior authorization by Medicaid. Effective May 20, 2002, the following three groups of medications will also require prior authorization: non-sedating antihistamines, COX-2 NSAID inhibitors, and proton pump inhibitors. 

 

Enclosed with this letter are drug class specific prior authorization forms, as well as background information and some suggested best practice guidelines. I have also enclosed the cost of various medications in the hope that we might all work to reduce cost, where appropriate, on a patient-by-patient basis.

 

We recognize that we need to provide more patient-centered education to support your efforts to care for our patients.  To that end, we are working with physicians to develop an asthma disease management program.  We will not only educate and encourage patients to improve their disease, but also supply providers with up-to-date information that will assist them with their care.  This project is going to be piloted in a few select areas and as it progresses, we will make this available statewide.  As the program moves forward, we will continually evaluate the process and monitor outcomes with you to assure improvement.  We want to focus our future efforts on areas that, together with you, will benefit both patients and providers.

 

Lastly, I am looking to you, the physicians and health care providers, to help in the process of efficiently and cost-effectively managing the program.  Many of you may have ideas on ways to improve the program and reduce costs.  I encourage you to share those with me.  I have received ideas related to improving our oxygen utilization and we are reviewing methods to improve the process in certain areas of durable medical equipment.  Some of the pharmacy utilization related to pain medication use has been a direct result of physician suggestions.  Please contact me with any thoughts you have.

 

Sincerely,

 

 

 

THOMAS R. YOUNG, M.D.

Medical Director

 

TRY/se

 

Enclosures

_________________________________________________________________________________________

State of Idaho, Division of Medicaid

PRIOR AUTHORIZATION FORM

COX-2 INHIBITORS (SELECTIVE NSAIDs)

Phone: 1-208-364-1829               One drug per form ONLY – Use black or blue ink             Fax: 1-208-364-1864

 

Patient Name:____________________________________Medicaid ID# __________________

                                                                      State Iicense or  

Physician Name: _______________________ Medicaid# ___________________ Phone:____________________

 

Physician Specialty:_____________________ Physician Fax: ______________________

 

Pharmacy ________________________________ Phone: ___________________Fax:______________________

 

Cox-2 Drug Requested

Drug                 Strength           Instructions                  Length of therapy

                                                                                        Days      or      Months  

q                       CelebrexR     ________          __________________     ________      ________

 

q                       VioxxR         ________          __________________     ________      ________

 

q                       BextraR        ________          __________________     ________      ________

 

q                       Other           ________          __________________     ________      ________

 

Cox-2 Indication

q                        Rheumatoid Arthritis

q                        Osteoarthritis

q                        Acute pain (treatment < 5 –7 days)

q                        Primary dysmenorrhea

q                        Familial Adenomatous Polyposis

 

Medical Necessity Documentation

q        Failure of older NSAIDs due to lack of tolerability (minimum of 2 agents, 14 day trial of each, *see list below), or

q        History of NSAID-induced GI bleed, or

q        Patients meets 2 of more of the following criteria:

q        Age > 65 years

q        Concurrent or history of peptic ulcer disease

q        Concurrent anticoagulant or antiplatelet therapy (excluding low dose aspirin)

q        Concurrent corticosteroid therapy

 

“Older” NSAIDs*

Acetic Acid                   Fenamates                    Oxicams                       Proprionic acids             Naphthylalkanones

Diclofenac (VoltarenR)         Meclofenamate              Piroxicam(FeldeneR)         Fenoprofen(NalfonR)         Nabumetone(RelafenR)

Indomethacin(IndocinR)     Mefenamic acid(PonstelR)                                     Flurbiprofen(AnsaidR)

Sulindac(ClinorilR)                                                                                     Ibuprofen(MotrinR)

Tolmetin(TolectinR)                                                                                   Ketoprofen((OrudisR)

Naproxen(NaprosynR)

**Please refer to back of form for algorithm to aid in decision making process.

 

Additional information which may aid in the Prior Authorization decision making process:________________________

______________________________________________________________________________________________

______________________________________________________________________________________________

 

Physician Signature: ________________________________________________Date:_________________________

By signing, physician agrees that documentation of above indication and medical necessity is available for review by Idaho Medicaid in patient’s current medical chart.

_____________________________________________________________________________________________________

 

Cox-2 Inhibitors Prior Authorization Criteria

 

Background

 

Prior to the advent of the selective COX-2 inhibitor nonsteroidal anti-inflammatory drugs (NSAIDs), this class of drugs consisted of agents with very similar efficacy and side effect profiles.  The COX-2 specific agents, released in 1999, consist of rofecoxib (VioxxR) and celecoxib (CelebrexR), with efficacy similar to the older drugs.  Recent studies report a lower incidence of GI bleeding, however, the clinical significance of this difference in patients without coexisting risk factors for GI bleed is questionable.  The daily cost of the newer COX-2 agents ranges from 5-10 times the cost of the older agents.  The Medicaid Pharmacy Unit encourages the use of the older agents, as listed below, prior to prescribing the COX-2 medications.

 

Acetic Acid     Fenamates        Oxicams        Proprionic acids          Naphthylalkanones

Diclofenac        Meclofenamate Piroxicam         Fenoprofen                   Nabumetone

Indomethacin    Mefenamic acid                        Flurbiprofen                                         

Sulindac                                                           Ibuprofen                                            

Tolmetin                                                           Ketoprofen                                          

                                                                        Naproxen

 

FDA approved indications

 

Use of the COX-2 inhibitor NSAIDs is limited to the FDA approved  indications:

 

COX2                          FDA approved indication                   Dose

VioxxR:             Osteoarthritis                                        12.5-25mg daily

                                    Acute pain, dysmenorrhea                    50mg daily x 5 days

 

CelebrexR:                    Osteoarthritis                                        200mg daily; 100mg BID

                                    Rheumatoid arthritis                              100mg-200mg BID

                                    Familial adenomatous polyposis            400mg BID

 

BextraR                                Osteoarthritis                                        10mg daily

                                    Rheumatoid arthritis                              10mg daily

                                    Primary dysmenorrhea              20mg BID prn

 

Medicaid Prior Authorization Criteria

 

·        FDA approved indication, and,

·        Failure of older NSAIDs due to lack of tolerability (minimum of two agents), or

·        History of NSAID induced GI bleed, or

·        Patient meets 2 or > of the following criteria:

a.       Age > 65 years

b.      Concurrent or history of peptic ulcer disease

c.       Concurrent anticoagulant or antiplatelet therapy (excluding low dose aspirin)

d.      Concurrent corticosteroid therapy

 

Cost comparison data

 

NSAIDs

 

 

Dose**

Cost of 4 weeks therapy*

Celcoxib (CelebrexR)

200mg QD

$72.60

Rofecoxib (VioxxR)

25 mg QD

$72.60

Valdecoxib (BextraR)

10mg QD

$77.00

Indomethacin (IndocinR)

50mg TID

$29.00

Etodolac (LodineR)

300mg BID

$64.20

Piroxicam (FeldeneR)

20mg QD

$3.39

Ibuprofen (MotrinR)

800mg TID

$9.58

Naproxen (NaprosynR)

500mg BID

$10.75

Nabumetone (RelafenR)

750mg BID

$80.88

 

*Cost based on average Medicaid reimbursement amount

 Does not include pharmacy dispensing fee

 

**Dose based on average dose for osteoarthritis

 

References

______________.  Are rofecoxib and celecoxib safer NSAIDS?  Drug and Therapeutics Bulletin 2000; 38; 81-85.

 

Beejay U, Wolfe MM.  Cyclooxygenase-2 selective inhibitors: Panacea or flash in the pan?  Gastroenterology 1999: 117: 1002-1005.

 

Bensen WG, Fiechtner JJ, McMillen JI, et al.  Treatment of osteoarthrisis with celecoxib, a cyclooxygenase–2 inhibitor: A randomized controlled trial.  Mayo Clinic Proc 1999; 74: 1095-1105.

 

Bombardier C.  An evidence-based evaluation of the gastrointestinal safety of coxibs.  Am J Cardiol 2002; 89 (suppl): 3D-9D.

 

Burke TA, Zabinski RA, Pettitt et al.  A framework for evaluating the clinical consequences of initial therapy with NSAIDs, NSAIDs plus gastroprotective agents, or celecoxib in the treatment of arthritis.  Pharmacoeconomics 2001; 19 (suppl): 33-47.

 

FDA Advisory Committee.  Briefing Information: NDA 21-042: Vioxx.  Vioxx Gastrointestinal Outcomes Research Study (VIGOR) February 8, 2001.

 

Fitzgerald GA, Patron C.  The coxibs, selective inhibitors of cyclooxygenase-2.  N Engl J Med 2001; 345: 433-441.

 

Silverstein FE, Faich G, Goldstein JL, et al.  Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis.  The Class Study: A randomized controlled trial.  JAMA 2000; 284: 1247-1255.

               

State of Idaho, Division of Medicaid

PRIOR AUTHORIZATION FORM

NON-SEDATING ANTIHISTAMINES

Phone: 1-208-364-1829               One drug per form ONLY – Use black or blue ink             Fax: 1-208-364-1864

 

Patient Name:_____________________________________Medicaid ID# __________________

                                                                      State Iicense or  

Physician Name: _______________________ Medicaid# ___________________ Phone:____________________

 

Physician Specialty:____________________________Physician Fax: ______________________

 

Pharmacy____________________________________Phone:____________________Fax:___________________

 

Non-Sedating Antihistamine Drug Requested (No PA required for patients between 6 and 20 years of age)**

**Claritin ReditabR requires PA regardless of age

Drug                 Strength                       Instructions                              Length of therapy

                                                                                                               Days    or    Months

q      AllegraR                _____________ _____________________           ______        ______

q      AllegraDR              ____12hr______            _____________________           ______        ______

q      ClaritinR                ____5mg______            _____________________           ______        ______

q      Claritin DR             ____12hr______            _____________________           ______         ______

q      Claritin DR             ____24hr______            _____________________           ______        ______

q      Claritin ReditabR** ____10mg_____  _____________________           ______        ______

q      ClarinexR              ____5mg______            _____________________           ______        ______

q      ZyrtecR                 _____________ _____________________           ______        ______

 

Non-Sedating Antihistamine FDA Approved Indication

q                        Seasonal allergic rhinitis

q                        Chronic urticaria

q                        Perennial allergic rhinitis

 

Medical Necessity Documentation

      

q        Patient between the age of 6-20 years or actively involved in an educational program, or

q        Patient symptoms have failed to improve on at least 2 multi-source generic antihistamine trials (30 day trial for each agent (*see list of “older” agents below), and

q        Patient is receiving no other medications which cause drowsiness

 

“Older” multi-source generic antihistamines

Hydroxyzine (VistarilR, AtaraxR)                          Chlorpheniramine (Chlor-TrimetonR)

Diphenhydramine (BenadrylR)                          Clemastine (TavistR)

Cyproheptadine (PeriactinR)

**Please refer to back of form for algorithm to aid in decision making process.

 

Additional information which may aid in the Prior Authorization decision making process:________________________

______________________________________________________________________________________________

______________________________________________________________________________________________

 

Physician Signature: ________________________________________________Date:_________________________

By signing, physician agrees that documentation of above indication and medical necessity is available for review by Idaho Medicaid in patient’s current medical chart.

_____________________________________________________________________________________

Non-sedating Antihistamine Prior Authorization Criteria

 

Background

Uses of the antihistamine class of drugs, in general, varies from intermittent use for the common cold/flu symptoms, to chronic allergic rhinitis.  The “older” first generation agents may produce drowsiness in some patients, however, tolerance to this side effect quickly develops with chronic use, and whether this “drowsiness” impairs the patient’s quality of life remains open to interpretation.  Additionally, the need for the non-sedating agents in patients currently receiving other sedating medications is questionable.  The cost of the newer non-sedating agents is significantly higher than the older agents.  The Medicaid Pharmacy Program has elected to restrict these medications to adults through Prior Authorization; patients ages 6 to 20 are excluded (school age).  Prescribers are encouraged to use agents from the following “older” antihistamines:

 

Hydroxyzine (VistarilR, AtaraxR)                         Chlorpheniramine (Chlor-TrimetonR)

Diphenhydramine (BenadrylR)                           Clemastine (TavistR)

Cyproheptadine (PeriactinR)                      

 

FDA approved indications

Use of the non-sedating oral antihistamines is limited to the FDA approved indications for the following products or combination products:

 

Brand name    FDA approved indication       Dose

Allegra®                Seasonal allergic rhinitis                     Children (6-11): 30mg twice daily

                                                                                                Adults (³ 12):  60mg twice daily or 180mg QD

                                Chronic urticaria                                   Children (6-11):  30mg twice daily

                                                                                                Adults (³ 12):  60mg twice daily

 

Claritin®                Allergic rhinitis/urticaria                     Children (2-5):  5mg (5ml) syrup once daily

                                                                                                Adults and children ³ 6:  10mg once daily

 

Clarinex®               Seasonal allergic rhinitis                     Adults and children ³ 12:  5mg once daily

 

Zyrtec®                 Seasonal allergic rhinitis                     Children (2-5):  2.5mg once daily,

                                Perennial allergic rhinitis                 Maximum dose of 5mg QD or 2.5mg Q 12

                                Chronic urticaria                                   Children (6-11):  5 or 10 mg once daily

                                                                                                Adults (³ 12):  5 or 10 mg once daily

 

Medicaid Prior Authorization Criteria

**Claritin Reditab requires PA regardless of age.

 

·        FDA approved indication, and,

·        Patient between the ages of 6 and 20 years old or actively involved in an education program, or

·        Patient symptoms have failed to improve on at least 2 multi-source generic antihistamine trials (30 day trial for each agent), and

·        Patient is receiving no other medications which cause drowsiness.


Non-sedating antihistamines

 

Cost comparison data

 

 

Dose*

Cost/month**

Cetirizine (ZyrtecR)

5 mg QD

$53.70

Cetirizine (ZyrtecR)

10mg QD

$53.70

Fexofenadine (AllegraR)

60mg BID

$64.80

Fexofenadine (AllegraR)

180mg QD

$62.10

Loratadine (ClaritinR)

10mg QD

$77.10

Desloratidine (ClarinexR)

5mg QD

$57.90

Hydroxyzine (VistarilR)

25mg TID

$4.33

Chlorpheniramine (Chlor TrimetonR)

8mg BID

$4.80

Cyproheptadine (PeriactinR)

4mg q12h

$24.00

Diphenhydramine (BenadrylR)

50mg TID

$4.23

Clemastine (TavistR)

2.68mg BID

$45.60

 

 

*Dose based on average medication dose for allergic rhinitis.

 

**Cost based on Medicaid average reimbursement amount. Does not include pharmacy dispensing fee.

 

References

 

Adelsberg BR.  Sedation and performance issues in the treatment of allergic conditions.  Arch Intern Med 1997; 157: 494-500.

 

Kay GG, Berman B, Mockoviale SH, et al.  Initial and steady-state effects of Diphenhydramine and Loratadine on sedation, cognition, mood and psychomotor performance.  Arch Intern Med 1997; 157: 2350-2356.

 

Nolen TM.  Sedative effects of antihistamines: safety, performance, learning, and quality of life.  Clinical Therapeutics 1997; 19: 39-55.

 

______________________________________________________________________________________

State of Idaho, Division of Medicaid

PRIOR AUTHORIZATION FORM

Proton Pump Inhibitors (PPI’s)

Phone: 1-208-364-1829               One drug per form ONLY – Use black or blue ink             Fax: 1-208-364-1864

 

Patient Name:____________________________________Medicaid ID# __________________

                                                                      State Iicense or  

Physician Name: _______________________ Medicaid# ___________________ Phone:____________________

 

Physician Specialty:_____________________ Physician Fax: ______________________

 

Pharmacy:_______________________________________Phone:___________________Fax:_________________

 

PPI Drug Requested

Drug                 Strength           Instructions*                 Length of therapy

                                                See dosages below               Days      or     Months

q      NexiumR               ________          __________________     ________      ________

 

q      PrevacidR              ________          __________________     ________      ________

 

q      PrilosecR              ________          __________________     ________      ________

 

q      ProtonixR              ________          __________________     ________      ________

 

q      AciphexR              ________          __________________     ________      ________

 

PPI Indication

q         Hypersecretory disorder (e.g. Zollinger-Ellison)

q         GERD with a history of erosive esophagitis or esophageal stricture

q         GERD (mild to moderate) which has failed a high dose H2 antagonist trial

q         Current H. pylori associated with PUD as part of a 2-4 drug eradication regimen (limited to 2 month duration)

q         Negative H. pylori patients with PUD who have failed H2 antagonists (limited to 2 month duration)

q         NSAID induced ulcer that requires continued non-COX-2 NSAID therapy

 

Recommended dosages

·            NexiumR 20mg unless in initial 60 days of acute therapy

·            PrevacidR 15mg unless in initial 60 days of acute therapy

·            PrilosecR 20mg unless in initial 60 days of acute therapy

·            ProtonixR 40mg

·            AciphexR 20mg

**Please refer to back of form for algorithm to aid in decision making process.

 

Additional information which may aid in the Prior Authorization decision making process:________________________

______________________________________________________________________________________________

______________________________________________________________________________________________

_______________________________________________________________________________________________

 

 

 

Physician Signature: ________________________________________________Date:_________________________

By signing, physician agrees that documentation of above indication and medical necessity is available for review by Idaho Medicaid in patient’s current medical chart.

_______________________________________________________________________________________

Proton Pump Inhibitors Prior Authorization Criteria

 

Background

 

Proton pump inhibitors are highly specific inhibitors of gastric acid secretion that are very effective in the treatment of gastrointestinal diseases resulting from over-production of gastric acid.  Although indications of the proton pump inhibitors are similar to the more traditional acid secreting inhibitor drugs, the H2-antagonists, the average cost of proton pump inhibitors is 20% more than that of the H2-antagonists for equivalent treatment time frames.   The Idaho Medicaid Pharmacy program has established best practice guidelines for proton pump inhibitors to encourage the most cost-effective use.  Coverage for proton pump inhibitors is limited to those situations in which the less costly H2-antagonists have failed or for which actual superiority with the proton pump inhibitors has been documented in the clinical literature.  

 

FDA Approved Indications

 

The proton pump inhibitors have FDA approved indications for active duodenal ulcer, benign gastric ulcer, erosive reflux esophagitis and Zollinger-Ellison syndrome. Actual indications vary by individual drug.  Doses vary by indication and acute vs maintenance therapy.

 

Active Duodenal Ulcer

Maintenance of Healed Duodenal Ulcer

Active Gastric Ulcer

Maintenance of Healed Gastric Ulcer

GERD*

Erosive Esophagitis

GERD*

Maintenance

Esomeprazole (NexiumR)

40 mg qd

No data. a

No data.a

Not an FDA approved indication

20 mg qd

20mg qd

Lansoprazole (PrevacidR)

15 mg qd

30 mg qd b

15 mg qd

30 mg qd

15 mg qd

30 mg qd

15 mg qd

Omeprazole (PrilosecR)

20 mg qd

40 mg qd b

20 mg qd

40 mg qd

20 mg qd

20 mg qd

20 mg qd

Pantoprazole (Protonix R)

40 mg qd a

20 mg qd a

40 mg qd a

No data. a

40 mg qd

40 mg qd

Rabeprazole

 (Aciphex R)

20 mg qd

20 mg qd

20mg qd a

20 mg qd a

20 mg qd

20 mg qd

 

Duration of treatment for active ulcer treatment and healing of erosive esophagitis is 4-8 week

* GERD = Gastroesophageal Reflux Disease

a Not an FDA approved indication

b limited to10-14 days for initial treatment of  H. pylori in approved combinations

 

Medicaid Prior Authorization Criteria

 

Indication

·            GERD with a history of erosive esophagitis or esophageal stricture

·            GERD (mild to moderate) which has failed a high-dose H2-antagonist trial

·            Hypersecretory syndrome such as Zollinger-Ellingson

·            Positive H.pylori - as part of a 2-4 drug eradication regimen

·            Negative H. pylori patients that have failed H2-antagonists

·            NSAID induced ulcer that requires continued non-Cox-2 NSAID Therapy


 

 

Dose

·            Esomeprazole (Nexium R) 20 mg unless in initial 60 days of acute therapy

·            Lansoprazole  (Prevacid R ) 15 mg unless in initial 60 days of acute therapy

·            Omeprazole  (Prilosec R )   20  mg unless in initial 60 days of acute therapy

·            Pantoprazole (Protonix R)  40 mg

·            Rabeprazole (Aciphex R )  20 mg

 

Concurrent Therapy

Concurrent use of proton pump inhibitors with Cox-2 Inhibitors or H2-antagonists will not be approved without appropriate documentation.

 

H2-antagonists and Proton Pump Inhibitors

 

Cost comparison data

 

 

Dose

Drug Cost for 4 Weeks of Therapy*

Cimetidine (TagametR, various generics)

300 mg qid

400 mg bid

800 mg hs

$ 15.72

$  9.22

$  8.34

Famotidine (PepcidR, various generics)

20 mg bid

40 mg hs

$ 37.26

$ 36.00

Nizatadine ( AxidR )

150 mg bid

300 mg hs

$ 140.40

$ 137.82

Ranitidine (ZantacR, various generics)

150 mg bid

300 mg hs

$ 35.46

$ 20.49

Esomeprazole (NexiumR)

40 mg qd

20 mg qd

$ 113.97

$ 113.97

Lansoprazole (PrevacidR)

30 mg qd

15 mg qd

$ 117.60

$ 115.40

Omeprazole (PrilosecR)

40 mg qd

20 mg qd

$ 174.81

$ 121.80

Pantoprazole (Protonix R)

40 mg qd

20 mg qd

$ 89.10

$ 89.10

Rabeprazole ( Aciphex R)

20 mg qd

$107.79

 

 

            *  Drug cost is based on average Medicaid reimbursement without dispensing fee

 

References

 

DeVault KR, Castell DO.  Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease.  Am Journal Gastroenterology 1999; 94: 1434-1442.

 

Howden CW, Hunt RH.  Guidelines for the management of Helicobacter pylori infection.  Am Journal Gastroenterology 1998; 93: 2330-2338.

 

O’Connor JB, Provenzale D, Brazer S.  Economic consideration in the treatment of gastroesophageal reflux disease: A review.  AM Journal Gastroenterology 2000; 95: 3356-3364.

 

Soll AH.  Medical treatment of peptic ulcer disease.  Practice guidelines.  (Consensus statement American College of Gastroenterology) JAMA 1996; 275: 622-629.