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
______________________________________________________________________________
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.
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
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.
NON-SEDATING ANTIHISTAMINES
Patient Name:_____________________________________Medicaid ID# __________________
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
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
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)
_____________________________________________________________________________________
Non-sedating Antihistamine Prior Authorization Criteria
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:
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
**Claritin Reditab requires PA regardless of age.
· 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
Cetirizine (ZyrtecR)
5 mg QD
$53.70
Fexofenadine (AllegraR)
60mg BID
$64.80
180mg QD
$62.10
Loratadine (ClaritinR)
$77.10
Desloratidine (ClarinexR)
5mg QD
$57.90
Hydroxyzine (VistarilR)
25mg TID
$4.33
Chlorpheniramine (Chlor TrimetonR)
8mg BID
$4.80
4mg q12h
$24.00
Diphenhydramine (BenadrylR)
$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.
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.
______________________________________________________________________________________
Proton Pump Inhibitors (PPI’s)
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
_______________________________________________________________________________________________
_______________________________________________________________________________________
Proton Pump Inhibitors Prior Authorization Criteria
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
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
30 mg qd
Omeprazole (PrilosecR)
40 mg qd b
Pantoprazole (Protonix R)
40 mg qd a
20 mg qd a
Rabeprazole
(Aciphex R)
20mg qd a
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
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
· 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 use of proton pump inhibitors with Cox-2 Inhibitors or H2-antagonists will not be approved without appropriate documentation.
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)
$ 35.46
$ 20.49
$ 113.97
$ 117.60
$ 115.40
$ 174.81
$ 121.80
$ 89.10
Rabeprazole ( Aciphex R)
$107.79
* Drug cost is based on average Medicaid reimbursement without dispensing fee
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.