Pharmacy Coverage Guidelines are subject to change as new information becomes available.

Transcription

1 PROTON PUMP INHIBITORS, NON-PREFERRED FORMS: ACIPHEX (rabeprazole sodium EC) oral tablet ACIPHEX SPRINKLE (rabeprazole sodium DR) oral capsule ESOMEPRAZOLE STRONTIUM (esomeprazole strontium DR) oral capsule NEXIUM (esomeprazole magnesium DR) oral capsule and oral granule packets PREVACID (lansoprazole DR) oral capsule and oral dispersible tablet PRILOSEC (omeprazole DR) oral capsule PROTONIX (pantoprazole sodium EC) oral tablet and oral granule packets ZEGERID (omeprazole-sodium bicarbonate) oral capsule, oral granules packets (brand and generic) Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Pharmacy Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Pharmacy Coverage Guidelines are subject to change as new information becomes available. For purposes of this Pharmacy Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. This Pharmacy Coverage Guideline does not apply to FEP or other states Blues Plans. Information about medications that require precertification is available at Some large (100+) benefit plan groups may customize certain benefits, including adding or deleting precertification requirements. Page 1 of 11

2 All applicable benefit plan provisions apply, e.g., waiting periods, limitations, exclusions, waivers and benefit maximums. Precertification for medication(s) or product(s) indicated in this guideline requires completion of the request form in its entirety with the chart notes as documentation. All requested data must be provided. Once completed the form must be signed by the prescribing provider and faxed back to BCBSAZ Pharmacy Management at (602) or ed to Incomplete forms or forms without the chart notes will be returned. Criteria: Criteria for initial therapy: Aciphex tablets, Aciphex Sprinkles, Esomeprazole Strontium capsule, Nexium capsule and granule packet, Prevacid capsule and oral dispersible tablet, Prilosec capsule, Protonix tablet and granule packet, Zegerid (brand or generic) capsule and granule packet is considered medically necessary and will be approved with ALL of the following criteria are met: 1. A confirmed diagnosis of ONE of the following: Barrett s esophagus, erosive esophagitis, gastroesophageal reflux disease (includes laryngeal and pharyngeal), non-steroidal anti-inflammatory drug related gastropathy, gastrointestinal bleed, Helicobacter pylori (as part of treatment with an antibiotic), Zollinger-Ellison syndrome, or ulcer 2. ONE of the following: Individual has no difficulty swallowing capsules or tablets and has tried, failed, or has a contraindication to use of ALL of the preferred agents which include brand Dexilant capsules, generics forms of esomeprazole magnesium capsules, lansoprazole capsules, omeprazole capsules, pantoprazole tablets, and rabeprazole tablets Individuals has difficulty swallowing or a has a feeding tube and has tried, failed, or has a contraindication to use of ALL of the following of the preferred agents which include: brand Dexilant capsules, generic forms of esomeprazole magnesium capsules, lansoprazole capsules, and omeprazole capsules and is unable to open a capsule to make a suspension or sprinkle contents on apple sauce 3. When applicable, use in individuals less than 18 years of age will follow FDA labeling 4. There are no contraindications such as receiving rilpivirine containing product or hypersensitivity to any component of the formulation Initial approval duration: 6 months Criteria for continuation of coverage (renewal request): Aciphex tablets, Aciphex Sprinkles, Esomeprazole Strontium capsule, Nexium capsule and granule packet, Prevacid capsule and oral dispersible tablet, Prilosec capsule, Protonix tablet and granule packet, Zegerid (brand or generic) capsule and granule packet is considered medically necessary with documentation of ALL of the following: Page 2 of 11

3 1. The condition has not worsened while on therapy 2. Individual has been adherent with the medication 3. Individual has not developed any contraindications or other significant level 4 adverse drug effects that may exclude continued use 4. There are no significant interacting drugs Renewal duration: 12 months Description: Proton Pump Inhibitors (PPIs) suppress gastric acid secretion at the final step of acid production through inhibition of the hydrogen-potassium adenosine triphosphatase [(H+ / K+)-ATPase] enzyme in the gastric parietal cell. The suppression of gastric acid secretion affords the utility of these agents in the treatment of various acid-related disorders. There are eight oral PPIs marketed in the United States for a variety of gastrointestinal disorders that may include but is not limited to the healing and maintenance of erosive esophagitis (EE), symptomatic treatment of gastroesophageal reflux disease (GERD), pathological hypersecretory conditions including Zollinger-Ellison (ZE) syndrome, and risk reduction of non-steroidal anti-inflammatory drug (NSAID) associated gastric ulcer. Several formulations are available over the counter. There are only minor differences among members of this class of agents; these differences have not consistently translated into clinically meaningful advantages for any individual agent. When clinical end-points such as healing of ulcers or esophagitis are compared, there are small and inconsistent differences seen between PPIs and therefore any agent within this group may be considered therapeutically equivalent to another. Dexlansoprazole is the R-isomer of lansoprazole and esomeprazole is the S-isomer of omeprazole. Precertification will be required for Non-Preferred Forms of Proton Pump Inhibitors: Aciphex tablets, Aciphex Sprinkles, Esomeprazole Strontium capsule, Nexium capsule and granule packet, Prevacid capsule and oral dispersible tablet, Prilosec capsule, Protonix tablet and granule packet, Zegerid (brand or generic) capsule and granule packet. Preferred agents include: brand Dexilant, generic esomeprazole magnesium, generic lansoprazole, generic omeprazole, generic pantoprazole and generic rabeprazole. For individuals with swallowing difficulties, several agents, the capsule can be opened and sprinkled in food or the capsule content can be mixed in fluid to form suspensions. Preferred agents include generic lansoprazole, generic omeprazole, generic esomeprazole magnesium, and brand Dexilant. Resources: Aciphex package insert 01AX2289A revised by manufacturer on May 2011, reviewed on Page 3 of 11

4 Dexilant package insert reference ID revised by manufacturer on October 2011, reviewed on Nexium package insert revised by manufacturer on January 2012, reviewed on Prevacid package insert reference ID revised by manufacturer on 10/2011, reviewed on Prilosec package insert revised by manufacturer on January 2012, reviewed on Protonix package insert reference ID revised by manufacturer on10/2011, reviewed on Zegerid package insert S0015G revised by manufacturer on 08/2010, reviewed on Pharmacist s Letter/Prescriber s Letter 2009;25(8):250801: Proton pump inhibitor dose comparison. Aciphex package insert revised by manufacturer on March 2013, reviewed on Esomeprazole strontium package insert reference ID revised by manufacturer on August 2013, reviewed on September 11, 2013 Page 4 of 11

5 Refer to package insert for complete prescribing and dosing information. FDA approved use for GI Disorders: Adult FDA approved indications: Dexilant Nexium Eso+ Prevacid Prilosec Zegerid Protonix Aciphex (Dexlans) (Esom) Stro (Lans) (Omep) (O+B) (Pan) (Rab) Healing of DU X X X X Maintenance of DU X Healing benign GU X X X Healing of EE X X X X X X X X Maintenance of EE X X X X X X X X GERD symptoms X X X X X X X X X X X X Reduce risk of NSAID GU X X X Healing of NSAID GU X Hypersecretory conditions (ZE, etc.) X X X X X X Age for use in Pediatric 12 y 1 mo 18 y 1 y 1 mo 18 y 5 y Tab 12 y Cap 1 y Dose forms & strengths availability: Dexlansoprazole Esomeprazole Esomeprazole -strontium Lansoprazole Omeprazole Omeprazole + Sodium Bicarbonate Pantoprazole Rabeprazole Rx forms & Strengths Generic for Rx OTC forms & Strengths Cap: 30mg, 60mg No No ODT: 30mg No No Cap: 20mg, 40mg Yes Cap & Tab: 22.3mg (20mg esomeprazole) Granules: 2.5, 5, 10, 20, 40mg No No Cap: 24.65mg, 49.3mg No No (20mg & 40mg esomeprazole) Cap: 15mg, 30mg Yes Cap: 15mg ODT: 15mg, 30mg No No Cap: 10mg, 20mg, 40mg Yes Tab: 20.6mg (20mg omeprazole) Granules: 2.5mg, 10mg No No Cap: mg, mg Yes Cap: mg Granules: mg, mg Yes No Tab: 20mg, 40mg Yes No Granules: 40mg No No Tab: 20mg Yes No Cap: 5mg, 10mg No No Page 5 of 11

6 Administration Options of Dosage Forms: Aciphex Aciphex Sprinkles (rabeprazole) Dexilant (dexlansoprazole) Esomeprazole + Strontium Nexium and generic esomeprazole Prevacid and generic lansoprazole Prilosec and generic omeprazole Protonix and generic pantoprazole Zegerid (omeprazole + Na bicarbonate) Brand and generic Information on oral delivery Tabs cannot not be crushed or split Caps must be opened and mixed in applesauce, yogurt, fruit or vegetable based baby food, or apple juice, infant formula, or pediatric electrolyte solution Caps can be opened and sprinkled on applesauce Cap content can be mixed in 20 ml water and given with an oral syringe ODT cannot be broken or split but can be dissolved in 20 ml water and given by oral syringe Caps can be opened and mixed in applesauce Caps can be opened and mixed in applesauce Granule packets of 2.5mg & 5mg should be mixed in 5 ml water, use 15 ml for other strengths Caps can be opened and mixed in applesauce, pudding, cottage cheese, yogurt, or 60 ml apple, orange, or tomato juices ODT cannot be broken or split, 15mg can be placed in 4 ml water, with 30mg use 10 ml and given by an oral syringe Caps can be opened and mixed in applesauce Granule packet of 2.5 mg should be mixed in 5 ml water, with 10mg use 15 ml of water Tabs cannot be crushed or split Granule can be mixed in 5 ml apple juice or in applesauce only, it should NOT be mixed in water or other liquids Caps cannot be opened, must be swallowed whole Suspension packet should be mixed in ml water Administration through tubes No information Cap contents mixed in 20 ml water may be given through NG ODT mixed in 20 ml water may be given through NG Cap contents mixed in 50 ml water can be given through NG Cap contents mixed in 50 ml water can be given through NG Granule packets of 2.5 mg & 5 mg should be mixed in 5 ml water, use 15 ml for other strengths can be given through NG or G-tube Cap contents mixed in 40 ml apple juice can be given through NG ODT 15 mg should be mixed in 4 ml water, with 30 mg use 10 ml, can be given through NG using an syringe Cap content can be mixed as a suspension by using the contents of 5 caps of 20 mg diluted with 50 ml sodium bicarbonate 8.4% (it is stable for 14 days at room temperature or 30 days refrigerated) Granule packet of 2.5mg should be mixed in 5 ml water, with 10mg use 10 ml, can be given through NG or G-tube Granules should be mixed in 10 ml of apple juice can be given through NG or G-tube Cannot open caps Suspension packet can be mixed in 20 ml water can be given through NG or OG tube Page 6 of 11

7 Approximate Dose Conversion: Daily dose that provides similar efficacy in GERD and/or effect on gastric ph Dexlansoprazole (Dexilant) Esomeprazole magnesium (Nexium) Esomeprazole strontium NA NA Lansoprazole (Prevacid) Omeprazole (Prilosec) Omeprazole with Na bicarbonate (Zegerid) NA NA Pantoprazole (Protonix) Rabeprazole (Aciphex, Aciphex Sprinkles) Brief Overview: Adult indications Dexlansoprazole (Dexilant): Healing of EE for up to 8 weeks Maintenance of EE for up to 6 months Symptoms of non-erosive GERD for 4 weeks Data on use in Children per package insert *Safety & effectiveness have been established in patients > 12 years of age for all grades of EE with capsules and for maintenance of healed EE and symptoms of non-erosive GERD *Safety & effectiveness have not been established in patients less than 12 years of age *Use is not recommended for symptomatic non-erosive GERD in patients less than 1 year of age Esomeprazole magnesium (Nexium): Healing of EE for 4-8 weeks Maintenance of EE for up to 6 months Treatment of GERD symptoms for 4-8 weeks Reduce risk of NSAID ulcer for 6 month Additional 4-8 weeks may be considered Additional 4 weeks may be considered *Safety & effectiveness established in pediatric patients 1-17 years of age for short-tern treatment (up to 8 weeks) of symptoms associated with GERD *Safety & effectiveness established in pediatric patients 1 month to < 1year of age for short-term treatment (up to 6 weeks) for healing of EE due to acid-mediated GERD *Safety and effectiveness have not been established in patients less than 1 month of age Esomeprazole strontium: Healing of EE for up to 8 weeks Maintenance of EE for up to 6 months Treatment of GERD symptoms for 4-8 weeks Reduce risk of NSAID ulcer for 6 months *Safety & effectiveness have not been established in pediatric patients (< 18 years of age) Strontium is known to compete with calcium for intestinal absorption and is incorporated into bone. Therefore use in pediatric patients is not recommended because adequate safety studies have not been performed. Additional 4-8 weeks may be considered Page 7 of 11

8 Additional 4 weeks may be considered Lansoprazole (Prevacid): Healing of DU for up to 4 weeks Maintenance for DU for up to 12 months Healing benign GU for up to 8 weeks Healing of EE for up to 8 weeks Maintenance of EE for up to 12 months GERD symptoms for up to 8 weeks Reduce risk of NSAID ulcer for up to 12 weeks Healing of NSAID ulcers for up to 8 weeks Additional 8-16 weeks may be considered *Safety & effectiveness established in pediatric patients 1-17 years of age for short-term treatment (8-12 weeks) of symptomatic GERD and EE, it is not effective in symptomatic GERD in patients 1 month to less than 1 year of age Omeprazole (Prilosec): Healing of DU for up to 4 weeks Healing of benign GU for 4-8 weeks Healing of EE for 4-8 weeks Maintenance of EE for up to 12 months GERD symptoms for 4-8 weeks Additional 4 weeks may be considered Additional 4 weeks may be considered & if recurs an additional 4-8 weeks may be considered *Safety & effectiveness for symptomatic GERD and shortterm (up to 8 weeks) treatment and maintenance (up to 12 months) of EE for 1-16 years of age *Safety & effectiveness for treatment of EE due to acidmediated GERD in patients 1 month to <1 year of age not established *Safety & effectiveness have not been established for patients < 1 year of age for treatment symptomatic GERD or maintenance of healing of EE due to acid-mediated GERD *Safety & effectiveness have not been established for pediatric patients for treatment of active DU, H pylori eradication, treatment of GU, or hypersecretory conditions *Safety & effectiveness have not been established in patients less than 1 month of age for any indication Omeprazole + Sodium bicarbonate (Zegerid): Healing of DU up to 4 weeks Healing of benign GU up to 4-8 weeks Healing of EE up to 4-8 weeks Maintenance of EE up to 12 months Symptoms of non-erosive GERD up to 4 weeks Risk reduction for UGIB in critically ill *Safety & effectiveness not established in patients < 18 years of age Additional 4 weeks may be considered Additional 4 weeks may be considered & if recurs an additional 4-8 weeks may be considered Page 8 of 11

9 Pantoprazole (Protonix) adult indications: Healing of EE up to 8 weeks Maintenance of EE up to 12 months Additional 8 weeks may be considered *There is no appropriate dosage strength in an ageappropriate formulation available and therefore the drug is indicated for patients 5 years and older for short-term treatment of EE associated with GERD, in addition safety beyond 8 weeks is not established *Safety & effectiveness for pediatric uses other than EE not established *Effectiveness for EE not demonstrated in patients < 1 year of age *Effectiveness for treating symptomatic GERD in pediatric patients has not been established *It was found to be not effective for treating symptomatic GERD in patients 1 through 11 months of age *It is not indicated in infants less than 1 year of age with symptomatic GERD Rabeprazole tabs (Aciphex) adult indications: Healing of DU up to 4 weeks Healing of EE up to 8 weeks Maintenance of EE up to 12 months Symptoms of GERD up to 4 weeks A few patients may require additional therapy Additional 8 weeks may be considered Additional 4 weeks may be considered *Safety & effectiveness for short-term treatment (up to 8 weeks) of symptomatic GERD for adolescent patients 12 years and older *Safety & effectiveness have not been established for pediatric patients for healing of erosive or ulcerative GERD, maintenance of healing of erosive or ulcerative GERD, treatment of symptomatic GERD, healing of DU, H pylori eradication, or hypersecretory conditions *Use of this formulation is not recommended in patients less than 12 years of age because the tablet strength exceeds the recommended dose for these patients. For use in these patients another formulation should be considered Rabeprazole caps (Aciphex Sprinkles) adult indications: Healing of DU up to 4 weeks Healing of EE up to 8 weeks Maintenance of EE up to 12 months Symptoms of GERD up to 4 weeks *Safety & effectiveness are supported for the treatment of GERD in pediatric patients 1-11 years of age *Studies conducted do not support the use for the treatment of GERD in pediatric patients younger than 1 year of age *Use in neonate patients with GERD is not recommended based on the risk of prolonged acid suppression and lack of demonstrated safety and effectiveness in neonates A few patients may require additional therapy Additional 8 weeks may be considered Additional 4 weeks may be considered Page 9 of 11

10 Fax completed prior authorization request form to or to Call to check the status of a request. All requested data must be provided. Incomplete forms or forms without the chart notes will be returned. Pharmacy Coverage Guidelines are available at Pharmacy Prior Authorization Request Form Do not copy for future use. Forms are updated frequently. REQUIRED: Office notes, labs, and medical testing relevant to the request that show medical justification are required. Member Information Member Name (first & last): Date of Birth: Gender: BCBSAZ ID#: Address: City: State: Zip Code: Prescribing Provider Information Provider Name (first & last): Specialty: NPI#: DEA#: Office Address: City: State: Zip Code: Office Contact: Office Phone: Office Fax: Dispensing Pharmacy Information Pharmacy Name: Pharmacy Phone: Pharmacy Fax: Requested Medication Information Medication Name: Strength: Dosage Form: Directions for Use: Quantity: Refills: Duration of Therapy/Use: Check if requesting brand only Check if requesting generic Check if requesting continuation of therapy (prior authorization approved by BCBSAZ expired) Turn-Around Time For Review Standard Urgent. Sign here: Exigent (requires prescriber to include a written statement) Clinical Information 1. What is the diagnosis? Please specify below. ICD-10 Code: Diagnosis Description: 2. Yes No Was this medication started on a recent hospital discharge or emergency room visit? 3. Yes No There is absence of ALL contraindications. 4. What medication(s) has the individual tried and failed for this diagnosis? Please specify below. Important note: Samples provided by the provider are not accepted as continuation of therapy or as an adequate trial and failure. Medication Name, Strength, Frequency Dates started and stopped or Approximate Duration Describe response, reason for failure, or allergy 5. Are there any supporting labs or test results? Please specify below. Date Test Value Blue Cross Blue Shield of Arizona, Mail Stop A115, P.O. Box 13466, Phoenix, AZ Page 1 of 2

11 Pharmacy Prior Authorization Request Form 6. Is there any additional information the prescribing provider feels is important to this review? Please specify below. For example, explain the negative impact on medical condition, safety issue, reason formulary agent is not suitable to a specific medical condition, expected adverse clinical outcome from use of formulary agent, or reason different dosage form or dose is needed. Signature affirms that information given on this form is true and accurate and reflects office notes Prescribing Provider s Signature: Date: Please note: Some medications may require completion of a drug-specific request form. Incomplete forms or forms without the chart notes will be returned. Office notes, labs, and medical testing relevant to the request that show medical justification are required. Blue Cross Blue Shield of Arizona, Mail Stop A115, P.O. Box 13466, Phoenix, AZ Page 2 of 2