Anthem Blue Cross and Blue Shield Medicaid: Pharmacy and Therapeutics Advisory Committee meeting

Transcription

1 Anthem Blue Cross and Blue Shield Medicaid: Pharmacy and Therapeutics Advisory Committee meeting 1. Inhaled corticosteroids (ICS) VAC 4q14 Inhaled corticosteroids for asthma Reason for review: Category review PRODUCTS INCLUDED IN THE REVIEW: QVAR (beclomethasone), Pulmicort Respules 1 mg/2 ml and Flexhaler (budesonide), Alvesco (ciclesonide), Aerospan HFA (flunisolide hemihydrate), Flovent HFA/Diskus (fluticasone propionate) and Asmanex (mometasone furoate) DECISION: Aerospan (flunisolide hemihydrate) will move from nonpreferred to preferred. 2. Long-acting beta agonists (LABA)/ ICS combinations Reason for review: Long-acting beta agonists (LABA)/ICS combinations Category review PRODUCTS INCLUDED IN THE REVIEW: ICS/LABA combination for asthma; Advair HFA/Diskus (fluticasone propionate/salmeterol), Dulera HFA (mometasone/formoterol) and Symbicort (budesonide/formoterol) HFA ; Other ICS/LABA combination product (Breo Ellipta) is approved only for use in chronic obstructive pulmonary disease (COPD). DECISION: Advair will move from preferred to nonpreferred. 3. Spiriva Respimat for COPD VAC Selected agent for COPD Reason for review: New formulation Spiriva Respimat PRODUCT INCLUDED IN REVIEW: Inhaled long-acting muscarinic antagonists (LAMA); Spiriva (tiotropium bromide) Respimat COMPARATOR PRODUCTS: Inhaled LAMA combinations; Spiriva (tiotropium bromide) Handihaler, Tudorza Pressair inhaler (aclidinium bromide) and Incruse Ellipta (umeclidinium) inhaler DECISION: Spiriva Respimat moves from nonpreferred to preferred. 4. Overactive bladder agents Reason for review: Agents for overactive bladder (OAB) Annual review Anthem Blue Cross and Blue Shield Medicaid is the trade name of Anthem Kentucky Managed Care Plan, Inc., independent licensee of the Blue Cross and Blue Shield Association. ANTHEM is a registered trademark of Anthem Insurance Companies, Inc. The Blue Cross and Blue Shield names and symbols are registered marks of the Blue Cross and Blue Shield Association. WEBPAKY November 2015

2 Page 2 of 9 Speaker notes: The overactive bladder products have similar efficacy and offer modest improvements in helping patients achieve continence. Side effects of Myrbetriq include more incidents of high blood pressure and nose and pharynx inflammation than placebo, but fewer dry mouth events compared with other overactive bladder agents. Blood pressure should be monitored for those using Myrbetriq. Myrbetriq is a β 3 agonist or nerve receptor stimulator and has a unique mechanism of action compared with the other agents (Detrol LA, Enablex, Toviaz, VESIcare, Gelnique and Oxytrol), which are antimuscarinic agents or nerve receptor blockers. PRODUCTS INCLUDED IN REVIEW: Enablex (darifenacin), Gelnique (oxybutynin gel), Mybetriq (mirabegron), Oxytrol (oxybutynin patch), Toviaz (fesoterodine) and Vesicare (solifenacin) COMPARATOR PRODUCTS: Detrol (tolterodine), Detrol LA (tolterodine ER), Ditropan XL (oxybutynin ER), generic oxybutynin, generic oxybutynin ER, Sanctura (trospium), Sanctura XR (trospium ER), generic tolterodine, generic trospium, generic trospium ER and generic tolterodine ER DECISION: Tolterodine, tolerodine ER, trospium and trospium ER move from nonpreferred to preferred. 5. Selected hepatitis C regimens Agents for hepatitis C Reason for review: New products Viekira Pak and Harvoni PRODUCTS INCLUDED IN REVIEW: Harvoni (Ledipasvir and sofosbuvir), Olysio (simeprevir), Sovaldi (sofosbuvir), Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets) and dasabuvir tablets DECISION: Harvoni will move from nonpreferred to preferred. 6. Selected anti-obesity agent Selected anti-obesity agent Reason for review: Review of over-the-counter (OTC) Alli PRODUCT INCLUDED IN REVIEW: OTC Alli COMPARATOR PRODUCTS: None; all other weight loss products are benefit exclusions. DECISION: OTC Alli will move from nonpreferred to preferred.

3 7. Select anti-infective agent- atovaquone suspension Reason for review: Brand Mepron Generic atovaquone suspension Nebupent pentamidine Anthem BlueCross BlueShield Medicaid Page 3 of 9 Select anti-infective agent- atovaquone suspension Comparison of atovaquone suspension to other prevention and treatment options for P. carinii pneumonia (PCP): Route of Indication administration Frequency PCP PCP and prevention treatment formulation Oral suspension Oral inhalation via nebulizer Prevention: QD Treatment: BID x 21 days Q 4 weeks Used in non- HIV pentamidine IM injection or Daily x Pentam for injection IV infusion days PRODUCTS INCLUDED IN REVIEW: Mepron (atovaquone), Nebupent (pentamidine inhalation) and Pentam (pentamidine injection) COMPARATOR PRODUCTS: For treatment; trimethoprim + dapsone, primaquine + clindamycin; For prophylaxis; dapsone + Daraprim + leucovorin DECISION: Atovaquone suspension will move from preferred to nonpreferred. 8. Select topical steroids Reason for review: Select topical steroids Focus on medium potency topical steroids PRODUCTS INCLUDED IN REVIEW: betamethasone dipropionate lotion, betamethasone valerate cream, betasone valerate locition, fluticasone cream, fluticasone ointment, fluocinolone cream, fluocinolone oil, fluocinolone ointment, fluocinolone solution, hydrocortisone valeratecream, hydrocortisone valerate ointment, mometasone cream, mometasone ointment, mometasone solution, prednicarbate cream, triamcinolone cream, triamcinolone ointment and triamcinolone lotion COMPARATOR PRODUCTS: not applicable DECISION: Hydrocortisone butyrate cream, ointment and solution will move from preferred to nonpreferred. 9. Selected antineoplastics: Revlimid and Thalomid VAC Selected antineoplastics: Revlimid and Thalomid

4 Page 4 of 9 Reason for review: Formulary alignment category PRODUCTS INCLUDED IN REVIEW: Thalomid (thalidomide) and Revlimid (lenalidomide) COMPARATOR PRODUCTS: not applicable Thalomid (thalidomide) oral has the following FDA-approved indications and additional compendia listed uses: Food and Drug Administration (FDA)- approved use National Comprehensive Cancer Network (NCCN) Clinical pharmacology DrugDex AHFS Newly diagnosed multiple myeloma in combination with dexamethasone Cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) Prevention and suppression of the cutaneous manifestations of ENL recurrence Multiple myeloma Waldenström's Macroglobulinemia/ Lymphoplasmacytic Lymphoma AIDS-associated wasting syndrome Aphthous ulcer Astrocytoma Behcet's syndrome Cachexia Crohn's disease Discoid lupus erythematosus Kaposi's sarcoma Malignant glioma Myelodysplastic syndrome (MDS) Prurigo Systemic lupus erythematosus (SLE) Glioblastoma multiforme MDS Prostate cancer Mycobacterial infection HIVassociated wasting Cancer associated cachexia GVHD in adult and pediatric bone marrow transplant GVHD in adult peripheral blood stem cell transplant Revlimid (lenalidomide) oral has the following FDA-approved indications and additional compendia listed uses: FDA-approved use NCCN DrugDex Multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality, with or without Hodgkin Lymphoma Multiple myeloma Myelodysplastic syndromes NHL Clinical pharmacology /AHFS No additional uses CLL (relapsed, refractory) Multiple myeloma (MM), in combination with dexamethasone first line

5 Page 5 of 9 additional cytogenetic abnormalities Mantle cell lymphoma (MCL) whose disease has relapsed or progressed DECISION: Revlimid and Thalomid will move from preferred to nonpreferred. 10. Oral anticoagulants and Enoxaparin Review dates: VAC based on 3Q14 CRC designations and comments for Eliquis and Pradaxa; VAC decision on enoxaparin (formulary alignment) Oral anticoagulants and selected injectable anticoagulant (enoxaparin) Reasons for review: Review of new indications for Eliquis (apixaban) and Pradaxa (dabigatran) Formulary alignment for injectable and oral anticoagulants Speaker notes: Eliquis has the additional FDA-approved use for thromboprophylaxis in total hip replacement or total knee replacement surgeries. Xarelto also has this indication. Pradaxa to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE. Xarelto also has this indication. Eliquis/Pradaxa/Xarelto: There are no head-to-head trials between Eliquis, Pradaxa and/or Xarelto for direct comparison. Eliquis: A head-to-head trial determined that 3.3 patients out of 1,000 taking Eliquis for atrial fibrillation would avoid a stroke or systemic embolism compared to those taking warfarin over one year. Pradaxa: A head-to-head trial determined that six patients out of 1,000 taking Pradaxa for atrial fibrillation would avoid a stroke or systemic embolism compared to those taking warfarin over one year. Xarelto: A head-to-head trial determined that Xarelto was noninferior to warfarin for preventing stroke or systemic embolism for those with atrial fibrillation. Eliquis: A head-to-head trial determined that 9.6 patients out of 1000 taking Eliquis for atrial fibrillation would avoid major bleeding compared to those taking warfarin over one year. Pradaxa/Xarelto: Major bleeding was not statistically significantly different between Pradaxa and warfarin; and Xarelto and warfarin for the treatment of atrial fibrillation. Pradaxa: Caution is advised for those > 75 years taking Pradaxa, due to decreased kidney function and data that showed a statistically significant increase in extracranial bleeding and gastrointestinal bleeding. Pradaxa: Caution is advised in patients with diminished kidney function (e.g., CrCl 15 to 30 ml/min) using the FDA-approved

6 Page 6 of 9 dose Pradaxa 75 mg twice daily. The 75 mg dose was approved based on laboratory (e.g., pharmacokinetic/pharmacodynamic) data and not studied in clinical trials. Eliquis/Pradaxa/Xarelto; The Clinical Review Committee states that there is concern that patients will casually discontinue Eliquis, Pradaxa or Xarelto, increasing the risk for stroke and recommends advocating for programs that improve adherence in patients taking anticoagulant medication. Lovenox (enoxaparin) is available generically. PRODUCTS INCLUDED IN REVIEW: Eliquis (apixaban), Pradaxa (dabigatran), Xarelto (rivaroxaban) and enoxaparin COMPARATOR PRODUCTS: Coumadin, Jantoven (warfarin), heparin, Fragmin (dalteparin), Arixtra (fondaparinux), Iprivask (desirudin), Lovenox (enoxaparin), dalteparin (Fragmin) and tinzaparin (Innohep) DECISIONS: Eliquis will move to from nonpreferred to preferred. Pradaxa will move to from preferred to nonpreferred. Xarelto will remain preferred. Warfarin will remain preferred. Enoxaparin will move from nonpreferred to preferred. 11. Glucagon-like peptide receptor agonists (GLP-1s) GLP-1s Reason for review: Class review of older and newer GLP-1s products Speaker notes: Victoza, Bydureon and Byetta lower HbA1C with accompanying weight loss (on average about four to seven pounds). At maximum dose, daily Victoza lowered HbA1C more (-0.21%) than once weekly Bydureon and Tanzeum, but Bydureon and Tanzeum were better tolerated. Victoza lowered HbA1C and fasting plasma glucose more than Byetta, but Byetta had a greater impact on postprandial glucose control. Bydureon was superior to Byetta in lowering HbA1C (-0.40%) and had fewer gastrointestinal side effects. Trulicity added to metformin was noninferior to a similar Victoza regimen and superior to Byetta in lowering HbA1c with comparable tolerability. Trulicity in combination with metformin was superior to Januvia and metformin in the reduction of HbA1c. Compared to other diabetes drugs, Trulicity, Victoza, Bydureon, Byetta, Tanzeum and metformin have higher rates of gastrointestinal side effects (nausea and vomiting). All of the

7 Page 7 of 9 GLP-1s are associated with an increased risk of pancreatitis. Trulicity, Bydureon and Tanzeum are given as a once weekly injection. Victoza is injected once daily and Byetta twice daily. All GLP-1 agonists are available in pen dispensers. PRODUCTS INCLUDED IN REVIEW: Bydureon (extended-release exenatide), Byetta (exenatide), Tanzeum (albiglutide), Trulicity (dulaglutide) and Victoza (liraglutide) DECISIONS: Tanzeum will move to from nonpreferred to preferred. Victoza will move from nonpreferred to preferred. Byetta will move to from preferred to nonpreferred. Trulicity will remain nonpreferred. Bydureon will remain nonpreferred. 12. Immune globulins Immune globulins Reason for review: Review of class, including new subcutaneous formulation HyQvia PRODUCTS INCLUDED IN REVIEW: Intravenous; Bivigam, Carimune NF, Flebogamma DIF, Gammagard, Gammagard S-D, Gammagard S-D less IgA, Gammaked, Gammaplex, Gamunex-C, Octagam and Privigen. Subcutaneous; Hizentra and HyQvia. Intramuscular; GamaSTAN S-D DECISIONS: Gamunex -C will move from nonpreferred to preferred. Octagam will move to from nonpreferred to preferred. Carimune NF will move from preferred to nonpreferred. Flebogamma DIF will move from preferred to nonpreferred. Gammagard S-D will move from preferred to nonpreferred. Gammaplex will move from preferred to nonpreferred. Hizentra will move from preferred to nonpreferred. Bivigam will remain nonpreferred. Gammagard will remain nonpreferred. Hammaked will remain nonpreferred. Privigen will remain nonpreferred. 13. Inflammatory bowel disease Focus on oral mesalamine products Reason for review: Annual review PRODUCTS INCLUDED IN REVIEW: Apriso (mesalamine ER), Asacol HD (mesalamine

8 Page 8 of 9 DR tabs), Delzicol (mesalamine DR caps), Pentasa (mesalamine CR), Lialda (mesalamine DR), Giazo (balsalazide) and Dipentum (olsalazine) COMPARATOR PRODUCTS: Colazal (balsalazide) and generic balsalazide DECISION: Balsalazide will move from nonpreferred to preferred. 14. Ophthalmic anti-allergy agent Ophthalmic anti-allergy agent- Refresh Redness Relief drops Reason for review: Formulary alignment check PRODUCT INCLUDED IN REVIEW: Refresh Redness Relief (phenylephrine 0.12%) COMPARATOR PRODUCTS: OTC phenylephrine, naphazoline and tetrahydrozoline formulations; prescription higher concentration 2.5%-10% phenylephrine formulations. DECISION: Refresh Redness Relief drops remain nonpreferred. 15. OTC Nexium Proton pump inhibitors with focus on OTC Nexium Reason for review: Annual review PRODUCTS INCLUDED IN REVIEW: Prescription; Nexium 20mg, Nexium 40 mg, Nexium granules; OTC; Nexium 24 HR COMPARATOR PRODUCTS: Prescription; Dexilant, lansoprazole capsules and suspension, omeprazole capsules, pantoprazole, Prilosec granules and rabeprazole; OTC; lansoprazole OTC, omeprazole OTC, Prevacid 24 HR and Prilosec OTC DECISION: OTC Nexium will move from nonpreferred to preferred. 16. Lancets Lancets Reason for review: Review of available lancets PRODUCTS INCLUDED IN REVIEW: Lancets manufactured by Agamatrix Inc., Allison Medical, Abbott Diabetes, Arkray USA, Aurora Health, Bayer Healthcare, BD Diabetes, Biosense Medical, Boca Pharmacal, Can-AM/Access C, Chain Drug Cons, CVS, Delta Hi-Tech, Diabetic Supply, Fifty50 Pharmaceutics, For a Care Inc, Global Diabetic, Good Neighbor, Harrington Hold, H&H Wholesale Inc, Home Aide Diagnostics, Invacare Supply, Kroger/Perrigo, Lifescan, Logimedix, Med Plastic Dev, Medicine Shop, Medicore, MHC Medical Pro, Medline Indust, Nipro Diagnostics, Omnis Health, One Pharmaceutics, Owen Mumford US, Philosys, Phoenix Healthcare, Prodigy Diabetes, Rite Aid Corp., Roche Diagnostics, Simple Diagnostics, Sterilance Medi, US Diagnostics, Vertex Diagnostics and Walgreen Co. DECISIONS:

9 Page 9 of 9 Manufacturer: Chain Drug Cons, Sterilance Medi, Med Plastic Dev, Arkray USA, Rite Aid Corp, CVS, Medicine Shop, Good Neighbor, Fora Care Inc., Kroger/Perrigo, H&H Wholesale Inc., Aurora Heath, Invacare supply, Agamatrix, Inc., Owen Mumford US, US Diagnostics, Logimedix, MHC Medical Pro, Nipro Diagnostic, Can-AM/Access C and Walgreen Co. will remain preferred. Manufacturer: Delta Hi-Tech, BD Diabetes, Allison Medical, Abbott Diabetes, Bayer Healthcare, Lifescan, Global Diabetic, Biosense Medical, Roche Diagnostics, One Pharmaceutical, Diabetic Supply, Prodigy Diabetes, Fifty50 Pharmaceutics, Philosys, Medlin Indus., Home Aide Diagnostic, Boca Pharmacal, Omnis Health, Simple Diagnostic, Harrington Hold, Medicore and Phoenix Healthcare will move from preferred to nonpreferred.