Revised date: 10/17/16 Issue Brief: Jan. 1, 2017, Formulary Changes OmedaRx regularly evaluates the performance and impact of medications using one of the most rigorous, evidence-based assessment processes in the country. The expertise, advice and tools OmedaRx delivers are well beyond FDA benchmarks and typical Pharmacy Benefits Manager (PBM) offerings. OmedaRx employs a multi-facetted quality assurance process to ensure the highest levels of scientific accuracy. The foundation of the quality assurance program is the OmedaRx Peer Review Process. This process is widely acknowledged throughout the pharmacy industry as best in class. Formulary updates effective Jan. 1, 2017, include medication cost-tier changes, changes in coverage from the pharmacy benefit to the medical benefit, changes to the Narrow Therapeutic Index and Optimum Value Lists, changes in coverage for over-the-counter medications, and a change to the PPACA Preventive Medications list. These updates reflect the highest value medications to provide our members with high quality, safe and cost-effective medications. OmedaRx has provided health plan account executives an optional letter to send to groups with affected members. We also communicate to affected members on the health plan s behalf, primarily through letters that help members navigate the formulary changes. Tier changes Medications change tier levels due to new safety information, new effectiveness information, or availability of better-value alternatives. Pre-authorization (PA) requirement Pre-authorization allows us to ensure medically necessary use of medications and encourage use of high-quality, safe and best-value medications. Change from pharmacy benefit to medical benefit Medications that are not self-administered should be covered under the medical benefit. Changes to the Narrow Therapeutic Index List For MAC A and B pharmacy benefit design contracts, members are assessed a penalty if they fill a brand name medication that has an FDA-approved generic available. This means the member pays their non-preferred copay plus an additional cost that is the differential between 1/1/17 Formulary Changes Page 1
brand and generic. The Narrow Therapeutic Index (NTI) List overrides this penalty for select medications. To be included on this list, a medication must have support among many sources that clinically meaningful differences may occur between brand and generic. Changes to the Optimum Value List Medications on the Optimum Value List are high-value with a proven track record for long-term outcomes. They have lower copay amounts, resulting in lower out-of-pocket costs for members. Benefits contracts exclude most non-fda-approved medications Benefits contracts exclude coverage for most medications that are not approved by the Food and Drug Administration (FDA). Over-the-counter medications not covered under benefits contracts Benefits contracts exclude coverage for most over the-counter medications. PPACA Preventive Care List The Centers for Medicare and Medicaid Services (CMS) reviews and adapts formularies annually to reflect changes in the market, including new generic drugs or new recommendations from the FDA. Changes: CHANGE FROM PREFERRED TO NON-PREFERRED TIER 1. Lindane shampoo. Move to non-preferred tier for existing utilizers. Tier change already in effect for new utilizers. This topical medication is used to treat head lice. Alternatives include malathion topical (generic tier) and permethrin topical (generic tier). Because this is typically a one-time treatment, we will not send letters to the affected members. 2. Eurax lotion. Move to non-preferred tier for existing utilizers. Tier change already in effect for new utilizers. This topical medication is used to treat scabies. Alternatives include ivermectin tablets (generic tier), malathion topical (generic tier), and permethrin topical (generic tier). Because this is typically a one-time treatment, we will not send letters to the affected members. 3. Cordran cream. Move to non-preferred tier for existing utilizers. Tier change already in effect for new utilizers. This topical medication is used to treat a variety of skin conditions. A generic alternative is now available (flurandrenolide) on the generic tier. In most cases, members will not need to obtain a new prescription. 4. Tikosyn. Move to non-preferred tier for existing utilizers. Tier change already in effect for new utilizers. This medication is used to treat heart rhythm abnormalities. A generic alternative is now available (dofetilide) on the generic tier. In most cases, members will not need to obtain a new prescription. 1/1/17 Formulary Changes Page 2
5. Toviaz, Vesicare. Move to non-preferred tier for new and existing utilizers. These medications are used to treat overactive bladder. There is no evidence that these medications are safer or more effective than better value alternatives. Alternatives include oxybutynin and oxybutynin ER (generic tier). Members will need to obtain a new prescription for the alternatives. 6. Canasa. Move to non-preferred tier for new and existing utilizers. This medication is used to treat inflammatory bowel disease. There is no evidence that these medications are safer or more effective than better value alternatives. Alternatives include mesalamine enema. Members will need to obtain a new prescription for this alternative. Medication Reason Condition treated Alternative(s) Lindane shampoo Comparable, less expensive alternatives available Head lice Generic tier malathion topical and permethrin topical Eurax lotion Scabies Generic tier ivermectin tablets, malathion topical, and permethrin topical Cordran cream Skin conditions Generic tier flurandrenolide Tikosyn Heart rhythm abnormalities Generic tier dofetilide Toviaz, Vesicare Overactive bladder Generic tier oxybutynin and oxybutynin ER Canasa Inflammatory bowel disease Mesalamine enema NEW PRE-AUTHORIZATION REQUIRED 7. Delzicol. New PA requirement for new and existing utilizers. This medication contains mesalamine and is used to treat inflammatory bowel disease. There is no evidence that it is safer or more effective than better value alternatives. Alternatives that also contain mesalamine include Apriso (preferred brand tier) and Lialda (preferred brand tier). Members will need to obtain a new prescription for the alternatives. 8. Uceris tablets. New PA requirement for new and existing utilizers. This medication contains budesonide and is used to treat inflammatory bowel disease. There is no evidence that it is safer or more effective than better value alternatives. Alternatives that also contain budesonide include budesonide DR capsules (generic tier). Members will need to obtain a new prescription for the alternative. 9. Giazo. New PA requirement for new and existing utilizers. This medication contains balsalazide and is used to treat inflammatory bowel disease. There is no evidence that it is safer or more effective than better value alternatives. Alternatives that also contain balsalazide include balsalazide capsules (generic tier). Members will need to obtain a new prescription for the alternative. 10. Restasis. New PA requirement for new and existing utilizers. This medication is an eye drop used to treat dry eyes. Alternatives include over-the-counter (OTC) artificial tears eye drops. 1/1/17 Formulary Changes Page 3
Medication Reason Condition treated Alternative(s) Delzicol Uceris tablets Comparable, less expensive alternatives available Inflammatory bowel disease Inflammatory bowel disease Preferred brand tier Apriso and Lialda Generic tier budesonide DR capsules Giazo Inflammatory bowel disease Generic tier balsalazide include balsalazide capsules Restasis Dry eyes Over-the-counter tears eye drops 11. High Cost Drugs with Lower Cost Alternatives. New PA requirement for new and existing utilizers. These medications will be coverable only when there is an intolerance or contraindication to an inactive ingredient in the specified lower cost alternative. High cost Drug Lower Cost Alternative Condition Treated New Prescription Needed Aggrenox aspirin/ dipyridamole Stroke prevention No* Cuprimine Depen Titratabs Wilson s disease (rare disease) Yes (penicillamine) Novacort Pramosone ointment and Skin conditions Yes lotion Rayos prednisone Inflammatory conditions Yes Xerese topical acyclovir + topical Skin conditions Yes hydrocortisone Zyclara imiquimod Skin conditions Yes Nilandron nilutamide Cancer No* Temodar temozolomide Cancer No* Elavil amitriptyline Mental health No* *unless provider has signed prescription dispense as written 12. High Cost Proton Pump Inhibitors (PPI). New PA requirement for new and existing utilizers. These medications are used to treat increased stomach acid and will be coverable only when alternatives have been ineffective, not tolerated, or are contraindicated. High cost PPI Prilosec Protonix Prevacid Zegerid omeprazole/sodium bicarbonate Lower Cost Alternatives omeprazole (new Rx not required), pantoprazole, lansoprazole, rabeprazole omeprazole, pantoprazole (new Rx not required), lansoprazole, rabeprazole omeprazole, pantoprazole, lansoprazole (new Rx not required), rabeprazole omeprazole, pantoprazole, lansoprazole, rabeprazole omeprazole, pantoprazole, lansoprazole, rabeprazole 1/1/17 Formulary Changes Page 4
13. High Cost Blood Pressure Medications. New PA requirement for new and existing utilizers. These medications are used to treat high blood pressure and other heart conditions. They will be coverable only when alternatives have been ineffective, not tolerated, or are contraindicated. High cost Antihypertensive Lower Cost Alternatives New Prescription Needed Accupril quinapril No* Accuretic quinapril/ HCTZ No* Aceon perindopril No* Altace ramipril No* Avalide irbesartan/ HCTZ No* Avapro irbesartan No* Byvalson Bystolic + valsartan Yes Clorpres chlorthalidone + clonidine Yes Corzide nadolol/ bendroflumethiazide No* Cozaar losartan No* Dutoprol metoprolol + HCTZ Yes Hyzaar losartan/ HCTZ No* Inderal LA propranolol ER No* Innopran XL/ Inderal XL propranolol ER Yes Lopressor HCT metoprolol/ HCTZ No* Lotensin benazepril No* Lotensin HCT benazepril/ HCTZ No* Lotrel amlodipine/ benazepril No* Mavik trandolapril No* Prestalia perindopril + amlodipine Yes Tarka trandolapril + verapamil Yes Tenoretic atenolol/ chlorthalidone No* trandolapril-verapamil trandolapril + verapamil Yes Vasotec enalapril No* Zestoretic lisinopril/ HCTZ No* Zestril lisinopril No* Ziac bisoprolol/ HCTZ No* *unless provider has signed prescription dispense as written NEW PRE-AUTHORIZATION REQUIRED; CHANGE FROM PREFERRED TO NON- PREFERRED TIER 14. Asacol HD, mesalamine DR 800mg, Pentasa. New PA requirement and move to nonpreferred tier for new and existing utilizers. These medications contain mesalamine and are used to treat inflammatory bowel disease. There is no evidence that these medications are safer or more effective than better value alternatives. Alternatives that also contain mesalamine include Apriso (preferred brand tier) and Lialda (preferred brand tier). Members will need to obtain a new prescription for the alternatives. 1/1/17 Formulary Changes Page 5
15. Dipentum. New PA requirement and move to non-preferred tier for new and existing utilizers. This medication is used to treat inflammatory bowel disease. There is no evidence that it is safer or more effective than better value alternatives. Similar alternatives include Apriso (preferred brand tier) and Lialda (preferred brand tier). Members will need to obtain a new prescription for the alternatives. 16. Crestor. New PA requirement and move to non-preferred tier for new and existing utilizers. This medication is used to treat high cholesterol. There is no evidence that it is safer or more effective than its generic, rosuvastatin (generic tier). In most cases, members will not need to obtain a new prescription for the alternative. Medication Reason Condition treated Alternative(s) Asacol HD, mesalamine DR 800mg, Pentasa Dipentum Comparable, less expensive alternatives available Inflammatory bowel disease Preferred brand tier Apriso and Lialda Inflammatory bowel disease Preferred brand tier Apriso and Lialda Crestor High cholesterol Generic tier rosuvastatin CHANGE FROM PHARMACY BENEFIT TO MEDICAL BENEFIT 17. Arestin. Moving to medical benefit for all utilizers. Arestin is an antibiotic implant used in dental procedures. Because it is not a self-administered medication, it should be covered under the medical benefit. Member cost-share may change as a result based on their benefit contract. Members are advised to contact member services at the number on the back of their identification card for assistance is determining their specific cost share. 18. Lupaneta. Moving to medical benefit for all utilizers. Lupaneta is used for the management of endometriosis. It contains oral tablets and an injection. Because the injection must be administered by a health care provider, Lupaneta should be covered under the medical benefit. Member cost-share may change as a result based on their benefit contract. Members are advised to contact member services at the number on the back of their identification card for assistance is determining their specific cost share. Medication Reason Condition treated Arestin Lupaneta All non-self-administered medications should be covered under the member s medical benefit Dental procedures Endometriosis CHANGES TO THE NARROW THERAPEUTIC INDEX LIST 19. Based our annual review of the Narrow Therapeutic Index list, we have added and removed several medications based on FDA sources, worldwide listings of NTI medications, and state boards of pharmacy. a. Additions: Sandimmune, Norpace, Prograf, Rapamune, Phenytek, Zarontin, Depakene, Zonegran. These medications will no longer incur the MAC Penalty. 1/1/17 Formulary Changes Page 6
b. Removals: These medications will now incur the MAC Penalty, meaning member cost-share will increase. Product Removed Condition Treated Alternative New Prescription Needed CellCept Immunosuppressant mycophenolate mofetil No* Keppra Seizures levetiracetam No* Keppra XR Seizures levetiracetam ER No* Topamax Seizures, migraine topiramate No* Topamax Sprinkles Seizures, migraine topiramate sprinkles No* *unless provider has signed prescription dispense as written 20. NOT COVERED UNDER BENEFITS CONTRACTS: OVER-THE-COUNTER MEDICATIONS Prilosec OTC, omeprazole tablet [store brand, OTC]. Due to the low cost of prescription proton pump inhibitors (PPIs), OTC Prilosec and omeprazole will now be excluded from coverage in line with benefit contracts. Better value alternatives include prescription omeprazole capsules (generic tier). In most cases, members will need to obtain a new prescription for this alternative. 21. NOT COVERED UNDER BENEFIT CONTRACTS; MOST NON-FDA APPROVED MEDICATIONS Benefits contracts exclude coverage for most medications that are not approved by the Food and Drug Administration (FDA). Comparable, more economical alternatives are available for these medications. Because the conditions treated by these medications vary, members are encouraged to speak with their doctor about other treatment options. In some cases, a new prescription will be needed for alternatives. Product removed Condition treated Alternatives Ala-quin Skin conditions Varies based on condition. Alcortin A Skin conditions Members are advised to talk Hydrocortisone-iodoquinol Analpram HC Hemorrhoids with their doctor for alternatives. GRX Hicort 25 Hemmorex HC Hydrocortisone acetate Hydrocortisone acetate/ pramoxine Cetacaine Numbing agent Isometheptene/ Headache dichloralphenazone/ acetaminophen Phenohytro Gastrointestinal issues and a variety of other disorders 1/1/17 Formulary Changes Page 7
22. CHANGES TO THE OPTIMUM VALUE LIST The Optimum Value List contains select medications covered at reduced cost share and/or bypassing deductible, depending on the group s benefit design. To be included on this list, a medication must be an exceptional value and have established health outcome or preventative benefits. During our annual review of this list, we have added and removed several medications based on current data and pricing. Additions: Lantus, digoxin, duloxetine, gabapentin, zonisamide, isosorbide, nitroglycerin patch, levetiracetam, topiramate, methotrexate tablets, azathioprine tablets, sulfasalazine, irbesartan/ HCTZ Removals: Member cost-share will increase on these medications: Product removed Reasoning Condition treated Alternatives on the Optimum Value List Actos generic available Diabetes pioglitazone No* cholestyramine, gemfibrozil Recent data concluded these medications do not improve cardiovascular High Cholesterol atorvastatin, lovastatin, pravastatin, simvastatin Yes outcomes Combivent discontinued Asthma ipratropium-albuterol nebulizer solution paroxetine ER formulation not best Mental paroxetine immediate extended value Health release (IR) and multiple release (ER) other mental health Singulair, Singulair packets generic tablet available; packets are not best value *unless provider has signed prescription dispense as written New prescription needed Yes Yes medications Allergies montelukast tablets Tablet: No* Packets: Yes 23. CHANGE TO PPACA PREVENTIVE MEDICATION LIST In February, aromatase inhibitors Exemestane, Letrozole, and Anastrozole used to treat breast cancer were removed from the PPACA Preventive Medications list. As recommended by U.S. Preventive Services Task Force (USPSTF), medications on the PPACA Preventive Medications list are used for the prevention of an illness or condition and to improve wellbeing, not to treat an existing disease or condition. While some members may be using these medications for the prevention of breast cancer, the USPSTF has found insufficient evidence to support their efficacy. Breast cancer medications used for prevention remaining on the list are Tamoxifen and Raloxifene. Visit the PPACA list at www.omedarx.com/node/63 for more information. We decided earlier this year to grandfather all members with 2016 claims through the end of the year. Beginning Jan. 1, 2017, regular cost shares or the chemotherapy benefit will apply. In addition, these chemotherapy drugs are subject to chemotherapy benefits with a 30-day supply limit, rather than a 90-day limit as approved by PPACA. 1/1/17 Formulary Changes Page 8
All affected members to receive letters communicating change. Phone calls to members whose cost difference is greater than $100 will be made by Member Services. Product removed Condition Treated Alternative (for preventive care) New Prescription Needed Exemestane Breast Cancer Tamoxifen and Raloxifene Yes Letrozole Breast Cancer Tamoxifen and Raloxifene Yes Anastrozole Breast Cancer Tamoxifen and Raloxifene Yes 1/1/17 Formulary Changes Page 9
FORMULARY CHANGES EFFECTIVE JAN. 1, 2017 PREFERRED TO NON-PREFERRED TIER Lindane shampoo Head lice Generic tier malathion topical and permethrin topical Eurax lotion Scabies Generic tier ivermectin tablets, malathion topical, and permethrin topical Cordran cream Skin conditions Generic tier flurandrenolide Tikosyn Heart rhythm abnormalities Generic tier dofetilide Toviaz, Vesicare Overactive bladder Generic tier oxybutynin and oxybutynin ER Canasa Inflammatory bowel disease Mesalamine enema NEW PRE-AUTHORIZATION REQUIRED Delzicol Inflammatory bowel disease Preferred brand tier Apriso and Lialda Uceris tablets Inflammatory bowel disease Generic tier budesonide DR capsules Giazo Inflammatory bowel disease Generic tier balsalazide include balsalazide capsules Restasis Dry eyes Over-the-counter tears eye drops Aggrenox Stroke prevention aspirin/ dipyridamole Cuprimine Wilson s disease (rare disease) Depen Titratabs (penicillamine) Novacort Skin conditions Pramosone ointment and lotion Rayos Inflammatory conditions prednisone Xerese Skin conditions topical acyclovir + topical hydrocortisone Zyclara Skin conditions imiquimod Nilandron Cancer nilutamide Temodar Cancer temozolomide Elavil Mental health amitriptyline Prilosec Stomach acid omeprazole (new Rx not required), pantoprazole, lansoprazole, rabeprazole Protonix Stomach acid omeprazole, pantoprazole (new Rx not required), lansoprazole, rabeprazole Prevacid Stomach acid omeprazole, pantoprazole, lansoprazole (new Rx not required), rabeprazole Zegerid Stomach acid omeprazole, pantoprazole, lansoprazole, rabeprazole omeprazole/ sodium bicarbonate Stomach acid omeprazole, pantoprazole, lansoprazole, rabeprazole Accupril High blood pressure and heart conditions quinapril Accuretic High blood pressure and heart conditions quinapril/ HCTZ Aceon High blood pressure and heart conditions perindopril Altace High blood pressure and heart conditions ramipril Avalide High blood pressure and heart conditions irbesartan/ HCTZ Avapro High blood pressure and heart conditions irbesartan Byvalson High blood pressure and heart conditions Bystolic + valsartan Clorpres High blood pressure and heart conditions chlorthalidone + clonidine Corzide High blood pressure and heart conditions nadolol/ bendroflumethiazide Cozaar High blood pressure and heart conditions losartan 1/1/17 Formulary Changes Page 10
NEW PRE-AUTHORIZATION REQUIRED Dutoprol High blood pressure and heart conditions metoprolol + HCTZ Hyzaar High blood pressure and heart conditions losartan/ HCTZ Inderal LA High blood pressure and heart conditions propranolol ER Innopran XL/ Inderal XL High blood pressure and heart conditions propranolol ER Lopressor HCT High blood pressure and heart conditions metoprolol/ HCTZ Lotensin High blood pressure and heart conditions benazepril Lotensin HCT High blood pressure and heart conditions benazepril/ HCTZ Lotrel High blood pressure and heart conditions amlodipine/ benazepril Mavik High blood pressure and heart conditions trandolapril Prestalia High blood pressure and heart conditions perindopril + amlodipine Tarka High blood pressure and heart conditions trandolapril + verapamil Tenoretic High blood pressure and heart conditions atenolol/ chlorthalidone trandolapril-verapamil High blood pressure and heart conditions trandolapril + verapamil Vasotec High blood pressure and heart conditions enalapril Zestoretic High blood pressure and heart conditions lisinopril/ HCTZ Zestril High blood pressure and heart conditions lisinopril Ziac High blood pressure and heart conditions bisoprolol/ HCTZ NEW PRE-AUTHORIZATION REQUIRED; CHANGE FROM PREFERRED TO NON-PREFERRED TIER Asacol HD, mesalamine Inflammatory bowel disease Preferred brand tier Apriso and Lialda DR 800mg, Pentasa Dipentum Inflammatory bowel disease Preferred brand tier Apriso and Lialda Crestor High cholesterol Generic tier rosuvastatin CHANGE FROM PHARMACY BENEFIT TO MEDICAL BENEFIT Arestin Dental procedures n/a Lupaneta Endometriosis n/a CHANGES TO THE NARROW THERAPEUTIC INDEX LIST CellCept Immunosuppressant mycophenolate mofetil Keppra Seizures levetiracetam Keppra XR Seizures levetiracetam ER Topamax Seizures, migraine topiramate Topamax Sprinkles Seizures, migraine topiramate sprinkles OVER-THE-COUNTER MEDICATIONS NOT COVERED UNDER BENEFITS CONTRACTS Prilosec OTC, omeprazole tablet (store brand, OTC) Stomach Acid Available over the counter 1/1/17 Formulary Changes Page 11
NON-FDA-APPROVED MEDICATIONS NOT COVERED UNDER BENEFITS CONTRACTS Medication Condition Treated Alternatives Ala-quin Skin conditions Varies based on condition. Members are Alcortin A Skin conditions advised to meet with their doctor for Hydrocortisone-iodoquinol alternative medications. Analpram HC Hemorrhoids GRX Hicort 25 Hemmorex HC Hydrocortisone acetate Hydrocortisone acetate/ pramoxine Cetacaine Numbing agent Isometheptene/ Headache dichloralphenazone/ acetaminophen Phenohytro Gastrointestinal issues and a variety of other disorders CHANGES TO THE OPTIMUM VALUE LIST Medication Removed Condition Treated Available Optimum Value Alternative Actos Diabetes Pioglitazone Chole-styramine, gemfibrozil High Cholesterol Atorvastatin, lovastatin, pravastatin, simvastatin Combivent Asthma Ipratropium-albuterol nebulizer solution Paroxetine extended release (ER) Mental Health Paroxetine immediate release (IR) and multiple other mental health medications Singular, Singular packets Allergies Montelukast tablets PPACA PREVENTIVE MEDICATIONS LIST CHANGES Medication Removed Condition Treated Available formulary alternative (for preventive care) Extemestane Breast Cancer Tamoxifen and Raloxifene Letrozole Breast Cancer Tamoxifen and Raloxifene Anastrozole Breast Cancer Tamoxifen and Raloxifene 1/1/17 Formulary Changes Page 12