Commercial, Medicare Part D (MPD) and Medicaid Formulary Decisions

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Interoffice Memo

To: All MAPMG Providers

From: Sheireen Huang, PharmD Carol Forster, MD

Regional Clinical Pharmacy Physician Director, Pharmacy Services Manager & Therapeutics/Medication Safety Pharmacy Co-Chair, Physician Co-Chair,

Regional P&T Committee Regional P&T Committee CC: Pharmacy Department

Date: March 6, 2015

Re: March Pharmacy and Therapeutics Committee Formulary Decisions

The chart below outlines KPMAS Commercial, Maryland HealthChoice, Virginia Medicaid and Medicare Part D (MPD) formulary decisions from the March 2015 KPMAS Regional Pharmacy & Therapeutics Committee meeting. Detailed evidence-based drug monographs used when evaluating these products are available by request. In addition, please see the attached for summary of tips on how to find formulary information online and the formulary review process. Please feel free to contact Sheireen Huang, PharmD and/or Carol Forster, MD via email at sheireen.k.huang@kp.org and/or

carol.a.forster@kp.org if there are any questions.

Commercial, Medicare Part D (MPD) and Medicaid Formulary Decisions

DRUG AND STRENGTH RESTRICTION/COMMENT

Trumenba (Meningococcal Group B Vaccine) 0.5 mL injection

• Trumenba is FDA-approved in individuals aged 10-25 years for active immunization against invasive disease caused by Neisseria

meningitidis serogroup B.

• Menactra and Menveo (for high risk patients) are the KP-preferred meningococcal vaccines.

• ADD Trumenba to the commercial, MD HealthChoice and VA Medicaid formularies; effective 3/2/2015.

• Maintain on Tier 6 of the MPD formulary. Vyvanse (lisdexamfetamine)

10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg capsules

• Vyvanse does not offer any clinically significant benefits over the formulary preferred stimulant, Adderall XR, for treatment of attention-deficit/hyperactivity disorder (ADHD) and should be reserved for those patients who have failed and/or are not candidates for Adderall XR.

• Although, Vyvanse was recently FDA-approved for the treatment of moderate to severe Binge Eating Disorder (BED), its comparative efficacy to current treatment options such as, selective serotonin reuptake inhibitors (SSRIs), is unknown.

• Reviewed and voted to REMOVE Vyvanse 20 mg, 30 mg 40 mg, 50 mg, 60 mg and 70 mg capsules from the commercial and VA Medicaid formularies; effective 5/5/2015.

• Reviewed and voted to NOT add Vyvanse 10 mg capsule to the commercial and VA Medicaid formularies.

• Vyvanse is carved out on the MD HealthChoice formulary.

• Maintain Vyvanse 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg on Tier 3; recommend to ADD Vyvanse 20 mg, 30 mg 40 mg, 50 mg, 60 mg, and 70 mg capsules to Tier 4 of the MPD formulary; effective 1/1/2016.

• Maintain Vyvanse 10 mg on Tier 4 of the MPD formulary.

Regional Pharmacy & Therapeutics Committee March 2015 Formulary Decisions Submitted by: Kodilichi Nwankwo, PharmD, MBA

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Commercial, Medicare Part D (MPD) and Medicaid Formulary Decisions cont’d

Colchicine (generic Mitigare) 0.6 mg capsules

• Colchicine capsule is the KP-preferred generic colchicine product and is indicated for gout flare prophylaxis in adults.

• Colchicine capsule is an authorized generic (AG) of Mitigare.

• Reviewed and voted to ADD colchicine capsule to the commercial, MD HealthChoice and VA Medicaid formularies; effective 3/23/2015.

• ADD on Tier 3 of the MPD formulary; effective 4/7/2015. Colchicine (generic Colcrys)

0.6 mg tablets

• Colchicine tablet is no longer the KP-preferred generic colchicine product.

• Reviewed and voted to REMOVE colchicine tablet from the

commercial, MD HealthChoice and VA Medicaid formularies; effective 5/5/2015.

• Maintain on Tier 2 of the MPD formulary. Azelastine (generic Astelin)

0.1% nasal spray

• Azelastine should be reserved for patients who do not respond or tolerate nasal corticosteroids and/or over-the-counter low-sedating oral antihistamines.

• Azelastine remains the most cost-effective intranasal antihistamine available and current prescribing restrictions has had little effect on utilization.

• Reviewed and voted to REMOVE prescribing restrictions to Allergy and ENT; maintain on commercial, MD HealthChoice and VA Medicaid formularies.

• Maintain on Tier 2 of the MPD formulary. Lovenox (enoxaparin)

300 mg/3 mL vial injection

• Low dose Lovenox, 30 mg and 40 mg, are not available in graduated syringes and this may lead to medication errors in pediatric patients during dose administration.

• Lovenox 300 mg/3 mL in multi-dose vials, administered with an insulin syringe, will allow for accurate dose administration in the pediatric patients requiring doses of less than 50 mg.

• Reviewed and voted to ADD Lovenox 300 mg/3 mL to the commercial and VA Medicaid formularies; effective 4/7/2015.

• ADD to the MD HealthChoice formulary; effective 5/5/2015.

• Maintain on Tier 3 of the MPD formulary. FIRST-Lansoprazole

(lansoprazole)

3 mg/mL oral suspension

• FIRST-lansoprazole compounding kit is a lansoprazole oral

suspension that should be limited to patients who are unable to use capsules, such as pediatric patients. Lansoproprazole is not the KP-preferred proton pump inhibitor (PPI).

• FIRST-lansoprazole contains benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal “gasping syndrome” in neonates.

• Reviewed and voted to NOT add FIRST-lansoprazole to the commercial, MD HealthChoice and VA Medicaid formularies.

• Maintain on Tier 4 of the MPD formulary.

• REMOVE extemporaneously compounded lansoprazole oral

suspension from the KPMAS List of Standard Compounds; effective 5/5/2015.

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First-Omeprazole (omeprazole) 2 mg/mL oral suspension

• Extemporaneously prepared omeprazole suspension is prepared using sodium bicarbonate which has had shortage issues.

• First-Omeprazole is a strawberry flavored omeprazole oral suspension with improved taste, tolerability, and efficiency of compounding. It is the preferred proton pump inhibitor (PPI) option for patients unable to swallow capsules.

• Reviewed and recommended to ADD First-Omeprazole to the

commercial, MD HealthChoice and VA Medicaid formularies; pending MPD tier change.

• Recommend ADD to Tier 3 of the MPD formulary.

• REMOVE extemporaneously compounded omeprazole oral

Omeprazole+SyrSpend SF Cherry Alka (omeprazole) 2 mg/mL oral suspension

• Omeprazole+SyrSpend SF Cherry Alka is a commercially available formulation of omeprazole oral suspension.

• A more cost-effective omeprazole oral suspension, First-Omeprazole is available and preferred at KPMAS.

• Reviewed and voted to NOT add Omeprazole+SyrSpend SF Cherry Alka to the commercial, MD HealthChoice and VA Medicaid

formularies.

• Maintain on Tier 4 of the MPD formulary.

• REMOVE extemporaneously compounded omeprazole oral

KPMAS List of Standard Compounds

Compounded Enalapril 1 mg/mL oral suspension (enalapril maleate 20 mg tablets, Ora-Sweet/Ora-Plus mixture or cherry syrup)

• Commercially formulated Epaned (enalapril) powder for 1 mg/mL oral solution is available in the same concentrations as the

extemporaneous compound.

• Epaned is not on the commercial, MD HealthChoice and VA Medicaid formularies.

• Extemporaneous compounds are not recommended over the commercially available product.

• Reviewed and voted to REMOVE extemporaneously compounded enalapril oral suspension from the KPMAS List of Standard

Compounds; effective 5/5/2015. Compounded Isoniazid 10 mg/mL

oral suspension (isoniazid 100 mg tablets, water, and sorbitol)

• Commercially formulated generic isoniazid 50 mg/5 mL syrup is available in the same concentrations as the extemporaneous compound. Generic isoniazid 50 mg/5 mL syrup is formulary.

• Extemporaneous compounds are not recommended over the commercially available product.

• Reviewed and voted to REMOVE extemporaneously compounded isoniazid oral suspension from the KPMAS List of Standard Compounds; effective 5/5/2015.

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KPMAS List of Standard Compounds cont’d

Compounded Carbamazepine 10 mg/mL oral suspension (carbamazepine

200 mg tablets, sterile water, and cherry syrup)

• Commercially formulated carbamazepine 100 mg/5 mL oral suspension is available and on the formulary.

• The concentration of the commercially available product is sufficiently similar to the extemporaneous compound.

• Reviewed and voted to REMOVE extemporaneously compounded carbamazepine oral suspension from the KPMAS List of Standard Compounds; effective 5/5/2015.

Mercaptopurine 50 mg/mL oral suspension (mercaptopurine 50 mg tablets, sterile water, simple syrup and cherry syrup)

• Commercially formulated Purixan (mercaptopurine) 20 mg/mL oral suspension is available.

• Purixan can eliminate the safety concerns of handling mercaptopurine, a cytotoxic agent, during compound preparation.

• Reviewed and voted to REMOVE extemporaneously compounded mercaptopurine oral suspension from the KPMAS List of Standard Compounds; effective 5/5/2015.

• At the February 2015 P&T meeting, recommended to ADD Purixan to the commercial, MD HealthChoice and VA Medicaid formularies; pending MPD change from Tier 4 to Tier 3.

Commercial, Medicare Part D (MPD) and Medicaid Formulary Decisions cont’d Class Reviews

Anti-Infective Agents

Anthelmintics • No changes recommended. Antibacterials • No changes recommended. Aminoglycosides • No changes recommended. Cephalosporins • No changes recommended. First Generation Cephalosporins • No changes recommended. Second Generation

Cephalosporins

• No changes recommended. Third Generation Cephalosporins • No changes recommended. Fourth Generation

Cephalosporins

• No changes recommended. Fifth Generation Cephalosporins • No changes recommended. Miscellaneous Beta Lactams • No changes recommended. Carbacephems • No changes recommended. Carbapenems • No changes recommended. Cephamycins • No changes recommended.

Monobactams • Reviewed and voted to REMOVE Azactam (aztreonam) 2 g injection from the commercial, MD HealthChoice, and VA Medicaid formularies; effective 5/5/2015.

• Maintain Azactam (aztreonam) 2 g injection on Tier 3 of the MPD formulary. Recommend to ADD Azactam (aztreonam) 2 g injection to Tier 4 of the MPD formulary; effective 1/1/2016.

• Reviewed and voted to ADD aztreonam (generic Azactam) 1 g and 2 g injection to the commercial and VA Medicaid formularies; effective 4/7/2015.

• ADD aztreonam (generic Azactam) 1 g and 2 g injectionto the MD HealthChoice formulary; effective 5/5/2015.

• Maintain aztreonam (generic Azactam) 1 g and 2 g injection on Tier 2 of the MPD formulary.

Chloramphenicol • No changes recommended.

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Class Reviews

Macrolides • No changes recommended. Erythromycins • No changes recommended. Ketolides • No changes recommended.

Other macrolides • Azithromycin (generic Zithromax) 1 g oral pack is available on formulary.

• Reviewed and voted to REMOVE Zithromax (azithromycin) 1 g oral pack from the commercial, MD HealthChoice, and VA Medicaid formularies; effective 5/5/2015.

• Maintain Zithromax (azithromycin) 1 g oral pack on Tier 3 of the MPD formulary. Recommend to ADD Zithromax (azithromycin) 1 g to Tier 4 of the MPD formulary; effective 1/1/2016.

Penicillins • No changes recommended. Natural Penicillins • No changes recommended.

Aminopenicillins • Ampicillin and sulbactam (generic Unasyn) 1.5 g and 3 g injection is available on formulary.

• Reviewed and voted to REMOVE Unasyn (ampicillin and sulbactam) 1.5 g and 3 g injection from the commercial, MD HealthChoice, and VA Medicaid formularies effective 5/5/2015.

• Maintain Unasyn (ampicillin and sulbactam) 1.5 g and 3 g injection on Tier 4 of the MPD formulary.

Penicillinase-resistant • No changes recommended. Extended-spectrum • No changes recommended. Quinolones • No changes recommended. Sulfonamides • No changes recommended. Tetracyclines • No changes recommended. Miscellaneous Antibacterials • No changes recommended. Aminocyclitols • No changes recommended. Bacitracins • No changes recommended. Cyclic Lipopeptides • No changes recommended. Glycopeptides • No changes recommended.

Lincomycins • Clindamycin (generic Cleocin) is continually used as a clinic administered medication in the Critical Decision Units (CDU) and Ambulatory Surgery Centers (ASC).

• Reviewed and voted to ADD clindamycin (generic Cleocin)

300 mg/2 mL, 600 mg/4 mL, 900 mg/6 mL injection to the commercial and VA Medicaid formularies; effective 4/7/2015.

• ADD clindamycin (generic Cleocin) 300 mg/2 mL, 600 mg/4 mL, 900 mg/6 mL injectionto the MD HealthChoice formulary; effective 5/5/2015.

• Clindamycin (generic Cleocin) 9 gm/60 mL (150 mg/mL) and 9000 mg/60 mL has low utilization.

• Reviewed and voted to REMOVE clindamycin (generic Cleocin) 9 gm/60 mL (150 mg/mL) and 9000 mg/60 mL from the commercial, MD HealthChoice, and VA Medicaid formularies; effective 5/5/2015.

• Maintain clindamycin (generic Cleocin) on Tier 2 of the MPD formulary.

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Oxazolidinone • Reviewed and voted to REMOVE Zyvox (linezolid) 2 mg/mL injection from the commercial, MD HealthChoice, and VA Medicaid formularies; effective 5/5/2015.

• Maintain Zyvox (linezolid) 2 mg/mL injection on Tier 5 of the MPD formulary.

• Reviewed and voted to ADD linezolid (generic Zyvox) 2 mg/mL injection to the commercial and VA Medicaid formularies; effective 4/7/2015.

• ADD linezolid (generic Zyvox) 2 mg/mL injectionto the MD HealthChoice formulary; effective 5/5/2015.

• Maintain linezolid (generic Zyvox) injection on Tier 2 of the MPD formulary.

Polymyxins • No changes recommended. Rifamycins • No changes recommended. Streptogramins • No changes recommended. Antifungals • No changes recommended. Allylamines • No changes recommended.

Azoles • No changes recommended.

Echinocandins • No changes recommended.

Polyenes • No changes recommended.

Pyrimidines • No changes recommended.

Miscellaneous Antifungals • Reviewed and voted to REMOVE Grifulvin V (griseofulvin) 500 mg tablets from the commercial, MD HealthChoice, and VA Medicaid formularies; effective 5/5/2015.

• Maintain Grifulvin V (griseofulvin) 500 mg tablets on Tier 4 of the MPD formulary.

• Reviewed and voted to ADD griseofulvin (generic Grifulvin V) 500 mg tablets to the commercial and VA Medicaid formularies; effective 4/7/2015.

• ADD griseofulvin (generic Grifulvin V) 500 mg tablets to the MD HealthChoice formulary; effective 5/5/2015.

• Maintain griseofulvin (generic Grifulvin V) on Tier 2 of the MPD formulary.

Antimycobacterials • No changes recommended. Antituberculosis Agents • No changes recommended. Miscellaneous Antimycobacterials • No changes recommended. Antivirals • No changes recommended. Adamantanes • No changes recommended. Antiretrovirals • No changes recommended. Interferons • No changes recommended. Monoclonal Antibodies • No changes recommended. Neuraminidase Inhibitors • No changes recommended. Nucleosides and Nucleotides • No changes recommended. HCV Protease Inhibitors • No changes recommended. Miscellaneous Antivirals • No changes recommended. Antiprotozoals • No changes recommended. Amebicides • No changes recommended. Antimalarials • No changes recommended. Miscellaneous Antiprotozoals • No changes recommended.

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Class Reviews

Urinary Anti-infectives • Macrodantin (nitrofurantoin) 25 mg capsules have low utilization and is available as generic in other strengths.

• Reviewed and voted to REMOVE Macrodantin (nitrofurantoin) 25 mg capsules from the commercial, MD HealthChoice, and VA Medicaid formularies; effective 5/5/2015.

• Maintain Macrodantin (nitrofurantoin) 25 mg capsules on Tier 3 of the MPD formulary. Recommend to ADD Macrodantin (nitrofurantoin) 25 mg capsules to Tier 4 of the MPD formulary; effective 1/1/2016. Autonomic Drugs

Parasympathomimetic • No changes recommended. Anticholinergic Agents • No changes recommended. Antimuscarinics/Antispasmodics • No changes recommended. Sympathomimetic (Adrenerigic)

Agents

• No changes recommended. Alpha Adrenergic Agonists • No changes recommended. Beta Adrenergic Agonists • No changes recommended. Non-selective Beta Adrenergic

Agonists

• No changes recommended. Selective Beta-1 Adrenergic

Agonists

• Dopamine and dobutamine injections are used in the pediatric and adult crash carts.

• Reviewed and voted to ADD dopamine 400 mg/250 mL injection to the commercial and VA Medicaid formularies; effective 4/7/2015.

• ADD dopamine 400 mg/250 mL injection to the MD HealthChoice formulary; effective 5/5/2015.

• Reviewed and voted to ADD dobutamine 500 mg/250 mL injection to the commercial and VA Medicaid formularies; effective 4/7/2015.

• ADD dobutamine 500 mg/250 mL injection to the MD HealthChoice formulary; effective 5/5/2015.

• Dopamine and dobutamine injections are exempt from the MPD formulary.

Selective Beta-2 Adrenergic Agonists

• ProAir (albuterol) multi-dose inhaler is available on formulary.

• Maintain Ventolin HFA (albuterol) 90 mcg/inhalation as nonformulary on the commercial, MD HealthChoice, and VA Medicaid formularies.

• Maintain Proventil HFA (albuterol) 90 mcg/inhalation as nonformulary on the commercial, MD HealthChoice, and VA Medicaid formularies.

• Maintain Ventolin HFA and Proventil HFA 90 mcg/inhalation on Tier 4 of the MPD formulary.

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Alpha and Beta Adrenergic Agonists

• Epinephrine (generic Adrenaclick) 0.15 mg and 0.3 mg auto-injector are available on formulary.

• Maintain Adrenaclick (epinephrine) 0.15 mg and 0.3 mg auto-injector as nonformulary on the commercial, MD HealthChoice, and VA Medicaid formularies.

• Maintain Auvi-Q (epinephrine) 0.3 mg auto-injector as nonformulary on the commercial, MD HealthChoice, and VA Medicaid formularies.

• Maintain Twinject (epinephrine) 0.15 mg and 0.3 mg auto-injector as nonformulary on the commercial, MD HealthChoice, and VA Medicaid formularies.

• Maintain Twinject 0.15 mg and 0.3 mg auto-injector on Tier 3 of the MPD formulary. Recommend to ADD Twinject 0.15 mg and 0.3 mg to Tier 4 of the MPD formulary; effective 1/1/2016.

• Maintain Adrenaclick and Auvi-Q 0.15 mg and 0.3 mg auto-injector on Tier 4 of the MPD formulary.

Sympatholyitc (Adrenergic Blocking) Agents

• No changes recommended. Alpha-adrenergic Blocking Agents • No changes recommended. Non-selective Alpha-adrenergic

Blocking Agents

• No changes recommended. Alpha1-selective Adrenergic

Blocking Agents

• No changes recommended. Skeletal Muscle Relaxants

(SMRs)

• No changes recommended. Centrally Acting Skeletal Muscle

Relaxants

• No changes recommended. Direct-acting Skeletal Muscle

Relaxants

• No changes recommended. GABA-derivative Skeletal Muscle

Relaxants

• No changes recommended.

Neuromuscular Blocking Agents • Reviewed and voted to ADD dantrium (generic Revonto) 20 mg injection to the commercial and VA Medicaid formularies; effective 4/7/2015.

• ADD dantrium (generic Revonto) 20 mg injection to the MD HealthChoice formulary; effective 5/5/2015.

• Dantrium (generic Revonto) is exempt from the MPD formulary.

• Dantrolene (generic Dantrium) 50 mg capsule is the only strength of dantrolene not included on formulary that is currently being utilized.

• Reviewed and voted to ADD dantrolene (generic Dantrium) 50 mg capsules to the commercial and VA Medicaid formularies; effective 4/7/2015.

• ADD dantrolene (generic Dantrium) 50 mg capsule to the MD HealthChoice formulary; effective 5/5/2015.

• Maintain dantrolene 50 mg (generic Dantrium) capsules on Tier 2 of the MPD formulary.

Miscellaneous Skeletal Muscle Relaxants

• No changes recommended. Miscellaneous Autonomic Drugs • No changes recommended.

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Decongestants

Symphathomimetic (Adrenergic) Agents

• Reviewed and voted to ADD all generic OTC products and REMOVE all branded OTC products, if an equivalent generic OTC is available, from the VA Medicaid formulary; effective 5/5/2015.

• Decongestant OTC products are exempt from the MD HealthChoice Formulary.

• OTC products are exempt from the commercial and MPD formularies. Alpha-Adrenergic Agonists • Reviewed and voted to ADD all generic OTC products and REMOVE

all branded OTC products, if an equivalent generic OTC is available, from the VA Medicaid formulary; effective 5/5/2015.

• OTC products are exempt from the commercial and MPD formularies. Alpha- and Beta- Adrenergic

Agonists

• Reviewed and voted to ADD all generic OTC products and REMOVE all branded OTC products, if an equivalent generic OTC is available, from the VA Medicaid formulary; effective 5/5/2015.

• OTC products are exempt from the commercial and MPD formularies. Nicotine Cessation

Autonomic Drugs, Miscellaneous • Reviewed and voted to ADD all generic OTC products and REMOVE all branded OTC products, if an equivalent generic OTC is available, from the VA Medicaid formulary; effective 5/5/2015.

• Nicotine cessation products are carved out of MD HealthChoice Formulary.

• OTC products are exempt from the commercial and MPD formularies. Prescribing Recommendations

Azelastine (generic Astelin) 1% Nasal Spray

• Azelastine 1% (generic Astelin) is an intranasal second-generation antihistamine recommended in clinical guidelines as an adjunct therapy for management of allergic and non-allergic rhinitis.

• This guideline promotes the use of nasal corticosteroids and OTC low-sedating oral antihistamines as first-line agents in treating seasonal allergic rhinitis.

• Azelastine should be reserved for patients who do not respond or tolerate nasal corticosteroids and/or OTC low-sedating oral antihistamines.

• Reviewed and endorsed.

Annual Review of Policies and Procedures

POLICIES AND PROCEDURES RESTRICTION/COMMENT

Medical Sales Representatives

• This policy outlines expectations and requirements regarding the appropriate relationships between MAPMG providers and KPMAS health plan staff with pharmaceutical manufacturers.

• Reviewed and endorsed.

Maryland HealthChoice and Virginia Medicaid Prior Authorizations

Hepatitis C Therapy Prior Authorization

• The prior authorization form was updated to include: o Viekira Pak on the medication list

o A new section reflecting Laboratory Results o A new section reflecting Treatment Plan o A new section reflecting Medical History and o A new section reflecting Prior Drug Utilization

• Reviewed and approved the revised prior authorization criteria for Harvoni, Olysio, Sovaldi, and Viekira Pak for Treatment of Hepatitis C.

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Inter-regional MPD Pharmacy and Therapeutics (iM-PacT) Committee February 4th, 2015 meeting

Drug Decisions

Blincyto (blinatumomab) 35 mcg injection

• Protected Class.

• Confirmed Specialty Tier 5 status. Opdivo (nivolumab)

40 mg/4 mL, 100 mg/10 mL injection

• Confirmed Specialty Tier 5 status. Lynparza (olaparib)

50 mg capsules

• Confirmed Specialty Tier 5 status, Protected Class. Grastek (timothy grass pollen

allergen extract) 2800 BAU sublingual tablets

• Retained on Non-Preferred Brand Tier 4.

2015 National Medicare Part D Formulary Initial Tier Placement for Recently Launched and Approved Products

Viekira Pak (ombitasvir, paritaprevir and ritonavir, co-packaged with dasabuvir) tablets

• Placed on Specialty Tier 5; effective 1/1/2015.

Lynparza (olaparib) 50 mg capsules

• Placed on Specialty Tier 5; effective 1/1/2015. Blincyto (blinatumomab)

35 mcg injection

• Placed on Specialty Tier 5; effective 1/1/2015. Opdivo (nivolumab)

40 mg/4 mL, 100 mg/10 mL injection

• Placed on Specialty Tier 5; effective 1/1/2015. Belsomra (suvorexant)

5 mg, 10 mg,15 mg, 20 mg tablets

• Placed on Non-Preferred Brand Tier 4; effective 2/3/2015. Trumenba (meningococcal group

B) vaccine injection

• Placed on Part D Vaccine Tier 6; effective 2/3/2015. Lemtrada (alemtuzumab)

12 mg/1.2 mL injection

• Placed on Specialty Tier 5; effective 2/3/2015. Gardasil 9 (human

papillomavirus 9-valent)

vaccine, recombinant injection

• Placed on Part D Vaccine Tier 6; effective 2/3/2015. Savaysa (edoxaban)

15 mg, 30 mg, 60 mg tablets

• Placed on Non-Preferred Brand Tier 4; effective 2/3/2015. Impavido (miltefosine)

50 mg capsules

• Placed on Non-Preferred Brand Tier 4; launch date pending. Movantik (naloxegol) 12 mg,

15 mg tablets

• Placed on Non-Preferred Brand Tier 4; launch date pending. Vitekta (elvitegravir)

85 mg, 150 mg tablets

• Placed on Specialty Tier 5 Pending; launch date pending. Xtoro (finafloxacin)

0.30% suspension

• Placed on Non-Preferred Brand Tier 4 Pending; launch date pending.

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February 4th, 2015 meeting

CMS/Medicare Part D Formulary Review: Formulary Decisions Based on Current/Ongoing Evaluations

Farxiga (dapagliflozin) 5 mg, 10 mg tablets

• New drug approval as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• Retained on Non- Preferred Brand Tier 4. Vimizim (elosufase alfa)

5 mg/5mL injection

• New drug approval for the treatment of mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

• Retained on Specialty Tier 5. Ragwitek (short ragweed pollen

allergen extract)

12 AMB A 1-U sublingual tablets

• New drug approval for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen- specific IgE antibodies for short ragweed pollen in adults 18 to 65 years of age.

• Retained on Non- Preferred Brand Tier 4. Oralair (sweet vernal, orchard,

perennial rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract)

100 IR, 300 IR sublingual tablets

• New drug approval for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the 5 grass species contained in this product in patients 10 through 65 years of age.

• Retained on Non- Preferred Brand Tier 4. Northera (droxidopa)

100 mg, 200 mg, 300 mg capsules

• New drug approval for the treatment of orthostatic dizziness, light-headedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson disease [PD], multiple system atrophy [MSA], and pure autonomic failure [PAF]), dopamine beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy.

• Specialist review in progress, remains on Specialty Tier 5. Cerdelga (eliglustat)

84 mg capsules

• New drug approval for the treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs).

• Specialist review in progress, remains on Specialty Tier 5. Kerydin (tavaborole)

5% topical solution

• New drug approval for the treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton

mentagrophytes.

• Specialist review in progress, remains on Non-Preferred Brand Tier 4. Striverdi Respimat (olodaterol)

2.5 mcg/actuation aerosol solution, inhalation

• New drug approval for the treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

• Specialist review in progress, remains on Non-Preferred Brand Tier 4.

Plegridy (peginterferon beta-1a) prefilled 125 mcg/0.5 mL prefilled syringe, 63 mcg/0.5 mL and 95 mcg/0.5 mL Starter Pak

• New drug approval for the treatment of patients with relapsing forms of multiple sclerosis.

• Specialist review in progress, remains on Specialty Tier 5. Ofev (nintedanib) 100 mg, 150 mg

capsules

• New drug approval for the treatment of idiopathic pulmonary fibrosis.

• Specialist review in progress, remains on Specialty Tier 5.

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CMS/Medicare Part D Formulary Review: Formulary Decisions Based on Current/Ongoing Evaluations cont’d

Orbactiv (oritavancin)

400 mg for intravenous injection

• New drug approval for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram- positive

microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates); Streptococcus pyogenes; Streptococcus agalactiae; Streptococcus

dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus); and Enterococcus faecalis (vancomycin- susceptible isolates only).

• Specialist review in progress, remains on Specialty Tier 5. Esbriet (pirfenidone)

267 mg capsules

• New drug approval for the treatment of idiopathic pulmonary fibrosis.

• Specialist review in progress, remains on Specialty Tier 5 Humira (adalimumab)

20 mg/0.4 mL, 40 mg/0.8 mL Injection

• New indication for the treatment of childhood arthritis in younger patients. Retained on Specialty Tier 5.

Other Decisions

National Part D 30 Day Supply Drug List

• Approved addition of the following drug(s) to the list:

o Obredon (guaifenesin 200 mg/hydrocodone 2.5 mg/5 mL) oral solution

o Viekira Pak (ombitasvir 12.5 mg, paritaprevir 75 mg and ritonavir 50 mg, co- packaged with dasabuvir 250 mg tablet) 2016 Calendar Year (CY)

Formulary Initial Tiering File

• Approved Opioid Retrospective Drug

Utilization Review, Quarters 2, 3, 2014 Report

• Approved

New Drugs and Indications

Tybost (cobicistat) 150 mg tablet • Protected Class.

• Specialist review in progress, remains on Non- Preferred Brand Tier 4. Jardiance (empagliflozin)

10 mg, 25 mg tablet

• Specialist review in progress, remains on Non- Preferred Brand Tier 4. Invokamet

(canagliflozin/metformin) 50 mg/500 mg, 150 mg/500 mg, 50 mg/1000 mg, 150 mg/100 mg tablet

• Specialist review in progress, remains on Non- Preferred Brand Tier 4.

Lemtrada (alemtuzumab) 12 mg/1.2 mL IV

• Specialist review in progress, remains on Specialty Tier 5 Akynzeo (netupitant and

palonosetron)

300 mg /0.5 mg capsule

• Specialist review in progress, remains on Non- Preferred Brand Tier 4.

Effective dates reflect implementation into the systems.

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KAISER PERMANENTE Mid-Atlantic States Region

Pharmacy & Therapeutics Committee

On the Kaiser Permanente Intranet

1. Where can I find the drug formulary online?

Click on “Formulary” link on KP HealthConnect home page (bottom right), or MAPMG Providers via intranet:

• Go to http://pithelp.co.kp.org/MAS/phcy_therpeutics.html Network Providers:

• Go to http://providers.kp.org/mas/formulary.html

2. How can I find out if something is on the drug formulary and view the drug monograph for a drug on the formulary?

MAPMG Providers

• To view the criteria for use, contraindications, adverse reactions, drug interactions, and dosing information, click on the Lexi-comp® Interactive Version under Full MAS Drug Formulary. When you enter the site, a search screen appears in the upper left hand corner of your screen. Type in the first few letters or the entire drug name and select SEARCH. All drugs containing that information are listed in the SEARCH RESULTS box. If a drug is not on formulary or it is spelled incorrectly, "No occurrences found" will appear in the SEARCH RESULTS box.

• Formulary status of a particular drug can be found in HealthConnect™ in the “Pharmacy” column in the drug listing. “Yes” in this column means that particular product is formulary. Remember, there are sometimes many duplicative products for a single drug entity. In that event, scroll down the list to look for the product that is formulary.

Network Providers

• Go to http://providers.kp.org/mas/formulary.html • Click on comprehensive listing of formulary drugs

• Press (ctrl+F) and search for the particular drug of interest on the “Find” field appearing on the upper left corner of the screen.

• If the drug is spelled incorrectly or is not on the formulary the following message will appear “The Item was not found”

3. How can I receive a copy of the formulary?

MAPMG Providers

• Go to http://pithelp.co.kp.org/MAS/formulary.html • You may print a copy of the formulary document Network Providers

• Go to http://providers.kp.org/mas/formulary.html • Click on comprehensive listing of formulary drugs • You may print a copy of the formulary document

You may also contact our Provider Relations Department at 1-877-806-7470 for a paper copy of our formularies.

Tips on how to find

formulary information

from the computer

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4. How can I request an addition or deletion from the formulary?

• New drug entities remain Non-formulary until reviewed by the Regional P&T Committee. We will review any drug upon written request with supporting evidence to make an evidence-based decision. The Drug Formulary Addition and Deletion Request Form can be obtained via the internet for both MAPMG and Network Providers:

MAPMG: • Go to http://pithelp.co.kp.org/MAS/documents/phcy_therpeutics/DrugFormularyAdditionAndDeletion RequestForm.pdf Network Providers: • Go to http://providers.kp.org/mas/formulary.html

• Under section “Request to review medications for addition/deletion to the formulary”, click on download a form.

The completed form can be

1. Faxed at 301-816-6372, attention: P&T Committee co-chairs 2. Mailed to:

Kaiser Permanente

Regional Office, Pharmacy 3-West

Attention: P&T Committee Co-Chairs, Drug Review 2101 East Jefferson Street

Rockville, MD 20852

3. Emailed by contacting any of the P&T Committee Co-Chairs: Carol Forster, MD

Sheireen Huang, PharmD

Ashely Kim, PharmD

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Applying evidence-based medicine, the Regional P&T Committee and its Consultants determine

whether a medicine should be added to the drug formulary. The key points of this

evidence-based review are highlighted; a full description of the formulary review process is available at:

http://pithelp.co.kp.org/MAS/documents/phcy_therpeutics/FormularyProcessGuide.pdf

Non-formulary Medication Exception Process:

• Developed to provide access to medically necessary drugs under a member’s drug benefit even when that drug is not on the Formulary.

• Ensures the practitioner makes the final decision regarding what drug is appropriate for the member. • Non-formulary drugs should be used only if the

member fails to respond to formulary drug therapy, or has special circumstances requiring the use of a non-formulary drug.

• Non-formulary Exception Reason:

o Allergy/Adverse reaction to formulary drug(s)

o Treatment failure to formulary drug(s) o Meets specific criteria/restriction according to

Kaiser Permanente drug treatment guidelines. o Formulary alternatives available/patient request

non-covered, non-formulary drug – the patient will pay full Member Rate price.

*Stewardship: We ensure our stewardship by using and managing our resources appropriately - KPMAS

Applying evidence-based medicine, the Regional Pharmacy and Therapeutics Committee and its Consultants determine whether a medicine should be added to the drug formulary. The key points of this evidence-based review are highlighted; a full description of the formulary review process is available at:

http://pithelp.co.kp.org/MAS/documents/phcy_therpeutics/For mularyProcessGuide.pdf

CONFIDENTIAL – FOR INTERNAL USE ONLY