Well Informed. Utilization Program Updates to Promote Guideline Adherence. Effective January 1, 2018:

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1 Q As we continue our rapid growth under the ownership of The Carlyle Group, we have a lot of exciting news to share. This edition details upcoming changes to our 2018 drug utilization programs and explores the merits of allowing transitional retail pharmacy fills. We also announce a recent award bestowed upon US Specialty Care; provide links to our H2 pipeline reports; and include a list of new FDA-approved drugs. We hope this information is beneficial and reflects our ongoing commitment to both our clients and plan participants. Please let us know if you have any questions or if there is anything we can do to strengthen our relationship. Sincerely, Zach Johnson, President, WellDyneRx Well Informed Effective January 1, 2018: Utilization Program Updates to Promote Guideline Adherence Beginning January 1, 2018, WellDyneRx will require prior authorizations (PAs) and/or quantity level limits (QLLs) for the following medications. These programs were developed in collaboration with an external pharmacy and therapeutics (P&T) committee to ensure prescribing practices are consistent with evidence and guidelines. The QLLs are based on safety and efficacy testing results. Quantities above the recommended limit are allowed on a case-by-case basis when evidence supports the use of higher doses. Actinic Keratosis (AK) Actinic keratosis, or sun spots, are rough, scaly or crusty growths on the skin that develop from years of exposure to the sun. There are numerous topical products on the market to treat AK, including four categories of topical medications: topical 5-fluorouracil (5-FU), topical imiquimod, topical ingenol mebutate, and topical diclofenac. The products within each of these categories are a mix of generic and brand name medications. The brand products vary in cost from $200 to $3000 for a one month supply. Clinical guidelines recommend using generic topical 5-FU or imiquimod, since these treatments are less expensive and range in price from between $75 and $300 for a one month supply. Prior authorizations will be required for approved indications and/or trial and failure of a less expensive medication, or the same medication(s) in a non-combination form. There are many treatment alternatives available for each of the drugs noted. Amrix Amrix is an extended-release formulation of Flexeril (cyclobenzaprine) which is indicated for the treatment of muscle spasms associated with acute painful musculoskeletal conditions. Amrix costs between $1200 and $2300 for a one month (Continues on next page) Q Well Informed

2 (Continued from previous page) supply, while a 90 day supply of cyclobenzaprine (at the highest dose) costs only $100. Cambia Cambia is a powder for oral solution formulation of diclofenac potassium and it is indicated for migraine attacks. Although Cambia is a nonsteroidal anti-inflammatory (NSAID) drug similar to ibuprofen, it costs $68 per packet while ibuprofen is available overthe-counter (OTC), and as a prescription, for about $20 a month. Diclofenac also comes in a tablet formulation and costs approximately $30 a month. Clinical guidelines show that ibuprofen, at standard doses, is effective for acute migraine treatment. Jublia and Kerydin Jublia and Kerydin are both topical formulations used to treat onychomycosis (toenail fungus). Jublia costs between $700 and $1,400 and must be applied daily for 48 weeks, yielding only a 15% cure rate. Kerydin costs between $700 and $1,700 and also must be applied daily for 48 weeks, yielding only a 9.1% cure rate. Clinical guidelines recommend the use of oral antifungals as first-line therapy, with topical formulations being reserved for the last line of treatment. Tetracyclines Tetracyclines are a class of medications commonly used to treat bacterial infections, including both bacterial-derived acne and inflammationderived acne. Despite being used successfully for many years, newer acne treatment options are available, but they do not necessarily improve safety or efficacy. These newer brand name products range in price from $1 to $35 per capsule. WellDyneRx recommends introducing additional controls on these products as existing, less expensive, therapies are equally effective. These programs are expected to cause minimal patient disruption while providing significant cost savings for your plan. While these policies do not go into effect until January 1, 2018, WellDyneRx clients may adopt them sooner. For more information, contact your Account Executive. Lidocaine Lidocaine 5% ointment is a topical anesthetic indicated for intubation, venipuncture, and minor skin discomfort and irritation. It costs between $200 and $1500 for a 100 gram tube and off-label utilization is common. For minor topical skin discomforts, WelldyneRx recommends that plan participants try OTC products before using Lidocaine ointment, and then only for FDAapproved indications. Q Well Informed 2

3 US SPECIALTY CARE WINS Specialty Pharmacy PATIENT CHOICE AWARDS US Specialty Care (USSC) was named the winner of the Specialty Pharmacy Patient Choice Awards (PBM/Payer Specialty Pharmacy category) during the 2017 Asembia Specialty Pharmacy Summit. The Patient Choice Award recognizes specialty pharmacies with the highest patient satisfaction ratings across the United States. John Monahan, CEO of Zitter Health Insights (ZHI) and co-sponsor of the event, said the award honors specialty pharmacies that deliver the highest levels of patient satisfaction in a complex and challenging industry that demands expert care for seriously ill patients. By providing a consistent level of care, concern and commitment for overall patient health and well-being, these U.S. specialty pharmacies are taking their profession to new heights. Specialty Medications: Transitional Retail Fills are Unnecessary When new clients engage with US Specialty Care (USSC), they often wonder whether or not they should allow their plan participants to fill initial prescriptions for specialty medications at retail pharmacies. They believe that adopting this grace period will enable their members to get their specialty medication(s) quickly, without having to wait for USSC prescription delivery shipments to arrive USSC was selected based on results from the ZHI 2016 Patient Satisfaction Survey, which is representative of 80 percent of specialty pharmacies across the United States. The other finalists in the PBM/Payer Specialty Pharmacy category were CVS Health and Humana Specialty Pharmacy. USSC ultimately won the award based on overall patient satisfaction scores. For more detailed information about the award, please read the press release. We are very proud of this achievement as it demonstrates our commitment to providing quality member care while containing our client s costs. in the mail. While this practice may offer some benefits for clients transitioning to mandatory prescription delivery service for traditional medications, it may actually delay treatment for members taking specialty medications. Nearly all specialty medications require prior authorizations (PAs), and there is usually a delay in therapy associated with fulfilling the PA requirements, irrespective of where the prescription is filled. Secondly, due to the high cost of most specialty medications, many retail pharmacies don t keep them in stock and only order (Continues on next page) Q Well Informed 3

4 (Continued from previous page) them for patients when they receive a paid claim. Due to these factors, initiation of therapy is usually delayed regardless of whether the prescription is filled at a retail or specialty pharmacy. Additionally, transitioning patients to a specialty pharmacy after the first fill can cause delays and gaps in treatment if the member does not fully appreciate that they must get subsequent prescriptions filled exclusively through USSC. Finally, allowing members to fill prescriptions for specialty medications at retail pharmacies often increases costs for our clients as these pharmacies may not receive the same contracted rates as USSC and the staff at these pharmacies are not as well versed in the financial solutions (copay cards, etc.) available for specialty medications. WellDyneRx recommends against allowing transitional retail fills for specialty medications. This plan design option does not translate well to specialty medications and ultimately puts the member at a higher risk for treatment gaps. Q Well Informed 4

5 H Drug Pipeline REPORTS NOW AVAILABLE Please click the links below to access drug pipeline reports for the second half of 2017: Biosimilar Drug Pipeline Report Brand Drug Pipeline Report Generic Drug Pipeline Report Specialty Drug Pipeline Report These publications include: Descriptions of newly approved drugs, including product highlights, place in therapy, and market impact Summaries of specialty, nonspecialty, biosimilar, and generic drugs with anticipated FDA approval dates in the upcoming 12 months Additional FDA actions, including rejections and indications for specific drugs If you have any questions, please contact your account management team. UPCOMING Conferences Tradeshows Representatives from WellDyneRx will be attending the following conferences in the near future. If you are attending any of these events and would like to schedule an onsite meeting, please let us know. TABA 2017 Fall Conference & Membership Meeting September 26-27, 2017 The Woodlands, TX (Attending Only - Not Exhibiting) AmeriBen s 49th Annual Leadership Conference September 27-29, 2017 Sun Valley, ID (Booth #TBD) SIIA 37th Annual National Education Conference October 8-10, 2017 Phoenix, AZ (Booth #300) IFEBP 63rd Annual Employee Benefits Conference October 22-25, 2017 Las Vegas, NV (Booth #204) & Q Well Informed 5

6 NEW FDA-APPROVED DRUGS BRAND NAME GENERIC NAME(S) THERAPEUTIC USE BRIEF DESCRIPTION POTENTIAL IMPACT Zerviate (Nicox Ophthalmics Inc.) cetirizine ophthalmic solution Allergies Zerviate is a histamine-1 receptor antagonist ophthalmic solution indicated for treatment of ocular itching associated with allergic conjunctivitis. It is available as 2.4 mg cetirizine in 1 ml sterile solution. The recommended dose is one drop in each affected eye twice daily. Kevzara (Sanofi Synthelabo) sarilumab Rheumatoid Arthritis Kevzara solution is an interleukin-6 receptor antagonist indicated for adults with moderateto-severe active rheumatoid arthritis (RA) with inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). It contains a black box warning for severe infection and it is available in 150 mg/1.14 ml or 200 mg/1.14 ml pre-filled syringes. The recommended dose is 200 mg once every 2 weeks subcutaneous (SQ). Radicava (Mitsubishi Tanabe Pharma) edaravone Amyotrophic Lateral Sclerosis Radicava is indicated for amyotrophic lateral sclerosis (ALS). It is available as a 30 mg/100 ml single dose for injection. The initial recommended dose is 60 mg intravenous (IV) daily for 14 days, followed by a 14 day drug free period. Subsequent cycles are 60 mg daily for 10 out of 14 days, followed by a 14 day drug free period. Kisqali Femara Co-Pack (Novartis Pharms Corp.) ribociclib; letrozole Breast Cancer Kisqali Femara Co-Pack is indicated for postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced, or metastatic breast cancer. It is available as 200 mg Kisqali and 2.5 mg Femara. Kisqali is dosed 600 mg daily for 21 days, followed by 7 days off. Femara is dosed 2.5 mg daily for 28 days. Q Well Informed 6

7 NEW FDA-APPROVED DRUGS BRAND NAME GENERIC NAME(S) THERAPEUTIC USE BRIEF DESCRIPTION POTENTIAL IMPACT Imfinzi (Astrazeneca) durvalumab Urothelial Carcinoma Imfinzi is a programmed death ligand-1 (PD-L1) blocking antibody indicated for locally advanced or metastatic urothelial carcinoma that has progressed during or following platinum containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. It is available as 500 mg/10 ml or 120 mg/2.4 ml vials for injection and is dosed at 10 mg/ kg IV every 2 weeks. Alunbrig (Ariad) brigatinib Non-Small Cell Lung Cancer Alunbrig is a kinase inhibitor indicated for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in patients who have progressed or are intolerant to crizotinib. It is available as a 30 mg or 90 mg tablet. The recommended dose is 90 mg once daily for 7 days, then increase to 180 mg once daily. Tymlos (Radius Health Inc.) abaloparatide Osteoporosis Tymlos is a human parathyroid hormone-related peptide analog indicated for postmenopausal women with osteoporosis at high risk for fracture. It is available as a 3120 mcg/1.56 ml prefilled syringe. The recommended dose is 80 mcg SQ once daily. Low Rydapt (Novartis Pharms Corp.) midostaurin Acute Myeloid Leukemia Rydapt is a kinase inhibitor indicated for adults with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive in combination with cytarabine and daunorubicin induction and cytarabine consolidation. It is available as a 25 mg capsule and is dosed at 50 mg twice daily. Q Well Informed 7

8 NEW FDA-APPROVED DRUGS BRAND NAME GENERIC NAME(S) THERAPEUTIC USE BRIEF DESCRIPTION POTENTIAL IMPACT Brineura (Biomarin Pharm) cerliponase alfa Tripeptidyl Peptidase 1 Deficiency Brineura is a hydrolytic lysosomal N-terminal tripeptidyl peptidase indicated for patients 3 years of age or older to slow the loss of ambulation in symptomatic patients with tripeptidyl peptidase 1 deficiency. It is available as a 150 mg/5 ml IV injection. The recommended dose is 300 mg once every other week. Xatmep (Silvergate Pharma, Inc.) methotrexate Juvenile idiopathic arthritis and acute lymphoid leukemia Xatmep is an oral solution of methotrexate indicated for management of active polyarticular juvenile idiopathic (pjia) arthritis and pediatric acute lymphoid leukemia (ALL). The recommended dose is 10 mg/m2 once weekly for pjia and 20 mg/ m2 once weekly for ALL. Renflexis (Samsung Bioepsis CO.) infliximab-abda Multiple immunologic disorders Renflexis is a biosimilar to Remicade used to treat Crohn s disease in adults and pediatrics; ulcerative colitis, RA, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. It is an antibody which neutralizes tumor necrosis factor alpha (TNFα). The dose is 5 mg/kg IV at 0, 2 and 6 weeks, then every 8 weeks. High RoxyBond (Inspirion Delivery Sciences, LLC) oxycodone hydrochloride Pain RoxyBond is an abuse-deterrent opioid agonist indicated to treat pain that is severe enough to require opioid analgesics and for which alternative treatments are inadequate. It is available in 5 mg, 15 mg, and 30 mg tablets. The recommended dose is 5 mg to 15 mg every 4 to 6 hours as needed for pain. Low Q Well Informed 8

9 NEW FDA-APPROVED DRUGS BRAND NAME GENERIC NAME(S) THERAPEUTIC USE BRIEF DESCRIPTION POTENTIAL IMPACT Ingrezza (Neurocrine) valbenazine tosylate Tardive dyskinesia Ingrezza is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated to treat tardive dyskinesia in adults. It is taken as a 40 mg capsule once daily for one week and then increased to 80 mg once daily as tolerated. Austedo (Teva) deutetrabenazine Huntington s Disease Austedo is a VMAT2 inhibitor indicated for the treatment of chorea associated with Huntington s disease. The dose is 6 mg tablet once daily and titrated at 6 mg per week if tolerated. Dupixent (Regeneron Pharmaceuticals) dupilumab Atopic dermatitis Dupixent is an interleukin-4 receptor alpha antagonist for patients with moderate-to-severe atopic dermatitis. The initial dose is 600 mg SQ, then 300 mg SQ every other week. Low Ocrevus (Genetech Inc.) ocrelizumab Multiple sclerosis Ocrevus is a CD-20 antibody indicated for adult patients with relapsing or primary progressive forms of multiple sclerosis. The initial dose is 300 mg IV followed two weeks later by a second 300 mg IV. Subsequent doses are 600 mg IV every 6 months. Zejula (Tesaro Inc.) niraparib tosylate Ovarian, fallopian tube, or primary peritoneal cancer Zejula is indicated for ovarian, fallopian tube, or primary peritoneal cancer to cause DNA damage, apoptosis, and cell death. It is a 300 mg capsule taken once daily. Q Well Informed 9

10 NEW FDA-APPROVED DRUGS BRAND NAME GENERIC NAME(S) THERAPEUTIC USE BRIEF DESCRIPTION POTENTIAL IMPACT Bavencio (EMD Serono Inc.) avelumab Metastatic Merkel cell carcinoma and urothelial carcinoma Bavencio is a PD-L1 blocking antibody indicated for adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial carcinoma. Bavencio is available as a 200 mg/10 ml solution single-dose vial. The recommended dose is 10 mg/ kg IV every 2 weeks. Symproic (Shionogi) naldemdine tosylate Opioid-induced constipation Symproic is an opioid antagonist used to treat opioid-induced constipation and chronic noncancer pain. It is a 0.2 mg tablet taken once daily. Xadago (US Worldmeds) safinamide mesylate Parkinson s Disease Xadago is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson s disease experiencing off episodes. It is a MAO type B inhibitor and works to increase dopamine in the brain. The recommended dose is 50 mg once daily, then titrated to 100 mg after 2 weeks based on tolerability. Low Kisqali (Novartis Pharmarceutical Corporation) ribociclib Breast cancer Kisqali tablets are indicated for postmenopausal women with HR+, HER2- advanced or metastatic breast cancer. It is available as 200 mg tabs and the recommended dose is 600 mg orally once daily for 21 days. Feedback, Questions or Suggestions. Please contact us at wellinformed@welldynerx.com. Thank you! Q Well Informed 10