Immunizations: An Overview. Sutter Health May 9, 2017 John Apostolo, PharmD, MBA Heidi Rens, PharmD

Transcription

1 Immunizations: An Overview Sutter Health May 9, 2017 John Apostolo, PharmD, MBA Heidi Rens, PharmD

2 Sutter Health: System Overview 2

3 Agenda Sutter Health Overview Sutter Health Vaccine overview Clinical Implications Business Considerations 3

4 Sutter Health Service Area Structure > 48,000 employees 5000 Physicians 26 Hospitals 35 Surgery Centers 4,372 licensed beds 5 Medical Foundations Bay Area Valley Area 4

5 Sutter Health Vaccine Organizational Structure Sutter Health Pharmacy & Therapeutics Committee Sutter Health Vaccine Advisory Committee (SHVAC) Advisory Committee on Immunization Practices (ACIP) SHVAC Clinical Sub-Committee System-wide Flu Workgroup Center for Disease Control (CDC) Administration Guidelines and Recommendations SHVAC Flu Season Sub-Committee Medical Foundation VAC (5) 5

6 Sutter Health Vaccine Committee Organization Multi-disciplinary Acute and medical practice site representation Practicing physicians Pediatrics Infectious disease Clinical Pharmacists Nurses Business Operations Pharmacy buyers 6

7 Sutter Health Vaccine Advisory Committee (SHVAC) Critical Success Factors System-wide communications ACIP decision and guidelines Consistent policy & procedures Storage & Handling Formulary & Contract compliance Incorporate alerts into electronic medical record Improve patient quality measures Electronic Medical Record Health Maintenance Alerts Formulary compliance Contract compliance / reduce purchase variation 7

8 SHVAC Clinical Subcommittee Key Issues: Reviews new clinical information, makes recommendations for new vaccines or changes to currently available vaccines Membership: Pediatricians, Clinicians, Infections Disease, Pharmacists Meets directly after ACIP in February, June and October ACIP is livecast by Clinical Pharmacy Coordinator and other members of committee ACIP Meeting is summarized and recommendations are made to SHVAC New Vaccine Recommendations are forwarded to the System Pharmacy and Therapeutics Committee for approval Advises Health Maintenance Committee for HM communication and Alerts 8

9 SHVAC Clinical Subcommittee ACIP Clinical Summaries MenB-FHbp (Trumenba) FDA approved label change in April for 2 or 3 dose series For healthy people ages who are not at increased risk recommends 2 dose schedule 0, 6 months. Early data on PCV13 Plateau since recommendation Increase in Serotype 3 Increase non vaccine Research-Indirect/Direct Tdap Reviewed recommendation in pregnancy. Available data suggest that earlier administration in week window will maximize response. Language change to emphasize this. Suggestion was to pair with glucose loading test Hepatitis B Updated guidelines Removed permissive recommendation to vaccinate infant in clinic Recommendation: Infants be immunized within 24 hours of birth prior to discharge Herpes Zoster Vaccine (GSK) Highly effective with longer immunogenicity FDA approval

10 SHVAC Clinical Subcommittee Key Issues Subcommittee can make a recommendation to change prior to publication of MMWR. 10

11 SHVAC-Health Maintenance(HM) Committee Key Issues: Provides Guidance HM Committee Patient Brochures Wall Posters EPIC Alerts Recommendation to use CDC/EPIC alerts 11

12 SHVAC-System Pharmacy and Therapeutics Committee Key Issues Provide Summary of changes and Decisions Approve New Vaccines 12

13 Vaccine Newsletter 13

14 Vaccine Purchase and Distribution Direct from Manufacturer Separate purchase Account(s) Purchase discounts Group purchasing organization pricing Increase accounts receivable Storage challenges during flu season Subject to return policy Vaccines vs. flu vaccines In-direct from wholesaler Separate purchase Account(s) Purchase discounts (?) Group purchasing organization pricing Efficient inventory management Paying only one distributor Subject to return policy Vaccines vs. flu vaccines 14

15 Seasonal Influenza Vaccine

16 Agenda Time Discussion Lead By / Topic Objective / Info / Decision / Action 12:00 (5 mins) Welcome & Agenda Review 12:05 (15 mins) Flu Review o Overview o Challenges/Opportunities Round table discussion 12:20 (35 mins) Overview of Products o 65 yrs: IIV3 HD vs aiiv3 o 6-35 mos flu vaccine Formal recommendation to SHVAC 12:55 (5 mins) Wrap Up Next Steps: 13:00 Adjourn 16

17 Season Overview Manufacturer Doses Doses Doses Doses Sanofi 409, , , ,029 (60%) GlaxoSmithKline 60,860 69, , ,048 (40%) MedImmune 30,240 45,000 40,870 0 Novartis Total 500, , , ,188 17

18 Season Overview Presentation Sanofi GSK Novartis Fluzone 0.5mL 203,914 Fluzone 0.25mL 56,920 Fluzone HD 79,570 Fluzone ID 470 Fluzone MDV 155 Fluarix 211,048 Flulaval 16,000 Fluvirin 111 Total 341, ,

19 ACIP 2016 LAIV4 wasn t recommended due to low effectiveness against influenza A(H1N1)pdm09 during the 2013/14 and 2015/16 seasons Additional discussion at upcoming ACIP meetings Egg Allergies: History of severe allergic reaction to egg: Vaccinate in an inpatient or outpatient medical setting with any flu vaccine, under the supervision of a health care provider who is able to recognize and manage severe allergic conditions New Vaccines: Fluad (aiiv3): FDA approved in 11/2015 for persons aged 65 years Flucelvax (cciiv4):fda approved in 5/2016 for persons aged 4 years 19

20 Flu Vaccines Name Manufacturer Type Dosage form Age Content Price Indication Fluarix GSK IIV4 0.5 ml PFS 3 yrs Egg 14.8 Flulaval GSK IIV4 0.5 ml PFS 6 mos Egg 14.8 Fluzone Sanofi IIV ml PFS 6-35 mos Egg 15.4 Sanofi IIV4 0.5 ml PFS 36 mos Egg 15.4 Fluzone HD Sanofi IIV3 HD 0.5 ml PFS 65 yrs Egg 39.3 Fluzone ID Sanofi IIV4 0.1 ml ID yrs Egg 15.4 Afluria Seqirus IIV4 0.5 ml PFS 18 yrs Egg 13.1 Flucelvax Seqirus IIV4 0.5 ml PFS 4 yrs Cell 14.1 Fluad Seqirus aiiv3 0.5 ml PFS 65 yrs Egg/ Latex 33.6 FluMist MedImmune LAIV4 0.2 ml Nasal 2-49 yrs Egg 20

21 Flu Vaccines Manufacturer Prioritization Return per NDC Delivery dates Delivery GSK Yes 30% 100% Before 9/30 Guarantee 10% discount on delays beyond 9/30 Sanofi No 25% 100% Before 10/31 No Seqirus No 20% 100% Before 9/30 No 21

22 65 yrs: IIV3 HD vs aiiv3 Fluzone HD Fluad Type IIV3 HD aiiv3 FDA Approval 12/ /2015 Content Outcomes Side effects 60 mcg of hemagglutinin per strain vs 15mcg Higher HAI titers & 24.2% more effective in preventing LCI 95% CI 9.7 to 36.5% (31,989) local and systemic but most were mild in severity transient MF59-adjuvanted Non-inferior immunogenic response to IIV3 & 63% more effective in preventing LCI 95% CI 4 to 86% (282) local and systemic but most were mild in severity Cost $ 39.3 $ 33.6 Allergies - Latex ACIP: No preference for any one of these vaccines over another for this age group. No data directly comparing high-dose IIV3 and aiiv3 are available. 22

23 6-35 mos: Flulaval vs Fluzone Fluzone Flulaval Type IIV4 IIV4 Volume 0.25 ml 0.5 ml (Same as adult) FDA Approval /2016 Efficacy Side effects Phase III, observer-blind, 69 centers, Children 6 35 months of age, N=2424. Flulaval was immunogenic non-inferior to Fluzone and that was demonstrated for all four strains in terms of geometric mean titer and seroconversion rate. Similar reactogenicity and safety profile Cost $ 15.4 $

24 Seasonal Influenza Critical Success Factors Participate on ACIP seasonal flu recommendations Advantage to live-casts Understand the advantages / disadvantages of using multiple suppliers Keep the number of influenza presentations and age indications simple Complete seasonal flu reservation process by March 31 st. Communication Plan 24

25 Seasonal Influenza Key Issues Initiate internal meetings to align influenza vaccine supply with patient/provider messaging Membership Clinical Nurses at each Foundation, Pharmacists, Pharmacy Buyers, Communications, Workgroup addresses any product clinical / supply challenges, i.e. FluMist and develops communication strategy Operationalizes key changes to Flu recommendations EHR updates and changes Distribute MMWR with any highlighted key changes to upcoming flu season. 25

26 Foundation Vaccine Advisory Committees Key Issues: Committee operationalizes system recommendations Membership: Pediatricians, Clinicians, Immunization Clinic Nurses, Pharmacy Buyers, Pharmacist, Revenue Cycle Develop foundation specific action plan around vaccine administration Creates foundation specific EHR solutions Performance on Quality Metrics Vaccine Policies are implemented at foundation through VAC Adoption of Technology to support vaccine administration 26

27 Questions John Apostolo, PharmD, MBA Lead, Pharmacy Service Line Supply Chain, Sutter Shared Services Heidi Rens, PharmD Clinical Pharmacy Coordinator Sutter Health 27