1. Primum non nocere Olabisi Oshikanlu M.D., F.A.A.P
Step Therapy Health Insurance Reform Commission Presentation September 27, 2016
Primum non nocere
Olabisi Oshikanlu M.D., F.A.A.P

2. Drug Formulary Development
Health Plans develop drug formularies by using objective evaluations from independent physicians, pharmacists and other health care professionals.
Virginia law requires health plans to have a Pharmacy & Therapeutics Committee (P & T Committee) comprised of independent practicing physicians and pharmacists to develop plan drug formularies.
Closed and/or Tiered formularies are tools health plans use to create efficiencies in the drug formularies.

3. Pharmacy and Therapeutics Committee
The P&T committee leverages its collective knowledge to design step therapy programs that:
Use external, peer-reviewed medical literature, drug compendia and FDA-approved indications
Recommend drugs based on safety and efficacy studies
Recommend drugs that have been extensively studied in high cost disease states (i.e. diabetes, heart failure, Hypertension , Cholesterol, Behavioral Health)
Dynamic continuous review as new drugs become available and clinical utility /evidence evolves

4. Step Therapy
Step therapy is one of the many tools used in medical management to ensure that patients receive medications that are:
Based on clinical guidelines and trials developed by independent experts
Safe
Effective
Cost effective

5. Byproducts of Step Therapy
Improves the quality of prescribing practices
Promotes safety with increased use of medications with a proven track record
Shapes prescribing practices toward use of therapeutically similar or equivalent, less expensive first line agents
Serves as an automated tool if required drugs are present, thereby avoiding administrative burden

6. Safety is FIRST Using the right drug at the right time
Using the most effective, least risky drugs before advancing to potentially more risky and expensive options
Ensuring efficient use of health care resources by limiting the cost of care yet maintaining positive health outcomes. 

7. Managing Mental Health
Drugs of misuse or abuse (Benzodiazepines and amphetamines)
Psychotherapy and drugs superior to medication alone
Medical illnesses can mimic psychiatric illnesses
MCO’S have mechanisms in place to protect children and ensure consistent application of treatment guidelines e.g. age edits

8. Continuity of Care
Most maintenance medications are included in the “Transition Fill” program which allows the member to obtain a one-time fill of the medication to allow time for the prior authorization to occur or for the member to work with their physician to switch to a preferred alternative therapy

9. Ensures Portability
Patients that go through step therapy and transfer to another plan do NOT have to repeat the steps as long as they are able to provide proof they completed the steps.
(State Law)

10. Drug Costs Continue to Rise
Prescription drug costs represent more than 10% of the overall healthcare dollar.1
In 2014, spending on medications increased 13.1% due to the new high-cost therapies, brand-price inflation, and the use of compound medications.1
When reviewing the preliminary results of the health plan survey on the most prescribed drugs requiring prior authorization, many of the drugs are those that are advertised in a special effort to drive individuals to these higher cost drugs.
In 2014, specialty drugs account for 33% of drug spending while only comprise of 1% of prescriptions written.
1Express Scripts, “How We Build a Formulary,” June 25, 2015

11. Protecting Patients
New studies show that more and more patients are moving to high deductible plans.
There is a shift in the cost burden from Employers to patients.
Out of pocket costs have nearly doubled over the past 10 years
Step therapy protects our members from these higher costs.
Kaiser news September 2016

12. Consequences of High Cost Drugs
Increases noncompliance
Increases the burden on health systems –emergency rooms, Inpatient admissions.
Other social implications -lost wages & productivity etc.

13. Brand to Generic Comparison Marketplace averages

14. Prior Authorization
Providers can send in requests for prior authorizations electronically or telephonically.
Health plans have formulary and clinical policies available on their websites.
We are continuing to develop IT solutions that meet the NCPDP standards and work with the providers EMR and e-Prescribing applications.

15. Exceptions Process
Peer to Peer and appeal guidelines and time lines are based on state regulations.
Appeals can be expedited or standard  
In both the Peer to Peer and or appeal, the staff applies the Aetna Clinical policy Bulletin criteria that is posted on the Aetna.com website.

16. Questions?