Well isn’t that Special?Putting the ‘Special’ in ‘Specialty Pharmacy’

Dr. Brigid Farrar, PharmD, MHA, AAHIVP, BCPSManager of Community-Based Specialty PharmacyWalgreens Co.

Disclosure and Conflict of Interest

Brigid Farrar has no personal or financial conflicts of interest to disclose.

Pharmacist Objectives

At the conclusion of this program, the pharmacist will be able to:

1. Identify specialty medications/health conditions.2. Recognize the difference between community and specialty

pharmacies.3. Outline available resources for patient financial assistance.

Technician Objectives

At the conclusion of this program, the technician will be able to:

1. Describe state/federal laws related to specialty pharmacy.2. Discuss the medication approval process (prior

authorizations).3. Outline resources to ensure the prescription is triaged

appropriately.

Specialty Pharmacy DefinedAPhA:• Two main factors: Cost and Complexity

CMS categorization: Minimum monthly cost = $600Other organizations may have a higher cost threshold

• Complexity of health conditions

Advisory Board:• Expensive drugs• Rare and complex health conditions

(HIV, autoimmune diseases, and organ transplant patients)• Require special handling• Patients require additional support

(Prior authorization, financial assistance, education)

Health Conditions DrugsHIV All

Hepatitis C AllOncology All

Hyperlipidemia? Evolocumab & AlirocumabChronic Inflammatory Disease?

Lupus (SLE)?Multiple Sclerosis?

Monoclonal AntibodiesInterferon Beta-1a

TeriflunomideSchizophrenia? Aripiprazole (IM), Paliperidone (IM)

Substance Use Disorder? Naltrexone IMBuprenorphine ER (SQ)

Migraines? Erenumab-aooe & Galcanezumab-gnlm

Limited Distribution Drugs (LDDs)• Limited distribution network:

Restricts the distribution channel of a drug to a very small number ofdistributors (pharmacies)Can restrict access to certain vendors (i.e. Amerisource Bergen)

• Examples:Pyrimethamine Hydroxyprogesterone TasimelteonEsketamine Buprenorphine ER (SQ) Valbenazine

• Special circumstances:Expedited Review REMS programsDrug handling/dispensing

• Special requirements:Inventory monitoring/reporting Referral updatesPatient education Ordering process

Assessment Question #1Which of the following drugs would likely be considered a specialty drug?

A. A generic, oral blood pressure medicationB. A monoclonal antibody to be injected SQ once weeklyC. A brand new GLP-1 Receptor AgonistD. A brand name oral anticoagulant

Answer: B

Assessment Question #2Which of the following drugs would be considered limited distribution (LDD) and why?

Answer: D

A. Erenumab-aooe, because it is a monoclonal antibodyB. Insulin Degludec, because it is brand name onlyC. Glecaprevir/Pibrentasvir, because it treats HCVD. Tasimelteon, because it is an orphan drug

Prior Authorizations (PAs)

• Definition:“A decision by your health insurer or plan that a health care service,treatment plan, prescription drug or durable medical equipment is

medicallynecessary”

• What’s required:Diagnosis code(s) Pertinent labs Chart notesDuration of treatment Diagnostic tests Previous treatment(s)

• Varies by insurance companyMedicaidMedicareCommercial: Express Scripts vs. Ambetter vs. Humana

Prior Authorizations (cont’d)• Example: Hepatitis C

Diagnosis code: B18.2 (Chronic Viral Hepatitis C)Labs: Genotype, viral load, co-infections – if present (HAV/HBV/HIV)Chart notes: How/when patient was diagnosed, current/past alcohol/IVDUDiagnostic test: Fibrosis scoreChild-Pugh ScoreDuration of treatment: Determined by fibrosis score and previous treatmentPrevious treatments: Treatment naïve or experienced

-Experienced: What treatment did they fail? Were they compliant?Is it viral rebound, non-responder, or a re-infection?

More information?

Appeals

• Definition:“A request for your health insurance company or the Health InsuranceMarketplace to review a decision that denies a benefit or payment.”

• What’s required:Additional questions to be answeredAdditional chart notes or labsReasons why an alternative drug cannot/should not be usedA letter written by the provider

Assessment Question #3How would you describe what a prior authorization is to a patient?

Answer: A

A. Information that must be submitted to your insurance (that includes chart notes, labs, etc.) to determine the medical necessity of a drug prior to insurance approval

B. A letter that must be written by your provider explaining why that particular medication is needed

C. The insurance wants you to try and fail other therapies before they’ll approve what your provider prescribed you

D. I don’t know, you’ll have to ask your provider

Assessment Question #4What would be an easy way to determine if a prescription must be filled through a specialty pharmacy?

Answer: B D?Both!

A. Let the patient figure it outB. Look up the health condition the medication treatsC. Call the insurance and ask themD. Call your local specialty pharmacy

Rules & Regulations

• Anti-Kickback Statute:“Prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate Federal health care program business”

• Stark Law:“Prohibits a physician from referring Medicare patients for designated health services to an entity with which the physician (or immediate family member) has a financial relationship, unless an exception applies”

• Company policies help maintain compliance-Provider authorization -Government requirements (CMS)

Financial Assistance• Additional support needed

Deductible Coverage gap (“donut hole”)• Resources:

Manufacturer Coupons ZHI Reimbursement PortalPANF™ PAF ™Good Days ™ HealthWell ™Patient Assistance Programs

• Can benefit those with Medicare/Medicaid, Commercially insured, and uninsured patients

• Requirements:Eligibility Financial InformationApplication Confirmation letter

Financial Assistance (cont’d)

Assessment Question #5

Which of the following scenarios would violate Stark Law?

Answer: A

A. A provider forcing their patients to fill at a certain pharmacybecause they do his/her PAs

B. A patient asking their provider to send the prescription to aparticular pharmacy

C. A pharmacy transferring a patient’s prescription at their request,but without provider approval

D. A provider encouraging the use of a certain pharmacy

Assessment Question #6Which of the following resources could help a Medicare patient obtain financial assistance for their prescription copay?

A. LexicompB. Abbvie’s manufacturer websiteC. Patient Access Network Foundation ™D. Facts & Comparisons

Answer: C

Patient Management• Basic Information:

Allergies Health ConditionsMed List (RX/OTC) Alternate Contact(s)

• Consultation:Administration Adverse ReactionsDrug Interactions Storage/HandlingDisposal

• Barriers to therapy:Financial TransportationLanguage Physical

• Care Plans• Shipment• Continued Counseling

URAC• Utilization Review Accreditation Commission

“An independent, nonprofit accreditation entity whose missionit is to advance healthcare quality through leadership,accreditation, measurement and innovation.”

• What the accreditation does:Insurance contractsLDD accessProvider and Patient relationships

• Requirements:Policies/Procedures Patient SatisfactionQuality Management Performance MeasuresPatient-Centered Strategy

Other Specialty Resources

• National Association of Specialty PharmacyNASP UniversityCenter for Specialty Pharmacy Education (http://www.proce.com/CSPE)

• Health Condition SpecificAmerican Academy of HIV Medicine (http://www.aahivm.org)Board of Pharmacy Specialties (http://www.bpsweb.org)

• NetworkingPharmacy association eventsOver the phoneIn person visits

Assessment Question #7

Which of the following pharmacies would be considered specialty?

A. A 24-hour CVSB. An independent pharmacy that specializes in compoundingC. A Health System Walgreens that has access to EsketamineD. All of the above

Answer: C

Assessment Question #8

How would you find an HIV certified pharmacist in your area?

A. Drive around looking for oneB. You won’t be able to find one C. Google itD. Go to http://www.aahivm.org and use their “Find a Provider” function

Answer: D

ResourcesAPhA. (2013, July 1). Specialty pharmacy: A unique and growing industry. Retrieved from https://www.pharmacist.com/specialty-pharmacy-unique-and-growing-industryAppeal - HealthCare.gov Glossary. (n.d.). Retrieved from https://www.healthcare.gov/glossary/appeal/Conway, L. (2018, February 22). Specialty pharmacy, explained. Retrieved from https://www.advisory.com/research/care-transformation-center/care-transformation-center-blog/2018/03/specialty-pharmacyCDC. (2018, November 2). Hepatitis C Questions and Answers for the Public | CDC. Retrieved from https://www.cdc.gov/hepatitis/hcv/cfaq.htmKaras, L., Shermock, K., Proctor, C., Socal, M., & Anderson, G. (2018, April 4). Limited Distribution Networks Stifle Competition in the Generic and Biosimilar Drug Industries. Retrieved from https://www.ajmc.com/journals/issue/2018/2018-vol24-n4/limited-distribution-networks-stifle-competition-in-the-generic-and-biosimilar-drug-industriesOffice of Inspector General. (n.d.). Comparison of the Anti-Kickback Statute and Stark law. Retrieved from https://oig.hhs.gov/compliance/provider-compliance-training/files/StarkandAKSChartHandout508.pdfPierce, S. (2019, March 29). FDA approves Spravato, a fast-acting antidepressant nasal spray. Retrieved from https://www.tmc.edu/news/2019/03/fda-approves-spravato-a-fast-acting-antidepressant-nasal-spray/Preauthorization - HealthCare.gov Glossary. (n.d.). Retrieved from https://www.healthcare.gov/glossary/preauthorization/Stieber, D. (2015, October 12). Limited-Distribution Products-The Debate Continues. Retrieved from https://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2015/october-2015/limited-distribution-products-the-debate-continuesTomen, A. (2018, January 25). The Ins and Outs of Limited Distribution Specialty Drugs. Retrieved from https://www.specialtypharmacytimes.com/news/the-ins-and-outs-of-limited-distribution-specialty-drugshttps://www.zhireimbursementportal.comhttp://www.proce.com/CSPEhttp://www.aahivm.orghttp://www.bpsweb.orghttps://www.urac.org/

Speaker Contact Information

Email: Brigid.Farrar@Walgreens.com

Linked In: www.linkedin.com/in/drbfarrar

Work information:Address: 440 E Tampa St Suite100

Springfield, MO 65806Phone number: 417-831-0001