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PBMs:
Presented by Holden Young | April 2021
What is a PBM?
• PBMs are companies that manage pharmacy benefits on behalf of their payers[17]
02
Holden Young | April 2021
PAYERS
• Health insurers
• Employers
• Union-sponsored plans
• Worker’s compensation
• Medicaid (State-level)
• Medicare (Federal)
• Clinics
• Hospitals
• Providers
$ $
Definitions
03
Holden Young | April 2021
● PBM (Pharmacy Benefit Manager)
○ PBMs negotiate drug pricing with pharmaceutical manufacturers, provide MTM and DURs, and create custom formularies for payers to treat specific disease states
 Payers include employers (eg. labor unions), health insurance agencies, and Medicare Part D drug plans.[17] [25]
● AWP (Average Wholesale Price)
○ Average Wholesale Price is considered a “sticker price” that is provided by the wholesaler. Retailers (community pharmacies) rarely pay the AWP but it is considered
the basis to which prices are set.[17]
● AAC (Average Acquisition Cost)
○ The actual average price that pharmacies pay within a specific state to purchase a generic and brand name medications. AACs are based on individual state
surveys of pharmacy invoices.[6] [9]
● MAC (Maximum Allowable Cost)
○ The MAC is the maximum price that a PBM is willing to pay specifically for generic medications or for multi-source medications (those that are available both as
brand and generic).[10]
● U&C (Usual and Customary)
○ “Retail” or “cash” price of a medication that pharmacies charge to a patient who either does not have or is not using insurance.[19]
Definitions
03
Holden Young | April 2021
● PSAO (Pharmacy Services Administration Organization)
○ PSAOs are groups that provide collective bargaining for independent pharmacies. Their services include negotiating of contracts with PBMs and allowing
pharmacies to bill a wide array of insurances that they would be unable to individually.[26]
● Tiered, open, and closed formularies
○ Tiered formulary: Eg. Three-tier plan.[30]
■ First tier: lowest copayments, roughly $10 for generics
■ Middle tier: Slight increase in copay for brand names added to formulary and indicated for a specific disease state
■ Third tier: Highest copay for non formulary medications
○ Closed formulary
■ Health plans that have a specific list of medications that they will cover. If prescribers write a prescription for a medication (specific medication, generic name,
brand name, dosage form, strength, indication) that is not on formulary, the patient will most likely have to pay the U&C.[20] [21]
○ Open formulary
■ Includes all FDA approved medications and thus has no limitations for the prescribing provider. An open formulary may still be a tiered formulary but can still
include all available medications.[20] [21]
History of PBMs
1960-70'S Beginnings
1980'S Establishment of PBMs
1990'S Manufacturers acquire PBMs
FTC
2000'S Retailers buy their own PBM
03
Holden Young | April 2021
1960-70's: Beginnings
04
• 1968: First PBM, Pharmaceutical Card Systems
(PCS, later AdvancePCS) is created [13]
⚬ 1970s: Credited with invention of plastic benefit card used for
purchase of medications[13]
• 1976: Diversified Pharmaceutical Services (DPS) is created internally
at HMO United HealthCare (now United HealthGroup)[11]
Holden Young | April 2021
1980's: Establishment of PBMs
05
• 1980’s
o Create pharmacy networks and introduce mail service benefits[17]
• 1987
o Real-time, electronic drug claims introduced
 Begin two-way communication of claims and clinical information[17]
 The now paperless claims process initiate PBMs collection of extremely
valuable database of prescription drug records[17]
Holden Young | April 2021
1990's: Manufacturers acquire PBMs
06
• 1993: Merck purchases Medco for $6 billion[13]
• 1994: Eli Lilly purchases PCS for $4 billion[13]
SmithKline Beecham purchases DPS from for $2.3 billion[13]
Former FTC official, “conflicts of interest raise severe concerns in the health care system.
Where a payor is also a provider they can manipulate the relationship to raise health
care costs. That is why, when pharmaceutical manufacturers obtained PBMs in the 1990’s,
the FTC acted to eliminate those conflicts of interest. The FTC challenged the acquisition of
PCS by Lilly and Medco by Merck, because of the concern that having a manufacturer own a
PBM would be giving the “fox the keys to the hen house door”—and would lead to higher
prices for consumers.”[8]
Holden Young | April 2021
2000's: Retailers buy their own PBMs
07
• 1999: Rite Aid acquires PCS from Eli Lilly for $1.5 billion
Express Scripts acquires DPS from SmithKline Beecham for $700 million
• 2003: Medco establishes as a spin off of Merck
• 2000: PBM Advance Paradigm acquires PCS for $1 billion (forming AdvancePCS)
• 2003: Caremark purchases AdvancePCS for $5.6 billion
• 2007: CVS purchases Caremark for $26.5 billion
• 2012: Express Scripts acquires Medco for $29.5 billion, combining two largest PBMs
• 2015: OptumRx acquires Catamaran for $12.8 billion
• 2018: Cigna acquires Express Scripts for $54 billion
Holden Young | April 2021
SOURCE: Feldman, B. S. (2016, March 17). Big pharmacies are dismantling the industry that keeps US drug
costs even sort-of under control. Quartz. https://qz.com/636823/big-pharmacies-are-dismantling-the-
industry-that-keeps-us-drug-costs-even-sort-of-under-control/
PBMs vs. Traditional Health Insurers
08
• Traditional health insurance agencies often provide coverage of medical expenses
including PCP visits, hospitalizations, and surgical procedures.[16]
• On behalf of insurers, PBMs negotiate drug pricing with pharmaceutical manufacturers,
provide MTM and DURs, and create custom formularies for payers to treat specific disease
states.[17]
Holden Young | April 2021
Just how big are PBMs today?
09
According to 2020’s Fortune 500…
• Caremark (CVS Health - #5)
• OptumRx (UnitedHealth - #7)
• Express Scripts (Cigna - #13)
Top 3 PBMs accounted for 76% of U.S. prescription claims in 2019[17]
Holden Young | April 2021
PBM Revenue Model
10
Holden Young | April 2021
SOURCE: A Deep Dive Into DIR Fees. (2018, September 7). Virginia Pharmacists.
https://virginiapharmacists.org/wp-content/uploads/2018/09/NCPA-Presentation-to-VPhA-on-DIR-Fees-
final.pdf
PBM Revenue Model (continued)
11
Express Scripts 2017 Annual Report (Pre-Cigna acquisition)
98.20%
1.80%
SOURCES OF REVENUE
Tangible product Services
Tangible Products Services
• Prescription drug sales in PBM’s retail
pharmacy network
• Negotiating pricing
• Dispensing fee
• Member co-payments
• Prescription dispensing from PBM’s in-
house mail-order and specialty
pharmacies
• Formulary management
• Medication benefit management
• DUR
• MTM
• Focused Claims Review
• Medication counseling services
“…as ingredient cost paid to pharmacies on generic drugs is incrementally lower than the
price charged to our clients, higher generic fill rates generally have a favorable impact on our
gross profit.”
Ingredient cost = actual amount paid to a pharmacy provider by a PBM for a prescription drug,
not including the dispensing fee or cost-sharing amount.
Holden Young | April 2021
SOURCE: Express Scripts 2017 Annual Report. (2018, January 31). SEC.
https://www.sec.gov/Archives/edgar/data/1532063/000153206318000004/esrx-
12312017x10k.htm#s292B544F205F5EE5B67E5937209B0EE0
Transparent vs. Opaque PBM models
12
Holden Young | April 2021
Transparent PBM
Opaque PBM
SOURCE: A Unique Approach: Transparent PBMs. (2019, April). ACHP.
https://achp.org/wp-content/uploads/PBM-Infographic_4.5.19.pdf
"Brand name preferred by health plan"
13
Holden Young | April 2021
Expectations
Generic becomes available Retail pharmacy begins
carrying generic
Patient co-pay covers most
if not all of costs
"Brand name preferred by health plan"
13
Holden Young | April 2021
Reality
Generic becomes available Manufacturer contracts
with PBM
Health plans billed for
brand name, patient co-pay
is on par with or even
lower than generic
Independent Pharmacies vs. Retail-owned PBM companies
14
Holden Young | April 2021
• Immunizations
• MTM
• Chronic disease state education
• Utilize pharmacist prescriptive authority
Collaborative practice agreements
• OTC management
Maximization of fees-for-services
Entrepreneurial Opportunities for Pharmacists
15
Holden Young | April 2021
Majority will most likely encompass the following:
• Remote-based
• Technological in nature
• Mass adaptation of web-based platform (video-calling, team/group chat, online
ordering) use across multiple generations within general population
References
16
Holden Young | April 2021
1. A Deep Dive Into DIR Fees. (2018, September 7). Virginia Pharmacists. https://virginiapharmacists.org/wp-content/uploads/2018/09/NCPA-Presentation-to-VPhA-on-DIR-Fees-final.pdf
2. A piece of the pie: Independents build new business models. (2020, March 20). Drug Store News. https://drugstorenews.com/pharmacy/a-piece-of-the-pie-independents-build-new-business-models
3. A Unique Approach: Transparent PBMs. (2019, April). ACHP. https://achp.org/wp-content/uploads/PBM-Infographic_4.5.19.pdf
4. AbbVie, Amgen settlement sets Humira U.S. biosimilar launch for 2023. (2017, September 28). Reuters. https://www.reuters.com/article/us-abbvie-amgen-humira/abbvie-amgen-settlement-sets-humira-u-s-biosimilar-launch-for-2023-
idUSKCN1C32G5
5. Abusive, Opaque PBM Pricing Schemes Receive More Attention Over Summer Congressional Recess. (2020, February 19). Senior Care Pharmacies. http://seniorcarepharmacies.org/abusive-opaque-pbm-pricing-schemes-receive-more-attention-
over-summer-congressional-recess/
6. Comparison of Acquisition-Cost Based Reimbursement Models. (n.d.). NCPA. http://www.ncpa.co/pdf/advocacy/medicaid-pricing-summary-2015.pdf
7. Denning, S. (2011, December 5). Pfizer’s Lipitor: How Big Pharma Blocks Reimbursement Of Generics. Forbes. https://www.forbes.com/sites/stevedenning/2011/11/30/pfizers-lipitor-how-big-pharma-blocks-reimbursement-of-
generics/?sh=74b357db7b8b
8. Draft Vertical Merger Guidelines for Public Comment. (2020, February 26). FTC. https://www.ftc.gov/system/files/attachments/798-draft-vertical-merger-guidelines/apha_comments_-_ftc.pdf
9. Drug Pricing Policy. (n.d.). FDB (First Databank). https://www.fdbhealth.com/drug-pricing-policy
10. Eberle, B. J., & Amber, A. (n.d.). Your PBM’s MAC list impacts your bottom line. Managed Healthcare Executive. https://www.managedhealthcareexecutive.com/view/your-pbms-mac-list-impacts-your-bottom-line
11. Express Scripts. (1999, February 9). Express Scripts to Acquire Diversified Pharmaceutical Services. PR Newswire. https://web.archive.org/web/20180127202647/https://www.prnewswire.com/news-releases/express-scripts-to-acquire-diversified-
pharmaceutical-services-74853317.html
12. Express Scripts 2017 Annual Report. (2018, January 31). SEC. https://www.sec.gov/Archives/edgar/data/1532063/000153206318000004/esrx-12312017x10k.htm#s292B544F205F5EE5B67E5937209B0EE0
References
16
Holden Young | April 2021
13. Feldman, B. S. (2016, March 17). Big pharmacies are dismantling the industry that keeps US drug costs even sort-of under control. Quartz. https://qz.com/636823/big-pharmacies-are-dismantling-the-industry-that-keeps-us-drug-costs-even-sort-of-
under-control/
14. Fortune 500. (2020, September 18). Fortune. https://fortune.com/fortune500/2020/search/
15. How Can Independent Pharmacy Compete. . .. (2019, August 2). QS/1 Pharmacy Management Systems. https://www.qs1.com/2017/09/05/how-can-independent-pharmacy-compete/
16. How U.S. Health Insurance Works | Vaden Health Services. (n.d.). Stanford - Valden Health Services. https://vaden.stanford.edu/insurance/health-insurance-overview/how-us-health-insurance-works
17. Leveling the Playing Field in the Pharmacy Benefit Management Industry. (2007). ValpoScholar. https://scholar.valpo.edu/cgi/viewcontent.cgi?referer=https://en.wikipedia.org/&httpsredir=1&article=1131&context=vulr
18. Lupkin, S. (2018, March 13). Patients Overpay For Prescriptions 23% Of The Time, Analysis Shows. Kaiser Health News. https://khn.org/news/paying-cash-for-prescriptions-could-save-you-money-23-of-the-time-analysis-shows/
19. Mattingly, J. P. (2012, June 20). Understanding Drug Pricing. U.S. Pharmacist. https://www.uspharmacist.com/article/understanding-drug-pricing
20. Medication Management. (n.d.). ASHP. https://www.ashp.org/-/media/store%20files/p2371-sample-chapter-4.pdf
21. Mikesell, M. (2020, July 29). Open to Closed: The Difference in Formularies. Apex Benefits. https://apexbg.com/open-to-closed-the-difference-in-
formularies/#:%7E:text=A%20closed%20formulary%20%E2%80%93%20meaning%20not,of%20a%20drug%20are%20covered
22. MultiBrief: Why would health insurers choose brand-name drugs over generic? (2018, April 5). Multibriefs: Exclusive. https://exclusive.multibriefs.com/content/why-would-health-insurers-choose-brand-name-drugs-over-generic/pharmaceutical
23. Our history. (n.d.). CVS Health. https://cvshealth.com/about-cvs-health/our-purpose/our-history
24. Pharma Pay-For-Delay Deals Called ‘Cost of Doing Business.’ (2020, February 10). Bloomberg Law. https://news.bloomberglaw.com/health-law-and-business/pharma-pay-for-delay-settlements-cost-of-doing-business
25. Pharmacy Benefit Managers and Their Role in Drug Spending | Commonwealth Fund. (2019, April 22). The Commonwealth Fund. https://www.commonwealthfund.org/publications/explainer/2019/apr/pharmacy-benefit-managers-and-their-role-drug-
spending
References
16
Holden Young | April 2021
26. Pharmacy Services Administrative Organizations (PSAOs) and their Little-Known Connections to Independent Pharmacies. (2021, February 1). PCMA. https://www.pcmanet.org/pharmacy-services-administrative-organizations-psaos-and-their-little-
known-connections-to-independent-pharmacies/
27. Samsung Bioepis Continues Global Market Expansion with Launch of HADLIMATM in Australia and Canada in partnership with Merck & Co. (2021, March 29). BioSpace. https://www.biospace.com/article/releases/samsung-bioepis-continues-global-
market-expansion-with-launch-of-hadlima-in-australia-and-canada-in-partnership-with-merck-and-co-/#:%7E:text=HADLIMA%E2%84%A2%20will%20be%20available,%2C%20NJ%2C%20USA%20in%202013
28. Strongin, R. (1999). The ABCs of PBMs (Vol. 749). National Health Policy Forum.
29. Trends in Use and Expenditures of Brand-name Atorvastatin After Introduction of Generic Atorvastatin. (2018, May). JAMA Network. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2674714
30. Understanding Drug Tiers. (2018, December 19). Patient Advocate Foundation. https://www.patientadvocate.org/explore-our-resources/understanding-health-insurance/understanding-drug-tiers/
31. Zetts, R., Hyman, D. A., Slotkin, J., Wyatt, M., Jordan, A., & Wakeman, S. E. (2018, March 9). A costly PBM trick: set lower copays for branded drugs than for generics. STAT. https://www.statnews.com/2018/03/12/pbm-copays-brand-name-drugs-
generics/

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PBMs Presentation (Holden Young - Roseman University of Health Sciences)

  • 1. Unknown Startups to Unknown Fortune 500 Companies PBMs: Presented by Holden Young | April 2021
  • 2. What is a PBM? • PBMs are companies that manage pharmacy benefits on behalf of their payers[17] 02 Holden Young | April 2021 PAYERS • Health insurers • Employers • Union-sponsored plans • Worker’s compensation • Medicaid (State-level) • Medicare (Federal) • Clinics • Hospitals • Providers $ $
  • 3. Definitions 03 Holden Young | April 2021 ● PBM (Pharmacy Benefit Manager) ○ PBMs negotiate drug pricing with pharmaceutical manufacturers, provide MTM and DURs, and create custom formularies for payers to treat specific disease states  Payers include employers (eg. labor unions), health insurance agencies, and Medicare Part D drug plans.[17] [25] ● AWP (Average Wholesale Price) ○ Average Wholesale Price is considered a “sticker price” that is provided by the wholesaler. Retailers (community pharmacies) rarely pay the AWP but it is considered the basis to which prices are set.[17] ● AAC (Average Acquisition Cost) ○ The actual average price that pharmacies pay within a specific state to purchase a generic and brand name medications. AACs are based on individual state surveys of pharmacy invoices.[6] [9] ● MAC (Maximum Allowable Cost) ○ The MAC is the maximum price that a PBM is willing to pay specifically for generic medications or for multi-source medications (those that are available both as brand and generic).[10] ● U&C (Usual and Customary) ○ “Retail” or “cash” price of a medication that pharmacies charge to a patient who either does not have or is not using insurance.[19]
  • 4. Definitions 03 Holden Young | April 2021 ● PSAO (Pharmacy Services Administration Organization) ○ PSAOs are groups that provide collective bargaining for independent pharmacies. Their services include negotiating of contracts with PBMs and allowing pharmacies to bill a wide array of insurances that they would be unable to individually.[26] ● Tiered, open, and closed formularies ○ Tiered formulary: Eg. Three-tier plan.[30] ■ First tier: lowest copayments, roughly $10 for generics ■ Middle tier: Slight increase in copay for brand names added to formulary and indicated for a specific disease state ■ Third tier: Highest copay for non formulary medications ○ Closed formulary ■ Health plans that have a specific list of medications that they will cover. If prescribers write a prescription for a medication (specific medication, generic name, brand name, dosage form, strength, indication) that is not on formulary, the patient will most likely have to pay the U&C.[20] [21] ○ Open formulary ■ Includes all FDA approved medications and thus has no limitations for the prescribing provider. An open formulary may still be a tiered formulary but can still include all available medications.[20] [21]
  • 5. History of PBMs 1960-70'S Beginnings 1980'S Establishment of PBMs 1990'S Manufacturers acquire PBMs FTC 2000'S Retailers buy their own PBM 03 Holden Young | April 2021
  • 6. 1960-70's: Beginnings 04 • 1968: First PBM, Pharmaceutical Card Systems (PCS, later AdvancePCS) is created [13] ⚬ 1970s: Credited with invention of plastic benefit card used for purchase of medications[13] • 1976: Diversified Pharmaceutical Services (DPS) is created internally at HMO United HealthCare (now United HealthGroup)[11] Holden Young | April 2021
  • 7. 1980's: Establishment of PBMs 05 • 1980’s o Create pharmacy networks and introduce mail service benefits[17] • 1987 o Real-time, electronic drug claims introduced  Begin two-way communication of claims and clinical information[17]  The now paperless claims process initiate PBMs collection of extremely valuable database of prescription drug records[17] Holden Young | April 2021
  • 8. 1990's: Manufacturers acquire PBMs 06 • 1993: Merck purchases Medco for $6 billion[13] • 1994: Eli Lilly purchases PCS for $4 billion[13] SmithKline Beecham purchases DPS from for $2.3 billion[13] Former FTC official, “conflicts of interest raise severe concerns in the health care system. Where a payor is also a provider they can manipulate the relationship to raise health care costs. That is why, when pharmaceutical manufacturers obtained PBMs in the 1990’s, the FTC acted to eliminate those conflicts of interest. The FTC challenged the acquisition of PCS by Lilly and Medco by Merck, because of the concern that having a manufacturer own a PBM would be giving the “fox the keys to the hen house door”—and would lead to higher prices for consumers.”[8] Holden Young | April 2021
  • 9. 2000's: Retailers buy their own PBMs 07 • 1999: Rite Aid acquires PCS from Eli Lilly for $1.5 billion Express Scripts acquires DPS from SmithKline Beecham for $700 million • 2003: Medco establishes as a spin off of Merck • 2000: PBM Advance Paradigm acquires PCS for $1 billion (forming AdvancePCS) • 2003: Caremark purchases AdvancePCS for $5.6 billion • 2007: CVS purchases Caremark for $26.5 billion • 2012: Express Scripts acquires Medco for $29.5 billion, combining two largest PBMs • 2015: OptumRx acquires Catamaran for $12.8 billion • 2018: Cigna acquires Express Scripts for $54 billion Holden Young | April 2021 SOURCE: Feldman, B. S. (2016, March 17). Big pharmacies are dismantling the industry that keeps US drug costs even sort-of under control. Quartz. https://qz.com/636823/big-pharmacies-are-dismantling-the- industry-that-keeps-us-drug-costs-even-sort-of-under-control/
  • 10. PBMs vs. Traditional Health Insurers 08 • Traditional health insurance agencies often provide coverage of medical expenses including PCP visits, hospitalizations, and surgical procedures.[16] • On behalf of insurers, PBMs negotiate drug pricing with pharmaceutical manufacturers, provide MTM and DURs, and create custom formularies for payers to treat specific disease states.[17] Holden Young | April 2021
  • 11. Just how big are PBMs today? 09 According to 2020’s Fortune 500… • Caremark (CVS Health - #5) • OptumRx (UnitedHealth - #7) • Express Scripts (Cigna - #13) Top 3 PBMs accounted for 76% of U.S. prescription claims in 2019[17] Holden Young | April 2021
  • 12. PBM Revenue Model 10 Holden Young | April 2021 SOURCE: A Deep Dive Into DIR Fees. (2018, September 7). Virginia Pharmacists. https://virginiapharmacists.org/wp-content/uploads/2018/09/NCPA-Presentation-to-VPhA-on-DIR-Fees- final.pdf
  • 13. PBM Revenue Model (continued) 11 Express Scripts 2017 Annual Report (Pre-Cigna acquisition) 98.20% 1.80% SOURCES OF REVENUE Tangible product Services Tangible Products Services • Prescription drug sales in PBM’s retail pharmacy network • Negotiating pricing • Dispensing fee • Member co-payments • Prescription dispensing from PBM’s in- house mail-order and specialty pharmacies • Formulary management • Medication benefit management • DUR • MTM • Focused Claims Review • Medication counseling services “…as ingredient cost paid to pharmacies on generic drugs is incrementally lower than the price charged to our clients, higher generic fill rates generally have a favorable impact on our gross profit.” Ingredient cost = actual amount paid to a pharmacy provider by a PBM for a prescription drug, not including the dispensing fee or cost-sharing amount. Holden Young | April 2021 SOURCE: Express Scripts 2017 Annual Report. (2018, January 31). SEC. https://www.sec.gov/Archives/edgar/data/1532063/000153206318000004/esrx- 12312017x10k.htm#s292B544F205F5EE5B67E5937209B0EE0
  • 14. Transparent vs. Opaque PBM models 12 Holden Young | April 2021 Transparent PBM Opaque PBM SOURCE: A Unique Approach: Transparent PBMs. (2019, April). ACHP. https://achp.org/wp-content/uploads/PBM-Infographic_4.5.19.pdf
  • 15. "Brand name preferred by health plan" 13 Holden Young | April 2021 Expectations Generic becomes available Retail pharmacy begins carrying generic Patient co-pay covers most if not all of costs
  • 16. "Brand name preferred by health plan" 13 Holden Young | April 2021 Reality Generic becomes available Manufacturer contracts with PBM Health plans billed for brand name, patient co-pay is on par with or even lower than generic
  • 17. Independent Pharmacies vs. Retail-owned PBM companies 14 Holden Young | April 2021 • Immunizations • MTM • Chronic disease state education • Utilize pharmacist prescriptive authority Collaborative practice agreements • OTC management Maximization of fees-for-services
  • 18. Entrepreneurial Opportunities for Pharmacists 15 Holden Young | April 2021 Majority will most likely encompass the following: • Remote-based • Technological in nature • Mass adaptation of web-based platform (video-calling, team/group chat, online ordering) use across multiple generations within general population
  • 19. References 16 Holden Young | April 2021 1. A Deep Dive Into DIR Fees. (2018, September 7). Virginia Pharmacists. https://virginiapharmacists.org/wp-content/uploads/2018/09/NCPA-Presentation-to-VPhA-on-DIR-Fees-final.pdf 2. A piece of the pie: Independents build new business models. (2020, March 20). Drug Store News. https://drugstorenews.com/pharmacy/a-piece-of-the-pie-independents-build-new-business-models 3. A Unique Approach: Transparent PBMs. (2019, April). ACHP. https://achp.org/wp-content/uploads/PBM-Infographic_4.5.19.pdf 4. AbbVie, Amgen settlement sets Humira U.S. biosimilar launch for 2023. (2017, September 28). Reuters. https://www.reuters.com/article/us-abbvie-amgen-humira/abbvie-amgen-settlement-sets-humira-u-s-biosimilar-launch-for-2023- idUSKCN1C32G5 5. Abusive, Opaque PBM Pricing Schemes Receive More Attention Over Summer Congressional Recess. (2020, February 19). Senior Care Pharmacies. http://seniorcarepharmacies.org/abusive-opaque-pbm-pricing-schemes-receive-more-attention- over-summer-congressional-recess/ 6. Comparison of Acquisition-Cost Based Reimbursement Models. (n.d.). NCPA. http://www.ncpa.co/pdf/advocacy/medicaid-pricing-summary-2015.pdf 7. Denning, S. (2011, December 5). Pfizer’s Lipitor: How Big Pharma Blocks Reimbursement Of Generics. Forbes. https://www.forbes.com/sites/stevedenning/2011/11/30/pfizers-lipitor-how-big-pharma-blocks-reimbursement-of- generics/?sh=74b357db7b8b 8. Draft Vertical Merger Guidelines for Public Comment. (2020, February 26). FTC. https://www.ftc.gov/system/files/attachments/798-draft-vertical-merger-guidelines/apha_comments_-_ftc.pdf 9. Drug Pricing Policy. (n.d.). FDB (First Databank). https://www.fdbhealth.com/drug-pricing-policy 10. Eberle, B. J., & Amber, A. (n.d.). Your PBM’s MAC list impacts your bottom line. Managed Healthcare Executive. https://www.managedhealthcareexecutive.com/view/your-pbms-mac-list-impacts-your-bottom-line 11. Express Scripts. (1999, February 9). Express Scripts to Acquire Diversified Pharmaceutical Services. PR Newswire. https://web.archive.org/web/20180127202647/https://www.prnewswire.com/news-releases/express-scripts-to-acquire-diversified- pharmaceutical-services-74853317.html 12. Express Scripts 2017 Annual Report. (2018, January 31). SEC. https://www.sec.gov/Archives/edgar/data/1532063/000153206318000004/esrx-12312017x10k.htm#s292B544F205F5EE5B67E5937209B0EE0
  • 20. References 16 Holden Young | April 2021 13. Feldman, B. S. (2016, March 17). Big pharmacies are dismantling the industry that keeps US drug costs even sort-of under control. Quartz. https://qz.com/636823/big-pharmacies-are-dismantling-the-industry-that-keeps-us-drug-costs-even-sort-of- under-control/ 14. Fortune 500. (2020, September 18). Fortune. https://fortune.com/fortune500/2020/search/ 15. How Can Independent Pharmacy Compete. . .. (2019, August 2). QS/1 Pharmacy Management Systems. https://www.qs1.com/2017/09/05/how-can-independent-pharmacy-compete/ 16. How U.S. Health Insurance Works | Vaden Health Services. (n.d.). Stanford - Valden Health Services. https://vaden.stanford.edu/insurance/health-insurance-overview/how-us-health-insurance-works 17. Leveling the Playing Field in the Pharmacy Benefit Management Industry. (2007). ValpoScholar. https://scholar.valpo.edu/cgi/viewcontent.cgi?referer=https://en.wikipedia.org/&httpsredir=1&article=1131&context=vulr 18. Lupkin, S. (2018, March 13). Patients Overpay For Prescriptions 23% Of The Time, Analysis Shows. Kaiser Health News. https://khn.org/news/paying-cash-for-prescriptions-could-save-you-money-23-of-the-time-analysis-shows/ 19. Mattingly, J. P. (2012, June 20). Understanding Drug Pricing. U.S. Pharmacist. https://www.uspharmacist.com/article/understanding-drug-pricing 20. Medication Management. (n.d.). ASHP. https://www.ashp.org/-/media/store%20files/p2371-sample-chapter-4.pdf 21. Mikesell, M. (2020, July 29). Open to Closed: The Difference in Formularies. Apex Benefits. https://apexbg.com/open-to-closed-the-difference-in- formularies/#:%7E:text=A%20closed%20formulary%20%E2%80%93%20meaning%20not,of%20a%20drug%20are%20covered 22. MultiBrief: Why would health insurers choose brand-name drugs over generic? (2018, April 5). Multibriefs: Exclusive. https://exclusive.multibriefs.com/content/why-would-health-insurers-choose-brand-name-drugs-over-generic/pharmaceutical 23. Our history. (n.d.). CVS Health. https://cvshealth.com/about-cvs-health/our-purpose/our-history 24. Pharma Pay-For-Delay Deals Called ‘Cost of Doing Business.’ (2020, February 10). Bloomberg Law. https://news.bloomberglaw.com/health-law-and-business/pharma-pay-for-delay-settlements-cost-of-doing-business 25. Pharmacy Benefit Managers and Their Role in Drug Spending | Commonwealth Fund. (2019, April 22). The Commonwealth Fund. https://www.commonwealthfund.org/publications/explainer/2019/apr/pharmacy-benefit-managers-and-their-role-drug- spending
  • 21. References 16 Holden Young | April 2021 26. Pharmacy Services Administrative Organizations (PSAOs) and their Little-Known Connections to Independent Pharmacies. (2021, February 1). PCMA. https://www.pcmanet.org/pharmacy-services-administrative-organizations-psaos-and-their-little- known-connections-to-independent-pharmacies/ 27. Samsung Bioepis Continues Global Market Expansion with Launch of HADLIMATM in Australia and Canada in partnership with Merck & Co. (2021, March 29). BioSpace. https://www.biospace.com/article/releases/samsung-bioepis-continues-global- market-expansion-with-launch-of-hadlima-in-australia-and-canada-in-partnership-with-merck-and-co-/#:%7E:text=HADLIMA%E2%84%A2%20will%20be%20available,%2C%20NJ%2C%20USA%20in%202013 28. Strongin, R. (1999). The ABCs of PBMs (Vol. 749). National Health Policy Forum. 29. Trends in Use and Expenditures of Brand-name Atorvastatin After Introduction of Generic Atorvastatin. (2018, May). JAMA Network. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2674714 30. Understanding Drug Tiers. (2018, December 19). Patient Advocate Foundation. https://www.patientadvocate.org/explore-our-resources/understanding-health-insurance/understanding-drug-tiers/ 31. Zetts, R., Hyman, D. A., Slotkin, J., Wyatt, M., Jordan, A., & Wakeman, S. E. (2018, March 9). A costly PBM trick: set lower copays for branded drugs than for generics. STAT. https://www.statnews.com/2018/03/12/pbm-copays-brand-name-drugs- generics/

Notes de l'éditeur

  1. PBMs are companies (often subsidiaries) that manage pharmacy benefits on behalf of their payers Payers include managed care organizations, health insurers, third-party administrators, employers, union-sponsored benefit plans, workers’ compensation plans, government health programs (Medicaid: state level, Medicare: federal level), providers, clinics, and hospitals PBMs negotiate drug pricing with pharmaceutical manufacturers, provide MTM and DURs, and create custom formularies for payers to treat specific disease states
  2. Revenue can be classified as either tangible product revenues or service revenues. Tangible product revenues: from sale of prescription drugs by retail pharmacies in their retail pharmacy networks and from dispensing prescription drugs from their in-house home delivery and specialty pharmacies.  Service revenues include fees for administration of formulary management processing, medical benefit management services, as well as other fee-for-service arrangements, such as medication counseling services.  Tangible product revenues generated by PBM and Other Business Operations segments represented 98.2% of revenues for the year ended December 31, 2017, as compared to 98.3% and 98.0% for the years ended December 31, 2016 and 2015, respectively. Our PBM revenues are primarily comprised of: Total prescription price, which includes a negotiated price with the client and a fee related to dispensing at retail pharmacies; Member co-payments; Offsets to revenues we consider client discounts, which include manufacturer rebates and administrative fees payable to clients, obligations under financial and service guarantees to clients, and pricing discounts; and Fees-for-services Generally, higher generic fill rates reduce PBM revenues, as generic drugs are typically priced lower than the branded drugs they replace. However, as ingredient cost paid to pharmacies on generic drugs is incrementally lower than the price charged to our clients, higher generic fill rates generally have a favorable impact on our gross profit. Ingredient cost means the actual amount paid to a pharmacy provider by a carrier or the carrier's pharmacy benefits manager for a prescription drug, not including the dispensing fee or cost-sharing amount.
  3. PBMs are contracted to negotiate rebates and discounts for health plans and thus their clients ACHP Opaque PBMs “Traditional PBMs” are paid a rebate (reimbursement or “cash back”) by drug manufacturers which should either be partially or fully passed onto health plans to lower out-of-pocket costs for patients. These PBMs do not pass it on, and patients still end up paying higher costs for their prescriptions. ACHP Clawbacks: When medication costs less than patient’s copay, PBM keeps the difference KHN Senior Care Pharmacies Pricing and fees for services provided by PBMs are not clearly provided for health plans and patients to understand Transparent PBMs Use “Pass-through” model, where PBM passes on all rebates and discounts and their revenue comes in the form of a flat administrative fee ACHP SOURCE: Abusive, Opaque PBM Pricing Schemes Receive More Attention Over Summer Congressional Recess. (2020, February 19). Senior Care Pharmacies. http://seniorcarepharmacies.org/abusive-opaque-pbm-pricing-schemes-receive-more-attention-over-summer-congressional-recess/
  4. NORMAL circumstances Generic arrives on market Retail pharmacy begins carrying generic Patient now fills much cheaper generic, which often costs so low that health plans do not need to cover any costs and patient co-pay is more than enough Exclusives Manufacturers + PBMs Manufacturers ensure that only a few companies produce medication (generic or brand) Manufacturers contract with PBMs to ensure that health plans still pay for brand name but patient co-pay is on par with or even lower than generic This is where retail pharmacies get notice of “brand name preferred by plan” From 2012-14, $4.3 billion was spent on Lipitor (brand name Atorvastatin). $2.1 billion was considered excess expenditures that could have been saved and passed onto health plans and patients (Statnews, JAMA) Manufacturers now settle with generic/biosimilar manufacturers to delay and stagger market entry across different regions globally Humira (Abbvie) Amgen (Imjevita) - Launch: Europe - 2018, US - 2023 Samsung Bioepis (Hadlima) - Launch: EU - 2018, Canada, AUS - 2021, US - 2023 4 year delay of Humira biosimilar entry in US provides market exclusivity for estimated revenue of $20 billion per year and clear timeline for competition’s market entry into specific regions Abbvie also has a clear as to when they should ensure Humira is preferred over biosimilars on as many PBM formularies possible Over 100 patents on Humira. Currently, last patent will expire in 2039, 37 years after it was first approved. This means that royalties can be expected to be paid by biosimilar companies to Abbvie at least until 2039 https://www.npr.org/sections/health-shots/2014/03/20/291858111/cholesterol-guidelines-could-lead-to-statins-for-half-of-adults SOURCE: AbbVie, Amgen settlement sets Humira U.S. biosimilar launch for 2023. (2017, September 28). Reuters. https://www.reuters.com/article/us-abbvie-amgen-humira/abbvie-amgen-settlement-sets-humira-u-s-biosimilar-launch-for-2023-idUSKCN1C32G5 Samsung Bioepis Continues Global Market Expansion with Launch of HADLIMATM in Australia and Canada in partnership with Merck & Co. (2021, March 29). BioSpace. https://www.biospace.com/article/releases/samsung-bioepis-continues-global-market-expansion-with-launch-of-hadlima-in-australia-and-canada-in-partnership-with-merck-and-co-/#:%7E:text=HADLIMA%E2%84%A2%20will%20be%20available,%2C%20NJ%2C%20USA%20in%202013 MultiBrief: Why would health insurers choose brand‑name drugs over generic? (2018, April 5). Multibriefs: Exclusive. https://exclusive.multibriefs.com/content/why-would-health-insurers-choose-brand-name-drugs-over-generic/pharmaceutical Zetts, R., Hyman, D. A., Slotkin, J., Wyatt, M., Jordan, A., & Wakeman, S. E. (2018, March 9). A costly PBM trick: set lower copays for branded drugs than for generics. STAT. https://www.statnews.com/2018/03/12/pbm-copays-brand-name-drugs-generics/ Trends in Use and Expenditures of Brand-name Atorvastatin After Introduction of Generic Atorvastatin. (2018, May). JAMA Network. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2674714 Pharma Pay-For-Delay Deals Called ‘Cost of Doing Business.’ (2020, February 10). Bloomberg Law. https://news.bloomberglaw.com/health-law-and-business/pharma-pay-for-delay-settlements-cost-of-doing-business Denning, S. (2011, December 5). Pfizer’s Lipitor: How Big Pharma Blocks Reimbursement Of Generics. Forbes. https://www.forbes.com/sites/stevedenning/2011/11/30/pfizers-lipitor-how-big-pharma-blocks-reimbursement-of-generics/?sh=74b357db7b8b
  5. NORMAL circumstances Generic arrives on market Retail pharmacy begins carrying generic Patient now fills much cheaper generic, which often costs so low that health plans do not need to cover any costs and patient co-pay is more than enough Exclusives Manufacturers + PBMs Manufacturers ensure that only a few companies produce medication (generic or brand) Manufacturers contract with PBMs to ensure that health plans still pay for brand name but patient co-pay is on par with or even lower than generic This is where retail pharmacies get notice of “brand name preferred by plan” From 2012-14, $4.3 billion was spent on Lipitor (brand name Atorvastatin). $2.1 billion was considered excess expenditures that could have been saved and passed onto health plans and patients (Statnews, JAMA) Manufacturers now settle with generic/biosimilar manufacturers to delay and stagger market entry across different regions globally Humira (Abbvie) Amgen (Imjevita) - Launch: Europe - 2018, US - 2023 Samsung Bioepis (Hadlima) - Launch: EU - 2018, Canada, AUS - 2021, US - 2023 4 year delay of Humira biosimilar entry in US provides market exclusivity for estimated revenue of $20 billion per year and clear timeline for competition’s market entry into specific regions Abbvie also has a clear as to when they should ensure Humira is preferred over biosimilars on as many PBM formularies possible Over 100 patents on Humira. Currently, last patent will expire in 2039, 37 years after it was first approved. This means that royalties can be expected to be paid by biosimilar companies to Abbvie at least until 2039 https://www.npr.org/sections/health-shots/2014/03/20/291858111/cholesterol-guidelines-could-lead-to-statins-for-half-of-adults https://www.dreamstime.com/illustration/deductible-copay.html SOURCE: AbbVie, Amgen settlement sets Humira U.S. biosimilar launch for 2023. (2017, September 28). Reuters. https://www.reuters.com/article/us-abbvie-amgen-humira/abbvie-amgen-settlement-sets-humira-u-s-biosimilar-launch-for-2023-idUSKCN1C32G5
  6. Essentially, “cutting out middleman - PBMs” and providing services outside of Rx filling Implementing multiple strategies to pivot from prescription sales as the dominant source of revenue for the pharmacy Improve patient outcomes Find niches Full utilization of RPh license MTM Immunizations Educational courses on chronic disease states (eg. DM) to be billed to Medicare Utilizing pharmacists’ prescriptive authority, collaborative agreements with physicians OTC Keeping in-stock items seasonal, lowering inventory costs CBD (leverage increased knowledge/education in area vs. Retail counterparts) High-end/niche vitamins (gluten-free?, organic, specific brand?) High-end/niche skin care products SOURCES: A piece of the pie: Independents build new business models. (2020, March 20). Drug Store News. https://drugstorenews.com/pharmacy/a-piece-of-the-pie-independents-build-new-business-models How Can Independent Pharmacy Compete. . .. (2019, August 2). QS/1 Pharmacy Management Systems. https://www.qs1.com/2017/09/05/how-can-independent-pharmacy-compete/
  7. I believe there will always be opportunities for entrepreneurs within pharmacy no matter the financial landscape But I do believe the majority that prove to be successful will encompass the following: Remote Technologically-based Align with the changes we are seeing socially → Mass adaptation of the population to use of smartphones and web-based platforms (Video-calling, Team/group chat)   Platforms devoted to healthcare teams and patient use for better overall better patient care (essentially an app/software/website that allows PACT-like team provide complete healthcare) HIPAA compliance, protects PHI Easy to use for healthcare workers and patients Allows for video calls, text message function Allows for appointment scheduling (annual PCP check-ups, mental health appt, MTM/pharmacist follow-up, specialty provider appt, lab draw, lab f/u call w/ provider, etc.) Patient-specific Dx state tabs that provide Patient education handouts Goals for each Dx state Eg. BP goal < 130/80 T2DM A1C <7% Similar Dx state tabs for each prescriber Allows prescriber to see current Dx states Trends for pt data (BP readings, BG) Last f/u with rest of healthcare team Software or application that allows pharmacies to document and bill for clinical or any other services that pharmacists provide outside of the prescription filling process Wearable devices Catered to aging population Eg. Dexcom - continuous glucose monitoring Continuous BP, HR monitoring SOURCES: A piece of the pie: Independents build new business models. (2020, March 20). Drug Store News. https://drugstorenews.com/pharmacy/a-piece-of-the-pie-independents-build-new-business-models How Can Independent Pharmacy Compete. . .. (2019, August 2). QS/1 Pharmacy Management Systems. https://www.qs1.com/2017/09/05/how-can-independent-pharmacy-compete/