Pro Pharma Talks

Remedies & Myths:

1. Krazy Glue can be used to seal small wounds

     a. Contains cyanoacrylate

     b. Con – irritate skin, kill cells, and aggravate infections, poison if swallowed

2. Treatment of burns

     a. Put Butter on a Burn

     b. Toothpaste on a burn

     c. Honey on a burn

     d. Aloe Vera on a burn

     e. For Cuts and Scrapes, Apply Peroxide and Leave Open to the Air

3. Throw Your Head Back to Stop a Nosebleed

     a. Throwing your head back causes blood down to the back of the throat and you may swallow it.  Swallowed blood irritates your stomach and causes vomiting

     b. Tx – tip head forward, pinch your nostrils together while leaning slightly forward

4. Vicks for Foot Fungus, Headaches, Ear Aches

     a. Vicks increases circulation

     b. Headaches

     c. Nail fungus

     d. Rub with Vicks in a cotton ball for ear aches

     e. Rub Vicks for stomach aches

5. Witch hazel for headaches

     a. Hot Tequila and honey for a sore throat

     b. Purple onion tea for cough

6. Tomatoes for tonsil aches

     a. Tomato juice is acidic so it is a poor choice for sore throats

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 Rebates 

• Spin – Rebates are a villain in producing higher drug costs

• What are they?  -- 

  o Discounts for favorable formulary placement

  o Rebates are like discounts based on the volume of sales

• Entities involved – PBM, rebate aggregator, Health Plan, drug manufacturer

• What is rebated?  -- brand name drugs only

• Contract between PBM or payer and drug manufacturer

  o Terms of contracts are secret

  o Manufacturers don’t want other manufacturers to know what they have guaranteed for discounts

  o PBMs don’t want clients to know how much they keep

  o PBMs negotiate discounts so the overall cost is lower, but they keep a percentage of the savings

• Largest contractor for rebates is Medicare

• Response

  o CVS is giving patients a lower cost by giving rebates/discounts at point-of-sale

  o Walgreens and others are doing the same

• Industry question – Are rebates going away, or are they just being moved to another cost that ultimately the patient or insurer still pays

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 This Weeks Topic:

1. Opiate issue

     a. Scale of problem

     b. Who is to blame?  PhRMA, doctors, patients

     c. Sites of Care – surgery, ER, dentists, primary care

2. Responses

      a. Discontinuation of therapy – CDC response to taper

      b. Opiate Stewardship

     c. State Programs to intervene

 ______

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• Are all consumers the same?

• Deloitte/ Four Consumer Classifications

   • Trailblazers

      o Younger, higher income, excellent health, more men, use report cards of doctors, hospitals, will change doctors if dissatisfied

   • Prospectors

      o 2nd youngest group, high income, men=women, open to wearable tech & virtual office visits, use quality ratings    

      o 2nd oldest, low income, women>men, not open to tech, avg. wellness, convenience > OOP, don’t change providers

   • Bystanders

      o Oldest, poorest, women > men, not open to tech, avg. wellness, don’t share info with doctor, least likely to follow healthy diet, choose doctor on OOP and convenience

• Why are we talking about this?  

      o If consumer can pick their health care option, then who are the consumers, i.e., what types do they fit?

      o What do they want?

      o With Congress and the States trying to model health care as ACA or an alternative, then what patient types should they consider?

• In actuality, the US already has a multi-tiered health care system –

      o Healthy, young people can buy commercial insurance or not

      o Poor people and children have Medicaid or County hospitals/clinics for caring for the poor and uninsured

      o General Public has the ACA

      o Older people have Medicare

      o Injuries have Workers Comp

• If we use the Deloitte Consumer Classifications, then we have one method of classifying different patient types.

• For other than Medicaid/Medicare, Workers Comp, and Commercial Insurance, the law of large numbers prevails.  To provide insurance for people with pre-existing conditions, healthy and sick people must participate.  Options include:

      o Modifying the ACA – produced low ER, low hospital, downward drug spend – needs alternative options for healthy individuals

      o Aggregating populations with sick and poor to contribute to insurance

      o Various per-capita formulae for different segments of the population

      o State or Federal government re-insurance programs

      o National health care

      o Other options

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 Topic: The Flu Vaccine

Influenza:

1. Why do we need a flu shot every year?

     a. Virus and vaccine

          i. Virus is constantly mutating/changing

          ii. Vaccine only works against one portion of a protein on the surface

          iii. WHO/CDC basically makes an educated guess as to which virus will be the most likely

     b. Even in a “bad” year when the vaccine doesn’t match well, the effectiveness is still about as good as most medications at preventing/treating their corresponding diseases.

2. Why should people get the flu shot?

     a. Because it decreases your chance of getting flu, getting a severe case of the flu, being hospitalized for the flu and even dying from the flu

     b. The “but I am a healthy adult” excuse…

          i. Healthy adults can die from influenza (e.g., WWI and many cases reported with H1N1)

          ii. Some evidence that certain strains can cause more severe disease in adults versus elderly or children due to a more robust immune response that causes more lung damage

          iii. You can still spread influenza even if you only have mild to almost no symptoms

3. So what are the symptoms of influenza?

     a. First, it isn’t a cold… typically no runny nose, doesn’t start slowly and take a few weeks to kick

     b. It also isn’t the “stomach flu”… this is caused by enteroviruses and other pathogens.  

          i. Patients with influenza may have vomiting and diarrhea, but it isn’t a classical symptom.  (also can have multiple viruses circulating)

     c. Influenza is typically fever (therefore chills), malaise, sore throat and headache.  If someone comes in and says they don’t feel well and is sniffling/sneezing, it isn’t the flu.  If they come in and say they feel like they are going to die, that’s the flu.

4. Who is most at risk for having complications or more severe influenza?

     a. Age… young children and elderly

     b. Other diseases… asthma, COPD, diabetes, heart disease, basically any other chronic disease that compromises any organ, including taking medications that lower your immune system.

     c. What else? Morbid obesity, neurological compromise, 

 PREGNANCY!

5. Why is pregnancy a risk?

     a. Basically causes both immunosuppression and puts strain on the mother’s organs

     b. We saw very high rates of hospitalization and mortality with H1N1.

     c. Numerous studies have shown it is safe and also protects the baby after birth (along with Tdap!)

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 Topic: Generic Vs. Brand Vs. Biosimilars

Top 10 Generic Pharmaceutical Companies – many are branded companies, e.g., 1, 2, 3, 9, 10

     1. Pfizer Established Pharma

     2. Teva Generics (including Allergan Gx)

     3. Sandoz / Novartis

     4. Sun Pharma – Indian multinational pharmaceutical company

     5. CR Pharmaceuticals – second largest distributor in Chinese pharmaceutical market

     6. Yangtze River Pharma – Chinese multinational pharmaceutical corporation

     7. Mylan – Morgantown

     8. EMS – largest pharmaceutical company in Brazil

     9. Abbott Established Pharma

     10. Hengrui Therapeutics in Princeton, NJ = Jiangsu Hengrui Medicine Co. Ltd. Is largest ethical pharmaceutical company in China

Effectiveness / Risk / Safety

     • Identical to brands

     • Possibly different fillers, color or shape

Cost

     • First 6 months -- 10-15% discount

     • After 6 months -- >=70% discount

Biosimilars

     • Highly similar, but not identical

     • No clinically meaningful differences in efficacy, safety, and potency vs. reference product

     • Reviewed and approved through an abbreviated FDA review process = 351(k) pathway

     • FDA guidance  the Agency reviews the totality of evidence and does not necessarily focus on one type of study to evaluate a manufacturer's application for demonstration of biosimilarity

     • The manufacturer of a biosimilar demonstrates biosimilarity primarily from nonclinical analyses in a stepwise approach that includes examining the structure and functional nature of the biosimilar molecule

Cost

     1. Europe about 15% discount

     2. US = 15% to 50%

______

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Episode Outline:

Topic: Amazon, Berkshire Hathaway, and JP Morgan Chase Tackle Healthcare

Goals 

     •Save money

     •Ensure Quality

     •Satisfy patients

Employers buy health care

     •Cost

          •Single Plan = $5,700 / employee

          •Family Plan = $14,900 / family

     •Employee pays = 28% of premium cost

Problems

     •Employer sponsored health care

     •Volume over Value

     •Patient not involved

Remember, Potential Solutions?

     •Patients get a seat at the table

     •Fixed fees for clinicians

     •Integrated care

     •Health coach

______

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Episode Outline:

Topic: How other countries handle Universal Health Care?

        • APPROACHES TO UNIVERSAL HEALTH CARE

               o Public Insurance -- United Kingdom

               o Private Insurance – Netherlands

               o Mixed Public-Private Insurance – France

        • PUBLIC INSURANCE

               o Single payer

               o Government finances with taxes

               o Direct contracting with providers

               o All care is provided

        • PRIVATE INSURANCE

               o Government sets policy and regulates private insurance

               o Insurance & delivery of care are run by private sector

               o Everyone required to have healthcare

               o Patients must buy supplementary insurance for glasses & dental

        • MIXED PUBLIC-PRIVATE

               o Government taxes support public and private insurance

               o Government manages 3 major non-profit funds who pay providers

               o All citizens must be covered

               o Cost-sharing for doctor visits, inpatient, dental and vision

        • REMEMBER…

               o Public Insurance – financed with tax revenues - Direct contracts with providers, everything covered, no co-pays

               o Private Insurance - Government sets policy and regulation - Private insurance and delivery of care are left to private sector - Supplementary insurance for glasses & dental

                o  Mixed Insurance - Government taxes support both public & private insurance - 

Cost-sharing for doctor visits, inpatient, dental & vision

______

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 Episode Outline:

FENTANYL – USE VS. ABUSE

Bottomline – When used appropriately (surgery, cancer) it is very beneficial! 

Approach:  How to balance benefits vs. risks?

What it is?

       • Synthetic narcotic painkiller and anesthetic – created 1960

       • Pharmacology – binds to opiate receptors in brain – fast and in small doses 50-100x > morphine, 50x > heroin

       • Dosage forms – injection, patch, sublingual, tablet, film, lozenges, lollipops

       • Rx pain after surgery, severe cancer pain

              o Rx requires enrollment in program to decrease risk of medication 

              o NMT 4x/day

       • Drug Interactions –

              o Heart:  Amiodarone, Diltiazem

              o Antibiotics: Clarithromycin, Erythromycin

              o Antifungals:  antifungals (fluconazole, itraconazole, ketoconazole)

              o Heart burn:  Cimetidine 

              o HIV drugs

              o Depressants: Benzodiazepines, muscle relaxants, sedatives, tranquilizers

Risks?

       • Narrow therapeutic index!

       • Withdrawal – muscle pain, diarrhea, vomiting, nausea, sweating, abdominal pain, cramping, tachycardia, insomnia, tremors, anxiety

       • NIH – 9580 deaths in 2015

       • Illegal – cut heroin

       • Addiction Treatment – 

              o Methadone, buprenorphine, naltrexone

              o Recovery, professional therapy, group counseling

_______

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Episode Outline:

Insulin Prices & What To Do About It

Sky rocking cost of insulin

       -  ADA and Health Care Cost Institute – prices 2x between 2012 and 2016, 3x in decade before 2012

       -  100 year history – R&D is over – price changes are PhRMA increases

       -  Sanofi

       -  Novo Nordisk

       -  Eli Lilly

Insulins

       -  Old – Humulin, Novolin

       -  New Analog insulins – Lantus, Levemir, Novolog, Humalog – less hypoglycemia

Harvard Study

       -  Type 2 diabetes

       -  JAMA recent study

       -  Anthem patients witched from new to old insulins

       -  Outcomes:  Patients less likely to reach Med D donut hole (80% vs. 53% after the switch), no increased risk of dangerously high/low BS, no increase in ED or hospital stays

House and Senate targeting cost of insulin

       -  House Energy & Commerce Committee 

       -  Senate Finance Committee 

Options:

       -  PhRMA regulations

       -  Legalize Canadian imports – patients, wholesalers, pharmacists

       -  PhRMA self-regulation

       -  Competition from human insulins

_______

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