Pro Pharma Talks

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1. The science of Covid-19

2. Pneumonia Vaccine

3. Immunocompromised patients do well with most vaccinations including RSV – these patients at increased risk of infections – new research indicates that vaccinations against human papillomavirus, hepatitis B, herpes zoster are not a problem to give

4. Misinformation

5. Supporting Information

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PP Talks – A Model for High Quality, Low Cost Health Care

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1. Who Makes HC Policy?

     a. State differences – access, price and coverage

     b. Individuals affected – 

          i. 17M buy insurance

          ii. 29M don’t have insurance

          iii. MCare & Medicaid not affected – State expansion of Medicaid, but higher rates of inflation in Red States

2. Hospital Closures & Medicaid Expansion

     a. ACA improving health care?

          i. Hospitals closed in States rejecting Medicaid

               1. States expanding Medicaid – lower and falling hospital closures

               2. ACA – improved hospital financial performance w/lower probability of closure for rural markets and counties w/large amt of uninsured

               3. Supreme Court left Medicaid expansion to the States

               4. Hospital closure leads to loss of well-paying and skilled jobs

3. Wall Street – Another Option for Paying For Health Care Benefits

     a. Sell wealth management to individuals

          i. Lower cost method to gain new customers

          ii. Morgan Stanley, Goldman, Fidelity, Charles Schwab, E*Trade, Amazon/JPMorgan/Berkshire Hathaway

          iii. Wall St has the analytics to redeploy investment dollars to benefits

          iv. Same as insurance brokers?

          v. TPA/PBM – middleman model to transactional model

4. Geography Matters – John Wennberg, MD

     a. Dartmouth Atlas of Health Care – cost of living, site of care, volume of services delivered, hospital/MD salaries

     b. Example – 

          i. SF Chronicle reports cost in No. CA 30% > So. Ca d/t UC Berkeley Petris Center on Health Care Markets and Consumer Welfare

          ii. Primary reasons -- D/t consolidation in hospitals, insurance and MD practices b/w 2010-2016 (adj for higher cost of living and wages)

          iii. Result – mergers/acquisitions in health care = HP+PBMs, MD practices, Plans, Pharmacies lead to higher costs

          iv. Marketplace competition, technology, telehealth, international competition, competitor ads leverage cost differences

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What do people believe in fake medicines?

1. Differences between fake and counterfeit?

     a. Counterfeit is medicine without active ingredient, contaminated, or wrong ingredient

          i. Counterfeit examples – Fentanyl, Oncology meds – BCNU, Botox, Artesunate for malaria, antibiotics, meningitis vaccines, ED drugs

     b. False treatments 

          i. Examples – fake miracle cancer cures, coronavirus treatments, nutritional supplements, cosmetic treatments, beauty treatments

     c. Result – harm, loss of hope and money

2. Fake coronavirus treatments

     a. Fake tests

     b. Alcohol-based hand sanitizers, counterfeit respirators, biomagnetism magnetic therapy, covid-19 test packages, OMI sale therapy pipes inhalers, amniotic fluid products, colloidal silver, CBD

     c. Fake treatments

          i. Hydroxychloroquine, chloroquine

          ii. Natural treatments and cures

               1. Herbal cold remedies, immune system support products, nutritional vitamins from natural sources to protect from infection, covid-19 cough syrups, natural zinc and vitamin C

3. Why do people believe?

     a. Confirmation bias

     b. Lack of credible evaluation

     c. Attention and impatience

     d. Cognitively lazy

     e. Emotions

     f. Reiteration

     g. Social pressure

4. Conclusion

     a. Skeptical of treats & cures

     b. Evidence, and confirmation

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PP Talks -- Is It Common for Compounds to Fail the FDA Approval Process?

1. Stages of FDA Approval Process IND

a. Phase 1 – Safety – 20-100 healthy, 2 yrs.

b. Phase 2 – Effectiveness – 100-500 patients, 2 yrs.

c. Phase 3 – Effectiveness & ADR, 1K-5K, 3.5 yrs.

2. Vaccines

a. Phase I fails = 37%

b. Phase II fails = 69%

c. Phase III fails = 42%

d. Biologics License Application (BLA) application

e. Vacc & Related Biologics Prod Adv Cmte (VRBPAC)

3. Risks

a. New vaccine for new virus

b. Clinical trials never succeed

c. Vaccine induced enhancement

d. Acquire study population

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What is it?

What causes it?

How is it treated?

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What aren’t people talking about health care?

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1. Public discussion

     - New information

     - Politics

     - MD subspecialties

     - Sources of data

     - Nonsense

     - PP Disclaimer

2. Expertise

     - Experts

          - ID specialists / epidemiologists

          - CDC

          - WHO

          - NIH

          - Survey data

          - FDA for potential treatments

     - Mistakes

     - Data acquisition / politics

3. Pearls

     - New treatments

     - Bogus treatments

     - Comps – 2019 vs. 1918

     - Information progresses

     - Experts change opinions

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The War Over Covid-19 Expertise and the Politicization of Health

Public discussion

     -New information

     -Politics

     -MD subspecialties

     -Sources of data

     -Nonsense

     -PP Disclaimer

Expertise

     -Experts

          -ID specialists / epidemiologists

          -CDC

          -WHO

          -NIH

          -Survey data

          -FDA for potential treatments

     -Mistakes

     -Data acquisition / politics

Pearls

     -New treatments

     -Bogus treatments

     -Comps – 2019 vs. 1918

     -Information progresses

     -Experts change opinions

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Questions for PP Talks – Covid-19 & Children

1. Rationale?

            a. Symptoms less severe than in adults

            b. Children may carry the virus w/o S/S, but may transfer it

            c. Data is variable and in many cases based on limited groups or on case reports

2. What do we know?

            a. 22% of US population is children

            b. 1.7% are reported cases (similar to China data)

            c. Case breakdown = 

                        i. 10-17 y/o = 60%

                        ii. 1 y/o = 15%

                        iii. 1-4 y/o = 11%

                        iv. 5-9 y/o = 15%

                        v. 57% males

            d. Comps to adults

                        i. Peds experience less fever, cough, SOB -- 73% peds vs. 93% adults

                        ii. Hospitalization – 5.7% peds vs. 10% adults

3. Treatments?

            a. Population at risk – no widespread testing, no testing for mild S/S

            b. Perinatal transmission to neonates – guidelines require mandatory testing of neonates

            c. Infants at higher risk than older children

            d. Extrapolate treatments for adults

                        i. Prevention = hand washing, face masks, social distancing

                        ii. Behavioral changes = target stress, excessive worry, sadness, poor eating habits, unhealthy sleep habits, difficulties with attention and concentration

                        iii. Remdesivir – for hospital, severe disease – available for children through FDA Emergency Use Authorization OR through compassionate use program

4. Risks?

            a. Standard vaccinations and wellness checks

            b. PMIS-TS

1. What is the current situation?

     a. US – slow response, extremely poor national management, high uninsured rate, high out-of-pocket costs, and comparatively low medical system capacity 

     b. States in competition over purchasing PPE

2. What are other countries doing?

     a. International experience – management, global partnering

     b. Asian experience – using lessons learned from SARS outbreak

     c. European experience – emphasize testing

     d. Scandinavia

          i. Swedish model – remained open, highest global death rate, economy in worst crisis since WWII

          ii. Denmark/Norway – locked down

          iii. Finland has low level of immunity – fears of a second wave

     e. Taiwan Model

          i. Geopolitical fight with China

          ii. Serious history of respiratory diseases

          iii. Coordinate government’s response

          iv. Quick and efficient in deploying counter measures

3. What have we learned?

     a. Proactive management like every other pandemic is crucial

     b. Global partnerships are crucial

     c. Quick and efficient testing

     d. US complicated with high uninsured rate, high OOP costs, low medical system capacity

     e. US has greater disease burden

      f. US has smaller workforce and acute hospital bed capacity

     g. Considerable variation among states

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1. What is off-label drug use?

     a. Off-label drug use is when doctors prescribe medications for unapproved uses

     b. FDA cannot control how doctors prescribe

     c. 20% of Rx in US are fore off-label uses

2. Why use a drug for off-label purposes?

     a. Tried all other options without success

     b. Literature to support drug’s use, even if limited

     c. Different dosage form

     d. Dosage for which there is evidence that a higher dose may be effective

     e. Drug is generic so there is no financial benefit for a manufacturer to obtain approvals

3. What are the risks?

     a. Balance between effectiveness and risk is tilted toward risk

     b. Investigational studies with close monitoring of safety

4. Approvals

     a. Experimental

     b. Benefit unknown

     c. Risks unknown

     d. Plan must pay for all consequences

5. Examples

     a. Gabapentin for anxiety

     b. High dose/strength opiates for pain

     c. Stimulants for weight loss

     d. Anti-epileptic medications for mood disorders/bipolar disease

     e. Examples of atypical antipsychotics include Seroquel, Zyprexa and Abilify. They are being used to treat an array of conditions off-label, including anxiety, attention-deficit disorder, sleep problems, behavioral problems in toddlers and dementia.

     f. Antipsychotics to treat dementia

     g. Cancer treatment – estimated 50% are off-label

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1. Goal:  Lower drug cost so that they are affordable to patients

     a. US Rate of Inflation (2017-2019) = 2.14% to 1.8%

     b. CPI = 2.0%

     c. CPI (health care) = 2.8% (2019)

2. Drug Cost Transparency

     a. Transparency = cost

     b. CA SB17: WAC >= $40 with 16% inflation in prior year, or 32% inflation in last 2 years

3. How do they differ?  Are they effective?  Pros/Cons

     a. White House Plan

     b. Congressional Action

     c. Congress – Democratic Plan

4. State Plans – What are they trying to do?  Pros/Cons

     a. California

     b. New York 

5. Discount Programs

     a. GoodRx

     b. TimesRx

     c. Misc.

6. PhRMA unregulated for innovation

     a. Largest PhRMA produce 11% of leading new Rx

     b. New Rx develo9ped by universities, academic centers, NIH, hospital research groups

     c. 2/3 of new Rx developed by France, Germany, Japan, Switzerland and UK

     d. Raw materials from China, India, Israel, Brazil, South Africa, Australia

7. Transparency

     a. Shoppable vs. urgent

     b. Uwe Reinhardt – Priced Out – health care spending increases private sector > public sector

     c. Gag Order Bans (half-of-states)

     d. 8 States – PhRMA must provide reasons for reasoning for drug cost decisions

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Science & Data vs. Misinformation & the risks of overemphasizing Covid-19 to the detriment of other diseases

1. Where is the science behind Covid-19?

2. What treatments have been approved? What treatments are of no value?

3. With the emphasis on Covid-19 vaccine, what are the risks for standard vaccinations for measles, mumps, chicken pox, etc.?

4. What should we do to mitigate these risks if physician offices are not open yet?

5. People stress the need for herd immunity, but what do we do if the Covid-19 only covers =< 60% of the people?

6. Do people with immunity and/or herd immunity from common diseases (in #3 above) lose immunity without boosters or additional shots?

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Racism’s Impact on Health Care

1. Scope of topic = any civic, cultural, spiritual divisiveness

2. Scale = racism, sexism, antisemitism, genderism, etc., emblematic of hatred, brutality, senseless violence, exclusion, bias

3. Genesis of this podcast – police murder of George Floyd and a history of police violation of their oath

4. How do health care professionals address hatred in its many forms?

     a. Merge physical and behavioral health treatment

     b. Consider stress as a genesis for physical and emotional health

5. What is the position of medical, nursing, and pharmacy associations regarding hatred, violence, racism, etc.?

     a. They consider it a public health care crisis

     b. They conjoin the individual experience with the community experience

6. Mudd Rule

7. Inconsistencies in the health care ethic

     a. Abortion

     b. Access to care

     c. Cost of care

     d. Rationing

     e. Triaging based on prognosis and responsiveness to care

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1. What has changed?

    a. Decreased MD office visits

    b. Decreased well visits

    c. Decreased oversight of chronic diseases

    d. Telehealth

    e. Changes in billing rules to allow for indirect patient care

2. How has technology impacted health care?

    a. Historical – health care behind other industries

    b. Current – catching up with telehealth, apps, home monitoring

3. What is the impact on children and people with disabilities?

    a. Did not participate in financial bail-outs

    b. Vaccination rates down about 40%

    c. Fear of epidemics, e.g., measles

4. What is the impact on MD and DDS offices?

    a. Decreased revenue, increased expenses

    b. Expect to be barraged with higher severity patients

    c. DDS patients delayed discretionary dental work

5. What is the impact on pharmacies?

    a. Increased 90-day scripts

    b. Shortages of respiratory medications

    c. Transparency and drug cost proposals

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1. What does “second wave” mean?

2. What is transmissibility and severity of COVID-19?

     a. After relaxation of interventions (social distancing, population behavior change, contact tracing)

     b. Covid-19 hits during fall flu season

     c. Problem is overcapacity of the health care system

3. Precedence – H1N1 pandemic in 2009

4. Immunity Passports – Chile was first to issue

     a. No evidence that patients can’t get the virus again

5. What Must Be Done

     a. Testing

     b. Contact surveillance

     c. Flu Shots

6. Treatment

     a. Vaccine is first priority

     b. Treatments

          i. Expedited, but do not help everyone

          ii. Expedite release means that safety is an issue

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Questions:

Outline – Notes:

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-Restrictions

      oLimited doctor visits

      oTelehealth for showing doctor your current medical signs and symptoms

      oLimited medical access (lab)

-Management

      oCardiac Disease

             -CHF: take weight daily – call MD if any increase in weight, then get an Rx for Lasix (Furosemide)

             -High blood pressure – keep BP < 140/90 with home monitoring

             -ASCVD/high cholesterol – keep diet low in fat

             -Lose weight

             -Comply with medication regimen

             - Continue ACE inhibitors and ARB medications

      oDiabetes

             -Taking daily blood sugar, keeping it in normal range, is sufficient to delay the A1c measurement.

             -Follow a low sugar diet

             -Lose weight

             -Check daily – feet, hands – for dry and blue appearance – if blue, then call MD and show on Skype

             -Moisturize skin to prevent dryness

      oAsthma/COPD

             -Stop smoking or use alternatives like Nicorette or generics

             -Use rescue medications only when necessary and use ICS as prescribed on a regular basis

             -Use breathing machine to maintain good volume capacity

             -Buy an oxygen monitor to measure your oxygenation.  Keep O2 at > 90%.

      oThyroid

      oPain (non-cancer)

      oPain (cancer)

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What We Learned From Previous Epidemics / Pandemics

Statistics

Epidemics History (very frequent until recent times after 1950s)

Pearls

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What do we need to know about inhalant medications?

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 Corona Virus (2019-nCoV)

1. What it 2019-nCoV is?

2. How it spreads?

3. Vaccines

4. Prevention

CDC Information

2019 Novel Coronavirus (2019-nCoV) is a virus (more specifically, a coronavirus) identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. Early on, many of the patients in the outbreak in Wuhan, China reportedly had some link to a large seafood and animal market, suggesting animal-to-person spread. However, a growing number of patients reportedly have not had exposure to animal markets, indicating person-to-person spread is occurring. At this time, it’s unclear how easily or sustainably this virus is spreading between people.  The latest situation summary updates are available on CDC’s web page 2019 Novel Coronavirus, Wuhan, China.

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Blood Shortage 

1. Usage = 32K pints of blood used every day in US

2. Type of blood in short supply = Type “O”

3. Impact – 4.5M

     a. 220mg-250mg of Iron lost for every donation – 24-30 weeks to replace iron

     b. Normal Iron levels = 10-30 mmol/L (also ferritin < 10mcg/L)

4. Donor requirements (Red Cross) – Good health, weight >= 110 pounds, >= 17 years old

     a. Eat iron rich foods (spinach, red meat, fish, poultry, beans, iron fortified cereals and raisins)

     b. Drink an extra 16 oz fluids

     c. Avoid fatty foods (hamburgers, fries, or ice cream)

     d. No upper age limit

5. OTC and homeopathics, herbals, nutritional supplements are acceptable

6. Anti-depressants, Xanax, ADHD drugs -- OK

7. Restrictions (Red Cross) – anyone who has used self-injected non-prescription drugs, anyone who lived in UK for >= 3 months (and other parts of Europe) since 1980-1996 due to mad cow disease (bovine spongiform encephalopathy), heavy periods

     a. Coronary artery disease

     b. Beta blockers

     c. HIV

     d. Hepatitis

     e. Active infection – wait 10 days after last antibiotic

     f. Autoimmune disease

     g. Receive a transfusion – wait 12 months

8. What categories of medications prevent people from giving blood?

     a. Acne meds – Isotretinoin (d/t birth defects)

     b. Finasteride and dutasteride (d/t birth defects)

     c. Psoriasis meds – Soriatane (acitretin) – wait 3 years d/t severe congenital birth defects

     d. Antiplatelet meds – wait 7-14 days for platelet donations

     e. Blood thinners – blood doesn’t clot

     f. Growth hormone injections

     g. Multiple sclerosis medications – Aubagio – wait 2 years d/t birth defects

9. Medications that can’t be used to give blood (must wait one month until you can give blood)

     a. Accutane, Amnesteem, Absorica, Claravis, Myorisan, Sotret, Zenatane (isotretinoin)

     b. Proscar (finasteride)

     c. Propecia (finasteride)

10. Recovery

     a. Blood replenished within 24 hours

     b. Red cells take 4-6 weeks

     c. Must wait 8 weeks between giving blood

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Topics for Security Talk

1. PHI = personal health information

2. Security

     a. Passwords – 8 characters can be hacked in less than 1 minute

     b. Two Factor Authentication

     c. Confidentiality refers to protection of information shared with an attorney, therapist, physician (or other) from being shared with third parties without express consent. ... Privacy, on the other hand, refers to the legal protection of personal medical information from being shared on a public platform.Mar 4, 2019

3. Privacy

     a. Professional Code of Ethics

          1. A pharmacist respects the autonomy and dignity of each patient. A pharmacist promotes the right of self-determination and recognizes individual self-worth by encouraging patients to participate in decisions about their health. A pharmacist communicates with patients in terms that are understandable.

     b. HIPAA

          i. The HIPAA Privacy Rule for the first time creates national standards to protect individuals' medical records and other personal health information. It gives patients more control over their health information. It sets boundaries on the use and release of health records.

               1. www.hhs.gov › hipaa › for-individuals › faq › what-does-the-hipaa-priv...

          ii. Treatment

          iii. Administration/Utilization

          iv. Payment

     c. HealthIT.gov

          i. The privacy and security of patient health information is a top priority for patients and their families, health care providers and professionals, and the government. ... The Security Rule sets rules for how your health information must be kept secure with administrative, technical, and physical safeguards. Dec 17, 2018 HealhtIT.gov

4. HIPAA

     a. Treatment

     b. Administration/Utilization

     c. Payment

5. Controversy over Security

     a. Pro:  Data needed for treatment

     b. Con:  How data is used?

     c. Long, detailed responses to data security before it can be used

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Medical Devices

- BP meters, blood glucose monitors 

- The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

       - Establishment registration,

       - Medical Device Listing,

       - Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),

       - Investigational Device Exemption (IDE) for clinical studies.

- MEDICAL Devices

       - Diagnostic equipment includes medical imaging machines, used to aid in diagnosis. Examples are ultrasound and MRI machines, PET and CT scanners, and x-ray machines. Treatment equipment includes infusion pumps, medical lasers and LASIK surgical machines.

- Home Use Devices

       - Safety & Efficacy

       - Medical devices that are authorized by the FDA for over-the-counter purchase that are not otherwise restricted and are appropriately described and labeled, such as:

               - Adhesive bandages

               - Crutches

               - Eyeglass frames

               - Otoscopes

               - Personal Sound Amplification Products (PSAPs)

               - Sharps containers

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What you need to know about Healthcare in 2020.

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Topic:  Washing Hands

- Goal – Prevention of infections and spreading disease

- How – water 100 degF or 38 degC, soap (?) for 20 seconds

- When

          - Preparing food

          - Using toilet or changing a diaper

          - Blowing nose, coughing, sneezing

          - Treat wounds or caring for a sick person

          - Handling garbage

          - Handling pets and their food

- Hand Sanitizer

          - Must have >= 60% alcohol

          - Antibacterial sanitizer is OK when hands are not dirty

- Antibiotic resistance

          - Global health threat

          - Need standard treatment guidelines

          - Misuse and overuse of antibiotics

          - Use hand washing prevention

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Update on HIV/AIDS

Main Points:

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Childhood Issues

• Storage

      o Keep out of reach

      o Products not prescriptions

      o Child-resistant packaging

• Safety

      o Administer as prescribed or labeled

      o Use dosing device (teaspoon, tablespoon, measuring cup, etc.)

      o Write clear instructions to caregivers

      o Share info with babysitters, family, friends

• Destruction

      o Clean out used or expired medications

      o Put in sealable bag and bring to pharmacies

• Safe Administration

      o Teach about always given by adult

      o Rx not candy

      o Drug use – storage, read drug label and facts, follow dosing instructions

• Poisoning

      o Have Poison Help number by phone (1-800-222-1222)

      o 24/7/365

      o How to take Rx and how to treat poisoning

• Special cases

      o Childhood obesity

      o Injury

      o Lice

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Compliance – Easy to talk about, but hard to do!

o Drug Compliance – definition

      o Same as compliance with doctor visits, lab draws, device use, BP measurements, BG measurements

      o Take medications as prescribed by your doctor

      o The best drug taken for the right reasons is no good, if it is not taken

      o Education is primary method

o History

      o A problem for decades

      o No general solution

      o Unintentional non-adherence

             o https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-12-98

             o 62% forgot

             o 37% ran out of medications

             o 23% careless about taking medications

o Barriers

      o Why?

             o Low perceived need

             o Affordability

             o Worse self-rated health

             o Youth

      o Prescriber/Pharmacists

             o Cost

             o Self-reporting

             o Time to track pill counts

             o Refill messages

             o Time for education

o Scheduling

      o 1-2x/day > 3-4x/day

      o Devices

              o Memory

              o Calendars

              o Automation – tops of medication bottles, app alerts

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Statistics

      o >30 million people in US, 1 in 4 don’t know they have it

      o 84 million US adults have prediabetes, and 90% don’t know they have it

      o 7th leading cause of death in US

      o Type 2 diabetes accounts for 90% to 95% of all diagnosed cases

      o # of adults diagnosed with diabetes has doubled with age and overweight/obese

Risk factors

      o Overweight

      o >= 45 y/o

      o Parent, brother, or sister with T2D

      o Physically active < 3x/week

      o Gestational diabetes (diabetes w/pregnancy) or given birth to baby weighing > 9 pounds

      o African Americans, Hispanic/Latino Americans, American Indians, Alaska Natives, Pacific Islanders, and some Asian Americans have higher risk for prediabetes and T2M

Leading cause of in 2019

      o Chronic kidney disease

      o Lower-limb amputations

      o Adult-onset blindness

Risk Factors -- independent

      o Diet

      o Over-weight

      o Lack of exercise

      o Smoking – 30-40% more likely to develop type 2 diabetes than non-smokers

      o Non-compliance with medications, weight loss, diet

Medications

      o Large armamentarium of drugs

      o Look for A1c lowering

      o Risk factors are independent and can still cause end-organ disease

      o Compliance with monitoring blood sugar – proxy for end-organ disease

      o Compliance with medication

      o Compliance with Insulin is approximately 50% across US

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Topic:  Care Transitions

What are care transitions?

       -Acute to home or chronic care/step down

       -Example:  Hospital to home

Concern

       -Don’t want patient to return to the hospital within 30 days for same problem

      - Medicare refusal to pay for certain conditions to promote prevention 

Issues

       -Understand discharge orders

       -Comply with discharge orders

       -Drug coordination from pre-hospital, to in hospital, or post-hospital regimen

       -Labs and services to follow up

Examples

       -Pneumonia & Serious infections – injectable to oral antibiotic,  antibiotics compliance, monitor for symptoms (temperature, swelling, pain, GI symptoms, dizzy/confused, etc.)

       -Heart Failure – monitor weight everyday,  comply with medicines

       -COPD/Emphysema – arrange for O2, use FiO2 to expand vital capacity, correct use of inhalers

       -Asthma – correct use of inhalers

       -Heart Attack – BP, lipid, ACEI regimen of medications – promote compliance

       -DVT – transition from injectable-to-oral anticoagulants – promote compliance, alert notification if bleed

       -Pain management – CDC recommendations

Support

       -Nurse case managers

       -Pharmacists

       -Home – rest, anabolic diet, hydration

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Value & Ethics in Drug Pricing

      1. What is the argument between high prices and value?

      2. How is value determined?

             a. ICER

             b. NICE

             c. Cochran Reviews

      3. How is pricing determined?

      4. What is the ethical question?

             a. Support prescription and prescriber’s plan

             b. 20% of standard Rx are for off-label

             c. 50% of cancer treatment is off-label or unapproved

      5. Actions to bridge value to price

             a. Value-based purchasing

             b. Non-inferiority trials

             c. Objective review of the literature

             d. Committee reviews, e.g., tumor boards, P&T Committees

      6. Outstanding question

             a. Cost vs. affordability

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Compounding Pharmacies / FWA

- Compound Requirements

         - Must be for medications for specific patients, for a specific condition, for a specific       prescription

         - Compounding in bulk for multiple patients before prescriptions are received is manufacturing!

- Limits

         - Patients will probably not know

         - Prescriber will not know unless they have a commercial arrangement with the pharmacy

         - Health Plans will only know when doing analysis of medication utilization

         - PBMs will only know when doing analysis of medication utilization

- What are compounds?

         - Injectables with custom ingredients and dosing

         - Oral tabs/caps with non-manufactured ingredients

         - Oral liquids for custom dosing

         - Topical medications in different bases for better absorption or non-allergic

- What are compounding pharmacies?

         - Regulated by State laws

         - Rationale:

                  - Children’s medications

                  - Allergic modifications

                  - Dosing modifications

                  - Mixing injectables

                  - Animal treatments

                  - Misc.

- Limits on compounding

         - PBM restrictions on medications currently manufactured

         - State oversight

         - Lack of absorption or effectiveness

- FWA

         - Small % of total  dispensing

         - Physician prescribing for custom medications with a commercial motive

         - Pharmacists dispensing/manufacturing for multiple patients for custom medications with a commercial motive

         - Sterility problems

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Gender Bias in Medicine and Drug Research

1. Women 51% of population, but few women in clinical research

2. Sex is based on reproductive organs and functions assigned by chromosomes

     - Gender is self-representation in response to socials institutions shaped by       environment and experience

     - Action: Education, research, workforce development

3. Medical Biases against women

     - Heart failure – Australia: women < men to receive recommended treatment for heart       failure

     - Alzheimer’s Disease – women perform better than men in early stages

     - Medical trials – women excluded

          - 8 Rx in US withdrawn between 1997-2001 for less safe and effective

          - Until early 1990’s women excluded from biomedical studies

          - Example:

               - Women:  ASA reduced risk of stroke, but not MI

               - Men:  ASA reduces risk of MI, but not stroke

     - CPR dummies – U of Penn (2018) women less likely to receive CPR

     - Endometriosis – 1/10  women wait > 7 years for diagnosis

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All About Vaccines with special guest Dr. Mark Walberg

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Vaping

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AI in Healthcare

Disclaimer – PP develops, innovates and utilizes AI for our clients

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 1. Quality of prescription drugs

    a. Health Canada responsible for efficacy and safety of drugs marketed in Canada

    b. Health Canada operates under the Food and Drugs Act and regulatory mandate under the Food and Drug Regulations

    c. Most drugs are not manufactured in Canada 

    d. There is no parity between drugs available without a prescription in US vs. Canada

2. Availability of prescription drugs

    a. US Rx received in Canadian pharmacy must be approved by a Canadian physician prior to it being filled – cosigning

    b. Canada Health Act – drugs administered in Canadian hospitals are approved at no cost to patients

    c. Employers cover many Canadians and their families

    d. Drug Shortages Canada – 

         i. Website for reporting drug shortages and discontinuations in Canada

         ii. Drug sellers must report that they cannot meet demand

3. Cost considerations

    a. Canada

         i. Most prescription drugs are imported

         ii. Government places price ceilings on Brand name medications imported into Canada

    b. Canadian internet pharmacies are suspect

    c. Bricks and mortar pharmacies are same as US

4. Opportunity Savings

    a. HIS Markit study – Abilify costs 87% less and Xarelto costs 60% less

    b. Concerns that manufacturers will increase prices for drugs in US and Canada

5. State Plans

    a. Florida

    b. Vermont

6. Trump’s Plan

    a. States, individual pharmacies, wholesalers can write proposals and submit for federal approval

    b. Exclusions – biologics, medications created from living organisms

    c. FDA would work with manufacturers to bring drugs made in foreign factories to the US (e.g., insulin)

7. Arguments Against – PhRMA

    a. Counterfeit, dangerous medications

    b. Canada drug market too small

    c. Canada doesn’t have an unlimited supply of medications

  ______

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1. Indigent / Homeless Population

     a. No address

     b. No phone

     c. No income, or no money for health care

     d. No transportation

     e. No time management

     f. Information varies dependent on associations

     g. Information sharing is variable and frequently based on incorrect concerns, false conversations, etc.

2. Health Care Issues

     a. Poor diet

     b. Poor exercise program

     c. Lack of follow up on relatively trivial problems that result in major complications

     d. Poor historians

     e. Frequently comorbid

     f. Frequently have behavioral health problems

     g. Inconsistent adherence – office visits, obtaining labs, picking up drugs

3. Medication Issues

     a. Can’t afford copays

     b. Frequently don’t have a watch for scheduling medication

     c. Medications cannot be evaluated as the patient may not be available to identify side effects, etc.

     d. Patients frequently cannot obtain labs to use for medication management

     e. Adherence is a problem, especially if they stop taking the medications due to side effects, etc.

  ______

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  Travel Health:

1. What are the most common health issues travelers may encounter?

       a. Travelers diarrhea

       b. In terms of “things that will kill you”, most travelers die from pre-existing medical conditions (MI) or accidents (specifically MVA)

2. Mentioned vaccines, are there other vaccines people will need to consider besides those for GI bugs?

       a. Yellow fever… basically a mosquito-borne disease that destroys your liver and has a very high fatality rate. Found in South America (Amazon) and Sub-Saharan Africa. Mosquitoes bite during the day and can also carry dengue, chikungunya and zika… so still have to prevent mosquito bites.

       b. Japanese encephalitis… similar to West Nile, it causes neurological symptoms. Found in Southeast Asia, mostly in rural parts. Need to have a travel health advisor assess whether or not you should get it.

       c. Rabies… fairly expensive, but lifesaving if bit by a rabid animal.

       d. All the routine vaccines you thought you didn’t need… Tdap, meningitis, polio, MMRV and FLU! (because it looks like malaria and you will be treated as such in tropical countries)

3. What about malaria?

       a. Parasitic disease that lays dormant for weeks to months and can result in death in 24-48 hours without treatment

       b. Mosquitos bite at night so need modern housing or a bed net

       c. Medication are typically taken before travel, while traveling and up to one month after

4. Anything else?

       a. Lots of other things to consider… altitude sickness, other parasites (even those you can get from bathing in contaminated water like lakes and rivers), jet lag, etc.

       b. Best to consult someone certified in travel health or tropical medicine… so they will have passed a competency exam

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Devices Used in Therapeutics

1. Types of devices used for TESTING / MONITORING and At-Home Test Kits discussed in this talk –

     a. Blood Glucose monitors

     b. Blood pressure monitors

     c. Prothrombin Blood Coagulation monitors

     d. Pregnancy test kits

     e. and others

2. FDA Medical Device Classes

     a. Class I = low to moderate risk to patient

          i. 47% of devices

          ii. 95% exempt

          iii. Examples = Enema kits, elastic bandages, manual stethoscopes, and bedpans

     b. Class II = moderate or high risk to patient

          i. 43% of devices (most devices)

          ii. Examples = powered wheelchairs, some pregnancy tests kits

     c. Class III = high risk to patients

          i. 10% of devices

          ii. Examples = Implantable pacemakers, breast implants

     d. FDA Regulatory Requirements

          i. FDA Registration  (21 CFR Part 807)

          ii. Medical Device Listing

          iii. Premarket Notification 510(k) OR Premarket Approval (PMA)

     iv. Investigational Device Exemption (IDE) for clinical studies

               1. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

     v. Quality System (QS) regulation

     vi. Labeling requirements

     vii. Medical Device Reporting (MDR)

3. Over-the-Counter use Tests

     a. Regulation by the FDA in the In Vitro Test Database (IVD) Over-the-Counter Database

     b. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm

4. QS by FDA approved home and Lab Tests, laboratory validation

     a.  https://www.fda.gov/industry/regulated-products/medical-device-overview

     b. https://www.pharmacytimes.com/publications/issue/2013/september2013/at-home-test-and-monitor-kits

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 Beliefs:

1. Cold temperatures bring on cold/flu

2. Going outside with wet hair gives you a cold

3. The flu shot causes the flu

4. Coffee Can Stunt Childhood Development

5. Cracking Knuckles Leads to Arthritis

6. Starve a Fever, Feed a Cold

7. Gluten is Bad

8. Sitting is the New Smoking

9. Eating chocolate gives you acne.

10. Walking around barefoot on a cold floor will give you varicose veins

11. Sugar causes hyperactivity in children.

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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    
 • Homesteaders

      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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Episode Outline:

Issues

      - Government through NIH grants provides money for investigators to find new drugs

      - PhRMA takes these findings and builds new drugs

      - Taxpayers don’t benefit from innovation, but pay high prices for drugs

      - Safe harbors for physicians and pharmacist who participates in studies

      - Safe harbor for physicians and pharmacist who participate in studies

PhRMA Issues

      - Development to production is costly

      - Research leads to many failures

      - Patent monopolies

      - Marketing is costly

Remember who benefits

      - Rare for counties to participate in profits of new drugs, either directly or indirectly

      - Universities profit from new drugs

      - Countries may provide tax incentives to help drug industry develop cheaper alternatives. 

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 Pro Pharma Talks - Episode 002

Topic: Skinny Health Plans

Episode Outline:

1. Skinny Health Plans = Short Term Health Plans

   -Sell for 365 days up from 90 days

   -Renew for 36 months

   -High Out-of-Pocket (OOP) Expenses

   -Premium = 20% of lowest priced ACA Bronze Plan

   -Don't Cover Pre-Existing Conditions

2. Benefits are Restricted

   -Don't C over:

        -1. Maternity Care

        -2. Outpatient Prescription Drugs

        -3. Substance Abuse

        -4. Mental Health Treatment

3. Impact on ACA Plans

   -Higher Costs:

        -CMS Projected 1% Increase

        -Urban Institute 18% Increase

   -Injured Individuals will return to ACA - leading to higher costs

   -Brokers make 20% commissions on Skinny vs. 5% on ACA

4. Remember 

   -Skinny = Lower Cost/ Higher OOP

   -Prohibit Underwriting = Pre-Existing Conditions NOT COVERED

   -Outpatient prescription Medications NOT COVERED

   -Brokers Make MORE Selling Skinny

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Pro Pharma Talks - Episode 001

Topic: What to Expect in 2019

Healthcare

1. Uncertainty vs. Stabilization of the Healthcare Market

2. Healthcare: Volume vs Value

3. Consolidation of Stakeholders

4. Retail"ization" of Healthcare Delivery

Drug Pricing

1. Drug Pricing Transparency

2. Drug Price Vs. Value

3. Specialty Drug Cost vs. Value

4. International Drug Pricing vs. US innovation Pricing

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